Sinoway Industrial Co., Ltd

Date: 13th May 2016
Leuprolide Acetate
Sinoway Industrial Co.,Ltd is a famous China leuprolide acetate manufacturer and supplier,Website:, welcome to buy GMP and EP leuprolide acetate from us and check the price with us.COA of Leuprolide acetate (EP7):Product NameLeuprolide AcetateStandardEP7CAS. No.74381-53-6Batch No.20150701Molecular FormulaC59H84N16O12Molecular Weight1209Manufacturing DateJan.,2015Retest DateDec.,2017StorageNMT 30??SequenceTEST ?ITEMSSPECIFICATIONRESULT1AppearanceWhite powderConforms2SolubilitySoluble in water or 1% acetic acid at aconcentration of ?1mg/ml to give a clear,colorless solutionConforms3IdentityA. IRSame with the reference spectrum of LeuprolideB. HPLCSame with the reference solutionC. Amino Acid AnalysisSer: PresentGlu: 0.85?1.1Pro: 0.85?1.1Leu: 1.80?2.2Tyr: 0.85?1.1His: 0.85?1.1Arg: 0.85?1.1Trp: PresentConformsConforms0.950.991. Optical Rotation-38.0?-42.0?[a]20D(c=1?1% HAc)-40.1?5RelatedSubstance(By HPLC)Total Impurities(%)?2.5%acetyl-leuprolide?1.0%D-His-leuprolide?0.5%L-Leu6-leuprolide?0.5%D-Ser-leuprolide?0.5%Any other Impurity?0.5%0.17%ConformsConformsConformsConforms0.17%6Acetate Content(By HPLC)4.7~9.0%7.5%7Water Content(Karl Fischer)?5.0%1.5%8Sulphate ash?0.3%Conforms9Bacterial Endotoxins?16.7 IU/mgConforms10Residual Organic SolventsAcetonitrile ?0.041%(By GC)DMF ?0.088%(By GC)MEOH ?0.3%(By GC)TFA ?0.1%(By HPLC)ConformsConformsConformsConforms11Assay(By Anhydrous, Acetic Acid-free )97.0?103.0%99.5%Functions of Leuprorelin Acetate :1) For prostate cancer treatment.2) For mammary gland cancePacking:plastic bottle(dedicated for peptide packing), quantity according toyour detail requirement.Storage:a cool(2~8 ) & dry place protected from light, keep package close when not in use
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