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TRANSCRIPT
Pharmaceutical Reference Standards
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Dear Customers and Colleagues,
2008 marks the completion of another exciting year for PRA and the beginning of
our eighth year in business. Certainly the biggest news of 2007 for us was being
welcomed into the Waters Corporation family as an important addition to their
chemical operations division. Almost immediately PRA began taking advantage of
Waters resources that will allow us to serve our customers even better. From access to
cutting-edge technologies like our new Waters UPLC instrument, to the introduction of
six-sigma quality practices stretching across our entire company, to world-class data
management facilities, the gap between our product and service quality and that of
our competitors will be even greater.
This catalog includes many products we have added to our offerings in the past year,
some of which you may not have known we provided. Our custom products group has
a rich history in cleaning validation and analyst qualifi cation product development,
so we decided to present some of our most common custom products in this year’s
catalog for all of our customers to see. We are very proud of our custom products
group and their capabilities in pharmaceutical reference materials; if you cannot locate
a particular pharmaceutical product that you need, please call us.
At PRA we place customer satisfaction and product quality at the top of our priority
list. We are thankful to our customers, who, because of their experience with us,
have referred us to their friends and colleagues. For those of you who have not done
business with us before and have a choice of vendors for the products and services we
offer, we would be thrilled to have an opportunity to exceed your expectations and win
you as a customer.
Best regards,
The PRA Family
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5 Analytik Jena and Lachat Calibration and Validation Standards
6 Anatel Access 643 & A643a Calibration and Validation Standards
7 Anatel Access 643 & A643a Bulk Calibration and Validation Standards
8 Anatel AnaTOC Calibration and Validation Standards
9 OI Analytical Calibration and Validation Standards
10 Shimadzu Calibration and Validation Standards
11 Sievers® Models 400 and 400 ES Calibration and Validation Standards
12 Sievers® Series 800 and 900 Calibration and Validation Standards
14 Teledyne Tekmar Calibration and Validation Standards
17 Cleaning Validation Products
18 Analyst Competency Testing
20 High-Purity Water
22 Conductivity Probe Validation Kits
24 PRA Sample Vials and Containers
26 Custom PRA Products
27–31 Master TOC Standards List by Manufacturer
Contents
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We are here to help!We have customer service, manufacturing and shipping personnel here to help you from 8:00 AM
to 5:00 PM GMT. If you want the standard tomorrow, just call us by 1:00 PM GMT and you will have
your standards the next day.
We are ISO 9001 registered and comply with all applicable technical, quality and regulatory
requirements. Call +44 (0) 161 946 2777 or email us at [email protected] and we will confi rm
your order by e-mail.
Terms and ConditionsAll orders are subject to the following terms and conditions:
Confi rmationAll orders are confi rmed via FAX or email to the person placing the order.
PricingPrices within this catalog are effective January 1, 2008 and maybe subject to change without notice.
TermsTerms are Net 30 days. Freight charges are pre-paid and addedto the invoices.
Fast ShippingDue to the semi-perishable nature of the standards we manufacture, we require the product be shipped for overnight delivery. Please follow instructions to refrigerate immediately upon receipt.
SafetyPRA products may be hazardous, and are intended for use by professional laboratory personnel, trained in the competent handling of these materials. Responsibility for the safe use of PRA standards rests entirely with the user. If you need MSDS sheets, please contact us at +44 (0) 161 946 2777.
Return/Replacement PolicyPlease inspect all orders immediately upon receipt for accuracy and to ensure there was no damage in shipment. PRA will immediately correct any problem that is reported. NO OTHER WARRANTY, WHETHER EXPRESS OR IMPLIED, IS MADE WITH RESPECT TO THE PRODUCTS AND/OR SERVICES. PRA EXPRESSLY EXCLUDES THE IMPLIED WARRANTIES OF MERCHANTABILITY AND OF FITNESS FOR A PARTICULAR PURPOSE. PRA SHALL NOT BE LIABLE FOR CONSEQUENTIAL, INCIDENTAL, SPECIAL OR ANY OTHER INDIRECT DAMAGES RESULTING FROM ECONOMIC LOSS OR PROPERTY DAMAGE SUSTAINED BY BUYER FROM THE USE OF ITS PRODUCTS.
Customer Care
Graham RoscoeManaging Director
Debbie RoscoeProduction Chemist
Caroline HydeProduction Technician
Curtis WoodDirector, Business Development and Regulatory Affairs
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Analytik Jena are leaders in the development of reliable composite parameter and elemental
systems designed to satisfy the diverse modern demands of today’s laboratory. PRA carries a number
of validation and calibration sets for AJ Total Organic Carbon instruments.
USP System Suitability Set (40 mL)Set includes (1) Reagent Water RW, (1) USP Sucrose
RS (0.500 ppm), and (1) USP 1,4-benzoquinone RSS
(0.500 ppm).
Cat # 18000 HCl-preserved for AJ multi N/C pharma HSCat # 18004 H3PO4-preserved for AJ multi N/C UV HS
USP System Suitability Set (250 mL)Set includes (1) Reagent Water RW, (1) USP Sucrose
RS (0.500 ppm), and (1) USP 1,4-benzoquinone RSS
(0.500 ppm).
Cat # 18050 HCl-preserved for AJ multi N/C pharma HSCat # 18049 H3PO4-preserved for AJ multi N/C UV HS
TOC Calibration Kit (Full) (250 mL)Set includes eight 250 mL amber bottles, (1) Water
blank, (1) 1.00 ppm NIST KHP, (1) 2.50 ppm NIST
KHP, (1) 5.00 ppm NIST KHP, (1) 10.0 ppm NIST KHP,
(1) 25 ppm NIST KHP, (1) 50.0 ppm NIST KHP, (1) 100
ppm NIST KHP.
Cat # 19970 HCl-preserved for AJ multi N/C 2100/3100Cat # 19971 H3PO4-preserved for AJ N/C UV HS
TOC Calibration Kit (Limited) (40 mL)Set includes (1) Reagent Water Blank, (1) USP
Sucrose (0.600 ppm).
Cat # 19980 HCl-preserved for AJ multi N/C pharma HSCat # 18981 H3PO4-preserved for AJ multi N/C UV HS
TOC Calibration Kit (Limited) (250 mL)Set includes (1) Reagent Water Blank, (1) USP
Sucrose (0.600 ppm).
Cat # 19985 HCl-preserved for AJ multi N/C pharma HSCat # 19986 H3PO4-preserved for AJ multi N/C UV HS
Cleaning Validation Kit (Full) (40 mL)Set includes fi ve 40 mL vials, (1) Water blank, (1)
0.250 ppm NIST Sucrose, (1) 0.500 ppm NIST
Sucrose, (1) 0.750 ppm NIST Sucrose, (1) 1.00 ppm
NIST Sucrose.
Cat # 19900 HCl-preserved for AJ multi N/C pharma HSCat # 19901 H3PO4-preserved for AJ multi N/C UV HS
Cleaning Validation Kit (Full) (250 mL)Set includes fi ve 250 mL amber bottles, (1) Water
blank, (1) 0.250 ppm NIST Sucrose, (1) 0.500 ppm
NIST Sucrose, (1) 0.750 ppm NIST Sucrose, (1) 1.00
ppm NIST Sucrose.
Cat # 19910 HCl-preserved for AJ multi N/C pharma HSCat # 19911 H3PO4-preserved for AJ multi N/C UV HS
Sample Vials40 mL Low TOC vials (80/cs)Cat. #25025 Scrupulously cleaned Low TOC vials for all TOC
sample analyses.
See page 24 for more information on PRA vials.
Analytik JenaCalibration and Validation Standards
Analytic Jena multi N/C pharma HS
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A 643 Calibration KitCat. #19200 Set includes fi ve vials, (2) Blanks, (1) 0.250 ppm
NIST Sucrose, (1) 0.500 ppm NIST Sucrose, (1) 0.750
ppm NIST Sucrose
A 643 Validation KitCat. #19210 Set includes ten vials, (2) Blanks, (1) 0.250 ppm NIST
Sucrose, (1) 0.500 ppm NIST Sucrose, (1) 0.750 ppm
NIST Sucrose, (1) 100 mS/cm Conductivity
Std., (1) USP System Suitability Set.
A 643 Validation Control KitCat. #19220 Set includes three vials, (2) Blanks, (1) 0.500 ppm
NIST Sucrose.
