Theophylline

Theophylline

Parameter Specification
Product Name Theophylline
Other Names 1,3-Dimethylxanthine; Theophylline anhydrous
CAS Number 58-55-9
Molecular Formula C7H8N4O2
Molecular Weight 180.16 g/mol
Appearance White to off-white crystalline powder
Assay (HPLC) 99.0% – 101.0% (on dried basis)
Solubility Slightly soluble in water; soluble in hot water, ethanol, and chloroform
Package 25 kg fiber drums with double polyethylene liners

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Theophylline Structure

Synonyms: Theophylline, 1,3-Dimethylxanthine, Theophylline anhydrous, 58-55-9, Theo-Dur, Uniphyl, Elixophyllin.

Theophylline is a naturally occurring methylxanthine alkaloid found in tea leaves and cacao beans, and it is produced synthetically for pharmaceutical use. Chemically, it is 1,3-dimethylxanthine, a close structural relative of caffeine and theobromine. Its bronchodilator properties have been recognized since the early 20th century, and it remains a key active pharmaceutical ingredient in respiratory care.

As a phosphodiesterase inhibitor and adenosine receptor antagonist, theophylline relaxes bronchial smooth muscle, improves diaphragmatic contractility, and reduces airway responsiveness to allergens. Its narrow therapeutic window demands high-purity material, making theophylline API a critical component in both immediate-release and sustained-release oral dosage forms.

At LyvBio, theophylline is supplied as a fine crystalline powder with an assay of 99.0%–101.0% (HPLC). Our production follows cGMP guidelines, and every batch is accompanied by a comprehensive Certificate of Analysis. The material is suitable for formulation into tablets, capsules, and oral solutions for the management of asthma and COPD.

Function & Mechanism

  • Bronchodilation: Inhibits phosphodiesterase, increasing cyclic AMP and relaxing bronchial smooth muscle.
  • Adenosine antagonism: Blocks adenosine A1 and A2 receptors, reducing bronchoconstriction and mast cell mediator release.
  • Anti-inflammatory: At lower doses, modulates inflammatory cell activity and reduces airway edema.
  • Respiratory stimulation: Enhances diaphragmatic contractility and improves mucociliary clearance.
  • Cardiovascular effects: Mild positive inotropic and chronotropic actions at therapeutic concentrations.

Source & Standardization

  • Source: Synthetic, derived from dimethylurea and ethyl acetoacetate or via methylation of xanthine.
  • Manufacturing: Controlled chemical synthesis followed by recrystallization and drying.
  • Standardization: Assay 99.0%–101.0% (HPLC); meets EP, USP, and BP monographs.
  • Forms: White to off-white crystalline powder.
  • Applications: Oral solid dosage forms, sustained-release tablets, injections, and research.

Quality Specifications (QC Tests)

Test Item Specification
Identification IR spectrum conforms to reference standard
Loss on Drying ≤ 0.5%
Residue on Ignition ≤ 0.1%
Heavy Metals ≤ 10 ppm
Organic Impurities Any unspecified impurity ≤ 0.10%; total impurities ≤ 0.5%
Residual Solvents Meets USP <467> / EP 5.4 requirements
Microbial Limits Total aerobic count ≤ 1000 CFU/g; absence of E. coli, Salmonella

Bulk Supply & Documentation

  • Monthly capacity: 5 metric tons
  • Lead time: 3-5 business days (stock items)
  • Documentation: COA, MSDS, TDS, and cGMP declaration available upon request.
  • Packaging: 25 kg fiber drums with double polyethylene liners, or customized packaging.

Frequently Asked Questions

What is the minimum order quantity (MOQ)?

Our standard MOQ is 1 kg. For larger quantities, we offer competitive pricing and flexible shipping options.

What is the delivery time?

For stock items, delivery is 3-5 business days after order confirmation. We ship globally via express couriers or air freight.

Do you provide a Certificate of Analysis (COA) and samples?

Yes, a COA is provided with every shipment. Samples are available for quality evaluation; please contact our sales team for arrangements.

Contact & Ordering Information

  • Company: LyvBio Co., Ltd.
  • Address: Room 5-0203, Courtyard 205, Lianhu District, Xi’an, Shaanxi, China
  • Email: info@lyvbio.com
  • Phone: +86-29-65816888

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