达格列净片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号D5551-23-012对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)19.2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%
112.342006112005442004662004272004582005010.04
212.372003682001632002660.08
单位质量响应值RSD%判断
16248.0616189.650.26数据可信
供试品溶液-1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%
5min1156485-15648577.80373.564.2777.8073.564.27
2154148-15414876.64176.64
3143112-14311271.15471.15
4144551-14455171.86971.87
5140694-14069469.95269.95
6148766-14876673.96573.97
10min1171506-17150685.27183.691.6085.3983.801.60
2170935-17093584.98785.10
3165402-16540282.23682.34
4168848-16884883.95084.06
5165153-16515382.11382.22
6168054-16805483.55583.67
15min1175705-17570587.35985.801.2987.6086.041.29
2173832-17383286.42886.67
3169569-16956984.30884.54
4173532-17353286.27986.51
5170910-17091084.97585.20
6171927-17192785.48185.72
20min1176771-17677187.88987.041.1188.2687.401.11
2175472-17547287.24387.62
3172484-17248485.75786.11
4177624-17762488.31388.68
5174209-17420986.61586.97
6173826-17382686.42586.79
30min1179312-17931289.15288.691.6989.6689.191.69
2178342-17834288.67089.17
3175575-17557587.29487.78
4183824-18382491.39691.89
5177315-17731588.15988.64
6175953-17595387.48287.98
45min1181620-18162090.30089.781.4890.9490.401.48
2181218-18121890.10090.74
3177698-17769888.35088.97
4184677-18467791.82092.45
5180613-18061389.79990.42
6177562-17756288.28288.91
60min1182883-18288390.92890.591.4291.7091.351.42
2182373-18237390.67491.45
3179544-17954489.26890.02
4186368-18636892.66093.43
5182668-18266890.82191.57
6179340-17934089.16689.92
极限1199326-19932699.103100.642.13100.02101.542.11
2201228-201228100.049100.96
3200279-20027999.577100.46
4208371-208371103.600104.51
5207216-207216103.026103.91
6198112-19811298.49999.39
达格列净片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号D5551-23-012对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)19.2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%
112.349921899199992709917299181992080.04
212.371008851010301009580.11
单位质量响应值RSD%判断
8039.558161.521.07数据可信
供试品溶液-2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%
5min175394-7539475.05774.713.7875.0674.713.78
270177-7017769.86369.86
374152-7415273.82073.82
478511-7851178.16078.16
575135-7513574.79974.80
676898-7689876.55476.55
10min189878-8987889.47687.812.1189.5987.922.11
287255-8725586.86586.97
385338-8533884.95685.07
489746-8974689.34589.46
587341-8734186.95087.06
689672-8967289.27189.39
15min192943-9294392.52790.442.1192.7790.692.11
290460-9046090.05590.29
387589-8758987.19787.44
491700-9170091.29091.54
590154-9015489.75189.99
692262-9226291.84992.10
20min194637-9463794.21491.721.9994.6092.101.99
291821-9182191.41091.78
389284-8928488.88589.25
492920-9292092.50492.89
591163-9116390.75591.13
692949-9294992.53392.92
30min196787-9678796.35493.242.2996.8893.762.29
293580-9358093.16193.67
390509-9050990.10490.61
493941-9394193.52194.05
592297-9229791.88492.40
694816-9481694.39294.92
45min198589-9858998.14895.342.7398.8296.002.72
295086-9508694.66195.31
392277-9227791.86492.50
498667-9866798.22698.89
593620-9362093.20193.85
696386-9638695.95596.62
60min199238-9923898.79495.332.2199.6196.132.20
295842-9584295.41396.20
393420-9342093.00293.78
495588-9558895.16095.97
593818-9381893.39894.19
696664-9666496.23297.04
极限1103894-103894103.429102.291.22104.40103.231.22
2104411-104411103.944104.88
3100949-100949100.497101.41
4102684-102684102.225103.18
5102108-102108101.651102.58
6102445-102445101.987102.94
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