熊去氧胆酸口服混悬液项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号C092A240304对照品来源原料对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数50
标示量(mg)250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%
114.165407953985540445389453993539990.13
214.175399753647538220.46
单位质量响应值RSD%判断
3813.493798.310.29数据可信
加速3月-供试品溶液-2025121651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%
5min132509-3250961.50161.870.8961.5061.870.89
232652-3265261.77161.77
332266-3226661.04161.04
433044-3304462.51362.51
532810-3281062.07062.07
632942-3294262.32062.32
10min135726-3572667.58767.410.5668.2768.100.56
235405-3540566.97967.67
335387-3538766.94567.62
435720-3572067.57568.27
535890-3589067.89768.59
635661-3566167.46468.16
15min137167-3716770.31369.620.5871.7571.060.56
236795-3679569.60971.04
336746-3674669.51670.94
436884-3688469.77771.22
536614-3661469.26770.71
636594-3659469.22970.67
20min137107-3710770.19970.340.7372.4172.550.71
236976-3697669.95272.16
336971-3697169.94272.14
437434-3743470.81873.04
537597-3759771.12673.34
637003-3700370.00372.21
30min138246-3824672.35471.870.7475.3574.860.71
238242-3824272.34775.33
337924-3792471.74574.72
438085-3808572.05075.06
537940-3794071.77574.78
637498-3749870.93973.93
45min138557-3855772.94272.951.3276.7476.741.26
238326-3832672.50576.29
338274-3827472.40776.18
438507-3850772.84876.66
539550-3955074.82178.62
638164-3816472.19975.98
60min138542-3854272.91472.980.4477.5277.580.44
238765-3876573.33677.93
338393-3839372.63277.21
438589-3858973.00377.62
538781-3878173.36678.00
638402-3840272.64977.23
极限138912-3891273.61473.041.1579.0378.451.06
238610-3861073.04378.45
338835-3883573.46878.85
437730-3773071.37876.81
538784-3878473.37278.82
638772-3877273.34978.74
熊去氧胆酸口服混悬液项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号C092A240304对照品来源原料对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数50
标示量(mg)250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%
114.165385253795538565378553866538310.08
214.175398454102540430.16
单位质量响应值RSD%判断
3801.623813.900.23数据可信
加速3月-供试品溶液-2025121651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%
5min132068-3206860.63761.222.0060.6461.222.00
232737-3273761.90261.90
332378-3237861.22361.22
432555-3255561.55861.56
533210-3321062.79662.80
631307-3130759.19859.20
10min135165-3516566.49366.561.3967.1767.241.39
235496-3549667.11967.81
335344-3534466.83167.51
434933-3493366.05466.74
535833-3583367.75668.45
634424-3442465.09265.75
15min136222-3622268.49169.010.8069.9070.420.81
236675-3667569.34870.78
336406-3640668.83970.26
436714-3671469.42270.84
536832-3683269.64571.10
636116-3611668.29169.67
20min137410-3741070.73870.200.8272.9172.380.82
237225-3722570.38872.59
337020-3702070.00072.19
436870-3687069.71771.91
537485-3748570.88073.10
636730-3673069.45271.59
30min137525-3752570.95571.150.8973.9174.120.90
237638-3763871.16974.16
337783-3778371.44374.41
437433-3743370.78173.75
538182-3818272.19875.21
637212-3721270.36373.27
45min138323-3832372.46472.351.0176.2176.111.01
238330-3833072.47776.25
338018-3801871.88775.65
438553-3855372.89976.65
538720-3872073.21577.03
637643-3764371.17874.87
60min138790-3879073.34773.100.6377.9077.660.61
238390-3839072.59177.17
338940-3894073.63178.19
438421-3842172.64977.21
538877-3887773.51278.14
638525-3852572.84677.33
极限138724-3872473.22273.390.3378.5978.760.35
238752-3875273.27578.66
338722-3872273.21978.59
438867-3886773.49378.86
539045-3904573.82979.27
638753-3875373.27778.57
