數(shù)量

QUANTITY

25KG

生產(chǎn)日期

MANUFACTURE DATE

2018.09.28

Sep.28.2018

檢驗(yàn)依據(jù)

TESTSTANDARD

《美國藥典》36版

USP XXXVI

有效日期

EXPIRATION DATE

2020.09.27

Sep.27.2020

  Apearance

White or off-white powder

Conforms

  Identification

UV conform

Conforms

  Organic nitrogenous bases

      Conforms

Conforms

  Citrate

      Conforms

Conforms

Solution

 Slightly soluble in water and in chloroform freely soluble in methanol sparingly soluble in alcohol insoluble in ether

Conforms

  Water

   Not more than 1.0%

0.33%

  Heavy metals

   Not more than 0.002%

Conforms

  Related impurities

   Related compound A : Not more than 2.0%

0.42%

   Individual: Not more than 0.5%

0.35%

Total impurities : not more than 2.0%

1.55%

（Z）isomer

      Between 30% to 50%

  31.2%

  Organic volatile impurities

Ethonol : not more than 5000PPM

800PPM

  Assay

Between 98.0% to 102.0%

 98.8%