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Product Description

Product Name:	simvastatin ammonium salt
Synonyms:	;SIMVASTATIN HYDROXY ACID, AMMONIUM SALT;Ammonium (3R,5R)-7-[(1S,2S,6R,8S,8aR)-8-(2,2-dimethylbutyryloxy)-1,2,6,7,8,8a-hexahydro-2,6-dimethyl-1-naphthyl]-3,5-dihydroxyheptanoate;1-Naphthaleneheptanoic acid, 8-(2,2-dimethyl-1-oxobutoxy)-1,2,6,7,8,8a;1-Naphthaleneheptanoic acid, 8-(2,2-dimethyl-1-oxobutoxy)-1,2,6,7,8,8a-hexahydro-,d-dihydroxy-2,6-dimethyl-, monoammonium salt, (R,dR,1S,2S,6R,8S,8aR)-;Simvastatin impurity A;(3R,5R)-7-((1S,2S,6R,8S,8aR)-8-(2,2-dimethylbutanoyloxy)-2,6-dimethyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl)-3,5-dihydroxyheptanoate ammonium salt;Simvastatin hydroxyl acid ammonium salt;Simvastatin Ammouium Salt;
CAS NO:	139893-43-9
Molecular Formula:	C₂₅H₃₉O₆·NH₄
Molecular Weight:	453.62
Molecular Structure:

Simvastatin燼mmonium爏alt

Simvastatin ammonium salt

Batch NO.20050101
Quantity 100kgs Report date 2005/01/01
Manufacture date 2005/01/03 REPORT DATE: 2005/01/03
Expiry date 2008/01/02
Test standard CP2000

Testing Items	Specification	Result
Description :	off-white or straw yellow crystalline powder
Loss On drying:	<=0.5%	0.06%
Single impurity:	<=0.4%	0.12%
Limited of lovastatin:	<=1.0%	0.1%
Assay (On Dry Basis):	>=98.0%	99.1%
Total Impurity:	<=1.5%	0.52%

This is certified that we, the undersigned, have inspected the quality of above-mentioned goods and found the result as following:

CONCLUSION: Be up to the Standard of CP2000

Approved by: WangRuZhou牋牋牋牋牋牋牋牋牋牋牋Tested by: ZhouShuHai

Execute Standard: Enterprise Standard

Certificated By: No

Packaging: By the order

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Zhejiang Jiangbei Pharmaceutical Co., Ltd. was founded in October, 1991. Located in Taizhou city (a scenic and coastal city at East Sea in China) of Zhejiang province, Zhejiang Jiangbei Pharmaceutical Co., Ltd. is a private manufacturing enterprise of APIs and pharmaceutical intermediates. Covering an area of 60,000sqm, Zhejiang Jiangbei Pharmaceutical Co., Ltd. now has CNY 80 million of fixed assets and more than 300 employees, 50 of them are technicians with college degree at least, and 10 own medium or senior technical titles. At present, Zhejiang Jiangbei Pharmaceutical Co., Ltd. is a technical enterprise of Zhejiang province, and a Hi-tech enterprise of Taizhou city and a "522" key backbone enterprise of Jiaojiang district. Following market demands, we invest more and more in technical innovations and the optimization of product structure, and lay great stresses on the importance of product quality. Our main products are the APIs and pharmaceutical intermediates of pharmaceuticals, including cardiovascular drugs, antituberculosis drugs, drugs for central nervous system and antiepileptic drugs, etc. Up to now, we have obtained a series of certificates successfully: We got the certificates of ISO9001 quality system and ISO14001 EMS in November, 2010, and the national GMP certification of China in January, 2011. As a licensed import and export enterprise, we have sold our products into more than 20 countries and regions such India, Japan, EU, USA and Southeast Asia, etc. WE sold more than CNY 200 million of products in 2011. Based on present successes, we aim to get a bright future. In addition to adjust and optimize the structure of products continuously, we are also working hard to be a manufacturer of pharmaceutical preparations. Through integrating the industrial chains of APIs and pharmaceutical preparations, we are striving to be a leading pharmaceutical enterprise in the world!

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Dongdai Dock Zhangan Street Jiaojiang District Taizhou City Zhejiang Province ,China

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simvastatin ammonium salt

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