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Merck

PHR1227

Fluorouracil

Pharmaceutical Secondary Standard; Certified Reference Material

Sinónimos:

5-Fluorouracil, 2,4-Dihydroxy-5-fluoropyrimidine, 5-FU, 5-Fluoro-2,4(1H,3H)-pyrimidinedione

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Fórmula empírica (notación de Hill):
C4H3FN2O2
Número CAS:
Peso molecular:
130.08
UNSPSC Code:
41116107
NACRES:
NA.24
PubChem Substance ID:
EC Number:
200-085-6
Beilstein/REAXYS Number:
127172
MDL number:
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InChI key

GHASVSINZRGABV-UHFFFAOYSA-N

InChI

1S/C4H3FN2O2/c5-2-1-6-4(9)7-3(2)8/h1H,(H2,6,7,8,9)

SMILES string

FC1=CNC(=O)NC1=O

grade

certified reference material, pharmaceutical secondary standard

agency

USP 12790000, traceable to Ph. Eur. F0250000

API family

fluorouracil

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

Quality Level

Gene Information

human ... TYMS(7298)

mp

282-286 °C (dec.) (lit.)

application(s)

cleaning products
cosmetics
food and beverages
personal care
pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

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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.
Fluorouracil, an analog of the pyrimidines, belongs to the class of antimetabolite drugs. It is generally utilized for the remediation of tumors such as breast adenocarcinoma, gastrointestinal tract, ovary, head and neck.

Application

Fluorouracil may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by different analytical techniques.
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.

Analysis Note

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

Other Notes

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.
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.
To see an example of a Certificate of Analysis for this material enter LRAC3468 in the slot below. This is an example certificate only and may not be the lot that you receive.

pictograms

Skull and crossbonesHealth hazard

signalword

Danger

hcodes

Hazard Classifications

Acute Tox. 3 Oral - Carc. 2

Clase de almacenamiento

6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

wgk

WGK 3


Certificados de análisis (COA)

Busque Certificados de análisis (COA) introduciendo el número de lote del producto. Los números de lote se encuentran en la etiqueta del producto después de las palabras «Lot» o «Batch»

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Analysis of pharmaceutical creams: a useful approach based on solid-phase extraction (SPE) and UV spectrophotometry
Bonazzi D, et al.
Journal of Pharmaceutical and Biomedical Analysis, 13(11), 1321-1329 (1995)
Polymeric nanoparticles for oral delivery of 5-fluorouracil: Formulation optimization, cytotoxicity assay and pre-clinical pharmacokinetics study
Mattos ACD, et al.
European Journal of Pharmaceutical Sciences, 84(11), 83-91 (2016)
Analysis of flucytosine dosage forms by derivative UV spectroscopy and liquid chromatography.
Cavrini V, et al.
Journal of Pharmaceutical and Biomedical Analysis, 9(5), 401-407 (1991)
André Bp van Kuilenburg et al.
Pharmacogenomics, 14(7), 799-811 (2013-05-09)
5-fluorouracil (5-FU) remains the cornerstone of all currently applied regimens for the treatment of patients with cancers of the gastrointestinal tract, breast, and head and neck. Unfortunately, a large variation in the clearance of 5-FU has been observed between patients
Jean-Yves Douillard et al.
The New England journal of medicine, 369(11), 1023-1034 (2013-09-13)
Patients with metastatic colorectal cancer that harbors KRAS mutations in exon 2 do not benefit from anti-epidermal growth factor receptor (EGFR) therapy. Other activating RAS mutations may also be negative predictive biomarkers for anti-EGFR therapy. In this prospective-retrospective analysis, we

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