Description

Beta Impurity Of Alpha Calcitriol n-2 is a high-purity reference standard and analytical impurity used in pharmaceutical research and development. This compound is critical for ensuring the quality and safety of active pharmaceutical ingredients (APIs) by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the synthesis, quality control, and validation of Calcitriol and related vitamin D analogs.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for calibrating analytical instruments and validating testing methods in QC/QA laboratories.
• Impurity Profiling & Characterization: Used to identify, monitor, and control the specified impurity during the synthesis and purification of Alpha Calcitriol API.
• Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for related substance analysis.
• 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 as a marker in forced degradation and long-term stability studies to understand the degradation pathways of the parent drug substance.
• Process Chemistry Research: Aids chemists in optimizing synthetic routes by tracking the formation and elimination of this specific impurity.

Basic Information

Item	Details
Product Name	Beta Impurity Of Alpha Calcitriol n-2
CAS No.	2239312-26-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Beta Impurity of Alpha Calcitriol; Impurity n-2 of Alpha Calcitriol; Alpha Calcitriol Related Compound n-2; Calcitriol Impurity B; Vitamin D Analog Impurity; 1α,25-Dihydroxyvitamin D3 Impurity; (5Z,7E)-9,10-Secocholesta-5,7,10(19)-triene-1α,3β,25-triol Impurity
EINECS	Contact for details

Quality Control

Every batch of Beta Impurity Of Alpha Calcitriol n-2 is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing, including identification by spectroscopic methods (IR, NMR, MS), purity assessment by HPLC, and control of specific impurities. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with specified standards. Our quality commitment aligns 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) or as indicated on the label. Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. 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 corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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