A 643 Validation Protocol KitCat. #19230 Set includes 38 vials, (10) Blanks, (3) 0.250 ppm
NIST Sucrose, (5) 0.500 ppm NIST Sucrose, (3) 0.750
ppm NIST Sucrose, (1) 100 µS/cm Conductivity
Std., (4) USP System Suitability Sets.
Conductivity Solution KitCat. #02610 Set includes one vial of 100 µS/cm KCI in water for
calibrating conductivity probe on Anatel A 643.
Individual Standards for the A 643Cat. #13300 Calibration Blank Cat. #13400 0.250 ppm NIST Sucrose Cat. #13500 0.500 ppm NIST Sucrose Cat. #13600 0.750 ppm NIST Sucrose Cat. #02610 100 µS/cm Conductivity Solution Kit
USP System Suitability SetCat. #18400 Set includes (2) Reagent Waters RW, (1) 0.500
ppm USP Sucrose RS, and (1) 0.500 ppm USP 1,4-
benzoquinone RSS.
Low TOC Sample Vial KitCat. #25045 Set includes one case of 68 pre-cleaned Low TOC
vials, 50 mL with pre-cleaned septa and aluminum
crimp cap. Use for grab samples to be analyzed on
Anatel A 643.
Please see page 27 or contact PRA for additional concentrations and volumes.
Anatel Access 643 & A643aCalibration and Validation Standards
PRA provides a complete line of standards designed for use with the Anatel 643 TOC analyzers.
The standards for these instruments are prepared using a carefully controlled process to remove
ionic contamination as well as TOC contamination from the entire system. The standards have a 30
day expiration and are guaranteed to meet the quality specifi cations throughout the entire 30 days.
All PRA standards are available in larger bulk packaged volumes. Customers who have used PRA’s
bulk packaged standards rate them superior in stability and accuracy to other vendor’s individually
packaged standards. If you are familiar with individual use standards and would like to try the bulk
packaged standards, please call us.Anatel Access A643a
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These PRA sucrose standards are used for calibration and validation of Anatel on-line TOC analyzers. PRA sucrose
standards are offered in ready-to-use containers (60 mL) for use with the Anatel Access 643 & 643a instruments.
We also package these standards in larger poly containers for pour off and use in multiple applications.
Anatel Access 643 & A643aBulk Calibration and Validation Standards
Bulk Packaged Standards forAccess 643 & 643a
125 mL Unpreserved TOC Calibration StandardsCat. #10019 Calibration Blank Cat. #10319 0.250 ppm NIST Sucrose Cat. #10619 0.500 ppm NIST Sucrose Cat. #10919 0.750 ppm NIST Sucrose Cat. #02600 100 µS/cm Conductivity Calibration Standard
250 mL Unpreserved TOC Calibration StandardsCat. #10031 Calibration Blank Cat. #10331 0.250 ppm NIST Sucrose Cat. #10631 0.500 ppm NIST Sucrose Cat. #10931 0.750 ppm NIST Sucrose Cat. #02250 100 µS/cm Conductivity Calibration Standard
500 mL Unpreserved TOC Calibration StandardsCat. #10120 Calibration Blank Cat. #10420 0.250 ppm NIST Sucrose Cat. #10720 0.500 ppm NIST Sucrose Cat. #11020 0.750 ppm NIST Sucrose Cat. #02500 100 µS/cm Conductivity Calibration Standard
USP System Suitability Sets Bulk Package for the Anatel A 643Cat. #18035 125 mL Cat. #18060 250 mL Cat. #18150 500 mL Cat. #18245 1 L
Call PRA for model TOC 600 Calibration andValidation standards.
Sample Bottles60 mL Low TOC bottlesCat. #25030 60 mL HDPE Bottle for A-643 (natural) Cat. #25033 60 mL HDPE Bottle for A-643 (amber)
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AnaTOC Validation SetCat. #19100 Set includes six bottles, (1) 250 mL TOC Blank, (1)
125 mL 0.500 ppm KHP, (1) 250 mL 1.00 ppm KHP,
(1) 125 mL USP System Suitability Set (one each:
Reagent Water RW, USP Sucrose RS (0.500 ppm), and
USP 1,4-benzoquinone RSS (0.500 ppm)).
AnaTOC Standards
125 mL Preserved TOC Calibration StandardsCat. #10015 TOC Water Blank Cat. #11720 0.250 ppm NIST KHP Cat. #11730 0.500 ppm NIST KHP Cat. #11810 1.00 ppm NIST KHP Cat. #18025 USP System Suitability Set
250 mL Preserved TOC Calibration StandardsCat. #10025 TOC Water Blank Cat. #11721 0.250 ppm NIST KHP Cat. #11735 0.500 ppm NIST KHP Cat. #11820 1.00 ppm NIST KHP Cat. #18050 USP System Suitability Set
500 mL Preserved TOC Calibration StandardsCat. #10100 TOC Water Blank Cat. #11722 0.250 ppm NIST KHP Cat. #11750 0.500 ppm NIST KHP Cat. #11900 1.00 ppm NIST KHP Cat. #13299 1000 ppm NIST KHP Cat. #18100 USP System Suitability Set
Individual Calibration and Validation Standards for A-1000Cat. #10211 Calibration Blank (1 L) Cat. #10511 0.250 ppm NIST Sucrose (1 L) Cat. #10811 0.500 ppm NIST Sucrose (1 L) Cat. #11111 0.750 ppm NIST Sucrose (1 L) Cat. #19030 USP System Suitability Set
Sample Vials40 mL Low TOC vials (80/cs)Cat. #25025 Scrupulously cleaned Low TOC vials for all TOC
sample analyses.
See page 24 for more information on PRA vials.
Anatel AnaTOC Calibration and Validation Standards
All AnaTOC TOC standards are preserved and have an extended (6-month) expiration. We provide
these standards in several volumes so you can purchase precisely what you will use.
Anatel Access 1000
Anatel AnaTOCAnatel AnaTOC
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Individual Standards for Calibration or Verifi cationCat. #10001 TOC/IC Calibration Blank 40 mL Cat. #10016 TOC/IC Calibration Blank 125 mL Cat. #11726 0.500 ppm from NIST KHP 40 mL Cat. #11731 0.500 ppm from NIST KHP 125 mL Cat. #11801 1.00 ppm from NIST KHP 40 mL Cat. #11811 1.00 ppm from NIST KHP 125 mL Cat. #12401 5.00 ppm from NIST KHP 40 mL Cat. #12411 5.00 ppm from NIST KHP 125 mL Cat. #12701 10.0 ppm from NIST KHP 40 mL Cat. #12711 10.0 ppm from NIST KHP 125 mL Cat. #13001 25.0 ppm from NIST KHP 40 mL Cat. #13021 25.0 ppm from NIST KHP 125 mL Cat. #13224 50.0 ppm from NIST KHP 40 mL Cat. #13227 50.0 ppm from NIST KHP 125 mL Cat. #18006 RW-Reagent Water USP 40 mL Cat. #18007 RS-0.500 ppm from USP Sucrose RS 40 mLCat. #18008 RSS-0.500 ppm from USP Benzoquinone 40 mLCat. #18029 RW-Reagent Water USP 125 mL Cat. #18031 RS-0.500 ppm from USP Sucrose RS 125 mLCat. #18032 RSS-0.500 ppm from USP Benzoquinone 125 mL
Please see page 30 or contact PRA for additional concentrations and volumes.
OI Analytical TOC Validation Set–Aurora Cat. #19007 Set includes nineteen 40 mL vials, (6) Water blank,
(1) 0.500 ppm NIST KHP, (3) 1.00 ppm NIST KHP, (1)
5.00 ppm NIST KHP, (1) 10.0 ppm NIST KHP, (1) 25.0
ppm NIST KHP, (1) 5.00 ppm NIST KHP/50.0 ppm
NaHCO3, (4) 0.500 ppm from USP Sucrose,
(1) 0.500 ppm from USP 1,4-benzoquinone.
Ultra Low-Level TOC Standards Kit Cat. #14203 Set includes twelve 40 mL vials, (3) TOC Water
Blanks, (1) each of 0.05, 0.06, 0.07, 0.08, 0.09, 0.100,
0.250, 0.500 and 1.00 ppm from NIST KHP.
USP System Suitability Set (40 mL)Cat. #18004 Set includes one each: Reagent Water RW, USP
Sucrose RS (0.500 ppm), and USP 1,4-benzoquinone
RSS (0.500 ppm).
