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%
110.123185173191633188583195233192233190570.13
210.123182593189623186100.16
单位质量响应值RSD%判断
31527.3731483.200.10数据可信
加速6月-供试品溶液-2023073011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%
5min1137038-13703838.99139.164.0538.9939.164.05
2131720-13172037.47737.48
3145622-14562241.43341.43
4133802-13380238.07038.07
5143215-14321540.74840.75
6134439-13443938.25138.25
10min1180972-18097251.49151.201.6851.5851.291.68
2176493-17649350.21650.30
3184123-18412352.38752.48
4177656-17765650.54750.63
5182420-18242051.90351.99
6178025-17802550.65250.74
15min1193738-19373855.12356.481.3855.3256.681.38
2199691-19969156.81757.01
3201242-20124257.25857.47
4197589-19758956.21956.42
5200674-20067457.09757.30
6198138-19813856.37556.57
20min1213419-21341960.72360.190.7261.0560.520.72
2209462-20946259.59759.92
3212819-21281960.55260.89
4211071-21107160.05560.38
5212172-21217260.36860.70
6210388-21038859.86060.18
30min1228066-22806664.89064.470.5665.3564.930.56
2225400-22540064.13264.59
3226897-22689764.55865.03
4225386-22538664.12864.58
5228029-22802964.88065.35
6225792-22579264.24364.70
45min1238971-23897167.99367.860.3668.6068.470.35
2237995-23799567.71568.31
3237466-23746667.56568.18
4239266-23926668.07768.67
5237895-23789567.68768.30
6239521-23952168.14968.75
60min1246513-24651370.13969.920.2870.8970.680.28
2244693-24469369.62170.37
3246277-24627770.07270.84
4245330-24533069.80270.55
5246092-24609270.01970.78
6245622-24562269.88570.64
极限1251336-25133671.51171.330.3172.4272.240.29
2250892-25089271.38572.29
3249623-24962371.02471.94
4251503-25150371.55972.46
5249959-24995971.11972.04
6250968-25096871.40672.31
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%
110.123189143183403194793191503191863190140.14
210.123223103212763217930.23
单位质量响应值RSD%判断
31523.1231797.730.62数据可信
长期6月-供试品溶液-2023073011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%
5min1140607-14060739.81138.894.5439.8138.884.54
2143606-14360640.66040.66
3127138-12713835.99736.00
4142688-14268840.40040.40
5135500-13550038.36538.36
6134504-13450438.08338.08
10min1177254-17725450.18750.622.4350.2850.702.43
2184763-18476352.31352.40
3172402-17240248.81348.89
4180708-18070851.16551.25
5176380-17638049.93950.02
6181113-18111351.27951.36
15min1194892-19489255.18155.871.7855.3856.071.78
2201821-20182157.14357.35
3193619-19361954.82055.01
4198816-19881656.29256.50
5194329-19432955.02155.22
6200492-20049256.76656.96
20min1207401-20740158.72259.480.9259.0559.800.92
2212723-21272360.22960.56
3210333-21033359.55359.86
4210740-21074059.66860.00
5208328-20832858.98559.30
6210829-21082959.69360.02
30min1222015-22201562.86063.550.9563.3164.010.96
2227553-22755364.42864.90
3224284-22428463.50363.95
4224936-22493663.68764.15
5222207-22220762.91563.36
6225809-22580963.93464.39
45min1231594-23159465.57266.711.0366.1767.311.03
2238146-23814667.42768.04
3235004-23500466.53867.12
4235765-23576566.75367.36
5235166-23516666.58467.17
6238077-23807767.40868.01
60min1238477-23847767.52168.581.0268.2669.321.01
2244875-24487569.33370.09
3244025-24402569.09269.82
4241092-24109268.26269.01
5240947-24094768.22068.96
6243901-24390169.05769.81
极限1244712-24471269.28670.431.0470.1871.331.04
2251311-25131171.15572.07
3251136-25113671.10571.99
4248116-24811670.25071.15
5247144-24714469.97570.86
6250066-25006670.80271.71
