Description

Azathioprine Ep Impurity E is a specified impurity of the immunosuppressive drug Azathioprine, as defined by the European Pharmacopoeia (EP). This high-purity reference standard is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is essential for researchers and quality assurance professionals in the pharmaceutical industry who require reliable materials to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for Azathioprine drug substance and product testing per EP, USP, and ICH guidelines.
• Analytical Method Development: Used to develop and optimize chromatographic methods (HPLC, UPLC) for the separation and quantification of impurities.
• Quality Control & Assurance: Critical for routine batch release testing to monitor and control impurity levels in active pharmaceutical ingredients (APIs).
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., ANDA, NDA) by providing necessary impurity characterization and qualification data.
• Stability Studies: Employed as a marker to track impurity profiles in Azathioprine formulations under various stress and storage conditions.
• Research & Development: Used in synthetic chemistry research to study degradation pathways and impurity formation mechanisms.

Basic Information

Product Name	Azathioprine Ep Impurity E
CAS No.	35681-68-6
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 E (EP); Azathioprine Related Compound E; 1H-Purine, 6-[(1-methyl-4-nitro-1H-imidazol-5-yl)thio]-; Azathioprine Nitroimidazole Impurity
EINECS	Contact for details

Quality Control

Every batch of Azathioprine Ep Impurity E is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure compliance with pharmacopoeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
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.