非布司他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241101对照品来源ZZ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%
19.993240731992317283207032172320740.78
210.003227132067321690.45
单位质量响应值RSD%判断
3210.613216.900.14数据可信
供试品溶液-6032401批-多替诺雷-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17384-738420.61523.7013.3620.6123.7013.36
29065-906525.30825.31
310002-1000227.92327.92
47755-775521.65021.65
57358-735820.54220.54
69363-936326.13926.14
10min118794-1879452.46953.595.0352.5053.635.04
219825-1982555.34755.39
320490-2049057.20457.25
418275-1827551.02051.06
518057-1805750.41150.45
619728-1972855.07655.12
15min123515-2351565.64966.541.9265.7766.671.93
224503-2450368.40768.54
323870-2387066.64066.78
423682-2368266.11566.24
523250-2325064.90965.03
624195-2419567.54767.68
20min126089-2608972.83573.811.4273.0774.051.42
227084-2708475.61375.86
326150-2615073.00573.26
426339-2633973.53373.76
526313-2631373.46073.69
626659-2665974.42674.67
30min128707-2870780.14481.231.4780.5081.601.47
229594-2959482.62082.99
328739-2873980.23380.61
429076-2907681.17481.53
528816-2881680.44880.80
629652-2965282.78283.15
45min130533-3053385.24285.711.0685.7386.211.06
231165-3116587.00687.52
330190-3019084.28484.79
430765-3076585.88986.38
530843-3084386.10786.59
630710-3071085.73686.25
60min131349-3134987.52088.270.7788.1588.910.77
231845-3184588.90489.56
331499-3149987.93888.59
431874-3187488.98589.62
531365-3136587.56488.19
631778-3177888.71789.37
极限131946-3194689.18690.200.9589.9690.990.95
232803-3280391.57992.38
332117-3211789.66490.46
432303-3230390.18390.96
532506-3250690.75091.52
632183-3218389.84890.65
非布司他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C025-22401010对照品来源自制对照品使用方法直接使用
对照品含量(%)101.3对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.052467362453642452212463782459882459370.27
210.042476042487062481550.32
单位质量响应值RSD%判断
24471.3424716.630.71数据可信
供试品溶液-6032401批-非布司他-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min169942-6994225.92829.6212.3925.9329.6212.39
284091-8409131.17331.17
394618-9461835.07635.08
473384-7338427.20427.20
571234-7123426.40726.41
686116-8611631.92431.92
10min1156968-15696858.19058.733.3958.2358.783.40
2162734-16273460.32760.38
3165421-16542161.32361.38
4153155-15315556.77656.82
5151925-15192556.32056.36
6160395-16039559.46059.51
15min1188271-18827169.79470.131.1469.9370.271.14
2191609-19160971.03171.18
3191014-19101470.81170.97
4188058-18805869.71569.85
5185918-18591868.92269.06
6190120-19012070.47970.63
20min1203573-20357375.46675.890.9075.7276.150.90
2207842-20784277.04977.32
3205476-20547676.17276.45
4204351-20435175.75576.01
5202536-20253675.08275.33
6204466-20446675.79876.07
30min1219725-21972581.45482.470.8581.8482.860.86
2225032-22503283.42283.82
3223046-22304682.68583.09
4221893-22189382.25882.64
5221311-22131182.04282.42
6223760-22376082.95083.35
45min1234477-23447786.92387.670.7087.4488.200.71
2239124-23912488.64689.18
3237442-23744288.02288.57
4236212-23621287.56688.09
5236513-23651387.67888.19
6235201-23520187.19187.73
60min1241895-24189589.67390.740.8090.3491.410.80
2247534-24753491.76392.45
3245289-24528990.93191.62
4243584-24358490.29990.96
5245811-24581191.12491.79
6244512-24451290.64391.32
极限1248274-24827492.03893.150.8992.8593.970.89
2253598-25359894.01194.85
3252293-25229393.52794.37
4249797-24979792.60293.42
5253644-25364494.02894.84
6250003-25000392.67993.51
