利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
110.123265323267473269903273203266223268420.10
210.123252223252833252520.02
单位质量响应值RSD%判断
32296.6432139.530.35数据可信
加速6月-供试品溶液-2023072811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%
5min1119527-11952733.25634.885.1533.2634.885.15
2128207-12820735.67135.67
3125435-12543534.90034.90
4115929-11592932.25532.25
5131245-13124536.51636.52
6131848-13184836.68436.68
10min1165184-16518445.95946.652.6946.0346.722.69
2169059-16905947.03747.12
3169705-16970547.21747.29
4160154-16015444.56044.63
5173315-17331548.22248.30
6168496-16849646.88146.96
15min1186739-18673951.95652.441.3552.1352.621.35
2190362-19036252.96553.15
3189658-18965852.76952.95
4184624-18462451.36851.54
5191445-19144553.26653.45
6187956-18795652.29552.48
20min1201127-20112755.96056.080.8856.2556.380.88
2200577-20057755.80756.11
3203242-20324256.54856.85
4200447-20044755.77056.06
5204193-20419356.81357.12
6199740-19974055.57455.88
30min1219892-21989261.18160.680.8761.6061.100.87
2216535-21653560.24760.67
3219819-21981961.16061.59
4217541-21754160.52760.94
5219347-21934761.02961.46
6215381-21538159.92660.35
45min1234673-23467365.29364.760.7565.8465.320.75
2231509-23150964.41364.97
3234240-23424065.17365.73
4232305-23230564.63465.18
5233720-23372065.02865.60
6230174-23017464.04164.60
60min1244617-24461768.06067.280.8368.7667.990.82
2240864-24086467.01667.72
3242823-24282367.56168.27
4241682-24168267.24367.93
5242332-24233267.42468.14
6238668-23866866.40567.11
极限1251221-25122169.89769.640.5570.7570.490.55
2249121-24912169.31370.16
3252005-25200570.11570.97
4249809-24980969.50470.34
5251161-25116169.88170.74
6248503-24850369.14169.99
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
110.123238173240943238223230983227603235180.18
210.123226993234883230940.18
单位质量响应值RSD%判断
31968.1831926.280.10数据可信
长期6月-供试品溶液-2023072811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%
5min1117383-11738332.93633.927.3532.9433.927.35
2118225-11822533.17233.17
3134873-13487337.84437.84
4120352-12035233.76933.77
5125970-12597035.34635.35
6108507-10850730.44630.45
10min1159290-15929044.69544.955.0844.7745.025.08
2158908-15890844.58844.66
3165695-16569546.49246.58
4162394-16239445.56645.64
5169212-16921247.47947.56
6145662-14566240.87140.94
15min1183213-18321351.40750.914.6351.5851.094.63
2182041-18204151.07851.25
3185354-18535452.00852.20
4184518-18451851.77351.95
5188637-18863752.92953.11
6164949-16494946.28346.44
20min1196371-19637155.09954.854.3455.3955.144.34
2199948-19994856.10356.39
3198516-19851655.70156.00
4198122-19812255.59155.88
5201443-20144356.52256.82
6178544-17854450.09750.36
30min1214366-21436660.14859.654.3260.5660.064.33
2217025-21702560.89561.31
3217118-21711860.92161.35
4215145-21514560.36760.78
5217833-21783361.12161.55
6194050-19405054.44854.82
45min1232810-23281065.32464.174.2665.8764.714.26
2234212-23421265.71766.26
3230686-23068664.72865.29
4230765-23076564.75065.30
5234529-23452965.80666.37
6209084-20908458.66659.16
60min1237662-23766266.68566.634.1167.3767.314.12
2242230-24223067.96768.66
3242546-24254668.05568.76
4240630-24063067.51868.21
5243650-24365068.36569.07
6218003-21800361.16961.79
极限1247233-24723369.37168.904.2870.2169.744.28
2252096-25209670.73571.58
3249690-24969070.06070.92
4248625-24862569.76170.60
5251280-25128070.50671.37
6224429-22442962.97263.73
