Products Description
Tirzepatide powder is a lyophilized (freeze-dried) form of the active pharmaceutical ingredient used in research and compounding, primarily known as a dual GIP and GLP-1 receptor agonist for blood sugar regulation and weight management. It requires reconstitution with sterile water before use, as it is not an oral powder or ready-to-inject solution. This powder form is intended for research purposes or prescription-based customized formulations only.
Suitable for (use under the guidance of a physician)
- Obese adults (BMI ≥ 30 kg/m²): For long-term weight management, requiring a low-calorie diet and increased physical activity.
- Overweight adults (BMI ≥ 27 kg/m²): With at least one weight-related comorbidity (such as hypertension, type 2 diabetes, dyslipidemia, obstructive sleep apnea, cardiovascular disease, etc.).
- Obese adults with moderate to severe obstructive sleep apnea: For improving sleep apnea symptoms.
- Specific ethnic thresholds: The BMI threshold for people of South Asian, Chinese, and other ethnic backgrounds is typically reduced by 2.5 kg/m² (i.e., the actual reference standard is BMI ≥ 27.5 kg/m² or ≥ 24.5 kg/m² with comorbidities).
Absolute contraindications (prohibited):
- Personal or family history of medullary thyroid carcinoma
- Patients with multiple endocrine neoplasia syndrome type 2
- Severe hypersensitivity to telpolide or any of its components
Undefined populations:
Children and adolescents under 18 years of age (safety and efficacy have not been established)
Product Feature
1. Dual-Target Synergistic Effect: A single molecule acts on two key targets simultaneously, enhancing weight loss and potentially alleviating gastrointestinal discomfort such as nausea-this is not a simple mixture of two drugs, but a natural design of a single molecule.
2. Long-Acting Design, Once a Week: The molecule contains a special fatty acid chain that extends the drug's duration of action in the body to approximately 5 days, requiring only once-weekly dosing. The powder itself is optimized for low-frequency use.
3. Intelligent Regulation, Low Risk of Hypoglycemia: The hypoglycemic effect strictly follows changes in blood glucose levels-working when blood glucose is high and automatically stopping when blood glucose is normal. Therefore, the risk of dangerous hypoglycemia is far lower than with traditional hypoglycemic drugs.
4. Multi-Organ Regulation, Comprehensive Metabolic Improvement: tirzepatide powder acts simultaneously on the liver (reducing glucose production and fat accumulation), adipose tissue (improving lipid clearance), and the brain (suppressing appetite and increasing energy expenditure), achieving comprehensive metabolic regulation across multiple pathways.
Quality Control
1. Raw Material Testing (Incoming Inspection)
All incoming raw materials undergo rigorous safety checks and batch consistency verification to ensure that each batch is inspected according to regulations and is traceable before use. This is the primary step in ensuring stable final product quality.
2. Process Control (In-process QC)
A four-fragment synthesis strategy is employed during production (each fragment contains no more than 14 amino acids). Each fragment undergoes UPLC purity verification after synthesis, enabling real-time monitoring and timely correction of key processes to ensure that intermediate quality meets preset standards.
3. Finished Product Testing
Before release, finished products must undergo multiple tests, including purity, moisture content, peptide content, bacterial endotoxins, and impurity profiles. Actual testing data shows that the product purity reaches over 99%, moisture content is controlled between 2% and 4%, peptide content exceeds 91%, and endotoxin levels are far below the upper limit of the injection-grade standard (<10 EU/mg). Consistency across batches is excellent.
4. Testing Capability Guarantee
Equipped with professional testing equipment such as HPLC, GC-MS, and LC-MS, the company possesses a complete quality control laboratory (QC lab) with independent testing capabilities. The quantitative detection range for impurities covers 0.1% to 1.0%, fully complying with ICH Q2 validation standards. Furthermore, the company collaborates with third-party testing institutions to independently verify key indicators, ensuring that test results are objective, accurate, and traceable.
Key Testing Indicators Summary Of Tirzepatide Powder
| Testing Item | Control Standard | Actual Test Value (Typical Batches) |
|---|---|---|
| Purity | ≥98% | 99.06%~99.33% |
| Water Content | ≤8.0% | 1.87%~3.7% |
| Peptide Content | ≥80% | 91.89%~94.04% |
| Bacterial Endotoxins | <10 EU/mg | <3 EU/mg |
| Single Impurity | ≤0.69% | Compliant with standard |
| Total Impurities | ≤1.80% | Compliant with standard |
Stability Supplement:
- Stable for 24 months or more under -20°C conditions (verified by 3 batches)
- Stable for 6 months under 5±3°C conditions
Manufacturing Scale
| Indicator | Specific Configuration | Capability Description |
|---|---|---|
| Factory Area | Located in Xi'an, with sufficient production and warehousing area | Supports simultaneous operation of multiple production lines, meeting large-scale production layout |
| GMP Workshop Grade | Class 10K (Grade 10,000) + Class 100K (Grade 100,000) clean rooms | Meets cleanliness requirements for different processes of peptide API, effectively controlling particle and microbial contamination |
| Annual Production Capacity | Ton-scale (tons/year) | Capable of steadily accepting large-volume orders with guaranteed supply |
| Number of Production Lines | Independent lines for Extraction / Mixing / Filling / Packaging | Smooth connection between processes, avoids cross-contamination, supports continuous production |
| Automation Level | High automation ratio, automatic control for key processes | Reduces human error, improves batch-to-batch consistency and reproducibility |
| Core Equipment Scale | Large-capacity reactors, preparative HPLC, freeze dryers, etc. | Meets integrated production needs from synthesis to finished product |
Local Advantages of Xi'an:
- Leverages Xi'an's mature university research resources (e.g., Xi'an Jiaotong University, Northwest University) and biopharmaceutical talent pool
- Benefits from the advantage of chemical raw material supply in Northwest China, reducing raw material procurement costs and transportation lead times
- Localized production and warehousing ensures rapid response and stable delivery for domestic orders
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