Description

Theophylline is a methylxanthine derivative and a well-established pharmaceutical active ingredient. It is a potent bronchodilator and respiratory stimulant, primarily valued for its efficacy in treating and managing chronic respiratory conditions. This high-purity compound is essential for manufacturers in the global pharmaceutical industry, particularly those producing medications for asthma, chronic obstructive pulmonary disease (COPD), and other airway disorders.

Application

• Pharmaceutical API: Primary use as the active pharmaceutical ingredient (API) in oral tablets, capsules, and extended-release formulations for respiratory diseases.
• Bronchodilator Medications: Key component in prescription drugs for the treatment of asthma, chronic bronchitis, and emphysema (COPD).
• Neonatal Apnea: Used in hospital settings for the treatment of apnea in premature infants.
• Cardiac Stimulant: Employed in certain therapeutic contexts for its positive inotropic and chronotropic effects on the heart.
• Diuretic Agent: Utilized for its mild diuretic properties in specific clinical formulations.
• Research & Development: Serves as a critical reference standard and biochemical tool in pharmacological and respiratory research.

Basic Information

Product Name	Theophylline
CAS No.	58-55-9
Molecular Formula	C7H8N4O2
Molecular Weight	180.16 g/mol
Synonyms	1,3-Dimethylxanthine; 1,3-Dimethyl-2,6-dioxopurine; Theophylline Anhydrous; Theophyll; Theolix; Elixophyllin; Slo-Bid; Theo-Dur; Uniphyl; Acetamidopyrazine
EINECS	200-385-7

Quality Control

Our Theophylline is manufactured under strict quality management systems, with grades available to meet USP, EP, and BP pharmacopeial standards. Every batch undergoes comprehensive analytical testing, including assay, impurity profiling, and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical actives. A Certificate of Analysis (COA) documenting purity, identity, and safety parameters is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, well-ventilated area at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation and caking.

Specification

Item	Specification
Appearance	White or almost white, crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.5% - 101.0% (on anhydrous basis)
Water (Karl Fischer)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.1%; Total impurities ≤ 0.5%
Microbial Limits	Meets EP/USP requirements

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