Description

Zoledronic Acid CAS NO 118072-93-8 is a highly potent nitrogen-containing bisphosphonate, serving as a critical active pharmaceutical ingredient (API) in the treatment of bone-related disorders. Its primary value lies in its exceptional ability to inhibit osteoclast-mediated bone resorption, making it a cornerstone therapy for conditions like osteoporosis and bone metastases. This compound is essential for pharmaceutical manufacturers and research institutions developing injectable formulations and advanced drug delivery systems targeting skeletal health.

Application

• Pharmaceutical API: Primary use as the active ingredient in injectable medications such as Zometa® and Reclast®/Aclasta®.
• Osteoporosis Treatment: Formulated for the treatment and prevention of postmenopausal osteoporosis and glucocorticoid-induced osteoporosis.
• Oncology Support: Management of skeletal-related events (SREs) including hypercalcemia of malignancy and bone metastases from solid tumors.
• Paget's Disease of Bone: Therapeutic agent for the treatment of this chronic bone disorder.
• Research & Development: Used in biochemical and pharmacological studies of bone metabolism and bisphosphonate mechanisms of action.
• Generic Drug Manufacturing: Sourcing for the production of cost-effective generic versions of branded zoledronic acid therapies.

Basic Information

Product Name	Zoledronic Acid
CAS No.	118072-93-8
Molecular Formula	C5H10N2O7P2
Molecular Weight	272.09 g/mol
Synonyms	Zoledronate; CGP 42446; (1-Hydroxy-2-imidazol-1-yl-phosphonoethyl)phosphonic acid; Zoledronic Acid Monohydrate; ZOL 446; Zoledronic Acid (anhydrous); IMD 353; Zoledronic Acid API
EINECS	Contact for details

Quality Control

Our Zoledronic Acid is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing to ensure it meets high-purity standards suitable for pharmaceutical applications. We provide full traceability and Certificates of Analysis (COA) confirming identity, purity, and impurity profiles, with specifications aligned with major pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption, which can affect stability and purity.

Specification

Item	Specification
Appearance	White to almost white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
pH (1% Solution)	2.0 - 3.0

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