Description

Dimenhydrinate Impurity 2 is a structurally defined degradation or synthetic by-product closely related to the antihistamine dimenhydrinate (a salt of diphenhydramine and 8-chlorotheophylline), widely used as a reference standard in pharmaceutical quality control. It plays a critical role in ensuring the safety, efficacy, and regulatory compliance of dimenhydrinate-based drug products by enabling accurate identification and quantification of impurities during stability studies and batch release testing. Pharmaceutical manufacturers, contract research organizations (CROs), and regulatory testing laboratories rely on this high-purity impurity standard for method development, validation, and pharmacopoeial compliance (USP, EP, JP). Dimenhydrinate Impurity 2 CAS NO 2212-35-3 supports rigorous quality assurance across global supply chains.

Application

• Primary reference standard for HPLC and LC-MS method development and validation in dimenhydrinate API and finished dosage form testing
• Quantitative calibration standard for impurity profiling and forced degradation studies per ICH Q1–Q5 guidelines
• Reference material for stability-indicating assay methods required by FDA, EMA, and PMDA submissions
• Quality control benchmark in GMP-compliant manufacturing environments for antihistamine formulations
• Use in pharmacopoeial compliance testing (USP Monograph Dimenhydrinate, EP 2.2.46)
• Supporting analytical qualification of chromatographic systems (system suitability testing)
• Research applications in impurity fate-and-effect studies and toxicological risk assessment (ICH M7)
• Proficiency testing and inter-laboratory comparison programs for pharmaceutical QC labs

Basic Information

Product Name	Dimenhydrinate Impurity 2
CAS No.	2212-35-3
Molecular Formula	C17H21ClN2O
Molecular Weight	304.81 g/mol
Synonyms	8-Chlorotheophylline; 8-Chloro-1,3-dimethylxanthine; 8-Chloro-1,3-dimethyl-3,7-dihydro-1H-purine-2,6-dione; 8-Chlorotheobromine; 8-Chloro-3,7-dihydro-1,3-dimethyl-1H-purine-2,6-dione; NSC 9359; 8-Chloroxanthine derivative; 8-Chloro-1,3-dimethyl-2,6-dioxo-2,3,6,7-tetrahydro-1H-purine
EINECS	218-637-2

Quality Control

Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request. Each batch is tested per ICH Q5 and Q6 guidelines for identity, purity, and residual solvents. Testing includes HPLC purity ≥ 99.5%, IR spectral match, water content (Karl Fischer), and residue on ignition. All materials are manufactured under ISO 9001-certified processes and comply with applicable REACH and FDA requirements for pharmaceutical reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at 15–25°C in a dry, well-ventilated area. Due to its hygroscopic nature, minimize exposure to ambient humidity and avoid repeated opening of the container.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	99.0% – 101.0%
Related Substances (HPLC)	Single impurity ≤ 0.3%; Total impurities ≤ 0.5%
Water (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Solubility	Soluble in chloroform, methanol, and DMSO; sparingly soluble in water

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