Description

Zoledronic Acid Trihydrate is a high-purity, nitrogen-containing bisphosphonate compound, essential for the development of advanced osteoporosis and oncology therapeutics. Its primary value lies in its potent and selective inhibition of osteoclast-mediated bone resorption, making it a critical active pharmaceutical ingredient (API) for injectable formulations. This material is specifically required by pharmaceutical manufacturers and research institutions engaged in the production of next-generation bone disease treatments and metabolic disorder drugs.

Application

• Pharmaceutical API: Primary use as the active ingredient in the manufacture of zoledronic acid injection for treating osteoporosis, Paget's disease, and hypercalcemia of malignancy.
• Oncology Supportive Care: Formulation into medications to prevent skeletal-related events (SREs) in patients with bone metastases from solid tumors.
• Research & Development: Serves as a key reference standard and intermediate in biochemical research for studying bone metabolism and osteoclast activity.
• Generic Drug Manufacturing: Used by generic pharmaceutical companies for the production of bioequivalent versions of branded bisphosphonate therapies.
• Veterinary Medicine: Potential application in developing treatments for bone disorders in companion and large animals.
• Analytical Standard: Utilized in quality control laboratories for HPLC, LC-MS, and other analytical method development and validation.

Basic Information

Product Name	Zoledronic Acid Trihydrate
CAS No.	904894-54-8
Molecular Formula	C5H10N2O7P2 · 3H2O
Molecular Weight	324.11 g/mol (Anhydrous basis)
Synonyms	Zoledronate Trihydrate; (1-Hydroxy-2-imidazol-1-yl-phosphonoethyl)phosphonic Acid Trihydrate; CGP 42446A; Zometa® (Brand Name) API; ZOL Trihydrate; 2-(Imidazol-1-yl)-1-hydroxyethane-1,1-diyldiphosphonic Acid Trihydrate; IUPAC: [1-Hydroxy-2-(1H-imidazol-1-yl)ethane-1,1-diyl]bis(phosphonic acid) trihydrate
EINECS	Contact for details

Quality Control

Our Zoledronic Acid Trihydrate is manufactured under strict quality management systems, targeting compliance with ICH Q7 guidelines for active pharmaceutical ingredients. Each batch undergoes comprehensive analytical testing, including identification, assay, impurity profiling, and residual solvent analysis. A Certificate of Analysis (COA) documenting purity (typically ≥98.0% by HPLC), related substances, and other critical parameters is provided with every shipment to ensure traceability and regulatory readiness.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under conditions of low humidity to prevent degradation and ensure long-term stability.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	14.0% - 17.0% (Theoretical for Trihydrate: ~14.3%)
Related Substances (HPLC)	Individual impurity: ≤0.5%; Total impurities: ≤2.0%
Heavy Metals	≤20 ppm
Residual Solvents (GC)	Complies with ICH Q3C guidelines
pH (1% Solution)	2.0 - 3.0
Specific Rotation	Contact for details

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