Microsoft word - equivalency study of microsolv filters.doc
Equivalency Study of MicroSolv Brand Syringe Filters and a Customer's Current Filters in their SOP's by the Customer
Any filters used in the dissolution should not affect the concentration of the active ingredient. Filter compatibility was performed by testing the Final Standard Solution for 25mg potency and the 24mg tablet dissolution sample with the following types of filters.
Titan2™ Reg. Cellulose 0.45µm Titan2™ PVDF 0.45µm Titan2™ No Prefilter Nylon 0.45µm Titan2™ Nylon 0.45µm MicroSolv™ Nylon 0.45µm MicroSolv™ Reg. Cellulose 0.45µm Gelman Acrodisc™ 1.2µm Supor membrane, non pyrogenic Gelman Acrodisc™ PVDF 0.45µm Gelman Acrodisc™ Nylon 0.45µm Gelman GHP Acrodisc™ GF 0.45µm
Stock Standard Solution: About 56.8mg of Ondansteron HCL standard was transferred into a 250ml volumetric flask, added about 100ml of Deionized water, sonicated for 10 minutes. Brought to volume with Deionized water and mixed well. Final Standard: for 24mg tablets (0.047mg/ml) Pipetted 6.0ml of the Stock Standard Solution into a 25ml volumetric flask, brouht to volume
with Deionized water and mixed well, discarding the
2. One tablet (Ondansetron 24mg F/C Tablet WWCN: 064D68 B# 68, R&D
0428) was weighed out and dissolution was run as a finished product (see Section E). Dissolution solution aliquot was taken at 60 minutes.
For each filter, the 1st ml, 3rd ml, 5th ml, 7th ml and 9th ml filtrates of the final standard solutions and the dissolution sample solution were collected. Each filtrate solution was injected twice on an HPLC system at the wavelength of 216nm.
4. Centrifuged solutions were used as reference standards
24mg Tablet Dissolution Sample Filter Type 1stml 3rdml 5thml 7thml 9thml
24mg Final Standard Filter Type 1stml 3rdml 5thml 7thml 9thml
Reference: JZ 1768/22-27, 1768/28-32 Limit: 98.0%-102.0%
6. Conclusion: For Sample Solution
Based on the studies done, it was found out that MicroSolv Nylon 0.45µm filter (discarding the first 2mls) and the Gelman Acrodisc™ Nylon 0.45µm filter (discarding the first 4mls) are suitable for final dissolution standard. For Sample Solution MicroSolv Nylon 0.45µm Filters (discarding the first 2mls) and Gelman Acrodisc™ 1.2µm Supor membrane, non pyrogenic filters (discarding the first 2mls) are suitable for dissolution solution.
The placebo formulation was prepared by mixing all the inert ingredients for Ondansetron HLC tablets 24mg in the same ration as per Finished Product Formulation
Microcrystalline Cellulose NF (Avicel PH 101)
Microcrystalline Cellulose, NF )Avicell PH 102)
Reference: CJ 1808/53 2. 371.0mg of placebo mix (equivalent to the amount of inactive ingredients
in one tablet weight) was weighed out and dissolution procedure as a finished product was carried out as per section E.
No interference of Ondansetron HCL was found from the placebo mix
Ondansteron HCL was not detected from the placebo mix.
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Grupo de Investigación: Optimización del Diseño y de la Evaluación de Medicamentos Departamento: Farmacia y Tecnología Farmacéutica Situación profesional: Profesor Titular (Universidad) Responsable de los siguientes proyectos/ayudas: • Proyectos Estudio para la determinación de la cantidad de flutamida remanente contenida en pellets previamente implantados y comparación con la