Heparin Sodium
CAS No.: 9041-08-1 (Anticoagulant)

Short Description:

Source: Extracted from pig intestinal mucosa
Function and use: It is an anticoagulant. It affects many aspects of the coagulation process and can prolong the coagulation time and prothrombin time. This product has rapid anticoagulant effect both in vivo and in vitro. It mainly acts on the formation of fibrin and can also reduce platelet aggregation. For the prevention and treatment of thromboembolic diseases, such as myocardial infarction, pulmonary embolism, cerebrovascular embolism, peripheral venous thrombosis, etc., it can prevent the formation and expansion of thrombus. It can also be used in the early stage of DIC and other anticoagulation in vitro and in vivo. Early application can prevent depletion of fibrinogen and coagulation factors. It can also be used as an anticoagulant in vitro instead of citrate during blood transfusion or during cardiopulmonary bypass.

Heparin?Sodium-Pharmacopoeia?Standard:?BP/EP

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Specification

Heparin Sodium
Source		Intestinal mucosa of pigs
Quality standard		CP	USP	EP
characters	Appearance	white or almost white;?hygroscopic powder	/	white or almost white;?hygroscopic powder
characters	solubility	freely soluble in water	/	freely soluble in water
specific rotation		≥+50°	/	/
identification		Anti- Xa activity/?anti-?IIa?: ?0.9 -?1.1	Anti- Xa activity/?anti-?IIa?: ?0.9 -?1.1	Anti- Xa activity/?anti-?IIa?: ?0.9 -?1.1
		reference solutions(3）：peak-to-valley minimum 1.3；the principal peak in the chromatogram obtained with test solution(a) is NMT 5% (RSD)in retention time and shape to the principal peak in the chromatogram obtained with reference solutions(3）	/	reference solutions(C）：peak-to-valley minimum 1.3；the principal peak in the chromatogram obtained with test solution(a) is similar in retention time and shape to the principal peak in the chromatogram obtained with reference solutions(C）
		It gives positive reaction of sodium	A solution of Heparin Sodium imparts an intense yellow color to a nonluminous flame	It complies with the test for 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 5.70-8.00ppm,No signals greater than 200% of the mean of the height of signals and 2 arepresent in the 3.75-4.55ppm for porcine heparin	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 5.70-8.00ppm,No signals greater than 200% of the mean of the height of signals and 2 are present in the 3.75-4.55ppm for porcine heparin
MW		M₂₄₀₀₀?:?NMT 20%, Mw :?15,000 -19,000Da, and the ratio of M_8000-16000?/M_16000-24000??≥1.0	M₂₄₀₀₀?:?NMT 20%, Mw :?15,000 -19,000Da, and the ratio of M_8000-16000?/M_16000-24000??≥1.0	M₂₄₀₀₀?:?NMT 20%, Mw :?15,000 -19,000Da, and the ratio of M_8000-16000?/M_16000-24000??≥1.0
Nitrogen		1.5 -2.5 %?(on the dried basis)	1.3?-2.5 %?(on the dried basis)	1.5 -2.5 %?(on the dried basis)
pH		5.0-8.0	5.0-7.5	5.0-8.0
Appearance of solution		clear；NMT: intensity?1	/	clear；NMT: intensity?5
Nucleotidic impurities		A260nm is not greater than 0.10	NMT 0.1% (w/w)	A260nm is not greater than 0.15
Protein		≤0?0.5 per cent (on the dried?basis)	NMT 0.1% (w/w)	≤0.5 %(on the dried?basis)
Related substances		no more than the area of the peak due to dermatan sulfate and chondroitin sulfate in the chromatogram obtained with reference solutions(5）(2.0 per cent)；no peak with an area greater than 0.01 times the area of the peak due to dermatan sulfate and chondroitin sulfate in the chromatogram obtained with reference solutions(e）is detected	/	no more than the area of the peak due to dermatan sulfate and chondroitin sulfate in the chromatogram obtained with reference solutions(e）(2.0 per cent);no peak with an area greater than 0.01 times the area of the peak (corresponding to a disregard limit of 0.02 per cent)
Residual solvents		Ethanol≤0.5%	/	/
Loss on drying		NMT 5.0%	NMT 5.0%	NMT 8.0%
Residue on Ignition		28.0%-41.0%	28.0%-41.0%	/
Sodium		10.5 per cent to 13.5 per cent (dried substance)	/	10.5 per cent to 13.5 per cent (dried substance)
Heavy metals		≤30ppm	/	/
Bacterial endotoxins		＜0.010EU/IU	<0.03EU/U	＜0.010EU/IU
Limit of Galactosamine in Total Hexosamine		/	NMT 1%	/
Absence of Oversulfated Chondroitin Sulfate		/	NO features associated with oversulfated chondroitin sulfate are found between 2.12 and 3.00 ppm; ??????????????????????No peaks corresponding to oversulfated chondroitin sulfate should be detected eluting after the heparin peak	/
Assay		≥180 IU/mg (on the dried basis)	≥180 USP U/mg (on the dried basis)	≥180 IU/mg (on the dried basis)