Description

Clodronate Impurity D CAS NO 87591-00-2 is a high-purity reference standard critical for the analytical profiling and quality control of Clodronate disodium, a bisphosphonate drug. This impurity standard is essential for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance. It is primarily used in research and development, method validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Clodronate disodium active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles during API synthesis and formulation.
• Quality Control & Assurance (QC/QA): Enables precise impurity testing to ensure batch-to-batch consistency and compliance with pharmacopeial standards (e.g., USP, EP, ICH guidelines).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Process Chemistry Research: Aids in optimizing synthesis pathways by identifying and controlling process-related impurities.

Basic Information

Product Name	Clodronate Impurity D
CAS No.	87591-00-2
Molecular Formula	C2H7Cl2O6P2
Molecular Weight	268.93 g/mol
Synonyms	Dichloromethylenebisphosphonic Acid Impurity D; (Dichloro-phosphono-methyl)-phosphonic Acid; Clodronic Acid Impurity D; Clodronate Related Compound D; 1-Hydroxy-2-(dichlorophosphono)ethane-1,1-diylbis(phosphonic acid); Phosphonic acid, P-[1-hydroxy-2-(dichlorophosphinyl)ethyl]-, P'-oxide; Clodronate Disodium Impurity D
EINECS	Contact for details

Quality Control

Every batch of Clodronate Impurity D is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, NMR, MS) to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 inert conditions or in a desiccator after opening to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 2.0%

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