PHR1934

Ibuprofen Impurity B

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonyme(s) : Ibuprofen Impurity B Sodium Salt, (2RS)-2- (4-BUTYLPHENYL)PROPANOIC ACID SODIUM SALT
• Formule empirique (notation de Hill): C₁₃H₁₇O₂Na
• Numéro CAS: 3585-49-7
• Poids moléculaire : 228.26
• Code UNSPSC : 41116107
• Nomenclature NACRES : NA.24

Propriétés

• Qualité: certified reference material; pharmaceutical secondary standard
• Niveau de qualité: 300
• Agence: traceable to Ph. Eur. B1220000
• Famille d'API: ibuprofen
• CofA (certificat d'analyse): current certificate can be downloaded
• Conditionnement: pkg of 20 mg
• Application(s): pharmaceutical (small molecule)
• Format: neat
• Température de stockage: 2-8°C

Description

Description générale

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

Remarque sur l'analyse

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

Note de bas de page

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.

Informations sur la sécurité

• Code de la classe de stockage: 11 - Combustible Solids
• Classe de danger pour l'eau (WGK): WGK 3
• Point d'éclair (°F): Not applicable
• Point d'éclair (°C): Not applicable