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High Purity Tirzepatide Peptide Powder | cGMP Manufacturer China
Product Overview
Tirzepatide Peptide Powder Overview
Tirzepatide peptide powder (CAS: 2023788-19-2; Molecular Formula: C225H348N48O68; Molecular Weight: 4813.53 Da) is a white to off-white lyophilized powder. As the first GIP/GLP-1 dual receptor agonist, it represents a significant advancement in metabolic disease therapy (FDA, 2022–2024). According to Grand View Research (2023), the global peptide therapeutics market is projected to exceed USD 55 billion by 2030, reflecting rising prevalence of type 2 diabetes and obesity worldwide.
Our quality standards adhere to HPLC purity ≥99%, with stringent control over impurities, residual solvents, microbial limits, and heavy metals, aligned with USP and EP monographs. Each batch is accompanied by a comprehensive COA and third-party verification (Eurofins, SGS).
Mechanism of Action & Clinical Applications
Tirzepatide engages both GIP and GLP-1 receptors, synergistically enhancing glucose-dependent insulin secretion, suppressing glucagon release, and promoting satiety. This dual mechanism supports blood glucose regulation, weight reduction, and may offer cardiovascular protective benefits.
Clinical studies demonstrate superior efficacy compared to GLP-1 receptor agonists alone, showing greater HbA1c reduction and significant weight loss in type 2 diabetes patients (FDA, May 2022). Approved indications include type 2 diabetes and chronic weight management, with ongoing investigations in obstructive sleep apnea (OSA) management.
Shaanxi Bolin's Manufacturing Advantages
We employ solid-phase and liquid-phase peptide synthesis technologies, ensuring precise molecular structure control, high batch-to-batch consistency, and zero risk of biological contamination. Our facilities include 500L reaction vessels with an annual production capacity of 40 kg, supporting R&D-scale grams to multi-kilogram commercial batches.
Our quality control system spans from raw material receipt to final product release, providing COA, HPLC spectra, MS verification, and optional third-party testing for every batch.
Regulatory & Technical Support
Shaanxi Bolin Biotechnology’s facilities comply with FDA, EMA, and NMPA cGMP standards and are FDA-registered. We provide a complete DMF package supporting US-DMF, EU-CTD, and other regional filings. Our technical team delivers end-to-end consultation, including stability studies compliant with ICH guidelines, assisting clients in determining appropriate shelf-life and formulation parameters.
Storage, Shipping & Safety Information
Tirzepatide peptide powder should be stored short-term at 0–4°C in a dry environment or long-term at –20°C, protected from light. Shipping options include cold-chain delivery with insulated containers, dry ice, or gel packs, and optional temperature loggers for quality assurance. Potential gastrointestinal side effects are rare; all handling and formulation should comply with clinical and regulatory guidance.
Frequently Asked Questions (FAQ)
Q: Minimum order quantity?A: Flexible, from gram-scale R&D samples to kilogram-scale commercial batches.
Q: Lead time for delivery?
A: Typically ≤7 days for R&D, customizable for larger orders.
Q: Payment methods accepted?
A: Wire transfer (T/T), LC, and other international payment options.
Q: Sample request process?
A: Contact our sales team with project details; COA and MS data provided.
Q: DMF availability?
A: Full DMF documentation available to support US-DMF, EU-CTD filings.
Q: Custom synthesis services?
A: Available for peptide derivatives and formulation optimization.
Conclusion
Shaanxi Bolin Biotechnology Co., Ltd. provides high-purity Tirzepatide peptide powder with reliable supply, rigorous quality control, and comprehensive regulatory and technical support. Our cGMP-compliant production, full DMF documentation, and international logistics expertise ensure global clients can confidently integrate our peptide API into R&D and commercial applications.
For more information about high purity Tirzepatide peptide powder, please contact Shaanxi Bolin Biotechnology Co., Ltd. at +86-29-84355551 or email us at sales1@bovlin.com. Our professional team will provide customized solutions and timely technical support.