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

Filter Compatibility

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.

SELECTIVITY

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
Ingredients Control
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.

Source: http://microsolv.net/PDF/MicroSolvFiltersEquivalency.pdf