非奈利酮卡格列净片项目信息
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250201对照品来源原料对照品使用方法直接使用
对照品含量(%)99.40对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
122.027053027049847055647053537054527053310.04
222.067120717117527119120.04
单位质量响应值RSD%判断
32031.3832271.620.53数据可信
供试品溶液-25091801批-非奈利酮-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%
5min140693-406935.6616.6413.455.666.6413.46
253244-532447.4087.41
349252-492526.8526.85
10min146804-468046.5128.6825.586.528.6925.58
278681-7868110.94610.96
361624-616248.5738.58
15min1133081-13308118.51520.9720.8318.5421.0020.83
2186990-18699026.01526.05
3132159-13215918.38718.41
20min1149085-14908520.74123.7415.2720.7923.8015.29
2199561-19956127.76427.84
3163207-16320722.70622.76
30min1210144-21014429.23631.6416.8529.3231.7416.84
2271300-27130037.74437.86
3200766-20076627.93128.03
45min1234073-23407332.56535.058.6532.7035.208.69
2276176-27617638.42338.61
3245543-24554334.16134.30
60min1269896-26989637.54939.8912.6937.7440.1112.70
2328483-32848345.70045.95
3261861-26186136.43136.63
极限1296086-29608641.19343.285.2441.4443.555.30
2328402-32840245.68946.01
3308684-30868442.94643.20
非奈利酮卡格列净片项目信息
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250201对照品来源原料对照品使用方法直接使用
对照品含量(%)99.40对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
122.027123777124217128357135517131307128630.07
222.067144937145487145200.01
单位质量响应值RSD%判断
32373.4332389.850.04数据可信
供试品溶液-25091802批-非奈利酮-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%
5min116827-168272.3243.7650.312.323.7650.36
222069-220693.0483.05
342706-427065.8995.90
10min138488-384885.3165.282.285.325.282.26
238915-389155.3755.38
337242-372425.1445.15
15min182862-8286211.44612.8614.4311.4612.8714.41
288092-8809212.16812.18
3108276-10827614.95714.97
20min1115374-11537415.93716.7015.9315.9716.7415.86
2142286-14228619.65519.69
3104989-10498914.50314.55
30min1155069-15506921.42022.043.9721.4822.113.97
2156892-15689221.67221.74
3166817-16681723.04323.11
45min1192612-19261226.60627.3910.4826.7027.4910.45
2221279-22127930.56630.67
3180898-18089824.98825.09
60min1214288-21428829.60030.062.2929.7430.212.28
2215252-21525229.73429.89
3223355-22335530.85331.00
极限1252417-25241734.86735.508.4735.0635.708.43
2280655-28065538.76838.97
3237900-23790032.86233.06
非奈利酮卡格列净片项目信息
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250201对照品来源原料对照品使用方法直接使用
对照品含量(%)99.40对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
122.027139617138857140677144227141407140950.03
222.067179747174867177300.05
单位质量响应值RSD%判断
32429.3832535.360.24数据可信
供试品溶液-25091803批-非奈利酮-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%
5min124804-248043.4163.9419.493.423.9419.45
235012-350124.8214.82
326016-260163.5833.58
10min135806-358064.9314.5912.654.944.5912.70
235652-356524.9094.92
328435-284353.9163.92
15min180458-8045811.08011.1818.4611.0911.2018.46
296580-9658013.30013.32
366624-666249.1759.19
20min195005-9500513.08312.675.4913.1212.705.53
294813-9481313.05613.09
386167-8616711.86611.89
30min1151392-15139220.84820.3316.3020.9020.3816.27
2169577-16957723.35223.41
3121918-12191816.78916.84
45min1168736-16873623.23622.636.5523.3222.726.56
2172217-17221723.71523.81
3152091-15209120.94421.02
60min1217310-21731029.92529.0312.6830.0529.1612.67
2233673-23367332.17832.32
3181445-18144524.98625.10
极限1234754-23475432.32731.786.0532.5031.956.07
2242297-24229733.36633.56
3215281-21528129.64529.80
非奈利酮卡格列净片项目信息
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250201对照品来源原料对照品使用方法直接使用
对照品含量(%)99.40对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
122.027171687165927169227155377145417161520.16
222.067217197213397215290.04
单位质量响应值RSD%判断
32522.8032707.570.41数据可信
供试品溶液批-非奈利酮-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%
5min168212-682129.3559.8017.499.359.8017.50
285283-8528311.69611.70
360930-609308.3568.36
10min1202727-20272727.80327.986.3327.8228.006.33
2217509-21750929.83029.85
3191799-19179926.30426.32
15min1290231-29023139.80440.482.4439.8740.542.45
2303418-30341841.61341.68
3291836-29183640.02440.08
20min1355275-35527548.72449.301.1348.8549.431.14
2363366-36336649.83449.97
3359745-35974549.33849.46
30min1440603-44060360.42760.900.7760.6461.110.77
2444100-44410060.90661.13
3447413-44741361.36161.57
45min1512715-51271570.31770.630.7170.6370.950.69
2513169-51316970.37970.70
3519181-51918171.20471.51
60min1552871-55287175.82476.340.9976.2576.770.99
2554023-55402375.98276.42
3562898-56289877.19977.63
极限1577120-57712079.15079.680.6879.7080.240.68
2580769-58076979.65080.22
3584992-58499280.22980.79
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