amylojel - eicl
TRANSCRIPT
AMYLOJELSuperdisintegrant
Every day, we earn the privilege of being a preferred
solutions provider to extraordinarily successful
customers. For over 75 years EICL has served such
customers across a range of industries.
What started as a vertical integration solution
for paper has since extended to Paint, Ink, Textiles,
Pharmaceuticals & Food, Oil & Gas Drilling, Fibreglass,
Rubber, etc. We are happy to connect the right raw
material to the right application. .
ABOUT EICL
Packing: 25/50 Kg open top HOPE barrels with inner virgin liners
AMYLOJEL Amylojel is a potato-based Sodium Starch Glycolate and is a powerful superdisintegrantused as
excipient in the pharmaceutical industry. It aids tablet dispersion, has a very disintegration rate and
high diffusivity rate in the stomach and protects heat sensitive active ingredient.
APPLICATION:To achieve rapid disintegration, high levels of superdisintegrant are added in Orally Disintegration Tablet formulations, depending upon the level & characteristics of the active pharmaceutical ingredient (API) and the desired release profile.
Data quoted are determined by use of EICL standard test methods, details of which, will be supplied on request. Every precaution is taken in production to ensure the products conform to our published data, but as they are based on naturally occuring raw materials, we reserve the right to change these data, should it become necessary. Sales are in accordance with our 'Conditions of Sale' which will be supplied on request.
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Base
Description
Appearance
Solubility
Moisture (%)
pH (2% acqueous solution)
Sodium chemically Linked (%)
Heavy Metals as Lead (ppm)
Iron (ppm)
Sodium Chloride (%)
Sodium Glycolate
Microbial Limit
TYPICAL ANALYSIS
Potato Starch
Sodium Salt of a carboxymethyl ether of Starch
Very fine, free flow, white, odourless powder
Practically insoluble in water and most organic solvent
10 max.
5.5-7.5
2.8-4.2
20 max.
20 max.
7.0 max.
2.0 max.
Absence of e-coli and salmonella in 1 gm
PARAMETER
Identification A, B, C & D
Solubility
pH
Loss on drying (%)
Sodium Chloride Content (%)
Sodium Glycolate (%)
Assay (sodium linked chemical) (%)
Heavy metal (ppm)
Iron (ppm)
MICROBIAL LIMITS
E.coli
Salmonellae
PERFORMANCE
Tablet Disintegration Time (2% SSG in 200 mg Tablet) (sec)
SPECIFICATION TYPICAL VALUES
Must Comply
Practically Insoluble in Water & Organic Solvent
5.5-7.5
10 max.
10 max.
IP USP BP Amylojel Imported Domestic
2 max.
2.8-4.5
20 max.
20 max.
Absent in 1 g Absent in 1 g Absent in 1 g
Absent in 1 g Absent in 1 g Absent in 1 g
Must Comply
-
5.5-7.5
10 max.
7 max.
2 max.
2.8-4.2
20 max.
20 max.
Must Comply
Practically insoluble in methylene chloride
5.5-7.5
10 max.
7 max.
2 max.
2.8-4.2
20 max.
20 max.
Complies
Complies
5.96
2.73
2.07
0.52
2.98
<20
<20
Complies Complies
Complies Complies
Complies
Complies
Complies
Complies
6.46
5.98
5.68
0.46
3.55
<20
<20
Complies
Complies
5.76
8-14
4.47
0.35
3.24
<20
<20
SPECIFICATION COMPARISION OF AMYLOJEL