Product Overview

Product Features

• High Purity & Bioactivity: HPLC ≥95.0%, full biological potency as human PTH (1–34).
• Bone-Forming Agent: The only anabolic osteoporosis drug; directly activates osteoblasts.
• Controlled Calcium Homeostasis: Regulates calcium/phosphate metabolism in bone and kidney.
• Hygroscopic & Thermosensitive: Requires strict low-temperature storage and moisture protection.
• GMP & Regulatory Compliance: Manufactured under cGMP; DMF available for API applications.

Physical & Chemical Properties

Physical Properties

1. Appearance: White to off-white crystalline/lyophilized powder.
2. Odor: Odorless.
3. Molecular Formula: C???H???N??O??S? · C?H?O? (acetate salt).
4. Molecular Weight: 4177.77 Da (acetate salt).
5. Melting Point: >205 °C (decomposition).
6. Solubility:
   • Water: ≥1 mg/mL (clear, colorless solution).
   • 1% Acetic acid: ≥1 mg/mL.
   • DMSO: Slightly soluble.
   • Insoluble in organic solvents (ethanol, acetone, ether).
7. pH (1 mg/mL in water): 3.8–4.5.
8. Hygroscopicity: Highly hygroscopic; absorbs moisture rapidly.
9. Stability: Thermally unstable; degrades at room temperature; light-sensitive.

Chemical Properties

1. Peptide Structure: Linear polypeptide with 34 amino acids; contains 2 methionine residues (prone to oxidation).
2. Acetate Salt: Weakly acidic; dissociates in aqueous solution to release teriparatide and acetate ions.
3. Oxidation Sensitivity: Methionine residues oxidize to sulfoxides under air/light, reducing bioactivity.
4. Hydrolysis: Stable at pH 3.8–4.5; hydrolyzes under strong acid/alkali, cleaving peptide bonds.
5. Incompatibility: Avoid strong oxidants, heavy metals, high temperature, and neutral/alkaline pH.

Applications

1. Pharmaceutical API:
   • Treatment of postmenopausal osteoporosis (high fracture risk).
   • Increase bone mass in male primary/hypogonadal osteoporosis.
   • Glucocorticoid-induced osteoporosis in adults.
2. Mechanism: Stimulates osteoblast activity, promotes new bone formation, improves bone microarchitecture.
3. Research Use:
   • In vitro bone metabolism studies; PTH signaling pathway research.
   • Preclinical models for osteoporosis and bone regeneration.
4. Formulation: Lyophilized powder for injection (subcutaneous administration, 20 μg daily).

Storage & Transportation Instructions

Storage Conditions

• Temperature: ?20 °C ± 5 °C (long-term); 2–8 °C (short-term, ≤30 days).
• Environment: Dry, dark, airtight container; avoid moisture, light, and oxygen.
• Packaging: Sealed glass vials or peptide-grade plastic vials with desiccant.
• Shelf Life: 3 years at ?20 °C (unopened); 30 days at 2–8 °C (after opening).

Transportation Requirements

• UN Number: Not classified as dangerous goods (non-hazardous).
• Hazard Class: None (no explosive, corrosive, or acute toxic properties).
• Packaging:
  • Inner: Sealed vial with desiccant (moisture-proof).
  • Outer: Foam-insulated cardboard box with ice packs (cold chain).
• Temperature: 2–8 °C during transit; avoid freezing (for formulated products).
• Precautions:
  • Avoid violent vibration, extrusion, and direct sunlight.
  • Do not transport with oxidants, acids, or food items.

Operation & Safety Notes

• GHS Classification: Carcinogenicity (Category 2); Reproductive toxicity (Category 2).
• PPE: Wear dust mask, chemical-resistant gloves, and safety goggles; work in a fume hood.
• Avoid: Inhalation of powder, skin/eye contact, and ingestion.
• First Aid:
  • Skin contact: Rinse with plenty of water for 15 min.
  • Eye contact: Rinse with water for 15 min; seek medical attention.

Regulatory Information

• CAS Number: 52232-67-4.
• EINECS Number: Not listed (peptide API).
• HS Code: 2937190090 (peptide hormones).
• Quality Standards: USP, EP, cGMP; COA, MSDS, and TSE/BSE certificates available.
• Restrictions: For pharmaceutical manufacturing and research use only; not for human consumption directly.

Full Product Parameter Table