非布司他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241101对照品来源ZZ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%
19.993215132245326483223832810324180.90
210.003236432418323910.12
单位质量响应值RSD%判断
3245.053239.100.13数据可信
供试品溶液-6032402批-多替诺雷-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19261-926125.62926.826.8925.6326.826.90
29767-976727.02927.03
39510-951026.31826.32
410622-1062229.39529.40
510223-1022328.29128.29
68767-876724.26224.26
10min120654-2065457.15856.001.4257.2056.041.42
220442-2044256.57156.62
320015-2001555.38955.43
419961-1996155.24055.29
520345-2034556.30356.35
619994-1999455.33155.37
15min124899-2489968.90567.741.0169.0467.881.01
224643-2464368.19768.34
324333-2433367.33967.48
424316-2431667.29267.43
524256-2425667.12667.27
624422-2442267.58567.72
20min127049-2704974.85573.581.6575.1173.831.64
226426-2642673.13173.38
326619-2661973.66573.91
426308-2630872.80573.06
526001-2600171.95572.21
627129-2712975.07775.32
30min129341-2934181.19880.011.0881.5880.381.08
228823-2882379.76580.14
328988-2898880.22180.59
428720-2872079.48079.85
528466-2846678.77779.15
629137-2913780.63481.00
45min130929-3092985.59384.690.9086.1185.200.90
230515-3051584.44784.95
330548-3054884.53885.04
430700-3070084.95985.47
530137-3013783.40183.91
630789-3078985.20585.71
60min131377-3137786.83386.390.9587.4987.040.94
231108-3110886.08886.74
331167-3116786.25286.90
431157-3115786.22486.87
530803-3080385.24485.89
631686-3168687.68888.33
极限132171-3217189.03087.860.9589.8388.660.95
231646-3164687.57788.37
331693-3169387.70788.50
431519-3151987.22688.02
531411-3141186.92787.71
632055-3205588.70989.50
非布司他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C025-22401010对照品来源自制对照品使用方法直接使用
对照品含量(%)101.3对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.052509432528412523362516842519112519430.29
210.042483422486162484790.08
单位质量响应值RSD%判断
25068.9624748.900.91数据可信
供试品溶液-6032402批-非布司他-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min192181-9218133.74134.315.9633.7434.315.95
294480-9448034.58234.58
391318-9131833.42533.42
4101746-10174637.24237.24
597355-9735535.63535.63
685391-8539131.25631.26
10min1172785-17278563.24462.241.0363.3062.301.03
2170680-17068062.47462.53
3168829-16882961.79661.85
4169986-16998662.22062.28
5170275-17027562.32562.38
6167677-16767761.37561.43
15min1198178-19817872.53971.320.8872.7071.480.87
2193619-19361970.87071.03
3194684-19468471.26071.42
4194835-19483571.31571.48
5193906-19390670.97571.14
6193899-19389970.97371.13
20min1209140-20914076.55175.890.9876.8376.170.98
2206286-20628675.50775.79
3206459-20645975.57075.85
4207287-20728775.87376.16
5204606-20460674.89275.17
6210161-21016176.92577.20
30min1223767-22376781.90580.890.7382.3281.300.73
2220356-22035680.65781.06
3221014-22101480.89781.30
4220906-22090680.85881.27
5218838-21883880.10180.51
6221044-22104480.90881.31
45min1235744-23574486.28985.480.8786.8486.020.87
2231508-23150884.73985.28
3233007-23300785.28785.83
4236171-23617186.44586.99
5231552-23155284.75585.29
6233227-23322785.36885.90
60min1243118-24311888.98887.830.7789.6888.510.76
2239145-23914587.53488.22
3240862-24086288.16288.84
4238785-23878587.40288.09
5237983-23798387.10987.79
6239828-23982887.78488.46
极限1247717-24771790.67189.310.8491.5190.140.84
2242043-24204388.59589.42
3244472-24447289.48490.31
4242751-24275188.85489.69
5242873-24287388.89889.72
6244178-24417889.37690.20
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