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200
标示量(mg)50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%
110.212831896283383028377212839265284060428366630.13
210.292825252282548528253680.01
单位质量响应值RSD%判断
277831.83274574.150.84数据可信
供试品溶液-2024052911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%
5min12081384-208138467.13967.872.8267.1467.872.81
22127072-212707268.61268.61
32081511-208151167.14367.14
42009452-200945264.81864.82
52153174-215317469.45469.45
62171663-217166370.05170.05
10min12515113-251511381.12981.691.6981.2481.801.69
22511943-251194381.02781.14
32530278-253027881.61981.73
42475421-247542179.84979.96
52566214-256621482.77882.89
62595511-259551183.72383.84
15min12604414-260441484.01085.011.5284.2685.261.52
22604748-260474884.02184.27
32633322-263332284.94285.19
42607213-260721384.10084.34
52657568-265756885.72485.98
62704570-270457087.24187.50
20min12633648-263364884.95386.141.4385.3486.541.43
22635410-263541085.01085.40
32670031-267003186.12786.52
42662830-266283085.89486.28
52684351-268435186.58886.99
62736899-273689988.28388.69
30min12655415-265541585.65586.871.4086.1887.401.40
22656726-265672685.69786.23
32698500-269850087.04587.58
42688579-268857986.72587.25
52701102-270110287.12987.67
62757852-275785288.95989.51
45min12667762-266776286.05387.241.4486.7287.921.44
22664601-266460185.95186.63
32713929-271392987.54388.22
42698787-269878787.05487.72
52712005-271200587.48088.17
62770680-277068089.37390.07
60min12669219-266921986.10087.481.6586.9288.311.65
22669339-266933986.10486.92
32720504-272050487.75588.58
42708224-270822487.35888.17
52714587-271458787.56488.40
62790776-279077690.02190.87
极限13003083-300308396.87097.330.8097.8398.300.80
23015724-301572497.27798.24
33016181-301618197.29298.26
43016541-301654197.30498.26
52990749-299074996.47297.45
63061649-306164998.75999.75
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200
标示量(mg)50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%
110.212842797284280428439202843807284440028435460.03
210.292825214282544628253300.01
单位质量响应值RSD%判断
278505.97274570.461.01数据可信
供试品溶液-2024052911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%
5min12104698-210469867.80966.471.6067.8166.471.60
22059564-205956466.35566.36
32066391-206639166.57566.58
42007052-200705264.66464.66
52084756-208475667.16767.17
62056110-205611066.24466.24
10min12697852-269785286.92082.952.7087.0383.062.70
22600024-260002483.76883.88
32547417-254741782.07382.18
42497797-249779780.47480.58
52569606-256960682.78882.90
62534442-253444281.65581.77
15min12841788-284178891.55786.992.9791.8287.242.97
22733679-273367988.07488.32
32671440-267144086.06986.32
42617347-261734784.32684.57
52691438-269143886.71386.96
62644305-264430585.19585.44
20min12886306-288630692.99188.143.1193.4088.543.10
22759798-275979888.91689.31
32718205-271820587.57687.97
42644273-264427385.19485.58
52735462-273546288.13288.53
62671080-267108086.05786.45
30min12921603-292160394.12989.123.3194.6989.663.31
22805041-280504190.37390.92
32734960-273496088.11588.65
42673337-267333786.13086.65
52775662-277566289.42789.97
62685850-268585086.53387.07
45min12965842-296584295.55489.743.7896.2890.423.78
22835729-283572991.36292.06
32745259-274525988.44789.13
42682428-268242886.42387.09
52786571-278657189.77890.47
62695589-269558986.84787.52
60min12975161-297516195.85489.883.7296.7490.723.71
22821923-282192390.91791.77
32755006-275500688.76189.59
42688724-268872486.62687.44
52790607-279060789.90890.75
62707603-270760387.23488.05
极限13054851-305485198.42297.670.5499.4698.660.55
23047629-304762998.18999.19
33020961-302096197.33098.31
43029791-302979197.61498.57
53018632-301863297.25598.24
63016900-301690097.19998.17
