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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

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About This Item

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
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Quality Level

300

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

SMILES string

CN1C(=O)N(C)c2[nH]cnc2C1=O

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

Gene Information

human ... ADORA1(134), ADORA2A(135), ADORA2B(136), ADORA3(140), PDE3A(5139), PDE3B(5140), PDE4A(5141), PDE4B(5142), PDE4C(5143), PDE4D(5144)

General description

Theophylline is a xanthine derivative, which is widely found in human diet. It occurs abundantly in chocolate food products.
Theophylline is a methylxanthine drug, most widely prescribed for the management of asthma and chronic obstructive pulmonary disease (COPD).
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

Application

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).
Theophylline may be used as a pharmaceutical reference standard for the determination of the analyte in drug dosage forms by chromatography and spectrophotometry.
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.

Biochem/physiol Actions

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

Analysis Note

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

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.

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pictograms

Skull and crossbonesHealth hazard
GHS06,GHS08

signalword

Danger

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

flash_point_f

Not applicable

flash_point_c

Not applicable

Regulatory Information

涉药品监管产品

This item has

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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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)
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)
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)
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Global Trade Item Number

SKUGTIN
PHR1023-1G04061835236947