Tretinoin Cream, chemical structure, molecular formula, Reference Standards
»Tretinoin Cream contains not less than 90.0percent and not more than 120.0percent of the labeled amount of tretinoin.
Packaging and storage
Preserve in collapsible tubes or in tight,light-resistant containers.
USP Reference standards á11ñ
USP Tretinoin RS.
The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparationobtained as directed in the Assay.
Minimum fill á755ñ:
meets the requirements.
[NOTEAvoid exposure to strong light,and use low-actinic glassware in the performance of the following procedure.Use stabilized tetrahydrofuran in the preparation of the Standard preparation and the Assay preparation.]
Dilute phosphoric acid
Dilute 10mLof phosphoric acid with water to 100mL.
Dissolve 1.38g of monobasic sodium phosphate in 1000mLof water,adjust with Dilute phosphoric acidto a pHof 3.0,and mix.
Prepare a mixture of water and Dilute phosphoric acid(9:1).
[NOTEPhosphate buffer and tetrahydrofuran may be filtered and degassed separately beforemixing.]Prepare a filtered and degassed mixture of Phosphate bufferand tetrahydrofuran (58:42).Make adjustments if necessary (see System Suitabilityunder Chromatography á621ñ).
Dissolve an accurately weighed quantity of USP Tretinoin RSin tetrahydrofuran to obtain a solution having a known concentration of about 0.4mg per mL.Dilute a known volume of this solution,quantitatively and stepwise if necessary,with a mixture of tetrahydrofuran and Diluting solution(3:2)to obtain a solution having a known concentration of about 4µg per mL.
Transfer an accurately weighed quantity of Cream,equivalent to 1.0mg of tretinoin,to a 50-mLvolumetric flask,and add 20.0mLof tetrahydrofuran.Shake the flask to disperse the cream,dilute with tetrahydrofuran to volume,mix,and filter,if necessary.Transfer 5.0mLof this solution to a 25-mLvolumetric flask,dilute with a mixture of tetrahydrofuran and Diluting solution(3:2)to volume,mix,and filter.
(see Chromatography á621ñ)The liquid chromatograph is equipped with a 365-nm detector and a 3.9-mm ×15-cm column that contains 4-µm packing L1.The flow rate is about 1mLper minute.Chromatograph the Standard preparation,and record the peak responses as directed for Procedure:the relative standard deviation for replicate injections is not more than 2.0%.
Separately inject equal volumes (about 25µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the responses for the major peaks.Calculate the quantity,in mg,of tretinoin (C20H28O2)in the portion of Cream taken by the formula:
in which Cis the concentration,in µg per mL,of USP Tretinoin RSin the Standard preparation,and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(PA6)Pharmaceutical Analysis 6
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