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氟米松酸丨28416-82-2丨质量指标COA

 

Product  name

6ALPHA,9ALPHA-DIFLUORO-11BETA, 17ALPHA-DIHYDROXY

-16ALPHA-METHYL-ANDROSTA-1,4-DIENE-3-ONE-17BETA-CARBOXYLIC ACID

Batch No.

200302

Quantity

50kg

Mfg. Date

Mar.,31, 2020

Expiry date

Mar.,30,2022

Specification

in-house specification

Items

Specification

Result

Description

almost white or white crystalline  powder

Almost white crystalline powder

Identification

IR Complies with the standard

Complies

Melting Range

280~290℃

288.5-289.5℃

Water    

not more than 0.5%

0.05%

HPLC purity

-flumethasone

not more than 0.15%

n.d

-21-dehydroxy

not more than 0.3%

n.d

- Any single impurity

not more than 0.1%

0.1%

- Total impurities

not more than 1.0%

0.2%

Assay(HPLC)

98.0%--102.0%

100.7%

Residual Solvents

Tetrahydrofuran not more than 1.5%

Complies

Acetone not more than 0.5%

Complies

Acetic acid not more than 0.05%

Complies

Conclusion: this batch of product complies with the in-house specification.

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