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Tirzepatide API is the world's first-in-class GIP/GLP-1 dual receptor agonist. As a core API for new-generation glycemic control and weight management, it has the unique identifier CAS 2023788-19-2. It provides potent blood glucose control, significant weight reduction, metabolic syndrome improvement, and cardiovascular benefits. This API is a milestone for the treatment of type 2 diabetes, obesity and related complications, and holds a core position in the global pharmaceutical market and innovative research and development.
Technical Specifications
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Product Name |
Tirzepatide API |
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Synonyms |
CAS 2023788-19-2, Tirzepatide powder, Tirzepatide raw material |
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Characteristic |
White to off-white crystalline powder |
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CAS Number |
2023788-19-2 |
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Assay |
≥99% (HPLC, Subject to the COA) |
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Formula |
C225H348N48O68 |
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Package |
Technical Package |
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Storage |
Store at -20℃ |
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Structure |
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As a reliable China Tirzepatide supplier, we cooperate with a number of GMP, FDA and CEP certified manufacturers. We provide global pharmaceutical companies, innovative drug developers and research institutions with one-stop solutions for Tirzepatide raw material through stable supply chains, compliant quality systems and customized services, covering the full cycle of R&D trials, pilot scale-up and commercial production.
Product Characteristics
Tirzepatide powder is produced through a combined process of solid-phase peptide synthesis, liquid-phase purification and lyophilization refinement. Peptide sequence, impurity profile and metal residues are precisely controlled to ensure the purity and uniformity of Tirzepatide raw material from the source. The product is a white to off-white lyophilized powder with excellent water solubility and fast reconstitution, suitable for the production of high-end preparations such as injections, prefilled syringes and pen injectors.
It has the following specifications: HPLC purity ≥99.0%, total impurities ≤0.8%, maximum single impurity ≤0.2%, moisture ≤6.0%, acetate 5.0%–11.0%, peptide content ≥72%; amino acid composition deviation ≤±8%, compliant with ICH Q7 and major pharmacopoeia standards; endotoxin, microbial limit and sterility meet injection-grade requirements.
Tirzepatide API activates both GIP and GLP-1 pathways, achieving synergistic effects of glucose-dependent glycemic control and centrally mediated weight management. It has a half-life of approximately 5 days, supports once-weekly administration, and greatly improves patient compliance.
Tirzepatide powder has uniform particle distribution and good flowability, with D90 ≤35μm. It can be quickly prepared into a clear injection solution, improving production efficiency and finished product qualification rate. Long-term stability data: stored sealed and protected from light at -20°C for 24 months; reconstituted solution remains stable at 2–8°C for 72 hours, meeting global logistics and storage requirements.
Full-Cycle Quality Control and Compliance Assurance
Full-Chain Traceability Management
We implement full-process traceability control for Tirzepatide API from starting materials, synthesis, purification, lyophilization, crushing, filling and packaging to finished product inspection. Each batch is assigned a unique batch number, with complete production and testing records retained, enabling full traceability, re-testing and auditing. Each delivery includes complete COA, HNMR, LC-MS, HPLC chromatograms, elemental impurities, microbiological data and stability reports to support global registration filings.
Strict Standards Aligned with International Requirements
Tirzepatide API (CAS 2023788-19-2) strictly complies with ICH Q7, USP, EP and CP standards. We conduct comprehensive testing including HPLC purity, GC residual solvents, elemental impurities, endotoxin, sterility and peptide content. Quality indicators are fully aligned with international pharmacopoeias, helping preparations enter major markets such as Europe, the United States, Japan, South Korea, Southeast Asia and the Middle East.
Continuous Process and Quality Optimization
Supported by continuous technological upgrading at partner facilities, we keep optimizing the synthesis and purification process of Tirzepatide powder. While improving purity and stability, we optimize Tirzepatide cost and supply efficiency. We have established a complete system for deviation handling, change control and annual quality review to ensure consistent and stable quality of every batch.
