Description

Calcitriol Impurity 14 is a high-purity reference standard used in the analytical profiling of pharmaceutical active ingredients. This compound is critical for ensuring the quality, safety, and regulatory compliance of Calcitriol and related vitamin D analogs during development and manufacturing. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and contract research organizations (CROs) focused on method validation and impurity identification.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Calcitriol API.
• Critical component in analytical method development and validation (HPLC, LC-MS) for compliance with ICH guidelines.
• Used in stability studies and forced degradation studies to understand impurity profiles.
• Essential for regulatory filing and submission documentation to agencies like the FDA and EMA.
• Supports quality control and assurance processes in pharmaceutical manufacturing.
• Valuable for academic and clinical research investigating the metabolism and synthesis pathways of vitamin D compounds.

Basic Information

Product Name	Calcitriol Impurity 14
CAS No.	171011-48-6
Molecular Formula	C27H44O3
Molecular Weight	416.64 g/mol
Synonyms	(5Z,7E)-9,10-Secocholesta-5,7,10(19)-triene-1α,3β,25-triol; 1α,25-Dihydroxy-9,10-secocholesta-5,7,10(19)-trien-3β-ol; Calcitriol Related Compound; Vitamin D3 Impurity; 1,25-Dihydroxycholecalciferol Impurity; 1α,25-Dihydroxyvitamin D3 Impurity
EINECS	Contact for details

Quality Control

Every batch of Calcitriol Impurity 14 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC for purity and spectroscopic methods for structural confirmation, to ensure compliance with the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and impurities.

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. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to preserve stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Water Content (KF)	≤ 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.