PHR1227 Supelco


Pharmaceutical Secondary Standard; Certified Reference Material

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

  • CAS Number 51-21-8

  • Empirical Formula (Hill Notation) C4H3FN2O2

  • Molecular Weight 130.08

  •  Beilstein/REAXYS Number 127172

  •  EC Number 200-085-6

  •  MDL number MFCD00006018

  •  PubChem Substance ID 329823233

  •  NACRES NA.24



Related Categories Additional Standards, Analytical Standards, Analytical/Chromatography, Capecitabine Metabolite, Chromatography,
Quality Level   300
grade   certified reference material
  pharmaceutical secondary standard
form   neat
application(s)   HPLC: suitable
  gas chromatography (GC): suitable
mp   282-286 °C (dec.) (lit.)
Featured Industry   Cleaning Products
Food and Beverages
Personal Care
Pharmaceutical (small molecule)
format   neat
pharmacopeia traceability   traceable to BP 995
  traceable to PhEur F0250000
  traceable to USP 12790000
SMILES string   FC1=CNC(=O)NC1=O
InChI   1S/C4H3FN2O2/c5-2-1-6-4(9)7-3(2)8/h1H,(H2,6,7,8,9)
Gene Information   human ... TYMS(7298)


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.


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, 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.


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.

Safety & Documentation

Safety Information

Signal word 
Hazard statements 
Precautionary statements 
UN 2811 6.1 / PGIII
WGK Germany 
Flash Point(F) 
Not applicable
Flash Point(C) 
Not applicable


Certificate of Analysis (COA)

Please Enter a Lot Number

Frequently Asked Questions

Which document(s) contains shelf-life or expiration date information for a given product?
If available for a given product, the recommended re-test date or the expiration date can be found on the Certificate of Analysis.
How do I get lot-specific information or a Certificate of Analysis?
The lot specific COA document can be found by entering the lot number above under the "Documents" section.
How do I find price and availability?
There are several ways to find pricing and availability for our products. Once you log onto our website, you will find the price and availability displayed on the product detail page. You can contact any of our Customer Sales and Service offices to receive a quote. USA customers: 1-800-325-3010 or view local office numbers.
What is the Department of Transportation shipping information for this product?
Transportation information can be found in Section 14 of the product's (M)SDS.To access the shipping information for this material, use the link on the product detail page for the product.
Why does the 5-Fluorouracil have no effect on my cell line, even at micromolar concentrations that should be more than high enough?
Some cells, and in particular cancer cells, may be resistant to 5-fluorouracil. Please see this paper Huanwen, W., et al., Molecular Cancer, 8, 125 (2009)which addresses this observation, as well as references 16 and 30 in this publication.If the cells are treated with the closely related gemcitabine (Sigma-Aldrich Product G6423), and cell growth is not inhibited by that drug either, you will have shown that the "problem" is with the cell line, and not with the drug(s).
Do you have 5-FU (5-Fluorouracil)for injection? If not, how can I prepare it from the powder?
Sigma-Aldrich lists several fluorouracil products, but we do not offer Fluorouracil for injection. Our 5-Fluorouracil (5-FU) products cannot be given to human patients. (Note that although Product F8423 meets USP testing specifications, it is nota pharmaceutical grade or PharmaGrade product.)Having said that, a solution for injection into research animalscould be prepared the same way as the Fluorouracil Injection, USP is. According to the, 'Fluorouracil Injection, USP, an antineoplastic anti-metabolite, is a colorless to yellow aqueous sterile, nonpyrogenic injectable solution for intravenous administration. Each mL contains: 50 mg fluorouracil; pH is adjusted to 8.6 to 9.4 with sodium hydroxide.'
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Protocols & Articles


HPLC Analysis of Fluorinated Pyrimidine Nucleosides on Ascentis® RP-Amide

From our library of Articles, Sigma-Aldrich presents HPLC Analysis of Fluorinated Pyrimidine Nucleosides on Ascentis® RP-Amide
Keywords: Chromatography, Clinical, High performance liquid chromatography

Peer-Reviewed Papers


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