Description

Doxylamine Chlorotheophyllinate is a pharmaceutical salt formed from the antihistamine doxylamine and the xanthine derivative chlorotheophylline. This compound is primarily valued for its synergistic properties, combining sedative and antiemetic effects. It is a critical active pharmaceutical ingredient (API) for manufacturers in the pharmaceutical industry, particularly for formulating sleep aids and anti-motion sickness medications. Global supply of this API requires stringent quality control to ensure efficacy and safety in final drug products.

Application

• Pharmaceutical API: Primary use as the active ingredient in sedative and sleep aid formulations.
• Antiemetic Preparations: Key component in medications designed to prevent and treat nausea and vomiting, especially related to motion sickness.
• Over-the-Counter (OTC) Sleep Aids: Manufacture of non-prescription sleep-inducing tablets and capsules.
• Veterinary Pharmaceuticals: Used in sedative formulations for animal health applications.
• Research & Development: Serves as a reference standard and building block in pharmacological and medicinal chemistry research.
• Combination Drug Therapy: Utilized in fixed-dose combination products that require both sedative and antiemetic action.

Basic Information

Product Name	Doxylamine Chlorotheophyllinate
CAS No.	23282-67-9
Molecular Formula	C17H22N2O · C7H7ClN4O2
Molecular Weight	541.04 g/mol
Synonyms	Doxylamine Theoclate; Doxylamine Chlorotheophylline Salt; Doxylamine 8-Chlorotheophyllinate; UNISOM (Key Brand Name); Doxylamine Succinate Analog (as chlorotheophyllinate salt); 2-[1-Phenyl-1-(2-pyridyl)ethoxy]-N,N-dimethylethanamine compound with 8-chloro-1,3-dimethyl-2,6-dioxo-1,2,3,6-tetrahydropurine; Doxylaminium 8-chlorotheophyllinate; Histadoxylamine Theoclate
EINECS	Contact for details

Quality Control

Our Doxylamine Chlorotheophyllinate is manufactured under strict quality management systems. Each batch is tested to ensure it meets high-purity standards suitable for pharmaceutical applications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing parameters such as assay, related substances, residual solvents, and identification. We support compliance with major pharmacopoeial standards, including USP and EP, upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a low-humidity environment to prevent degradation. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on dried basis)
Loss on Drying	≤ 1.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Heavy Metals	≤ 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Microbial Limits	Complies with USP <61> and <62>

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