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)0
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%
111.233803943797833803383802623807313803020.09
211.113789663798753794200.17
单位质量响应值RSD%判断
33864.8334151.220.60数据可信
加速6月-供试品溶液-2025082921批-pH4.5(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1260761-26076168.95559.2329.7268.9559.2329.72
2258236-25823668.28768.29
3259549-25954968.63468.63
4122030-12203032.26932.27
5284734-28473475.29475.29
6158596-15859641.93941.94
10min1319391-31939184.45982.745.6784.5782.845.70
2323045-32304585.42585.54
3326504-32650486.34086.45
4282956-28295674.82474.88
5325830-32583086.16186.29
6299594-29959479.22479.29
15min1337208-33720889.17088.362.2089.4388.602.24
2336593-33659389.00789.26
3341270-34127090.24490.50
4320622-32062284.78484.96
5337803-33780389.32789.60
6331471-33147187.65387.85
20min1341019-34101990.17890.491.1490.5890.881.17
2343670-34367090.87991.28
3347941-34794192.00892.42
4335968-33596888.84289.16
5342516-34251690.57490.99
6342161-34216190.48090.83
30min1347223-34722391.81892.500.7992.3793.030.81
2349248-34924892.35492.91
3352744-35274493.27893.84
4346322-34632291.58092.05
5352938-35293893.33093.90
6350310-35031092.63593.13
45min1351179-35117992.86593.350.8193.5794.040.82
2353778-35377893.55294.26
3357789-35778994.61295.33
4349893-34989392.52493.14
5351380-35138092.91893.64
6354126-35412693.64494.30
60min1351784-35178493.02593.740.8793.8994.590.87
2354145-35414593.64994.51
3359393-35939395.03795.91
4352339-35233993.17193.95
5352297-35229793.16094.04
6357045-35704594.41695.22
极限1353050-35305093.35994.000.9494.3895.000.94
2356402-35640294.24695.27
3360299-36029995.27696.31
4351741-35174193.01393.94
5353288-35328893.42294.46
6357947-35794794.65495.62
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)0
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%
111.233793003786563786663790533789293789210.08
211.113789523786523788020.06
单位质量响应值RSD%判断
33741.8534095.590.74数据可信
加速6月-供试品溶液-2025082921批-pH4.5(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1246952-24695265.47656.2732.4565.4856.2732.45
2144410-14441038.28838.29
3275784-27578473.12073.12
4282664-28266474.94474.94
5118133-11813331.32131.32
6205470-20547054.47754.48
10min1318489-31848984.44383.196.1984.5583.286.21
2313672-31367283.16583.23
3327925-32792586.94487.07
4326641-32664186.60486.73
5275670-27567073.09073.14
6320218-32021884.90184.99
15min1332999-33299988.29088.582.3088.5488.812.33
2335200-33520088.87389.08
3339873-33987390.11290.38
4338291-33829189.69389.96
5319321-31932184.66384.84
6338831-33883189.83690.07
20min1339312-33931289.96490.711.3990.3691.091.42
2342384-34238490.77891.13
3346153-34615391.77792.19
4343962-34396291.19691.62
5334193-33419388.60688.92
6346841-34684191.96092.34
30min1345071-34507191.49092.580.9892.0493.110.99
2349169-34916992.57793.08
3352085-35208593.35093.92
4349409-34940992.64193.21
5345685-34568591.65392.12
6353684-35368493.77494.31
45min1349411-34941192.64193.780.8593.3494.460.86
2354370-35437093.95694.61
3356576-35657694.54195.27
4353604-35360493.75394.48
5351204-35120493.11793.73
6357075-35707594.67395.36
60min1351476-35147693.18994.071.4094.0494.911.42
2357784-35778494.86195.67
3357450-35745094.77395.66
4355735-35573594.31895.20
5346451-34645191.85692.63
6359831-35983195.40496.25
极限1352175-35217593.37494.230.8394.3895.230.84
2358003-35800394.91995.89
3357982-35798294.91495.95
4354303-35430393.93894.98
5351993-35199393.32694.25
6358002-35800294.91995.93
