Description

Teriparatideacetate is the acetate salt form of the recombinant human parathyroid hormone (1-34) fragment, a critical therapeutic peptide. It is a potent anabolic agent primarily used to stimulate new bone formation in patients with severe osteoporosis. This high-purity active pharmaceutical ingredient (API) is essential for pharmaceutical manufacturers developing injectable treatments for metabolic bone disorders. Its quality and stability are paramount for ensuring final drug product efficacy and patient safety.

Application

• Pharmaceutical API: Primary active ingredient in formulated injectable drugs for the treatment of postmenopausal osteoporosis.
• Anabolic Bone Therapy: Used in medications to increase bone mineral density and reduce the risk of fractures in high-risk patients.
• Metabolic Bone Disorder Research: Serves as a reference standard and key reagent in preclinical and clinical research on bone physiology and pathology.
• Biosimilar Development: Critical raw material for companies developing biosimilar versions of established teriparatide-based therapies.
• Drug Delivery System Development: Used in R&D for novel delivery mechanisms, such as long-acting injectables or implantable devices.

Basic Information

Product Name	Teriparatideacetate
CAS No.	99294-94-7
Molecular Formula	C181H291N55O51S2 • xC2H4O2
Molecular Weight	~4117.8 g/mol (free base)
Synonyms	Teriparatide Acetate; Recombinant human parathyroid hormone (1-34) acetate; hPTH (1-34) acetate; Parathyroid hormone fragment 1-34 (human) acetate; PTH (1-34) acetate; Forteo™ API (acetate salt); Forsteo™ API (acetate salt); LY333334 acetate
EINECS	Contact for details

Quality Control

Our Teriparatideacetate is manufactured under strict cGMP guidelines to ensure the highest standards of purity and consistency for pharmaceutical applications. Each batch is subjected to a comprehensive battery of analytical tests, including identity confirmation by mass spectrometry and peptide mapping, purity assessment by reverse-phase HPLC, and stringent limits for related substances and residual solvents. A detailed Certificate of Analysis (COA) is provided with every shipment, documenting compliance with in-house specifications aligned with major pharmacopoeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store frozen at -20°C or below. For long-term storage, maintain at -70°C. The product is hygroscopic (moisture-sensitive); allow the sealed vial to equilibrate to room temperature before opening to prevent condensation. Store in a dedicated freezer away from volatile substances.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC/MS)	Conforms to reference standard
Assay (HPLC)	≥ 98.0% (on anhydrous basis)
Purity (Related Substances)	Total impurities ≤ 2.0%
Single Unknown Impurity	≤ 0.5%
Peptide Content (UV)	≥ 80.0%
Water Content (KF)	≤ 10.0%
Acetic Acid Content (HPLC)	5.0% - 12.0%
Bacterial Endotoxins	< 10 EU/mg
Sterility (for sterile grade)	Sterile

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.