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%
112.602091852082672084932094902091552089180.25
212.662113422110742112080.09
单位质量响应值RSD%判断
16580.7916683.100.44数据可信
供试品溶液-1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%
5min1148295-14829571.68873.061.2571.6973.061.24
2149725-14972572.37972.38
3151129-15112973.05873.06
4152445-15244573.69473.69
5151693-15169373.33073.33
6153478-15347874.19374.19
10min1168302-16830281.35981.501.1881.4781.601.18
2165746-16574680.12480.23
3167817-16781781.12581.23
4169925-16992582.14482.25
5171565-17156582.93783.05
6168164-16816481.29281.40
15min1175230-17523084.70884.500.9984.9484.730.99
2172176-17217683.23283.46
3174814-17481484.50784.74
4175964-17596485.06385.30
5177020-17702085.57485.81
6173571-17357183.90684.14
20min1179818-17981886.92686.471.2387.2886.831.23
2175556-17555684.86685.22
3178876-17887686.47186.83
4179950-17995086.99087.35
5181764-18176487.86788.23
6177275-17727585.69786.06
30min1183196-18319688.55988.651.2089.0589.141.19
2180621-18062187.31487.80
3183691-18369188.79889.29
4184484-18448489.18289.67
5186766-18676690.28590.78
6181541-18154187.75988.25
45min1189477-18947791.59590.921.6692.2291.541.65
2184374-18437489.12989.74
3187437-18743790.60991.23
4189076-18907691.40292.03
5192884-19288493.24293.87
6185235-18523589.54590.16
极限1199597-19959796.48896.961.0597.2497.721.04
2199580-19958096.47997.22
3198132-19813295.77996.54
4200566-20056696.95697.72
5204200-20420098.71399.48
6201422-20142297.37098.12
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%
112.602071262085962086252085942089662083810.35
212.662102572103032102800.02
单位质量响应值RSD%判断
16538.1716609.790.31数据可信
供试品溶液-1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%
5min1154497-15449774.94673.142.7874.9573.142.78
2152212-15221273.83873.84
3151215-15121573.35473.35
4148886-14888672.22572.22
5154416-15441674.90774.91
6143394-14339469.56069.56
10min1172578-17257883.71881.751.7983.8381.861.79
2167401-16740181.20681.32
3169031-16903181.99782.11
4164596-16459679.84579.95
5171195-17119583.04783.16
6166340-16634080.69280.80
15min1180180-18018087.40585.301.6887.6485.541.68
2173798-17379884.30984.54
3176738-17673885.73685.97
4171804-17180483.34283.57
5177521-17752186.11586.35
6175043-17504384.91385.14
20min1184814-18481489.65387.121.9490.0287.481.94
2176798-17679885.76586.12
3180372-18037287.49887.86
4176066-17606685.41085.76
5182222-18222288.39688.76
6177306-17730686.01186.36
30min1190388-19038892.35789.631.9892.8690.121.98
2181911-18191188.24588.73
3186983-18698390.70591.20
4181594-18159488.09188.57
5186148-18614890.30090.80
6181604-18160488.09688.58
45min1194202-19420294.20791.212.4694.8591.842.46
2184397-18439789.45190.07
3191282-19128292.79193.42
4182960-18296088.75489.37
5190760-19076092.53893.17
6184596-18459689.54790.16
极限1204587-20458799.24597.141.40100.0397.901.41
2198337-19833796.21396.97
3202778-20277898.36899.14
4197629-19762995.87096.62
5199599-19959996.82597.60
6198505-19850596.29597.04
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%
112.602083892085092099852093802085722089670.34
212.662090502088732089620.06
单位质量响应值RSD%判断
16584.6816505.690.34数据可信
供试品溶液-1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%
5min1140505-14050568.27869.653.6268.2869.653.62
2144309-14430970.12670.13
3142448-14244869.22269.22
4135573-13557365.88165.88
5146399-14639971.14271.14
6150758-15075873.26073.26
10min1159407-15940777.46378.882.8677.5778.982.86
2164446-16444679.91280.02
3161752-16175278.60378.71
4155999-15599975.80775.91
5162625-16262579.02779.13
6169672-16967282.45182.56
15min1167992-16799281.63582.612.1181.8582.842.12
2174552-17455284.82385.05
3169071-16907182.15982.38
4164769-16476980.06980.28
5170310-17031082.76182.99
6173323-17332384.22584.46
20min1170609-17060982.90784.172.4583.2584.512.45
2180236-18023687.58587.94
3172605-17260583.87684.22
4168458-16845881.86182.19
5171379-17137983.28183.63
6175930-17593085.49285.85
30min1176753-17675385.89286.432.7586.3686.902.74
2186646-18664690.70091.18
3174506-17450684.80085.27
4172870-17287084.00584.46
5176713-17671385.87386.35
6179632-17963287.29187.78
45min1178658-17865886.81888.473.4987.4189.073.48
2193729-19372994.14294.76
3180664-18066487.79388.39
4175041-17504185.06085.64
5181016-18101687.96488.57
6183248-18324889.04889.67
极限1200241-20024197.30698.091.7798.0398.821.77
2208377-208377101.260102.02
3200374-20037497.37198.10
4200245-20024597.30898.02
5198487-19848796.45497.19
6203339-20333998.81299.56
