Medroxyprogesterone Acetate API Manufacturer & Supplier in India

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101

Medroxyprogesterone Acetate API Manufacturer in India

Medroxyprogesterone Acetate (MPA) is a synthetic progestogen and acetate ester of medroxyprogesterone. It is a steroidal pharmaceutical compound that produces effects similar to those of the naturally occurring hormone progesterone.

Medroxyprogesterone Acetate is widely used in pharmaceutical formulations for contraception, gynecological conditions and hormone-related therapies. It is available in oral and injectable dosage forms, with the injectable form being used as a long-acting hormonal contraceptive.

Medroxyprogesterone Acetate Chemical Properties

Medroxyprogesterone Acetate has the molecular formula C24H34O4 and a molecular weight of approximately 386.53 g/mol. Its CAS Number is 71-58-9.

It is a synthetic pregnane steroid and is structurally related to progesterone. The acetate ester provides different physicochemical and pharmacokinetic properties compared with medroxyprogesterone itself.

Mechanism of Action

Medroxyprogesterone Acetate acts primarily as an agonist of progesterone receptors. After binding to progesterone receptors, the resulting receptor complex influences the expression of progesterone-responsive genes.

In contraceptive applications, MPA suppresses gonadotropin secretion and ovulation, while also producing changes in cervical mucus and the endometrium that contribute to contraceptive activity.

Pharmaceutical Applications

Medroxyprogesterone Acetate is used in pharmaceutical formulations for:

  • Hormonal contraception
  • Management of secondary amenorrhea
  • Management of abnormal uterine bleeding associated with hormonal imbalance
  • Endometrial protection in selected hormone therapy regimens
  • Selected hormone-dependent conditions
  • Palliative treatment of certain advanced hormone-responsive cancers

The approved indications depend on the dosage form, strength and regulatory jurisdiction.

Medroxyprogesterone Acetate API Characteristics

  • Active Pharmaceutical Ingredient
  • Synthetic Progestogen
  • Steroidal Hormone
  • Progesterone Receptor Agonist
  • CAS Number: 71-58-9
  • Molecular Formula: C24H34O4
  • Molecular Weight: 386.53 g/mol
  • Therapeutic Category: Hormonal / Reproductive Health
  • Pharmacological Class: Progestogen
  • Primary Target: Progesterone Receptor
  • Route of Administration: Oral / Intramuscular
  • Drug Type: Small-Molecule Steroidal Pharmaceutical

Medroxyprogesterone Acetate Quality and Analytical Testing

Medroxyprogesterone Acetate API can be evaluated using validated analytical procedures for identification, assay, related substances, water content, residual solvents, elemental impurities and other applicable quality attributes.

HPLC, infrared spectroscopy and other validated analytical methods may be used for identification, assay and purity determination. Steroidal impurities, degradation products and residual process-related impurities should be appropriately controlled.

Final acceptance criteria should be based on the applicable manufacturer's approved drug-substance specification and Certificate of Analysis.

Medroxyprogesterone Acetate Storage

Medroxyprogesterone Acetate should be stored in a tightly closed pharmaceutical-grade container under controlled conditions and protected from excessive heat, moisture and direct light.

Specific storage and transportation conditions should follow the applicable manufacturer's approved specification.

Medroxyprogesterone Acetate API Supply

Medroxyprogesterone Acetate API may be supplied for qualified pharmaceutical manufacturing, formulation development, analytical and research applications, subject to applicable regulatory and quality requirements.

Medroxyprogesterone Acetate API Manufacturer and Supplier in India

Medroxyprogesterone Acetate API is available for qualified pharmaceutical development and manufacturing requirements. Customers can request product specifications, Certificate of Analysis, analytical documentation, packaging information and commercial details according to their requirements.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 2.0%
Residue on Ignition NMT 1.0%
Individual Impurity NMT 0.5%
Total Impurities NMT 2.0%
Water Content NMT 2.0%
Melting Point Approximately 200–210 °C
Get Bulk Quote via WhatsApp