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HEPARIN SODIUM

HEPARIN SODIUM

Heparin sodium, also known as unfractionated heparin (UFH), is a medication and naturally occurring glycosaminoglycan. Since heparins depend on the activity of antithrombin, they are considered anticoagulants. Specifically, it is also used in the treatment of heart attacks and unstable angina. It is given intravenously or by injection under the skin. Other uses for its anticoagulant properties include inside blood specimen test tubes and kidney dialysis machines.

A typical specification for Heparin Sodium IP/BP/EP/USP is:

Sr.No. Tests Specification  
1 Description A white or pale coloured amorphous powder odourless and hygroscopic.
2 Solubility Soluble in water.
3 Identification
a) By 1H NMR Spectrum
b) Chromatographic identity
c) Anti- Factor Xa to Anti factor IIa Ratio
d) Molecular weight determination
e) By reaction of sodium 		No unidentified signals greater than 4% of the mean of the height of signals 1 and 2 are present in the following ranges 0.10-2.00, 2.10-3.20 and 5.70-8.00 ppm No signals greater than 200% of the mean of the height of signals 1 and 2 are present in the 3.75-4.55 ppm for porcine heparin.
The retention time of the major peak of the sample solution corresponds to that of the standard solution.
0.9-1.1.
M24000 is Not more than 20%, Mw between 15000 - 19000 Da, The ratio of M8000-16000 and M16000-24000 is Not less than 1.0
A solution of Heparin sodium imparts an intense yellow color to a nonluminous flame.
4 Nitrogen determination Between 1.3% to 2.5% (Calculate on dried basis)
5 Residue on Ignition Between 28.0%-41.0%
6 Limit of Galactosamine in total Hexosamine Not more than 1 %
7 Nucleotide Impurities Not more than 0.1 % (w/w)
8 Protein Impurities Not more than 0.1 % (w/w)
9 Bacterial Endotoxin Not more than 0.03 USP Endotoxin Unit / USP heparin Unit.
10 Loss on drying Not more than 5.0 %
11 Absence of over sulphated Chondroitin sulphate
a) Identification test A
b) Identification test B		 No features associated with over sulphated chondroitin sulphate are found between 2.12 and 3.00 ppm
No Peaks corresponding to over sulphated chondroitin sulphate should be detected eluting after the heparin peak.
12 pH Between 5.0 – 7.5
13 Sterility Test It meets the requirement.
14 Assay
a) Anti-factor Xa activity
b) Anti-factor IIa activity		 Not less than 180 IU/mg
Not less than 180 IU/mg
15 Addition test
15.1 Residual solvents (by GC-HS)
a) Methanol
b) Ethanol		 Not more than 5000 ppm
Not more than 3000 ppm
15.2 Microbial Limit Test
a) Total aerobic microbial limit/Total molds and yeasts count
b) Escherichia coli
c) Salmonella
d) Staphylococcus aeruginosa
e) Pseudomonas aureus 		Not more than 100 cfu/g
Not more than 10 cfu/g
Should be absent
Should be absent
Should be absent
Should be absent