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Name Dosage USP Apparatus Speed (RPM's) Medium Volume (mL) Rec.Sampling Times Data Updated
Indomethacin Rectal Suppository Refer to USP 2021-08-26
Bempedoic Acid Tablet II (Paddle) 50 0.05 M Phosphate buffer, pH 6.6 900 5, 10, 15, 20 and 30 2021-08-19
Entrectinib Capsule II (Paddle) with Sinker 75 50 mM Potassium Phosphate, pH 6.0 with 0.374% w/v polysorbate 80 1000 15, 20, 30, 45, 60 and 75 2021-08-19
Fedratinib HCl Capsule I (Basket) 50 0.1 N HCl 900 5, 10, 15, 20 and 30 2021-08-19
Bempedoic Acid/Ezetimibe Tablet II (Paddle) 50 Bempedoic Acid: 0.05 M Phosphate buffer, pH 6.6; Ezetimibe: 0.05M Sodium Acetate Buffer pH 4.5 with 0.45% SLS 900 5, 10, 15, 20, 30, and 45 2021-08-19
Palbociclib Tablet II (Paddle) 75 0.1 N HCl 900 10, 15, 20, 30 and 45 2021-08-19
Apomorphine HCl Film (Sublingual) V (paddle over disk) 75 20mM BIS-TRIS HCl Buffer, pH 6.4 500 2.5, 5, 7.5, 10, 12.5, 15 and 20 2021-08-19
Osilodrostat Phosphate Tablet Refer to FDA's Dissolution Guidance, 2018 2021-08-19
Isosorbide Dinitrate/Hydralazine HCl Tablet Refer to FDA's Dissolution Guidance, 2018 2021-08-19
Ledipasvir/Sofosbuvir Pellets II (Paddle) 75 1.0% polysorbate 80 in 25 mM Potassium Phosphate Buffer, with 0.005 mg/mL Butylated Hydroxytoluene (BHT), pH 5.5 900 5, 10, 15, 20, 30, 45 and 60 2021-08-19
Efavirenz/Lamivudine/Tenofovir Disoproxil Fumarate Tablet II (Paddle) 75 2% SLS in Water 1000 5, 10, 15, 20 and 30 2021-08-19
Guanfacine HCl Tablet Refer to FDA's Dissolution Guidance, 2018 500 2021-08-19
Amifampridine Tablet Refer to FDA's Dissolution Guidance, 2018 2021-08-19
Penicillin G Benzathine Injectable Develop a method to characterize in vitro release 2021-08-19
Elexacaftor, Ivacaftor, Tezacaftor [FDC:ELE+ IVA+ TEZ]; Ivacaftor [IVA] Tablet/Tablet (Copackage) II (Paddle) FDC: ELE: 75/IVA: 65 FDA: ELE: 1.8% (v/v) Polysorbate 20 in 50 mM sodium phosphate, pH 6.8/ IVA: 0.4% (w/v) SLS in 50 mM sodium phosphate, pH 6.8/TEZ: 0.2% (w/v) SLS solution in 0.1N HCl; IVA: 1.8% (v/v) Polysorbate 20 in 50 mM sodium phosphate, pH 6.8 FDC: ELE: 900/IVA: 9 5, 10, 15, 20 and 30 2021-08-19
Amifampridine Phosphate Tablet Refer to FDA's Dissolution Guidance, 2018 2021-08-19
Selinexor Tablet II (Paddle) 75 10 mM Citric Acid Buffer, pH 4.5 with 0.5% SDS 900 10, 15, 20, 30 and 45 2021-08-19
Fostemsavir Tromethamine Tablet (Extended Release I (Basket) 100 0.05 M Phosphate Buffer, pH 6.8 buffer, pH 6.8 1000 1, 2, 3, 5, 7, 10, 12, 16, 20 and 24 hours 2021-08-19
Semaglutide Tablet II (Paddle) 70 50 mM Phosphate Buffer with 0.05% Brij 35 (polyoxyethylene lauryl ether), pH 6.8 500 10, 15, 20, 30, 45, 60 and 75 2021-08-19
Istradefylline Tablet II (Paddle) with Sinker 50 0.5% sodium lauryl sulfate (SLS) in Water (degas) 900 5, 10, 15, 20 and 30 2021-08-19