Description

Risedronate Related Compound B Disodium Salt is a high-purity chemical reference standard critical for analytical and pharmaceutical development. This compound is essential for ensuring the quality, safety, and efficacy of risedronate sodium, a widely prescribed bisphosphonate drug. It is primarily used by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, impurity profiling, and quality control testing.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in risedronate sodium active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for purity and stability-indicating assays.
• Quality Control (QC) & Quality Assurance (QA): Employed in routine QC testing to monitor batch-to-batch consistency and ensure compliance with pharmacopeial specifications (USP, EP, JP).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA) to meet FDA, EMA, and other global health authority requirements.
• Stability Studies: Used to identify and track degradation products in forced degradation and long-term stability studies of risedronate formulations.
• Research & Development: Facilitates process chemistry research and the development of robust synthetic pathways for risedronate sodium with minimized impurity formation.

Basic Information

Product Name	Risedronate Related Compound B Disodium Salt
CAS No.	1486466-30-1
Molecular Formula	C7H9NNa2O7P2 (or related hydrate form)
Molecular Weight	Contact for details
Synonyms	Risedronate Impurity B Disodium Salt; Risedronate Sodium Related Compound B; Disodium (1-hydroxy-2-(3-pyridinyl)ethylidene)bisphosphonate (Related Compound B); Risedronate EP Impurity B; Risedronate USP Related Compound B; 1-Hydroxy-2-(3-pyridinyl)ethylidene-1,1-bisphosphonic Acid Disodium Salt (Related Compound); Risedronate Process Impurity B
EINECS	Contact for details

Quality Control

Every batch of our Risedronate Related Compound B Disodium Salt is manufactured and tested under strict quality systems. We provide comprehensive analytical data to support its use as a reference standard. Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request, detailing HPLC purity, identity confirmation (IR, MS), and impurity profile against relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Avoid exposure to excessive heat and humidity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.