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ENOXAPARIN SODIUM Injection (PFS)

ENOXAPARIN SODIUM Injection (PFS)

Enoxaparin sodium injection is used to prevent and treat harmful blood clots. This helps to reduce the risk of a stroke or heart attack. This medication helps keep your blood flowing smoothly by lowering the activity of clotting proteins in the blood. Enoxaparin is an anticoagulant, also known as a "blood thinner." It is also low molecular weight heparin. It can be used in Conditions that increase your risk of developing blood clots including certain types of surgeries (such as knee/hip replacement, abdominal), long periods of being immobile, certain types of heart attack, and a specific type of chest pain called unstable angina. For some medical conditions, enoxaparin may be used in combination with other "blood thinners. This injection is available is the dosages of 40mg(4000 iu), 60mg(6000 iu), 80mg(8000 iu) & 100mg(10000 iu).

A typical specification for Enoxaparin Sodium injection IP/USP is:

Sr.No. Tests Specification  
1 Description Clear colorless solution prefilled syringe blister pack.
2 Identification
a) by Chemical
b) by UV
c) Sodium 		A creamy white precipitate is formed.
The spectra exhibit maxima at 231 ±2 nm.
Meets the requirements.
3 pH 5.5 - 7.5
4 Benzyl alcohol (By HPLC) 1.35 per cent to 1.65 per cent.
5 Free Sulphate Not more than 0.12 per cent (w/w).
6 Sterility Injection complies with the test for Sterility.
7 Bacterial Endotoxins It contains less than 0.01 USP Endotoxin Unit/unit of Anti-factor Xa activity in Anti-factor Xa IU.
8 Assay
a) Anti-factor Xa activity
b) Anti-factor IIa activity
c) Anti-factor Xa to anti-factor IIa ratio. 		Not less than 90.0 per cent and Not more than 110.0 Xa IU/mg of the stated activity.
Not less than 20.0 per cent and Not more than 35.0 per cent Anti-factor IIa IU/mg.
The ratio of anti –factor Xa activity to anti-factor IIa activity is Not less than 3.3 and Not more than 5.3.
9 Particulate matter in Injection Meet the requirement
10 Content Uniformity Acceptance value (AV)
L1=15.0 unless otherwise specified
L2=25.0 unless otherwise specified
(The preparation being examined complies with the test if in the total samples of 30 containers not more than one individual value is outside the limits 85% to 115% and none is outside the limits 75% to 125% of the average value).