Description

Impurity A Of Maxacalcitol is a key reference standard and impurity used in the pharmaceutical development and quality control of Maxacalcitol, a vitamin D3 analog. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a benchmark in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in the synthesis, formulation, and regulatory compliance of vitamin D-related therapeutics.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Impurity A in Maxacalcitol API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating high-performance liquid chromatography (HPLC) and other chromatographic methods.
• Quality Control & Assurance (QC/QA): Critical for routine batch testing to monitor and control impurity profiles, ensuring compliance with ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions during drug stability testing.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Used by chemists to study and optimize synthetic pathways to minimize the formation of this specific impurity.

Basic Information

Product Name	Impurity A Of Maxacalcitol
CAS No.	929721-98-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Maxacalcitol Impurity A; 22-Oxa-1α,25-dihydroxyvitamin D3 Impurity A; (1R,3S,5Z)-5-[(2E)-2-[(1R,3aS,7aR)-1-[(1R,2E,4S)-4-ethyl-1,5-dihydroxy-4-methylhex-2-en-1-yl]-7a-methyloctahydro-1H-inden-4-ylidene]ethylidene]-4-methylidenecyclohexane-1,3-diol (related); Vitamin D3 Analog Impurity; OCT Impurity A; 22-Oxacalcitriol Related Compound A
EINECS	Contact for details

Quality Control

Our Impurity A Of Maxacalcitol is produced and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification via spectroscopic methods, 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 every shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed in a desiccated environment and handled under conditions that minimize exposure to light and atmospheric moisture to maintain stability and purity.

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)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
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.