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%
110.123190143196013187273194153203613194240.20
210.123203563194223198890.21
单位质量响应值RSD%判断
31563.6431609.580.11数据可信
中间条件6月-供试品溶液-2023073011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%
5min1142584-14258440.46439.155.1740.4639.165.16
2126026-12602635.76535.77
3147200-14720041.77441.77
4135857-13585738.55538.56
5138438-13843839.28739.29
6137704-13770439.07939.08
10min1184503-18450352.36050.983.6252.4551.073.62
2168638-16863847.85847.94
3187552-18755253.22653.32
4179703-17970350.99851.08
5177848-17784850.47250.56
6179681-17968150.99251.08
15min1204611-20461158.06756.922.7158.2757.122.71
2191895-19189554.45854.64
3207160-20716058.79059.00
4200861-20086157.00357.20
5197296-19729655.99156.19
6201649-20164957.22657.43
20min1218189-21818961.92060.941.6862.2661.271.69
2208505-20850559.17259.48
3218201-21820161.92462.27
4214095-21409560.75861.08
5215528-21552861.16561.49
6213884-21388460.69861.03
30min1227956-22795664.69264.540.9865.1665.011.00
2223926-22392663.54863.99
3230825-23082565.50665.99
4227549-22754964.57665.04
5227670-22767064.61165.07
6226662-22666264.32564.79
45min1241164-24116468.44068.300.4669.0668.910.48
2239022-23902267.83268.41
3242196-24219668.73369.36
4239833-23983368.06368.67
5240891-24089168.36368.97
6240922-24092268.37268.98
60min1248009-24800970.38370.340.2071.1571.100.22
2247421-24742170.21670.95
3248661-24866170.56871.35
4247568-24756870.25871.01
5247470-24747070.23070.99
6248115-24811570.41371.17
极限1253943-25394372.06771.870.3072.9972.790.30
2252368-25236871.62072.51
3252775-25277571.73572.67
4253792-25379272.02472.94
5252638-25263871.69672.61
6254029-25402972.09173.00
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%
110.123213203214443218703217923214873215830.08
210.123210743209653210200.03
单位质量响应值RSD%判断
31776.9831721.340.13数据可信
加速6月-供试品溶液-JPS5249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%
5min1156788-15678844.26741.495.3744.2741.495.37
2132710-13271037.46937.47
3150151-15015142.39342.39
4147415-14741541.62141.62
5147585-14758541.66941.67
6147016-14701641.50841.51
10min1198276-19827655.98154.412.5456.0854.502.54
2184189-18418952.00452.09
3196489-19648955.47655.57
4191458-19145854.05654.15
5192979-19297954.48554.58
6192912-19291254.46654.56
15min1216992-21699261.26560.041.3861.4960.261.39
2207790-20779058.66758.87
3212839-21283960.09360.31
4212386-21238659.96560.18
5212920-21292060.11560.33
6213003-21300360.13960.35
20min1227619-22761964.26663.700.8664.6264.050.87
2221949-22194962.66562.99
3225567-22556763.68664.04
4226533-22653363.95964.30
5225899-22589963.78064.13
6226164-22616463.85564.20
30min1239240-23924067.54767.490.4568.0567.980.46
2237131-23713166.95167.42
3239249-23924967.54968.04
4240187-24018767.81468.30
5239784-23978467.70068.19
6238630-23863067.37467.86
45min1249115-24911570.33569.470.9570.9970.110.96
2242488-24248868.46469.08
3247684-24768469.93170.57
4244715-24471569.09269.73
5245634-24563469.35269.99
6246742-24674269.66570.30
60min1254979-25497971.99071.690.3372.8072.480.34
2252515-25251571.29572.06
3253717-25371771.63472.43
4253928-25392871.69472.49
5254415-25441571.83172.62
6253939-25393971.69772.49
极限1258695-25869573.04072.850.3574.0173.800.35
2257472-25747272.69473.62
3256964-25696472.55173.51
4258280-25828072.92273.87
5257467-25746772.69373.65
6259312-25931273.21474.17
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%