Bulk Preserved USP System Suitability SetsThese standards come preserved and packaged in
ultra-clean amber bottles for use with OI Analytical
TOC analyzers. Each standard has a 6-month
expiration period from the day it is shipped.
Cat. #18024 125 mL Cat. #18049 250 mL Cat. #18104 500 mL Cat. #18204 1 L
Sample Vials40 mL Low TOC vials (80/cs)Cat. #25025 Scrupulously cleaned Low TOC vials for all TOC
sample analyses.
See page 24 for more information on PRA vials.
OI Analytical TOC analyzers have been used in critical applications requiring
ultra-low carbon analysis since 1984. For OI Analytical TOC instrument
validation, calibration and system suitability, PRA recommends using only
preserved TOC standards to meet USP <643> criteria for pharmaceutical
water quality monitoring.
The products below are commonly purchased for use with OI Analytical
TOC instruments.
OI Analytical Calibration and Validation Standards
OI Aurora
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Individual Standards for Calibration or Verifi cationCat. #10000 TOC/IC Calibration Blank 40 mL Cat. #10015 TOC/IC Calibration Blank 125 mL Cat. #11725 0.500 ppm from NIST KHP 40 mL Cat. #11730 0.500 ppm from NIST KHP 125 mL Cat. #11800 1.00 ppm from NIST KHP 40 mL Cat. #11810 1.00 ppm from NIST KHP 125 mL Cat. #12400 5.00 ppm from NIST KHP 40 mL Cat. #12410 5.00 ppm from NIST KHP 125 mL Cat. #12700 10.0 ppm from NIST KHP 40 mL Cat. #12710 10.0 ppm from NIST KHP 125 mL Cat. #13000 25.0 ppm from NIST KHP 40 mL Cat. #13020 25.0 ppm from NIST KHP 125 mL Cat. #13225 50.0 ppm from NIST KHP 40 mL Cat. #13226 50.0 ppm from NIST KHP 125 mL Cat. #18000 USP System Suitability Set 40 mL Cat. #18001 RW-Reagent Water USP 40 mL Cat. #18002 RS-0.500 ppm from USP Sucrose RS 40 mLCat. #18003 RSS-0.500 ppm from USP Benzoquinone 40 mLCat. #18026 RW-Reagent Water USP 125 mL Cat. #18027 RS-0.500 ppm from USP Sucrose RS 125 mLCat. #18028 RSS-0.500 ppm from USP Benzoquinone 125 mL
See page 29 or contact PRA for additional concentrations and volumes.
USP System Suitability Set (40 mL)Cat. #18000 Set includes (1) Reagent Water RW, (1) USP Sucrose
RS (0.500 ppm), and (1) USP 1,4-benzoquinone RSS
(0.500 ppm).
Bulk Preserved USP System Suitability SetsThese standards come preserved and packaged
in ultra-clean amber bottles for use with Shimadzu
TOC analyzers. Each standard has a 6-month
expiration period from the day it is shipped.
Cat. #18025 125 mL Cat. #18050 250 mL Cat. #18100 500 mL Cat. #18200 1 L
Ultra Low-Level TOC Standards Kit Cat. #14200 Set includes twelve 40 mL vials, (3) TOC Water
Blanks, (1) each of 0.05, 0.06, 0.07, 0.08, 0.09, 0.100,
0.250, 0.500 and 1.00 ppm from NIST KHP.
Sample Vials40 mL Low TOC vials (80/cs)Cat. #25025 Scrupulously cleaned Low TOC vials for all TOC
sample analyses.
See page 24 for more information on PRA vials.
Shimadzu Calibration and Validation Standards
Shimadzu is a brand familiar to laboratory instrumentation users and a company with a rich history
in TOC analysis. We recommend using only preserved standards for calibration, validation and
system suitability as required by USP <643>.
The products below are commonly purchased for use with Shimadzu instruments.
Shimadzu TOC–VWs
Shimadzu TOC–TCs
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Individual Use Standards
30 mL TOC Calibration StandardsCat. #13700 Calibration Blank Cat. #14100 1.25 ppm NIST Sucrose Calibration StandardCat. #02700 25 µS/cm Conductivity Calibration Standard
Bulk Packaged Standards
125 mL TOC Calibration StandardsCat. #10020 Calibration Blank Cat. #11520 1.25 ppm NIST Sucrose Calibration StandardCat. #01400 25 µS/cm Conductivity Calibration Standard
250 mL TOC Calibration StandardsCat. #10030 Calibration Blank Cat. #11530 1.25 ppm NIST Sucrose Calibration StandardCat. #01350 25 µS/cm Conductivity Calibration Standard
500 mL TOC Calibration StandardsCat. #10110 Calibration Blank Cat. #11601 1.25 ppm NIST Sucrose Calibration StandardCat. #01300 25 µS/cm Conductivity Calibration Standard
Sample Vials30 mL poly vial for Sievers® Model 400Cat. #25015
See page 24 for more information on PRA vials.
USP System Suitability SetSet includes (1) Reagent Water RW, (1) USP Sucrose
RS (0.500 ppm), and (1) USP 1,4-benzoquinone RSS
(0.500 ppm).
Cat. #18300 30 mL Cat. #18030 125 mL Cat. #18055 250 mL Cat. #18140 500 mL
Replacement UV LampsCat. #20040 Replacement UV Lamp for Sievers® Model 400Cat. #20045 Replacement UV Lamp for Sievers® Model 500
Miscellaneous Replacement PartsCat. #20035 60 Micron in-line Stainless Filter Cat. #25040 Fan fi lter for Sievers® Model 400 and 800Cat. #20055 Replacement pump-tubing for Sievers® Model 400
The Sievers® Model 400 and 400 ES analyzers are similar to their bench top models with the
important distinction that the analyzer cannot be subjected to ionic chemicals. It is for this reason
that PRA manufactures standards for these instruments using a distinctly different process. In
addition the containers used for storage, transportation and introduction of these standards are all
plastic to make certain no extra ions are introduced to the instrument from a glass container. We
also package these standards in larger poly containers for pour off and use in multiple applications.
Sievers® Models 400 & 400 esCalibration and Validation Standards
Sievers® 400 ES
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Sievers® Model 900 Multi-PointCalibration Set (40 mL)Catalog # 19610 Set includes eleven vials, (1) blank, (1) each of 1, 5,
10, 25 and 50 ppm KHP, (1) each of 1, 5, 10, 25 and
50 ppm NaHCO3. Replaces Sievers® Part STD 90000.
Sievers® Model 900 Autoreagents Calibration Set (40 mL)Catalog # 19611 Set includes four vials, (1) blank, (1) 25.0 ppm
KHP, (1) 25 ppm NaHCO3, (1) 50 ppm C6H5NO2
(Nicotinamide). Replaces Sievers® Part STD 90036.
USP System Suitability Set (40 mL)Cat. #18000 Set includes (1) Reagent Water RW, (1) USP Sucrose
RS (0.500 ppm), and (1) USP 1,4-benzoquinone RSS
(0.500 ppm). Replaces Sievers® Part STD 31004.
Ultra Low-Level TOC Standards KitCat. #14200 Set includes twelve 40 mL vials, (3) TOC Water
Blanks, (1) each of 0.05, 0.06, 0.07, 0.08, 0.09, 0.100,
0.250, 0.500 and 1.00 ppm from NIST KHP.
Sievers® Model 800 AutosamplerCalibration Set (40 mL)Cat. #19500 Set includes twelve vials, (4) blanks, (4) 25 ppm KHP, (4)
25 ppm NaHCO3. Replaces Sievers® Part STD 31002.
Please see page 29 for individual standards.
Sievers® Model 800 Grab ModeCalibration Set (40 mL)Cat. #19510 Set includes six vials, (2) blanks, (2) 25 ppm KHP, (2)
25 ppm NaHCO3. Replaces Sievers® Part STD 31001.
Sievers® 800 and 900 Linearity Set (40 mL)Cat. #19515 Set includes four vials, (1) blank, (1) 250 ppb KHP,
(1) 500 ppb KHP, (1) 750 ppb KHP. Replaces Sievers®
Part STD 31012.
