托伐普坦口崩片项目信息
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101242-202302对照品来源工作对照品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2000
标示量(mg)7.5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%
116.484011774016694018564017174019744016790.08
216.554044314041724043020.05
单位质量响应值RSD%判断
24373.7324429.120.17数据可信
供试品溶液-2025050821批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min141149-4114910.10810.304.1210.1110.304.13
241153-4115310.10910.11
340089-400899.8489.85
442106-4210610.34310.34
545133-4513311.08711.09
641878-4187810.28710.29
10min174601-7460118.32518.301.7518.3418.321.75
273694-7369418.10218.12
373221-7322117.98618.00
474255-7425518.24018.26
576956-7695618.90418.92
674302-7430218.25218.27
15min1103411-10341125.40225.301.4925.4525.341.48
2102385-10238525.15025.20
3101311-10131124.88624.93
4103082-10308225.32125.37
5105694-10569425.96326.01
6102009-10200925.05825.11
20min1126324-12632431.03031.141.0531.1231.231.05
2126463-12646331.06531.15
3125663-12566330.86830.96
4127556-12755631.33331.42
5129071-12907131.70531.80
6125635-12563530.86130.95
30min1161202-16120239.59839.871.4439.7440.011.44
2162539-16253939.92640.07
3158464-15846438.92539.06
4164257-16425740.34840.49
5165018-16501840.53540.68
6162340-16234039.87740.02
45min1202494-20249449.74149.750.9149.9549.960.91
2202678-20267849.78649.99
3200175-20017549.17149.38
4204473-20447350.22750.44
5204645-20464550.26950.48
6200794-20079449.32349.53
60min1230650-23065056.65756.470.6756.9556.760.67
2231807-23180756.94157.23
3227264-22726455.82656.11
4229998-22999856.49756.79
5230338-23033856.58156.88
6229259-22925956.31656.61
90min1267447-26744765.69665.630.3466.0866.010.34
2268139-26813965.86666.25
3266318-26631865.41965.80
4266186-26618665.38665.77
5268196-26819665.88066.27
6266719-26671965.51765.90
120min1292954-29295471.96271.940.6972.4672.440.70
2294859-29485972.43072.92
3289063-28906371.00671.49
4293442-29344272.08272.58
5294119-29411972.24872.75
6292775-29277571.91872.41
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1304859-30485974.88675.330.4975.5075.950.49
2309241-30924175.96276.58
3306238-30623875.22575.83
4305844-30584475.12875.74
5307017-30701775.41676.04
6306912-30691275.39076.00
托伐普坦口崩片项目信息
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101242-202302对照品来源工作对照品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2000
标示量(mg)7.5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%
116.484036924037544033354035894026214033980.12
216.554073924073514073720.01
单位质量响应值RSD%判断
24478.0324614.620.40数据可信
供试品溶液-2025050821批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min140532-405329.8989.913.879.909.913.86
241274-4127410.07910.08
338375-383759.3719.37
443087-4308710.52210.52
540362-403629.8569.86
639800-398009.7199.72
10min172259-7225917.64517.602.1617.6617.622.17
273564-7356417.96417.98
370347-7034717.17817.19
474200-7420018.11918.14
571296-7129617.41017.43
670774-7077417.28317.30
15min1100027-10002724.42624.371.6624.4724.411.66
2101384-10138424.75724.80
397500-9750023.80923.85
4101808-10180824.86124.91
599506-9950624.29924.34
698529-9852924.06024.11
20min1122799-12279929.98730.051.2430.0730.141.25
2124499-12449930.40230.49
3121374-12137429.63929.72
4125296-12529630.59630.69
5122563-12256329.92930.01
6121932-12193229.77529.86
30min1159248-15924838.88738.851.5639.0238.981.55
2161076-16107639.33439.47
3155136-15513637.88338.02
4162208-16220839.61039.75
5158130-15813038.61438.75
6158676-15867638.74838.88
45min1198793-19879348.54448.541.1948.7548.741.19
2201747-20174749.26549.47
3195390-19539047.71347.91
4200627-20062748.99249.20
5196809-19680948.05948.26
6199239-19923948.65348.85
60min1226975-22697555.42655.391.0255.7155.681.02
2229408-22940856.02056.31
3223184-22318454.50054.78
4229034-22903455.92956.22
5225632-22563255.09855.38
6226837-22683755.39255.67
90min1265557-26555764.84764.510.8765.2264.880.87
2265864-26586464.92265.30
3260740-26074063.67164.04
4266446-26644665.06465.45
5262136-26213664.01264.38
6264238-26423864.52564.90
120min1288912-28891270.55070.700.8971.0371.180.89
2290631-29063170.97071.46
3285807-28580769.79270.27
4292088-29208871.32671.82
5287468-28746870.19870.68
6292150-29215071.34171.82
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1303160-30316074.03074.170.8874.6374.770.88
2307974-30797475.20575.81
3300985-30098573.49874.09
4305668-30566874.64275.25
5301375-30137573.59474.19
6303185-30318574.03674.63
托伐普坦口崩片项目信息
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101242-202302对照品来源工作对照品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2000
标示量(mg)7.5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%
116.484078044075734073084072804084604076850.12
216.554075924069854072880.11
单位质量响应值RSD%判断
24738.1724609.550.37数据可信
供试品溶液-2025050621批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min142809-4280910.40010.514.6210.4010.514.63
244464-4446410.80210.80
344292-4429210.76010.76
444498-4449810.81010.81
539406-394069.5739.57
644177-4417710.73210.73
10min173611-7361117.88218.312.8217.9018.332.81
277327-7732718.78518.80
377154-7715418.74318.76
476250-7625018.52318.54
572000-7200017.49117.51
675930-7593018.44618.46
15min1103238-10323825.08025.411.6625.1325.461.67
2106896-10689625.96826.02
3105114-10511425.53525.58
4104911-10491125.48625.54
5101957-10195724.76824.81
6105366-10536625.59725.65
20min1128223-12822331.14931.511.2231.2431.601.22
2132046-13204632.07832.17
3130575-13057531.72131.81
4130257-13025731.64331.73
5127836-12783631.05531.14
6129329-12932931.41831.51
30min1179024-17902443.49040.903.3343.6341.043.31
2169959-16995941.28841.43
3164125-16412539.87140.02
4165532-16553240.21340.36
5165111-16511140.11140.25
6166387-16638740.42140.56
45min1206507-20650750.16750.050.7950.3850.260.79
2208849-20884950.73650.95
3204854-20485449.76549.98
4205904-20590450.02050.23
5204214-20421449.61049.81
6205807-20580749.99750.21
60min1238085-23808557.83857.061.1158.1457.351.11
2237464-23746457.68757.99
3234394-23439456.94257.24
4234988-23498857.08657.38
5232822-23282256.56056.85
6231421-23142156.21956.51
90min1275818-27581867.00565.522.2067.4065.912.19
2272210-27221066.12866.52
3270249-27024965.65266.04
4271555-27155565.96966.36
5258411-25841162.77663.16
6270090-27009065.61366.00
120min1300827-30082773.08071.680.9773.5972.180.97
2293451-29345171.28871.79
3294158-29415871.46071.96
4294426-29442671.52572.02
5293764-29376471.36471.85
6293682-29368271.34471.84
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1315366-31536676.61275.191.0477.2475.811.04
2309923-30992375.29075.91
3306275-30627574.40475.02
4309904-30990475.28575.90
5307092-30709274.60275.21
6308600-30860074.96875.58
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