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%
110.209613696913961769603596225962970.37
210.099664397044968440.30
单位质量响应值RSD%判断
9440.889598.021.17数据可信
供试品溶液-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%
5min143847-4384741.03841.967.3841.0441.967.39
239024-3902436.52436.52
344594-4459441.73841.74
447872-4787244.80644.81
545634-4563442.71142.71
648003-4800344.92844.93
10min182942-8294277.62976.295.6677.7076.365.66
275305-7530570.48270.54
379394-7939474.30974.38
480514-8051475.35775.43
581664-8166476.43376.50
689269-8926983.55183.63
15min195058-9505888.96989.773.1989.1789.973.19
292187-9218786.28286.46
395119-9511989.02689.22
494032-9403288.00988.21
598756-9875692.43092.63
6100353-10035393.92594.14
20min197170-9717090.94692.021.0291.2992.371.03
298157-9815791.87092.19
398387-9838792.08592.43
497800-9780091.53691.88
598224-9822491.93392.29
6100162-10016293.74694.12
30min197088-9708890.86992.501.2891.3793.001.27
299615-9961593.23493.71
398310-9831092.01392.51
498594-9859492.27992.78
598577-9857792.26392.77
6100792-10079294.33694.86
45min197757-9775791.49592.821.2292.1493.481.22
2100311-10031193.88694.52
398804-9880492.47593.12
498749-9874992.42493.08
598470-9847092.16392.82
6100961-10096194.49495.18
60min197909-9790991.63892.871.1592.4493.671.15
2100287-10028793.86394.65
398518-9851892.20893.01
499020-9902092.67893.48
598702-9870292.38093.19
6100886-10088694.42495.27
极限198766-9876692.44093.591.4393.3994.551.43
2101287-10128794.79995.74
398877-9887792.54493.50
499748-9974893.35994.32
599070-9907092.72493.69
6102200-10220095.65496.65
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(%)100对照品水分(%)0对照品稀释倍数10
标示量(mg)1000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%
110.121091479109099410931081089558108932010908920.15
210.091096172109549010958310.05
单位质量响应值RSD%判断
107795.65108605.650.53数据可信
供试品溶液-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%
5min1669468-66946855.68656.536.2255.6956.536.22
2603420-60342050.19250.19
3680321-68032156.58956.59
4714970-71497059.47159.47
5689371-68937157.34257.34
6720340-72034059.91859.92
10min11089017-108901790.58488.494.5990.6888.584.59
2995843-99584382.83482.92
31039070-103907086.43086.52
41053687-105368787.64687.74
51064466-106446688.54288.64
61140738-114073894.88794.99
15min11189217-118921798.91999.042.1799.1699.282.18
21157252-115725296.26096.48
31180303-118030398.17898.42
41178395-117839598.01998.26
51207177-1207177100.413100.66
61231713-1231713102.454102.71
20min11200380-120038099.848100.470.71100.26100.870.71
21211715-1211715100.790101.17
31200588-120058899.865100.27
41205994-1205994100.315100.72
51205098-1205098100.240100.65
61223072-1223072101.735102.16
30min11197577-119757799.614100.530.82100.19101.110.82
21220263-1220263101.501102.05
31202060-120206099.987100.56
41207667-1207667100.454101.03
51202939-1202939100.060100.64
61221161-1221161101.576102.17
45min11200592-120059299.865100.560.73100.61101.300.73
21218148-1218148101.326102.04
31207570-1207570100.446101.18
41207866-1207866100.470101.21
51198971-119897199.730100.47
61220247-1220247101.500102.27
60min11201108-120110899.908100.380.72100.82101.290.72
21213920-1213920100.974101.86
31200161-120016199.829100.73
41206358-1206358100.345101.26
51198788-119878899.715100.63
61220345-1220345101.508102.45
极限11196616-119661699.534100.260.98100.61101.340.98
21215354-1215354101.093102.15
31197012-119701299.567100.64
41202951-1202951100.061101.14
51195906-119590699.475100.55
61223997-1223997101.812102.92
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%
110.209673096569962389659196830965920.24
210.099663496724966790.07
单位质量响应值RSD%判断
9469.809581.670.84数据可信
供试品溶液-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%
5min138393-3839335.90934.337.4035.9134.327.40
237839-3783935.39135.39
340032-4003237.44237.44