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200
标示量(mg)50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%
110.212823849282532028249722825295282591528250700.03
210.292833681283305728333690.02
单位质量响应值RSD%判断
276696.38275351.700.35数据可信
供试品溶液-F56971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%
5min12074831-207483166.96965.892.5266.9765.882.52
22056098-205609866.36466.36
32064849-206484966.64766.65
41975535-197553563.76463.76
52096824-209682467.67967.68
61979489-197948963.89163.89
10min12587795-258779583.52682.161.5983.6482.271.59
22577175-257717583.18383.29
32549810-254981082.30082.41
42476940-247694079.94880.05
52557429-255742982.54582.66
62524329-252432981.47781.58
15min12738718-273871888.39786.591.3088.6586.841.30
22699718-269971887.13887.39
32677954-267795486.43686.68
42635381-263538185.06185.30
52664851-266485186.01386.26
62680662-268066286.52386.77
20min12780827-278082789.75688.280.9890.1588.670.97
22739249-273924988.41488.81
32719512-271951287.77788.17
42716399-271639987.67688.06
52708471-270847187.42187.81
62745643-274564388.62089.01
30min12830613-283061391.36390.591.3791.9191.131.35
22776829-277682989.62790.17
32757974-275797489.01889.56
42822350-282235091.09691.62
52790923-279092390.08290.62
62861127-286112792.34892.88
45min12879566-287956692.94392.391.9893.6493.081.97
22799127-279912790.34791.04
32785395-278539589.90390.59
42897467-289746793.52194.20
52888246-288824693.22393.91
62924677-292467794.39995.09
60min12883281-288328193.06393.342.5993.9294.182.56
22814379-281437990.83991.68
32797769-279776990.30391.14
42947182-294718295.12595.96
52921330-292133094.29195.14
62986622-298662296.39897.24
极限13054235-305423598.58198.000.5899.5999.000.58
23046853-304685398.34299.34
33011343-301134397.19698.18
43053387-305338798.55399.55
53026626-302662697.69098.69
63025908-302590897.66698.67
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200
标示量(mg)50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%
110.212821852282154028218012821460282163628216580.01
210.292843063284216128426120.03
单位质量响应值RSD%判断
276362.19276249.950.03数据可信
供试品溶液-F56971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%
5min12073104-207310466.84466.262.0866.8466.262.07
22112341-211234168.10968.11
32005823-200582364.67564.67
42025065-202506565.29565.30
52089735-208973567.38167.38
62024780-202478065.28665.29
10min12605315-260531584.00582.811.9184.1282.921.91
22606482-260648284.04284.16
32499856-249985680.60480.71
42512057-251205780.99881.11
52601806-260180683.89284.00
62583225-258322583.29283.40
15min12779761-277976189.62987.562.3589.8887.812.35
22727972-272797287.96088.21
32612697-261269784.24384.48
42665972-266597285.96186.20
52746429-274642988.55588.81
62760682-276068289.01489.26
20min12842350-284235091.64889.752.3792.0590.142.37
22784866-278486689.79490.19
32672364-267236486.16786.55
42744811-274481188.50388.89
52813866-281386690.72991.13
62842128-284212891.64092.04
30min12924972-292497294.31292.222.1294.8792.762.12
22871615-287161592.59193.14
32751725-275172588.72589.25
42846693-284669391.78892.32
52860479-286047992.23292.78
62904636-290463693.65694.20
45min12972288-297228895.83793.871.9296.5594.561.92
22920850-292085094.17994.88
32813674-281367490.72391.40
42944429-294442994.93995.63
52884362-288436293.00293.71
62931161-293116194.51195.22
60min12988938-298893896.37494.371.9797.2495.221.96
22952281-295228195.19296.05
32832136-283213691.31892.14
42963571-296357195.55696.40
52886921-288692193.08593.94
62936436-293643694.68195.54
极限13031647-303164797.75196.940.8098.7897.950.79
23013354-301335497.16198.18
33009198-300919897.02798.00
43028752-302875297.65898.66
52974988-297498895.92496.94
62980752-298075296.11097.13
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