Medroxyprogesterone API Manufacturer & Supplier in India

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

Medroxyprogesterone API Manufacturer in India

Medroxyprogesterone is a synthetic progestogen structurally related to the naturally occurring steroid hormone progesterone. It is used in pharmaceutical formulations for hormone-related conditions and as part of certain contraceptive preparations.

Medroxyprogesterone produces progestational effects by binding to progesterone receptors, influencing gene transcription and reproductive-system physiology. The compound is commonly used in the form of medroxyprogesterone acetate (MPA), which is the acetate ester of medroxyprogesterone.

Medroxyprogesterone Chemical Properties

Medroxyprogesterone is a synthetic steroidal progestogen with the molecular formula C22H32O3 and a molecular weight of approximately 344.49 g/mol. Its CAS Number is 520-85-4.

Medroxyprogesterone should be distinguished from medroxyprogesterone acetate, which has a different molecular formula, molecular weight and CAS number.

Mechanism of Action

Medroxyprogesterone acts primarily through the progesterone receptor. After receptor binding, the hormone-receptor complex influences transcription of progesterone-responsive genes.

Its progestational effects can suppress endometrial proliferation, alter cervical mucus and influence the hypothalamic-pituitary-gonadal axis.

Pharmaceutical Applications

Medroxyprogesterone and its acetate derivative have pharmaceutical applications in hormonal therapy, reproductive health and contraception.

Medroxyprogesterone acetate is particularly well established in injectable contraceptive formulations and is also used in selected gynecological and hormone-dependent conditions.

Medroxyprogesterone API Characteristics

  • Active Pharmaceutical Ingredient
  • Synthetic Progestogen
  • Steroidal Hormone
  • Progesterone Receptor Agonist
  • CAS Number: 520-85-4
  • Molecular Formula: C22H32O3
  • Molecular Weight: 344.49 g/mol
  • Therapeutic Category: Hormonal / Reproductive Health
  • Pharmacological Class: Progestogen
  • Primary Target: Progesterone Receptor
  • Route of Administration: Oral / Injectable depending on formulation
  • Drug Type: Small-Molecule Steroidal Pharmaceutical

Medroxyprogesterone Quality and Analytical Testing

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

HPLC, infrared spectroscopy and other validated analytical techniques can be used for identity, assay and purity determination. Steroid-related impurities and degradation products should be appropriately controlled.

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

Medroxyprogesterone Storage

Medroxyprogesterone 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 requirements should follow the applicable manufacturer's approved specification.

Medroxyprogesterone API Supply

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

Medroxyprogesterone API Manufacturer and Supplier in India

Medroxyprogesterone 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%
Heavy Metals NMT 10 ppm
Individual Impurity NMT 0.5%
Total Impurities NMT 2.0%
Water Content NMT 2.0%
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