地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号2.0对照品来源EP对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数100
标示量(mg)90供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.251694289169547116954381694882169425416948670.04
210.311700945170213717015410.05
单位质量响应值RSD%判断
165352.88165037.920.14数据可信
供试品溶液-24111501-2批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min11091-10910.0660.065.410.070.068.16
21073-10730.0650.06
3942-9420.0570.06
41075-10750.0650.07
51029-10290.0620.06
61007-10070.0610.06
30min11807-18070.1090.117.620.110.119.69
21670-16700.1010.10
31929-19290.1170.12
41734-17340.1050.11
51754-17540.1060.11
61536-15360.0930.09
45min12196-21960.1330.125.640.130.134.08
21931-19310.1170.12
32064-20640.1250.13
41903-19030.1150.12
52094-20940.1270.13
62125-21250.1290.13
60min12419-24190.1460.147.230.150.145.78
22506-25060.1520.15
32382-23820.1440.15
42026-20260.1230.13
52350-23500.1420.15
62233-22330.1350.14
90min12330-23300.1410.143.350.150.143.78
22328-23280.1410.15
32175-21750.1320.14
42343-23430.1420.15
52268-22680.1370.14
62180-21800.1320.14
120min12424-24240.1470.145.330.150.153.53
22424-24240.1470.15
32457-24570.1490.15
42252-22520.1360.14
52153-21530.1300.14
62392-23920.1450.15
极限12388-23880.1440.154.120.150.153.37
22469-24690.1490.16
32556-25560.1550.16
42302-23020.1390.15
52380-23800.1440.15
62319-23190.1400.15
地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号2.0对照品来源EP对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数100
标示量(mg)90供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.251696044169638916960911696118169792316965130.05
210.311704354170351717039360.04
单位质量响应值RSD%判断
165513.46165270.220.11数据可信
供试品溶液-24111501-2批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1865-8650.0520.0511.320.050.0511.07
2808-8080.0490.05
3719-7190.0430.04
4755-7550.0460.05
5889-8890.0540.05
6662-6620.0400.04
30min11628-16280.0980.099.290.100.098.53
21534-15340.0930.09
31470-14700.0890.09
41280-12800.0770.08
51306-13060.0790.08
61425-14250.0860.09
45min12038-20380.1230.125.390.120.125.28
21859-18590.1120.11
32133-21330.1290.13
42031-20310.1230.12
51930-19300.1170.12
61884-18840.1140.12
60min12211-22110.1340.142.990.140.142.96
22227-22270.1350.14
32315-23150.1400.14
42291-22910.1380.14
52352-23520.1420.14
62177-21770.1310.13
90min12242-22420.1350.145.100.140.145.78
22389-23890.1440.15
32301-23010.1390.14
42537-25370.1530.16
52271-22710.1370.14
62223-22230.1340.14
120min12486-24860.1500.154.840.160.165.22
22359-23590.1420.15
32633-26330.1590.17
42419-24190.1460.15
52332-23320.1410.15
62574-25740.1550.16
极限12512-25120.1520.157.140.160.167.24
22359-23590.1420.15
32775-27750.1680.18
42511-25110.1520.16
52304-23040.1390.15
62655-26550.1600.17
地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号2.0对照品来源EP对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数100
标示量(mg)90供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.251706391170526117038201704350170460617048860.06
210.311718416171785817181370.03
单位质量响应值RSD%判断
166330.34166647.620.14数据可信
供试品溶液-24111501-2批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11266-12660.0760.069.720.080.0612.88
21056-10560.0630.06
31021-10210.0610.06
4971-9710.0580.06
51118-11180.0670.07
61052-10520.0630.06
15min12155-21550.1290.127.680.130.126.19
22018-20180.1210.12
31983-19830.1190.12
41938-19380.1160.12
51746-17460.1050.11
62168-21680.1300.13
30min12394-23940.1440.142.290.150.152.76
22428-24280.1460.15
32430-24300.1460.15
42320-23200.1390.14
52413-24130.1450.15
62484-24840.1490.15
45min12618-26180.1570.1719.300.160.1719.64
22604-26040.1560.16
32526-25260.1520.16
42400-24000.1440.15
52626-26260.1580.16
63858-38580.2310.24
60min12897-28970.1740.166.350.180.166.33
22679-26790.1610.17
32576-25760.1550.16
42455-24550.1470.15
52512-25120.1510.16
62498-24980.1500.16
90min12599-25990.1560.163.920.160.164.66
22701-27010.1620.17
32622-26220.1570.16
42572-25720.1540.16
52404-24040.1440.15
62638-26380.1580.17
120min12560-25600.1540.162.480.160.163.32
22686-26860.1610.17
32682-26820.1610.17
42537-25370.1520.16
52627-26270.1580.17
62559-25590.1540.16
极限12692-26920.1620.1611.690.170.1711.35
22603-26030.1560.17
32732-27320.1640.17
42365-23650.1420.15
53339-33390.2000.21
62711-27110.1630.17
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