99% Raw Powder Larotrectinib Sulfate CAS 1223405-08-0 Pharmaceutical Powder Loxo-101

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Beijing Mesochem Technology Co., Ltd.

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1223405-08-0
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Mesochem
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Product Description
Certificate  of  Analysis
Product Name:
Larotrectinib
  CAS: 1223405-08-0
Batch No.HF160822Quantity1240kgs
Mfg. DateAug22, 2016PackageAs required
Rep. DateAug25, 2016Exp. DateAug21, 2018
ItemsStandardsResults
AppearanceWhite or off-white powderOff-white powder
IdentificationBy HPLCComplies
Melting Point120ºC~130ºC126ºC
Loss on Drying1.00%0.21%
Heavy Metals 10ppmComplies
Sulfated Ash 0.10%0.03%
Content17.5%~19.5%19.3%
 Content 0.1ppm0.09ppm
Lead VContent 3.0ppm0.50ppm
Content 0.1ppm0.10ppm
Content 0.1ppm0.10ppm
Microbiological TestColiforms:NegativeNegative
SalmonellaNegativeComplies
Total plate count1000 CFU/gPass
Yeast&Mold: 50 CFU/gPass
Related SubstancesImpurity A: 0.30%0.18%
Other unknown impurity0.10%0.07%
Total Impurities0.50%0.42%
Assay 98.0%99.50%
Reference StandardUSP Standard
ConclusionThe product complied to USP standard.
StoragePreserve in tight,light-resistant containers in a cool place
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