Ethynodiol Diacetate API Manufacturer & Supplier in India

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Ethynodiol Diacetate API Manufacturer & Supplier in India

Ethynodiol Diacetate is a synthetic progestin and an active pharmaceutical ingredient (API) used primarily in hormonal contraceptive formulations. It is a derivative of 19-nortestosterone and acts as a progestational agent.

Ethynodiol Diacetate is used in combination with an estrogen in certain combined oral contraceptive formulations, where its progestogenic activity contributes to suppression of ovulation and prevention of pregnancy.

What is Ethynodiol Diacetate?

Ethynodiol Diacetate is the diacetate ester of ethynodiol, a synthetic progestin. It is metabolized in the body to ethynodiol, which has progestational activity.

CAS Number: 297-76-7
Molecular Formula: C₂₄H₃₄O₄
Molecular Weight: 386.53 g/mol

Mechanism of Action

Ethynodiol Diacetate exerts progestational effects primarily through interaction with progesterone receptors.

In combined oral contraceptive formulations, its effects include:

  • Suppression of ovulation
  • Alteration of cervical mucus
  • Changes in the endometrium
  • Reduction of conditions favorable for sperm penetration
  • Regulation of reproductive hormone activity

Pharmaceutical Applications

Ethynodiol Diacetate is used in pharmaceutical formulations for:

  • Hormonal contraception
  • Combined oral contraceptive preparations
  • Prevention of pregnancy
  • Progestational hormonal therapy in approved formulations

The exact use depends on the final formulation, country and applicable regulatory labeling.

Ethynodiol Diacetate API

Ethynodiol Diacetate is a steroidal progestin API with defined chemical and stereochemical characteristics. Pharmaceutical-grade material requires appropriate control of identity, assay, related substances and other quality attributes.

Typical quality evaluation may include:

  • Identification
  • Assay
  • Related substances
  • Specific optical rotation
  • Water content
  • Residual solvents
  • Elemental impurities
  • Melting point
  • Particle-size characteristics, where applicable

Quality & Regulatory Considerations

Pharmaceutical-grade Ethynodiol Diacetate should comply with the applicable pharmacopoeial monograph, approved specification and regulatory requirements.

A qualified supplier should provide Certificate of Analysis (CoA), specification sheet, SDS/MSDS, batch traceability and applicable regulatory documentation.

Storage

Store Ethynodiol Diacetate in a tightly closed container, protected from excessive moisture, heat and direct light, according to the manufacturer's approved storage and stability requirements.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.5%
Heavy Metals NMT 10 ppm
pH (1% Solution) 2.0 – 4.0
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
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