Description

Calcipotriol Ep Impurity B is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Calcipotriol, a synthetic vitamin D3 analog. This impurity is critical for ensuring the safety and efficacy of the final active pharmaceutical ingredient (API) by enabling accurate identification and quantification during analysis. It is primarily utilized by analytical chemists, quality assurance professionals, and researchers in pharmaceutical R&D and manufacturing.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the identification and quantification of Calcipotriol Ep Impurity B in Calcipotriol API and related drug products.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity profiles and ensure compliance with stringent pharmacopeial standards (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of this specific impurity over time under various storage conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research on Degradation Pathways: Aids in studying the degradation chemistry of Calcipotriol, helping to improve formulation and packaging strategies.

Basic Information

Product Name	Calcipotriol Ep Impurity B
CAS No.	2948288-30-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Calcipotriol EP Impurity B; Calcipotriol Impurity B (EP); (5Z,7E,22E)-9,10-Secocholesta-5,7,10(19),22-tetraene-1α,3β,24-triol; 1α,24-Dihydroxy-22-ene-vitamin D3 impurity; Vitamin D3 analog impurity; Calcipotriol related compound B
EINECS	Contact for details

Quality Control

Our Calcipotriol Ep Impurity B is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. We provide comprehensive Certificates of Analysis (COA) with each shipment, detailing batch-specific results. Our quality standards align with ICH guidelines and support compliance in cGMP environments for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). Keep the container in a dry, cool, and well-ventilated area. Handle and store under an inert atmosphere if specified.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 2.0%
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.