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ENOXAPARIN SODIUM

ENOXAPARIN SODIUM

Enoxaparin is used to prevent blood clots in the leg in patients who are on bedrest or who are having a hip replacement, knee replacement, or stomach surgery. It is used in combination with aspirin to prevent complications from angina (chest pain) and heart attacks. It is also used in combination with warfarin to treat blood clots in the leg. Enoxaparin is in a class of medications called low molecular-weight heparins. It works by stopping the formation of substances that cause clots.

Enoxaparin sodium is used to treat and prevent deep vein thrombosis (DVT) and pulmonary embolism (PE) including during pregnancy and following certain types of surgery. It is also used in those with the acute coronary syndrome (ACS) and heart attacks. It is given by injection just under the skin or into a vein. It is also used during haemodialysis.

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

Sr.No. Tests Specification  
1 Description A white or almost white powder, hygroscopic.
2 Solubility Freely soluble in water.
3 Identification
a) by Ultraviolet Absorption
b) by 13C NMR Spectrum
c) Determined by Assay
d) Molecular weight distribution and weight average molecular weight. (By size exclusion chromatography)
e) Sodium 		a) Spectra exhibit maxima at 231±2nm
b) The Test solution and Standard solution shows similar spectra.
c) The ratio of Anti Factor Xa activity to Anti Factor IIa activity is not less than 3.3 and not more than 5.3.
d) M2000 is between 12.0% and 20.0%, M2000-8000 is between 68.0% to 82.0%, M8000 is not more than 18.0%.
e) Meets the requirement.
4 Benzyl alcohol content (by HPLC) Not more than 0.1%
5 Nitrogen determination (on dried basis) Between 1.8% to 2.5%
6 Sodium content (by AAS) (On dried basis) Between 11.3% to 13.5%
7 pH Between 6.2 - 7.7
8 Loss on drying Not more than 10%
9 Specific absorbance (by U.V spectroscopy) (on dried basis) Between 14.0 to 20.0
10 Bacterial endotoxins Not more than 0.01 USP endotoxin Unit /IU Anti factor Xa activity.
11 Assay
a) Anti-factor Xa activity (on the dried basis)
b) Anti-factor IIa activity		 Not less than 90.0 IU/mg and Not more than 125.0 IU/mg
Not less than 20.0 IU/mg and Not more than 35.0 IU/mg