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PHR1004

Supelco

Ibuprofen

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):
IB, IBU, α-Methyl-4-(isobutyl)phenylacetic acid, (±)-2-(4-Isobutylphenyl)propanoic acid
Empirical Formula (Hill Notation):
C13H18O2
CAS Number:
Molecular Weight:
206.28
EC Number:
MDL number:
PubChem Substance ID:

grade

certified reference material
pharmaceutical secondary standard

Quality Level

Agency

traceable to BP 539
traceable to Ph. Eur. I0020000
traceable to USP 1335508

API family

ibuprofen

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

SMILES string

CC(C)Cc1ccc(cc1)C(C)C(O)=O

InChI

1S/C13H18O2/c1-9(2)8-11-4-6-12(7-5-11)10(3)13(14)15/h4-7,9-10H,8H2,1-3H3,(H,14,15)

InChI key

HEFNNWSXXWATRW-UHFFFAOYSA-N

Gene Information

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This Item
I0020000BP539PHR1935
Ibuprofen Pharmaceutical Secondary Standard; Certified Reference Material

Supelco

PHR1004

Ibuprofen

Ibuprofen European Pharmacopoeia (EP) Reference Standard

I0020000

Ibuprofen

Ibuprofen British Pharmacopoeia (BP) Reference Standard

BP539

Ibuprofen

Supelco

Supelco

PHR1935

Ibuprofen Impurity N

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

technique(s)

-

technique(s)

-

technique(s)

-

application(s)

pharmaceutical (small molecule)

application(s)

pharmaceutical (small molecule)

application(s)

-

application(s)

pharmaceutical (small molecule)

format

neat

format

neat

format

neat

format

neat

storage temp.

2-30°C

storage temp.

-

storage temp.

2-8°C

storage temp.

2-8°C

Quality Level

300

Quality Level

-

Quality Level

-

Quality Level

300

General description

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.
Ibuprofen is a substituted arylpropionic acid, used as a non-steroidal anti-inflammatory drug (NSAID).

Application

Ibuprofen may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by spectrophotometry and chromatography techniques.
Ibuprofen may be used as a standard in the quantitative determination of ibuprofen in samples of human plasma using high performance liquid chromatography (HPLC). It may also be used as a reference standard in the determination of ibuprofen in dog plasma using liquid chromatography (LC).
These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Biochem/physiol Actions

Cyclooxygenase (COX) inhibitor that has greater activity against COX-1 than against COX-2.
Cyclooxygenase (COX) inhibitor that has greater activity against COX-1 than against COX-2.

Analysis Note

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

Other Notes

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.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAC0253 in the slot below. This is an example certificate only and may not be the lot that you receive.

related product

Product No.
Description
Pricing

Pictograms

Exclamation mark

Signal Word

Warning

Hazard Statements

Hazard Classifications

Acute Tox. 4 Oral - Eye Irrit. 2 - STOT SE 3

Target Organs

Respiratory system

Storage Class Code

11 - Combustible Solids

WGK

WGK 3


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Spectrofluorometric determination of ibuprofen in pharmaceutical formulations
Damiani PC, et al.
Journal of Pharmaceutical and Biomedical Analysis, 25(3-4), 679-683 (2001)
Simultaneous determination of ibuprofen and hydroxypropylmethylcellulose (HPMC) using HPLC and evaporative light scattering detection
Whelan MR, et al.
Journal of Pharmaceutical and Biomedical Analysis, 30(4), 1355-1359 (2002)
Simultaneous determination of caffeine, paracetamol, and ibuprofen in pharmaceutical formulations by high-performance liquid chromatography with UV detection and by capillary electrophoresis with conductivity detection
Cunha RR, et al.
Journal of Separation Science, 38(10), 1657-1662 (2015)
Simultaneous spectrophotometric determination of pseudoephedrine hydrochloride and ibuprofen in a pharmaceutical preparation using ratio spectra derivative spectrophotometry and multivariate calibration techniques
Palabiyik IM, et al.
Journal of Pharmaceutical and Biomedical Analysis, 34(3), 473-483 (2004)
Determination of ibuprofen in dog plasma by liquid chromatography and application in pharmacokinetic studies of an ibuprofen prodrug in dogs
Wang P, et al.
Journal of Pharmaceutical and Biomedical Analysis, 38, 714-719 (2005)

Related Content

Assay of Ibuprofen Esters and Impurities

The application note describes the separation of Ibuprofen and its related impurities using an Ascentis® Express 90Å C18 column with excellent peak shape and limits of quantification of 1 ppm or less.

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