Description

Strontium Ranelate Impurity B is a designated reference standard used for the identification and quantification of a specific process-related impurity in the active pharmaceutical ingredient, strontium ranelate. This high-purity analytical standard is critical for ensuring the quality, safety, and efficacy of pharmaceutical formulations by enabling precise impurity profiling. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) departments, and regulatory affairs teams involved in the development and manufacturing of strontium ranelate-based medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for analytical method development and validation in accordance with ICH Q2(R1) and Q3B(R2) guidelines.
• Quality Control & Assurance: Used in routine HPLC/LC-MS analysis to monitor and control the level of Impurity B in strontium ranelate drug substance and finished dosage forms.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing definitive impurity identification and specification data.
• Stability Studies: Employed as an analytical marker to track impurity formation and degradation pathways in stability-indicating assays for strontium ranelate.
• Pharmacopoeial Testing: Facilitates compliance testing against monographs in pharmacopoeias such as USP, EP, or BP that specify limits for related substances.
• Process Chemistry R&D: Aids chemists in optimizing synthesis and purification processes to minimize the formation of this specific impurity.

Basic Information

Product Name	Strontium Ranelate Impurity B
CAS No.	674773-13-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	5-[Bis(carboxymethyl)amino]-2-carboxy-4-cyano-3-thiophenacetic Acid Distrontium Salt Impurity B; Ranelic Acid Impurity B; Strontium Ranelate Related Compound B; Protelos Impurity B; 674773-13-8; UNII-7VJ280J5Q5
EINECS	Contact for details

Quality Control

Every batch of Strontium Ranelate Impurity B is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
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.