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Our Reference Specification, for more details, pls contact us for COA,MSDS and certification:
Email & Skype: support@dideu.com Telephone:+86-29-89586682
Mobile:+86-15129568250; Whatsapp: +8615129568250
Fluorouracil Cream | |
| Action and use | Pyrimidine analogue; cytotoxic. |
Definition | Fluorouracil Cream contains Fluorouracil in a suitable basis. The cream complies with the requirements stated under Topical Semi-solid Preparations and with the following requirements. |
Content of fluorouracil, C4H3FN2O2 | 90.0 to 110.0% of the stated amount. |
| Identification | A. Dry a quantity containing 50 mg of Fluorouracil at a pressure not exceeding 0.7 kPa, mix with 100 ml of ether, decant, wash the white, crystalline residue with 50 ml of ether and dry in air. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of fluorouracil (RS 153). B. The light absorption, Appendix II B, in the range 230 to 350 nm of the final solution obtained in the Assay exhibits a maximum only at 266 nm. |
Tests Related substances | 5-Hydroxyuracil Carry out the method for thin-layer chromatography, Appendix III A, using a silica gel precoated plate (Merck silica gel 60 plates are suitable) and a mixture of 70 volumes of ethyl acetate, 40 volumes of acetone and 10 volumes of water as the mobile phase. Apply separately to the plate 20 µl of each of the following solutions. For solution (1) shake a quantity of the cream containing 0.10 g of Fluorouracil with 10 ml of water for 5 minutes, add 10 ml of ethanol (96%), mix and filter through glass-fibre paper. Solution (2) contains 0.00125% w/v of 5-hydroxyuracil in methanol (50%). After removal of the plate, allow it to dry in air, spray with a freshly prepared 0.5% w/v solution of fast blue B salt and then with 0.1m sodium hydroxide. Any spot corresponding to 5-hydroxyuracil in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (2). Urea Carry out the method described under 5-Hydroxyuracil applying separately to the plate 20 µl of each of the following solutions. For solution (1) shake a quantity of the cream containing 0.10 g of Fluorouracil with 10 ml of water for 5 minutes, add 10 ml of ethanol (96%), mix and filter through glass-fibre paper. Solution (2) contains 0.0050% w/v of urea in water. After removal of the plate, allow it to dry in air, spray with a mixture of 10 volumes of a 1% w/v solution of 4-dimethylaminobenzaldehyde in ethanol (96%) and 1 volume of hydrochloric acid and heat at 100° until maximum intensity of the spots is obtained. Any spot corresponding to urea in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (2). |
| Assay | To a quantity containing 50 mg of Fluorouracil add 50 ml of 0.1m hydrochloric acid and shake for 5 minutes. Extract with three 25-ml quantities of chloroform, discard the chloroform, dilute the aqueous solution to 250 ml with 0.1m hydrochloric acid and filter (Whatman No. 42 paper is suitable). Dilute 5 ml to 100 ml with 0.1m hydrochloric acid and measure the absorbance of the resulting solution at the maximum at 266 nm, Appendix II B. Calculate the content of C4H3FN2O2 taking 552 as the value of A(1%, 1 cm) at the maximum at 266 nm. |
Our Reference Specification, for more details, pls contact us for COA,MSDS and certification:
Email & Skype: support@dideu.com Telephone:+86-29-89586682
Mobile:+86-15129568250; Whatsapp: +8615129568250
Fluorouracil Cream | |
| Action and use | Pyrimidine analogue; cytotoxic. |
Definition | Fluorouracil Cream contains Fluorouracil in a suitable basis. The cream complies with the requirements stated under Topical Semi-solid Preparations and with the following requirements. |
Content of fluorouracil, C4H3FN2O2 | 90.0 to 110.0% of the stated amount. |
| Identification | A. Dry a quantity containing 50 mg of Fluorouracil at a pressure not exceeding 0.7 kPa, mix with 100 ml of ether, decant, wash the white, crystalline residue with 50 ml of ether and dry in air. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of fluorouracil (RS 153). B. The light absorption, Appendix II B, in the range 230 to 350 nm of the final solution obtained in the Assay exhibits a maximum only at 266 nm. |
Tests Related substances | 5-Hydroxyuracil Carry out the method for thin-layer chromatography, Appendix III A, using a silica gel precoated plate (Merck silica gel 60 plates are suitable) and a mixture of 70 volumes of ethyl acetate, 40 volumes of acetone and 10 volumes of water as the mobile phase. Apply separately to the plate 20 µl of each of the following solutions. For solution (1) shake a quantity of the cream containing 0.10 g of Fluorouracil with 10 ml of water for 5 minutes, add 10 ml of ethanol (96%), mix and filter through glass-fibre paper. Solution (2) contains 0.00125% w/v of 5-hydroxyuracil in methanol (50%). After removal of the plate, allow it to dry in air, spray with a freshly prepared 0.5% w/v solution of fast blue B salt and then with 0.1m sodium hydroxide. Any spot corresponding to 5-hydroxyuracil in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (2). Urea Carry out the method described under 5-Hydroxyuracil applying separately to the plate 20 µl of each of the following solutions. For solution (1) shake a quantity of the cream containing 0.10 g of Fluorouracil with 10 ml of water for 5 minutes, add 10 ml of ethanol (96%), mix and filter through glass-fibre paper. Solution (2) contains 0.0050% w/v of urea in water. After removal of the plate, allow it to dry in air, spray with a mixture of 10 volumes of a 1% w/v solution of 4-dimethylaminobenzaldehyde in ethanol (96%) and 1 volume of hydrochloric acid and heat at 100° until maximum intensity of the spots is obtained. Any spot corresponding to urea in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (2). |
| Assay | To a quantity containing 50 mg of Fluorouracil add 50 ml of 0.1m hydrochloric acid and shake for 5 minutes. Extract with three 25-ml quantities of chloroform, discard the chloroform, dilute the aqueous solution to 250 ml with 0.1m hydrochloric acid and filter (Whatman No. 42 paper is suitable). Dilute 5 ml to 100 ml with 0.1m hydrochloric acid and measure the absorbance of the resulting solution at the maximum at 266 nm, Appendix II B. Calculate the content of C4H3FN2O2 taking 552 as the value of A(1%, 1 cm) at the maximum at 266 nm. |
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