多替诺雷非布司他片项目信息
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101278-202405对照品来源中检所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250
标示量(mg)40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%
110.933458734398347683468034423345710.47
211.093525835633354460.75
单位质量响应值RSD%判断
3162.953196.210.74数据可信
供试品溶液-J187N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%
5min126537-2653775.04271.724.9375.0471.724.93
226037-2603773.62873.63
324840-2484070.24370.24
426719-2671975.55675.56
523664-2366466.91766.92
624375-2437568.92868.93
10min132743-3274392.59191.101.4092.7291.221.41
232427-3242791.69791.82
331717-3171789.69089.81
432661-3266192.35992.49
531797-3179789.91690.03
631950-3195090.34990.46
15min133581-3358194.96194.291.5995.2494.561.59
233564-3356494.91395.19
332653-3265392.33692.60
433810-3381095.60895.89
532691-3269192.44492.71
633755-3375595.45395.72
20min133846-3384695.71095.521.4096.1595.951.40
233728-3372895.37695.81
332876-3287692.96793.39
434099-3409996.42596.86
533956-3395696.02196.44
634172-3417296.63297.06
30min133909-3390995.88895.921.2996.4996.511.29
233887-3388795.82696.42
333270-3327094.08194.66
434333-3433397.08797.69
533671-3367195.21595.79
634459-3445997.44498.03
45min134516-3451697.60596.701.4098.3697.451.39
234238-3423896.81997.57
333290-3329094.13894.87
434420-3442097.33398.09
534131-3413196.51697.25
634586-3458697.80398.55
60min134629-3462997.92496.921.1798.8497.831.17
234276-3427696.92697.84
333598-3359895.00995.90
434390-3439097.24898.17
534074-3407496.35597.25
634681-3468198.07198.98
90min134418-3441897.32897.061.1198.4198.131.10
234301-3430196.99798.07
333714-3371495.33796.38
434326-3432697.06798.15
534906-3490698.70899.76
634275-3427596.92398.00
极限134341-3434197.11096.801.2998.3598.041.28
234651-3465197.98699.22
333627-3362795.09196.30
434756-3475698.28399.53
533869-3386995.77597.00
634150-3415096.57097.81
多替诺雷非布司他片项目信息
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101278-202405对照品来源中检所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250
标示量(mg)40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%
110.937042971030704457088870172705930.51
211.097046670572705190.11
单位质量响应值RSD%判断
6458.656358.791.11数据可信
供试品溶液-J057M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%
5min146232-4623264.86467.014.5364.8667.014.53
247310-4731066.37766.38
345044-4504463.19863.20
447723-4772366.95666.96
549074-4907468.85268.85
651187-5118771.81671.82
10min162384-6238487.52687.302.7087.6387.412.70
260777-6077785.27185.38
360122-6012284.35284.46
462341-6234187.46687.58
562814-6281488.12988.24
664891-6489191.04391.16
15min165575-6557592.00391.891.7592.2692.151.75
265546-6554691.96292.21
363596-6359689.22689.47
465741-6574192.23692.49
565342-6534291.67691.94
667178-6717894.25294.52
20min166870-6687093.82093.401.9294.2393.811.92
266545-6654593.36493.77
364273-6427390.17690.57
467278-6727894.39294.80
566386-6638693.14193.56
668069-6806995.50295.93
30min167314-6731494.44394.001.7495.0194.571.74
267225-6722594.31894.88
364996-6499691.19191.74
468022-6802295.43696.00
566377-6637793.12893.70
668072-6807295.50696.09
45min167554-6755494.77994.451.5095.5095.171.50
267230-6723094.32595.04
365583-6558392.01492.71
468369-6836995.92396.65
566982-6698293.97794.70
668199-6819995.68496.43
60min167828-6782895.16494.521.6896.0495.401.68
267713-6771395.00395.88
365382-6538291.73292.58
468006-6800695.41496.30
566765-6676593.67294.55
668516-6851696.12997.04
90min168870-6887096.62694.881.7697.6695.921.76
267268-6726894.37895.41
365779-6577992.28993.29
468218-6821895.71196.76
566933-6693393.90894.95
668690-6869096.37397.44
极限168178-6817895.65595.680.4996.8596.870.50
268088-6808895.52996.72
367983-6798395.38196.54
468676-6867696.35497.56
567768-6776895.08096.27
668470-6847096.06597.29
多替诺雷非布司他片项目信息
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101278-202405对照品来源中检所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250