Sievers® Model 800 Low LevelValidation Set (40 mL)Cat. #19520 Set includes 37 vials, (10) blanks, (4) 25 ppm KHP,
(4) 25 ppm NaHCO3 , (2) 250 ppb KHP, (9) 500 ppb
KHP, (2) 750 ppb KHP, and (2) USP System Suitability
Sets. Replaces Sievers Part STD 38101.
Bulk Preserved USP System Suitability SetsThese standards come preserved and packaged
in ultra-clean amber bottles for use with Sievers®
Model 800 and 900 TOC analyzers. Each standard
has a 6-month expiration period from the day it
is shipped.
Cat. #18025 125 mL Cat. #18050 250 mL Cat. #18100 500 mL Cat. #18200 1 L
PRA prepares a complete list of calibration and validation standards for use with the Sievers®
brand of laboratory TOC analyzers. The standards can be used for any calibration or validation
application found in the Sievers® literature. If you want a specifi c “kit” or standard supplied to
you at periodic intervals, just tell us what you want and when you want them, and we’ll take
care of the rest.
Try PRA for use with your Sievers® instrument today. We guarantee our products unconditionally.
Sievers® Series 800 and 900Calibration and Validation Standards
Sievers® Model 900
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ReagentsCat. #21000 150 mL H3PO4 Reagent Cartridge for Sievers® 800Cat. #21010 150 mL H3PO4 Reagent Cartridge for Sievers® 900Cat. #21005 150 mL (NH4)2S2O8 Reagent Cartridge for Sievers® 800Cat. #21015 150 mL (NH4)2S2O8 Reagent Cartridge for Sievers® 900
Sample Vials40 mL Low TOC vials (80/cs)Cat. #25025 Scrupulously cleaned Low TOC vials for all TOC
sample analyses.
See page 24 for more information on PRA vials.
Replacement UV LampsCat. #20040 Replacement UV Lamp for Sievers® Model 800Cat. #20045 Replacement UV Lamp for Sievers® Model 900
Miscellaneous Replacement PartsCat. #20035 60 Micron in-line Stainless Filter Cat. #25040 Fan fi lter for Sievers® Models 400 and 800Cat. #20050 Replacement tubing for Sievers® 800
Did you know?The Oxidizable Substance Test was introduced by the
USP in 1890. The Chapter <643> TOC method was
introduced in the USP 23 Fifth Supplement in May
1997. The Oxidizable Substance Test was deleted from
the 8th Supplement in May 1998.
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Individual Standards for Calibration or Verifi cationCat. #10001 TOC/IC Calibration Blank 40 mL Cat. #10016 TOC/IC Calibration Blank 125 mL Cat. #11726 0.500 ppm from NIST KHP 40 mL Cat. #11731 0.500 ppm from NIST KHP 125 mL Cat. #11801 1.00 ppm from NIST KHP 40 mL Cat. #11811 1.00 ppm from NIST KHP 125 mL Cat. #12401 5.00 ppm from NIST KHP 40 mL Cat. #12411 5.00 ppm from NIST KHP 125 mL Cat. #12701 10.0 ppm from NIST KHP 40 mL Cat. #12711 10.0 ppm from NIST KHP 125 mL Cat. #13001 25.0 ppm from NIST KHP 40 mL Cat. #13021 25.0 ppm from NIST KHP 125 mL Cat. #13224 50.0 ppm from NIST KHP 40 mL Cat. #13227 50.0 ppm from NIST KHP 125 mL Cat. #18006 RW-Reagent Water USP 40 mL Cat. #18007 RS-0.500 ppm from USP Sucrose RS 40 mLCat. #18008 RSS-0.500 ppm from USP Benzoquinone 40 mLCat. #18024 USP System Suitability Set 125 mL Cat. #18029 RW-Reagent Water USP 125 mL Cat. #18031 RS-0.500 ppm from USP Sucrose RS 125 mLCat. #18032 RSS-0.500 ppm from USP Benzoquinone 125 mL
Please see pages 30-31 for additional concentrations and volumes.
USP System Suitability Set (40 mL)Cat. #18004 Set includes Reagent Water RW, USP Sucrose
RS (0.500 ppm), and USP 1,4-benzoquinone
RSS (0.500 ppm).
Teledyne Tekmar Validation Set–PhoenixCat. #19002 Set includes eighteen 40 mL vials, (2) Blanks, (3)
0.500 ppm NIST KHP, (6) 1.00 ppm NIST KHP, (1) 2.00
ppm NIST KHP, (1) 5.00 ppm NIST KHP, (1) 50.0 ppm
NIST KHP, (1) 100 ppm NaHCO3, (1) USP System
Suitability Set (one water blank RW, one 0.500 ppm
from USP Sucrose RS, one 0.500 ppm from USP 1,4-
benzoquinone RSS).
Teledyne Tekmar Validation Set–FusionCat. #19004 Set includes eleven 40 mL vials and one 125 mL
bottle, (3) Blanks, (3) 1.00 ppm NIST KHP, (1) 125 mL
5.00 ppm NIST KHP, (1) 10.0 ppm NIST KHP, (1) 25.0
ppm NaHCO3, (1) USP System Suitability Set (one
water blank RW, one 0.500 ppm from USP Sucrose RS,
one 0.500 ppm from USP 1,4-benzoquinone RSS).
Ultra Low-Level TOC Standards KitCat. #14203 Set includes twelve vials, (3) blanks, (1) each of 0.05,
0.06, 0.07, 0.08, 0.09, 0.100, 0.250, 0.500 and 1.00
ppm from NIST KHP.
Tekmar has been a pioneer in the TOC business for more than 35 years, and PRA is pleased
to offer a full range of standards and reagents for use with your DC-180, DC-190, Phoenix,
Apollo or Fusion. For Tekmar TOC instrument validation, calibration and system suitability, PRA
recommends using only preserved TOC standards to meet USP <643> criteria for pharmaceutical
water quality monitoring.
The products below are commonly purchased for use with Tekmar instruments.
Teledyne TekmarCalibration and Validation Standards
Teledyne Tekmar Fusion
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Bulk Preserved USP System Suitability SetsThese standards come preserved and packaged
in ultra-clean amber bottles for use with Teledyne
Tekmar TOC analyzers. Each standard has a 6-month
expiration period from the day it is shipped.
Cat. #18024 125 mL Cat. #18049 250 mL Cat. #18104 500 mL Cat. #18204 1 L
Sample Vials40 mL Low TOC vials (80/cs)Cat. #25025 Scrupulously cleaned Low TOC vials for all TOC
sample analyses.
See page 24 for more information on PRA vials.
ReagentsKey to accurate low-level analyses on
pharmaceutical waters is keeping the overall
instrument background (TOC contribution from the
“system”) as low as possible. PRA offers acid and
persulfate reagents specifi cally for Teledyne Tekmar
TOC systems that are manufactured with only the
highest purity chemicals and ultra-clean containers.
The care we take ensures the lowest possible
contribution of background TOC from the reagents.
• 10% Ammonium Persulfate
((NH4)2S2O8) Reagent
• 15% Phosphoric Acid (H3PO4) Reagent
PRA offers 1 L pre-made reagents for Teledyne
Tekmar and OI Analytical TOC instruments as
well as reagent prep kits with pre-measured ultra
phosphoric acid and ammonium persulfate that
can easily be diluted to volume in your containers
or ours.
Please call PRA for more information or to order reagents for your Teledyne Tekmar or OI Analytical TOC.
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PRA Standards Traceability
We understand the criticality of conformity
and traceability in the pharmaceutical
industry when utilizing analytical standards
and reference materials as it relates to the
data quality infrastructure of our customers.
Documented traceability is one critical part of
the process to generate defensible analytical
data. It creates rational levels of confi dence
in data generated and allows for vigorous
support of analytical data in your lab today
and in the future. As would be expected in
a cGMP environment, all of PRA’s standards
are accompanied by a Certifi cate of Analysis
(C of A) that includes important criteria
such as a material’s intended use, method
of preparation, certifi ed value and relative
measurement uncertainty.
the process to generate defensible analytical
data. It creates rational levels of confi dence
in data generated and allows for vigorous
of preparation, certifi ed value and relative
measurement uncertainty.
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Cleaning Validation Sampling KitsCat. #CV10000 Vial and Swab Sampling Kit
28 certifi ed clean swabs14 certifi ed clean vials
Cat. #CV10005 Vial and Swab Sampling Kit 175 certifi ed clean swabs80 certifi ed clean vials
Cleaning Validation CouponsSpecial Order Coupons Coupons of any size, material or swabbing area
(metals, plastics, rubbers). Certifi cates of analysis
for materials traceability, fi nish and cleanliness.
