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)5补液体积(ml)5
对照品批号110755-202306对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6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%
114.105512855632551705507855356552730.42
214.145553855818556780.36
单位质量响应值RSD%判断
3920.073937.620.32数据可信
加速3月-供试品溶液-2025121551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%
5min130737-3073756.10454.614.6856.1054.614.67
230415-3041555.51655.52
330119-3011954.97654.98
427096-2709649.45849.46
530589-3058955.83355.83
630546-3054655.75555.75
10min134022-3402262.10061.561.1362.4161.861.14
233990-3399062.04162.35
333263-3326360.71461.02
433284-3328460.75361.03
534121-3412162.28062.59
633682-3368261.47961.79
15min135466-3546664.73563.891.0965.3964.541.10
235169-3516964.19364.85
334775-3477563.47464.12
434371-3437162.73763.35
535150-3515064.15864.81
635089-3508964.04764.70
20min136116-3611665.92265.800.5366.9466.800.55
236148-3614865.98066.99
335984-3598465.68166.68
435763-3576365.27766.24
536321-3632166.29667.31
635968-3596865.65266.66
30min137169-3716967.84467.441.0869.2368.801.08
237268-3726868.02469.40
337325-3732568.12869.49
436277-3627766.21667.54
536888-3688867.33168.71
636746-3674667.07268.44
45min138003-3800369.36668.830.9571.1370.580.96
238211-3821169.74671.50
337524-3752468.49270.23
437198-3719867.89769.59
537635-3763568.69470.45
637699-3769968.81170.56
60min138158-3815869.64969.460.9471.7971.580.94
238571-3857170.40372.54
338192-3819269.71171.83
437489-3748968.42870.50
537919-3791969.21371.35
637988-3798869.33971.47
极限138590-3859070.43770.170.7472.9772.680.76
238813-3881370.84473.38
338575-3857570.41072.92
438003-3800369.36671.81
538432-3843270.14972.67
638259-3825969.83372.35
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)5补液体积(ml)5
对照品批号110755-202306对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6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%
114.105554055460554875553755434554920.09
214.145594055966559530.04
单位质量响应值RSD%判断
3935.603957.070.39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%
5min126850-2685048.79249.723.1248.7949.723.12
227736-2773650.40250.40
328648-2864852.05952.06
426342-2634247.86847.87
526785-2678548.67348.67
627800-2780050.51850.52
10min130747-3074755.87356.881.8856.1457.161.89
231677-3167757.56357.84
332086-3208658.30658.60
430810-3081055.98856.25
530796-3079655.96256.23
631693-3169357.59257.87
15min132747-3274759.50860.401.5260.0961.001.53
233393-3339360.68161.28
333897-3389761.59762.21
432880-3288059.74960.33
532786-3278659.57860.16
633731-3373161.29661.90
20min133511-3351160.89662.711.8261.8163.641.80
234327-3432762.37963.32
334912-3491263.44264.40
435033-3503363.66264.57
534150-3415062.05762.97
635111-3511163.80364.74
30min135274-3527464.10064.681.0365.3565.961.03
235288-3528864.12565.41
335801-3580165.05766.37
435522-3552264.55065.81
535461-3546164.43965.70
636227-3622765.83167.13
45min136579-3657966.47166.921.0168.0868.561.01
236419-3641966.18067.82
336835-3683566.93668.61
436705-3670566.70068.32
536934-3693467.11668.73
637483-3748368.11469.78
60min137000-3700067.23668.351.8269.2170.361.77
236865-3686566.99169.00
337562-3756268.25770.30
438707-3870770.33872.33
537519-3751968.17970.17
638031-3803169.11071.15
极限137896-3789668.86468.971.0471.2171.351.03
237458-3745868.06870.45
337957-3795768.97571.40
437803-3780368.69571.08
537940-3794068.94471.31
638658-3865870.24972.67
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)5补液体积(ml)5
