PHR1023

Theophylline

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): 1,3-Dimethylxanthine, 2,6-Dihydroxy-1,3-dimethylpurine, 3,7-Dihydro-1,3-dimethyl-1H-purine-2,6-dione
• Empirical Formula (Hill Notation): C₇H₈N₄O₂
• CAS Number: 58-55-9
• Molecular Weight: 180.16
• UNSPSC Code: 41116107
• NACRES: NA.24
• PubChem Substance ID: 329823053
• EC Number: 200-385-7
• Beilstein/REAXYS Number: 13463
• MDL number: MFCD00079619

Properties

• Product Name: Theophylline, Pharmaceutical Secondary Standard; Certified Reference Material
• InChI: 1S/C7H8N4O2/c1-10-5-4(8-3-9-5)6(12)11(2)7(10)13/h3H,1-2H3,(H,8,9)
• InChI key: ZFXYFBGIUFBOJW-UHFFFAOYSA-N
• SMILES string: CN1C(=O)N(C)c2[nH]cnc2C1=O
• grade: certified reference material; pharmaceutical secondary standard
• agency: USP 1653004; traceable to Ph. Eur. T080000
• API family: theophylline
• CofA: current certificate can be downloaded
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• application(s): food and beverages; pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-30°C
• Quality Level: 300
• Gene Information: human ... ADORA1(134), ADORA2A(135), ADORA2B(136), ADORA3(140), PDE3A(5139), PDE3B(5140), PDE4A(5141), PDE4B(5142), PDE4C(5143), PDE4D(5144)

Description

Analysis Note

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

Application

Theophylline may be used as a pharmaceutical reference standard for the determination of the analyte in drug dosage forms by chromatography[1][2] and spectrophotometry.[3]

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).[4]

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.

General description

Theophylline is a xanthine derivative, which is widely found in human diet.[4] It occurs abundantly in chocolate food products.[4]

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).[1]

Biochem/physiol Actions

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

Other Notes

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.

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.

Safety Information

• pictograms: GHS06,GHS08
• signalword: Danger
• hcodes: H301,H360D
• pcodes: P202 - P264 - P280 - P301 + P310 - P405 - P501
• Hazard Classifications: Acute Tox. 3 Oral - Repr. 1B
• Storage Class: 6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
• wgk: WGK 1
• flash_point_f: Not applicable
• flash_point_c: Not applicable