Description

A Zoledronic Acid Related Compound CAS NO 2043362-88-3 is a high-purity chemical reference standard and synthetic intermediate critical for pharmaceutical research and development. This compound is essential for ensuring the quality, safety, and efficacy of zoledronic acid and related bisphosphonate drug substances through precise analytical control. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method development, impurity profiling, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity or related substance standard for the quality control (QC) and stability testing of Zoledronic Acid API and finished drug products.
• Analytical Method Development: Serves as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity identification and quantification.
• Process Chemistry Research: Employed as a key intermediate or byproduct reference in the synthesis and scale-up optimization of bisphosphonate active pharmaceutical ingredients (APIs).
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized material for impurity qualification and identification studies.
• Academic & Contract Research: Utilized in universities and CROs for metabolic studies, degradation pathway analysis, and pharmacological research on bone resorption inhibitors.

Basic Information

Product Name	A Zoledronic Acid Related Compound
CAS No.	2043362-88-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Zoledronic Acid Impurity; Zoledronic Acid Related Substance; Zoledronate Related Compound; Bisphosphonate Related Compound; (1-Hydroxy-2-imidazol-1-yl-1-phosphonoethyl)phosphonic acid derivative; 2043362-88-3; ZOL Related Compound
EINECS	Contact for details

Quality Control

This high-grade reference material is produced under strict quality management systems. Each batch undergoes comprehensive analytical characterization using techniques such as HPLC, NMR, and MS to confirm identity and purity, ensuring it meets the exacting standards required for pharmaceutical analysis. A comprehensive Certificate of Analysis (COA) detailing purity, impurities, and analytical methods is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5% Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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