D'ULTILOXANNUAL PRODUCT REVIEWTAHUN : 2013PRODUCT
NAME:ULTILOXHALAMAN :
........................PRODUCTIONBatchBatchDate ofExpiryWater
Drying ( OVEN )Final
MixingTablettingYieldNo.SizeManufactureDateAmountTemp.TimeWaterMachineSpeedTimeMachineTimeSpeedContent(Agt
/ Ch)(pcs)( THN )( lt )( C )( hour )( % )( no. invt )( rpm )( min.
)( no. invt )( hour )( rpm )( % )180.0005585236 - 48 3.0Sejong
SM-20060291.0 -296/INV/04500100.0B3A020180,00028/02/2013MAR
2018655293.503.0296/INV/TAB/04602073/INV/TAB/039.7593.0127/03/2013500B3A021180,00001/03/2013MAR
2018655293.503.0296/INV/TAB/04602073/INV/TAB/039.0093.1204/04/2013500B3A022180,00005/03/2013MAR
2018655234.503.0296/INV/TAB/04602073/INV/TAB/039.7594.0109/04/2013500G3A029180,00031/07/2013AGT
2018495237.002.48017/INV/TAB/03low2073/INV/TAB/0311.3392.426/08/2013lowG3A030180,00031/07/2013AGT
2018495235.002.74017/INV/TAB/03low2073/INV/TAB/0311.2594.1802/09/2013low180,00006/11/2013NOP
201818/11/2013
ULTILOX TAB.LAMPIRAN PADA PROTAP PENGKAJIAN TAHUNAN ATAS
PRODUKNO. 5.10.009.00PENGKAJIAN TAHUNAN ATAS PRODUK
PRODUK: ULTILOX TABLETNO. METODE PENGUJIAN : 41054/PM/04PUSTAKA:
USP XXVI hal 75PENGAWASAN MUTUNo.No. AnalisaTanggal
pembuatanTanggal ujiDalu-warsaNo. BetsDiameterTebalBobot rata -
rata (mg/tab)Variasi bobotKeke-rasanFriabilityK P APenetapan
kadarAl(OH)3Mg(OH)2104747/LO/1328 February 201307 March 2013March
2018B3A02016,23 mm4,32 mm1101,05 mg( 1084,4 - 1115,0 ) mg12,56
kp0.17%18,760 meq101.99%102.01%13 March 2013204748/LO/1301 March
201308 March 2013March 2018B3A02116,22 mm4,35 mm1104,56 mg( 1091,08
- 1119,35 ) mg12,42 kp0.13%18,879 meq102.04%102.18%15 March
2013304749/LO/1305 March 201311 March 2013April 2018B3A02216,27
mm4,35 mm1099,20 mg( 1092,2 - 1109,6 ) mg12,3 kp0.15%18,670
meq101.99%102.08%18 March 2013409518/LO/1331 July 201302 August
2013August 2018G3A02916,22 mm4,40 mm1111,84 mg( 1096,3 - 1125,7 )
mg12,03 kp0.11%19,184 meq101.90%101.92%23 August 2013509519/LO/1331
July 201303 August 2013August 2018G3A03016,23 mm4,30 mm1108,92 mg(
1092,7 - 1116,5 ) mg12,1 kp0.20%19,012 meq101.83%101.84%13 August
2013
Dra. Sianita, Apt, MSQC. Manager
Halaman : &P dari &N
dataNo. AnalisaTanggal pembuatanTanggal ujiDalu-warsaNo.
BetsDiameterTebalBobot rata - rata (mg/tab)Variasi
bobotKeke-rasanFriabilityK P APenetapan kadarAl(OH)3Mg(OH)2 16,15
mm4,20 - 4,50 mm1100 mg(1067,0 - 1133,0) mg7 - 15 kp<
1%>12,15 meq90,0 - 110,0%90,0 - 110,0%04747/LO/1328 February
201307 March 2013March 2018B3A02016,23 mm4,32 mm1101,05 mg( 1084,4
- 1115,0 ) mg12,56 kp0.17%18,760 meq101.99%102.01%04748/LO/1301
March 201308 March 2013March 2018B3A02116,22 mm4,35 mm1104,56 mg(
1091,08 - 1119,35 ) mg12,42 kp0.13%18,879
meq102.04%102.18%04749/LO/1305 March 201311 March 2013April
2018B3A02216,27 mm4,35 mm1099,20 mg( 1092,2 - 1109,6 ) mg12,3
kp0.15%18,670 meq101.99%102.08%09518/LO/1331 July 201302 August
2013August 2018G3A02916,22 mm4,40 mm1111,84 mg( 1096,3 - 1125,7 )
mg12,03 kp0.11%19,184 meq101.90%101.92%09519/LO/1331 July 201303
August 2013August 2018G3A03016,23 mm4,30 mm1108,92 mg( 1092,7 -
1116,5 ) mg12,1 kp0.20%19,012 meq101.83%101.84%
