Description

Calcitriol Impurity 8 is a specified impurity of Calcitriol, a biologically active form of Vitamin D3, used as a reference standard in analytical chemistry. This compound is critical for pharmaceutical quality control, ensuring the purity and safety of Calcitriol-based drug substances and products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Calcitriol Impurity 8 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Essential for developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods to monitor impurities.
• Quality Control & Assurance: Serves as a system suitability standard in routine QC testing to ensure the specificity and accuracy of impurity profiling for Calcitriol.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., light, heat, oxidation) during drug stability testing.
• Research & Development: Used in metabolic and pharmacokinetic studies to understand the degradation pathways of Calcitriol.

Basic Information

Product Name	Calcitriol Impurity 8
CAS No.	171015-31-9
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 (isomer); Pre-Calcitriol related compound; Vitamin D3 analogue impurity; Calcitriol EP Impurity H; Calcitriol related compound A; 1,25-Dihydroxycholecalciferol Impurity
EINECS	Contact for details

Quality Control

Every batch of Calcitriol Impurity 8 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity, purity, and assay testing using advanced techniques like HPLC and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. Due to its light-sensitive and easily oxidized nature, it is recommended to store the material under an inert atmosphere (e.g., nitrogen or argon) for long-term stability. Keep the container in a dry, cool, and well-ventilated place.

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%
Assay	90.0% - 110.0% (on dried basis)
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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