Description

Dimenhydrinate Impurity (8-Chloro-1-Methyl-2,3,6,7-Tetrahydro-1H-Purine-2,6-Dione) is a high-purity reference standard and impurity crucial for pharmaceutical research and development. This compound serves as a critical quality marker in the analytical profiling and validation of Dimenhydrinate, an active pharmaceutical ingredient (API) used in antiemetic and antivertigo medications. It is essential for laboratories focused on method development, stability studies, and ensuring regulatory compliance for drug safety. The CAS number for this compound is 6136-36-3.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Dimenhydrinate API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, and GC methods to ensure specificity, accuracy, and precision in impurity detection.
• Stability Indicating Studies: Used to monitor the formation of this specific degradant under various stress conditions (e.g., heat, light, humidity) as part of drug stability protocols.
• Quality Control & Assurance (QC/QA): Enables in-house quality control laboratories to set accurate specification limits and ensure batch-to-batch consistency of Dimenhydrinate.
• Regulatory Compliance & Filing: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive impurity characterization data required for drug master files (DMFs).
• Research on Degradation Pathways: Facilitates research into the chemical degradation mechanisms of Dimenhydrinate, aiding in the development of more stable formulations.

Basic Information

Product Name	Dimenhydrinate Impurity (8-Chloro-1-Methyl-2,3,6,7-Tetrahydro-1H-Purine-2,6-Dione)
CAS No.	6136-36-3
Molecular Formula	C7H7ClN4O2
Molecular Weight	214.61 g/mol
Synonyms	8-Chlorotheophylline; 8-Chloro-1,3-dimethyl-2,6-dioxo-1,2,3,6-tetrahydro-7H-purine; 8-Chloro-1,3-dimethylxanthine; 8-Chloro-1-methyl-2,6-dioxo-1,2,3,6-tetrahydro-7H-purine; Dimenhydrinate Related Compound; Theophylline Impurity C (8-Chloro); 1-Methyl-8-chlorotheophylline; 8-Chloro-1,3-dimethyl-7H-purine-2,6-dione
EINECS	Contact for details

Quality Control

Our Dimenhydrinate Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and comprehensive spectroscopic identification (IR, NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profile is provided with every shipment to support your regulatory and research needs.

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 product is hygroscopic (moisture-sensitive) and should be handled in a low-humidity environment to prevent degradation.

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%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w
Heavy Metals	≤ 20 ppm

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