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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

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About This Item

Empirical Formula (Hill Notation):
C13H18O2
CAS Number:
Molecular Weight:
206.28
EC Number:
MDL number:
UNSPSC Code:
41116107
PubChem Substance ID:
NACRES:
NA.24

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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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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).[1][2]

Application

Ibuprofen may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by spectrophotometry[2][3] and chromatography techniques.[4]
Ibuprofen may be used as a standard in the quantitative determination of ibuprofen in samples of human plasma using high performance liquid chromatography (HPLC).[5] It may also be used as a reference standard in the determination of ibuprofen in dog plasma using liquid chromatography (LC).[6]
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.

Recommended products

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.

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pictograms

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Warning

Hazard Classifications

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

target_organs

Respiratory system

Storage Class

11 - Combustible Solids

wgk_germany

WGK 1

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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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)
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)
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)
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)

Related Content

Ibuprofen and impurity separation using Ascentis Express 90Å C18 column with excellent peak shape and low quantification limits.

Questions

1–2 of 2 Questions  
  1. How can I determine the shelf life / expiration / retest date of this product?

    1 answer
    1. If this product has an expiration or retest date, it will be shown on the Certificate of Analysis (COA, CofA). If there is no retest or expiration date listed on the product's COA, we do not have suitable stability data to determine a shelf life. For these products, the only date on the COA will be the release date; a retest, expiration, or use-by-date will not be displayed.
      For all products, we recommend handling per defined conditions as printed in our product literature and website product descriptions. We recommend that products should be routinely inspected by customers to ensure they perform as expected.
      For products without retest or expiration dates, our standard warranty of 1 year from the date of shipment is applicable.
      For more information, please refer to the Product Dating Information document: https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/449/386/product-dating-information-mk.pdf

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  2. How is shipping temperature determined? And how is it related to the product storage temperature?

    1 answer
    1. Products may be shipped at a different temperature than the recommended long-term storage temperature. If the product quality is sensitive to short-term exposure to conditions other than the recommended long-term storage, it will be shipped on wet or dry-ice. If the product quality is NOT affected by short-term exposure to conditions other than the recommended long-term storage, it will be shipped at ambient temperature. As shipping routes are configured for minimum transit times, shipping at ambient temperature helps control shipping costs for our customers. For more information, please refer to the Storage and Transport Conditions document: https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/316/622/storage-transport-conditions-mk.pdf

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