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%
114.005562555817558225574455807557630.15
214.025582456168559960.44
单位质量响应值RSD%判断
3983.073994.010.20数据可信
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%
5min113626-1362624.49930.6813.5224.5030.6813.51
214831-1483126.66526.67
317542-1754231.54031.54
419374-1937434.83434.83
518379-1837933.04533.04
618639-1863933.51233.51
10min115433-1543327.74833.1811.2427.8833.3511.25
216301-1630129.30829.46
318927-1892734.03034.21
419986-1998635.93436.13
520309-2030936.51536.70
619762-1976235.53135.72
15min117537-1753731.53136.4310.1331.8236.7810.15
217864-1786432.11932.43
320838-2083837.46637.83
421162-2116238.04838.44
522271-2227140.04240.43
621900-2190039.37539.76
20min119515-1951535.08739.509.0935.5540.059.12
219400-1940034.88035.37
322449-2244940.36240.93
423342-2334241.96842.57
523844-2384442.87043.48
623254-2325441.81042.41
30min122122-2212239.77443.247.7440.4344.027.79
221359-2135938.40339.09
324485-2448544.02344.82
425428-2542845.71846.56
525879-2587946.52947.38
625012-2501244.97045.81
45min124961-2496144.87947.686.5145.7648.706.57
223864-2386442.90643.80
327234-2723448.96550.01
427548-2754849.53050.62
528369-2836951.00652.11
627148-2714848.81149.90
60min128067-2806750.46352.535.1951.5953.815.27
226811-2681148.20549.34
330006-3000653.94955.26
430049-3004954.02755.39
530954-3095455.65457.04
629423-2942352.90154.26
极限133507-3350760.24461.601.7861.6663.181.89
233983-3398361.10062.50
334408-3440861.86463.48
433915-3391560.97862.64
535268-3526863.41065.11
634489-3448962.01063.66
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%
114.005581455873560435583156060559240.22
214.025624556152561980.12
单位质量响应值RSD%判断
3994.574008.420.25数据可信
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%
5min121167-2116737.93442.398.4337.9342.388.43
221592-2159238.69638.70
323290-2329041.73941.74
424532-2453243.96543.96
525178-2517845.12245.12
626145-2614546.85546.86
10min122328-2232840.01545.209.2840.2345.449.27
222797-2279740.85541.07
324697-2469744.26044.49
426250-2625047.04447.29
527341-2734148.99949.25
627923-2792350.04250.30
15min124379-2437943.69048.438.1744.1248.918.18
224883-2488344.59445.04
326251-2625147.04547.52
427775-2777549.77750.28
529204-2920452.33852.86
629642-2964253.12253.66
20min125775-2577546.19250.358.0046.8751.118.01
225538-2553845.76846.46
327093-2709348.55449.29
429443-2944352.76653.55
530051-3005153.85554.67
630675-3067554.97455.81
30min127138-2713848.63553.838.4349.5754.878.43
227380-2738049.06950.01
329023-2902352.01353.02
431447-3144756.35757.43
532304-3230457.89359.01
632940-3294059.03360.17
45min129415-2941552.71656.867.4353.9258.207.45
228937-2893751.85953.08
330656-3065654.94056.24
433120-3312059.35660.74
533973-3397360.88462.32
634273-3427361.42262.89
60min132002-3200257.35260.215.4958.8561.865.56
231375-3137556.22857.73
332494-3249458.23459.84
434831-3483162.42264.14
535405-3540563.45165.22
635462-3546263.55365.36
极限135374-3537463.39565.272.2265.2167.252.38
235643-3564363.87765.69
336237-3623764.94266.87
436785-3678565.92467.99
537060-3706066.41768.54
637408-3740867.04069.20
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%
114.005677856336561915619856255563520.44
214.025631156051561810.33
单位质量响应值RSD%判断
4025.144007.200.32数据可信
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%
5min127790-2779049.62251.783.7549.6251.783.75
228137-2813750.24150.24
328216-2821650.38250.38
429605-2960552.86252.86
529794-2979453.20053.20
630445-3044554.36254.36
10min129439-2943952.56654.513.1852.8454.803.19
229658-2965852.95753.24
329915-2991553.41653.70
431033-3103355.41255.71
531539-3153956.31656.61
631584-3158456.39656.70
15min130442-3044254.35756.062.9154.9256.642.91
230597-3059754.63455.21
330923-3092355.21655.79
432845-3284558.64859.25
531807-3180756.79457.40
631746-3174656.68557.30
20min131032-3103255.41056.922.2256.2857.822.24
231263-3126355.82356.70
331484-3148456.21757.10
432236-3223657.56058.49
532536-3253658.09659.02
632704-3270458.39659.33
30min131696-3169656.59658.082.0657.7759.302.08
232085-3208557.29158.48
332059-3205957.24458.44
432930-3293058.79960.05
533010-3301058.94260.19
633379-3337959.60160.86
45min132618-3261858.24259.041.2659.7360.581.29
232697-3269758.38359.89
332758-3275858.49260.01
433324-3332459.50361.08
533494-3349459.80761.38
633482-3348259.78561.37
60min132665-3266558.32659.411.3060.1461.271.32
233047-3304759.00860.84
333095-3309559.09460.93
433897-3389760.52662.43
533537-3353759.88361.79
633376-3337659.59661.51
极限133353-3335359.55560.200.6961.6962.400.71
233949-3394960.61962.78
333621-3362160.03362.20
433603-3360360.00162.24
533837-3383760.41962.66
633926-3392660.57862.83
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%
114.005626856141561415585756187561190.28
214.025561056085558480.61
单位质量响应值RSD%判断
4008.503983.450.45数据可信
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%
5min130693-3069355.08256.442.0755.0856.442.07
230756-3075655.19555.20
331526-3152656.57756.58
431779-3177957.03157.03
532420-3242058.18258.18
631516-3151656.55956.56
10min132416-3241658.17458.521.8358.4858.841.83
231895-3189557.23957.55
332511-3251158.34558.66
432927-3292759.09259.41
533613-3361360.32360.65
632288-3228857.94558.26
15min132282-3228257.93459.261.6358.5659.901.63
232752-3275258.77759.40
332900-3290059.04359.68
433321-3332159.79960.44
533864-3386460.77361.43
633018-3301859.25559.89
20min132701-3270158.68659.581.6259.6460.551.62
232953-3295359.13860.09
333113-3311359.42560.39
433479-3347960.08261.06
534142-3414261.27262.27
632807-3280758.87659.84
30min133324-3332459.80459.692.4461.0860.992.40
233236-3323659.64660.93
333582-3358260.26761.56
431845-3184557.15058.46
534343-3434361.63362.97
633248-3324859.66860.96
45min133599-3359960.29860.053.9461.9161.683.85
233918-3391860.87062.48
333848-3384860.74462.38
430893-3089355.44157.07
534720-3472062.30963.99
633788-3378860.63762.26
60min133711-3371160.49959.704.7462.4461.664.62
233873-3387360.78962.74
333595-3359560.29062.26
430211-3021154.21756.15
534800-3480062.45364.48
633398-3339859.93761.90
极限133739-3373960.54960.980.8662.8363.280.88
234101-3410161.19863.49
333984-3398460.98863.29
433867-3386760.77863.02
534488-3448861.89364.26
633705-3370560.48862.78
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