多替诺雷片项目信息
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D241101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(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
1 10.163266032913327833287132646327750.37
2 10.243285432774328140.18
单位质量响应值RSD%判断
3225.893204.490.48数据可信
供试品溶液-2025042721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%
5min129286-2928681.72577.3710.8781.7277.3710.87
221660-2166060.44460.44
327982-2798278.08678.09
429257-2925781.64481.64
528968-2896880.83780.84
629201-2920181.48781.49
10min133466-3346693.38990.924.5693.5391.054.57
229639-2963982.71082.81
332798-3279891.52591.66
433079-3307992.30992.45
532826-3282691.60391.74
633682-3368293.99294.13
15min134363-3436395.89293.962.9396.1894.242.94
231846-3184688.86889.11
333603-3360393.77194.05
434074-3407495.08695.38
533552-3355293.62993.92
634596-3459696.54296.83
20min134431-3443196.08295.561.9296.5396.001.94
233047-3304792.22092.61
334033-3403394.97195.41
434748-3474896.96797.42
534353-3435395.86496.31
634858-3485897.27497.73
30min134647-3464796.68596.581.6497.3097.171.65
233686-3368694.00394.54
334300-3430095.71696.31
434987-3498797.63498.24
534716-3471696.87797.48
635311-3531198.53899.15
45min134935-3493597.48897.772.0898.2698.532.09
233979-3397994.82195.52
334638-3463896.66097.42
436119-36119100.792101.57
535083-3508397.90198.67
635456-3545698.94299.72
60min135021-3502197.72897.921.4998.6698.841.50
234330-3433095.80096.66
334653-3465396.70297.62
435633-3563399.436100.38
535311-3531198.53899.47
635579-3557999.286100.23
极限135754-3575499.774100.550.93100.87101.640.94
235739-3573999.732100.75
336393-36393101.557102.64
436257-36257101.178102.28
535700-3570099.623100.72
636352-36352101.443102.55
多替诺雷片项目信息
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D241101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(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
1 10.163343533119330873290933053331210.59
2 10.243276832641327040.28
单位质量响应值RSD%判断
3259.943193.751.46数据可信
供试品溶液-2025042721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%
5min126561-2656173.85974.5311.6273.8674.5311.62
229042-2904280.75880.76
321731-2173160.42860.43
424711-2471168.71568.72
529351-2935181.61881.62
629415-2941581.79681.80
10min132516-3251690.41989.896.4590.5490.026.46
233224-3322492.38892.52
328141-2814178.25378.35
433052-3305291.90992.02
533488-3348893.12293.26
633544-3354493.27793.41
15min134950-3495097.18793.884.4397.4694.164.44
234077-3407794.76095.05
330780-3078085.59185.82
434155-3415594.97695.24
534304-3430495.39195.68
634308-3430895.40295.69
20min134222-3422295.16394.553.0295.6094.983.03
234201-3420195.10495.55
331942-3194288.82389.20
434461-3446195.82796.25
534497-3449795.92796.38
634685-3468596.45096.90
30min134924-3492497.11595.912.7097.7196.502.71
234406-3440695.67496.28
332698-3269890.92591.45
434786-3478696.73197.32
534778-3477896.70997.32
635349-3534998.29798.91
45min134853-3485396.91796.542.1697.6797.292.18
234639-3463996.32297.09
333300-3330092.59993.27
434975-3497597.25798.00
535052-3505297.47198.24
635490-3549098.68999.46
60min135085-3508597.56397.122.0498.4898.022.06
234925-3492597.11898.04
333560-3356093.32294.15
435143-3514397.72498.63
535202-3520297.88898.82
635636-3563699.095100.03
极限135577-3557798.93199.270.46100.01100.340.48
235627-3562799.070100.16
335518-3551898.76799.75
435962-35962100.001101.07
535709-3570999.298100.39
635810-3581099.579100.68
多替诺雷片项目信息
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D241101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(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
1 10.166553665522654886548065482655020.04
2 10.246603565971660030.07
单位质量响应值RSD%判断
6447.056445.610.02数据可信
供试品溶液-2025042722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%
5min158126-5812680.90175.884.5580.9075.884.55
253434-5343474.37074.37
350815-5081570.72570.73
454574-5457475.95775.96
554042-5404275.21775.22
656115-5611578.10278.10
10min165514-6551491.18390.651.2491.3290.781.24
264449-6444989.70189.83
364681-6468190.02490.14
466588-6658892.67892.80
564658-6465889.99290.12
664883-6488390.30590.44
15min168319-6831995.08794.151.3595.3794.431.35
267271-6727193.62993.90
367568-6756894.04294.31
468804-6880495.76396.04
566168-6616892.09492.37
667747-6774794.29194.57
20min169538-6953896.78495.431.2897.2395.861.28
268407-6840795.21095.64
368837-6883795.80896.23
469226-6922696.35096.79
567048-6704893.31893.75
668331-6833195.10495.54
30min170210-7021097.71996.451.2098.3397.041.20
269128-6912896.21396.80
369682-6968296.98597.57
470024-7002497.46198.06
568084-6808494.76095.34
668658-6865895.55996.16
45min170354-7035497.92096.871.1598.6997.631.15
269441-6944196.64997.40
369857-6985797.22897.97
470506-7050698.13198.90
568431-6843195.24395.99
669025-6902596.07096.83
60min170438-7043898.03796.991.1598.9797.911.15
269530-6953096.77397.68
369764-6976497.09998.01
470682-7068298.37699.30
568539-6853995.39496.29
669172-6917296.27597.19
极限170773-7077398.50397.591.0399.6098.661.03
269707-6970797.01998.09
370263-7026397.79398.86
471114-7111498.978100.07
569431-6943196.63597.70
669396-6939696.58697.66
多替诺雷片项目信息
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D241101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(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
1 10.166523165201652466516465160652000.06
2 10.246671966715667170.01
单位质量响应值RSD%判断
6417.326515.331.08数据可信
供试品溶液-2025042722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%
5min154223-5422375.23972.2311.7575.2472.2311.75
255337-5533776.78576.79
354905-5490576.18676.19
456016-5601677.72777.73
539903-3990355.36955.37
651935-5193572.06572.06
10min166022-6602291.61288.355.5091.7488.475.51
265484-6548490.86590.99
362778-6277887.11087.24
465925-6592591.47791.61
556948-5694879.02179.11
664855-6485589.99290.11
15min167372-6737293.48592.473.1393.7692.733.15
267338-6733893.43893.72
365713-6571391.18391.45
468136-6813694.54594.83
562841-6284187.19887.42
668426-6842694.94795.22
20min167726-6772693.97693.852.5294.4194.282.53
268106-6810694.50394.94
366519-6651992.30192.73
468992-6899295.73396.17
564910-6491090.06990.44
669566-6956696.52996.96
30min168439-6843994.96595.341.3195.5695.921.32
268886-6888695.58696.18
367423-6742393.55694.13
469558-6955896.51897.12
568126-6812694.53195.05
669816-6981696.87697.47
45min169038-6903895.79696.221.1696.5596.961.15
269209-6920996.03496.79
367964-6796494.30695.04
470119-7011997.29698.06
569730-6973096.75797.43
670007-7000797.14197.89
60min168961-6896195.69096.410.7896.6097.310.77
269477-6947796.40697.32
368747-6874795.39396.28
470092-7009297.25998.18
569655-6965596.65397.49
669955-6995597.06997.98
极限169976-6997697.09897.870.7198.1798.930.70
271361-7136199.020100.09
370264-7026497.49898.55
470648-7064898.03199.11
570746-7074698.16699.17
670201-7020197.41098.48
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