5-Fluorouracil (5-FU) CAS 51-21-8 Assay 98.5%~101.0% Factory High Quality

Short Description:

Chemical Name: 5-Fluorouracil (5-FU)

CAS: 51-21-8

Appearance: White or Almost White Crystalline Powder

Assay: 98.5%~101.0%

High Quality, Commercial Production

Contact: Dr. Alvin Huang

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E-Mail: alvin@ruifuchem.com

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51-21-8 - Description:

Ruifu Chemical is the leading supplier of 5-Fluorouracil (5-FU) (CAS: 51-21-8) with high quality. 5-Fluorouracil is mainly used as a pharmaceutical intermediate for the synthesis of drugs such as Doxifluridine and etc.
Ruifu Chemical has been supplying pharmaceutical intermediates more than 15 years.
Ruifu Chemical can provide worldwide delivery, competitive price, excellent service.
Purchase 5-Fluorouracil (5-FU), please contact us by e-mail: alvin@ruifuchem.com

51-21-8 - Chemical Properties:

Chemical Name	5-Fluorouracil
Synonyms	5-FU; Fluorouracil; 5-Fluoro-2,4(1H,3H)-Pyrimidinedione; 5-Fluoro-2,4-Pyrimidinedione; 5-Fluoro-1H-Pyrimidine-2,4-Dione
CAS Number	51-21-8
Stock Status	In Stock, Production Capacity 20 Tons/Month
Molecular Formula	C4H3FN2O2
Molecular Weight	130.08
Melting Point	282.0-286.0℃(dec.) (lit.)
Solubility in Water	Slightly Soluble in Water
Solubility	Soluble in Dimethylformamide; Slightly Soluble in Methanol; Insoluble in Chloroform, Benzene, Ether
Sensitive	Air Sensitive
Shelf Life	24 Months When Properly Stored
COA & MSDS	Available
Origin of Product	Shanghai, China
Product Categories	Pharmaceutical Intermediates
Test Standard	Enterprise Standard; United States Pharmacopoeia (USP)
Brand	Ruifu Chemical

51-21-8 - Specifications:

Item	Specifications	Results
Appearance	White or Almost White Crystalline Powder	White Crystalline Powder
Identification	IR	Complies
Loss on Drying	≤0.50% (80℃ for 4 h)	0.06%
Residue on Ignition	≤0.10%	0.04%
Heavy Metals (Pb)	≤20ppm	Complies
Chloride	≤0.014%	Complies
Fluorine Content	13.9%~15.0%	14.3%
Assay	98.5%~101.0%	99.9%
Conclusion:This product by inspection accords with the standard USP43.

51-21-8 - Package/Storage/Shipping:

Package: Bottle, aluminium foil bag, 25kg/cardboard drum, or according to customer's requirement.
Storage Condition: Keep the container tightly closed. Store in a cool, dry (2-8℃) and well-ventilated warehouse away from incompatible substances. Prevent direct sunlight; avoid fire and heat sources; avoid moisture/water. It is strictly prohibited to mix or transport with toxic and harmful substances. This product is non-dangerous goods, can be transported according to general chemicals. Light loading and unloading.
Shipping: Deliver to worldwide by air, by sea, by FedEx / DHL Express. Provide fast and reliable delivery.

51-21-8 - Synthetic Route:

51-21-8 - Advantages:

51-21-8 - FAQ:

51-21-8 - Risk and Safety:

Risk Codes
R22 - Harmful if swallowed
R20/21/22 - Harmful by inhalation, in contact with skin and if swallowed.
R52 - Harmful to aquatic organisms
R25 - Toxic if swallowed
Safety Description
S36 - Wear suitable protective clothing.
S36/37 - Wear suitable protective clothing and gloves.
S36/37/39 - Wear suitable protective clothing, gloves and eye/face protection.
S22 - Do not breathe dust.
S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.)
S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.
UN IDs UN 2811 6.1/PG 3
WGK Germany 3
RTECS YR0350000
FLUKA BRAND F CODES 10-23
TSCA T
HS Code 2933599099
Hazard Note Irritant/Highly Toxic
Hazard Class 6.1
Packing Group III
Toxicity LD50 orally in Rabbit: 230 mg/kg

51-21-8 - Application:

Shanghai Ruifu Chemical Co., Ltd. is the leading manufacturer and supplier of 5-Fluorouracil (CAS: 51-21-8) with high quality, widely used in organic synthesis, synthesis of pharmaceutical intermediates and Active Pharmaceutical Ingredient (API) synthesis.
5-Fluorouracil, RNA and DNA synthesis inhibitor, is an anticancer agent. 5-Fluorouracil as fluorouracil for pyrimidine antimetabolites, is currently clinically commonly used a chemotherapy drug, having effect on proliferation, can prevent the thymine formation, inhibition of DNA biosynthesis, thereby inhibiting the growth of cancer cells.

