CERTIFICATE OF ANALYSIS

Product Name HEPARIN SODIUM PURE 1,00,000 IU/VIAL CAS Number 01-08-9041
Molecular Formula ---------- Catalogue No. AL2367
Molecular Weight ---------- Batch Number
Manufacturing Date December-2020 Expire Date November-2025

TYPE OF TEST

STANDARD

OBSERVED

Description
2 Identification
a. It delays the clotting of freshly shed blood
b. A blue color produced with Ferric Chloride solution
c. Reaction for sodium
3 Solubility
4 pH of 1% w/v solution
5 Clarity & color of solution
6 Heavy metals
7 Protein & Nucleotidic impurities
@ 260 nm
@ 280 nm
8 Bacterial endotoxins
9 Sulphated ash
10 Loss on drying
11 Assay Potency on dry basis Potency on ‘AS IS’ basis
White or grayish powder, moderately hygroscopic
Positive
Positive
Positive
Soluble in water & saline solution, forming a clear, colorless or straw color liquid
5.5 – 8.0
Clear & colorless solution
Max 40 ppm
NMT 0.200
NMT 0.150
NMT 0.03 EU /I.U
30.0- 43.0% w/v
NMT 8.0% w/v
NLT 100.0 I.U/mg on dried basis
Complies
Complies
Complies
Complies
Complies
7
Complies
Passes test
0.106
0.086
Passes test
33.6%
5.5 % w/v
159.0 IU/mg
Result: The above product complies with EP grade

Tested By
Hitesh Kunjathur