Visually Clean Training CouponsSpecial Order Organoleptic Coupons Proprietary formulation soils bracketing your
MAC limits for use as visually clean indicators.
Cleaning Validation Kits for Recovery Studies and Analyst TrainingCustom Cleaning Validation Kit
• Protocols for Swabbing Validation
• Six coupons in the material of your choice (Steel,
Aluminum, Titanium, Rubbers, Plastic Polymers–3"
x 6" or 6" x 6" cleaned coupons, etched with four
25 cm2 spiking areas—metals).
• 3-6 Sucrose-spiked coupons per your
specifi cations
• 3-6 API-spiked coupons per your specifi cations
• Certifi cates of analysis for materials traceability
and cleanliness (TOC)
• 24 Certifi ed Low TOC Vials
• 100 Certifi ed Low TOC Swabs
• 6 Pairs Powder-free Nitrile Gloves
• 1 set of linearity standards appropriate for
your working range
Options• Validation documentation for swabbing development
• Residue method development services
• Coupons soiled with unknown compounds
for swabbing and qualifi cation training
• Coupons soiled with proprietary customer
formulations (compounds and concentrations
can be selected by PRA or your experts)
• Performance evaluations and training certifi cates
available in conjunction with blind sample kit options
PRA is the premier manufacturer of HPLC and TOC cleaning validation coupons and kits, providing
certifi ed clean vials, swabs and coupons that can be customized to suit your laboratory, analyst
and validation needs. We have been the leading provider of proprietary formulation services for
cleaning validation for more than 7 years, offering surface soiling services for rinse, swab and
organoleptic cleaning validation schema.
Cleaning Validation Products
”
“While it is understood that rinse samples are capable of sampling larger surface areas, particularly ones which are diffi cult to access, for the purposes of cleaning validation, rinse samples alone would not be acceptable unless a direct measurement of the residue or contaminant has been made.
Human DrugcGMP NotesVol. 6, No. 4December 1998
s.
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Water Quality Testing
WQT–Total Organic CarbonCat. #A013 Contains one 60 mL water sample containing Total
Organic Carbon in the range of 0.10 to 5.0 mg/L.
WQT–ConductivityCat. #A014 Contains one 250 mL water sample with a
Conductivity value in the range of 25 to 250 µS/cm.
WQT–Total and Fecal ColiformCat. #A010 Designed to the specifi cations of USP Chapter
<1231>. Contains three lyophilized samples to be
analyzed for presence, absence and/or enumeration
of total and fecal coliforms. Each sample is provided
with one 99 mL phosphate-buffered dilution water
for re-hydration of the lyophilized sample. The
organisms present in each sample will be selected
from the following list:
Escherichia coli.
Enterobacter cloacae
Pseudomonas aeruginosa
Proteus vulgaris
Blank
WQT–Fecal StreptococcusCat. #A011 Designed to the specifi cations of USP Chapter
<1231>. Contains one lyophilized sample to be
analyzed for presence, absence and/or enumeration
of fecal streptococcus or Enterococci. Each
sample is provided with one 99 mL phosphate-
buffered dilution water for re-hydration of the
lyophilized sample.
WQT–Isolate Identifi cationCat. #A012 Designed to the specifi cations of USP Chapter
<1231>. Contains one lyophilized sample to be
identifi ed for one of the Genera listed below. Each
sample is provided with one 99 mL phosphate-
buffered dilution water for re-hydration of the
lyophilized sample.
Brevundimonas Burkholderia
Chromobacterium Enterococcus
Erysipelothrix Klebsiella
Kocuria Methylobacterium
Micrococcus Morganella
Pseudomonas Pseudonocardia
Ralstonia Shewanella
Sphingomonas Stenotrophomonas
Yersinia
It is an FDA requirement for pharmaceutical laboratories to demonstrate adequacy of training
for all laboratory personnel. Although it is not a requirement for each analyst to perform “blind”
sample analysis (analysis of unknowns), FDA regulators agree that it is the most defensible
argument for completeness of training and analyst competency. PRA is pleased to offer a suite
of standard catalog tests for analyst competency as well as a custom products group capable of
developing and administering blind sample analysis for virtually any analytical requirement you
have. PRA provides the sample to the laboratory (or specifi c analyst) complete with instructions for
analysis and data submission. Upon successful analysis, PRA issues a certifi cate of competency.
Analyst Competency Testing
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Microbial Limit TestingCat. #(See Below) Designed to the specifi cations of USP Chapter <61>. Each
set contains quantitative lyophilized samples to be tested for
the analytes listed below. Each set is provided with one 99
mL phosphate-buffered dilution water for re-hydration of the
lyophilized samples.
Cat. # Analytes
A001 Staphylococcus aureusTotal aerobic microbial countTotal and combined molds and yeast
A002 Escherichia coli.Bile-tolerant and Gram-negative bacilliTotal aerobic microbial count
A003 Pseudomonas aeruginosaBile-tolerant and Gram-negative bacilliTotal aerobic microbial count
A004 Salmonella speciesEscherichia coli.
Bile-tolerant and Gram-negative bacilliA005 Clostridium species
Salmonella species Total aerobic microbial countA006 Candida albicans Total and combined molds and yeast Total aerobic microbial count
Antimicrobial Effectiveness TestingCat. #A007 Designed to the specifi cations of USP Chapter <51>. Each set
contains quantitative lyophilized samples to be tested for the
organisms listed below. Each set is provided with fi ve
phosphate-buffered dilution waters for re-hydration of the
lyophilized samples.
Escherichia coli.
Staphylococcus aureus.
Pseudomonas aeruginosa
Candida albicans
Aspergillus niger
Environmental Monitoring Isolate Identifi cation
EMII–FungusCat. #A009 Designed to the specifi cations of USP Chapter <1231>. Consists of
one KWIK-STIK™ sample containing one fungus from the list below.
Absidia Acremonium Alternaria
Aspergillus Asteromyces Beauveria
Chryosporium Cladiosporium Cunninghamella
Geotrichum Glioccladium Microsphaeropsis
Paecilomyces Penicillium Rhizipus
Scopulariopsis Sepedonium Sodaria
Sporobolomyces Syncephalostrum Trichoderma
Trichophyton Verticillum Wallerni
EMII–BacteriumCat. #A008 Designed to the specifi cations of USP Chapter <1231>. Consists
of one KWIK-STIK™ sample containing one bacterium from the
list below:
Aerococcus Bacillus Brevundimonas
Budvica Burkholderia Citrobacter
Corynebacterium Delftia Edwardsiella
Enterococcus Erysipelothrix Klebsiella
Kocuria Lactococcus Leciercia
Listeria Methylobacterium Micrococcus
Moraxella Morganella Mycobacterium
Nocardia Oligella Paenibacillus
Proteus Providencia Pseudomonas
Ralstonia Shewanella Sphingomonas
Staphylococcus Stenotrophomonas Streptococcus
Yersinia
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High-Purity Water
PRA offers high-purity water suitable for use with your total organic carbon or liquid chromatography
system. All PRA waters are prepared with the highest level of care throughout the Ion-Exchange-
Filtration-RO-UV purifi cation process. Our waters must pass a rigorous testing scheme, and we
guarantee the analysis of each bottle as well as your satisfaction.
USP Purifi ed–Certifi ed Low TOC WaterCat. #PW10000 USP purifi ed Low TOC Water 4L Cat. #PW10005 USP purifi ed Low TOC Water 4 x 4L case
Guaranteed Specifi cations: pH . . . . . . . . . . . . . . . . . . . . . 5-7
Residue after Evaporation . . 1 ppm max.
Conductivity (at Bottling) . . 1.0 µS/cm max @ 20ºC
Total Organic Carbon . . . . . . 50 ppb max.
Total Bacterial Count . . . . . . < 10 cfu/mL
Color (APHA) . . . . . . . . . . . . 5 max.
Did you know?Total Organic Carbon (TOC) chapter <643> of the
USP water monographs is targeted for revision in 2008
as it relates to Process Analytical Technology (PAT)
considerations. Watch for proposed revisions from the
USP Pharmaceutical Water Expert Committee.
PRA Product Stability
When it comes to standards in the
pharmaceutical laboratory, quality,
consistency and stability are essential.