熊去氧胆酸口服混悬液项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号C092A240304对照品来源原料对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数50
标示量(mg)250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%
114.165385353968540365398454230540140.26
214.175432254169542460.20
单位质量响应值RSD%判断
3814.553828.230.26数据可信
-供试品溶液-2025121651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%
5min127888-2788852.54552.991.3752.5452.991.37
227992-2799252.74152.74
328185-2818553.10453.10
427589-2758951.98151.98
528439-2843953.58353.58
628651-2865153.98253.98
10min133063-3306362.29561.081.3262.8861.671.31
232186-3218660.64361.23
332644-3264461.50662.10
431971-3197160.23860.82
532612-3261261.44662.04
632026-3202660.34160.94
15min134251-3425164.53464.071.4665.8165.331.44
234573-3457365.14066.40
334424-3442464.86066.13
433274-3327462.69363.94
533766-3376663.62064.90
633727-3372763.54664.82
20min135002-3500265.94965.781.0167.9467.761.00
235089-3508966.11368.10
335332-3533266.57068.56
434349-3434964.71866.66
534654-3465465.29367.28
635037-3503766.01567.99
30min136250-3625068.30067.751.4071.0370.461.38
236218-3621868.24070.96
336416-3641668.61371.35
435054-3505466.04768.71
535728-3572867.31670.03
636089-3608967.99770.71
45min137139-3713969.97569.181.2173.4672.641.20
237116-3711669.93273.41
336988-3698869.69073.19
436058-3605867.93871.33
536350-3635068.48871.95
636642-3664269.03972.50
60min136876-3687669.47969.141.2473.7473.371.23
237122-3712269.94374.20
337026-3702669.76274.03
435910-3591067.65971.81
536424-3642468.62872.85
636817-3681769.36873.60
极限137109-3710969.91869.411.7174.9574.411.66
237478-3747870.61475.64
337406-3740670.47875.52
435848-3584867.54372.45
536417-3641768.61573.60
636774-3677469.28774.29
熊去氧胆酸口服混悬液项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号C092A240304对照品来源原料对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数50
标示量(mg)250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%
114.165362153614538385371353686536940.17
214.175365753294534760.48
单位质量响应值RSD%判断
3791.953773.890.34数据可信
-供试品溶液-2025121651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%
5min126494-2649450.42650.512.7050.4350.512.70
227326-2732652.01052.01
325498-2549848.53048.53
426998-2699851.38551.39
525897-2589749.29049.29
627011-2701151.41051.41
10min131119-3111959.22959.151.1959.7959.721.21
231597-3159760.13960.72
330541-3054158.12958.67
431209-3120959.40059.97
530790-3079058.60359.15
631220-3122059.42159.99
15min132991-3299162.79263.121.9564.0164.341.95
233947-3394764.61165.86
332212-3221261.30962.49
433696-3369664.13465.36
532727-3272762.28963.49
633412-3341263.59364.82
20min134341-3434165.36165.301.5267.2867.221.53
234910-3491066.44468.41
333454-3345463.67365.54
434700-3470066.04567.99
534008-3400864.72866.62
634424-3442465.51967.46
30min135548-3554867.65967.730.9570.3070.380.97
235772-3577268.08570.79
334989-3498966.59569.17
436005-3600568.52871.21
535610-3561067.77770.39
635604-3560467.76570.43
45min135719-3571967.98469.141.7071.3872.541.68
237407-3740771.19774.66
335807-3580768.15271.47
436543-3654369.55272.99
536381-3638169.24472.61
636111-3611168.73072.15
60min136449-3644969.37369.450.4473.5273.620.49
236603-3660369.66773.92
336191-3619168.88272.95
436545-3654569.55673.77
536541-3654169.54973.68
636615-3661569.68973.87
极限136592-3659269.64670.130.8374.5775.060.86
237280-3728070.95575.98
336487-3648769.44674.28
437103-3710370.61875.60
536720-3672069.88974.79
636884-3688470.20175.16
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