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对照品来源原料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%
114.005523255301553975505855280552540.23
214.025558455650556170.09
单位质量响应值RSD%判断
3946.713966.980.37数据可信
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%
5min119259-1925934.90438.519.1634.9038.509.16
219264-1926434.91334.91
321071-2107138.18838.19
420893-2089337.86637.87
522884-2288441.47441.47
624109-2410943.69443.69
10min121605-2160539.15642.558.1539.3542.768.15
221361-2136138.71438.91
323312-2331242.25042.46
423523-2352342.63242.84
524583-2458344.55344.78
626485-2648548.00048.24
15min123672-2367242.90246.427.2143.3146.877.22
223717-2371742.98443.39
325276-2527645.80946.26
425816-2581646.78847.24
526690-2669048.37248.85
628501-2850151.65452.16
20min125634-2563446.45849.596.3647.1150.306.38
225614-2561446.42247.07
327034-2703448.99549.70
427380-2738049.62350.33
528306-2830651.30152.05
630200-3020054.73355.53
30min127777-2777750.34253.425.5451.2554.405.57
227911-2791150.58551.49
329374-2937453.23654.21
429424-2942453.32754.31
530135-3013554.61655.65
632215-3221558.38559.49
45min130874-3087455.95557.643.5957.1458.923.67
230779-3077955.78356.97
331325-3132556.77258.04
431596-3159657.26358.54
532493-3249358.88960.22
633766-3376661.19662.62
60min132963-3296359.74161.232.6861.2462.832.77
232868-3286859.56961.07
333605-3360560.90562.49
433799-3379961.25662.85
534134-3413461.86363.53
635336-3533664.04265.81
极限135629-3562964.57365.471.4966.4067.411.60
235633-3563364.58066.41
336126-3612665.47367.40
435983-3598365.21467.15
536298-3629865.78567.79
637070-3707067.18469.30
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对照品来源原料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%
114.005553355546555785558055512555500.06
214.025544755508554780.08
单位质量响应值RSD%判断
3967.863957.060.20数据可信
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%
5min125270-2527045.73351.3913.0845.7351.3913.08
225365-2536545.90545.91
326370-2637047.72447.72
429158-2915852.77052.77
529127-2912752.71452.71
635083-3508363.49363.49
10min127781-2778150.27856.3410.2650.5356.6310.28
228335-2833551.28051.54
329836-2983653.99754.26
431794-3179457.54057.83
532673-3267359.13159.42
636373-3637365.82766.18
15min129645-2964553.65159.138.0354.1859.728.07
230290-3029054.81855.36
331915-3191557.75958.32
433488-3348860.60661.22
533926-3392661.39962.02
636760-3676066.52867.25
20min130810-3081055.76061.047.0456.5961.977.09
231390-3139056.80957.65
333126-3312659.95160.84
435082-3508263.49164.44
535024-3502463.38664.35
636940-3694066.85467.94
30min133232-3323260.14363.855.1061.2865.115.18
233342-3334260.34261.50
334664-3466462.73563.95
436544-3654466.13767.44
536371-3637165.82467.14
637522-3752267.90769.37
45min134767-3476762.92166.124.1964.4067.744.28
234809-3480962.99764.49
336232-3623265.57267.14
437515-3751567.89469.56
537425-3742567.73169.41
638471-3847169.62471.46
60min135463-3546364.18167.513.2566.0169.503.36
236516-3651666.08667.93
336933-3693366.84168.77
438037-3803768.83970.89
538218-3821869.16671.22
638649-3864969.94772.17
极限137415-3741567.71368.941.4469.8971.311.60
237470-3747067.81370.03
338100-3810068.95371.26
438651-3865169.95072.38
538305-3830569.32471.76
638627-3862769.90772.52
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对照品来源原料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%
114.005568655702556765557555622556520.10
214.025571955859557890.18
单位质量响应值RSD%判断
3975.143979.240.08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%
5min119237-1923734.68639.3210.5534.6939.3210.54
219742-1974235.59635.60
320890-2089037.66637.67
422803-2280341.11641.12
522796-2279641.10341.10
625377-2537745.75745.76
10min121938-2193839.55644.249.7939.7544.469.79
222201-2220140.03040.23
323418-2341842.22542.43
425709-2570946.35546.58
525933-2593346.75946.99
628005-2800550.49550.75
15min123970-2397043.22047.678.9043.6348.148.91
224211-2421143.65444.07
325156-2515645.35845.80
427789-2778950.10650.59
527676-2767649.90250.39
629840-2984053.80454.34
20min125623-2562346.20050.488.1746.8551.218.19
225726-2572646.38647.05
326753-2675348.23848.93
429708-2970853.56654.33
529063-2906352.40353.17
631114-3111456.10156.93
30min127749-2774950.03453.566.8650.9454.566.91
227566-2756649.70450.62
328628-2862851.61952.58
431452-3145256.71157.77
530327-3032754.68255.74
632490-3249058.58259.73
45min130033-3003354.15257.135.5255.3458.435.58
229807-2980753.74454.94
330714-3071455.38056.63
433244-3324459.94261.32
532335-3233558.30359.66
633965-3396561.24262.71
60min131998-3199857.69559.644.0759.1861.274.17
231424-3142456.66058.16
332403-3240358.42559.98
434378-3437861.98663.70
533521-3352160.44162.13
634753-3475362.66264.47
极限135145-3514563.36964.381.7565.1866.341.90
235332-3533263.70665.52
335099-3509963.28665.17
436175-3617565.22667.28
535837-3583764.61766.64
636641-3664166.06768.23
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对照品来源原料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%
114.005578855678558515587255881558140.16
214.025566255784557230.16
单位质量响应值RSD%判断
3986.713974.540.22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%
5min126613-2661347.94450.636.1047.9450.626.10
226252-2625247.29447.29
327183-2718348.97148.97
428684-2868451.67551.68
529188-2918852.58352.58
630687-3068755.28455.28
10min129384-2938452.93656.105.6353.2056.385.63
229284-2928452.75653.02
330189-3018954.38654.66
431993-3199357.63657.92
532587-3258758.70659.00
633398-3339860.16860.47
15min131126-3112656.07459.044.9756.6359.634.97
231223-3122356.24956.81
331600-3160056.92857.50
433727-3372760.76061.37
534317-3431761.82362.44
634624-3462462.37663.02
20min132594-3259458.71961.344.6059.5962.264.61
232303-3230358.19559.06
333060-3306059.55960.45
435297-3529763.58964.53
535202-3520263.41764.38
635843-3584364.57265.56
30min133919-3391961.10663.413.4262.3064.673.44
234035-3403561.31562.51
334413-3441361.99663.22
436133-3613365.09566.39
536551-3655165.84867.16
636144-3614465.11566.46
45min135360-3536063.70265.793.2565.2467.403.29
235425-3542563.81965.35
335562-3556264.06665.63
437312-3731267.21968.88
537806-3780668.10969.79
637644-3764467.81769.53
60min136162-3616265.14766.992.4667.0468.972.51
236247-3624765.30067.19
336778-3677866.25768.18
437685-3768567.89169.92
538319-3831969.03371.09
637910-3791068.29670.38
极限137519-3751967.59268.581.1569.8570.931.23
237587-3758767.71469.96
338103-3810368.64470.93
438364-3836469.11471.52
538612-3861269.56172.00
638234-3823468.88071.34
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