PHR1146

Ibuprofen Related Compound C

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): 4′-Isobutylacetophenone, 1-(4-Isobutylphenyl)ethanone, 1-Acetyl-4-isobutylbenzene
• Empirical Formula (Hill Notation): C₁₂H₁₆O
• CAS Number: 38861-78-8
• Molecular Weight: 176.25
• EC Number: 254-159-8
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 100; 300
• Agency: traceable to BP 557; traceable to USP 1335541
• CofA: current certificate can be downloaded
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-8°C
• InChI: 1S/C12H16O/c1-9(2)8-11-4-6-12(7-5-11)10(3)13/h4-7,9H,8H2,1-3H3
• InChI key: KEAGRYYGYWZVPC-UHFFFAOYSA-N

Description

General description

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.

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.

It is an impurity of the nonsteroidal anti-inflammatory drug (NSAID)― ibuprofen and presents itself as a degradation product of the parent drug. It is used for the treatment of mild and moderate pain such as during rheumatoid arthritis, osteoarthritis, and dysmenorrhea.

Application

This pharmaceutical secondary standard can also be used as follows:

• Simultaneous determination of ibuprofen and its 17 related impurities by an ICH validated reversed-phase high-performance liquid chromatography (RP-HPLC) method in tablets
• Analysis of combined dosage tablet of ibuprofen and famotidine for their quantitative estimation in the presence of their impurities using thin layer chromatography (TLC) and HPLC

Analysis Note

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

Footnote

To see an example of a Certificate of Analysis for this material enter LRAB2151 in the slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• Pictograms: GHS07,GHS09
• Signal Word: Warning
• Hazard Statements: H315 - H317 - H411
• Precautionary Statements: P261 - P264 - P272 - P273 - P280 - P302 + P352
• Hazard Classifications: Aquatic Chronic 2 - Skin Irrit. 2 - Skin Sens. 1B
• Storage Class Code: 10 - Combustible liquids
• WGK: WGK 2
• Flash Point(F): 286.7 °F - closed cup
• Flash Point(C): 141.5 °C - closed cup