恩格列净片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DC033-12306002对照品来源分装对照品使用方法直接使用
对照品含量(%)98.99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%
110.135683645698495695935696225697965694450.11
210.255727465729405728430.03
单位质量响应值RSD%判断
56213.7255887.120.42数据可信
供试品溶液-2024053011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%
5min1443574-44357470.50673.003.0370.5173.003.03
2459412-45941273.02373.02
3444313-44431370.62370.62
4458139-45813972.82172.82
5475735-47573575.61875.62
6474248-47424875.38175.38
10min1553422-55342287.96689.081.2688.0889.201.27
2558526-55852688.77788.90
3555548-55554888.30488.42
4561547-56154789.25889.38
5559890-55989088.99489.12
6573466-57346691.15291.28
15min1567232-56723290.16191.461.2590.4391.731.25
2580487-58048792.26892.54
3570449-57044990.67290.94
4575189-57518991.42691.70
5572241-57224190.95791.23
6586858-58685893.28193.56
20min1568526-56852690.36792.111.4690.7892.531.46
2589508-58950893.70294.13
3574503-57450391.31791.73
4578653-57865391.97692.40
5576335-57633591.60892.03
6589421-58942193.68894.12
30min1571385-57138590.82192.701.6891.3993.281.68
2596471-59647194.80995.39
3576887-57688791.69692.26
4582309-58230992.55893.13
5578919-57891992.01992.60
6593359-59335994.31494.90
45min1578737-57873791.99093.401.4392.7194.131.43
2600086-60008695.38396.12
3585027-58502792.99093.71
4584778-58477892.95093.68
5581315-58131592.40093.13
6595626-59562694.67495.42
60min1575386-57538691.45793.411.7792.3394.301.76
2603725-60372595.96296.86
3581933-58193392.49893.37
4585866-58586693.12394.01
5583123-58312392.68793.57
6596041-59604194.74095.64
极限1604437-60443796.07597.790.9797.1098.830.97
2616536-61653697.99899.05
3619278-61927898.43499.46
4618093-61809398.24599.29
5612508-61250897.35898.40
6620383-62038398.60999.67
恩格列净片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DC033-12306002对照品来源分装对照品使用方法直接使用
对照品含量(%)98.99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%
110.135725295721015720635720365725715722600.05
210.255711415706755709080.06
单位质量响应值RSD%判断
56491.6155698.341.00数据可信
供试品溶液-2024053011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%
5min1439328-43932869.77869.914.1969.7869.914.19
2438017-43801769.57069.57
3410883-41088365.26065.26
4435593-43559369.18569.19
5466649-46664974.11874.12
6450567-45056771.56371.56
10min1560008-56000888.94689.461.8789.0689.571.87
2552675-55267587.78187.90
3554814-55481488.12188.23
4575644-57564491.42991.54
5576944-57694491.63691.76
6559270-55927088.82988.95
15min1581137-58113792.30292.331.7992.5792.601.79
2569155-56915590.39990.66
3574923-57492391.31591.57
4592104-59210494.04494.31
5595457-59545794.57694.85
6575288-57528891.37391.64
20min1586765-58676593.19693.062.0593.6193.472.05
2572245-57224590.88991.30
3579333-57933392.01592.42
4594763-59476394.46694.89
5604424-60442496.00096.43
6577788-57778891.77092.19
30min1593414-59341494.25293.992.4894.8394.562.48
2573054-57305491.01891.58
3589043-58904393.55794.12
4598493-59849395.05895.64
5615284-61528497.72598.32
6581140-58114092.30292.87
45min1597875-59787594.96094.512.4695.6995.252.45
2575029-57502991.33292.05
3597061-59706194.83195.55
4603484-60348495.85196.59
5615151-61515197.70498.46
6581810-58181092.40993.14
60min1601814-60181495.58694.802.5896.4795.692.57
2575806-57580691.45592.32
3600337-60033795.35196.23
4606602-60660296.34697.25
5615713-61571397.79398.71
6581099-58109992.29693.18
极限1605438-60543896.16296.831.2397.2197.871.24
2598890-59889095.12196.14
3607185-60718596.43997.47
4618737-61873798.27499.33
5617274-61727498.04199.12
6610219-61021996.92197.96