Application Scenarios
Treatment and Prevention of Type 2 Diabetes
Tirzepatide API is a preferred first/second-line raw material for adult type 2 diabetes. It is used to manufacture once-weekly injections, either as monotherapy or combined with metformin and SGLT-2 inhibitors. Studies show that the 15mg dose group achieves a maximum HbA1c reduction of 2.3%, with 86.7% of patients reaching HbA1c ≤6.5%, significantly better than semaglutide and basal insulin. It effectively improves blood glucose fluctuation, reduces the risk of microvascular complications, and provides a highly effective option for patients failing oral therapy. Meanwhile, it can reduce the 3-year progression risk by 93% in pre-diabetic obese populations, offering key support for primary prevention of metabolic diseases.
Chronic Weight Management
Tirzepatide API is used for long-term weight control in obese and overweight adults. Studies show that non-diabetic obese patients achieve an average weight loss of 20.9% at 72 weeks, with a maximum of over 25%, close to the effect of bariatric surgery; Chinese patients show an average weight loss of 17.5% and an average waistline reduction of 18.4cm at 52 weeks. It reduces LDL-C by 18.2%, triglycerides by 26.5% and systolic blood pressure by about 7mmHg, significantly lowering cardiovascular risk. It is suitable for people with BMI ≥30 or ≥27 with comorbidities. Clinical data confirm sustained weight and body fat loss, along with improved metabolic indicators such as waist circumference, blood lipids and blood pressure, making it one of the most effective raw materials for weight management.
Metabolism-Related Complications
Tirzepatide powder can be used in the development of innovative formulations for metabolic diseases such as obstructive sleep apnea, non-alcoholic steatohepatitis and high cardiovascular risk factors. Multiple Phase II clinical data show significant improvements in clinical indicators, expanding the application scope in chronic disease treatment.
Innovative Drug R&D and Standard Reference
Tirzepatide API can be used as a reference standard and standard substance to support pharmacology, toxicology, pharmacokinetics, formulation screening and quality standard establishment. It is also used in the R&D of long-acting peptides, prodrugs, nanoformulations and oral drug delivery systems, supporting technological breakthroughs in glycemic control and weight management.
Social Media Popularity
Tirzepatide is a top trending pharmaceutical product on global social media. On platforms such as X and Instagram, total topic views exceed 1.2 billion, with over 500,000 new real experience posts about weight loss and glycemic control added monthly. User satisfaction remains above 92%. Test results by overseas KOLs and medical bloggers show an average weight loss of 12%–18% after 12 weeks of regular use, with significantly improved glycemic control rates. This has driven strong and growing demand for Tirzepatide raw material and finished formulations, making it a high-demand product in the global pharmaceutical supply chain.
Packaging and Transportation
Tirzepatide powder is vacuum-sealed in pharmaceutical-grade lyophilized vials or aluminum foil bags with desiccants and light protection, housed in moisture-proof and oxidation-resistant outer packaging. Standard specifications: 100mg, 1g, 10g, 100g, 500g, 1kg. Customized Tirzepatide packaging is available.
The whole transportation process uses cold chain or low-temperature light-proof conditions with real-time temperature monitoring. Domestic distribution is handled by professional pharmaceutical logistics companies; international transportation complies with UN and IATA regulations, providing air, sea and international express services with full tracking and efficient customs clearance.
Our Advantages
Stable Capacity and In-Stock Guarantee
We have long-term supply agreements with leading GMP facilities. Tirzepatide in stock supports to urgent orders. R&D trial orders start from 100mg, and commercial production supports bulk Tirzepatide purchases to avoid delays in R&D and production.
Premium Quality and Registration Support
Products are manufactured in GMP/FDA/CEP certified facilities. Tirzepatide API purity is ≥99.0%, exceeding international pharmacopoeia standards. We provide complete registration documents to support global filings.
Transparent and Reasonable Tirzepatide Price
Large-scale production and stable supply chains ensure high cost performance, helping customers control costs. Prices are open and transparent with no hidden fees.
Mature Global Export and Services
We have complete systems for customs declaration, inspection, logistics and documentation, with compliant sales to more than 60 countries worldwide. We provide 7×12 hour multilingual support, technical assistance and prompt after-sales service.
Flexible Customization Services
We offer customized Tirzepatide services, with adjustable purity, particle size, moisture content, packaging specifications and more to meet special formulation and R&D requirements.
FAQ
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