Description

Zoledronic Acid Related Compound CAS NO 805228-36-8 is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound is essential for ensuring the quality, safety, and efficacy of zoledronic acid, a widely used bisphosphonate medication. It serves as a vital analytical tool for researchers and quality control laboratories in the pharmaceutical and biotechnology industries, enabling precise method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Reference Standard: Used for the identification, qualification, and quantification of related substances and degradation products in zoledronic acid Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: A critical component in developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-High-Performance Liquid Chromatography (UHPLC), and other chromatographic methods for purity analysis.
• Quality Control & Assurance (QC/QA): Employed as a system suitability standard and for routine batch testing in pharmaceutical manufacturing to ensure compliance with stringent pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Used to monitor and characterize impurities that may form during the forced degradation and long-term stability testing of zoledronic acid formulations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with the FDA, EMA) to demonstrate comprehensive impurity control and the safety profile of the drug substance.
• Research & Development: Supports synthetic route optimization, process chemistry development, and the study of metabolic pathways in preclinical and clinical research.

Basic Information

Product Name	Zoledronic Acid Related Compound
CAS No.	805228-36-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Zoledronic Acid Impurity; Zoledronic Acid Related Substance; Zoledronate Related Compound; (1-Hydroxy-2-imidazol-1-yl-phosphonoethyl)phosphonic Acid Derivative; Aclasta Impurity; Reclast Impurity; Zometa Impurity; Bisphosphonate Related Compound
EINECS	Contact for details

Quality Control

Our Zoledronic Acid Related Compound is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency. We provide comprehensive Certificates of Analysis (COA) with each shipment, detailing all test results against established specifications. Our quality commitment aligns with the standards expected for pharmaceutical reference materials, supporting compliance with ICH Q3A/B, USP, and EP 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). This material is hygroscopic (moisture-sensitive) and must be kept under anhydrous conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C

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