Description

Calcipotriol Impurity 1 is a specified impurity of Calcipotriol, a synthetic vitamin D3 analog used in pharmaceutical formulations. This impurity is a critical reference standard for analytical method development, validation, and quality control in the manufacturing of Calcipotriol active pharmaceutical ingredients (APIs) and finished drug products. It is essential for pharmaceutical companies, contract research organizations (CROs), and analytical laboratories focused on ensuring product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Calcipotriol Impurity 1 in drug substances and products.
• Analytical Method Development: Used to develop and optimize chromatographic methods (e.g., HPLC, UPLC) for impurity profiling of Calcipotriol.
• Quality Control & Assurance: Serves as a system suitability standard and for routine batch testing to monitor impurity levels against ICH guidelines.
• Regulatory Compliance & Filing: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions.
• Research & Development: Used in synthetic chemistry R&D to understand and control impurity formation pathways during Calcipotriol synthesis.

Basic Information

Product Name	Calcipotriol Impurity 1
CAS No.	112849-47-5
Molecular Formula	C₂₇H₄₀O₃
Molecular Weight	412.61 g/mol
Synonyms	(5Z,7E,22E,24S)-24-Cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1α,3β,24-triol; 1α,24(S)-Dihydroxy-22-ene-24-cyclopropyl-vitamin D3; Pre-Calcipotriol; Calcipotriene Impurity 1; MC 903 Impurity 1; (1α,3β,5Z,7E,22E,24S)-24-Cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1,3,24-triol
EINECS	Contact for details

Quality Control

Every batch of Calcipotriol Impurity 1 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity, purity, and assay testing using advanced techniques including HPLC, 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 each shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

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)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Assay (HPLC)	90.0% - 110.0% on anhydrous basis
Water Content (KF)	≤ 5.0%

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