Description

Caffeine Impurity E Nitrate Solution is a high-purity reference standard solution used for analytical and quality control purposes. This compound is critical for the accurate identification and quantification of process-related impurities in caffeine and its pharmaceutical derivatives. It is an essential material for analytical laboratories, quality assurance departments, and research institutions within the pharmaceutical and fine chemical sectors, ensuring product safety and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Primary use as a certified reference material (CRM) for method development and validation in HPLC and LC-MS analysis of caffeine APIs and drug products.
• Quality Control & Assurance: Serves as a system suitability standard and for establishing impurity limits in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Used to monitor the formation of degradation products in caffeine-based formulations under various stress conditions.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing definitive impurity identification data for health authorities like the FDA and EMA.
• Research & Development: Facilitates the study of caffeine synthesis pathways, degradation mechanisms, and the development of purer manufacturing processes.
• Calibration Standard: Used to calibrate analytical instrumentation to ensure accurate and reproducible impurity quantification.

Basic Information

Product Name	Caffeine Impurity E Nitrate Solution
CAS No.	209725-34-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Caffeine Nitrate Impurity E; Caffeine Related Compound E Nitrate; 1,3,7-Trimethylxanthine Impurity E Nitrate; Theophylline Derivative Impurity; Caffeine Nitrated Impurity; Analytical Reference Standard 209725-34-8; Caffeine Process Impurity E
EINECS	Contact for details

Quality Control

Every batch of our Caffeine Impurity E Nitrate Solution is manufactured and analyzed under strict quality management systems. The product is characterized using advanced spectroscopic and chromatographic techniques, including NMR, MS, and HPLC, to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality protocols are designed to meet the stringent requirements of pharmaceutical reference standard applications.

Storage

Preserve in a tightly closed container, protected from light. Store at the recommended temperature, typically 2-8°C or as specified on the label. Keep away from strong oxidizers. The solution is light-sensitive (store away from light) and should be handled to minimize exposure. Ensure proper laboratory ventilation and use appropriate personal protective equipment during handling.

Specification

Item	Specification
Appearance	Clear, colorless to pale yellow solution
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Assay (HPLC)	≥95.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤5.0%
Solvent Content (GC)	As per declared concentration
Solution Stability	Stable for period defined on COA under recommended storage

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