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%
112.602105972108822113222103152107202107670.18
212.662125642123312124480.08
单位质量响应值RSD%判断
16727.5416781.040.23数据可信
供试品溶液-1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%
5min1141365-14136567.83869.943.6267.8469.943.62
2152405-15240573.13673.14
3148868-14886871.43971.44
4139256-13925666.82666.83
5149680-14968071.82871.83
6142908-14290868.57868.58
10min1162173-16217377.82380.653.9577.9380.763.95
2177504-17750485.18085.29
3173580-17358083.29783.40
4160601-16060177.06977.17
5169370-16937081.27781.38
6165206-16520679.27979.38
15min1170558-17055881.84784.944.2282.0785.174.22
2186737-18673789.61189.85
3185485-18548589.01089.24
4169636-16963681.40581.62
5176585-17658584.73984.97
6173041-17304183.03983.26
20min1174707-17470783.83887.174.4784.1887.524.47
2191314-19131491.80792.18
3191869-19186992.07492.44
4174170-17417083.58083.92
5181420-18142087.06087.42
6176436-17643684.66885.01
30min1180509-18050986.62289.593.8687.0990.083.86
2193911-19391193.05493.56
3197083-19708394.57695.08
4180803-18080386.76387.23
5186281-18628189.39289.88
6181616-18161687.15487.63
45min1185387-18538788.96391.473.1989.5692.093.20
2196249-19624994.17694.82
3199619-19961995.79396.44
4184553-18455388.56389.16
5189989-18998991.17291.79
6187887-18788790.16390.77
极限1204145-20414597.96598.192.2098.7098.952.19
2200793-20079396.35697.15
3211332-211332101.414102.20
4200495-20049596.21396.94
5208810-208810100.203100.96
6202171-20217197.01797.76
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%
112.602085972076102088282088132089042085500.26
212.662133042126002129520.24
单位质量响应值RSD%判断
16551.5916820.851.15数据可信
供试品溶液-1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%
5min1139152-13915267.05367.373.0767.0567.373.07
2133673-13367364.41264.41
3140423-14042367.66567.67
4144389-14438969.57669.58
5136671-13667165.85765.86
6144543-14454369.65069.65
10min1168971-16897181.42179.142.4481.5279.242.44
2157513-15751375.90076.00
3167422-16742280.67580.78
4163802-16380278.93179.03
5162881-16288178.48778.59
6164846-16484679.43479.54
15min1187261-18726190.23583.154.6090.4683.384.59
2163242-16324278.66178.87
3170741-17074182.27482.50
4172544-17254483.14383.37
5169784-16978481.81382.03
6171834-17183482.80183.02
20min1193471-19347193.22785.654.7393.5985.994.73
2169162-16916281.51381.84
3173812-17381283.75484.10
4179321-17932186.40986.76
5174157-17415783.92084.26
6176499-17649985.04985.40
30min1197444-19744495.14288.333.9895.6488.803.97
2177087-17708785.33285.78
3182224-18222487.80888.28
4183212-18321288.28488.76
5178889-17888986.20186.67
6180945-18094587.19187.67
45min1197800-19780095.31391.352.6495.9591.962.64
2190664-19066491.87592.45
3187730-18773090.46191.06
4191884-19188492.46293.07
5184850-18485089.07389.67
6184541-18454188.92489.53
极限1199106-19910695.94295.262.0096.7396.001.99
2202578-20257897.61598.33
3195490-19549094.20094.94
4196287-19628794.58495.33
5191784-19178492.41493.14
6200918-20091896.81697.56
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%
112.602107072115262107742114152115582111960.20
212.662089412079752084580.33
单位质量响应值RSD%判断
16761.5916465.881.26数据可信
供试品溶液-1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%
5min1135680-13568065.66667.175.1965.6767.175.19
2137391-13739166.49466.49
3137313-13731366.45666.46
4134659-13465965.17265.17
5134437-13443765.06465.06
6153261-15326174.17574.17
10min1154606-15460674.82577.184.7574.9277.284.75
2158960-15896076.93377.03
3158993-15899376.94977.05
4150954-15095473.05873.16
5160044-16004477.45777.55
6173227-17322783.83883.95
15min1164447-16444779.58881.073.5779.8081.293.57
2167354-16735480.99581.21
3169119-16911981.84982.06
4158943-15894376.92477.13
5168117-16811781.36481.58
6177109-17710985.71685.95
20min1166473-16647380.56983.382.8680.9083.722.87
2173464-17346483.95284.29
3175310-17531084.84685.18
4166629-16662980.64480.97
5172891-17289183.67584.01
6178966-17896686.61586.98
30min1173046-17304683.75085.712.4884.2086.182.49
2177446-17744685.87986.34
3179583-17958386.91487.38
4171541-17154183.02283.47
5177398-17739885.85686.32
6183616-18361688.86689.36
45min1177928-17792886.11387.792.1786.6988.382.18
2184187-18418789.14289.73
3184413-18441389.25189.85
4175536-17553684.95585.52
5181195-18119587.69488.28
6185114-18511489.59190.22
极限1198224-19822495.93693.332.2996.6494.052.28
2193077-19307793.44594.17
3196468-19646895.08695.82
4189471-18947191.69992.39
5186274-18627490.15290.87
6193482-19348293.64194.40
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