Methylprednisolone (API – CAS 83-43-2 | DMF, KFDA)

Overview

Methylprednisolone is a potent corticosteroid active pharmaceutical ingredient (API) in the Corticosteroid therapeutic category. It is widely used in topical, ophthalmic, oral, and parenteral formulations for its anti-inflammatory and immunosuppressive properties. Manufactured to IP / BP / USP / EP pharmacopoeial standards.

Therapeutic Application

Methylprednisolone is a synthetic glucocorticoid used in oral and injectable formulations for a wide range of inflammatory, allergic, and autoimmune conditions including rheumatoid arthritis and severe asthma.

Specifications

• CAS Number: 83-43-2
• Appearance: White to off-white crystalline powder
• Typical Assay/Purity: ≥ 99.0%
• Common Pharmacopeial Grades: IP / BP / USP / EP
• Storage: Store in a cool, dry place, away from light
• Shelf Life: Typically 24 months under recommended storage conditions

Regulatory & Compliance

Pharmint Exports adheres to WHO-GMP manufacturing practices, ensuring that Methylprednisolone is produced in compliance with international quality standards. DMF Status: DMF Available. Approved regulatory authorities/registrations: KFDA. Availability of regulatory documents such as USDMF, CEP, and EU-GMP certificates, along with Certificates of Analysis (COA) and Certificates of Suitability (COS), is subject to inquiry.

Packaging & Shipping

Methylprednisolone is packaged in 25kg HDPE drums with double LDPE liners, palletized for secure transport. All necessary export documentation is provided, facilitating shipping to key markets including EU, USA, Brazil, China, South Korea, Taiwan, Middle East.

Common Use Cases & Finished Dosage Forms

This API is typically incorporated into various dosage forms including:

• Tablets
• Capsules
• Injectable solutions

Ordering Information

The minimum order quantity (MOQ) for Methylprednisolone is subject to inquiry. Interested parties are encouraged to request a Certificate of Analysis (COA) and a quote via this listing. For further inquiries, please contact Pharmint Exports directly.