Description

Calcitriol Impurity 10 is a specified impurity and reference standard used in the analytical profiling of Calcitriol, the active form of Vitamin D3. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical products containing Calcitriol, such as those used to treat hypocalcemia and secondary hyperparathyroidism. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for quality control, method validation, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Calcitriol Impurity 10 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, calibrating, and validating chromatographic methods to monitor impurities during drug manufacturing.
• Quality Control & Assurance (QC/QA): Serves as a critical benchmark in routine batch testing to ensure drug substance and product purity meets ICH Q3A/B guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity characterization data for drug master files (DMFs) and marketing authorization applications.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions, ensuring product shelf-life and storage recommendations are accurate.
• Research & Development (R&D): Used in synthetic chemistry and process development to understand and minimize impurity formation during the synthesis of Calcitriol.

Basic Information

Product Name	Calcitriol Impurity 10
CAS No.	157809-61-5
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); Vitamin D3 Impurity; 1α,25-Dihydroxyvitamin D3 Impurity; Calcitriol Related Compound; (1α,3β,5Z,7E)-9,10-Secocholesta-5,7,10(19)-triene-1,3,25-triol
EINECS	Contact for details

Quality Control

Every batch of Calcitriol Impurity 10 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC and LC-MS to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
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.