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%
114.105478954685548545440554561546590.33
214.145515654943550500.28
单位质量响应值RSD%判断
3876.523893.210.31数据可信
中间条件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%
5min131324-3132457.82256.821.7457.8256.821.74
230592-3059256.47156.47
330277-3027755.89055.89
431139-3113957.48157.48
531270-3127057.72357.72
630087-3008755.53955.54
10min134864-3486464.35762.711.5064.6863.031.50
233566-3356661.96162.27
333645-3364562.10762.42
434126-3412662.99563.31
534091-3409162.93063.25
633551-3355161.93362.24
15min136484-3648467.34765.611.8268.0366.271.82
235422-3542265.38766.04
335048-3504864.69765.35
435588-3558865.69366.36
536018-3601866.48767.16
634698-3469864.05064.70
20min137186-3718668.64367.521.3469.7068.551.35
236355-3635567.10968.13
335975-3597566.40867.42
436855-3685568.03269.07
536960-3696068.22669.27
636142-3614266.71667.72
30min138293-3829370.68769.001.8872.1270.401.86
236839-3683968.00369.40
336535-3653567.44168.83
438009-3800970.16271.57
537616-3761669.43770.86
636986-3698668.27469.65
45min138925-3892571.85370.601.3473.6872.391.34
237665-3766569.52771.30
337894-3789469.95071.71
438471-3847171.01572.82
538668-3866871.37973.18
637864-3786469.89571.65
60min139403-3940372.73671.711.6174.9673.891.60
238576-3857671.20973.37
338189-3818970.49572.64
439784-3978473.43975.64
538760-3876071.54973.75
638366-3836670.82172.97
极限139653-3965373.19772.320.9975.8374.900.99
238862-3886271.73774.29
338592-3859271.23973.78
439315-3931572.57375.18
539236-3923672.42775.03
639396-3939672.72375.26
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%
114.105485554753549465526354777549190.38
214.145538655159552720.30
单位质量响应值RSD%判断
3894.963908.910.26数据可信
中间条件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%
5min131477-3147757.85058.002.2357.8558.002.23
231458-3145857.81557.82
330669-3066956.36556.37
432143-3214359.07459.07
532581-3258159.87959.88
631029-3102957.02757.03
10min134869-3486964.08463.861.5264.4164.181.52
234878-3487864.10164.42
333884-3388462.27462.59
434764-3476463.89164.22
535504-3550465.25165.58
634571-3457163.53763.85
15min136089-3608966.32766.101.0167.0066.781.01
236391-3639166.88267.56
335633-3563365.48966.15
436179-3617966.49267.18
536061-3606166.27566.97
635431-3543165.11765.79
20min136862-3686267.74767.751.3068.7968.791.30
237261-3726168.48169.53
336484-3648467.05368.08
437199-3719968.36769.42
537255-3725568.47069.53
636107-3610766.36067.39
30min137403-3740368.74269.481.0670.1670.901.05
237733-3773369.34870.78
337297-3729768.54769.94
437969-3796969.78271.21
538147-3814770.10971.55
638282-3828270.35771.76
45min138036-3803669.90570.121.4671.7171.931.45
239030-3903071.73273.55
337569-3756969.04770.82
438558-3855870.86472.68
538091-3809170.00671.84
637647-3764769.19070.98
60min138267-3826770.32970.570.6172.5272.760.61
238712-3871271.14773.36
338258-3825870.31372.47
438536-3853670.82473.04
538523-3852370.80073.02
638088-3808870.00072.18
极限138516-3851670.78771.030.8373.3773.620.83
238825-3882571.35573.96
338276-3827670.34672.90
439024-3902471.72174.33
538924-3892471.53774.15
638327-3832770.44073.00
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%
114.105523254959550575498355223550910.24
214.145526155227552440.05
单位质量响应值RSD%判断
3907.163906.930.01数据可信
中间条件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%
5min134412-3441263.16263.491.6063.1663.491.60
233782-3378262.00562.01
334183-3418362.74162.74
435121-3512164.46364.46
535074-3507464.37764.38
634977-3497764.19964.20
10min136716-3671667.39067.381.1567.7467.741.15
236465-3646566.93067.27
336085-3608566.23266.58
436702-3670267.36567.72
537291-3729168.44668.80
637018-3701867.94568.30
15min137419-3741968.68169.301.1169.4170.031.10
237522-3752268.87069.59
337331-3733168.51969.24
438127-3812769.98070.71
537781-3778169.34570.08
638375-3837570.43571.17
20min138247-3824770.20170.111.2171.3171.221.21
238216-3821670.14471.24
337321-3732168.50169.60
438278-3827870.25771.38
538460-3846070.59271.71
638666-3866670.97072.10
30min138549-3854970.75570.950.8772.2572.460.87
238233-3823370.17571.66
338431-3843170.53872.02
438825-3882571.26172.77
538721-3872171.07172.59
639188-3918871.92873.45
45min139180-3918071.91371.820.8973.8073.710.88
239083-3908371.73573.61
338555-3855570.76672.64
439639-3963972.75674.66
539210-3921071.96873.88
639093-3909371.75373.67
60min139559-3955972.60972.110.9874.9074.410.97
238954-3895471.49873.78
338830-3883071.27173.53
439414-3941472.34374.65
539838-3983873.12175.43
639136-3913671.83274.15
极限139461-3946172.42972.480.4875.1275.180.49
239347-3934772.22074.89
339272-3927272.08274.74
439450-3945072.40975.12
539647-3964772.77075.49
639772-3977273.00075.72
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%
114.105568255747553245554955497555600.30
214.145545755597555270.18
单位质量响应值RSD%判断
3940.433926.940.25数据可信
中间条件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%
5min130744-3074456.04757.131.3556.0557.131.35
231960-3196058.26458.26
330998-3099856.51056.51
431496-3149657.41857.42
531429-3142957.29657.30
631410-3141057.26157.26
10min132352-3235258.97959.670.9459.2959.990.93
232878-3287859.93860.26
333213-3321360.54860.86
432767-3276759.73560.05
532697-3269759.60859.93
632479-3247959.21059.53
15min132641-3264159.50559.970.6360.1460.620.64
233150-3315060.43361.09
332835-3283559.85960.51
433136-3313660.40861.06
532875-3287559.93260.58
632745-3274559.69560.34
20min133209-3320960.54160.570.7661.5161.550.75
233637-3363761.32162.31
332875-3287559.93260.91
433139-3313960.41361.40
533181-3318160.49061.47
633320-3332060.74361.72
30min134369-3436962.65661.551.0163.9662.860.98
233949-3394961.89063.22
333513-3351361.09562.41
433602-3360261.25762.58
533521-3352161.11062.43
633607-3360761.26762.58
45min133468-3346861.01361.300.2762.6762.960.27
233673-3367361.38763.06
333609-3360961.27062.93
433734-3373461.49863.16
533658-3365861.36063.02
633623-3362361.29662.95
60min133682-3368261.40361.310.7163.4063.310.69
233893-3389361.78863.81
333320-3332060.74362.74
433438-3343860.95862.96
533889-3388961.78163.78
633548-3354861.15963.16
极限133584-3358461.22561.280.6063.5663.630.57
233337-3333760.77463.14
333455-3345560.98963.32
433704-3370461.44363.79
533733-3373361.49663.84
633885-3388561.77364.11
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