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Theophylline melting point standard

Pharmaceutical Secondary Standard; Certified Reference Material

1,3-Dimethylxanthine, 3,7-Dihydro-1,3-dimethyl-1H-purine-2,6-dione, 2,6-Dihydroxy-1,3-dimethylpurine, Theophylline
Empirical Formula (Hill Notation):
CAS Number:
Molecular Weight:
EC Number:
MDL number:
PubChem Substance ID:

Quality Level


certified reference material
pharmaceutical secondary standard


current certificate can be downloaded


HPLC: suitable
gas chromatography (GC): suitable


~Approximately 272 °C


pharmaceutical (small molecule)



pharmacopeia traceability

traceable to USP 1653117

storage temp.


SMILES string




InChI key


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General description

Theophylline is a naturally occurring alkaloid. In addition to its bronchodilator, immunomodulatory and anti-inflammatory effects, it also acts as a respiratory stimulant, used in the treatment of asthma.
Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.


These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.
Theophylline may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by spectrophotometry and chromatography techniques.

Biochem/physiol Actions

Phosphodiesterase inhibitor; diuretic; cardiac stimulant; muscle relaxant; asthma medication.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP (PhEur) and BP primary standards, where they are available.

Other Notes

Values of analytes vary lot to lot.
This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.


To see an example of a Certificate of Analysis for this material enter LRAA7175 in the slot below. This is an example certificate only and may not be the lot that you receive.


Skull and crossbones

Signal Word


Hazard Statements

Precautionary Statements

Hazard Classifications

Acute Tox. 3 Oral

Storage Class Code

6.1D - Non-combustible, acute toxic Cat.3 / toxic hazardous materials or hazardous materials causing chronic effects



Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis

Certificate of Origin

More documents

Quotes and Ordering

Chemometrics-assisted UV-spectroscopic strategies for the determination of theophylline in syrups
Culzoni MJ, et al.
Journal of Pharmaceutical and Biomedical Analysis, 39(5), 1068-1074 (2005)
Simultaneous determination of caffeine, theobromine and theophylline in foods and pharmaceutical preparations by using ion chromatography.
Chen QC, et al.
Analytica Chimica Acta, 371(2-3), 287-296 (1998)
Theophylline in asthma
Weinberger M and Hendeles L
The New England Journal of Medicine, 334(21), 1380-1388 (1996)
Dosage of theophylline in bronchial asthma.
Piafsky KM and Ogilvie IR
The New England Journal of Medicine, 292(23), 1218-1222 (1975)
Spectrophotometric determination of caffeine and theophylline in pure alkaloids and its application in pharmaceutical formulations.
Singh DK and Sahu A
Analytical Biochemistry, 349(2), 176-180 (2006)


HPLC Analysis of Xanthines on Purospher® STAR RP-18 endcapped

Xanthine is a purine base found in most human body tissues and fluids as well as in other organisms. Methylated xanthines (methylxanthines), which include caffeine, paraxanthine, theobromine, and theophylline, commonly used for their effects as mild stiµlants and as bronchodilators, notably in the treatment of asthma symptoms. This application shows the efficient separation of several common xanthines and may be applied their analysis in any number of desired matrices.

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