标示量(mg)40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%
110.932720372723792725012728242734282726340.20
211.092774632777522776080.08
单位质量响应值RSD%判断
24943.6425032.280.26数据可信
供试品溶液-3788B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%
5min1171949-17194961.87061.7214.5361.8761.7214.54
2123519-12351944.44444.44
3183088-18308865.87865.88
4179371-17937164.54064.54
5195812-19581270.45670.46
6175491-17549163.14463.14
10min1236281-23628185.01785.562.1785.1285.672.19
2228486-22848682.21382.29
3241123-24112386.76086.87
4241523-24152386.90387.01
5242140-24214087.12587.24
6237236-23723685.36185.47
15min1256850-25685092.41892.541.5392.6692.791.54
2254582-25458291.60291.81
3257630-25763092.69992.95
4259842-25984293.49593.75
5262749-26274994.54194.80
6251542-25154290.50890.76
20min1265982-26598295.70494.701.1496.1095.091.14
2261539-26153994.10594.47
3263450-26345094.79395.20
4266656-26665695.94796.35
5262966-26296694.61995.04
6258482-25848293.00693.40
30min1267660-26766096.30895.610.6196.8796.170.59
2267386-26738696.20996.73
3265278-26527895.45196.02
4264277-26427795.09195.66
5263740-26374094.89795.48
6266018-26601895.71796.27
45min1273316-27331698.34396.721.3499.0697.441.33
2269755-26975597.06297.74
3267528-26752896.26096.99
4268417-26841796.58097.31
5271061-27106197.53298.27
6262811-26281194.56395.28
60min1272759-27275998.14396.171.4699.0397.051.46
2265013-26501395.35596.20
3266803-26680396.00096.89
4264170-26417095.05295.94
5271367-27136797.64298.54
6263531-26353194.82295.69
90min1270598-27059897.36595.781.2298.4196.821.21
2264172-26417295.05396.05
3266631-26663195.93896.98
4268996-26899696.78997.83
5264899-26489995.31496.38
6261839-26183994.21395.24
极限1264552-26455295.19095.170.8896.4096.370.88
2263954-26395494.97496.13
3268078-26807896.45897.66
4262285-26228594.37495.58
5266172-26617295.77396.99
6261998-26199894.27195.46
多替诺雷非布司他片项目信息
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101278-202405对照品来源中检所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250
标示量(mg)40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%
110.935322265347015344155357785363505346940.30
211.095454725458735456720.06
单位质量响应值RSD%判断
48919.8549203.970.41数据可信
供试品溶液-4229B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%
5min1331426-33142660.73759.5410.2060.7459.5410.20
2348029-34802963.78063.78
3322310-32231059.06659.07
4262117-26211748.03648.04
5355428-35542865.13665.14
6330087-33008760.49260.49
10min1475756-47575687.18784.523.6487.2984.623.65
2476179-47617987.26487.37
3460926-46092684.46984.57
4430357-43035778.86778.95
5464883-46488385.19485.30
6459191-45919184.15184.25
15min1513984-51398494.19392.161.7394.4492.401.74
2511875-51187593.80694.06
3500446-50044691.71291.95
4491144-49114490.00790.22
5497559-49755991.18391.43
6502425-50242592.07492.32
20min1523809-52380995.99394.761.8396.4095.161.84
2531554-53155497.41297.82
3510907-51090793.62994.02
4505310-50531092.60392.96
5513499-51349994.10494.51
6517529-51752994.84295.24
30min1530486-53048697.21796.191.9597.7896.751.95
2542214-54221499.36699.94
3520987-52098795.47696.02
4516446-51644694.64495.16
5514846-51484694.35194.91
6524471-52447196.11496.67
45min1528631-52863196.87796.741.8397.6097.461.83
2543055-54305599.520100.26
3516822-51682294.71395.42
4527293-52729396.63297.31
5518597-51859795.03895.75
6532995-53299597.67798.39
60min1527145-52714596.60496.101.2697.4996.971.26
2531705-53170597.44098.34
3514001-51400194.19695.06
4525885-52588596.37497.21
5519038-51903895.11995.99
6528455-52845596.84597.72
90min1533366-53336697.74596.151.5898.7997.181.58
2535108-53510898.06499.13
3517363-51736394.81295.83
4519567-51956795.21696.21
5516138-51613894.58795.62
6526412-52641296.47097.51
极限1527388-52738896.64996.181.4497.8697.381.44
2534896-53489698.02599.25
3520638-52063895.41296.59
4526805-52680596.54297.70
5512497-51249793.92095.11
6526822-52682296.54597.74
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