Description

Zoledronic Acid Impurity A is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the identification, quantification, and control of process-related impurities in the manufacturing of Zoledronic Acid, a potent bisphosphonate drug. It is primarily utilized by analytical laboratories, quality control units, and regulatory affairs departments within the global pharmaceutical and biotechnology industries to ensure product safety, efficacy, and compliance with stringent regulatory guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine quality control testing of Zoledronic Acid Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Research: Used in HPLC, UPLC, and LC-MS studies for the precise identification and quantification of Zoledronic Acid Impurity A in complex matrices.
• Regulatory Compliance & Documentation: Critical for preparing regulatory submission dossiers (e.g., for FDA, EMA, ICH) to demonstrate thorough impurity profiling and control strategies.
• Process Chemistry & Optimization: Employed by R&D and manufacturing scientists to monitor and minimize the formation of this specific impurity during the synthesis and purification stages of Zoledronic Acid.
• Stability Studies: Used as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Zoledronic Acid.
• Contract Research Organizations (CROs): Essential material for CROs providing analytical and bioanalytical services to pharmaceutical clients.

Basic Information

Product Name	Zoledronic Acid Impurity A
CAS No.	1627731-60-5
Molecular Formula	C5H10N2O7P2
Molecular Weight	272.09 g/mol
Synonyms	1-Hydroxy-2-(1H-imidazol-1-yl)ethane-1,1-diyldiphosphonic Acid; Zoledronic Acid Related Compound A; (1-Hydroxy-2-imidazol-1-yl-ethylidene)bisphosphonic Acid; Zoledronate Impurity A; ZOL Impurity A; Imidazol-1-yl-hydroxyethylidene-1,1-bisphosphonic Acid; ZA Imp A
EINECS	Contact for details

Quality Control

Every batch of Zoledronic Acid Impurity A is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profile. We support compliance with ICH Q3A/B guidelines and relevant pharmacopeial standards.

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 dry, inert conditions to maintain stability and purity. For long-term storage, consider desiccants or an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown 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.