Transcription of NO.16-3 1 INTRINSIC による 回転 - agilent.com
1 1 BRYAN CRIST, SCIENTIFIC AFFAIRS MANAGER, AGILENT TECHNOLOGIES, INC. INTRINSIC : . INTRINSIC : . 4 . : INTRINSIC .. pH . (API) . 6 (BCS) 1 . dissoGUARD .. 7 .. ( : mg/min/cm2) . (DDG) .. API .. mg/min/. 8 cm2 1 mg/.. min/cm2 .. API .. INTRINSIC . / .. in vivo .. mg/min/cm2 .. 1. INTRINSIC . API . ( AP I . ) C .. <1087> Apparent INTRINSIC Dissolution2 3 API . INTRINSIC . ( Woods ) INTRINSIC 10 % .. 20 mg 200 mg API . INTRINSIC 1 .. API . / . USP 2,175 PSI (150 Bar) . 15 MPa (Megapascals) 1 .. API .. ( ) INTRINSIC . 2 . USP .. INTRINSIC . cm ( ) . C . 2.. INTRINSIC . 500 1000. 3/8 . mL C . 250. rpm .. 5 .. 10 % .. USP <711> .. UV HPLC .. mg/min/cm2 2. INTRINSIC .. INTRINSIC URL.. 1. Amidon, ; Lennernas, H.; Shah, ;Crison, , A Theoretical Basis for a Biopharmaceutic Drug Classification: The Correlation of In Vitro Drug Product Dissolution and In Vivo Bioavailability, Pharmaceutical Research 1995, Vol.
2 12, No. 3. 2. USP <1087> Apparent INTRINSIC Dissolution Dissolution Procedures for Rotating Disk and Stationary Disk, US Pharmacopeia 38, Rockville, MD, 2015. INTRINSIC .. cm 7000E/7010 708-DS 705-DS* 12-4101. * cm 12-4110. cm 12-4120. 12-4140. 12-4150. 12-4130. * 1 . 3. BRYAN CRIST, SCIENTIFIC AFFAIRS MANAGER, AGILENT TECHNOLOGIES, INC. : . ( ) . USP <711> Dissolution . C .. 1.. 3 .. 2 .. 30 85 % .. HPLC . 30 85 % .. USP .. 4.. Millipore SterivacTM GP20 Vacuum Filtration Unit2 USP .. 3.. (Millex -FG50 ) . 2 .. SterivacTM .. SterivacTM .. pH. USP C . 8 .. 5 . pH . 4. USP .. 1. US Pharmacopeia Physical Test <711> Dissolution, USP 38, 2015. 2. Millipore Technical Publication P35904, Rev. D, 5/2003; SterivacTM is a registered trademark of Millipore Corporation.
3 5. DAN SPISAK, DISSOLUTION PRODUCT MANAGER, AGILENT TECHNOLOGIES, INC. DISSOGUARD .. : USP <1092> . 5. dissoGUARD 708-DS . USP General Chaper <1092> .. 6.. BRYAN CRIST, SCIENTIFIC AFFAIRS MANAGER, AGILENT TECHNOLOGIES, INC.. (DDG) . dissoGUARD .. LED .. 2011 DDG 1 .. 22 .. DDG .. DDG .. DDG .. : . SOP: USP <1092> .. 22 Bryan Crist .. DDG . Agilent Dissolution Exchange . DDG .. 6. dissoGUARD . dissoGUARD com/nxtbooks/agilent/dissolution_ #/1 .. dissoGUARD .. 7.. : USP .. : SS USP <701> Disintegration .. : .. : .. Agilent Technologies, Inc. 2016. Printed in Japan, July 25, 2016. 5991-7169 JAJP. 8.
