Hydroxyprogesterone Caproate API Manufacturer in India

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

Hydroxyprogesterone Caproate API Manufacturer in India

Hydroxyprogesterone Caproate is a synthetic progestogen and ester derivative of hydroxyprogesterone. It is a steroidal active pharmaceutical ingredient that produces progestational activity by interacting with progesterone receptors.

Hydroxyprogesterone Caproate has the molecular formula C27H40O4 and a molecular weight of 428.61 g/mol. Its CAS Number is 630-56-8.

Hydroxyprogesterone Caproate API Overview

Hydroxyprogesterone Caproate is a long-acting ester of hydroxyprogesterone. The caproate ester increases the lipophilicity of the parent steroid and has historically been used in depot formulations designed for prolonged progestogenic activity.

It is relevant to pharmaceutical research, steroidal API development and formulation development.

Mechanism of Action

Hydroxyprogesterone Caproate exerts its effects primarily through progesterone receptors.

Following administration, the compound provides progestational activity that can influence reproductive tissues and progesterone-responsive biological pathways.

Pharmaceutical Applications

Hydroxyprogesterone Caproate API has been used in the development and manufacture of:

  • Progestogen formulations
  • Injectable steroidal formulations
  • Depot formulations
  • Hormonal pharmaceutical products
  • Pharmaceutical research and development
  • Analytical and formulation research

Hydroxyprogesterone Caproate API Manufacturing

Hydroxyprogesterone Caproate is a synthetic steroidal compound manufactured through controlled chemical synthesis and esterification processes, followed by purification, crystallization and drying.

Quality testing may include identity, assay, related substances, water content, residue on ignition, optical rotation and residual solvents according to the applicable approved specification.

Physical and Chemical Properties

Hydroxyprogesterone Caproate is generally supplied as a white or almost white crystalline powder. It is practically insoluble in water and soluble in selected organic solvents.

Storage

Hydroxyprogesterone Caproate should be stored in a tightly closed container, protected from excessive moisture, heat and direct light. Storage conditions should follow the manufacturer's current CoA, SDS and validated stability requirements.

Quality Documentation

Depending on the intended application, documentation may include:

  • Certificate of Analysis (CoA)
  • Safety Data Sheet (SDS)
  • Product specification
  • Analytical test report
  • Residual-solvent information
  • Stability information
  • Regulatory documentation

Conclusion

Hydroxyprogesterone Caproate is a synthetic steroidal progestogen with established progestational activity. Its long-acting ester structure and pharmaceutical properties make it relevant to steroidal API research, formulation development and hormonal pharmaceutical applications.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 97.0% – 103.0%
Loss on Drying NMT 1.0%
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
Water Content NMT 1.0%
Specific Rotation Approximately +50° to +60°
Melting Point Approximately 120–124°C
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