Description

Zoledronic Acid Impurity B CAS NO 1627731-61-6 is a high-purity reference standard used for the analytical characterization and quality control of Zoledronic Acid, a potent bisphosphonate drug. This impurity is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product. It is primarily utilized in research and development, method validation, and regulatory compliance testing within the pharmaceutical and biotechnology sectors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Zoledronic Acid Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure drug substance and product meet stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions to establish shelf life and storage requirements.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and new drug applications (NDAs).
• Process Chemistry Research: Aids in understanding and controlling impurity formation during the synthesis and purification of Zoledronic Acid.

Basic Information

Product Name	Zoledronic Acid Impurity B
CAS No.	1627731-61-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Zoledronate Impurity B; Zoledronic Acid Related Compound B; (1-Hydroxy-2-imidazol-1-yl-1-phosphonoethyl)phosphonic acid impurity B; ZOL Impurity B; Zoledronic acid EP Impurity B; Zoledronic acid USP Impurity B; Desired impurity profile component for Zoledronic Acid.
EINECS	Contact for details

Quality Control

Our Zoledronic Acid Impurity B is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment, supporting compliance with ICH Q3A, Q3B, 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 compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

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

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