对照品批号110755-202306对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6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%
114.105541955503556585559255468555280.18
214.145538755660555240.35
单位质量响应值RSD%判断
3938.163926.730.21数据可信
加速3月-供试品溶液-2025121851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%
5min133722-3372261.49661.541.1761.5061.541.17
233078-3307860.32160.32
333807-3380761.65161.65
433670-3367061.40161.40
534285-3428562.52262.52
633919-3391961.85561.85
10min135883-3588365.43665.750.7765.7866.090.77
235617-3561764.95165.29
336145-3614565.91466.26
436028-3602865.70166.04
536337-3633766.26466.61
636324-3632466.24166.58
15min137346-3734668.10467.810.5068.8168.520.50
236955-3695567.39168.09
337182-3718267.80568.51
437103-3710367.66168.37
537455-3745568.30369.02
637081-3708167.62168.33
20min137758-3775868.85669.121.7169.9470.201.69
237477-3747768.34369.41
337494-3749468.37469.46
437609-3760968.58469.67
539179-3917971.44772.54
637904-3790469.12270.21
30min138253-3825369.75869.740.7871.2271.210.77
237668-3766868.69170.14
338345-3834569.92671.39
438328-3832869.89571.36
538507-3850770.22171.71
638371-3837169.97371.44
45min138703-3870370.57970.660.7072.4372.520.69
238853-3885370.85272.68
338277-3827769.80271.66
438763-3876370.68872.54
539106-3910671.31473.20
638778-3877870.71672.58
60min139065-3906571.23971.100.2673.4873.350.27
238813-3881370.77973.00
338933-3893370.99873.24
439069-3906971.24673.49
539045-3904571.20373.48
639015-3901571.14873.40
极限139171-3917171.43271.170.4874.0773.820.48
238713-3871370.59773.22
339241-3924171.56074.20
438939-3893971.00973.65
539061-3906171.23273.91
639038-3903871.19073.84
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)5补液体积(ml)5
对照品批号110755-202306对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6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%
114.105560155177555405531955368554010.31
214.145589756167560320.35
单位质量响应值RSD%判断
3929.153962.660.61数据可信
加速3月-供试品溶液-00637A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%
5min130931-3093156.21456.200.9356.2156.200.93
231084-3108456.49256.49
331114-3111456.54756.55
430601-3060155.61555.61
530558-3055855.53655.54
631256-3125656.80556.80
10min131860-3186057.90358.430.7558.2258.740.75
232379-3237958.84659.16
332046-3204658.24158.55
432432-3243258.94259.25
531922-3192258.01558.32
632252-3225258.61558.93
15min133083-3308360.12559.780.6160.7660.420.59
232864-3286459.72760.37
332695-3269559.42060.06
432872-3287259.74260.38
533163-3316360.27160.90
632678-3267859.38960.03
20min133163-3316360.27160.110.4761.2461.080.46
232943-3294359.87160.84
333324-3332460.56361.53
433087-3308760.13361.10
532917-3291759.82460.79
633010-3301059.99360.96
30min133281-3328160.48560.390.5661.7961.700.55
233072-3307260.10561.41
333446-3344660.78562.09
432953-3295359.88961.19
533266-3326660.45861.76
633363-3336360.63461.94
45min133685-3368561.21961.031.0362.8662.671.00
233827-3382761.47863.12
333669-3366961.19062.83
432915-3291559.82061.46
533833-3383361.48863.12
633556-3355660.98562.63
60min133650-3365061.15661.000.4063.1362.980.40
233721-3372161.28563.27
333668-3366861.18963.17
433499-3349960.88162.85
533441-3344160.77662.75
633400-3340060.70262.68
极限133431-3343160.75861.020.6263.0863.340.60
233802-3380261.43263.75
333812-3381261.45063.77
433622-3362261.10563.41
533306-3330660.53162.84
633478-3347860.84363.16
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