Professional Overview
As a premier supplier of high-purity synthetic peptides, we provide Tirzepatide API (39-amino acid sequence) engineered specifically for pharmaceutical R&D, clinical trial material (CTM) supply, and advanced formulation development. Our manufacturing infrastructure, operating under ICH Q7-aligned Quality Management Systems, ensures seamless scalability from small-scale process validation to multi-kilogram commercial production. We are dedicated to providing consistent batch traceability and robust regulatory support for pharmaceutical innovators worldwide.
Technical Specifications & Purity Profile
Our API is supplied as a high-integrity lyophilized powder, meeting rigorous analytical standards:
Chemical Purity: HPLC purity ≥ 98.0% (custom specifications available upon request).
Molecular Weight: ~4813.45 Da (Verified via Mass Spectrometry).
Molecular Formula: C₂₂₅H₃₄₈N₄₈O₆₈.
Physical Form: White to off-white lyophilized powder.
Storage Conditions: 2°C – 8°C (or as specified by validated stability study data).
Manufacturing & Process Control
We leverage advanced automated peptide synthesis technology and stringent in-process controls to guarantee manufacturing reproducibility:
Controlled Synthesis: Validated solid-phase peptide synthesis (SPPS) protocols optimized to maximize coupling yield and minimize truncated peptide sequences.
Purification Strategy: Utilization of preparative HPLC systems to achieve target purity, followed by controlled lyophilization to maintain peptide stability and structural integrity.
Consistency Management: Standardized synthesis parameters and qualified raw material sourcing ensure batch-to-batch consistency for critical long-term procurement programs.
Quality Assurance & Regulatory Support (CMC)
Each batch is released under a comprehensive quality management system. The following documentation package is provided to facilitate your qualification and regulatory filings (Chemistry, Manufacturing, and Controls):
Analytical Reports: Full package including Certificate of Analysis (COA), HPLC chromatograms, and Mass Spectrum reports.
Core Characterization: Amino acid sequence verification, water content analysis, residual solvent testing (ICH Q3C compliant), and acetic acid content determination.
Regulatory Support: SDS, Technical Data Sheets (TDS), and additional characterization reports are available to support your CMC submissions.
Scalability & Global Supply Chain Security
We provide a scalable supply chain designed to mitigate procurement risks throughout the drug development lifecycle:
Research Phase: Gram-scale quantities for method development and initial formulation testing.
Clinical/Commercial Phase: Multi-kilogram production capacity with flexible scheduling to meet project milestones.
Supply Chain Security: Specialized packaging, including moisture-proof, sterile glass vials, and cold-chain logistics solutions, ensuring product stability during international transit.
Intended Use & Applications
This product is intended for industrial and professional scientific use only. Typical applications include:
1.API development and process validation.
2.Formulation research and stability study protocols.
3.Analytical method development and reference standard preparation.
4.Contract Manufacturing Organization (CDMO) projects.
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