Octreotide Peptide API: Technical Specifications and Manufacturing Standards
Octreotide is a synthetic somatostatin analogue (octapeptide) formulated as an active pharmaceutical ingredient (API) for the management of acromegaly, neuroendocrine tumors (NETs), and related gastrointestinal pathologies. Our production focuses on the precise control of the cyclic disulfide bridge and sequence integrity required for parenteral drug development and commercial-scale manufacturing.
Manufacturing Precision & Technical Rationale
We define "quality" through verifiable process controls to ensure the reliability of downstream formulation:
Synthesis Fidelity: We utilize automated Solid-Phase Peptide Synthesis (SPPS) with optimized coupling cycles. This approach minimizes the accumulation of truncated sequences (deletion peptides), which are the primary impurities inherent in peptide synthesis.
Controlled Oxidation: The disulfide bridge formation (Cys2-Cys7) is performed under high-dilution, controlled-pH conditions to prevent intermolecular dimerization. This ensures the API maintains the correct bioactive conformation.
Purification Strategy: We employ multi-stage preparative HPLC using specific gradients to isolate the target sequence from structurally similar impurities (such as diastereomers or oxidation by-products), consistently achieving purity levels ≥98.0%.
Batch Stability: Every batch is lyophilized under qualified parameters to ensure a low residual moisture content, which is critical to preventing hydrolysis and peptide aggregation during long-term storage.
Comprehensive Analytical Verification
We provide a granular data package for every batch to support your quality assurance (QA) and regulatory filings:
Identity & Purity: Confirmed via HPLC chromatogram (purity quantification) and Mass Spectrometry (MS) for molecular weight verification.
Impurity Profiling: Full report on related substances, including tracking of non-target isomers and process-related impurities.
Solvent & Residue Control: Analysis of residual solvents and amino acid composition to ensure alignment with pharmacopeial standards.
Stability Documentation: Data provided from forced degradation or accelerated stability studies to guide your formulation development.
Technical Specifications
|
Parameter |
Specification |
|
Product Name |
Octreotide Peptide API |
|
Sequence |
H-D-Phe-Cys-Phe-D-Trp-Lys-Thr-Cys-Thr-ol |
|
CAS Number |
79517-01-4 |
|
Molecular Formula |
C₄₉H₆₆N₁₀O₁₀S₂ |
|
Molecular Weight |
1019.24 g/mol |
|
Manufacturing Method |
Solid-Phase Peptide Synthesis (SPPS) |
|
Appearance |
White to off-white lyophilized powder |
|
Purity (HPLC) |
≥98.0% |
|
Identification |
Mass Spectrometry / HPLC |
|
Storage |
2–8 ∘ C (Anhydrous/Protected) |
Applications
Our Octreotide API is intended for pharmaceutical manufacturing and industrial use, supporting:
Injectable and long-acting release (LAR) formulations.
Generic drug development and bioequivalence studies.
Hospital-grade pharmaceutical products and R&D projects.
Supply Chain & Regulatory Support
We facilitate the supplier qualification process for pharmaceutical manufacturers by providing:
Direct Technical Communication: Inquiries are routed to our internal process chemists to ensure accurate data transmission.
Scale-up Consistency: We maintain consistent synthesis protocols from gram-scale R&D batches to multi-kilogram commercial production, ensuring the impurity profile remains stable as the batch size increases.
Regulatory Preparedness: We provide a comprehensive documentation package (COA, SDS, TDS, origin statements) to align with your internal Quality Management System (QMS) and regulatory roadmap.
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