Description

Caffeine Ep Impurity E is a high-purity reference standard and analytical impurity used in pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and regulatory compliance of caffeine-based active pharmaceutical ingredients (APIs) and finished drug products. It is primarily required by analytical chemists, quality control laboratories, and R&D scientists working in the pharmaceutical and biotechnology sectors to perform accurate impurity profiling and method validation.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Caffeine Ep Impurity E in drug substances and products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity detection in caffeine APIs.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines and pharmacopeial limits (USP/EP).
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability testing.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Process Chemistry Research: Aids in understanding and optimizing API synthesis and purification processes to minimize the formation of this impurity.

Basic Information

Product Name	Caffeine Ep Impurity E
CAS No.	10184-35-7
Molecular Formula	C8H10N4O2
Molecular Weight	194.19 g/mol
Synonyms	1,3,7-Trimethyl-2,6-dioxopurine; Caffeine Related Compound E; Caffeine Impurity E; Caffeine EP Impurity E; 1H-Purine-2,6-dione, 3,7-dihydro-1,3,7-trimethyl-; Theophylline-7-acetic acid lactam (derivative); 8-Oxocaffeine
EINECS	Contact for details

Quality Control

Every batch of Caffeine Ep Impurity E is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC, NMR, and mass spectrometry to ensure it meets the exacting standards for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant pharmacopeial guidelines (USP/EP).

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 should be handled in a low-humidity environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities: ≤ 2.0% Any individual impurity: ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%
Heavy Metals	≤ 20 ppm

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