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%
110.041713445171822917178381719377171925817176290.15
210.081722001172459317232970.11
单位质量响应值RSD%判断
171078.59170962.000.05数据可信
供试品溶液-ACSB24026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%
5min11575599-157559923.00923.693.0023.0123.693.00
21619222-161922223.64623.65
31631488-163148823.82523.83
41708729-170872924.95324.95
51619405-161940523.64923.65
61576950-157695023.02923.03
15min11666417-166641724.33624.541.0324.3724.581.04
21674325-167432524.45124.49
31702816-170281624.86724.91
41700118-170011824.82824.87
51678819-167881924.51724.56
61661485-166148524.26424.30
30min11635596-163559623.88524.611.7923.9624.691.80
21702787-170278724.86724.95
31698556-169855624.80524.89
41709084-170908424.95925.04
51704690-170469024.89424.97
61659833-165983324.23924.32
45min11641237-164123723.96824.451.5524.0924.581.54
21684176-168417624.59524.72
31695998-169599824.76824.89
41691868-169186824.70724.83
51692229-169222924.71324.83
61641855-164185523.97724.10
60min11629573-162957323.79824.221.1423.9624.381.14
21667641-166764124.35324.52
31682440-168244024.57024.73
41659767-165976724.23824.40
51666861-166686124.34224.51
61644312-164431224.01324.17
90min11629466-162946623.79624.130.9323.9924.340.95
21663597-166359724.29424.50
31668207-166820724.36224.57
41655841-165584124.18124.39
51660069-166006924.24324.45
61638079-163807923.92224.12
120min1-0.0000.00-0.240.242.13
2-0.0000.24
3-0.0000.25
4-0.0000.25
5-0.0000.24
6-0.0000.24
极限1-0.0000.00-0.240.242.13
2-0.0000.24
3-0.0000.25
4-0.0000.25
5-0.0000.24
6-0.0000.24
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%
110.041719065171770517252651718947172027617202520.18
210.081737113173289117350020.18
单位质量响应值RSD%判断
171339.84172123.210.33数据可信
供试品溶液-ACSB24026批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11346-13460.0200.0249.200.020.0248.99
21466-14660.0210.02
31483-14830.0220.02
41545-15450.0220.02
51503-15030.0220.02
6-0.0000.00
15min11798-17980.0260.0313.080.030.0312.90
22033-20330.0300.03
32088-20880.0300.03
42063-20630.0300.03
51977-19770.0290.03
62612-26120.0380.04
30min12057-20570.0300.035.740.030.0415.65
22403-24030.0350.04
32370-23700.0340.03
42322-23220.0340.03
52409-24090.0350.04
62429-24290.0350.04
45min12481-24810.0360.045.270.040.040.00
22496-24960.0360.04
32624-26240.0380.04
42519-25190.0370.04
52475-24750.0360.04
62805-28050.0410.04
60min17099-70990.1030.0551.970.100.0548.99
22621-26210.0380.04
32769-27690.0400.04
42673-26730.0390.04
52699-26990.0390.04
62826-28260.0410.04
90min12485-24850.0360.044.560.040.040.00
22549-25490.0370.04
32791-27910.0410.04
42591-25910.0380.04
52571-25710.0370.04
62580-25800.0380.04
120min12546-25460.0370.0540.040.040.0535.00
25649-56490.0820.08
32732-27320.0400.04
42538-25380.0370.04
52561-25610.0370.04
62588-25880.0380.04
极限12463-24630.0360.0420.180.040.0418.85
22658-26580.0390.04
33833-38330.0560.06
42486-24860.0360.04
52553-25530.0370.04
62413-24130.0350.04
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%
110.041740384173715417348831735725173636417369020.13
210.081729344173010317297240.04
单位质量响应值RSD%判断
172998.21171599.600.58数据可信
供试品溶液-ACSB24026批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min18434-84340.1220.128.110.120.127.00
28750-87500.1270.13
37542-75420.1090.11
47244-72440.1050.11
58466-84660.1230.12
67420-74200.1080.11
15min16677-66770.0970.1417.750.100.1416.96
29405-94050.1360.14
311760-117600.1700.17
49500-95000.1380.14
510908-109080.1580.16
69919-99190.1440.14
30min111139-111390.1610.1611.800.160.1611.97
211530-115300.1670.17
39857-98570.1430.14
413851-138510.2010.20
511030-110300.1600.16
610845-108450.1570.16
45min111881-118810.1720.1716.810.170.1717.38
210873-108730.1580.16
312405-124050.1800.18
415504-155040.2250.23
510377-103770.1500.15
610147-101470.1470.15
60min111419-114190.1660.1610.740.170.1712.40
211375-113750.1650.17
39875-98750.1430.14
413408-134080.1940.20
511556-115560.1680.17
610361-103610.1500.15
90min111929-119290.1730.176.500.170.176.20
212561-125610.1820.18
310884-108840.1580.16
411373-113730.1650.17
511820-118200.1710.17
610453-104530.1520.15
120min112626-126260.1830.1531.130.180.1530.58
24004-40040.0580.06
311625-116250.1690.17
411742-117420.1700.17
59776-97760.1420.14
611472-114720.1660.17
极限111686-116860.1690.165.220.170.174.90
210856-108560.1570.16
310763-107630.1560.16
412243-122430.1770.18
510824-108240.1570.16
611548-115480.1670.17
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%
110.041738399174212017433391743530174308417420940.13
210.081783578178385617837170.02
单位质量响应值RSD%判断
173515.34176956.051.39数据可信
供试品溶液-ACSB24026批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1813722-81372211.59811.541.0611.6011.541.08
2818516-81851611.66711.67
3800096-80009611.40411.40
4801406-80140611.42311.42
5804396-80439611.46611.47
6818759-81875911.67011.67
15min11014198-101419814.45614.450.5214.4814.470.54
21019904-101990414.53714.56
31011228-101122814.41414.43
41019828-101982814.53614.56
51010390-101039014.40214.42
61006906-100690614.35214.37
30min11116438-111643815.91315.910.3515.9615.950.35
21114748-111474815.88915.93
31115183-111518315.89515.94
41122185-112218515.99516.04
51116828-111682815.91915.96
61110287-111028715.82615.87
45min11185043-118504316.89116.680.9916.9616.740.99
21162085-116208516.56416.63
31160484-116048416.54116.61
41184257-118425716.88016.95
51165500-116550016.61316.68
61162213-116221316.56616.64
60min11196720-119672017.05817.080.6417.1617.180.63
21194204-119420417.02217.12
31198096-119809617.07717.17
41210237-121023717.25017.35
51202267-120226717.13717.23
61187624-118762416.92817.03
90min11237413-123741317.63817.630.6217.7617.750.62
21235007-123500717.60317.73
31238039-123803917.64717.77
41247729-124772917.78517.91
51236995-123699517.63217.76
61223999-122399917.44617.57
120min11256683-125668317.91217.980.6618.0718.130.65
21258703-125870317.94118.10
31261919-126191917.98718.14
41269648-126964818.09718.25
51270945-127094518.11618.27
61249034-124903417.80317.96
极限11275748-127574818.18418.200.5518.3718.380.55
21273718-127371818.15518.34
31275348-127534818.17818.36
41286439-128643918.33618.52
51281987-128198718.27318.46
61266125-126612518.04718.23
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