Product Identification
Teriparatide is a synthetic 34-amino acid peptide corresponding to the biologically active N-terminal fragment of human parathyroid hormone. It is utilized in the development of pharmaceutical formulations and the manufacturing of finished dosage forms.
Manufacturing and Process Control
The production process is centered on standardized Solid-Phase Peptide Synthesis (SPPS) conducted under strict GMP-compliant conditions.
Synthesis: Controlled chain assembly is monitored to minimize the formation of truncated sequences and deletion peptides.
Purification: Crude peptide undergoes multi-stage preparative HPLC. This stage is optimized to achieve the target purity profile and remove process-related impurities, including diastereomers and coupling reagents.
Batch-to-Batch Consistency: Operational parameters-including temperature, solvent ratios, and cleavage conditions-are fixed and recorded. This reduces process-induced variation, ensuring that subsequent batches meet established specifications for impurity profiles and chromatographic behavior.
Supply Chain Security: We have established a robust supply chain management system for raw materials to ensure consistent production cycles and mitigate supply risks.
Analytical Verification and Quality Standards
Each production lot is released only after passing a comprehensive analytical battery, adhering to ICH guidelines:
Purity: Quantified via HPLC (Area %). The current standard is ≥98.0%.
Identity: Verified by Mass Spectrometry (MS) to confirm the molecular weight, supplemented by amino acid sequence analysis to verify primary structure.
Impurity Control: Quantitation of residual solvents by Gas Chromatography (GC) and moisture content determination via Karl Fischer titration.
Content Determination: Peptide content is determined and reported to facilitate accurate dosing during formulation development.
Documentation and Regulatory Support
To expedite qualification and CMC (Chemistry, Manufacturing, and Controls) filing, every shipment is accompanied by a comprehensive documentation package:
Certificate of Analysis (COA): Includes detailed results for all testing parameters.
Analytical Data: Representative HPLC chromatograms, MS spectra, and summary reports for residual solvents and water content.
Regulatory Documentation: Provision of Safety Data Sheet (SDS), Product Specification Sheet, BSE/TSE statements, and relevant manufacturing documentation.
Quality Certification: We operate under verified GMP standards; relevant site master files and audit support documentation are available upon request to support customer-led regulatory filings.
Technical Specifications Table
|
Parameter |
Specification |
|
Molecule |
Human Parathyroid Hormone (1-34) |
|
Synthesis Method |
Solid-Phase Peptide Synthesis (SPPS) |
|
HPLC Purity |
≥98.0% |
|
Identity Testing |
Mass Spectrometry (MS) |
|
Solubility |
Water soluble (process-dependent) |
|
Storage Requirements |
≤-20°C, protected from light and moisture |
Supply Capacity, Logistics, and Stability
Scale: Production capacity is validated for quantities ranging from laboratory-scale (grams) to commercial-scale (kilograms).
Packaging and Transport: Products are handled and packaged using validated cold-chain protocols.
Stability Data: Comprehensive stability studies, including long-term and accelerated data, are available to verify integrity during international transit and storage.
Customization: We support requests for specific counter-ion variants (e.g., acetate, trifluoroacetate), defined particle sizes, or specialized packaging configurations to meet specific formulation requirements.
Intended Use
This Teriparatide API is produced for legitimate pharmaceutical development and research activities, including:
Pharmaceutical formulation development
Finished dosage manufacturing
Analytical method development and validation
Process validation and stability studies
Preparation of reference materials