非奈利酮片项目信息
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D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
111.203854333857493851853852873849523853210.08
211.253859553859473859510.01
单位质量响应值RSD%判断
34403.6634306.760.20数据可信
供试品溶液-1批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13967-39671.0381.7829.941.041.7829.83
26701-67011.7541.75
38413-84132.2022.20
47985-79852.0902.09
54760-47601.2461.25
68905-89052.3312.33
10min117286-172864.5255.9721.044.535.9721.04
222820-228205.9735.98
328621-286217.4927.50
423342-233426.1106.11
517372-173724.5474.55
627379-273797.1677.17
15min127325-273257.1538.6115.757.168.6215.76
233309-333098.7198.73
339742-3974210.40310.42
432486-324868.5048.52
527010-270107.0707.08
637510-375109.8199.83
20min134193-341938.95010.5916.278.9710.6216.28
241351-4135110.82410.85
348808-4880812.77612.81
440333-4033310.55810.59
531907-319078.3528.37
646259-4625912.10912.14
30min142833-4283311.21212.8113.7311.2512.8513.74
249460-4946012.94712.99
357328-5732815.00615.06
447859-4785912.52812.57
540457-4045710.59010.63
655608-5560814.55614.61
45min155443-5544314.51315.2710.6214.5715.3410.65
256931-5693114.90214.97
366931-6693117.52017.60
456353-5635314.75114.82
550081-5008113.10913.16
664302-6430216.83216.91
60min162101-6210116.25616.767.7116.3316.857.75
263891-6389116.72416.82
370417-7041718.43218.54
462543-6254316.37116.46
556648-5664814.82814.90
668538-6853817.94118.05
极限178149-7814920.45620.483.8320.5620.603.84
278106-7810620.44520.56
384036-8403621.99722.14
476550-7655020.03820.16
576665-7666520.06820.17
675836-7583619.85119.99
非奈利酮片项目信息
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D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
111.201969531966611966761968011963101966800.13
211.251942371945081943720.10
单位质量响应值RSD%判断
17560.7117277.511.15数据可信
供试品溶液-2批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12800-28001.4461.6919.321.451.7019.27
22517-25171.3001.30
33560-35601.8381.84
43445-34451.7791.78
53057-30571.5781.58
64299-42992.2202.22
10min18042-80424.1524.7121.294.154.7121.32
26717-67173.4683.47
311230-112305.7985.80
49970-99705.1475.15
57557-75573.9023.90
611190-111905.7775.78
15min114825-148257.6548.8316.687.668.8416.70
213183-131836.8066.81
319775-1977510.21010.22
419100-191009.8619.87
515862-158628.1898.20
619824-1982410.23510.25
20min119046-190469.83311.4216.269.8611.4516.25
217644-176449.1109.13
325125-2512512.97213.00
425604-2560413.21913.25
520057-2005710.35510.38
625238-2523813.03013.06
30min125212-2521213.01714.3713.0613.0614.4113.07
222926-2292611.83711.87
330820-3082015.91215.96
431520-3152016.27416.32
525768-2576813.30413.34
630715-3071515.85815.91
45min129727-2972715.34816.729.5315.4116.789.54
228307-2830714.61514.67
334745-3474517.93918.02
435782-3578218.47418.55
531073-3107316.04316.11
634619-3461917.87417.95
60min132656-3265616.86017.856.6416.9517.946.68
231233-3123316.12516.20
336337-3633718.76118.87
437246-3724619.23019.34
534309-3430917.71417.80
635650-3565018.40618.51
极限139140-3914020.20820.022.5420.3220.142.53
237942-3794219.58919.69
339000-3900020.13520.27
440081-4008120.69420.83
539120-3912020.19720.32
637324-3732419.27019.41
非奈利酮片项目信息
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D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
111.203860313863243866413860723862573862650.07
