PHR1004

Ibuprofen

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): IB, IBU, α-Methyl-4-(isobutyl)phenylacetic acid, (±)-2-(4-Isobutylphenyl)propanoic acid
• Empirical Formula (Hill Notation): C₁₃H₁₈O₂
• CAS Number: 15687-27-1
• Molecular Weight: 206.28
• EC Number: 239-784-6
• MDL number: MFCD00010393
• PubChem Substance ID: 329823035

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to BP 539; traceable to Ph. Eur. I0020000; traceable to USP 1335508
• API family: ibuprofen
• CofA: current certificate can be downloaded
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-30°C
• SMILES string: CC(C)Cc1ccc(cc1)C(C)C(O)=O
• InChI: 1S/C13H18O2/c1-9(2)8-11-4-6-12(7-5-11)10(3)13(14)15/h4-7,9-10H,8H2,1-3H3,(H,14,15)
• InChI key: HEFNNWSXXWATRW-UHFFFAOYSA-N
• Gene Information: human ... PTGS1(5742) , PTGS2(5743)

Description

General description

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.
Ibuprofen is a substituted arylpropionic acid, used as a non-steroidal anti-inflammatory drug (NSAID).

Application

Ibuprofen may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by spectrophotometry and chromatography techniques.

Ibuprofen may be used as a standard in the quantitative determination of ibuprofen in samples of human plasma using high performance liquid chromatography (HPLC). It may also be used as a reference standard in the determination of ibuprofen in dog plasma using liquid chromatography (LC).

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

Cyclooxygenase (COX) inhibitor that has greater activity against COX-1 than against COX-2.

Cyclooxygenase (COX) inhibitor that has greater activity against COX-1 than against COX-2.

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.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAC0253 in the slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• Pictograms: GHS07
• Signal Word: Warning
• Hazard Statements: H302 - H319 - H335
• Precautionary Statements: P261 - P264 - P271 - P280 - P301 + P312 - P305 + P351 + P338
• Hazard Classifications: Acute Tox. 4 Oral - Eye Irrit. 2 - STOT SE 3
• Target Organs: Respiratory system
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 3