Description

Zoledronic Acid Hydrate is a high-purity, nitrogen-containing bisphosphonate compound, recognized for its potent inhibitory activity against osteoclast-mediated bone resorption. Its primary commercial value lies in its role as the active pharmaceutical ingredient (API) in critical osteoporosis and oncology treatments. This material is essential for pharmaceutical manufacturers and advanced research institutions developing injectable formulations for bone-related disorders. Consistent quality and reliable supply are paramount for ensuring the safety and efficacy of the final medicinal products.

Application

• Pharmaceutical API: Primary use as the active ingredient in sterile injectable formulations for the treatment of osteoporosis, Paget's disease of bone, and hypercalcemia of malignancy.
• Oncology Supportive Care: Key component in medications used to prevent skeletal-related events (SREs) such as fractures, spinal cord compression, and bone pain in patients with bone metastases from solid tumors.
• Research & Development: Serves as a critical reference standard and building block in biochemical research focused on bone metabolism, osteoclast biology, and the development of novel bisphosphonate therapies.
• Veterinary Medicine: Investigational and applied use in treating similar bone resorption conditions in companion and large animals.
• Analytical Standard: Used in quality control laboratories for method development, validation, and assay calibration of finished drug products.

Basic Information

Product Name	Zoledronic Acid Hydrate
CAS No.	165800-06-6
Molecular Formula	C5H10N2O7P2 • xH2O
Molecular Weight	Anhydrous: 272.09 g/mol
Synonyms	Zoledronate Monohydrate; (1-Hydroxy-2-imidazol-1-yl-phosphonoethyl)phosphonic Acid Monohydrate; CGP 42446; Zometa (trade name, finished product); Reclast (trade name, finished product); Aclasta (trade name, finished product); 2-(Imidazol-1-yl)-1-hydroxyethane-1,1-diyldiphosphonic Acid Hydrate; IUPAC: [1-Hydroxy-2-(1H-imidazol-1-yl)ethylidene]bis(phosphonic acid) hydrate
EINECS	Contact for details

Quality Control

Our Zoledronic Acid Hydrate is manufactured under strict quality systems, targeting compliance with major pharmacopoeial standards such as USP and EP. Every batch undergoes comprehensive analytical testing including identification, assay, impurity profiling, and residual solvent analysis to ensure it meets stringent specifications for pharmaceutical use. A Certificate of Analysis (COA) documenting purity, related substances, and other critical parameters is provided with each shipment to guarantee traceability and quality assurance.

Storage

Preserve in a tightly closed container, protected from light. Due to its hygroscopic (moisture-sensitive) nature, the material must be stored in a cool, dry place, ideally at controlled room temperature (15-25°C). For long-term storage, consider desiccated conditions to maintain stability and potency.

Specification

Item	Specification
Appearance	White to almost 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)	Contact for details
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Heavy Metals	≤ 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Microbial Enumeration	Complies with Ph. Eur. 2.6.12 / USP <61>

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