Merck
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PHR1934

Supelco

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):
C13H17O2
Molecular Weight:
205.27

grau

certified reference material
pharmaceutical secondary standard

Nível de qualidade

Agency

traceable to Ph. Eur. B1220000

Certificado de análise (CofA)

current certificate can be downloaded

embalagem

pkg of 20 mg

application(s)

pharmaceutical (small molecule)

formato

neat

temperatura de armazenamento

2-8°C

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grade

certified reference material, pharmaceutical secondary standard

grade

certified reference material, pharmaceutical secondary standard

grade

certified reference material, pharmaceutical secondary standard

grade

certified reference material, pharmaceutical secondary standard

packaging

pkg of 20 mg

packaging

pkg of 50 mg

packaging

pkg of 50 mg

packaging

pkg of 50 mg

application(s)

pharmaceutical (small molecule)

application(s)

-

application(s)

-

application(s)

-

format

neat

format

-

format

-

format

neat

storage temp.

2-8°C

storage temp.

2-30°C

storage temp.

-10 to -25°C

storage temp.

2-30°C

Quality Level

300

Quality Level

100

Quality Level

300

Quality Level

100

Descrição geral

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.

Aplicação

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

Nota de análise

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

Nota de rodapé

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.

Código de classe de armazenamento

11 - Combustible Solids

WGK

WGK 3

Ponto de fulgor (ºF)

Not applicable

Ponto de fulgor (ºC)

Not applicable

Certificate of Analysis

Enter Lot Number to search for Certificate of Analysis (COA).

Certificate of Origin

Enter Lot Number to search for Certificate of Origin (COO).

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