51-21-8 - USP43 Standard:

Fluorouracil
C4H3FN2O2 130.08
2,4(1H,3H)-Pyrimidinedione, 5-fluoro-;
5-Fluorouracil [51-21-8]; UNII: U3P01618RT.
DEFINITION
Fluorouracil contains NLT 98.0% and NMT 102.0% of uorouracil (C4H3FN2O2), calculated on the dried basis.
[ CAUTION- Great care should be taken to prevent inhaling particles of Fluorouracil and exposing the skin to it.]
IDENTIFICATION
Change to read:
• A. SPECTROSCOPIC IDENTIFICATION TESTS <197>, Infrared Spectroscopy: 197M (CN 1-MAY-2020)
Change to read:
• B. SPECTROSCOPIC IDENTIFICATION TESTS <197>, Ultraviolet-Visible Spectroscopy: 197U (CN 1-MAY-2020)
Medium: pH 4.7 acetate buffer prepared from 8.4 g of sodium acetate and 3.35 mL of glacial acetic acid mixed with water to make 1000 mL
Sample solution: 10 µg/mL in Medium
Acceptance criteria: Meets the requirements
• C. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
ASSAY
• PROCEDURE
Buffer: 6.8 g/L of monobasic potassium phosphate in water. Adjust with 5 M potassium hydroxide to a pH of 5.7 ± 0.1.
Mobile phase: Acetonitrile and Buffer (5:95)
Standard solution: 10 µg/mL of USP Fluorouracil RS in water
Sample solution: 10 µg/mL of Fluorouracil in water
Chromatographic system
(See Chromatography <621>, System Suitability.)
Mode: LC
Detector: UV 254 nm
Column: 4.6-mm × 25-cm; 5-µm packing L1
Flow rate: 1.0 mL/min
Injection volume: 20 µL
System suitability
Sample: Standard solution
Suitability requirements
Relative standard deviation: NMT 0.73%, Standard solution
Tailing factor: NMT 1.5, Standard solution
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of uorouracil (C4H3FN2O2) in the portion of Fluorouracil taken:
Result = (ru /rs ) × (Cs /Cu ) × 100
ru = peak response from the Sample solution
rs = peak response from the Standard solution
Cs = concentration of USP Fluorouracil RS in the Standard solution (µg/mL)
Cu = concentration of Fluorouracil in the Sample solution (µg/mL)
Acceptance criteria: 98.0%-102.0% on the dried basis
IMPURITIES
• RESIDUE ON IGNITION <281>: NMT 0.1%
• ORGANIC IMPURITIES
Protect the Standard solution and Sample solution from light.
Mobile phase: 6.8 g/L of monobasic potassium phosphate in water. Adjust with 5 M potassium hydroxide to a pH of 5.7 ± 0.1.
Standard solution: 0.1 µg/mL each of USP Fluorouracil RS, USP Fluorouracil Related Compound A RS, USP Fluorouracil Related
Compound B RS, and USP Uracil RS, and 0.2 µg/mL of USP Fluorouracil Related Compound E RS in Mobile phase
Sample solution: 0.1 mg/mL of Fluorouracil in Mobile phase
Chromatographic system
(See Chromatography <621>, System Suitability.)
Mode: LC
Detector: UV 266 nm
Column: 4.6-mm × 25-cm; 5-µm packing L1
Flow rate: 1.0 mL/min
Injection volume: 20 µL
Run time: NLT 3 times the retention time of the uorouracil peak
System suitability
Sample: Standard solution
Suitability requirements
Resolution: NLT 2 between the uracil and uorouracil peaks
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of uorouracil related compound A, uorouracil related compound B, and uracil in the portion of
Fluorouracil taken:
Result = (ru /rs ) × (Cs /Cu ) × 100
ru = peak response of relevant uorouracil related compound from the Sample solution
rs = peak response of relevant uorouracil related compound from the Standard solution
Cs = concentration of relevant uorouracil related compound in the Standard solution (mg/mL)
