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101242-201201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(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
116.457896777902867900217895837900087899150.04
216.527980107981217980660.01
单位质量响应值RSD%判断
48019.1548309.080.43数据可信
供试品溶液-4D88SDA1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%
5min179010-790109.8439.435.199.849.435.17
280194-801949.9909.99
376558-765589.5379.54
474851-748519.3259.32
569158-691588.6158.62
674482-744829.2799.28
10min1150921-15092118.80118.742.4318.8218.762.43
2153883-15388319.17019.19
3152793-15279319.03419.05
4151772-15177218.90718.92
5143630-14363017.89317.91
6149495-14949518.62318.64
15min1207636-20763625.86625.892.2425.9125.942.23
2208220-20822025.93925.99
3215723-21572326.87426.92
4208100-20810025.92425.97
5201439-20143925.09425.14
6205844-20584425.64325.69
20min1250873-25087331.25331.051.1031.3431.141.09
2250555-25055531.21331.30
3251697-25169731.35531.45
4248758-24875830.98931.08
5244115-24411530.41130.50
6249389-24938931.06831.16
30min1306178-30617838.14238.060.5338.2938.200.54
2304440-30444037.92638.07
3306561-30656138.19038.33
4306455-30645538.17738.32
5302759-30275937.71637.85
6306864-30686438.22838.37
45min1360330-36033044.88844.870.4945.0945.080.50
2361777-36177745.06845.28
3359008-35900844.72344.93
4359792-35979244.82145.03
5357695-35769544.56044.76
6362457-36245745.15345.36
60min1397270-39727049.49049.580.4649.7749.860.46
2395929-39592949.32349.61
3398994-39899449.70549.99
4396785-39678549.43049.71
5397819-39781949.55849.83
6401023-40102349.95850.24
90min1429750-42975053.53654.190.7853.9054.550.77
2437040-43704054.44454.81
3432316-43231653.85654.22
4434919-43491954.18054.54
5437292-43729254.47654.83
6438488-43848854.62554.99
120min1455650-45565056.76357.380.7057.2257.840.70
2462476-46247657.61358.07
3459934-45993457.29657.75
4458565-45856557.12657.58
5462907-46290757.66758.11
6464328-46432857.84458.30
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
180min1470667-47066758.63359.751.4259.1860.301.41
2482006-48200660.04660.60
3473214-47321458.95159.50
4483913-48391360.28460.83
5479177-47917759.69460.24
6488790-48879060.89161.44
240min1459393-45939357.22960.002.3257.8760.642.31
2489788-48978861.01561.67
3485345-48534560.46261.11
4488102-48810260.80561.45
5483322-48332260.21060.85
6483790-48379060.26860.92
300min1497618-49761861.99161.551.3462.7362.291.32
2499708-49970862.25163.00
3485114-48511460.43361.18
4497568-49756861.98562.73
5498203-49820362.06462.81
6486123-48612360.55961.31
360min1502198-50219862.56161.671.6963.4162.521.67
2498043-49804362.04462.90
3478910-47891059.66060.51
4500357-50035762.33263.19
5495108-49510861.67862.52
6495617-49561761.74262.60
极限1493917-49391761.53061.960.7162.4862.920.71
2500515-50051562.35263.31
3494124-49412461.55662.51
4499452-49945262.21963.18
5494804-49480461.64062.59
6501633-50163362.49163.45
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101242-201201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(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
116.457953427946647951877948247946567949350.04
216.528006478001978004220.04
单位质量响应值RSD%判断
48324.3248451.690.19数据可信
供试品溶液-4D88SDA1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%
5min177090-770909.5599.255.289.569.255.27
273246-732469.0829.08
376317-763179.4639.46
473071-730719.0619.06
568281-682818.4678.47
679521-795219.8609.86
10min1154226-15422619.12418.702.5419.1418.722.55
2149622-14962218.55318.57
3153197-15319718.99619.01
4154519-15451919.16019.18
5144898-14489817.96717.98
6148411-14841118.40318.42
15min1211256-21125626.19525.492.0826.2425.542.07
2204890-20489025.40625.45
3210480-21048026.09926.15
4203481-20348125.23125.28
5202295-20229525.08425.13
6201227-20122724.95225.00
20min1255617-25561731.69630.692.5131.7930.782.51
2243020-24302030.13430.22
3253325-25332531.41231.50
4247232-24723230.65630.75
5246747-24674730.59630.68
6239057-23905729.64329.73
30min1319336-31933639.59738.182.1539.7438.322.15
2304191-30419137.71937.86
3311675-31167538.64738.79
4306241-30624137.97338.11
5304889-30488937.80637.94
6300972-30097237.32037.46
45min1366134-36613445.40044.751.2845.6144.951.28
2356088-35608844.15444.36
3366584-36658445.45645.66
4360534-36053444.70544.91
5359862-35986244.62244.82
6356155-35615544.16244.36
60min1399856-39985649.58149.361.1049.8749.641.10
2393004-39300448.73249.01
3404788-40478850.19350.48
4398514-39851449.41549.69
5398723-39872349.44149.72
6393570-39357048.80249.08
90min1433482-43348253.75153.971.1354.1254.341.13
2428411-42841153.12253.48
3442830-44283054.91055.28
4436095-43609554.07554.44
5437804-43780454.28754.64
6433035-43303553.69554.05
120min1463863-46386357.51856.891.7257.9857.341.72
2449861-44986155.78256.23
3467579-46757957.97958.44
4464663-46466357.61758.07
5457506-45750656.73057.18
6449280-44928055.71056.15
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
180min1476867-47686759.13059.291.3559.6859.831.34
2475271-47527158.93359.47
3486008-48600860.26460.82
4484725-48472560.10560.65
5468632-46863258.10958.65
6477230-47723059.17659.71
240min1472530-47253058.59360.152.3459.2560.802.31
2490978-49097860.88061.52
3493945-49394561.24861.90
4494556-49455661.32461.97
5468958-46895858.15058.79
6489676-48967660.71961.35
300min1496968-49696861.62361.211.9462.3761.961.93
2486780-48678060.36061.10
3504736-50473662.58663.34
4495476-49547661.43862.19
5499621-49962161.95262.69
6478281-47828159.30660.04
360min1502080-50208062.25761.002.0263.1161.842.00
2490750-49075060.85261.69
3493635-49363561.21062.07
4503467-50346762.42963.28
5480363-48036359.56460.40
6481144-48114459.66160.50
极限1502970-50297062.36761.411.5963.3262.361.57
2497301-49730161.66462.60
3482403-48240359.81760.78
4503152-50315262.39063.35
5494715-49471561.34462.28
6491187-49118760.90661.84
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