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%
112.312053122053532051452052532047192051560.13
212.312052092052592052340.02
单位质量响应值RSD%判断
16665.8016672.140.03数据可信
供试品溶液-25031701批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1160716-16071677.51976.803.2177.5276.803.21
2161571-16157177.93177.93
3159182-15918276.77976.78
4162674-16267478.46378.46
5149089-14908971.91171.91
6162075-16207578.17478.17
10min1175192-17519284.50185.591.6484.6285.711.64
2177889-17788985.80285.92
3175735-17573584.76384.88
4181833-18183387.70487.82
5174381-17438184.11084.22
6179708-17970886.67986.80
15min1178788-17878886.23587.661.6786.4887.901.67
2181710-18171087.64587.89
3179922-17992286.78287.02
4186803-18680390.10190.35
5179548-17954886.60286.84
6183627-18362788.56988.82
20min1180100-18010086.86888.431.6887.2488.801.68
2183549-18354988.53288.91
3181734-18173487.65688.03
4188426-18842690.88491.27
5181076-18107687.33987.70
6185119-18511989.28989.67
30min1182651-18265188.09989.521.8188.6090.021.81
2185812-18581289.62390.13
3183392-18339288.45688.96
4191176-19117692.21192.73
5182923-18292388.23088.72
6187597-18759790.48491.00
45min1184546-18454689.01390.631.7789.6591.271.77
2188848-18884891.08891.73
3186422-18642289.91890.55
4193091-19309193.13493.79
5184690-18469089.08289.71
6189828-18982891.56092.21
60min1186955-18695590.17591.741.8290.9492.521.82
2191060-19106092.15592.94
3188987-18898791.15591.93
4195362-19536294.23095.03
5186329-18632989.87390.63
6192507-19250792.85393.64
极限1204130-20413098.45998.600.8499.3699.520.84
2206522-20652299.612100.53
3203717-20371798.26099.17
4206509-20650999.606100.55
5202647-20264797.74398.64
6203016-20301697.92198.85
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%
112.312044402045082044132048042047072045740.09
212.312075192058872067030.56
单位质量响应值RSD%判断
16618.5216791.470.74数据可信
供试品溶液-25031701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%
5min1156276-15627675.21779.232.9675.2279.242.96
2163776-16377678.82678.83
3165949-16594979.87279.87
4164576-16457679.21179.21
5171321-17132182.45882.46
6165836-16583679.81879.82
10min1176822-17682285.10587.841.9785.2287.961.97
2182146-18214687.66887.79
3181591-18159187.40187.52
4181887-18188787.54387.66
5187193-18719390.09790.22
6185431-18543189.24989.37
15min1181932-18193287.56589.751.5387.8190.001.53
2188057-18805790.51390.76
3186028-18602889.53689.79
4185229-18522989.15289.40
5190333-19033391.60891.87
6187279-18727990.13990.39
20min1184409-18440988.75790.711.4189.1391.101.41
2190750-19075091.80992.19
3189256-18925691.09091.48
4186489-18648989.75890.14
5191425-19142592.13492.53
6188506-18850690.72991.12
30min1185268-18526889.17191.741.7389.6892.261.72
2194397-19439793.56494.09
3191769-19176992.30092.82
4188544-18854490.74791.27
5192925-19292592.85693.39
6190738-19073891.80392.33
45min1187839-18783990.40893.071.6891.0593.731.68
2197215-19721594.92195.58
3194142-19414293.44294.10
4192427-19242792.61693.27
5195701-19570194.19294.87
6192942-19294292.86493.53
60min1189516-18951691.21593.731.7491.9994.521.74
2199340-19934095.94496.75
3196090-19609094.37995.18
4192536-19253692.66993.46
5196066-19606694.36895.18
6194857-19485793.78694.59
极限1205644-20564498.97899.640.4799.89100.580.48
2208069-208069100.145101.09
3206249-20624999.269100.21
4207601-20760199.920100.85
5207856-207856100.042101.00
6206712-20671299.492100.43
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%
112.312060702062972063172062082062832062350.05
212.312044392046702045540.08
单位质量响应值RSD%判断
16753.4516616.900.58数据可信
供试品溶液-25031701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%
5min1192528-19252892.77493.391.1092.7793.381.10
2194065-19406593.51593.51
3195467-19546794.19094.19
4192343-19234392.68592.68
5191397-19139792.22992.23
6197011-19701194.93494.93
10min1204903-20490398.73798.151.1898.8898.291.18
2203311-20331197.97098.11
3207582-207582100.028100.17
4201554-20155497.12397.26
5201017-20101796.86597.00
6203726-20372698.17098.31
15min1204136-20413698.36898.690.7398.6598.980.73
2204771-20477198.67498.96
3207588-207588100.031100.32
4203800-20380098.20698.49
5203441-20344198.03398.32
6205130-20513098.84799.14
20min1204095-20409598.34898.991.6298.7899.421.62
2204554-20455498.56999.00
3211984-211984102.149102.59
4203559-20355998.09098.52
5203002-20300297.82198.25
6205388-20538898.97199.41
30min1204778-20477898.67799.050.7799.2699.640.77
2205535-20553599.04299.62
3208376-208376100.411101.01
4204368-20436898.47999.06
5204118-20411898.35998.94
6206170-20617099.34899.93
45min1204611-20461198.59799.160.7299.3399.900.72
2205171-20517198.86699.60
3207775-207775100.121100.87
4204000-20400098.30299.03
5207210-20721099.849100.57
6205927-20592799.23199.97
60min1206186-20618699.35598.780.72100.2399.660.72
2204552-20455298.56899.45
3207114-20711499.803100.70
4203519-20351998.07098.94
5203433-20343398.02998.90
6205107-20510798.83699.72
极限1203412-20341298.01998.491.1599.0599.521.15
2203539-20353998.08099.11
3208783-208783100.607101.65
4203079-20307997.85898.88
5202340-20234097.50298.52
6205204-20520498.88299.91
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