Description

Tacalcitol Impurity 1 is a designated impurity of the active pharmaceutical ingredient Tacalcitol, a synthetic vitamin D3 analog. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical characterization and quality control of Tacalcitol drug substances and products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure product purity, safety, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Tacalcitol Impurity 1 in drug substance and finished product analysis.
• Method Development and Validation: Essential for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, for Tacalcitol.
• Quality Control (QC) Testing: Employed in routine QC testing of Tacalcitol Active Pharmaceutical Ingredients (APIs) to monitor impurity profiles and ensure batch-to-batch consistency.
• Stability Studies: Used to track the formation of this specific degradation product during forced degradation and long-term stability studies of Tacalcitol formulations.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity limits and control strategies.
• Research and Development: Supports synthetic route optimization and process chemistry research to understand and minimize impurity formation.

Basic Information

Product Name	Tacalcitol Impurity 1
CAS No.	57333-95-6
Molecular Formula	C₂₇H₄₄O₃
Molecular Weight	416.64 g/mol
Synonyms	(5Z,7E,22E)-9,10-Secocholesta-5,7,10(19),22-tetraene-1α,3β,24-triol; 1α,24-Dihydroxy-22-ene-vitamin D3; 24-Hydroxy Tacalcitol; 1α,24(OH)₂-22-ene-D3; Tacalcitol Related Compound A; Tacalcitol EP Impurity B; Tacalcitol USP Impurity; (1R,3S)-5-[(2E)-2-[(1R,3aS,7aR)-1-[(1R)-1,5-Dimethylhexyl]-7a-methyl-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylidenecyclohexane-1,3-diol
EINECS	Contact for details

Quality Control

Our Tacalcitol Impurity 1 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure high purity and identity confirmation. Quality is assured through comprehensive testing via HPLC, NMR, and MS. Each batch is supplied with a detailed Certificate of Analysis (COA) that includes data on purity, related substances, and identification. The material is suitable for use as a reference standard in compliance with ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below under an inert atmosphere. Due to its hygroscopic nature, the container should be allowed to reach room temperature before opening to minimize moisture absorption. For long-term storage, keep desiccated.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
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.