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101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4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%
112.311984031988561984401980091982471983910.16
212.271987911976791982350.40
单位质量响应值RSD%判断
16116.2516156.070.18数据可信
供试品溶液-WK2927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%
5min196713-9671348.18846.0516.4048.1946.0516.40
291039-9103945.36145.36
390146-9014644.91644.92
492772-9277246.22546.22
568233-6823333.99834.00
6115604-11560457.60157.60
10min1154639-15463977.05175.655.1477.1275.725.15
2156059-15605977.75877.83
3154583-15458377.02377.09
4150886-15088675.18175.25
5136649-13664968.08768.14
6158091-15809178.77178.86
15min1164380-16438081.90482.695.1882.0982.875.17
2166483-16648382.95283.14
3181094-18109490.23290.41
4163978-16397881.70481.89
5154470-15447076.96677.12
6165355-16535582.39082.59
20min1168111-16811183.76386.964.8484.0787.274.83
2172938-17293886.16886.48
3190680-19068095.00895.33
4176271-17627187.82988.13
5169505-16950584.45884.73
6169652-16965284.53184.86
30min1175433-17543387.41191.655.1887.8592.095.15
2181574-18157490.47190.91
3197678-19767898.49598.96
4182359-18235990.86291.30
5192881-19288196.10596.50
6173759-17375986.57787.03
45min1188837-18883794.09094.944.2194.6695.524.18
2191441-19144195.38895.96
3201556-201556100.427101.04
4186157-18615792.75593.33
5196583-19658397.95098.49
6178729-17872989.05489.64
60min1192589-19258995.96096.354.1096.6797.074.07
2193399-19339996.36397.08
3203311-203311101.302102.06
4188234-18823493.79094.50
5200837-200837100.069100.76
6181908-18190890.63891.36
极限1198316-19831698.81399.781.3799.67100.641.37
2202107-202107100.702101.56
3204231-204231101.760102.67
4198046-19804698.67999.53
5201449-201449100.374101.21
6197426-19742698.37099.22
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101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4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%
112.311981691987821990931988001975931984870.31
212.271984431993681989060.33
单位质量响应值RSD%判断
16124.0516210.760.38数据可信
供试品溶液-WK2927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%
5min198092-9809248.78149.4320.0148.7849.4320.00
294145-9414546.81846.82
385714-8571442.62642.63
474754-7475437.17537.18
5113231-11323156.31056.31
6130390-13039064.84364.84
10min1146831-14683173.01976.277.4273.0976.357.43
2150905-15090575.04575.12
3148772-14877273.98474.05
4139974-13997469.60969.66
5162873-16287380.99781.08
6170896-17089684.98785.08
15min1156477-15647777.81681.217.1778.0081.407.18
2158823-15882378.98379.17
3157705-15770578.42778.60
4150940-15094075.06375.22
5176166-17616687.60787.81
6179703-17970389.36689.59
20min1157983-15798378.56583.086.8578.8683.396.86
2163392-16339281.25581.56
3161845-16184580.48680.78
4156306-15630677.73178.00
5180357-18035789.69290.03
6182514-18251490.76491.12
30min1167856-16785683.47587.176.0283.8987.606.04
2169075-16907584.08184.50
3171767-17176785.42085.83
4165665-16566582.38582.77
5188519-18851993.75194.22
6188800-18880093.89094.39
45min1176825-17682587.93592.853.7088.4893.423.71
2184618-18461891.81192.36
3192971-19297195.96596.51
4181037-18103790.03090.54
5192699-19269995.82996.44
6192109-19210995.53696.17
60min1185454-18545492.22696.262.8692.9096.962.85
2194113-19411396.53397.22
3202546-202546100.726101.41
4191271-19127195.11995.77
5194022-19402296.48797.24
6193985-19398596.46997.25
极限1201016-20101699.96599.701.60100.78100.551.56
2199691-19969199.306100.14
3206343-206343102.614103.45
4200298-20029899.608100.40
5198611-19861198.76999.67
6196947-19694797.94298.87
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