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)0
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%
111.233798693795213798343789543791353794630.11
211.113787993786523787260.03
单位质量响应值RSD%判断
33790.1234088.750.63数据可信
加速6月-供试品溶液-2025083021批-pH4.5(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1274266-27426672.67370.055.9072.6770.055.90
2256693-25669368.01668.02
3242023-24202364.12964.13
4267878-26787870.98070.98
5258317-25831768.44768.45
6286966-28696676.03876.04
10min1330004-33000487.44286.890.8787.5687.010.87
2325306-32530686.19786.31
3325367-32536786.21386.32
4331251-33125187.77287.89
5330248-33024887.50687.62
6325412-32541286.22586.35
15min1343604-34360491.04591.050.8591.3191.310.85
2342333-34233390.70890.97
3342233-34223390.68290.93
4348963-34896392.46592.73
5344031-34403191.15891.42
6340491-34049190.22090.49
20min1346706-34670691.86792.491.0292.2992.911.02
2347003-34700391.94692.35
3348046-34804692.22292.62
4353836-35383693.75694.18
5353232-35323293.59694.01
6345609-34560991.57692.00
30min1355459-35545994.18694.461.0994.7695.031.08
2355214-35521494.12294.68
3355780-35578094.27194.83
4362871-36287196.15096.73
5358315-35831594.94395.51
6351302-35130293.08593.66
45min1361456-36145695.77595.701.1096.5096.431.09
2359627-35962795.29196.01
3361669-36166995.83296.54
4366474-36647497.10597.84
5363260-36326096.25396.98
6354608-35460893.96194.69
60min1362708-36270896.10796.031.1197.0096.911.11
2359587-35958795.28096.16
3362766-36276696.12396.99
4367312-36731297.32798.22
5365760-36576096.91697.80
6356291-35629194.40795.29
极限1361277-36127795.72895.631.2296.7896.681.21
2363235-36323596.24797.28
3355490-35549094.19595.23
4366197-36619797.03298.09
5363536-36353696.32797.37
6355766-35576694.26895.31
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)0
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%
111.233794483798563798133787463801563796040.15
211.113789943792783791360.06
单位质量响应值RSD%判断
33802.6734125.650.68数据可信
加速6月-供试品溶液-2025083021批-pH4.5(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1241893-24189364.04860.5120.5664.0560.5120.56
2274922-27492272.79472.79
3185689-18568949.16749.17
4280803-28080374.35174.35
5164405-16440543.53143.53
6223407-22340759.15459.15
10min1322902-32290285.49884.812.4485.6084.912.46
2330361-33036187.47387.59
3313324-31332482.96283.04
4327380-32738086.68386.81
5311139-31113982.38382.46
6316748-31674883.86883.97
15min1340181-34018190.07389.281.4290.3289.521.44
2340942-34094290.27490.54
3335890-33589088.93789.16
4342651-34265190.72791.00
5331700-33170087.82788.04
6331733-33173387.83688.07
20min1347640-34764092.04891.420.8692.4591.810.88
2345937-34593791.59792.01
3343672-34367290.99791.37
4349015-34901592.41292.83
5340788-34078890.23490.59
6344507-34450791.21891.60
30min1354066-35406693.74992.870.8694.3093.410.88
2353394-35339493.57194.14
3347373-34737391.97792.50
4352834-35283493.42394.00
5347916-34791692.12192.63
6348859-34885992.37192.91
45min1357618-35761894.69094.120.7295.4094.820.74
2355779-35577994.20394.93
3353028-35302893.47494.15
4358489-35848994.92095.65
5352001-35200193.20393.86
6355895-35589594.23494.92
60min1357014-35701494.53094.330.9395.4095.180.95
2358227-35822794.85195.73
3354331-35433193.81994.65
4360610-36061095.48296.37
5351065-35106592.95593.77
6356206-35620694.31695.16
极限1357672-35767294.70494.211.0095.7395.221.02
2356526-35652694.40195.44
3352416-35241693.31294.30
4361475-36147595.71196.76
5352093-35209393.22794.20
6354570-35457093.88394.89
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