GMP factory supply high purity Thymalfasin peptide CAS 69558-55-0 with NMPA Thymalfasin powder

1. Product Description

2. Key Specifications

3. Mechanism of Action

• Acts as a potent immunomodulator, binding to specific receptors on T lymphocytes, dendritic cells, and NK cells, regulating the activation, differentiation, and maturation of immune cells to restore immune homeostasis[1][4].
• Promotes the proliferation and maturation of T lymphocytes, increases the ratio of CD4⁺/CD8⁺ T cells, enhances T cell-mediated immune responses, and reverses T cell exhaustion caused by immunosuppression[1][2].
• Boosts the activity of NK cells and stimulates the secretion of immune cytokines (e.g., IL-2, IFN-γ, IL-7), enhancing the body’s ability to resist viral infections and tumor cell proliferation[1][2][3].
• Regulates the balance of Th1/Th2 immune responses, preferentially enhancing Th1-type immune responses to strengthen antiviral and antitumor effects, while suppressing excessive inflammatory responses[1][2].
• Exhibits a plasma half-life of approximately 30–60 minutes in humans, rapidly metabolized by proteases in the liver and kidneys, with no obvious accumulation in the body and high safety[1][4].
• Augments the effects of ionizing radiation by arresting cancer cells in the G2/M phase of the cell cycle, and helps restore immunocompetence in immunosuppressed subjects[4].

4. Main Applications

• Pharmaceutical API: Used in the R&D and production of injectable preparations for the treatment of primary immunodeficiency diseases, chronic viral infections (e.g., hepatitis B, HIV/AIDS), rheumatoid arthritis, and auxiliary treatment of tumors, to enhance immune function and improve treatment outcomes[3][4].
• Research & Development: Applied in preclinical pharmacology, toxicology, and formulation optimization studies related to immune system disorders, viral infections, tumors, and immunomodulatory drugs[1][3].
• Scientific Research: Suitable for laboratory studies on immune cell regulation mechanisms, thymic hormone function, immunomodulatory pathways, and the development of novel immunotherapeutic agents[1][4].
• Biomedical Research: Used in studies on sepsis, immune senescence, and immunosuppression caused by chemotherapy/radiotherapy, as well as high-throughput screening of drugs targeting immune regulation[1][3].

5. Our Advantages

• Ultra-High Purity: HPLC ≥98.0%, strict control of impurities, ensuring high biological activity and safety for pharmaceutical R&D and formulation[3][4].
• Stable Pentapeptide Structure: Produced via advanced solid-phase synthesis technology, ensuring the integrity of the 32-36 amino acid sequence and optimal binding affinity to immune cell receptors[1][4].
• Stable Quality: Strict production process control and comprehensive analytical testing (COA, HPLC, MS, NMR) provided for each batch, ensuring batch-to-batch consistency[3][4].
• Professional Manufacturing: Produced in a GMP-compliant cleanroom with strict contamination control, meeting international pharmaceutical and research standards[3][4].
• Excel-Exportable Specifications: The key specifications table can be directly copied to Excel, facilitating your product management and customer communication.
• Complete Documentation: Full technical dossiers, including COA, MSDS, stability data, and analytical reports, available upon request to support global regulatory filings[3][4].

6. Storage & Handling

• Storage: Store at ≤ -20°C, protected from light, heat, and moisture; keep desiccated in a dark place to avoid degradation[2][3]. Shelf life is 2 years under proper storage conditions; shelf life at -80°C is extended to 3 years[2].
• Transport: Transport with dry ice or professional cold-chain packaging to maintain low-temperature stability; short-term ambient temperature transport (≤24 hours) is acceptable[2].
• Reconstituted Solution: Use within 2 weeks if stored at 2–8°C, and within 3 months if stored at -20°C; avoid repeated freeze-thaw cycles[2].
• Avoid repeated freeze-thaw cycles, as this may affect peptide activity and biological potency[2][3].
• Handling: Wear protective gloves, clothing, and goggles; operate in a well-ventilated area to avoid inhalation and skin/eye contact[3][4].

7. Safety & Compliance Notice

• For research and industrial manufacturing use only.
• Not for direct human or animal administration; intended for pharmaceutical formulation, laboratory research, or R&D use only[3][4].
• Strictly comply with local laws and regulations regarding peptide APIs, pharmaceutical raw materials, and controlled substances; Thymalfasin is a prescription-only drug in most jurisdictions[3]. It is contraindicated in patients with hypersensitivity to any component of the product[4].
• Full MSDS (Material Safety Data Sheet) with detailed safety information, including adverse effects (e.g., mild fever, local injection site reaction, transient fatigue) and handling precautions, is provided with each order[3][4].

8. Packaging & Shipping

• Packing: 0.1g, 0.5g, 1g, 5g, 10g, 100g sealed lyophilized vials or aluminum foil bags; customizable packaging available based on order quantity[3][4].
• MOQ: Flexible, supporting small-batch R&D orders and large-scale bulk orders.
• Lead Time: In-stock items shipped within 2–3 working days; custom orders negotiated based on quantity.
• Shipping: Cold-chain transport via DHL, FedEx, UPS, or international air/sea freight, with full tracking provided to ensure safe delivery[3][4].