PHR1934

Ibuprofen Impurity B

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Ibuprofen Impurity B Sodium Salt, (2RS)-2- (4-BUTYLPHENYL)PROPANOIC ACID SODIUM SALT
• Empirical Formula (Hill Notation): C₁₃H₁₇O₂Na
• CAS Number: 3585-49-7
• Molecular Weight: 228.26
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to Ph. Eur. B1220000
• API family: ibuprofen
• CofA: current certificate can be downloaded
• packaging: pkg of 20 mg
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-8°C

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, used for the treatment of mild and moderate pain such as rheumatoid arthritis, osteoarthritis, and dysmenorrhea.

Application

This pharmaceutical secondary standard can also be used as follows:

• Development of a reverse-phase ultraperformance liquid chromatographic (RP-UPLC) method for the estimation of ibuprofen and diphenhydramine citrate along with their related impurities in their combined dosage form
• 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 Note

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

Footnote

To see an example of a Certificate of Analysis for this material enter LRAB8256 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable