Description

Theophylline Impurity 1 CAS NO 5614-53-9 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical products containing theophylline. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of this well-characterized impurity is essential for compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Theophylline Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurity profiles in compliance with ICH Q3B(R2) guidelines.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch release testing in pharmaceutical manufacturing to ensure product purity and consistency.
• Stability Studies: Employed to identify and track degradation products in Theophylline formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) submitted to agencies like the FDA and EMA.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Theophylline.

Basic Information

Product Name	Theophylline Impurity 1
CAS No.	5614-53-9
Molecular Formula	C7H8N4O2
Molecular Weight	180.16 g/mol
Synonyms	1,3-Dimethyluric acid; 1,3-Dimethyl-2,6,7,8-tetrahydro-1H-purine-2,6,8-trione; 1,3-Dimethyl-2,6-dioxo-1,2,3,6-tetrahydro-7H-purine-7-one; Theophylline Impurity A; Theophylline Related Compound A; 1,3-Dimethyl-2,6-dioxo-1,2,3,6-tetrahydropurine-7-one; Uric acid, 1,3-dimethyl-
EINECS	Contact for details

Quality Control

Every batch of Theophylline Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using validated analytical methods such as HPLC, NMR, and mass spectrometry to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting its use as a reference standard for pharmaceutical analysis.

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 to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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