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%
1 11.041902371902411899391902121900611901380.08
2 11.101892861888541890700.17
单位质量响应值RSD%判断
17222.6417033.330.79数据可信
供试品溶液-2025060821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%
5min149533-4953326.00724.7015.8126.0124.7015.81
258778-5877830.86130.86
348326-4832625.37425.37
441548-4154821.81521.81
537012-3701219.43319.43
647073-4707324.71624.72
10min197922-9792251.41450.606.0051.4650.646.01
296930-9693050.89350.94
3101549-10154953.31853.36
496994-9699450.92750.96
585129-8512944.69744.73
699656-9965652.32552.37
15min1118487-11848762.21261.774.4962.3461.894.50
2116742-11674261.29661.43
3121438-12143863.76163.89
4119682-11968262.83962.96
5107582-10758256.48656.59
6121896-12189664.00264.13
20min1130840-13084068.69868.613.6668.9368.843.67
2130765-13076568.65868.90
3133855-13385570.28170.52
4132957-13295769.80970.04
5121374-12137463.72863.93
6134211-13421170.46870.70
30min1145756-14575676.52976.602.9576.8876.942.96
2146746-14674677.04977.40
3147926-14792677.66978.02
4149044-14904478.25678.60
5137448-13744872.16772.47
6148393-14839377.91478.27
45min1157320-15732082.60182.932.5183.0883.402.52
2160140-16014084.08284.56
3160782-16078284.41984.90
4160047-16004784.03384.51
5150259-15025978.89479.32
6159113-15911383.54384.02
60min1163677-16367785.93986.431.9186.5587.041.92
2167179-16717987.77888.40
3166967-16696787.66688.29
4166060-16606087.19087.80
5158787-15878783.37183.93
6164998-16499886.63287.25
极限1169908-16990889.21089.980.9589.9790.740.97
2172180-17218090.40391.17
3173710-17371091.20791.98
4172258-17225890.44491.20
5169409-16940988.94889.65
6170813-17081389.68690.45
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%
1 11.041889191885381883891882081884901885090.14
2 11.101893991890521892260.13
单位质量响应值RSD%判断
17075.0917047.390.12数据可信
供试品溶液-2025060921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%
5min135028-3502818.46320.8620.0818.4620.8620.09
234647-3464718.26218.26
339468-3946820.80320.80
453052-5305227.96327.96
531250-3125016.47216.47
644027-4402723.20623.21
10min193235-9323549.14347.595.3849.1747.625.39
286496-8649645.59145.62
385314-8531444.96845.00
496991-9699151.12351.17
586317-8631745.49745.52
693329-9332949.19349.23
15min1117073-11707361.70859.754.8561.8259.874.85
2106901-10690156.34656.45
3107578-10757856.70356.81
4118261-11826162.33462.47
5111251-11125158.63958.74
6119120-11912062.78762.91
20min1130908-13090869.00067.933.3569.2268.143.36
2122510-12251064.57464.77
3126910-12691066.89367.10
4131962-13196269.55669.79
5126616-12661666.73866.94
6134355-13435570.81771.04
30min1147334-14733477.65876.662.4777.9976.982.48
2141303-14130374.47974.79
3141756-14175674.71875.03
4147460-14746077.72578.08
5144344-14434476.08276.39
6150408-15040879.27979.62
45min1158944-15894483.77883.331.7184.2483.791.72
2154670-15467081.52581.96
3156172-15617282.31782.76
4159045-15904583.83184.31
5157326-15732682.92583.36
6162431-16243185.61686.09
60min1165774-16577487.37887.021.3287.9887.611.34
2162333-16233385.56486.13
3163515-16351586.18786.76
4165536-16553687.25287.87
5164713-16471386.81987.40
6168659-16865988.89889.52
极限1170481-17048189.85989.270.6590.6090.010.66
2167793-16779388.44289.15
3169172-16917289.16989.89
4168645-16864588.89189.66
5169374-16937489.27590.00
6170702-17070289.97590.74
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%
