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.

:

:

:

:

:

:

:

:

:

:

:

:

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