The analytical thoroughness applied to
every step of our manufacturing process
ensures that each of PRA’s products will
meet even the strictest expectations for
quality. If it doesn’t meet our quality
requirements it doesn’t leave the building.
The stability studies that have been
performed on each of our products
ensure that the quality specifi cations
they were designed and manufactured
to will be maintained throughout the
shipping process to your laboratory.
Our goal is to deliver our products with
the longest possible expiry dates when
handled as indicated in the instructions
you receive with each package. Expiry
periods range from 30-180 days and have
been confi dently assigned after our tiring
efforts to prove product stability.
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Conductivity Probe Validation Kits
Validating the detection limits, accuracy and precision of a conductivity sensor in ultrapure water
has been very elusive using traditional calibration solution schemes. Therefore, PRA is offering a
three solution Validation Kit that will allow an accurate, verifi able, and FDA approved approach to
validating the sensor for your USP <645> methods. The kits come in single-use 125 mL volumes as
well as multi-use 500 mL bottles. Each Validation Kit consists of three (3) conductivity calibration
solutions. Measurements are made at each level and the results used to determine the Method
Detection Limit (MDL), Limit of Detection (LOD) and Limit of Quantitation (LOQ). In addition, the
data are used to verify probe accuracy and linearity. For a complete explanation of how to use
the conductivity Probe Validation Kits, please call and request one of several application notes
available from PRA.
Did you know? Conductivity chapter
<645> of the USP
water monographs is
targeted for revision
proposals in 2008 as the
signifi cance of Process
Analytical Technology
(PAT) expands.
Watch for proposed
revisions from the USP
Pharmaceutical Water
Expert Committee.
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Individual Use 125 mLConductivity Validation KitCat. #02850 Kit Includes three bottles, (1) 25 µS/cm HCl in Water,
(1) 100 µS/cm KCl in Water, and (1) 146.93 µS/cm
KCl in Water.
Multiple Use 500 mLConductivity Validation KitCat. #02900 Kit Includes three bottles, (1) 25 µS/cm HCl in Water,
(1) 100 µS/cm KCl in Water, and (1) 146.93 µS/cm
KCl in Water.
Individual Low-Level Conductivity Standard 25 µS/cm HCl in WaterPRA’s Solution 25 is the lowest level, stable
conductivity solution available in water. Other
low-level conductivity solutions are made from
alcohol-water mixtures. This solution is an excellent
verifi cation solution once you have calibrated
your cell using Solution D. This standard can
verify that the accuracy of your cell meets the USP
requirements and will positively demonstrate and
document that you are using non-compensated
conductivity measurements as required.
Cat. #01200 1 L Solution 25 at 25 µS/cm Cat. #01300 500 mL Solution 25 at 25 µS/cm Cat. #01400 125 mL Solution 25 at 25 µS/cm Cat. #02700 Sievers® Model 400 25 µS/cm Conductivity Calibration Standard Replaces Sievers Part STD 30030Cat. #02000 125 mL Wide Mouth Pre-cleaned HDPE containers for measuring calibration solutions. Cat. #01000 1 L Solution 25 Test Kit Includes Solution 25 and 10 pre-cleaned 125 mL containers.Cat. #01100 500 mL Solution 25 test Kit Includes Solution 25 and 5 pre-cleaned 125 mL containers.
Individual Mid-Level Conductivity Standard100 µS/cm KCl in WaterManufactured using NIST traceable materials and
certifi ed, this KCl solution is an excellent calibration
or calibration verifi cation solution. This solution is
certifi ed by analysis and does not require the use of a
reference blank for accurate calibration or validation.
Cat. #02400 1 L of Solution 100 at 100 µS/cm Cat. #02500 500 mL of Solution 100 at 100 µS/cm Cat. #02600 125 mL of Solution 100 at 100 µS/cm Cat. #02610 Anatel Model A-643 Conductivity Calibration Standard – 60 mLCat. #02200 1 L Solution 100 test Kit Includes Solution 100 and 10 pre-cleaned 125 mL containers.Cat. #02300 500 mL Solution 100 test Kit Includes Solution 100 and 5 pre-cleaned 125 mL containers.Cat. #02000 125 mL Wide Mouth Pre-cleaned HDPE containers for measuring calibration solutions.
Individual Mid-Level Conductivity Standard146.93 µS/cm KCl in WaterManufactured according to the ASTM 1125 Test
Method for conductivity and conductivity calibration.
This solution is the lowest level solution that can
be made following a NIST protocol for conductivity
solution preparations. This standard makes an
excellent calibration or verifi cation solution together
with PRA’s Solution 25 (Solution D).
Cat. #01700 1 L of Solution D at 146.93 µS/cm Includes Reference Blank.Cat. #01800 500 mL of Solution D at 146.93 µS/cm
Includes Reference Blank.Cat. #01900 125 mL of Solution D at 146.93 µS/cm
Includes Reference Blank.Cat. #02000 125 mL Wide Mouth Pre-cleaned HDPE containers for measuring calibration solutions.Cat. #01500 1 L Solution D test Kit
Includes Solution D, Reference Blank,and 20 pre-cleaned 125 mL containers.
Cat. #01600 500 mL Solution D test Kit Includes Solution D, Reference Blank, and 10 pre-cleaned 125 mL containers.
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PRA Sample Vials and Containers
Ever wonder what the USP means by: “Use glassware and sample containers that have been
scrupulously cleaned of organic residues?”1
Just like the USP, we here at PRA demand scrupulously cleaned vials for our TOC standards. All of our
vials, whether glass or polymer, represent the most consistently clean sample vials available anywhere.
They are the perfect vial for your purifi ed water (PW) or water for injection (WFI) sample analysis.
40 mL Glass TOC vials40 mL Low TOC vials (80/cs)Cat. #25025 We have partnered with C&G containers to develop
a process that removes virtually all residual TOC
from our 40 mL sample vials; our average residual
TOC level is < 5 ppb. How do we know this?
Because we analyze every single batch.
Over the years our data demonstrates that these
vials are uniformly lower in TOC than any other vial
available. Each case of vials (80 per case) is packaged
in a clean-room quality carton and comes with a
certifi cate of analysis to document their quality. Each
vial is capped with a Tefl on-lined septa and protected
by a hardened plastic dust cover. We guarantee these
low-level TOC vials will exceed your expectations.
Plastic Containers
AnatelCat. #25030 60 mL HDPE Bottle for Anatel A 643 (natural)Cat. #25033 60 mL HDPE Bottle for Anatel A 643 (amber)
SieversCat. #25015 30 mL poly vial for Sievers® Model 400Cat. #02000 125 mL Wide Mouth HDPE container
Pre-cleaned HDPE containers formeasuring calibration solutions.
1 United States Pharmacopeia Monographs, Chapter <661>–Containers.
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Your Product When You Need It
Think of PRA as your stockroom for TOC
and Cleaning Validation products. Let us
know what you need and when you need
it, and we’ll take care of the rest.
We deliver product around the world,
shipping hundreds of packages per
week between our Arvada, Colorado,
US and Manchester, UK manufacturing
facilities. We understand the importance
of delivering our products promptly
and reliably and that’s why we work
with two preferred couriers FedEx™
and UPS™. Customers can select to use
their own account or we can ship using
international rates. Package tracking is
available and in the event of delivery
exceptions, customers are notifi ed and
we expedite delivery from our end.
Same day shipping is available on most
products. For orders received before
13:00 GMT Monday through Thursday,
you’ll receive them the next working day.
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Custom PRA Products
TOC and Conductivity StandardsPRA maintains the most complete list of TOC standards available anywhere; however, it is possible
that you have a need for a standard we do not list in our catalog. If that is the case, please call us!
PRA’s chemists have many years of experience in preparing TOC standards. If the standard you
need can be made, we would be pleased to manufacture it for you. We begin by listening to your
requirements and then asking some questions of our own to make certain we know exactly what
you need. For example, the TOC standards we prepare for on-line analyzers are unpreserved and
handled differently than standards prepared for use with laboratory analyzers. Furthermore, we
need to make certain we use the appropriate source material and manufacture to the correct level of
uncertainty (error). Once we know exactly what TOC standard you would like, we prepare, test and
certify the standard for you. We will ship you the standard together with a complete Certifi cate of
Analysis. Our turn around time is typically 24-48 hours, and we do not have any premium charges
for preparing the product specifi cally for you. You can count on the fact that if a TOC or conductivity
standard can be made, PRA has the technical capability and experience to make it for you.
