Megestrol Acetate API Manufacturer in India

Megestrol Acetate API

Megestrol Acetate is a synthetic progestin derived from progesterone. It is a hormonal pharmaceutical ingredient with progestational activity and is used in pharmaceutical formulations for specific hormone-dependent conditions. It is also used to help manage anorexia and cachexia associated with cancer or AIDS.

Megestrol Acetate API Manufacturer in India

Megestrol Acetate is a specialized hormonal pharmaceutical API used in the development and manufacture of oral pharmaceutical formulations.

Important quality attributes include identity, assay, related substances, water content, residual solvents, residue on ignition, specific optical rotation and elemental impurities, according to the applicable API specification.

Chemical Information

CAS Number: 595-33-5
Molecular Formula: C24H32O4
Molecular Weight: 384.52 g/mol
Chemical Name: Megestrol Acetate
Drug Class: Progestin
Therapeutic Class: Hormonal Agent / Appetite Stimulant
Therapeutic Area: Oncology / Hormonal Therapy
Molecule Type: Synthetic Steroidal Compound

Mechanism of Action

Megestrol Acetate is a synthetic progestational agent that binds to progesterone receptors and produces progesterone-like effects.

Its pharmacological activity is associated with:

• Progesterone receptor activation
• Modulation of hormone-responsive tissues
• Progestational effects
• Appetite stimulation in selected clinical settings

Pharmaceutical Applications

Megestrol Acetate API is used in pharmaceutical development for:

• Anorexia associated with cancer
• Cachexia associated with cancer
• AIDS-associated anorexia and significant weight loss
• Hormone-dependent conditions
• Progestin-based pharmaceutical formulations
• Oncology pharmaceutical research

Dosage Form Applications

Megestrol Acetate is commonly formulated as:

• Oral tablets
• Oral suspensions
• Other oral pharmaceutical preparations

Physical Characteristics

Megestrol Acetate is generally described as a white to off-white crystalline powder. Its physical and solid-state characteristics should be controlled according to the applicable API specification.

Manufacturing Process

A controlled Megestrol Acetate API manufacturing process may involve:

1. Selection and qualification of steroidal starting materials
2. Controlled steroid synthesis
3. Chemical modification of the steroid nucleus
4. Acetylation
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 Megestrol Acetate API testing may include:

• Identification by IR
• HPLC identification
• Assay by HPLC
• Related substances
• Water content
• Residual solvents
• Residue on ignition
• Elemental impurities
• Specific rotation
• Melting range
• Particle-size distribution, where applicable
• Stability testing

Storage

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

Pharmaceutical Research

Megestrol Acetate is relevant to research involving:

• Progesterone receptors
• Progestin pharmacology
• Steroidal hormones
• Appetite regulation
• Cancer-associated cachexia
• AIDS-associated wasting
• Oncology supportive care
• Hormonal pharmaceutical development

Megestrol Acetate API Summary

Megestrol Acetate is a synthetic progestin pharmaceutical API with CAS Number 595-33-5, molecular formula C24H32O4, and molecular weight 384.52 g/mol. It is primarily used in oral pharmaceutical formulations and is associated with appetite stimulation and management of anorexia and cachexia in selected clinical settings.

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