二甲双胍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对照品来源中检院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2000
标示量(mg)5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%
110.469702597281971669721797295971970.12
210.559750697731976180.17
单位质量响应值RSD%判断
9292.269252.890.31数据可信
供试品溶液-24030501-1批-恩格列净-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%
5min141589-4158939.95948.3313.6839.9648.3313.68
243600-4360041.89141.89
354932-5493252.77952.78
455412-5541253.24053.24
558242-5824255.95955.96
648022-4802246.14046.14
10min186090-8609082.71686.416.7682.7886.496.76
280897-8089777.72677.80
395820-9582092.06492.15
494559-9455990.85390.94
594929-9492991.20891.30
687301-8730183.87983.96
15min1100118-10011896.19495.591.2596.4095.821.25
297968-9796894.12894.33
3100352-10035296.41996.66
499539-9953995.63895.88
598035-9803594.19394.44
6100942-10094296.98697.20
20min1100630-10063096.68695.961.0497.0596.351.03
2100147-10014796.22296.58
3100749-10074996.80097.20
4100087-10008796.16496.56
597896-9789694.05994.46
699768-9976895.85896.24
30min1101378-10137897.40596.201.1297.9396.741.10
2100894-10089496.94097.46
3100603-10060396.66097.22
4100100-10010096.17796.74
598264-9826494.41394.97
699506-9950695.60696.14
45min1101063-10106397.10296.161.1097.7996.871.09
2101014-10101497.05597.73
3100644-10064496.69997.42
499985-9998596.06696.79
598153-9815394.30695.02
699664-9966495.75896.46
60min1101286-10128697.31696.081.1498.1796.941.12
2100701-10070196.75497.59
3100535-10053596.59597.48
499687-9968795.78096.66
598038-9803894.19595.07
699741-9974195.83296.69
极限1101577-10157797.59696.831.4298.6197.861.40
2102525-10252598.50799.51
3101349-10134997.37798.42
4100604-10060496.66197.70
598353-9835394.49895.53
6100270-10027096.34097.36
二甲双胍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DA-11412209074对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数20
标示量(mg)500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%
110.024762604768054772204766784769734767870.08
210.104799304801444800370.04
单位质量响应值RSD%判断
47583.5347528.420.09数据可信
供试品溶液-24030501-1批-二甲双胍-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%
5min1261280-26128049.39857.9611.4749.4057.9611.47
2273813-27381351.76751.77
3329864-32986462.36562.36
4329440-32944062.28462.28
5349718-34971866.11866.12
6295196-29519655.81055.81
10min1471018-47101889.05192.175.1689.1392.265.17
2451159-45115985.29785.38
3513322-51332297.04997.15
4505520-50552095.57495.68
5508369-50836996.11396.22
6475567-47556789.91190.00
15min1523259-52325998.92898.310.8899.1698.560.86
2520709-52070998.44698.67
3522710-52271098.82499.09
4516644-51664497.67797.94
5512551-51255196.90497.17
6524158-52415899.09899.34
20min1522697-52269798.82298.150.9799.2298.560.96
2525115-52511599.27999.67
3521926-52192698.67699.11
4516233-51623397.60098.03
5511529-51152996.71097.14
6517284-51728497.79898.21
30min1522536-52253698.79198.111.0399.3598.691.01
2525417-52541799.33699.89
3521847-52184798.66199.26
4515530-51553097.46798.06
5510984-51098496.60797.20
6517342-51734297.80998.38
45min1520942-52094298.49097.870.9899.2298.610.96
2524016-52401699.07199.79
3520472-52047298.40199.16
4514881-51488197.34498.10
5510240-51024096.46797.22
6515459-51545997.45398.19
60min1521546-52154698.60497.761.0599.4998.671.03
2523071-52307198.89399.78
3519921-51992198.29799.22
4513568-51356897.09698.01
5508837-50883796.20197.12
6515679-51567997.49598.39
极限1519265-51926598.17397.611.0199.2398.670.99
2522943-52294398.86899.92
3519569-51956998.23099.32
4513204-51320497.02798.10
5508971-50897196.22797.30
6513671-51367197.11598.17