1 11.041885251883971887181884361882391884630.10
2 11.101884901885751885320.04
单位质量响应值RSD%判断
17070.9216984.860.36数据可信
供试品溶液-2025061021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%
5min143886-4388623.17717.8031.8523.1817.8031.85
234475-3447518.20718.21
345921-4592124.25224.25
421910-2191011.57111.57
520312-2031210.72710.73
635752-3575218.88218.88
10min188435-8843546.70542.949.9146.7442.979.92
279969-7996942.23442.26
389266-8926647.14447.18
477524-7752440.94240.96
567821-6782135.81835.84
684808-8480844.78944.82
15min1109759-10975957.96655.995.7758.0856.095.79
2104585-10458555.23455.33
3110878-11087858.55758.68
4105523-10552355.72955.82
594765-9476550.04850.13
6110546-11054658.38258.49
20min1124254-12425465.62264.384.1865.8364.574.20
2119871-11987163.30763.50
3124603-12460365.80666.02
4122559-12255964.72664.91
5112794-11279459.56959.73
6127304-12730467.23267.44
30min1144258-14425876.18674.693.3976.5174.993.40
2137405-13740572.56772.87
3142823-14282375.42875.75
4142366-14236675.18775.48
5134222-13422270.88671.15
6147423-14742377.85878.17
45min1159119-15911984.03582.662.4184.4883.082.42
2152087-15208780.32180.74
3157135-15713582.98783.44
4157443-15744383.15083.56
5152026-15202680.28980.67
6161287-16128785.18085.62
60min1167107-16710788.25387.021.7588.8487.581.76
2160572-16057284.80285.36
3164872-16487287.07387.66
4165427-16542787.36687.92
5162413-16241385.77486.29
6168248-16824888.85689.44
极限1171872-17187290.77089.581.3191.5190.291.32
2165930-16593087.63288.33
3169947-16994789.75390.49
4169864-16986489.70990.41
5168461-16846188.96889.62
6171651-17165190.65391.39
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%
1 11.041879351879891880711880441880041880090.03
2 11.101885681882901884290.11
单位质量响应值RSD%判断
17029.8016975.590.23数据可信
供试品溶液-2025060921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%
5min148779-4877925.79925.8420.6125.8025.8420.60
256484-5648429.87529.87
352398-5239827.71427.71
449819-4981926.35026.35
556243-5624329.74729.75
629356-2935615.52715.53
10min1120051-12005163.49661.9610.2663.5462.0010.26
2128367-12836767.89467.94
3104974-10497455.52155.57
4120571-12057163.77163.81
5128800-12880068.12368.17
6100086-10008652.93652.96
15min1144616-14461676.48876.476.7776.6476.626.77
2153657-15365781.27081.43
3128871-12887168.16168.30
4150089-15008979.38379.53
5152833-15283380.83481.00
6137466-13746672.70772.82
20min1155404-15540482.19482.515.2782.4782.785.27
2163045-16304586.23586.53
3141609-14160974.89875.15
4161916-16191685.63885.92
5161643-16164385.49485.79
6152375-15237580.59280.83
30min1164240-16424086.86788.132.7487.2888.542.75
2170325-17032590.08690.53
3159409-15940984.31284.69
4171701-17170190.81491.24
5168790-16879089.27489.71
6165245-16524587.39987.77
45min1172222-17222291.08991.801.5091.6592.361.52
2176445-17644593.32393.92
3170323-17032390.08590.60
4176879-17687993.55294.13
5173406-17340691.71592.30
6172135-17213591.04391.56
60min1174770-17477092.43793.431.3893.1594.141.39
2178995-17899594.67195.42
3174768-17476892.43693.10
4180413-18041395.42196.15
5175393-17539392.76693.51
6175520-17552092.83493.50
极限1180122-18012295.26896.511.1296.1397.371.12
2183584-18358497.09998.00
3182777-18277796.67297.49
4185778-18577898.25999.15
5181072-18107295.77096.67
6181450-18145095.97096.79
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