Goserelin API | Goserelin Acetate Pharmaceutical API Manufacturer in India

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Goserelin API

Goserelin is a synthetic decapeptide gonadotropin-releasing hormone (GnRH) agonist used to suppress sex-hormone production. It is supplied pharmaceutically as goserelin acetate and is administered as a subcutaneous depot implant.

Goserelin initially stimulates the pituitary GnRH receptors, causing a temporary increase in luteinizing hormone (LH) and follicle-stimulating hormone (FSH). With continued administration, persistent receptor stimulation produces downregulation and desensitization of the GnRH receptor, resulting in marked suppression of testosterone or estrogen production.

Goserelin API Manufacturer in India

Goserelin is a specialized synthetic peptide pharmaceutical API requiring controlled peptide synthesis, purification and advanced characterization. Because it is a peptide, quality assessment includes peptide identity, purity, related peptides, water content, residual solvents and biological activity.

Chemical Information

CAS Number: 65807-02-5
Molecular Formula: C59H84N18O14
Molecular Weight: 1269.43 g/mol
Pharmaceutical Form: Goserelin Acetate
Drug Class: GnRH Agonist
Therapeutic Class: Hormonal Antineoplastic / Endocrine Therapy
Therapeutic Area: Oncology / Reproductive Endocrinology

Mechanism of Action

Goserelin is a potent GnRH receptor agonist. Initial administration stimulates secretion of LH and FSH, producing a transient rise in sex hormones.

Continuous administration subsequently suppresses pituitary GnRH receptor responsiveness. This decreases LH and FSH secretion and consequently reduces testosterone production in males and estrogen production in females.

Pharmaceutical Applications

Goserelin is used in several hormone-dependent conditions, including:

  • Prostate cancer
  • Breast cancer in appropriate premenopausal/perimenopausal patients
  • Endometriosis
  • Management of certain uterine conditions

Approved indications and dosing schedules vary by product and regulatory jurisdiction.

Goserelin in Prostate Cancer

In prostate cancer, continuous goserelin therapy suppresses testicular testosterone production. This provides an androgen-deprivation therapy (ADT) approach for hormone-sensitive prostate cancer.

Goserelin in Endometriosis

By suppressing ovarian estrogen production, goserelin can reduce estrogen-dependent stimulation of endometrial implants and is used in the management of endometriosis under appropriate clinical supervision.

Physical and Chemical Properties

Goserelin is a synthetic decapeptide derived from GnRH. The peptide contains a modified amino acid at position 6 and a D-serine-derived residue at the C-terminal portion, contributing to its prolonged biological activity.

The free peptide has a molecular weight of approximately 1269.43 g/mol. Commercial pharmaceutical formulations commonly contain goserelin acetate.

Quality and Analytical Testing

Goserelin API quality evaluation may include:

  • Peptide identity by LC-MS
  • Peptide mapping
  • HPLC purity
  • Assay/content
  • Related peptides
  • Degradation products
  • Water content
  • Residual solvents
  • Acetate content
  • Bacterial endotoxins
  • Microbial limits
  • Biological potency

Storage

Goserelin API should be stored in a tightly closed container under controlled pharmaceutical conditions and protected from excessive heat, moisture and direct light. Exact storage conditions should follow validated stability data and the applicable product-specific specification.

Pharmaceutical Research and Development

Goserelin remains an important synthetic peptide in hormonal therapy, oncology and reproductive medicine. Its long-acting GnRH agonist activity has made it useful for sustained suppression of gonadal hormone production.

Goserelin API Summary

Goserelin is a synthetic GnRH agonist decapeptide with CAS Number 65807-02-5, molecular formula C59H84N18O14, and molecular weight 1269.43 g/mol. It is commonly formulated as goserelin acetate and is used for hormone-dependent conditions including prostate cancer, certain breast cancers and endometriosis.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) NLT 98.0% by HPLC
Loss on Drying NMT 0.5%
Residue on Ignition ≤2.0%
pH (1% Solution) 3.0 – 5.0
Individual Impurity ≤ 0.5%
Total Impurities NMT 1.0%
Water Content NMT 0.5%
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