二甲双胍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对照品来源中检院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2000
标示量(mg)5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%
110.469855798432982019844398393984050.14
210.559883898898988680.05
单位质量响应值RSD%判断
9407.749371.370.28数据可信
供试品溶液-24030501-2-1批-恩格列净-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%
5min152610-5261049.91850.6515.4749.9250.6515.47
252259-5225949.58549.59
352982-5298250.27150.27
457779-5777954.82354.82
539724-3972437.69137.69
664912-6491261.59161.59
10min192936-9293688.18188.319.1388.2688.409.13
290694-9069486.05486.14
395493-9549390.60790.69
497687-9768792.68992.78
578218-7821874.21674.28
6103417-10341798.12698.23
15min1100382-10038295.24696.192.3195.4896.432.31
2102231-10223197.00097.23
3105302-10530299.914100.15
4101398-10139896.21096.46
598271-9827193.24393.43
6100695-10069595.54395.81
20min1100769-10076995.61396.831.5096.0097.221.50
2102621-10262197.37097.76
3104899-10489999.53299.93
4101545-10154596.34996.76
5101421-10142196.23296.57
6101065-10106595.89496.32
30min1100735-10073595.58196.971.5896.1397.521.57
2102647-10264797.39597.94
3105094-10509499.717100.28
4101526-10152696.33196.90
5102320-10232097.08597.59
6100872-10087295.71196.30
45min1100311-10031195.17896.851.5995.8997.571.57
2102534-10253497.28898.00
3104845-10484599.481100.21
4101662-10166296.46097.19
5102367-10236797.12997.79
6100743-10074395.58896.33
60min1100566-10056695.42096.771.4496.2997.651.43
2102240-10224097.00997.88
3104562-10456299.212100.11
4101300-10130096.11797.00
5102457-10245797.21598.04
6100816-10081695.65896.56
极限1100366-10036695.23197.041.5996.2698.081.58
2102989-10298997.71998.76
3104930-10493099.561100.63
4101391-10139196.20397.25
5102677-10267797.42398.41
6101309-10130996.12597.19
二甲双胍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DA-11412209074对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数20
标示量(mg)500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%
110.024843464841354840424838924835334839900.07
210.104858994856664857820.04
单位质量响应值RSD%判断
48302.4048097.230.31数据可信
供试品溶液-24030501-2-1批-二甲双胍-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%
5min1317418-31741859.21059.9513.2659.2159.9413.26
2311844-31184458.17058.17
3319313-31931359.56459.56
4344450-34445064.25364.25
5252748-25274847.14747.15
6382397-38239771.33171.33
10min1500021-50002193.27293.046.7793.3793.146.78
2485683-48568390.59890.69
3510360-51036095.20195.30
4519436-51943696.89497.00
5439778-43977882.03582.11
6537316-537316100.229100.35
15min1520364-52036497.06798.211.4097.3298.471.40
2528091-52809198.50898.76
3540455-540455100.815101.07
4525156-52515697.96198.23
5523003-52300397.55997.77
6521970-52197097.36797.65
20min1521063-52106397.19798.301.2797.6198.721.27
2527708-52770898.43798.85
3538879-538879100.521100.95
4525006-52500697.93398.36
5528506-52850698.58698.96
6520621-52062197.11597.56
30min1519565-51956596.91898.251.3297.5098.841.30
2527569-52756998.41198.99
3538575-538575100.464101.06
4524461-52446197.83198.43
5529266-52926698.72899.27
6520876-52087697.16397.77
45min1519151-51915196.84198.171.3297.5898.921.31
2526920-52692098.29099.03
3538183-538183100.391101.15
4524827-52482797.90098.66
5528474-52847498.58099.29
6520046-52004697.00897.78
60min1519944-51994496.98998.131.2697.8999.041.25
2526041-52604198.12699.03
3537939-537939100.345101.27
4523976-52397697.74198.66
5528113-52811398.51399.38
6520387-52038797.07198.01
极限1518131-51813196.65197.971.3397.7199.041.32
2526137-52613798.14499.21
3537348-537348100.235101.33
4522795-52279597.52198.60
5527246-52724698.35199.39
6519487-51948796.90398.00
