Nadroparin Calcium
CAS No.: 37270-89-6 (Low molecular weight heparin)

Short Description:

Source: extracted from pig intestinal mucosa, degraded by sodium nitrite, and obtained after calcium transfer.
Function and use: Nadroparin calcium is a low molecular weight heparin, which is depolymerized from unfractionated heparin with antithrombotic and anticoagulant effects; it has high anticoagulant factor Xa activity and low anticoagulant Factor IIa or antithrombin activity. In surgery, for the prevention of venous thromboembolic disease in situations of high or high risk of venous thrombosis; for the treatment of established deep vein thrombosis; in combination with aspirin for the acute treatment of unstable angina and non-Q-wave myocardial infarction ; Prevention of clot formation in extracorporeal circulation during hemodialysis.

Nadroparin Calcium-Pharmacopoeia Standard: EP

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Specification

Nadroparin calcium
Source		Intestinal mucosa of pigs
Quality standard		EP
characters	Appearance	white or almost white; hygroscopic powder
	solubility	freely soluble in water
identification		The ¹³C NMR spectrum obtained is similar to that obtained with the appropriate specific nadroparin calcium CRS
		Anti- factor Xa activity/ anti-factor IIa : 2.5-4.0
		Mw : 3600 -5000Da, M_≤2000 : NMT 15%, M_2000-8000:75%-95%, M_2000-4000:35%-55%
		It complies with the test for calcium
Appearance of solution		The solution is not more opalescent than reference suspension II and not more intensely coloured than reference solution Y5
Ethanol		≤1.0%
pH		5.5-8.0
N-NO groups		≤ 0.25 ppm
Free sulfates		≤ 0.5%
Molar ratio of Sulfate carboxylate		≥1.8
Nitrogen		1.5 %-2.5 % (on the dried basis)
calcium		9.5% -11.5% (on the dried basis)
Loss on drying		NMT 10.0%
Bacterial endotoxins		＜0.01EU/IU
Assay		95-130 IU/mg (on the dried basis)