Product  name

Meprednisone Hemisuccinate

Batch No.

220801

Quantity

53.50kg

Mfg. Date

Aug.,25, 2022

Expiry date

Aug.,24, 2025

Specification

Enterprise Standard

Items

Standard

Results

Description

white or almost white  crystalline  powder

white crystalline powder

Identification

A(IR), B(HPLC)

complies

Loss on drying

≤1.0%

0.31%

Residue on ignition

≤0.1%

0.03%

Light absorption

310~330

323.7

Specific rotation

+174º~ + 182º

+178.8º

Related substance

single impurity not more than 1.0%

0.52%

total impurities not more than 2.0%

0.68%

Assay

98.0%~102.0%

99.2%

Particle size

90%≤20um

complies

80%≤10um

complies

CONCLUSION:THIS BATCH OF PRODUCT CONFORM TO ENTERPRISE STANDARD

Analyst

Checker

Approved by