certificate of analysis -...

2
(A Unit of Niranthara Scientific Solutions Private Limited) CERTIFICATE OF ANALYSIS Product Name: Green Coffee Bean Extract 50% Manufacturing date: Oct .2012 Batch Number: GCS001 Expiry Date: Sept. 2015 PARAMETERS SPECIFICATION RESULT Method Description Light yellow to yellowish brown powder. Light yellow to yellowish cream powder. Visual Odor and taste Characteristic Odor and taste Complies Organoleptic Identification Complies with TLC/HPTLC Complies In House Loss on drying Not more than 5.0% 3.01% USP<731>/EP 2.2.32 Bulk Density 0.40/ml-0.70g/ml 0.5384gm/ml USP<616>/ E.P 2.9.34. Particle Size 100% passing through 40 mesh Complies USP<281>/ EP 2.4.16 pH of 1% solution 4.0-7.0 4.71 USP/EP 2.2.3. Pesticide Residues Absent Complies E.C396/2005 & EP Assay Chlorogenic acids by HPLC Not Less Than :50% 50.20% In House Caffeine Content Not More Than:2% Complies In-House Myco-toxins Total Aflatoxins <10 PPB Complies In-House Aflatoxin B1 <5 PPB Complies In -House Heavy Metals Arsenic Not More Than: 2.0ppm Complies AAS/ EP 2.4.27. Lead Not More Than: 1.0ppm Complies AAS/ EP 2.4.27. Cadmium Not More Than: 1.0ppm Complies AAS/ EP 2.4.27. Mercury Not More Than: 0.1ppm Complies AAS/ EP 2.4.27. Residual Solvent Should Be Absent Complies In-House

Upload: phamnhan

Post on 20-Jun-2018

234 views

Category:

Documents


0 download

TRANSCRIPT

(A Unit of Niranthara Scientific Solutions Private Limited)

CERTIFICATE OF ANALYSIS

Product Name: Green Coffee Bean Extract 50% Manufacturing date: Oct .2012

Batch Number: GCS001 Expiry Date: Sept. 2015

PARAMETERS SPECIFICATION RESULT Method

Description Light yellow to yellowish brown powder.

Light yellow to yellowish cream powder.

Visual

Odor and taste Characteristic Odor and taste

Complies Organoleptic

Identification Complies with TLC/HPTLC Complies In House

Loss on drying Not more than 5.0% 3.01% USP<731>/EP 2.2.32

Bulk Density 0.40/ml-0.70g/ml 0.5384gm/ml USP<616>/ E.P 2.9.34.

Particle Size 100% passing through 40 mesh

Complies USP<281>/ EP 2.4.16

pH of 1% solution 4.0-7.0 4.71 USP/EP 2.2.3.

Pesticide Residues Absent Complies E.C396/2005 & EP

Assay

Chlorogenic acids by HPLC Not Less Than :50% 50.20% In House

Caffeine Content Not More Than:2% Complies In-House

Myco-toxins

Total Aflatoxins <10 PPB Complies In-House

Aflatoxin B1 <5 PPB Complies In -House

Heavy Metals

Arsenic Not More Than: 2.0ppm Complies AAS/ EP 2.4.27.

Lead Not More Than: 1.0ppm Complies AAS/ EP 2.4.27.

Cadmium Not More Than: 1.0ppm Complies AAS/ EP 2.4.27.

Mercury Not More Than: 0.1ppm Complies AAS/ EP 2.4.27.

Residual Solvent Should Be Absent Complies In-House

(A Unit of Niranthara Scientific Solutions Private Limited)

Checked By Approved by

Microbial Parameters Limit Result Method

Total plate count NMT 5000cfu/g 925 CFU/G Harmonized method USP <61>

Yeast and mould NMT 100cfu/g <10 CFU/G Harmonized method USP <61>

Entero-bacteriaceae NMT: 100 cfu/g <10 CFU/G Harmonized method USP <62>

E.coli Should be Absent/1gm Absent Harmonized method USP <62>

Salmonella Should be Absent/10gm Absent Harmonized method USP <62>

Staphylococcus aureus Should be Absent/1gm Absent Harmonized method USP <62>

Pseudomonas aeroginosa Should be Absent/1gm Absent Harmonized method USP <62>