地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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)360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%
19.961698279170272016991711697860169695716989970.14
210.251717744171764017176920.01
单位质量响应值RSD%判断
170582.03167579.711.26数据可信
供试品溶液-2025031221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%
5min1-0.0000.01126.110.000.01122.48
22418-24180.0360.04
31249-12490.0180.02
41038-10380.0150.02
5-0.0000.00
6-0.0000.00
15min11814-18140.0270.037.610.030.030.00
21985-19850.0290.03
32091-20910.0310.03
41760-17600.0260.03
51837-18370.0270.03
62069-20690.0310.03
30min12320-23200.0340.045.120.030.0415.65
22383-23830.0350.04
32415-24150.0360.04
42264-22640.0330.03
52322-23220.0340.03
62583-25830.0380.04
45min12262-22620.0330.0450.240.030.0453.25
22333-23330.0340.03
32248-22480.0330.03
42106-21060.0310.03
55712-57120.0840.08
62286-22860.0340.03
60min12250-22500.0330.032.450.030.030.00
22275-22750.0340.03
32211-22110.0330.03
42182-21820.0320.03
52281-22810.0340.03
62308-23080.0340.03
90min12182-21820.0320.033.830.030.030.00
22103-21030.0310.03
32254-22540.0330.03
42022-20220.0300.03
52116-21160.0310.03
62212-22120.0330.03
120min12062-20620.0300.0452.170.030.0453.25
21915-19150.0280.03
31976-19760.0290.03
42122-21220.0310.03
55356-53560.0790.08
62258-22580.0330.03
极限12142-21420.0320.0439.680.030.0435.00
22132-21320.0310.03
32105-21050.0310.03
41956-19560.0290.03
51896-18960.0280.03
64376-43760.0650.06
地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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)360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%
19.961694499169539116958041695457169782416957950.08
210.251747078174700617470420.01
单位质量响应值RSD%判断
170260.54170443.120.08数据可信
供试品溶液-2025031221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%
5min11001-10010.0150.00244.950.010.00244.95
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min11913-19130.0280.0490.370.030.0487.17
21864-18640.0270.03
38465-84650.1240.12
41938-19380.0280.03
51585-15850.0230.02
62153-21530.0320.03
30min12302-23020.0340.0574.600.030.0580.00
22253-22530.0330.03
32270-22700.0330.03
43469-34690.0510.05
59018-90180.1320.13
62305-23050.0340.03
45min12191-21910.0320.033.840.030.030.00
22258-22580.0330.03
32303-23030.0340.03
42329-23290.0340.03
52090-20900.0310.03
62345-23450.0340.03
60min12152-21520.0320.035.900.030.0315.50
22340-23400.0340.03
32196-21960.0320.03
42450-24500.0360.04
52373-23730.0350.04
62122-21220.0310.03
90min12330-23300.0340.035.420.030.030.00
22241-22410.0330.03
32172-21720.0320.03
42250-22500.0330.03
52231-22310.0330.03
61982-19820.0290.03
120min12198-21980.0320.035.710.030.030.00
22089-20890.0310.03
32015-20150.0300.03
42064-20640.0300.03
52099-20990.0310.03
61843-18430.0270.03
极限12169-21690.0320.032.800.030.030.00
22090-20900.0310.03
32241-22410.0330.03
42185-21850.0320.03
52102-21020.0310.03
62223-22230.0330.03
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