436675-3667534.30234.30
532463-3246330.36330.36
634805-3480532.55332.55
10min174478-7447869.65968.585.3369.7268.635.33
272561-7256167.86667.93
379287-7928774.15774.22
474561-7456169.73769.79
567484-6748463.11863.17
671549-7154966.92066.97
15min190262-9026284.42284.881.7584.6085.051.76
292843-9284386.83687.01
391861-9186185.91786.10
491016-9101685.12785.30
588226-8822682.51882.67
690276-9027684.43584.60
20min195774-9577489.57789.861.6189.8990.171.60
298923-9892392.52392.84
394312-9431288.21088.54
495741-9574189.54689.86
596261-9626190.03390.33
695415-9541589.24289.55
30min197077-9707790.79690.451.4491.2690.911.43
299144-9914492.72993.20
395089-9508988.93789.41
496687-9668790.43190.90
595806-9580689.60790.05
696432-9643290.19390.65
45min197105-9710590.82290.611.3091.4491.221.30
299128-9912892.71493.34
395365-9536589.19589.82
496767-9676790.50691.12
596235-9623590.00890.60
696675-9667590.42091.03
60min196788-9678890.52690.571.2991.2991.331.28
299118-9911892.70593.49
395439-9543989.26490.04
496960-9696090.68791.45
596476-9647690.23490.98
696216-9621689.99190.75
极限198665-9866592.28191.641.0693.2092.561.05
299533-9953393.09394.03
396518-9651890.27391.20
497606-9760691.29192.21
598005-9800591.66492.56
697566-9756691.25392.16
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(%)100对照品水分(%)0对照品稀释倍数10
标示量(mg)1000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%
110.121098141109374610956191097590109552910961250.17
210.091092821109449210936560.11
单位质量响应值RSD%判断
108312.75108390.090.06数据可信
供试品溶液-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%
5min1594945-59494549.41847.615.6549.4247.615.65
2587865-58786548.83048.83
3611568-61156850.79950.80
4570009-57000947.34747.35
5521508-52150843.31843.32
6553265-55326545.95645.96
10min1986803-98680381.96781.494.2682.0581.574.26
2966127-96612780.24980.33
31052049-105204987.38687.47
4988179-98817982.08182.16
5924531-92453176.79476.87
6968459-96845980.44380.52
15min11142735-114273594.91995.181.0895.1495.401.08
21151903-115190395.68195.90
31163126-116312696.61396.84
41148900-114890095.43195.65
51126072-112607293.53593.74
61142688-114268894.91595.13
20min11188182-118818298.69499.060.8699.0799.430.85
21209808-1209808100.490100.86
31184684-118468498.40398.79
41183283-118328398.28798.66
51199707-119970799.651100.01
61189992-118999298.84499.21
30min11192147-119214799.02399.050.5899.5799.590.57
21204557-1204557100.054100.60
31185411-118541198.46499.02
41190113-119011398.85499.39
51187660-118766098.65199.17
61195035-119503599.26399.80
45min11189558-118955898.80899.030.5199.5299.740.50
21203236-120323699.944100.65
31185258-118525898.45199.17
41190751-119075198.90799.61
51191851-119185198.99999.69
61192892-119289299.08599.78
60min11188451-118845198.71698.910.3899.5999.780.37
21198518-119851899.553100.43
31187020-118702098.59899.48
41189397-118939798.79599.66
51193768-119376899.158100.01
61187856-118785698.66799.53
极限11186255-118625598.53498.710.5599.5799.750.54
21199656-119965699.647100.69
31180913-118091398.09099.14
41187675-118767598.65299.68
51191001-119100198.92899.95
61184861-118486198.41899.45
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%
110.209665496370967789639095985964350.32
210.099658096664966220.07
单位质量响应值RSD%判断
9454.419576.020.91数据可信
供试品溶液-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%
5min132608-3260830.53238.4218.7030.5338.4218.71
244107-4410741.29941.30
339499-3949936.98436.98
437028-3702834.67134.67
554736-5473651.25151.25
638237-3823735.80335.80
10min170545-7054566.05473.688.6766.1073.758.68
284270-8427078.90578.97
377622-7762272.68072.74
475261-7526170.47070.53
589203-8920383.52483.61
675266-7526670.47470.53
15min189256-8925683.57486.992.6183.7387.172.63
294835-9483588.79889.00
393659-9365987.69787.88
491063-9106385.26685.44
595784-9578489.68689.91
692801-9280186.89387.07
