Description

Zoledronate Disodium Tetrahydrate is a high-purity bisphosphonate compound, serving as the active pharmaceutical ingredient (API) for advanced osteoporosis and oncology treatments. Its primary commercial value lies in its potent inhibition of osteoclast-mediated bone resorption, making it critical for developing long-acting injectable formulations. This material is essential for pharmaceutical manufacturers and research institutions focused on metabolic bone disease therapies, cancer-related hypercalcemia, and novel drug delivery systems.

Application

• Pharmaceutical API: Primary active ingredient in the manufacture of Zoledronic Acid injection for osteoporosis and Paget's disease.
• Oncology Supportive Care: Formulation component for drugs treating bone metastases and malignancy-induced hypercalcemia.
• Generic Drug Development: Key starting material for companies developing bioequivalent versions of branded bisphosphonate therapies.
• Research & Development: Biochemical tool for studying bone metabolism, osteoclast function, and calcium regulation pathways.
• Preclinical Studies: Used in animal models to evaluate efficacy and pharmacokinetics of new bone-targeting agents.
• Analytical Reference Standard: Serves as a high-purity standard for HPLC, LC-MS, and other quality control testing methods.

Basic Information

Product Name	Zoledronate Disodium Tetrahydrate
CAS No.	165800-07-7
Molecular Formula	C5H8N2Na2O7P2 · 4H2O
Molecular Weight	406.07 g/mol (Anhydrous basis)
Synonyms	Zoledronic Acid Disodium Salt Tetrahydrate; Zoledronate Sodium Tetrahydrate; CGP 42446; ZOL 446; (1-Hydroxy-2-imidazol-1-yl-phosphonoethyl)phosphonic Acid Disodium Salt Tetrahydrate; Zometa® API Intermediate; Disodium (1-hydroxy-2-(1H-imidazol-1-yl)ethylidene)bis(phosphonate) tetrahydrate
EINECS	Contact for details

Quality Control

Our Zoledronate Disodium Tetrahydrate is manufactured under strict quality management systems, targeting specifications suitable for pharmaceutical ingredient use. Each batch is tested to ensure identity, purity, and consistency, with analytical methods including HPLC for assay and related substances. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for appearance, assay, water content, residual solvents, and heavy metals. We support compliance with ICH Q7 guidelines and can supply material referenced to pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Due to its hygroscopic nature, the product must be stored in a cool, dry place with controlled humidity. Recommended long-term storage temperature is 2°C to 8°C. For extended stability, consider storage under an inert atmosphere. Keep the container sealed when not in use to prevent moisture absorption and potential degradation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	14.0% - 18.0% (Theoretical for Tetrahydrate: ~17.7%)
Related Substances (HPLC)	Total impurities ≤ 2.0%; Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
pH (1% Solution)	6.0 - 8.0

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