首页制药产品大全原料药 Heparin Sodium directly manufacture with best price 2016

Heparin Sodium directly manufacture with best price 2016

更新时间：2024-12-04

价格：面议

CAS号： 9041-08-1

药典：中国药典,美国药典,英国药典,欧洲药典,日本药典

级别：注射级

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产品详情

产品包装规格： 1 5 8 10kg/bag

供货能力： 1000kg

交货周期： 20 days

主要销售市场：中/南美洲,西欧,东欧,大洋洲,亚洲,中东,非洲

是否提供样品：是

产品描述：

Name			Heparin Sodium		Batch No.	ZH150504
	Specification			API		Test Date	2015.05.14
	Report Date			2015.05.21		Total Quantity	62.485 Kg
	Expiry Date			2018.05.13
Test Standard				CP 2010 V2
Test Items				Standards			Results
1	Character			White or off white powder, hygroscopic, freely soluble in **,			Qualified
2	Identi-ficat-ion	A:HPLC		In chromatogram recorded under concerned matter, the retention time of main peak of test solution should be accordance with reference solution.			Qualified
3		B:Sodium Salt		Sodium salt is found in ** solution.			Qualified
4	Test	Specific Rotation		≥+50º			+50.5º
5		Total Nitrogen		1.3%~2.5%			2.0%
6		PH		5.0~7.5			7.4
7		Clarity and Color of Solution		Meet the standard			Qualified
8		Absorbance		260nm:≤0.10			0.035
				280nm≤0.10			0.021
9		Concerned Matter		Dermatan sulfate ≤ 5.0%,other impurities are not less than 3.0% which is calculated with area normalization method after main peak of heparin sodium.			Dermatan sulfate:0.8% Other impurities: Negative
10		Residue Solvant		Calculated with peak area according to internal standard method, content of methanol, ethanol and acetone should be separately less than 0.3%, 0.5% and 0.5%.			Methanol:Negative Ethanol:0.0007% Acetone:Negative
11		Loss on Drying		≤ 5.0%			1.3%
12		Residue on Ignition		28.0%~41.0%			38.6%
13		Sodium		9.5%~12.5%			11.1%
14		Heavy Metal		≤Thirty millionths			Qualified
15		Bacterial Endotoxin		< 0.010EU/(IUof heparin)			Qualified
16		Potency		≥170IU/mg(Should be 91%~110% of labeled amount)			208IU/mg
17	Microbial Limit	Bacterium		≤100CFU/g			<10CFU/g
18		Mould		≤10CFU/g			<10CFU/g
19		E.coli		Negative			Negative
20		Salmonella		Negative			Negative
Conclusions				The product is qualified after tested according to CP2010 V2

辰欣药业股份有限公司

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注册资本250,000,000至499,999,999

公司地址

山东省济宁市高新区同济路

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