Cleaning Validation CouponsPRA continues to maintain a leadership role in cleaning validation products.
Coupons of any composition (metals, rubbers, plastics) are available with custom cutting, cleaning,
serialization and scoring. Coupons come with Certifi cates of Analysis for cleanliness and materials
traceability (exact material specifi cations like type, density and fi nish).
Coupon spiking services for product recovery studies, swabbing validation, “visually clean”
training and analyst performance qualifi cations are available.
Cleaning Validation Coup
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TOC Standards by Manufacturer
AnatelPlease see pages 6-8 for Anatel product descriptions.
60 mL Single-Use A-643 Standards (unpreserved)Cat. #02610 100 µS/cm Conductivity Soln Kit Cat. #13300 Calibration Blank Cat #13390 USP SST with 250 ppb check Cat. #13400 0.250 ppm NIST Sucrose Cat. #13500 0.500 ppm NIST Sucrose Cat. #13600 0.750 ppm NIST Sucrose Cat. #18400 USP System Suitability Set Cat. #19200 Access 643 Calibration
Standards KitCat. #19210 Access 643 Validation Kit Cat. #19220 Access 643 Validation
Control KitCat. #19230 Access 643 Validation Protocol
Standards Kit
Cat. #25045 Low TOC Sample Vial Kit
Bulk Packaged Standards for Access 643 (unpreserved)Cat. #10019 Calibration Blank – 125 mL Cat. #10319 0.250 ppm NIST Sucrose – 125 mL Cat. #10619 0.500 ppm NIST Sucrose – 125 mL Cat. #10919 0.750 ppm NIST Sucrose – 125 mL Cat. #02600 100 µS/cm Conductivity Cal Standard – 125 mLCat. #18035 System Suitability Set – 125 mL Cat. #10031 Calibration Blank – 250 mL Cat. #10331 0.250 ppm NIST Sucrose – 250 mL Cat. #10631 0.500 ppm NIST Sucrose – 250 mL Cat. #10931 0.750 ppm NIST Sucrose – 250 mL Cat. #02250 100 µS/cm Conductivity Soln
Standard – 250 mLCat. #18060 System Suitability Set – 250 mL Cat. #10120 Calibration Blank – 500 mL Cat. #10420 0.250 ppm NIST Sucrose – 500 mL Cat. #10720 0.500 ppm NIST Sucrose – 500 mL Cat. #11020 0.750 ppm NIST Sucrose – 500 mL Cat. #02500 100 µS/cm Conductivity Cal
Standard – 500 mLCat. #18150 System Suitability Set – 500 mL
Single-Use Anatel AnaTOC Standards (preserved)Cat. #10015 TOC Water Blank – 125 mL Cat. #11720 0.250 ppm NIST KHP – 125 mL Cat. #11730 0.500 ppm NIST KHP – 125 mL Cat. #11810 1.00 ppm NIST KHP – 125 mL Cat. #18025 USP System Suitability Set – 125 mL Cat. #10025 TOC Water Blank – 250 mL Cat. #11721 0.250 ppm NIST KHP – 250 mL Cat. #11735 0.500 ppm NIST KHP – 250 mL Cat. #11820 1.00 ppm NIST KHP – 250 mL Cat. #18050 USP System Suitability Set – 250 mL Cat. #10100 TOC Water Blank – 500 mL Cat. #11722 0.250 ppm NIST KHP – 500 mL Cat. #11750 0.500 ppm NIST KHP – 500 mL Cat. #11900 1.00 ppm NIST KHP – 500 mL Cat. #13299 1000 ppm NIST KHP – 500 mL Cat. #18100 USP System Suitability Set – 500 mL Cat. #25025 40 mL Low TOC vials (80/cs)
Single-use Standards for the Anatel A-1000Cat. #10211 Calibration Blank – 1 L Cat. #10511 0.250 ppm NIST Sucrose – 1 L Cat. #10811 0.500 ppm NIST Sucrose – 1 L Cat. #11111 0.750 ppm NIST Sucrose – 1 L Cat. #19030 USP System Suitability Set – 1 L
All of PRA’s unpreserved standards have a 30-day expiration period regardless of size. Preserved
single-use standards have a 60-day expiration period and bulk preserved standards have a 6-month
expiration period.
The following is not a complete list of all volumes and concentrations of TOC standards offered by
PRA; please call us if there is a product you need that you cannot locate here.
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TOC Standards by Manufacturer
Sievers® 400, 400 ES and Thornton 5000Please see page 11 for product descriptions.
30 mL Unpreserved Standards Cat. #13700 Calibration Blank Cat. #14100 1.25 ppm NIST Sucrose for
calibrationCat. #02700 25 µS/cm Conductivity for
calibrationCat. #18300 Model 400 USP System
Suitability Set
Bulk Packaged Standards – 6-month expiration
System Suitability SetsCat. #18030 System Suitability Set – 125 mL Cat. #18055 System Suitability Set – 250 mL Cat. #18140 System Suitability Set – 500 mL Cat. #18240 System Suitability Set – 1 L
125 mL TOC Calibration StandardsCat. #10020 Calibration Blank Cat. #11520 1.25 ppm NIST Sucrose
Calibration StandardCat. #01400 25 µS/cm Conductivity
Calibration Standard
250 mL TOC Calibration StandardsCat. #10030 Calibration Blank Cat. #11530 1.25 ppm NIST Sucrose
Calibration StandardCat. #01350 25 µS/cm Conductivity
Calibration Standard
500 mL TOC Calibration StandardsCat. #10110 Calibration Blank Cat. #11601 1.25 ppm NIST Sucrose
Calibration StandardCat. #01300 25 µS/cm Conductivity
Calibration Standard
VialsCat. #25015 30 mL poly vial for Sievers® Model 400
Did you know?Watch for Process Analytical Technology (PAT)
developments through the FDA’s Center for
Drug Evaluation and Research (CDER). The
Offi ce of Pharmaceutical Science (OPS) has
formed a new subcommittee of the Advisory
Committee for Pharmaceutical Science: the
Process Analytical Technologies Subcommittee,
to assemble expert advice on process analytical
technologies. You can keep up to date by
visiting http://cdernet.cder.fda.gov/ops/pat.
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Shimadzu, Sievers® 800 and 900, AJ N/C 2100/3100, Lachat IL 550Please see pages 5, 10-13 for product descriptions.
