Description

Cholecalciferol Impurity A is a high-purity reference standard critical for pharmaceutical quality control and analytical research. This compound serves as a key impurity marker in the synthesis and purification of Vitamin D3 (Cholecalciferol), ensuring the safety and efficacy of final pharmaceutical products. It is essential for laboratories and manufacturers in the pharmaceutical, nutraceutical, and fine chemical industries who require precise analytical standards for method development, validation, and regulatory compliance.

Application

• Primary use as a pharmaceutical reference standard for impurity profiling and identification.
• Critical component in analytical method development and validation (HPLC, LC-MS) for Vitamin D3 and related products.
• Quality control and assurance in the manufacturing of Cholecalciferol (Vitamin D3) APIs and finished dosage forms.
• Research and development of stable isotope-labeled internal standards for mass spectrometry.
• Used in regulatory compliance testing to meet pharmacopeial standards (USP, EP, BP).
• Essential for stability studies to monitor degradation pathways in Vitamin D3 formulations.

Basic Information

Product Name	Cholecalciferol Impurity A
CAS No.	22350-41-0
Molecular Formula	C₂₇H₄₄O
Molecular Weight	384.64 g/mol
Synonyms	Previtamin D3; (6Z)-Tacalciol; (6Z)-9,10-Secocholesta-5(10),6,8-trien-3β-ol; 6Z-Previtamin D3; (3β,6Z)-9,10-Secocholesta-5(10),6,8-trien-3-ol; Vitamin D3 Impurity A; Cholecalciferol Related Compound A
EINECS	Contact for details

Quality Control

Our Cholecalciferol Impurity A is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (NMR, IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with every shipment to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a cool, dry place. This material is light-sensitive (store away from light). For long-term storage under inert atmosphere, please contact our technical team for specific recommendations.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Single Maximum Unknown Impurity	≤ 0.5%
Residual Solvents (GC)	Complies with ICH guidelines

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