Description

Theophylline Monohydrate is a white, crystalline powder belonging to the methylxanthine class of compounds. It serves as a key active pharmaceutical ingredient (API) and a vital intermediate in the synthesis of more complex therapeutic agents. This product is essential for manufacturers in the pharmaceutical and fine chemical industries, where consistent purity and reliable supply are paramount for producing effective bronchodilator medications and other specialized formulations.

Application

• Primary Pharmaceutical API: The primary active ingredient in medications for asthma, chronic obstructive pulmonary disease (COPD), and other respiratory conditions due to its bronchodilator properties.
• Fine Chemical Synthesis: A crucial intermediate for the production of other methylxanthine derivatives and more complex pharmaceutical compounds.
• Research & Development: Used in biochemical and pharmacological research to study adenosine receptor antagonism and phosphodiesterase inhibition.
• Veterinary Medicine: Employed in formulations for treating respiratory ailments in animals.
• Reference Standard: Serves as a high-purity analytical standard for quality control testing in pharmaceutical laboratories.

Basic Information

Product Name	Theophylline Monohydrate
CAS No.	5967-84-0
Molecular Formula	C7H8N4O2 • H2O
Molecular Weight	198.18 g/mol (Monohydrate)
Synonyms	1,3-Dimethylxanthine Monohydrate; 3,7-Dihydro-1,3-dimethyl-1H-purine-2,6-dione Monohydrate; Theophylline Hydrate; 1,3-Dimethyl-2,6-dioxopurine Monohydrate; Theo-Dur (as API); Theolair (as API); Elixophyllin (as API)
EINECS	227-813-7 (Anhydrous base)

Quality Control

Our Theophylline Monohydrate is manufactured under a strict quality management system. It is tested to meet relevant pharmacopeial standards such as USP, EP, or BP, depending on the grade. Every batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles to ensure it meets your specific application requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed after opening to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White or almost white, crystalline powder
Identification (IR)	Conforms to standard
Assay (HPLC)	98.5% - 101.0% (on anhydrous basis)
Water Content (KF)	8.0% - 9.5%
Related Substances (HPLC)	Total impurities ≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Microbial Enumeration	Meets Ph. Eur. / USP criteria

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