211.253873463871253872360.05
单位质量响应值RSD%判断
34487.9534420.980.14数据可信
供试品溶液-1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%
5min114439-144393.76911.3759.673.7711.3759.67
235159-351599.1779.18
346201-4620112.05912.06
482072-8207221.42121.42
563731-6373116.63416.63
619815-198155.1725.17
10min176095-7609519.86135.9644.2519.8735.9844.25
2125844-12584432.84632.86
3133520-13352034.84934.87
4224057-22405758.48058.52
5193211-19321150.42950.46
673816-7381619.26619.28
15min1192237-19223750.17558.8320.2750.2158.9120.30
2218839-21883957.11857.19
3234097-23409761.10161.18
4280173-28017373.12773.26
5267920-26792069.92970.04
6159065-15906541.51741.56
20min1247738-24773864.66170.5910.4964.7870.7710.55
2263971-26397168.89869.06
3281469-28146973.46573.65
4305648-30564879.77680.03
5293264-29326476.54476.77
6230662-23066260.20460.31
30min1290532-29053275.83080.425.5576.0680.715.61
2305064-30506479.62379.90
3320486-32048683.64983.95
4329836-32983686.08986.48
5315961-31596182.46882.82
6286819-28681974.86175.07
45min1313096-31309681.72086.113.6082.0886.543.65
2332962-33296286.90587.32
3340045-34004588.75489.20
4343609-34360989.68490.22
5330677-33067786.30986.80
6319009-31900983.26383.60
60min1323244-32324484.36988.512.9784.8689.083.02
2344415-34441589.89490.45
3347364-34736490.66491.25
4349520-34952091.22791.91
5338044-33804488.23188.87
6332097-33209786.67987.15
极限1348750-34875091.02692.192.2691.6692.902.28
2360890-36089094.19494.90
3359032-35903293.70994.45
4360895-36089594.19695.03
5343230-34323089.58590.37
6346366-34636690.40391.02
非奈利酮片项目信息
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D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
111.201956071954841952941952801951221953570.10
211.251941891943391942640.06
单位质量响应值RSD%判断
17442.5917267.910.72数据可信
供试品溶液-2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%
5min14901-49012.5407.5660.962.547.5660.96
221805-2180511.29911.30
318862-188629.7749.77
426169-2616913.56013.56
56071-60713.1463.15
69676-96765.0145.01
10min120609-2060910.67926.8746.1210.6826.8846.13
270673-7067336.62136.64
366864-6686434.64734.66
480424-8042441.67441.70
535969-3596918.63818.64
636557-3655718.94318.95
15min143086-4308622.32647.9238.3222.3547.9738.33
2121630-12163063.02563.11
3118203-11820361.25061.32
4129671-12967167.19267.28
574893-7489338.80838.84
667345-6734534.89634.94
20min169551-6955136.03964.4728.8836.1064.6028.90
2148108-14810876.74676.93
3150136-15013677.79677.97
4162642-16264284.27784.48
5118498-11849861.40361.50
697536-9753650.54150.64
30min1115512-11551259.85580.4114.0959.9780.6514.15
2165191-16519185.59885.91
3165440-16544085.72786.03
4177106-17710691.77292.12
5161775-16177583.82784.03
6146006-14600675.65675.84
45min1140026-14002672.55887.758.8972.7888.138.95
2175320-17532090.84691.30
3172216-17221689.23889.69
4182121-18212194.37094.87
5177462-17746291.95692.30
6168960-16896087.55187.86
60min1152858-15285879.20790.956.6079.5591.486.67
2180700-18070093.63494.24
3175270-17527090.82091.42
4184651-18465195.68196.34
5182013-18201394.31494.81
6177641-17764192.04992.50
极限1171129-17112988.67494.993.8989.1595.673.93
2183572-18357295.12295.89
3179119-17911992.81593.56
4188469-18846997.66098.47
5188187-18818797.51398.17
6189412-18941298.14898.76
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