Description

Impurity A of Tacalcitol is a designated impurity of the active pharmaceutical ingredient Tacalcitol, a synthetic vitamin D3 analog. This reference standard is critical for analytical method development and validation, ensuring the purity and safety of Tacalcitol-based pharmaceutical formulations. It is primarily required by pharmaceutical R&D laboratories, quality control units, and regulatory affairs departments for compliance testing and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Impurity A in Tacalcitol drug substance and finished products.
• Analytical Method Development: Essential for developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods for impurity analysis.
• Quality Control & Assurance: Serves as a system suitability standard in routine QC testing to monitor batch-to-batch consistency and impurity thresholds.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing characterized impurity data.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions.
• Research & Development: Used in synthetic chemistry research to study the formation pathway and control strategies for this impurity.

Basic Information

Product Name	Impurity A of Tacalcitol
CAS No.	1294517-97-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tacalcitol Impurity A; Tacalcitol Related Compound A; (1R,3R,5Z)-5-[(2E)-2-[(1R,3aS,7aR)-1-[(1R,2E,4R)-4-Cyclohexyl-4-hydroxy-1-methylbut-2-en-1-yl]-7a-methyloctahydro-1H-inden-4-ylidene]ethylidene]-4-methylidenecyclohexane-1,3-diol (IUPAC); 1α,24(R)-Dihydroxy-22,23-didehydrovitamin D3 impurity; 22-Dehydro-1α,24(R)-dihydroxyvitamin D3 impurity
EINECS	Contact for details

Quality Control

Our Impurity A of Tacalcitol is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural characterization by NMR and MS, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.