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c031-5250311对照品来源原料对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数100
标示量(mg)100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%
110.761546496154664515484751546746154833215473390.07
210.811563239156284515630420.02
单位质量响应值RSD%判断
143804.74144592.230.39数据可信
供试品溶液-25091801批-卡格列净-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%
5min190926-909265.6696.9015.665.676.9015.63
2123053-1230537.6737.67
3118246-1182467.3737.37
10min1105353-1053536.5698.9726.056.588.9826.04
2180173-18017311.23411.25
3145931-1459319.0999.11
15min1289048-28904818.02319.8213.8418.0419.8513.85
2368501-36850122.97723.01
3296111-29611118.46318.49
20min1315400-31540019.66621.418.6019.7221.478.63
2374263-37426323.33623.41
3340574-34057421.23521.29
30min1407547-40754725.41125.875.0825.4925.965.11
2438645-43864527.35027.46
3398479-39847924.84624.94
45min1446787-44678727.85827.142.8327.9827.272.81
2436637-43663727.22527.38
3422279-42227926.33026.46
60min1452717-45271728.22828.300.6528.4028.480.62
2451557-45155728.15528.36
3457115-45711528.50228.68
极限1448589-44858927.97029.484.5828.1929.714.58
2479526-47952629.89930.15
3490282-49028230.57030.80
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%
122.027123777124217128357135517131307128630.07
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c031-5250311对照品来源原料对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数100
标示量(mg)100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%
110.761565239156592215657551567618156623715661540.06
210.811566567156749015670280.05
单位质量响应值RSD%判断
145553.35144960.960.29数据可信
供试品溶液-25091802批-卡格列净-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%
5min164798-647984.0113.4015.744.013.4015.69
250513-505133.1273.13
349266-492663.0493.05
10min133597-335972.0803.0849.772.093.0949.62
278236-782364.8434.85
337377-373772.3142.32
15min1232481-23248114.39012.2418.4114.4012.2518.38
2200879-20087912.43412.45
3159900-1599009.8979.91
20min1148231-1482319.17511.8622.589.2111.8922.50
2234737-23473714.53014.56
3192007-19200711.88511.91
30min1350648-35064821.70419.7312.4421.7519.7812.42
2331354-33135420.51020.57
3274398-27439816.98517.03
45min1268334-26833416.60919.7213.7216.6919.8013.67
2347492-34749221.50921.60
3340028-34002821.04721.12
60min1389744-38974424.12423.653.7424.2423.773.75
2390862-39086224.19324.32
3365604-36560422.63022.74
极限1355337-35533721.99423.556.9122.1523.716.85
2378383-37838323.42123.59
3407767-40776725.24025.39
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c031-5250311对照品来源原料对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数100
标示量(mg)100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%
110.761567656156838415678771569221156837815683030.04
210.811575618157566815756430.01
单位质量响应值RSD%判断
145753.07145757.910.01数据可信
供试品溶液-25091803批-卡格列净-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%
5min190743-907435.5986.0111.935.606.0111.91
2110855-1108556.8386.84
390715-907155.5965.60
10min1116571-1165717.1916.817.517.206.827.49
2113547-1135477.0047.02
3100962-1009626.2286.24
15min1192284-19228411.86112.0515.4111.8812.0715.39
2226980-22698014.00114.02
3167015-16701510.30210.32
20min1224850-22485013.87013.642.5613.9113.682.59
2223816-22381613.80613.85
3214590-21459013.23713.27
30min1321049-32104919.80419.5012.7119.8719.5612.68
2353457-35345721.80321.87
3273613-27361316.87816.94
45min1350469-35046921.61921.363.4121.7221.463.43
2355424-35542421.92522.03
3333002-33300220.54120.63
60min1348913-34891321.52321.602.7421.6621.742.67
2341338-34133821.05621.20
3360374-36037422.23022.35
极限1333889-33388920.59621.363.0920.7721.533.05
2352476-35247621.74321.92
3352271-35227121.73021.89
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
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c031-5250311对照品来源原料对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数100
标示量(mg)100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%
110.761575028157443115738241571605156917315728120.16
210.811584792158474315847680.01
单位质量响应值RSD%判断
146172.12146602.040.21数据可信
供试品溶液批-卡格列净-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%
5min189364-893645.4895.536.725.495.536.73
284411-844115.1845.18
396428-964285.9235.92
10min1208276-20827612.79214.4312.6512.8014.4312.64
2229508-22950814.09614.10
3266932-26693216.39516.40
15min1306403-30640318.81920.499.2818.8520.529.27
2327302-32730220.10320.13
3367274-36727422.55822.59
20min1368454-36845422.63022.424.2622.6922.484.22
2378522-37852223.24923.31
3348061-34806121.37821.45
30min1337531-33753120.73120.252.2620.8320.362.22
2328955-32895520.20420.31
3322695-32269519.82019.93
45min1348493-34849321.40420.704.3021.5420.844.24
2341984-34198421.00421.14
3320781-32078119.70219.85
60min1323835-32383519.89020.555.4620.0620.725.44
2324151-32415119.90920.08
3355597-35559721.84122.02
极限1322942-32294219.83520.071.0320.0420.281.04
2328759-32875920.19220.40
3328793-32879320.19420.41
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