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
110.123281023279403275283276243274603277310.09
210.123289773282603286180.16
单位质量响应值RSD%判断
32384.4932472.130.20数据可信
中间条件6月-供试品溶液-2023072811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%
5min1117530-11753032.48832.288.2132.4932.288.21
2101607-10160728.08728.09
3109840-10984030.36330.36
4120190-12019033.22433.22
5127663-12766335.28935.29
6123840-12384034.23334.23
10min1156870-15687043.36343.335.1643.4443.405.16
2144919-14491940.05940.12
3149991-14999141.46141.53
4161040-16104044.51644.59
5167157-16715746.20646.28
6160513-16051344.37044.45
15min1178449-17844949.32849.233.6549.5049.403.66
2170145-17014547.03247.18
3171850-17185047.50447.66
4179646-17964649.65949.83
5188152-18815252.01052.19
6180357-18035749.85550.03
20min1190725-19072552.72153.132.4953.0053.412.50
2187359-18735951.79152.05
3187284-18728451.77052.04
4194792-19479253.84654.13
5199695-19969555.20155.50
6193316-19331653.43753.72
30min1209005-20900557.77458.091.3958.1758.481.41
2209072-20907257.79358.16
3206004-20600456.94557.33
4211662-21166258.50958.91
5214685-21468559.34459.76
6210428-21042858.16858.57
45min1223842-22384261.87662.390.9262.4062.920.94
2225607-22560762.36462.86
3223079-22307961.66562.17
4226389-22638962.58063.11
5228844-22884463.25863.81
6226494-22649462.60963.14
60min1231159-23115963.89864.670.9564.5665.330.96
2233698-23369864.60065.24
3232658-23265864.31364.96
4235084-23508464.98365.66
5237620-23762065.68466.38
6233420-23342064.52365.20
极限1242886-24288667.14067.380.5667.9468.190.57
2243159-24315967.21568.00
3241941-24194166.87967.67
4245690-24569067.91568.73
5244585-24458567.61068.45
6244296-24429667.53068.35
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
110.123223133223493223353226483227553224800.07
210.123228913235073231990.14
单位质量响应值RSD%判断
31865.6131936.660.16数据可信
加速6月-供试品溶液-2023072911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%
5min1129539-12953936.40036.922.4936.4036.922.49
2131056-13105636.82636.83
3126681-12668135.59735.60
4136118-13611838.24838.25
5133683-13368337.56437.56
6131222-13122236.87336.87
10min1171047-17104748.06348.250.9048.1448.340.90
2171525-17152548.19748.28
3169553-16955347.64347.72
4173274-17327448.68948.77
5173700-17370048.80948.89
6171274-17127448.12748.21
15min1191951-19195153.93754.330.7454.1254.520.74
2194270-19427054.58954.78
3194787-19478754.73454.92
4191451-19145153.79653.99
5194562-19456254.67154.86
6193028-19302854.24054.43
20min1203973-20397357.31558.200.8057.6258.510.80
2207280-20728058.24458.55
3208887-20888758.69659.00
4207504-20750458.30758.62
5207822-20782258.39758.71
6207271-20727158.24258.55
30min1220017-22001761.82362.651.1962.2663.091.18
2224145-22414562.98363.42
3226296-22629663.58864.02
4219848-21984861.77662.22
5224955-22495563.21163.65
6222495-22249562.52062.96
45min1234304-23430465.83866.661.1566.4167.241.14
2236993-23699366.59367.17
3241225-24122567.78368.36
4234609-23460965.92466.50
5239513-23951367.30267.89
6236806-23680666.54167.12
60min1242575-24257568.16268.991.0368.8869.711.03
2245767-24576769.05969.79
3249126-24912670.00370.73
4243047-24304768.29569.02
5247473-24747369.53870.27
6245073-24507368.86469.59
极限1249626-24962670.14371.170.9971.0172.060.99
2253545-25354571.24472.13
3256770-25677072.15173.04
4252419-25241970.92871.81
5255181-25518171.70472.59
6252229-25222970.87571.75
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
