Description

Minodronic Acid Impurity 7 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products containing Minodronic Acid. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in drug development and quality control. The availability of this well-characterized impurity standard is essential for method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material for the identification and quantification of impurities in Minodronic Acid Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, to monitor impurity levels during manufacturing.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure drug substance and drug product purity meets stringent pharmacopeial standards (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Used to track the formation and growth of this specific impurity over time under various storage conditions, supporting shelf-life determination.
• Regulatory Compliance & Filing: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Research & Development: Supports synthetic route optimization and degradation pathway studies in pharmaceutical R&D laboratories.

Basic Information

Product Name	Minodronic Acid Impurity 7
CAS No.	2303523-19-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Minodronate Impurity 7; Minodronic Acid Related Compound 7; 1-Hydroxy-2-(imidazo[1,2-a]pyridin-3-yl)ethylidene-1,1-bisphosphonic Acid Impurity; YM-529 Impurity 7; ONO-5920 Impurity; Bisphosphonate Impurity; Minodronic Acid Process Impurity; Minodronic Acid Degradant
EINECS	Contact for details

Quality Control

Our Minodronic Acid Impurity 7 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity assay and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming identity, purity, and traceability. Our quality protocols align with ICH guidelines and current Good Manufacturing Practice (cGMP) principles.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under anhydrous conditions. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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