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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
Diflucortolone Oily Cream | |
| Action and use | Glucocorticoid. |
Definition | Diflucortolone Oily Cream contains Diflucortolone Valerate in a suitable oily basis. The cream complies with the requirements stated under Topical Semi-solid Preparations and with the following requirements. |
Content of diflucortolone valerate, C27H36F2O5 | 90.0 to 110.0% of the stated amount. |
| Identification | A. Carry out the method for thin-layer chromatography, Appendix III A, using a silica gel 60 F254 precoated plate (Merck silica gel 60 plates are suitable) and a mixture of 2 volumes of diethylamine, 50 volumes of cyclohexane and 50 volumes of ethyl acetate as the mobile phase. Apply separately to the plate 20 µl of each of the following solutions. For solution (1) disperse a quantity of the cream containing 1 mg of Diflucortolone Valerate in 10 ml of dichloromethane by heating on a water bath, shake vigorously for 1 minute, cool in ice, filter the dispersion and use the filtrate. Solution (2) contains 0.01% w/v of diflucortolone valerate BPCRS in dichloromethane. Solution (3) contains a mixture of equal volumes of solutions (1) and (2). Develop the chromatogram twice drying the plate in air for 15 minutes between developments. After removal of the plate, allow it to dry in air for 15 minutes and examine under ultraviolet light (254 nm). The principal spot in the chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (2). The principal spot in the chromatogram obtained with solution (3) appears as a single compact spot. B. In the Assay, the chromatogram obtained with solution (2) shows a peak with the same retention time as the peak due to diflucortolone valerate in the chromatogram obtained with solution (1). |
| Assay | Carry out the method for liquid chromatography, Appendix III D, injecting 20 µl of each of the following solutions. For solution (1) dissolve 20 mg of diflucortolone valerate BPCRS in a 0.02% w/v solution of clocortolone hexanoate BPCRS (internal standard) in methanol and dilute to 200 ml with the internal standard solution. Add 30 ml of methanol to 10 ml of the resulting solution and dilute to 50 ml with water. For solution (2) add 40 ml of methanol to a quantity of the cream containing 1 mg of Diflucortolone Valerate, disperse by heating on a water bath at 60° for 5 minutes and shake for 30 seconds. Add 10 ml of water, cool in ice for 10 minutes and filter. Prepare solution (3) in the same manner as solution (2) but adding 10 ml of a 0.02% w/v solution of clocortolone hexanoate BPCRS in methanol and 30 ml of methanol. The chromatographic procedure described under Diflucortolone Cream may be used. Calculate the content of C27H36F2O5 in the cream using the declared content of C27H36F2O5 in diflucortolone valerate BPCRS. |
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
Diflucortolone Oily Cream | |
| Action and use | Glucocorticoid. |
Definition | Diflucortolone Oily Cream contains Diflucortolone Valerate in a suitable oily basis. The cream complies with the requirements stated under Topical Semi-solid Preparations and with the following requirements. |
Content of diflucortolone valerate, C27H36F2O5 | 90.0 to 110.0% of the stated amount. |
| Identification | A. Carry out the method for thin-layer chromatography, Appendix III A, using a silica gel 60 F254 precoated plate (Merck silica gel 60 plates are suitable) and a mixture of 2 volumes of diethylamine, 50 volumes of cyclohexane and 50 volumes of ethyl acetate as the mobile phase. Apply separately to the plate 20 µl of each of the following solutions. For solution (1) disperse a quantity of the cream containing 1 mg of Diflucortolone Valerate in 10 ml of dichloromethane by heating on a water bath, shake vigorously for 1 minute, cool in ice, filter the dispersion and use the filtrate. Solution (2) contains 0.01% w/v of diflucortolone valerate BPCRS in dichloromethane. Solution (3) contains a mixture of equal volumes of solutions (1) and (2). Develop the chromatogram twice drying the plate in air for 15 minutes between developments. After removal of the plate, allow it to dry in air for 15 minutes and examine under ultraviolet light (254 nm). The principal spot in the chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (2). The principal spot in the chromatogram obtained with solution (3) appears as a single compact spot. B. In the Assay, the chromatogram obtained with solution (2) shows a peak with the same retention time as the peak due to diflucortolone valerate in the chromatogram obtained with solution (1). |
| Assay | Carry out the method for liquid chromatography, Appendix III D, injecting 20 µl of each of the following solutions. For solution (1) dissolve 20 mg of diflucortolone valerate BPCRS in a 0.02% w/v solution of clocortolone hexanoate BPCRS (internal standard) in methanol and dilute to 200 ml with the internal standard solution. Add 30 ml of methanol to 10 ml of the resulting solution and dilute to 50 ml with water. For solution (2) add 40 ml of methanol to a quantity of the cream containing 1 mg of Diflucortolone Valerate, disperse by heating on a water bath at 60° for 5 minutes and shake for 30 seconds. Add 10 ml of water, cool in ice for 10 minutes and filter. Prepare solution (3) in the same manner as solution (2) but adding 10 ml of a 0.02% w/v solution of clocortolone hexanoate BPCRS in methanol and 30 ml of methanol. The chromatographic procedure described under Diflucortolone Cream may be used. Calculate the content of C27H36F2O5 in the cream using the declared content of C27H36F2O5 in diflucortolone valerate BPCRS. |
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