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    This certificate of analysis is for a 550kg batch of ampicillin trihydrate produced by North China Pharmaceutical Group Semisyntech Co., Ltd. on August 20, 2014. The results of tests for characteristics, identification, assay, water content, appearance of solution, pH, specific optical rotation, sulphated ash, and related substances all comply with British Pharmacopoeia 2012 specifications. N,N-Dimethylaniline is not used in the manufacturing process.

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    This certificate of analysis is for a 550kg batch of ampicillin trihydrate produced by North China Pharmaceutical Group Semisyntech Co., Ltd. on August 20, 2014. The results of tests for characteristics, identification, assay, water content, appearance of solution, pH, specific optical rotation, sulphated ash, and related substances all comply with British Pharmacopoeia 2012 specifications. N,N-Dimethylaniline is not used in the manufacturing process.

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    15 views1 page

    Amp Pow PDF

    Uploaded by

    Tan Yoong
    This certificate of analysis is for a 550kg batch of ampicillin trihydrate produced by North China Pharmaceutical Group Semisyntech Co., Ltd. on August 20, 2014. The results of tests for characteristics, identification, assay, water content, appearance of solution, pH, specific optical rotation, sulphated ash, and related substances all comply with British Pharmacopoeia 2012 specifications. N,N-Dimethylaniline is not used in the manufacturing process.

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    NORTH CHINA PHARMACEUTICAL GROUP SEMISYNTECH CO.，LTD.

    CERTIFICATE OF ANALYSIS

    AMPICILLIN TRIHYDRATE

    BATCH NO.: 1214082009 MANUFACTURING DATE: 20/08/2014

    QUANTITY: 550kg REPORT DATE: 23/08/2014

    PACKING: 25kg/drum EXPIRATION DATE: 07/2017

    ITEMS SPECIFICATIONS RESULTS

    Characteristic A white crystalline powder A white crystalline powder

    Identification conforms conforms

    Assay
    96.0% ~ 102.0% 99.1%
    (on the anhydrous substance)

    Water 12.0% ~ 15.0% 13.5%

    Appearance of solution ≤2 1

    pH 3.5 ~ 5.5 4.4

    Specific optical rotation +280°~ +305° +297°

    Sulphated ash ≤0.5% 0.1%

    Related substances ≤1.0% 0.2%

    CONCLUSION: COMPLIES WITH BP2012


    Remark: N,N-Dimethylaniline is
    not used in the manufacturing Quality Manager:
    process of Ampicillin Trihydrate

    Address : No.20 Yangzi Road Shijiazhuang Economic &Technological Development Zone,Hebei,P.R.China


    Tel: +86-311-83098234 Fax : +86-311-83098198
    Post code: 052165 E-mail: xiantai@sohu.com

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