Description

Calcitriol Impurity 9 is a specified impurity of Calcitriol, a biologically active form of Vitamin D3, and is a critical reference standard in pharmaceutical development and quality control. This compound is essential for ensuring the purity, safety, and efficacy of Calcitriol-based drug products by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the synthesis, testing, and approval of active pharmaceutical ingredients (APIs) and finished dosage forms.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of Calcitriol impurities.
• Critical component in analytical method development and validation (HPLC, LC-MS) for Calcitriol API and formulations.
• Essential for quality control and batch release testing to comply with pharmacopeial monographs (USP, EP, JP).
• Used in stability studies to monitor impurity profiles and degradation pathways of Calcitriol products.
• Supports regulatory submissions (e.g., ANDA, NDA) by providing impurity characterization data.
• Valuable for research and development of Calcitriol synthesis processes and impurity fate mapping.

Basic Information

Product Name	Calcitriol Impurity 9
CAS No.	157809-60-4
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; Pre-Calcitriol; Calcitriol Related Compound; Vitamin D3 Impurity; 1α,25(OH)2D3 Impurity; 1α,25-Dihydroxycholecalciferol Impurity
EINECS	Contact for details

Quality Control

Our Calcitriol Impurity 9 is manufactured under strict quality systems suitable for use as a reference standard. Each batch undergoes comprehensive analytical testing, including HPLC for purity and spectroscopic methods (NMR, MS) for structural confirmation, to ensure identity, strength, and composition. A comprehensive Certificate of Analysis (COA) is provided, detailing the analytical results and traceability. We support compliance with ICH Q3A/B guidelines and major pharmacopeial requirements.

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 storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits

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