Description

Azathioprine Ep Impurity D is a specified impurity used in the quality control and analytical profiling of the immunosuppressive drug Azathioprine. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product in compliance with stringent pharmacopeial standards such as the European Pharmacopoeia (EP). It is an essential reference standard for research, method development, and regulatory submissions within the pharmaceutical industry.

Application

• Primary use as a pharmacopoeial reference standard for Azathioprine impurity identification and quantification.
• Critical component in analytical method development and validation (HPLC, LC-MS) for Azathioprine drug substance and product.
• Used in stability studies and forced degradation studies to monitor impurity profiles.
• Essential for quality control (QC) laboratories to establish specification limits for impurities.
• Supports regulatory compliance and filing (e.g., for ANDA, NDA, MAA) by providing characterized impurity material.
• Valuable for research and development into the metabolism and degradation pathways of Azathioprine.

Basic Information

Product Name	Azathioprine Ep Impurity D
CAS No.	6339-54-4
Molecular Formula	C9H7N7O2S
Molecular Weight	277.27 g/mol
Synonyms	6-[(1-Methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine; 6-[(1-Methyl-4-nitroimidazol-5-yl)thio]purine; Azathioprine Impurity D (EP); Azathioprine Related Compound D; 1H-Purine, 6-[(1-methyl-4-nitro-1H-imidazol-5-yl)thio]-; Azathioprine Nitroimidazole Impurity
EINECS	Contact for details

Quality Control

Our Azathioprine Ep Impurity D is manufactured and handled under strict quality systems suitable for use as a reference standard. Each batch undergoes comprehensive analytical characterization, including identity confirmation by spectroscopic methods (IR, NMR, MS) and purity determination by HPLC. Certificates of Analysis (COA) with detailed chromatographic data are provided, ensuring traceability and compliance with pharmaceutical reference standard 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 must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	Yellow to orange powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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