恩格列净片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DC033-12306002对照品来源分装对照品使用方法直接使用
对照品含量(%)98.99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%
110.135756665753815747205748395747085750630.08
210.255750735744625747680.08
单位质量响应值RSD%判断
56768.3156074.930.87数据可信
供试品溶液-F56971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%
5min1377590-37759059.62554.6612.1059.6254.6612.09
2308076-30807648.64848.65
3394986-39498662.37262.37
4316073-31607349.91149.91
5301540-30154047.61647.62
6378451-37845159.76159.76
10min1500945-50094579.10375.246.1179.2075.336.11
2446818-44681870.55670.64
3506878-50687880.04080.14
4464141-46414173.29273.37
5441828-44182869.76869.85
6498222-49822278.67378.77
15min1524032-52403282.74980.113.9982.9880.334.00
2491999-49199977.69177.89
3530128-53012883.71283.95
4499420-49942078.86379.07
5478964-47896475.63275.83
6519418-51941882.02082.25
20min1532422-53242284.07482.133.0584.4482.483.07
2512825-51282580.97981.31
3542809-54280985.71486.09
4508570-50857080.30780.64
5500344-50034479.00879.33
6523851-52385182.72083.09
30min1540321-54032185.32184.762.9085.8385.242.89
2533038-53303884.17184.63
3558539-55853988.19888.72
4514389-51438981.22681.70
5547212-54721286.40986.86
6526933-52693383.20783.71
45min1546520-54652086.30086.323.6586.9586.953.64
2551704-55170487.11987.72
3571338-57133890.21990.89
4518028-51802881.80182.41
5562467-56246788.81889.42
6529789-52978983.65884.30
60min1549463-54946386.76587.034.0187.5687.803.98
2563818-56381889.03189.78
3577259-57725991.15491.97
4520036-52003682.11882.86
5565483-56548389.29490.04
6530799-53079983.81884.60
极限1603491-60349195.29695.781.8196.2496.701.81
2611905-61190596.62597.52
3622719-62271998.33299.30
4591480-59148093.40094.28
5610616-61061696.42197.32
6599053-59905394.59595.52
恩格列净片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DC033-12306002对照品来源分装对照品使用方法直接使用
对照品含量(%)98.99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%
110.135740965733235732045728235728375732570.10
210.255785695794245789960.11
单位质量响应值RSD%判断
56590.0356487.410.13数据可信
供试品溶液-F56971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%
5min1389569-38956961.38657.478.4061.3957.478.40
2357723-35772356.36856.37
3368519-36851958.07058.07
4307796-30779648.50148.50
5390868-39086861.59161.59
6373673-37367358.88258.88
10min1500619-50061978.88579.523.5978.9979.623.60
2511013-51101380.52380.62
3513366-51336680.89480.99
4471177-47117774.24674.33
5524118-52411882.58882.69
6507499-50749979.96980.07
15min1533781-53378184.11184.542.6984.3484.772.70
2541985-54198585.40385.63
3543199-54319985.59585.83
4509340-50934080.25980.46
5550962-55096286.81887.06
6539814-53981485.06185.29
20min1543786-54378685.68786.112.5386.0686.482.54
2554275-55427587.34087.71
3551302-55130286.87287.25
4520232-52023281.97682.31
5558853-55885388.06188.45
6550498-55049886.74587.12
30min1540369-54036985.14987.972.7185.6788.482.71
2566678-56667889.29489.81
3569362-56936289.71790.24
4537598-53759884.71285.19
5570702-57070289.92990.46
6564917-56491789.01789.53
45min1568696-56869689.61289.413.3990.2790.073.39
2576188-57618890.79391.46
3570258-57025889.85990.53
4529639-52963983.45884.07
5582547-58254791.79592.48
6577247-57724790.96091.63
60min1578194-57819491.10990.273.6591.9291.083.65
2582077-58207791.72192.54
3572745-57274590.25091.07
4531649-53164983.77584.53
5589002-58900292.81293.65
6583404-58340491.93092.75
极限1602400-60240094.92396.131.6195.8897.091.62
2614601-61460196.84697.82
3625158-62515898.50999.48
4596915-59691594.05994.95
5611037-61103796.28497.27
6610158-61015896.14697.12
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