Exenatide Peptide API | Pharmaceutical Grade
We supply high-purity, GMP-compliant Exenatide API for pharmaceutical development, CDMO projects, and research institutions. From gram-scale pilot batches to multi-kilogram commercial supply, we provide reliable, documentation-ready materials for your pharmaceutical pipeline. Our manufacturing facility operates under strict ICH Q7 guidelines, and our dedicated Regulatory Affairs (RA) team is fully prepared to provide comprehensive support for your DMF (Drug Master File) filing requirements. We maintain a high level of transparency and welcome on-site quality audits by qualified pharmaceutical partners.
Manufacturing Technology: Synthesis & Purification
Exenatide production utilizes automated solid-phase peptide synthesis (SPPS) platforms. By precisely controlling coupling efficiency and deprotection cycles, we minimize the formation of deletion sequences at the synthesis stage. The crude peptide is refined through multi-stage preparative HPLC to isolate the target sequence, ensuring high purity and chemical uniformity essential for downstream formulation. We employ orthogonal purification strategies to ensure impurity profiles remain well within the stringent limits required for parenteral drug products.
Quality Control & Regulatory Alignment
Our manufacturing processes adhere to pharmaceutical quality standards, supported by comprehensive, ICH-compliant documentation. Every lot undergoes rigorous testing:
Purity Validation: HPLC analysis confirms purity ≥98.0% (customizable to specific requirements).
Identity Verification: LC-MS is used to confirm the molecular mass (~4186.6 Da), alongside sequence verification.
Impurity Control: Strict monitoring of residual solvents, process-related substances, and heavy metals ensures compliance with stringent safety profiles.
Batch-to-Batch Reproducibility: Standardized Batch Manufacturing Records (BMR) and validated cleaning protocols ensure consistent product performance across every delivery.
Quality Assurance: All production is conducted under a robust Quality Management System (QMS). We provide full transparency in our supply chain, ensuring all raw materials are of non-animal origin and fully traceable.
Product Features & Supply Benefits
Reliable Manufacturing: High-purity specifications (≥98.0% HPLC) reduce the burden of downstream analytical validation and formulation instability.
Sequence Precision: Leveraging advanced coupling and LC-MS molecular verification to ensure the 39-amino acid sequence matches target specifications perfectly.
Logistics & Stability:
Packaging: Sterile glass vials, moisture-resistant aluminum foil bags, or customized OEM solutions.
Cold-Chain Integrity: We utilize qualified, temperature-controlled shipping solutions equipped with data loggers to ensure product integrity throughout the entire global supply chain. Recommended storage at 2–8°C for short-term and -20°C or below for long-term stability.
Technical Specifications
|
Parameter |
Specification |
|
Product Name |
Exenatide Peptide API |
|
CAS Number |
141732-76-5 |
|
Appearance |
White to off-white lyophilized powder |
|
Molecular Formula |
C₁₈₄H₂₈₂N₅₀O₆₀S |
|
Molecular Weight |
~4186.6 Da |
|
Purity (HPLC) |
≥98.0% (Customizable) |
|
Identification |
HPLC & LC-MS verified |
|
Storage |
2–8°C (short-term) or ≤-20°C (long-term) |
Procurement & Service Advantages
Scalable Platforms: Capability to transition from gram-scale R&D quantities to multi-kilogram batches for commercial launch.
Comprehensive Documentation: Full package provided: Certificate of Analysis (COA), HPLC chromatograms, LC-MS reports, SDS, and Technical Data Sheets (TDS).
Flexible OEM Services: Full support for private labeling, customized documentation packages, and bespoke supply agreements tailored to your project timeline.
Dedicated Technical Support: Our team offers 24/7 responsiveness to assist with your regulatory, technical, and formulation inquiries.
FAQ