110.123216723223993219493223873221793221170.10
210.123231863217633224740.32
单位质量响应值RSD%判断
31829.7431865.020.08数据可信
长期6月-供试品溶液-JPS5249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%
5min1127068-12706835.76636.185.5935.7736.185.59
2121516-12151634.20334.20
3136799-13679938.50438.50
4124472-12447235.03535.03
5123243-12324334.68934.69
6138193-13819338.89738.90
10min1178538-17853850.25350.292.7150.3350.372.71
2171313-17131348.21948.30
3186581-18658152.51652.60
4178320-17832050.19150.27
5178911-17891150.35850.43
6178350-17835050.20050.29
15min1200969-20096956.56656.501.9456.7656.701.95
2195381-19538154.99355.18
3206506-20650658.12558.33
4198450-19845055.85756.05
5199706-19970656.21156.40
6203456-20345657.26657.46
20min1217142-21714261.11861.111.5161.4461.431.51
2212322-21232259.76260.07
3221790-22179062.42762.76
4214779-21477960.45360.77
5218443-21844361.48561.80
6218249-21824961.43061.76
30min1234235-23423565.93065.910.8466.3866.360.85
2232455-23245565.42965.87
3237782-23778266.92867.40
4232577-23257765.46365.91
5233407-23340765.69666.15
6234465-23446565.99466.46
45min1248190-24819069.85770.200.4870.4670.800.48
2250840-25084070.60371.19
3250108-25010870.39771.02
4248438-24843869.92770.52
5250479-25047970.50271.10
6248431-24843169.92570.53
60min1253389-25338971.32171.820.4172.0872.580.40
2256188-25618872.10972.85
3255817-25581772.00472.78
4254563-25456371.65172.40
5255710-25571071.97472.73
6255348-25534871.87272.64
极限1259118-25911872.93373.140.1973.8574.050.18
2260347-26034773.27974.18
3259954-25995473.16974.10
4260015-26001573.18674.09
5260222-26022273.24474.16
6259375-25937573.00673.93
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%
110.123204183197003197113203773201003200610.11
210.123221973214403218180.17
单位质量响应值RSD%判断
31626.5831800.200.39数据可信
中间条件6月-供试品溶液-JPS5249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%
5min1136040-13604038.45340.213.6638.4540.213.66
2142233-14223340.20340.20
3149532-14953242.26742.27
4137132-13713238.76238.76
5146410-14641041.38441.38
6142150-14215040.18040.18
10min1181450-18145051.28852.561.4651.3752.651.46
2185800-18580052.51852.61
3189446-18944653.54953.64
4185427-18542752.41352.50
5187842-18784253.09553.19
6185712-18571252.49352.58
15min1203921-20392157.64058.180.4957.8458.380.49
2206737-20673758.43658.64
3205690-20569058.14058.35
4206186-20618658.28058.48
5206198-20619858.28458.49
6206207-20620758.28658.49
20min1220490-22049062.32362.050.8762.6562.380.85
2222241-22224162.81863.15
3217270-21727061.41361.76
4219674-21967462.09362.42
5217469-21746961.47061.81
6219996-21999662.18462.52
30min1230616-23061665.18665.511.2265.6565.981.21
2235988-23598866.70467.18
3228770-22877064.66465.14
4232644-23264465.75966.23
5229033-22903364.73865.21
6233524-23352466.00866.48
45min1243105-24310568.71668.711.3169.3369.331.30
2247447-24744769.94370.57
3237618-23761867.16567.79
4243893-24389368.93869.55
5242580-24258068.56769.19
6243834-24383468.92269.54
60min1250759-25075970.87970.501.3871.6471.281.36
2253645-25364571.69572.47
3244313-24431369.05769.83
4251815-25181571.17871.95
5246765-24676569.75070.52
6249296-24929670.46671.24
极限1254812-25481272.02571.811.3872.9572.741.37
2258381-25838173.03473.97
3248737-24873770.30871.23
4256962-25696272.63373.56
5251858-25185871.19072.12
6253587-25358771.67972.61
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