Description

Minodronic Acid Impurity 2 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient, Minodronic Acid, a bisphosphonate used in osteoporosis treatment. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and contract research organizations (CROs) involved in method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification in Minodronic Acid API and finished drug products.
• Analytical Method Development and Validation (HPLC, UPLC, LC-MS) for accurate quantification of related substances.
• Quality Control and Release Testing to ensure API and drug product meet ICH Q3A/B regulatory guidelines.
• Stability Studies to monitor the formation of degradation products under various stress conditions.
• Reference Standard for Pharmacopeial Testing (e.g., USP, EP) to confirm the identity and purity of Minodronic Acid.
• Research and Development of new synthetic routes and process optimization for Minodronic Acid manufacturing.

Basic Information

Product Name	Minodronic Acid Impurity 2
CAS No.	127657-45-8
Molecular Formula	C9H12N2O7P2
Molecular Weight	322.15 g/mol
Synonyms	Minodronate Impurity 2; (1-Hydroxy-2-imidazo[1,2-a]pyridin-3-ylethane-1,1-diyl)bis(phosphonic acid); YM-529 Impurity 2; ONO-5920 Impurity 2; Minodronic Acid Related Compound 2; Minodronic Acid EP Impurity B; Minodronic Acid USP Impurity
EINECS	Contact for details

Quality Control

Every batch of Minodronic Acid Impurity 2 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity, identity confirmation (IR, NMR), and residual solvent analysis, to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

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 tightly after each use to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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