Cu = concentration of Fluorouracil in the Sample solution (mg/mL)
Calculate the percentage of 5-methoxyuracil, uorouracil related compound E, and any unspecied impurity in the portion of
Fluorouracil taken:
Result = (ru /rs ) × (Cs /Cu ) × (1/F) × 100
ru = peak response of each impurity from the Sample solution
rs = peak response of uorouracil from the Standard solution
Cs = concentration of USP Fluorouracil RS in the Standard solution (mg/mL)
Cu = concentration of Fluorouracil in the Sample solution (mg/mL)
F = relative response factor for each individual impurity (see Table 1)
Acceptance criteria: See Table 1. Disregard any impurity peaks less than 0.05%.
Table 1
Name Relative Retention Time Relative Response Factor Acceptance Criteria, NMT (%)
Fluorouracil related compound A a 0.5 - 0.15
Fluorouracil related compound B b 0.7 - 0.15
Uracil 0.9 - 0.15
Name Relative Retention Time Relative Response Factor Acceptance Criteria, NMT (%)
Fluorouracil 1.0 - -
5-Methoxyuracil c 1.6 0.67 0.15
Fluorouracil related compound E d 1.9 0.77 0.15
Any individual unspecied impurity - 1.0 0.10
Total impurities - - 0.5
a Pyrimidine-2,4,6(1H,3H,5H)-trione.
b Dihydropyrimidine-2,4,5(3H)-trione.
c 5-Methoxypyrimidine-2,4(1H,3H)-dione.
d 5-Chloropyrimidine-2,4(1H,3H)-dione.
• LIMITS OF FLUOROURACIL RELATED COMPOUND F AND UREA
Diluent: Methanol and water (1:1)
Standard solution A: 0.025 mg/mL of USP Fluorouracil Related Compound F RS in Diluent
Standard solution B: 0.02 mg/mL of USP Urea RS in methanol
Sample solution: 10 mg/mL of Fluorouracil in Diluent
Chromatographic system
(See Chromatography <621>, Thin-Layer Chromatography.)
Mode: TLC
Adsorbent: Chromatographic silica gel mixture
Application volume: 10 µL
Developing solvent system: Ethyl acetate, methanol, and water (70:15:15)
Reagent: Prepare a 10-mg/mL solution of p-dimethylaminobenzaldehyde in anhydrous alcohol. Prepare a mixture of this solution
and hydrochloric acid (10:1).
Analysis
Samples: Standard solution A, Standard solution B, and Sample solution
Procedure: Develop with Developing solvent system, followed by air drying. Examine the plate under UV light at 254 nm for
uorouracil related compound F. Spray the plate at least twice with Reagent, and dry the plate in an oven at 80° for 3-4 min.
Examine the plate under daylight for urea. [NOTE- The urea produces a yellow spot, and uorouracil is not detected by the spray.]
Acceptance criteria: The spot of uorouracil related compound F in the Sample solution is not more intense than the spot of
uorouracil related compound F from Standard solution A (NMT 0.25%). The spot of urea in the Sample solution is not more
intense than the spot of urea from Standard solution B (NMT 0.2%).
SPECIFIC TESTS
• LOSS ON DRYING <731>
Analysis: Dry under vacuum over phosphorus pentoxide at 80° for 4 h.
Acceptance criteria: NMT 0.5%
ADDITIONAL REQUIREMENTS
• PACKAGING AND STORAGE: Preserve in tight, light-resistant containers.
• USP REFERENCE STANDARDS <11>
USP Fluorouracil RS
USP Fluorouracil Related Compound A RS
Pyrimidine-2,4,6(1H,3H,5H)-trione.
C4H4N2O3 128.09
USP Fluorouracil Related Compound B RS
Dihydropyrimidine-2,4,5(3H)-trione.
C4H4N2O3 128.09
USP Fluorouracil Related Compound E RS
5-Chloropyrimidine-2,4(1H,3H)-dione.
C4H3ClN2O2 146.53
USP Fluorouracil Related Compound F RS
2-Ethoxy-5-uoropyrimidin-4(1H)-one.
C6H7FN2O2 158.13
USP Uracil RS
Uracil.
C4H4N2O2 112.09