Description

Minodronic Acid Impurity 21 is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient, Minodronic Acid, by serving as a benchmark in chromatographic analysis. It is an essential material for pharmaceutical R&D laboratories, quality assurance units, and contract research organizations (CROs) involved in the development and manufacturing of bisphosphonate drugs. The availability of this well-characterized impurity supports regulatory compliance and robust analytical method development.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Minodronic Acid Impurity 21 in drug substances and products.
• Analytical Method Development and Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control and Batch Release: Used in-house by QC laboratories to establish impurity limits and ensure batch-to-batch consistency of Minodronic Acid API.
• Regulatory Submissions: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing characterized impurity data for drug approval processes.
• Stability Studies: Employed to monitor the formation of this specific impurity under various stress conditions and throughout shelf-life studies.
• Research and Development: Used by synthetic chemists and process development teams to study impurity formation pathways and optimize synthesis routes.

Basic Information

Product Name	Minodronic Acid Impurity 21
CAS No.	1507308-67-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Minodronate Impurity 21; Minodronic Acid Related Compound 21; 1-Hydroxy-2-(imidazo[1,2-a]pyridin-3-yl)ethylidene-1,1-bisphosphonic Acid Impurity; UNII-Contact for details; Bisphosphonate Impurity; Minodronic Acid Process Impurity; Analytical Reference Standard 1507308-67-9
EINECS	Contact for details

Quality Control

Every batch of Minodronic Acid Impurity 21 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA), detailing batch-specific results, is provided with each shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. Due to its hygroscopic (moisture-sensitive) nature, the container must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability.

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 guidelines
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.