二甲双胍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对照品来源中检院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2000
标示量(mg)5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%
110.469742897648975949774797492975820.13
210.559901999367991930.25
单位质量响应值RSD%判断
9329.069402.180.56数据可信
供试品溶液-24030501-2-2批-恩格列净-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%
5min150818-5081848.34245.2514.9648.3445.2514.95
252588-5258850.02550.03
350307-5030747.85647.86
451120-5112048.62948.63
547043-4704344.75144.75
633541-3354131.90731.91
10min192312-9231287.81482.559.7887.8982.639.78
291090-9109086.65186.73
390724-9072486.30386.38
491215-9121586.77086.85
585092-8509280.94581.02
670270-7027066.84666.90
15min1102742-10274297.73595.274.4197.9695.484.43
2101036-10103696.11396.34
399778-9977894.91695.14
4104831-10483199.72399.95
5100597-10059795.69595.90
691921-9192187.44287.61
20min1102552-10255297.55596.802.2897.9497.172.29
2101041-10104196.11796.51
399736-9973694.87695.26
4105636-105636100.488100.88
5102338-10233897.35197.72
699248-9924894.41294.72
30min1103123-10312398.09897.192.0598.6597.722.06
2101232-10123296.29996.85
3100173-10017395.29295.83
4105713-105713100.562101.12
5102483-10248397.48998.02
6100303-10030395.41595.88
45min1102638-10263897.63697.111.8998.3597.801.90
2101275-10127596.34097.05
3100177-10017795.29595.99
4105322-105322100.190100.92
5102743-10274397.73698.43
6100345-10034595.45596.08
60min1102958-10295897.94197.042.0698.8297.902.06
2101232-10123296.29997.17
399490-9949094.64295.50
4105446-105446100.308101.20
5102370-10237097.38298.24
6100556-10055695.65696.44
极限1103822-10382298.76397.631.7599.8098.641.76
2101763-10176396.80497.83
3100586-10058695.68496.70
4105413-105413100.276101.34
5102919-10291997.90498.92
6101269-10126996.33497.28
二甲双胍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DA-11412209074对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数20
标示量(mg)500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%
110.024809114813714811164809584810764810860.04
210.104869964880174875060.15
单位质量响应值RSD%判断
48012.5748267.920.38数据可信
供试品溶液-24030501-2-2批-二甲双胍-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%
5min1312276-31227658.32354.8412.8858.3254.8412.88
2322033-32203360.14560.15
3307946-30794657.51457.51
4311217-31121758.12558.13
5288555-28855553.89353.89
6219798-21979841.05141.05
10min1500867-50086793.54688.888.3693.6488.978.37
2498572-49857293.11793.22
3493099-49309992.09592.19
4494160-49416092.29392.39
5470744-47074487.92088.01
6397726-39772674.28374.35
15min1534478-53447899.82398.273.21100.0898.513.22
2531006-53100699.17599.43
3521065-52106597.31897.57
4543873-543873101.578101.83
5531364-53136499.24299.48
6495166-49516692.48192.67
20min1533056-53305699.55899.111.6199.9899.521.62
2529869-52986998.96399.38
3520447-52044797.20397.61
4543603-543603101.528101.95
5534666-53466699.859100.26
6522360-52236097.56097.91
30min1532969-53296999.54299.041.55100.1399.611.56
2529102-52910298.81999.41
3520098-52009897.13897.71
4542801-542801101.378101.97
5533748-53374899.687100.26
6522977-52297797.67598.18
45min1532294-53229499.41698.811.48100.1799.541.48
2528890-52889098.78099.53
3519012-51901296.93597.67
4539939-539939100.843101.60
5532772-53277299.505100.24
6521360-52136097.37398.05
60min1531400-53140099.24998.741.61100.1799.641.62
2528513-52851398.70999.62
3517328-51732896.62097.52
4541600-541600101.154102.08
5531599-53159999.286100.19
6521609-52160997.42098.25
极限1530235-53023599.03198.491.46100.1199.551.47
2526849-52684998.39999.48
3517944-51794496.73597.79
4539101-539101100.687101.78
5529806-52980698.951100.02
6520035-52003597.12698.12
