Description

Alfacalcidol Impurity 6 is a high-purity chemical reference standard, specifically identified as a known impurity of the active pharmaceutical ingredient Alfacalcidol. This compound is critical for pharmaceutical research, development, and quality control processes, enabling precise analytical method validation and impurity profiling. It is primarily utilized by analytical chemists, quality assurance professionals, and R&D scientists in the pharmaceutical and biotechnology industries to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quantitative and qualitative analysis of Alfacalcidol drug substances and finished products.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to develop, optimize, and validate chromatographic methods for impurity detection and separation.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in GMP environments to monitor and control impurity levels, ensuring compliance with ICH guidelines.
• Stability Studies: Employed to identify and quantify degradation products formed during drug stability testing under various stress conditions.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMF), investigational new drug (IND) applications, and new drug applications (NDA).
• Research on Metabolic Pathways: Can be used in research settings to study the degradation pathways and metabolism of Alfacalcidol.

Basic Information

Product Name	Alfacalcidol Impurity 6
CAS No.	160796-62-3
Molecular Formula	C27H44O2
Molecular Weight	400.64 g/mol
Synonyms	(5Z,7E)-9,10-Secocholesta-5,7,10(19)-triene-1α,3β-diol; 1α,3β-Dihydroxy-9,10-secocholesta-5,7,10(19)-triene; Alfacalcidol Related Compound; Alfacalcidol EP Impurity; Alfacalcidol USP Impurity; Vitamin D3 Analog Impurity
EINECS	Contact for details

Quality Control

Every batch of Alfacalcidol Impurity 6 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is supplied with each shipment, detailing batch-specific results and confirming compliance with relevant specifications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
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.