多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D241101对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.193306032635334163285033228330380.93
210.203332333668334960.73
单位质量响应值RSD%判断
3242.203283.920.91数据可信
供试品溶液-H147S批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113595-1359537.38238.233.4137.3838.233.41
213227-1322736.37036.37
313882-1388238.17138.17
414032-1403238.58438.58
514060-1406038.66138.66
614629-1462940.22540.23
10min122563-2256362.04261.720.9162.1061.790.90
222496-2249661.85761.92
322273-2227361.24461.31
422210-2221061.07161.14
522759-2275962.58162.65
622379-2237961.53661.60
15min126661-2666173.31073.220.8773.4873.390.87
226712-2671273.45073.61
326399-2639972.59072.76
426833-2683373.78373.95
526869-2686973.88274.05
626300-2630072.31772.49
20min129159-2915980.17980.180.8780.4780.470.87
229504-2950481.12781.41
328958-2895879.62679.91
429067-2906779.92680.21
529414-2941480.88081.17
628864-2886479.36879.66
30min131745-3174587.29086.720.7287.7187.150.71
231492-3149286.59487.02
331643-3164387.00987.43
431583-3158386.84487.27
531655-3165587.04287.47
631114-3111485.55485.98
45min132892-3289290.44390.510.5791.0191.080.57
233046-3304690.86791.43
332952-3295290.60891.17
433182-3318291.24191.81
532701-3270189.91890.49
632722-3272289.97690.54
60min133516-3351692.15992.060.8592.8892.780.84
233715-3371592.70693.42
333189-3318991.26091.98
433685-3368592.62493.34
533702-3370292.67193.39
633076-3307690.94991.66
90min133883-3388393.16893.150.4994.0494.020.49
233996-3399693.47994.35
333749-3374992.80093.67
434077-3407793.70294.58
533930-3393093.29894.17
633628-3362892.46793.33
120min134055-3405593.64193.640.9294.6794.660.92
234465-3446594.76995.80
333503-3350392.12493.15
434056-3405693.64494.67
534187-3418794.00495.04
634053-3405393.63694.66
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限134599-3459995.13795.231.0796.3296.421.05
235367-3536797.24998.43
334451-3445194.73095.91
434548-3454894.99796.18
534367-3436794.49995.69
634472-3447294.78895.96
多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D241101对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.193320132911330483302732913330200.37
210.203351633547335320.07
单位质量响应值RSD%判断
3240.433287.451.02数据可信
供试品溶液-H149S批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113470-1347037.02936.613.1837.0336.613.19
213464-1346437.01237.01
313422-1342236.89736.90
412530-1253034.44534.44
513240-1324036.39736.40
613778-1377837.87637.88
10min121862-2186260.09959.772.3160.1659.832.31
222103-2210360.76160.82
321721-2172159.71159.77
420769-2076957.09457.15
521886-2188660.16560.23
622116-2211660.79760.86
15min126166-2616671.93072.010.8872.0972.170.88
226512-2651272.88173.04
326206-2620672.04072.20
425803-2580370.93271.08
526287-2628772.26372.42
626194-2619472.00772.17
20min128787-2878779.13578.581.0179.4278.861.01
228778-2877879.11179.40
328626-2862678.69378.97
428197-2819777.51377.78
528263-2826377.69577.98
628860-2886079.33679.62
30min131196-3119685.75885.271.0486.1785.681.04
231100-3110085.49485.91
330996-3099685.20885.62
430697-3069784.38684.79
530636-3063684.21884.63
631493-3149386.57486.99
45min133239-3323991.37489.971.2891.9390.531.28
232531-3253189.42889.99
332790-3279090.14090.69
432459-3245989.23089.77
532185-3218588.47689.03
633174-3317491.19591.76
60min133684-3368492.59791.231.2093.3191.941.20
233057-3305790.87491.58
333105-3310591.00691.71
433208-3320891.28991.98
532549-3254989.47790.18
633524-3352492.15792.87
90min134134-3413493.83492.861.4694.7093.721.46
233737-3373792.74393.60
333796-3379692.90593.76
433377-3337791.75392.59
533143-3314391.11091.96
634498-3449894.83595.70
120min134193-3419393.99693.361.4995.0294.371.48
233456-3345691.97092.98
334363-3436394.46495.47
433805-3380592.93093.92
533356-3335691.69692.70
634596-3459695.10496.13
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限134251-3425194.15694.010.5995.3395.180.59
234197-3419794.00795.17
334202-3420294.02195.19
433868-3386893.10394.25
534186-3418693.97795.13
634491-3449194.81696.00
多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D241101对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.193313233019331773300133135330930.24
210.203391433759338360.33
单位质量响应值RSD%判断
3247.603317.251.51数据可信
供试品溶液-H147S批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17039-703919.24218.018.1519.2418.018.15
26960-696019.02619.03
37070-707019.32719.33
46220-622017.00417.00
55739-573915.68915.69
66492-649217.74717.75
10min112754-1275434.86531.166.2334.9031.196.23
210985-1098530.03030.06
311158-1115830.50230.53
411107-1110730.36330.39
510822-1082229.58429.61
611575-1157531.64231.67
15min116415-1641544.87341.563.9744.9641.643.97
214977-1497740.94241.02
314806-1480640.47540.56
415037-1503741.10641.19
514878-1487840.67240.75
615110-1511041.30641.39
20min119215-1921552.52849.003.6052.6949.153.60
217631-1763148.19848.35
317504-1750447.85048.00
417618-1761848.16248.31
517710-1771048.41448.56
617861-1786148.82648.98
30min122621-2262161.83959.162.5162.0959.392.51
221700-2170059.32159.55
321705-2170559.33559.56
421136-2113657.77958.01
521159-2115957.84258.07
621528-2152858.85159.08
45min126155-2615571.49968.412.2371.8668.742.24
224899-2489968.06668.40
324824-2482467.86168.19
424774-2477467.72468.05
524763-2476367.69468.01
624737-2473767.62367.95
60min128262-2826277.25974.351.9277.7374.801.93
226980-2698073.75574.20
327025-2702573.87874.32
426946-2694673.66274.10
526994-2699473.79374.23
626988-2698873.77774.22
90min130759-3075984.08581.352.0384.6981.922.04
230074-3007482.21382.78
329738-2973881.29481.86
429145-2914579.67380.23
529185-2918579.78380.34
629641-2964181.02981.60
120min132189-3218987.99585.261.8388.7485.961.84
231397-3139785.82986.53
331245-3124585.41486.11
430653-3065383.79684.49
530713-3071383.96084.65
630929-3092984.55085.25
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限132676-3267689.32687.541.3290.2288.391.33
232087-3208787.71688.56
332245-3224588.14888.99
431714-3171486.69687.53
531467-3146786.02186.85
631953-3195387.34988.19
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