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%
1 12.261999501995961999491994851998671997690.11
2 12.302005102007222006160.08
单位质量响应值RSD%判断
16294.3716310.240.07数据可信
供试品溶液-2025041711批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1170730-17073084.20184.501.3584.2084.501.35
2173890-17389085.75985.76
3171225-17122584.44584.45
4170428-17042884.05284.05
5173899-17389985.76485.76
6167821-16782182.76682.77
10min1185816-18581691.64192.481.4291.7792.611.41
2187926-18792692.68292.81
3190589-19058993.99594.12
4184973-18497391.22591.35
5190712-19071294.05694.18
6185104-18510491.29091.41
15min1191735-19173594.56095.011.3894.8295.281.38
2193817-19381795.58795.85
3191387-19138794.38994.66
4190943-19094394.17094.43
5197517-19751797.41297.68
6190524-19052493.96394.22
20min1195292-19529296.31496.791.4896.7297.201.48
2196923-19692397.11997.53
3194532-19453295.94096.35
4194559-19455995.95396.36
5201845-20184599.54699.96
6194389-19438995.86996.27
30min1198906-19890698.09798.411.7098.6598.961.70
2200099-20009998.68599.24
3197359-19735997.33497.89
4197662-19766297.48398.03
5206068-206068101.629102.19
6197141-19714197.22697.77
45min1200056-20005698.66499.251.7199.3699.951.71
2201547-20154799.399100.10
3199187-19918798.23598.93
4199758-19975898.51799.21
5208005-208005102.584103.30
6198951-19895198.11998.81
极限1200687-20068798.97599.361.8499.82100.211.83
2201667-20166799.458100.31
3198508-19850897.90198.75
4199979-19997998.62699.47
5208663-208663102.909103.78
6199268-19926898.27599.11
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%
1 12.262012802009162013322008132007382010160.14
2 12.302016352014562015460.07
单位质量响应值RSD%判断
16396.0816385.850.05数据可信
供试品溶液-2025041711批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min179552-7955239.02145.4615.7739.0245.4615.77
279748-7974839.11839.12
383922-8392241.16541.16
4104682-10468251.34851.35
593013-9301345.62445.62
6115211-11521156.51356.51
10min1122168-12216859.92568.1710.6159.9868.2410.61
2132908-13290865.19365.25
3127313-12731362.44962.51
4151225-15122574.17874.26
5139322-13932268.33968.41
6160878-16087878.91379.00
15min1144512-14451270.88579.747.9571.0379.927.96
2158086-15808677.54377.70
3153961-15396175.52075.68
4175570-17557086.12086.31
5165351-16535181.10781.28
6177962-17796287.29387.50
20min1158169-15816977.58485.666.3677.8485.956.37
2170801-17080183.78084.05
3168887-16888782.84183.11
4182170-18217089.35789.67
5178062-17806287.34287.63
6189761-18976193.08093.41
30min1176589-17658986.61992.484.2786.9992.904.29
2185811-18581191.14391.54
3184190-18419090.34890.74
4194198-19419895.25795.71
5191148-19114893.76194.18
6199256-19925697.73898.21
45min1191858-19185894.10996.762.5994.6197.322.62
2195286-19528695.79196.33
3192055-19205594.20694.73
4201005-20100598.59699.19
5198848-19884897.53898.10
6204531-204531100.325100.95
极限1203801-20380199.96799.242.06100.6199.942.08
2200836-20083698.51399.19
3195410-19541095.85196.52
4203934-203934100.032100.77
5202020-20202099.09499.80
6207940-207940101.997102.77
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%
1 12.261994271994561993001992601991361993160.07
2 12.302010822017322014070.23
单位质量响应值RSD%判断
16257.4216374.550.51数据可信
供试品溶液-2025041711批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1146429-14642972.15667.288.4372.1667.288.44
2127542-12754262.84962.85
3134854-13485466.45366.45
4144013-14401370.96670.97
5119008-11900858.64458.64
6147372-14737272.62172.62
10min1173223-17322385.36084.174.7185.4784.274.71
2167758-16775882.66782.76
3172530-17253085.01885.12
4172271-17227184.89185.00
5157284-15728477.50677.59
6181726-18172689.55089.66
15min1182322-18232289.84490.173.4490.0890.403.44
2182196-18219689.78290.00
3183696-18369690.52190.75
4184140-18414090.74090.97
5172951-17295185.22685.43
6192653-19265394.93495.18
20min1185839-18583991.57792.733.1491.9593.093.14
2188004-18800492.64493.00
3188449-18844992.86393.23
4187804-18780492.54592.91
5180385-18038588.88989.22
6198547-19854797.83998.22
30min1189708-18970893.48395.763.3093.9996.263.30
2194358-19435895.77596.27
3193624-19362495.41395.92
4193057-19305795.13495.64
5188635-18863592.95593.42
6206556-206556101.786102.32
45min1191671-19167194.45197.753.5195.1098.403.51
2198691-19869197.91098.55
3196747-19674796.95297.60
4197068-19706897.11097.76
5194406-19440695.79896.40
6211661-211661104.301104.99
极限1192756-19275694.98598.393.5795.7899.183.56
2199969-19996998.54099.32
3197847-19784797.49498.28
4197727-19772797.43598.23
5196343-19634396.75397.50
6213340-213340105.129105.97
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%
1 12.262013962018412018812020442020742018470.14
2 12.302015662015892015780.01
单位质量响应值RSD%判断
16463.8716388.460.33数据可信
供试品溶液-2025041711批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1161247-16124778.92577.282.8178.9277.282.80
2157527-15752777.10477.10
3156736-15673676.71776.72
4160241-16024178.43278.43
5149853-14985373.34873.35
6161768-16176879.18079.18
10min1176714-17671486.49586.240.9886.6186.360.98
2176036-17603686.16486.28
3176489-17648986.38586.50
4177287-17728786.77686.89
5172896-17289684.62784.74
6177723-17772386.98987.11
15min1183017-18301789.58190.080.6389.8390.320.63
2183681-18368189.90690.15
3185129-18512990.61490.86
4184586-18458690.34990.60
5182489-18248989.32289.56
6185312-18531290.70490.95
20min1186772-18677291.41892.280.6191.8092.660.61
2187537-18753791.79392.17
3189709-18970992.85693.24
4188585-18858592.30692.69
5189303-18930392.65793.03
6189251-18925192.63293.02
30min1189406-18940692.70894.561.0593.2395.081.05
2192675-19267594.30894.83
3193704-19370494.81195.33
4194376-19437695.14095.66
5195185-19518595.53696.05
6193747-19374794.83395.36
45min1193025-19302594.47996.101.1995.1496.761.18
2195055-19505595.47396.13
3197556-19755696.69797.36
4197009-19700996.42997.09
5199824-19982497.80798.46
6195574-19557495.72796.39
极限1198104-19810496.96597.190.6897.7797.990.67
2197444-19744496.64297.44
3198574-19857497.19598.00
4198962-19896297.38598.19
5200962-20096298.36499.16
6197304-19730496.57497.38
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