110.123214493221903213763209763213863214750.14
210.123218083214753216420.08
单位质量响应值RSD%判断
31766.3031782.810.04数据可信
长期6月-供试品溶液-2023072911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%
5min1127539-12753935.98035.952.4035.9835.952.41
2131434-13143437.07937.08
3129862-12986236.63636.64
4127461-12746135.95835.96
5122896-12289634.67134.67
6125373-12537335.36935.37
10min1172428-17242848.64448.460.6948.7248.540.69
2173079-17307948.82848.91
3171323-17132348.33248.41
4172838-17283848.76048.84
5170115-17011547.99248.07
6170888-17088848.21048.29
15min1195170-19517055.06054.850.2755.2555.040.27
2194182-19418254.78154.97
3194371-19437154.83455.02
4194925-19492554.99155.18
5194107-19410754.76054.94
6193847-19384754.68754.87
20min1210091-21009159.26958.870.4859.5859.180.48
2208066-20806658.69859.01
3208114-20811458.71259.02
4209801-20980159.18759.50
5208176-20817658.72959.03
6207873-20787358.64458.95
30min1227838-22783864.27663.870.5364.7264.310.52
2225010-22501063.47863.92
3225109-22510963.50663.95
4227508-22750864.18364.62
5226750-22675063.96964.40
6226238-22623863.82564.26
45min1242131-24213168.30868.040.4068.8968.630.39
2239734-23973467.63268.22
3240667-24066767.89568.48
4242202-24220268.32868.91
5241472-24147268.12268.70
6240969-24096967.98068.56
60min1249459-24945970.37670.420.3571.1171.160.35
2249096-24909670.27371.01
3248529-24852970.11370.85
4251004-25100470.81171.55
5250190-25019070.58271.31
6249422-24942270.36571.10
极限1257645-25764572.68572.730.3373.5873.620.32
2256671-25667172.41073.30
3257021-25702172.50973.40
4258458-25845872.91473.81
5258673-25867372.97573.86
6258412-25841272.90173.79
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
110.123230783231653229463228773226083229350.07
210.123226493225353225920.03
单位质量响应值RSD%判断
31910.5731876.680.08数据可信
中间条件6月-供试品溶液-2023072911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%
5min1125423-12542335.25136.035.2935.2536.035.30
2117034-11703432.89432.89
3127793-12779335.91735.92
4136967-13696738.49638.50
5129316-12931636.34536.35
6132536-13253637.25037.25
10min1170372-17037247.88547.502.6047.9647.582.61
2161102-16110245.27945.35
3167448-16744847.06347.14
4172066-17206648.36148.45
5169546-16954647.65247.73
6173478-17347848.75848.84
15min1194051-19405154.54053.811.6254.7254.001.63
2187643-18764352.73952.91
3188733-18873353.04553.23
4192600-19260054.13254.33
5190203-19020353.45853.64
6195491-19549154.94555.14
20min1206030-20603057.90757.470.9158.2157.770.91
2203868-20386857.29957.59
3202972-20297257.04757.35
4203135-20313557.09357.41
5203332-20333257.14857.45
6207484-20748458.31558.63
30min1224371-22437163.06262.470.9263.5062.900.92
2223424-22342462.79563.21
3220839-22083962.06962.50
4219661-21966161.73862.18
5220921-22092162.09262.52
6224353-22435363.05763.50
45min1239350-23935067.27266.431.1367.8567.001.12
2238221-23822166.95467.51
3235927-23592766.30966.88
4232436-23243665.32865.91
5234174-23417465.81766.39
6238028-23802866.90067.48
60min1247413-24741369.53868.701.1070.2669.421.10
2246615-24661569.31370.02
3243059-24305968.31469.03
4240773-24077367.67268.39
5242454-24245468.14468.86
6246244-24624469.20969.94
极限1255331-25533171.76371.031.0072.6471.910.99
2254921-25492171.64872.51
3251839-25183970.78271.65
4249318-24931870.07370.95
5250593-25059370.43271.30
6254431-25443171.51072.40
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