Description

Risedronate Impurity C is a designated impurity of the active pharmaceutical ingredient Risedronate Sodium, a bisphosphonate used in the treatment of osteoporosis and Paget's disease. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control to ensure drug purity and safety. It is primarily utilized by analytical chemists, quality assurance professionals, and R&D scientists in the pharmaceutical and biotechnology industries for impurity profiling and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Risedronate Impurity C in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating precise HPLC, UPLC, or LC-MS methods to monitor impurity levels during manufacturing.
• Quality Control & Assurance (QC/QA): A critical component in routine batch release testing to ensure API and drug product specifications meet pharmacopeial (USP, EP) and ICH guidelines.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light) as per ICH Q1A(R2).
• Regulatory Submissions: Provides necessary data on impurity identity, characterization, and control strategies for regulatory filings (e.g., FDA, EMA).
• Process Chemistry Research: Used to study and optimize synthesis pathways to minimize the formation of this impurity during the manufacturing of Risedronate Sodium.

Basic Information

Product Name	Risedronate Impurity C
CAS No.	105462-25-7
Molecular Formula	C7H11NO7P2
Molecular Weight	283.11 g/mol
Synonyms	(1-Hydroxy-1-phosphonoethyl)phosphonic Acid; 1-Hydroxy-1,1-ethylidenediphosphonic Acid; 1-Hydroxyethane-1,1-diphosphonic Acid; HEDP Impurity; Etidronic Acid Impurity; Risedronate Related Compound C; Risedronate EP Impurity C; Risedronate USP Impurity C
EINECS	Contact for details

Quality Control

Our Risedronate Impurity C is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure high purity and batch-to-batch consistency. Quality is assured through comprehensive characterization using techniques including HPLC, NMR, and Mass Spectrometry. A detailed Certificate of Analysis (COA) is provided with each batch, confirming identity, purity, and compliance with relevant standards. We support compliance with ICH Q3A, Q3B, USP, and EP guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider desiccants.

Specification

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

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