Lanreotide API | Somatostatin Analog API Manufacturer in India

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Lanreotide API

Lanreotide is a long-acting synthetic octapeptide somatostatin analogue that primarily binds to somatostatin receptor subtypes, particularly SSTR2 and SSTR5. It suppresses the secretion of several hormones, including growth hormone, and is used in the management of acromegaly and certain neuroendocrine tumors.

Lanreotide is formulated as a long-acting injectable depot preparation, providing sustained pharmacological activity.

Lanreotide API Manufacturer in India

Lanreotide is a specialized peptide pharmaceutical ingredient requiring controlled peptide synthesis, purification and comprehensive characterization.

Important quality attributes include identity, peptide purity, related peptides, water content, residual solvents, counter-ion content, molecular integrity, microbial quality and stability.

Chemical Information

CAS Number: 108736-35-2
Molecular Formula: C54H69N11O10
Molecular Weight: 1096.20 g/mol
Drug Class: Somatostatin Analogue
Pharmacological Class: Somatostatin Receptor Agonist
Therapeutic Class: Hormonal / Antineoplastic Agent
Therapeutic Area: Endocrinology / Oncology

Mechanism of Action

Lanreotide mimics the activity of endogenous somatostatin by binding to somatostatin receptors, particularly SSTR2 and SSTR5.

This receptor activation suppresses hormone secretion and can:

  • Reduce growth hormone secretion
  • Decrease IGF-1 production
  • Suppress secretion of certain gastrointestinal and pancreatic hormones
  • Reduce hormone-mediated activity of some neuroendocrine tumors

Pharmaceutical Applications

Lanreotide is used for:

  • Acromegaly
  • Long-term control of growth hormone and IGF-1 levels
  • Treatment of certain gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in approved settings

Specific indications and dosing depend on the applicable regulatory labeling.

Somatostatin Analogue Characteristics

Lanreotide is structurally related to somatostatin but has been modified to provide greater metabolic stability and prolonged activity.

Its long-acting formulation allows administration at relatively extended intervals compared with naturally occurring somatostatin.

Manufacturing Process

Typical peptide API manufacturing may involve:

  1. Selection and preparation of protected amino acids
  2. Stepwise peptide synthesis
  3. Coupling and deprotection
  4. Peptide cleavage
  5. Crude peptide isolation
  6. Preparative chromatographic purification
  7. Desalting / counter-ion exchange
  8. Lyophilization
  9. Final characterization
  10. Controlled packaging

Quality and Analytical Testing

Lanreotide API quality evaluation may include:

  • Identification by HPLC
  • Mass spectrometry
  • Peptide mapping
  • Assay
  • Related peptides
  • Degradation products
  • Water content
  • Residual solvents
  • Counter-ion determination
  • Elemental impurities
  • Microbial limits
  • Bacterial endotoxins
  • Optical / stereochemical purity
  • Stability testing

Storage

Lanreotide should be stored according to validated stability data and approved product requirements. Appropriate temperature control and protection from moisture, excessive heat and inappropriate light exposure should be maintained.

Pharmaceutical Research and Development

Lanreotide is relevant to research involving:

  • Somatostatin receptors
  • SSTR2 and SSTR5 signaling
  • Growth hormone regulation
  • IGF-1 regulation
  • Acromegaly
  • Neuroendocrine tumors
  • Peptide therapeutics
  • Long-acting injectable formulations
  • Endocrine pharmacology

Lanreotide API Summary

Lanreotide is a long-acting synthetic somatostatin analogue with CAS Number 108736-35-2, molecular formula C54H69N11O10, and molecular weight 1096.20 g/mol. It primarily activates somatostatin receptors SSTR2 and SSTR5 and is used in the treatment of acromegaly and certain neuroendocrine tumors.

Detailed Specifications

Parameter Specification
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.5%
Individual Impurity NMT 0.5%
Total Impurities ≤ 1.5%
Water Content NMT 1.0%
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