PRODUCT:

Methylprednisolone

ANALYSIS DATE:

2019-9-5

BATCH NO:

1909001

DATE OF MANUFACTURING:

2018-9-1

RETEST DATE:

2021-8-31

QUANTITY:

10KG

CAS NO:

83-43-2

DATE OF

REEVALUATION:

2021-8-31

DATE OF EXPIRY:

2021-8-31

STANDARD:

USP34

ITEM AND RESULT

Item

Test based on

specification

Result

Appearance

USP34

White to practically white

Crystalline powder

Almost white crystalline powder

Identification

USP34

A.IR

B.UV

C.Positive reaction

Complies

Specific rotation

USP34

+79°~+86°

+82.5°

Loss on drying

USP34

≤1.0%

0.19%

Residue on ignition

USP34

≤0.2%

0.06%

Chromatographic purity

USP34

Single impurity≤1.0%

0.26%

Total impurities≤2.0%

0.58%

Residual solvents

In-house Standard

Methanol≤0.2%

Dichloromethane≤0.05%

Acetone≤0.2%

Ethanol≤0.3%

Ethyl acetate≤0.3%

0.02%

ND

ND

0.06%

ND

Assay

USP34

97.0%~103.0%

99.1%