Cat. #10000 TOC Water Blank Cat. #11701 0.050 ppm NIST KHP Cat. #11704 0.060 ppm NIST KHP Cat. #11707 0.070 ppm NIST KHP Cat. #11710 0.080 ppm NIST KHP Cat. #11713 0.090 ppm NIST KHP Cat. #11716 0.100 ppm NIST KHP Cat. #11719 0.250 ppm NIST KHP Cat. #11725 0.500 ppm NIST KHP Cat. #11780 0.750 ppm NIST KHP Cat. #11800 1.00 ppm NIST KHP Cat. #12100 2.00 ppm NIST KHP Cat. #12350 4.00 ppm NIST KHP Cat. #12400 5.00 ppm NIST KHP Cat. #12700 10.0 ppm NIST KHP Cat. #12905 12.0 ppm NIST KHP Cat. #12910 12.5 ppm NIST KHP Cat. #12940 15.0 ppm NIST KHP Cat. #13000 25.0 ppm NIST KHP Cat. #13210 30.0 ppm NIST KHP Cat. #13225 50.0 ppm NIST KHP Cat. #13275 100 ppm NIST KHP Cat. #13280 150 ppm NIST KHP Cat. #13285 200 ppm NIST KHP Cat. #13290 250 ppm NIST KHP Cat. #13295 500 ppm NIST KHP
System Suitability SetsBulk system suitability sets include one each:
Reagent Water RW, USP Sucrose RS (0.500 ppm), and
USP 1,4-benzoquinone RSS (0.500 ppm)
Cat. #18000 USP System Suitability Set – 40 mL
Validation Sets (40 mL vials)Cat. #19500 Sievers® 800 Autosampler
Calibration SetCat. #19510 Sievers® 800 Grab Mode
Calibration SetCat. #19515 Sievers® 800 Linearity Set Cat. #19520 Sievers® 800 Low-Level
Validation Set
125 mL Bulk StandardsCat. #10015 TOC Water Blank Cat. #11702 0.050 ppm NIST KHP Cat. #11717 0.100 ppm NIST KHP Cat. #11720 0.250 ppm NIST KHP Cat. #11730 0.500 ppm NIST KHP Cat. #11785 0.750 ppm NIST KHP Cat. #11810 1.00 ppm NIST KHP Cat. #12110 2.00 ppm NIST KHP Cat. #12360 4.00 ppm NIST KHP Cat. #12410 5.00 ppm NIST KHP Cat. #12710 10.0 ppm NIST KHP Cat. #12912 12.5 ppm NIST KHP Cat. #12945 15.0 ppm NIST KHP Cat. #13020 25.0 ppm NIST KHP Cat. #13226 50.0 ppm NIST KHP
250 mL Bulk StandardsCat. #10025 TOC Water Blank Cat. #11703 0.050 ppm NIST KHP Cat. #11718 0.100 ppm NIST KHP Cat. #11721 0.250 ppm NIST KHP Cat. #11735 0.500 ppm NIST KHP Cat. #11790 0.750 ppm NIST KHP Cat. #11820 1.00 ppm NIST KHP Cat. #12120 2.00 ppm NIST KHP Cat. #12420 5.00 ppm NIST KHP Cat. #12720 10.0 ppm NIST KHP Cat. #12914 12.5 ppm NIST KHP Cat. #12950 15.0 ppm NIST KHP Cat. #13040 25.0 ppm NIST KHP Cat. #13228 50.0 ppm NIST KHP Cat. #13277 100 ppm NIST KHP
500 mL Bulk StandardsCat. #10100 TOC Water Blank Cat. #11714 0.100 ppm NIST KHP Cat. #11722 0.250 ppm NIST KHP Cat. #11750 0.500 ppm NIST KHP Cat. #11795 0.750 ppm NIST KHP Cat. #11900 1.00 ppm NIST KHP Cat. #12200 2.00 ppm NIST KHP Cat. #12500 5.00 ppm NIST KHP Cat. #12800 10.0 ppm NIST KHP Cat. #12920 12.5 ppm NIST KHP Cat. #12955 15.0 ppm NIST KHP Cat. #13100 25.0 ppm NIST KHP Cat. #13215 30.0 ppm NIST KHP Cat. #13230 50.0 ppm NIST KHP Cat. #13278 100 ppm NIST KHP
TOC Standards by Manufacturer
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TOC Standards by Manufacturer
OI Analytical, Teledyne Tekmar, AJ N/C UV HS, Lachat IL 500Please see pages 5, 9, 14-15 for product descriptions.
40 mL Single Use Vials and Sets Cat. #10001 TOC Water Blank Cat. #11666 0.050 ppm NIST KHP Cat. #11669 0.060 ppm NIST KHP Cat. #11670 0.070 ppm NIST KHP Cat. #11671 0.080 ppm NIST KHP Cat. #11672 0.090 ppm NIST KHP Cat. #11673 0.100 ppm NIST KHP Cat. #11678 0.250 ppm NIST KHP Cat. #11726 0.500 ppm NIST KHP Cat. #11781 0.750 ppm NIST KHP Cat. #11801 1.00 ppm NIST KHP Cat. #12101 2.00 ppm NIST KHP Cat. #12401 5.00 ppm NIST KHP Cat. #12701 10.0 ppm NIST KHP Cat. #13001 25.0 ppm NIST KHP Cat. #13224 50.0 ppm NIST KHP Cat. #18006 RW-Reagent Water USP Cat. #18007 RS-0.500 ppm from USP
Sucrose RSCat. #18008 RSS-0.500 ppm from USP
BenzoquinoneCat. #13273 100 ppm NIST KHP
Validation SetsCat. #19007 OI Analytical Validation Set –Aurora Cat. #19002 Teledyne Tekmar Validation Set–
PhoenixCat. #19004 Teledyne Tekmar Validation Set–
FusionCat. #14203 OI and Tekmar Low-Level
Linearity Set
System Suitability SetsSystem suitability sets include one each: Reagent
Water RW, USP Sucrose RS (0.500 ppm), and USP
1,4-benzoquinone RSS (0.500 ppm)
Cat. #18004 USP System Suitability Set – 40 mL Cat. #18024 System Suitability Set – 125 mL Cat. #18049 System Suitability Set – 250 mL Cat. #18104 System Suitability Set – 500 mL Cat. #18204 System Suitability Set – 1 L
125 mL Bulk StandardsCat. #10016 TOC/IC Calibration Blank Cat. #11667 0.050 ppm from NIST KHP Cat. #11674 0.100 ppm from NIST KHP Cat. #11731 0.500 ppm from NIST KHP Cat. #10786 0.750 ppm from NIST KHP Cat. #11811 1.00 ppm from NIST KHP Cat. #12411 5.00 ppm from NIST KHP Cat. #12711 10.0 ppm from NIST KHP Cat. #13021 25.0 ppm from NIST KHP Cat. #13227 50.0 ppm from NIST KHP Cat. #13305 1000 ppm from NIST KHP Cat. #13308 2000 ppm from NIST KHP Cat. #18029 RW-Reagent Water USP Cat. #18031 RS-0.500 ppm from USP
Sucrose RSCat. #18032 RSS-0.500 ppm from USP
Benzoquinone
250 mL Bulk StandardsCat. #10026 TOC/IC Calibration Blank Cat. #11668 0.050 ppm from NIST KHP Cat. #11675 0.100 ppm from NIST KHP Cat. #10322 0.250 ppm from NIST Sucrose Cat. #11736 0.500 ppm from NIST KHP Cat. #10622 0.500 ppm from NIST Sucrose Cat. #11791 0.750 ppm from NIST KHP Cat. #10922 0.750 ppm from NIST Sucrose Cat. #11821 1.00 ppm from NIST KHP Cat. #12121 2.00 ppm from NIST KHP Cat. #12421 5.00 ppm from NIST KHP Cat. #12721 10.0 ppm from NIST KHP Cat. #13041 25.0 ppm from NIST KHP Cat. #13229 50.0 ppm from NIST KHP Cat. #13306 1000 ppm from NIST KHP Cat. #13309 2000 ppm from NIST KHP Cat. #18046 RW-Reagent Water USP Cat. #18047 RS-0.500 ppm from USP Sucrose RS Cat. #18048 RSS-0.500 ppm from USP
Benzoquinone
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500 mL Bulk StandardsCat. #10101 TOC/IC Calibration Blank Cat. #11676 0.100 ppm from NIST KHP Cat. #10401 0.250 ppm from NIST Sucrose Cat. #11751 0.500 ppm from NIST KHP Cat. #10701 0.500 ppm from NIST Sucrose Cat. #11796 0.750 ppm from NIST KHP Cat. #11001 0.750 ppm from NIST Sucrose Cat. #11901 1.00 ppm from NIST KHP Cat. #12201 2.00 ppm from NIST KHP Cat. #12501 5.00 ppm from NIST KHP Cat. #12801 10.0 ppm from NIST KHP Cat. #13101 25.0 ppm from NIST KHP Cat. #13231 50.0 ppm from NIST KHP Cat. #13307 1000 ppm from NIST KHP Cat. #13310 2000 ppm from NIST KHP Cat. #18105 RW-Reagent Water USP Cat. #18106 RS-0.500 ppm from USP
Sucrose RSCat. #18107 RSS-0.500 ppm from USP
Benzoquinone
1000 mL Bulk StandardsCat. #10201 TOC/IC Calibration Blank Cat. #11677 0.100 ppm from NIST KHP Cat. #10501 0.250 ppm from NIST Sucrose Cat. #11776 0.500 ppm from NIST KHP Cat. #10801 0.500 ppm from NIST Sucrose Cat. #11101 0.750 ppm from NIST Sucrose Cat. #12001 1.00 ppm from NIST KHP Cat. #12301 2.00 ppm from NIST KHP Cat. #12601 5.00 ppm from NIST KHP Cat. #12901 10.0 ppm from NIST KHP Cat. #13201 25.0 ppm from NIST KHP Cat. #13236 50.0 ppm from NIST KHP Cat. #18205 RW-Reagent Water USP Cat. #18206 RS-0.500 ppm from USP
Sucrose RS Cat. #18207 RSS-0.500 ppm from US
Benzoquinone
TOC VialsCat. #25025 40 mL Low TOC vials (80/cs)
TOC Standards by Manufacturer
Floats Road Wythenshawe Manchester M23 9LZ U.K.