CERTIFICATE OF ANALYSIS

Material : Sodium Starch Glycollate (DISIJEL) IP/BP

Material Code : 1100563 A.R.No. : 18RM0555
SAP Batch No. : 1000072240 Specification No. : RMS/F1/098-02
Manufacturer Vendor Batch No. :
Mfg. Date : 31/05/2018 Analysis Started on : 08/12/2018
Exp. Date : 04/2023 Report Date : 11/12/2018
Retest Date : 11/12/2019 Analysts :
Qty. Received : X = 0.000
Sampled qty. : KG
Sr.No TEST SPECIFICATION OBSERVATION

1 Description
2 Solubility
3 Identification Test
A Very fine, white or off-white,free flowing A very fine, white,free flowing powder,
powder, odourless or almost odourless,very odourless very hygroscopic.
hygroscopic.
Practically insoluble in water, insoluble in Practically insoluble in water,
methylene chloride insoluble in most organic insoluble in methylene chloride
solvent. It gives a translucent suspension in insoluble in most organic solvent. It
water. gives a translucent suspension in
water.

a. Identification-A Compare the spectrum with that obtained Complies

with sodium starch glycolate reference
standard/working standard or with the
reference spectrum of sodium starch
glycolate.

b. Identification-B The solution becomes blue or violet. The solution becomes blue.

c. Identification-C Reaction of sodium Salts 1.A dense,white Complies

precipitates is formed. 2.No precipitate is
formed.

d. Identification-D pH : 5.5 to 7.5 6.37

e. Identification-E A suspension forms that settle after A suspension forms that settle after
standing. standing.
4 pH 5.5 and 7.5 6.37
5 Heavy metals Maximum 20 ppm Less than 20 ppm
6 Iron Maximum 20 ppm Less than 20 ppm
7 Sodium chloride Maximum 7.0% 4.61%

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 CERTIFICATE OF ANALYSIS

Material : Sodium Starch Glycollate (DISIJEL) IP/BP

Material Code : 1100563 A.R.No. : 18RM0555
SAP Batch No. : 1000072240 Specification No. : RMS/F1/098-02
Manufacturer Vendor Batch No. :
Mfg. Date : 31/05/2018 Analysis Started on : 08/12/2018
Exp. Date : 04/2023 Report Date : 11/12/2018
Retest Date : 11/12/2019 Analysts :
Qty. Received : X = 0.000
Sampled qty. : KG
Sr.No TEST SPECIFICATION OBSERVATION

8 Sodium Glycollate Maximum 2.0% 0.18%

9 Microbial Limit Test

a. Escherichia coli Should be Absent/g Abesnt/g

b. Salmonella spp Should be Absent/10g Abesnt/10g

c. Shigella Should be Absent/10 g Abesnt/10g

10 Loss on drying Maximum 10.0% 5.98%
11 Assay (on dried basis) 2.80% to 4.2% of Sodium 3.44%
12 Appearance of solution Solution S1 is clear and colourless. Solution S1 is clear and colourless.
S1

Remarks :

Compiled By Reviewed By Approved By

Name:___________________ Name:___________________ Name:___________________

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