二甲双胍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对照品来源中检院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2000
标示量(mg)5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%
110.469779497933977929786197820978400.07
210.559898099317991480.25
单位质量响应值RSD%判断
9353.739397.910.34数据可信
供试品溶液-24030501-2-3批-恩格列净-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%
5min134611-3461132.88838.7313.1332.8938.7213.13
234931-3493133.19233.19
341433-4143339.37139.37
445507-4550743.24243.24
547694-4769445.32045.32
640351-4035138.34338.34
10min173458-7345869.80278.679.0769.8678.749.07
276759-7675972.93872.99
384523-8452380.31680.38
486082-8608281.79781.87
594705-9470589.99190.07
681245-8124577.20177.27
15min193567-9356788.91094.403.4489.0894.603.45
297329-9732992.48592.66
3101103-10110396.07196.27
4100981-10098195.95596.16
5103178-10317898.04298.27
699938-9993894.96495.16
20min199574-9957494.61896.621.2494.9496.981.26
2101250-10125096.21096.54
3102495-10249597.39397.75
4102027-10202796.94997.32
5103252-10325298.11398.50
6101506-10150696.45496.80
30min1100443-10044395.44496.981.0995.9297.501.11
2102263-10226397.17397.66
3102790-10279097.67498.20
4102022-10202296.94497.47
5103590-10359098.43498.99
6101259-10125996.21996.73
45min1101543-10154396.48997.520.8797.1298.200.89
2102217-10221797.12997.78
3103240-10324098.10198.79
4102383-10238397.28797.98
5104059-10405998.88099.60
6102347-10234797.25397.92
60min1101658-10165896.59897.200.5997.3998.040.61
2101827-10182796.75997.57
3103101-10310197.96998.82
4101936-10193696.86297.72
5102926-10292697.80398.68
6102303-10230397.21198.05
极限1102512-10251297.41097.820.4698.3798.820.48
2102483-10248397.38298.36
3103406-10340698.25999.27
4102874-10287497.75498.77
5103607-10360798.45099.49
6102769-10276997.65498.65
二甲双胍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DA-11412209074对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数20
标示量(mg)500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%
110.024814924816764817624818344817464817020.03
210.104872144885534878840.20
单位质量响应值RSD%判断
48074.0548305.350.34数据可信
供试品溶液-24030501-2-3批-二甲双胍-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%
5min1229172-22917242.75848.4410.5542.7648.4410.55
2228901-22890142.70742.71
3263079-26307949.08449.08
4282320-28232052.67452.67
5296345-29634555.29155.29
6257893-25789348.11748.12
10min1415138-41513877.45585.487.6477.5385.567.64
2427577-42757779.77679.85
3469930-46993087.67887.76
4469095-46909587.52287.61
5513426-51342695.79395.89
6453606-45360684.63284.71
15min1506310-50631094.46597.812.3094.6798.032.31
2513651-51365195.83596.04
3534153-53415399.66099.89
4526264-52626498.18898.42
5537534-537534100.291100.54
6527512-52751298.42198.64
20min1526878-52687898.30398.940.8998.6699.330.91
2526262-52626298.18898.55
3535446-53544699.901100.30
4527538-52753898.42698.82
5537082-537082100.207100.63
6528606-52860698.62599.01
30min1527874-52787498.48998.820.8299.0199.370.83
2526386-52638698.21198.74
3534088-53408899.648100.21
4526948-52694898.31698.88
5536135-536135100.030100.62
6526423-52642398.21898.77
45min1528281-52828198.56598.790.7499.2599.510.75
2527531-52753198.42599.12
3533654-53365499.567100.29
4524951-52495197.94398.67
5534925-53492599.804100.56
6527712-52771298.45999.17
60min1527399-52739998.40098.530.6699.2599.410.67
2525276-52527698.00498.86
3531467-53146799.159100.05
4524174-52417497.79898.69
5532953-53295399.436100.36
6527189-52718998.36199.24
极限1526095-52609598.15798.330.7399.1799.380.73
2525080-52508097.96798.99
3530818-53081899.038100.10
4522093-52209397.41098.46
5532266-53226699.308100.39
6525899-52589998.12099.16
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