Pharmaceutical Fludrocortisone Acetate Reference Standard Comparison Study

Project Description

Pharmaceutical Laboratory needed for comparison testing of Fludrocortisone acetate between EU (Ireland) and Australia reference products. The following evidence is required: Evidence that the overseas and Australian reference products:- have the same size, shape, weight, colour and markings- contain the same nominal quantity of drug substance- have the same qualitative formulation (e.g. as detailed in product information documents) Copies of the labels and product information (or equivalent document) for both the overseas and Australian reference products. Certificates of analysis for both the overseas and Australian reference products analysed using the specifications proposed in the application for the generic medicine. Comparative dissolution profiles of the overseas and the Australian reference products. The profiles should be determined across the physiological pH range (pH 1.2-6.8), including the Quality Control method.-Mean weight and weight uniformity for 20 dosage units each.-Fourier transform infra-red (FTIR) spectra of each product overlaid for comparison.-Powder X-ray diffraction (XRD) spectra of each product overlaid for comparison. I look forward to hearing from you!

Project Information

Number:20-01821

Industry:Pharmaceuticals

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Pharmaceutical Fludrocortisone Acetate Reference Standard Comparison Study

Project Description

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