Methylprednisolone(83-43-2)–Excipients Featured Image
  • Methylprednisolone(83-43-2)–Excipients


CAS No.: 83-43-2

EINECS No.: 374.4706

MF: C22H30O5

Product Detail

New Description

Product Description

●  Methylprednisolone, an organic compound, is a medium-acting glucocorticoid with strong anti-inflammatory effects.

● Methylprednisolone is used for emergency treatment of critical diseases and also for endocrine disorders, rheumatic diseases, collagenous diseases, skin diseases, allergic reactions, ophthalmic diseases, gastrointestinal diseases, blood diseases, leukemia, shock, cerebral edema, polyneuritis, myelitis and prevention of vomiting caused by cancer chemotherapy. Currently, it is mainly used in clinical practice for organ transplantation.

● Quality Standard: USP

Product Methylprednisolone Manufacturing date 2017.05.15
Batch No. NXEMP 170601 Report date 2017.06.14
Criteria EP 8.0 Retest date 2019.05.15
Specification Result
Characteristic A white or almost white, crystalline powder White crystalline powder
Identification A(IR), B(HPLC) Conforms
Specific optical rotation +97.0° 〜+103.0° +99.7°
Related substances Total impurities < 2.0%

Impurity A < 0.3%

Impurity B < 0.2%

Impurity C < 0.15%

Impurity D (D isomerl and D isomer2)< 0.5%

Impurity E < 0.15%

Impurity H < 0.2%

The sum of impurities G and I < 0.3%

Unspecified impurities < 0.10%

Total: 0.14%<0.05%0.08%<0.05%D isomerl :<0.05%D isomer2:<0.05%<0.05%<0.05%<0.05%Conforms
Loss on drying <1.0% 0.16%
Assay 97.0% ~ 102.0% 100.8%
Residual solvents Dichloromethane < 600ppmMethanol < 3000ppm 73ppm249ppm
Batch size 72.3kg
Quantity 72.3kg
Conclusion The above product conforms to EP8.0

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