Active Pharmaceutical Ingredient

Methylprednisolone Hemisuccinate API Manufacturer & Supplier in India | MEDIOCON INC

CAS: 2921-57-5 Active Pharmaceutical Ingredient USP / Pharmaceutical Grade GMP Certified Aurangabad, Maharashtra, India
Methylprednisolone Hemisuccinate API Manufacturer & Supplier in India | MEDIOCON INC — Mediocon Inc
Methylprednisolone Hemisuccinate API Manufacturer & Supplier in India | MEDIOCON INC

Product Overview

CAS No: 2921-57-5 | Grade: USP / Pharmaceutical Grade | Category: Active Pharmaceutical Ingredient

Methylprednisolone Hemisuccinate API Manufacturer & Supplier in India

MEDIOCON INC is a trusted global Methylprednisolone Hemisuccinate API Manufacturer & Supplier in India, providing pharmaceutical-grade active pharmaceutical ingredient information and technical support for pharmaceutical manufacturing, corticosteroid formulation development, analytical testing, quality control, stability studies, and research applications. Methylprednisolone Hemisuccinate is a corticosteroid ester associated with methylprednisolone and is used as an important pharmaceutical intermediate/API form in the development of corticosteroid formulations.

Methylprednisolone Hemisuccinate is the hemisuccinate ester of methylprednisolone and belongs to the synthetic glucocorticoid class. The compound is chemically identified as 11β,17,21-Trihydroxy-6α-methylpregna-1,4-diene-3,20-dione 21-(hydrogen succinate). It has the molecular formula C₂₆H₃₄O₈, molecular weight 474.54 g/mol, and CAS Number 2921-57-5. The USP monograph defines Methylprednisolone Hemisuccinate at 97.0%–103.0%, calculated on the dried basis.

MEDIOCON INC provides Methylprednisolone Hemisuccinate API-related technical and quality information to pharmaceutical manufacturers, formulation companies, contract manufacturing organizations (CMOs), contract development and manufacturing organizations (CDMOs), analytical laboratories, research organizations, and other qualified pharmaceutical industry users, with applicable documentation including COA, MSDS/SDS, Technical Data Sheet (TDS), analytical information, and product specifications.

 

Product Specifications

Product NameMethylprednisolone Hemisuccinate API Manufacturer & Supplier in India | MEDIOCON INC
CAS Number2921-57-5
CategoryActive Pharmaceutical Ingredient
GradeUSP / Pharmaceutical Grade
StandardsUSP

Analytical Specifications

ParameterSpecification
Assay (HPLC)97.0% – 103.0%
Loss on DryingNMT 1.0%
Residue on IgnitionNMT 0.20%
Individual ImpurityNMT 1.0%
Total ImpuritiesNMT 2.0%
Water ContentNMT 1.0%.
Specific Rotation+87° to +95°
SolubilityQuantitative general solubility specification not reliably available / Cannot be verified; USP uses dioxane as the solvent for the specific-rotation test.

Sourcing, Regulatory & Export Information

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Methylprednisolone Hemisuccinate API Manufacturer & Supplier in India | MEDIOCON INC (CAS 2921-57-5) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Methylprednisolone Hemisuccinate API Manufacturer & Supplier in India | MEDIOCON INC is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing before release with a Certificate of Analysis.

Export Markets

  • USA — FDA-registered facility; DMF support available for ANDA/NDA filings
  • Europe — EMA-compliant documentation; CEP/EDMF support on request
  • Africa & Middle East — WHO-GMP certified; competitive pricing for emerging markets
  • Southeast Asia — established logistics network; temperature-controlled shipments
  • India domestic — schedule H/X compliance; all state licensing documentation provided

Quality & Compliance

  • ISO 9001:2015 certified quality management system
  • GMP-certified manufacturing facility, Aurangabad, Maharashtra
  • Full batch traceability from raw material to finished API
  • Dedicated QA team for customer audits and regulatory queries

Frequently Asked Questions — Methylprednisolone Hemisuccinate API Manufacturer & Supplier in India | MEDIOCON INC

What is Methylprednisolone Hemisuccinate API?
Methylprednisolone Hemisuccinate is a synthetic glucocorticoid ester of methylprednisolone containing a hydrogen succinate group. It is identified by CAS Number 2921-57-5 and molecular formula C₂₆H₃₄O₈.
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