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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
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


food and beverages
pharmaceutical (small molecule)



pharmacopeia traceability

traceable to BP 327
traceable to PhEur T080000
traceable to USP 1653004

storage temp.


SMILES string




InChI key


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General description

Theophylline is a xanthine derivative, which is widely found in human diet. It occurs abundantly in chocolate food products.
Certified pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to pharmacopeia primary standards
Theophylline is a methylxanthine drug, most widely prescribed for the management of asthma and chronic obstructive pulmonary disease (COPD).


Theophylline may be used as a reference standard in determining the concentration of theophylline present in beverages, food and herbal products using high performance liquid chromatography (HPLC).
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 drug dosage forms by chromatography and spectrophotometry.

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

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 LRAA7171 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

Development and validation of a stability-indicating HPLC method for the simultaneous determination of salbutamol sulphate and theophylline in pharmaceutical dosage forms.
Maithani M and Singh R
Journal of Analytical and Bioanalytical Techniques , 1(116), 11-11 (2011)
Simultaneous HPLC determination of caffeine, theobromine, and theophylline in food, drinks, and herbal products
Srdjenovic B, et al.
Journal of Chromatographic Science, 46, 144-149 (2008)
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)
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)
Manja Wachsmuth et al.
Nucleic acids research, 41(4), 2541-2551 (2013-01-01)
Riboswitches are regulatory RNA elements typically located in the 5'-untranslated region of certain mRNAs and control gene expression at the level of transcription or translation. These elements consist of a sensor and an adjacent actuator domain. The sensor usually is


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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