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Xinyu Pharmaceutical Co., Ltd.

Address: 158, Jintai 5th Road, Economic

development zone, Suzhou, Anhui, China

E-mail: seco@xinyupharm.cn

Tel: +86-557-3621963

Contact: Ma Hongjuan +86-13696716656

Fax: +86-557-3622061

Website: www.xinyupharm.cn

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Lincomycin Hydrochloride (APIs)

Quality standard:CHP/USP/EP

Registered trademark:Wanbei

Specification:20kgA/drum; 25kg/drum

Home sales Tel: +86-557-3621963  Contact: Guo Fei +86-13805578207 CaoXuezhu +86-13365570668)

Export sales Tel: +86-557-3621963  Contact: Li Xiangzhao +86-13305570133 Ma Hongjuan +86-13696716656

Antibiotic medicine; for infection caused by staphylococcus, pneumococcus and streptococcus; for preparation of many dosage form, such as, lincomycin tablet, capsula and injection; for synthesis of clindamycin type derivative

In March, 2013, our production line of lincomycin hydrochloride passed CGMP review check of FDA;

In 2013, we got third-class prize of Anhui scientific and technological progress for our project: breeding lincomycin high-producing strain through mutagenesis technology and its industrialization study;

In October, 2013, our lincomycin hydrochloride fermentation and extraction project was listed in 1st batch of core project of patent by Anhui intellectual property office;

In November, 2011, production method of lincomycin hydrochloride was issued of patent of invention;

In April, 2011, our company passed Germany GMP authentication and got GMP certificate;

In March, 2010, production line of lincomycin hydrochloride passed America FDA authentication (DMF: 19056);

In February, 2009, production line of bulk pharmaceutical chemicals of lincomycin hydrochloride passed GMP authentication;

In 2009, we got third-class prize of Anhui scientific and technological progress for our project: technique improvement of lincomycin producing strain through genetic engineering and its industrialization exploitation;

In 2008, transformation of energy-saving technology of production line of lincomycin hydrochloride got national award;

In 2005, we undertook Torch Plan project: manufacturing of materials of lincomycin hydrochloride through preferred culture and resin absorption technique;

In 2005, we undertook project of technique improvement of lincomycin producing strain through genetic engineering and its industrialization exploitation;

In 2004, our production line of bulk pharmaceutical chemicals of lincomycin hydrochloride got GMP certificate;

In 2000, our lincomycin hydrochloride was awarded of 1st prize high-tech product in Anhui;

In 2000, the project of high yield and high quality strain breeding and new technique of lincomycin

In 2000, the project of high yield and high quality strain breeding and new technique of lincomycin, was awarded of Anhui 2nd prize for scientific and technological progress;

In 1999, our company got self-owned import and export right;

In 1999, bulk pharmaceutical chemical of lincomycin hydrochloride was approved as new and high-tech product;

In 1999, material and lincomycin hydrochloride and its injection were praised as Anhui famous-brand product;

In 1999, “Wanbei” brand lincomycin hydrochloride material and its injection were evaluated as Anhui famous trademark;

In December, 1990, bulk pharmaceutical chemical of lincomycin hydrochloride was put into operation.

[ English name ]Lincomycin Hydrochloride 

[ Structural formula ] 

[ Molecular formula ]C18H34N2O6S·HCl·H2O
[ Molecular weight ]461.02
[ Appearance ]white crystal powder with bitter taste
[ Category ]It is antibiotic drug. It is efficient for respiratory tract infection, skin soft-tissue infection, reproductive tract infections, pelvic cavity infections and abdominal infection caused by staphylococcus, Streptococcus, streptococcus pneumonia and anaerobic bacteria.
[ Packaging ]20kgA/drum; 5kg/tin; 25kg/drum

Quality standard:

Item EP specification USP specification 1 USP specification 2 CP specification 1 CP specification 2 CP specification 3
lincomycin B ≤3.0% ≤ 2.0% ≤0.1% ≤4.5% ≤2.0% <1.0%
unkown impurity ≤0.3% ≤0.3% ≤0.10% ≤1.0% up to specification up to specification
total unkown impurity ≤0.6% ≤0.6% / ≤2.0% up to specification up to specification
impurities
(including lincomycin B)
≤3.0% ≤ 3.0% ≤1.0% / / /
Content 82.5-93.0% ≥790ug/mg ≥83.0%

Address: 158, Jintai 5th Road, Economic development zone, Suzhou, Anhui, China  Tel: +86-557-3622083,  +86-557-3621963  Fax: +86-557-3622061

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