PHR1934

Ibuprofen Impurity B

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(e): Ibuprofen Impurity B Sodium Salt, (2RS)-2- (4-BUTYLPHENYL)PROPANOIC ACID SODIUM SALT
• Empirische Formel (Hill-System): C₁₃H₁₇O₂Na
• CAS-Nummer: 3585-49-7
• Molekulargewicht: 228.26
• UNSPSC-Code: 41116107
• NACRES: NA.24

Eigenschaften

• Qualität: certified reference material; pharmaceutical secondary standard
• Qualitätsniveau: 300
• Agentur: traceable to Ph. Eur. B1220000
• API-Familie: ibuprofen
• Analysenzertifikat (CofA): current certificate can be downloaded
• Verpackung: pkg of 20 mg
• Anwendung(en): pharmaceutical (small molecule)
• Format: neat
• Lagertemp.: 2-8°C

Beschreibung

Allgemeine Beschreibung

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.

Anwendung

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

Hinweis zur Analyse

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

Fußnote

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.

Sicherheitshinweise

• Lagerklassenschlüssel: 11 - Combustible Solids
• WGK: WGK 3
• Flammpunkt (°F): Not applicable
• Flammpunkt (°C): Not applicable