Methylprednisolone Acetate API Manufacturer in India

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Methylprednisolone Acetate API

Methylprednisolone Acetate is a synthetic glucocorticoid corticosteroid with anti-inflammatory and immunosuppressive properties. It is the acetate ester of methylprednisolone and is used in pharmaceutical formulations for managing inflammatory and immune-mediated conditions.

Methylprednisolone Acetate acts primarily through the glucocorticoid receptor, regulating gene transcription and suppressing the production of inflammatory mediators.

Methylprednisolone Acetate API Manufacturer in India

Methylprednisolone Acetate is a specialized corticosteroid pharmaceutical API used in the manufacture of injectable and other pharmaceutical formulations.

The USP monograph specifies NLT 97.0% and NMT 103.0% methylprednisolone acetate, calculated on the dried basis.

Chemical Information

CAS Number: 53-36-1
Molecular Formula: C24H32O6
Molecular Weight: 416.51 g/mol
Chemical Name: Methylprednisolone Acetate
Synonyms: 6α-Methylprednisolone 21-acetate; Methylprednisolone 21-acetate
Drug Class: Glucocorticoid
Therapeutic Class: Corticosteroid / Anti-inflammatory
Therapeutic Area: Immunology / Rheumatology / Dermatology / Allergy
Molecule Type: Synthetic Steroidal Compound

PubChem lists CAS 53-36-1, molecular formula C24H32O6, and molecular weight 416.5 g/mol.

Mechanism of Action

Methylprednisolone Acetate acts as a glucocorticoid receptor agonist. Following receptor activation, it influences gene expression involved in inflammatory and immune responses.

Its pharmacological effects include:

  • Suppression of inflammatory mediator production
  • Reduction of immune-system activity
  • Modulation of cytokine signaling
  • Reduction of inflammatory tissue responses
  • Glucocorticoid receptor-mediated transcriptional regulation

Pharmaceutical Applications

Methylprednisolone Acetate API is used in pharmaceutical development for conditions involving inflammation and immune responses, including:

  • Rheumatic disorders
  • Allergic conditions
  • Dermatological disorders
  • Respiratory inflammatory conditions
  • Autoimmune and inflammatory disorders
  • Other corticosteroid-responsive conditions

Dosage Form Applications

Methylprednisolone Acetate is particularly associated with:

  • Injectable suspensions
  • Intramuscular formulations
  • Intra-articular preparations
  • Other corticosteroid pharmaceutical formulations

Physical Characteristics

Methylprednisolone Acetate is a steroidal crystalline pharmaceutical substance. The exact appearance and physical characteristics should be controlled according to the applicable pharmacopoeial or approved API specification.

Manufacturing Process

A controlled Methylprednisolone Acetate API manufacturing process may involve:

  1. Selection of qualified steroidal starting material
  2. Controlled steroid-ring synthesis/modification
  3. Introduction of the required methyl and hydroxyl functionalities
  4. Acetylation of the 21-hydroxyl group
  5. Purification
  6. Crystallization
  7. Filtration
  8. Controlled drying
  9. Milling or sieving where required
  10. Final analytical testing
  11. Pharmaceutical-grade packaging

Quality Control Testing

Typical Methylprednisolone Acetate API testing includes:

  • Identification by IR
  • HPLC identification
  • Assay
  • Related substances
  • Water / loss on drying
  • Residual solvents
  • Elemental impurities
  • Optical/stereochemical purity where applicable
  • Residue on ignition
  • Melting range
  • Particle-size characteristics where applicable
  • Stability testing

Storage

Store Methylprednisolone Acetate API in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive moisture, heat and direct light.

Pharmaceutical Research

Methylprednisolone Acetate is relevant to research involving:

  • Glucocorticoid receptors
  • Corticosteroid pharmacology
  • Inflammatory diseases
  • Immune modulation
  • Rheumatology
  • Dermatology
  • Allergy and respiratory inflammation
  • Steroidal drug development

Methylprednisolone Acetate API Summary

Methylprednisolone Acetate is a synthetic glucocorticoid corticosteroid with CAS Number 53-36-1, molecular formula C24H32O6, and molecular weight 416.51 g/mol. The current USP monograph defines its content as 97.0%–103.0% on the dried basis.

Detailed Specifications

Parameter Specification
Appearance White crystalline powder or crystals
Identification IR & HPLC compliant
Assay (HPLC) 97.0%–103.0%
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.2%
Heavy Metals NMT 20 ppm
Water Content NMT 1.0%
Melting Point Approximately 224–230°C
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