GMP factory supply high purity Teriparatide peptide CAS 99294-94-7 with DMF and NMPA Teriparatide powder

1. Product Description

2. Key Specifications

3. Mechanism of Action

• Acts as a specific agonist of parathyroid hormone receptors (PTH1R), binding to PTH1R on the surface of osteoblasts, osteoclasts, and renal tubular cells with high affinity (EC₅₀≈0.8 μM), thereby activating the receptor signaling pathway[1][3].
• Promotes osteoblast proliferation, differentiation, and activity, enhancing bone formation and increasing bone mineral density (BMD); simultaneously regulates osteoclast activity in a time-dependent manner, balancing bone resorption and formation to improve bone strength[1][5].
• Regulates calcium and phosphorus homeostasis by promoting renal tubular reabsorption of calcium, increasing intestinal calcium absorption (via vitamin D activation), and enhancing phosphorus excretion, maintaining normal serum calcium and phosphorus levels[1][5].
• Activates the cyclic adenosine monophosphate (cAMP) signaling pathway and phospholipase C (PLC) signaling pathway, increasing intracellular cAMP, calcium ion (Ca²⁺) concentration, and inositol triphosphate (IP3) levels, which serve as second messengers to mediate its physiological effects[1][3].
• Exhibits a short plasma half-life of approximately 1–2 hours in humans, rapidly metabolized by proteases in the liver and kidneys, with minimal accumulation in the body[1][3].
• Exerts anabolic effects on bone tissue, making it effective in reversing bone loss and improving bone microarchitecture, particularly in patients with osteoporosis[1][5].

4. Main Applications

• Pharmaceutical API: Used in the R&D and production of injectable preparations for the treatment of osteoporosis (especially postmenopausal osteoporosis, male osteoporosis, and glucocorticoid-induced osteoporosis), to increase bone mineral density and reduce the risk of fractures[1][5].
• Research & Development: Applied in preclinical pharmacology, toxicology, and formulation optimization studies related to bone metabolism disorders, osteoporosis, and PTH receptor-targeted drugs[1][3].
• Scientific Research: Suitable for laboratory studies on bone formation and resorption mechanisms, PTH receptor signaling pathways, osteoblast/osteoclast regulation, and the development of novel bone anabolic agents[1][5].
• Biomedical Research: Used in studies on bone regeneration, fracture healing, and metabolic bone diseases, as well as high-throughput screening of drugs targeting bone metabolism and PTH1R[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][5].
• Stable Polypeptide Structure: Produced via advanced solid-phase synthesis technology, ensuring the integrity of the 1-34 amino acid sequence and optimal binding affinity to PTH1R[1].
• Stable Quality: Strict production process control and comprehensive analytical testing (COA, HPLC, MS, NMR) provided for each batch, ensuring batch-to-batch consistency[3][5].
• Professional Manufacturing: Produced in a GMP-compliant cleanroom with strict contamination control, meeting international pharmaceutical and research standards[3][5].
• 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][5].

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][5].

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][5].
• Strictly comply with local laws and regulations regarding peptide APIs, pharmaceutical raw materials, and controlled substances; Teriparatide is a prescription-only drug in most jurisdictions[5]. It is contraindicated in patients with hypercalcemia, hypercalciuria, severe renal impairment, and hypersensitivity to any component of the product[5].
• Full MSDS (Material Safety Data Sheet) with detailed safety information, including adverse effects (e.g., hypercalcemia, nausea, headache, bone pain, dizziness) and handling precautions, is provided with each order[4][5].

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][5].
• 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][5].