Description

Alfacalcidol Impurity 5 is a designated reference standard used in the analytical profiling and quality control of Alfacalcidol, a synthetic vitamin D3 analog. This impurity is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized by professionals in pharmaceutical R&D, quality assurance, and contract research organizations (CROs) for method development, validation, and stability studies.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Alfacalcidol Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating precise HPLC, UPLC, or LC-MS methods to monitor impurities during manufacturing and stability testing.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to confirm that Alfacalcidol meets stringent pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (light, heat, humidity) to establish product shelf life.
• Regulatory Compliance & Filings: Provides necessary data for regulatory submissions (e.g., FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research on Degradation Pathways: Aids in understanding the chemical degradation mechanisms of Alfacalcidol, supporting formulation improvement.

Basic Information

Product Name	Alfacalcidol Impurity 5
CAS No.	2227309-93-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Alfacalcidol Related Compound 5; Alfacalcidol Impurity; 1α-Hydroxyvitamin D3 Impurity 5; (5Z,7E)-9,10-Secocholesta-5,7,10(19)-triene-1α,3β-diol Impurity; Vitamin D3 Analog Impurity; Alfacalcidol Degradation Product; 1α-OH-D3 Impurity
EINECS	Contact for details

Quality Control

Our Alfacalcidol Impurity 5 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification via spectroscopic methods (IR, NMR, MS). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided to ensure traceability and compliance with ICH Q3A/B guidelines for impurities in new drug substances and products.

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 desiccated environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.