Description

Calcitriol Impurity 16 is a high-purity reference standard used in the pharmaceutical development and quality control of Calcitriol, an active pharmaceutical ingredient. This compound is critical for ensuring the safety and efficacy of pharmaceutical products by enabling the accurate identification and quantification of related substances. It is an essential material for analytical laboratories, research institutions, and manufacturers in the pharmaceutical industry focused on vitamin D analogs and related therapies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Calcitriol Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, validating, and verifying HPLC, UPLC, and other chromatographic methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., with FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and new drug applications (NDAs/ANDAs).
• Stability Studies: Used to monitor the formation of degradation products in Calcitriol formulations under various stress conditions.
• Process Chemistry & Optimization: Aids in the identification of process-related impurities during the synthesis and purification of Calcitriol, helping to refine manufacturing processes.
• Academic & Clinical Research: Serves as a key reagent in studies investigating the metabolism, pharmacokinetics, and biochemical pathways of vitamin D compounds.

Basic Information

Product Name	Calcitriol Impurity 16
CAS No.	214351-92-5
Molecular Formula	C27H44O3
Molecular Weight	416.64 g/mol
Synonyms	(1R,3S,5Z)-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; (5Z,7E)-(1S,3R)-1,3-Dihydroxy-9,10-secocholesta-5,7,10(19)-trien-24-oic Acid Impurity; 1,25-Dihydroxycholecalciferol Related Compound; Vitamin D3 Metabolite Impurity; 1α,25-Dihydroxyvitamin D3 Impurity 16
EINECS	Contact for details

Quality Control

Our Calcitriol Impurity 16 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data, chromatograms, and traceability information. Our quality commitment aligns with the standards expected for pharmaceutical reference materials, supporting your GMP and regulatory 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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 2.0%
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.