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Merck
CN

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

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About This Item

Empirical Formula (Hill Notation):
C13H17O2Na
CAS Number:
3585-49-7
Molecular Weight:
228.26
UNSPSC Code:
41116107
NACRES:
NA.24

Key Documents

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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

Related Categories

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 and EP primary standards, where they are available.

Other Notes

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.

Storage Class Code

11 - Combustible Solids

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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Development and validation of an HPLC method for simultaneous determination of ibuprofen and 17 related compounds
Han Z, et al.
Chromatographia, 80, 1353-1360 (2017)

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