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东康源的地塞米松Dexamethasone什么质量标准,好不好看检测数据

CERTIFICATE OF ANALYSIS

质量报告单

Product Name: Dexamethasone Base       Cas No.:     50-02-2

Batch  No.:  20200803                 MFG Date:    Aug.03.2020

Report Date:  Aug.03.2020              Expiry Date:  Jul.31. 2022

Quantity:    100Kgs                  Confirm:     EP7.0

 

Item

Specification

Result

Appearance

White or almost White,
crystalline powder

Almost White
crystalline powder

Identification

B:IR
C:TLC

Conforms

Specific optical
rotation

+75°~+80°

+76.4°

Result
substances

 Individual impurity≤0.5%

0.37%

Total impurities≤1.0%

0.85%

Loss on drying

≤0.5%

0.20%

Assay

97.0%-103.0%

99.8%

Conclusion:  

The above product conforms to the specification of EP7.0

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