20min195239-9523989.17689.411.2789.4889.741.27
295788-9578889.69090.04
397348-9734891.15191.48
493709-9370987.74388.06
595904-9590489.79990.17
694923-9492388.88089.20
30min195237-9523789.17489.651.5189.6290.131.52
295514-9551489.43389.93
398305-9830592.04792.53
494028-9402888.04288.51
596225-9622590.09990.62
695138-9513889.08189.55
45min195441-9544189.36589.961.4889.9690.581.48
295308-9530889.24189.89
398607-9860792.33092.96
494478-9447888.46389.07
596185-9618590.06290.74
696412-9641290.27490.89
60min196315-9631590.18390.161.3290.9390.941.32
295629-9562989.54190.34
398446-9844692.17992.97
494647-9464788.62289.38
596699-9669990.54391.37
696023-9602389.91090.68
极限196437-9643790.29891.081.4391.1992.011.42
296432-9643290.29391.24
3100050-10005093.68194.62
497175-9717590.98991.89
596787-9678790.62591.60
696757-9675790.59791.52
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(%)100对照品水分(%)0对照品稀释倍数10
标示量(mg)1000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%
110.121094107109352410935131095242108934010931450.21
210.091097275109505110961630.15
单位质量响应值RSD%判断
108018.28108638.550.41数据可信
供试品溶液-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%
5min1519334-51933443.14751.6515.3043.1551.6515.30
2660704-66070454.89254.89
3594862-59486249.42249.42
4572726-57272647.58347.58
5792361-79236165.83065.83
6590182-59018249.03349.03
10min1960772-96077279.82286.906.3479.8986.996.35
21105175-110517591.81991.91
31025309-102530985.18485.27
41022600-102260084.95985.04
51143283-114328394.98695.10
61018721-101872184.63784.72
15min11149586-114958695.50997.991.4395.7198.221.45
21191607-119160799.00099.24
31174007-117400797.53897.76
41176552-117655297.75097.97
51193189-119318999.13299.40
61191635-119163599.00399.23
20min11198422-119842299.56799.560.6599.9399.950.64
21193525-119352599.16099.57
31205782-1205782100.178100.56
41193233-119323399.13599.52
51189657-118965798.83899.27
61209316-1209316100.472100.86
30min11197444-119744499.48599.490.60100.02100.060.59
21191083-119108398.95799.53
31208085-1208085100.369100.92
41193902-119390299.19199.74
51190637-119063798.92099.52
61204209-1204209100.047100.60
45min11196339-119633999.39399.560.87100.09100.280.85
21191057-119105798.95599.69
31211899-1211899100.686101.41
41193665-119366599.17199.89
51186911-118691198.61099.37
61210073-1210073100.535101.26
60min11207146-1207146100.29199.570.65101.15100.460.63
21189420-118942098.81999.72
31205289-1205289100.137101.03
41195182-119518299.297100.18
51190684-119068498.92499.85
61203059-120305999.952100.84
极限11190501-119050198.90899.240.8499.94100.300.82
21185140-118514098.46399.53
31204347-1204347100.059101.11
41204876-1204876100.103101.15
51182072-118207298.20899.30
61200202-120020299.714100.77
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%
110.209668396685966089646096613966100.10
210.099726397322972920.05
单位质量响应值RSD%判断
9471.579642.421.27数据可信
供试品溶液-24080502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%
5min135289-3528932.89935.497.0032.9035.497.01
237857-3785735.29335.29
341786-4178638.95638.96
440696-4069637.94037.94
535563-3556333.15533.15
637222-3722234.70134.70
10min172077-7207767.19670.344.9367.2570.404.93
274707-7470769.64869.71
381269-8126975.76675.83
478734-7873473.40273.47
573122-7312268.17068.23
672784-7278467.85567.91
15min191397-9139785.20886.832.2685.3787.002.26
292347-9234786.09386.27
395774-9577489.28889.48
494183-9418387.80587.99
594745-9474588.32988.50
690355-9035584.23684.41
20min197048-9704890.47691.040.8690.7891.360.86
297539-9753990.93491.25
398077-9807791.43591.78
497712-9771291.09591.43
598959-9895992.25892.57
696561-9656190.02290.33
30min198356-9835691.69692.120.6392.1692.600.63
298753-9875392.06692.54
398967-9896792.26592.76
498766-9876692.07892.56
599902-9990293.13793.61
698139-9813991.49391.95
45min199087-9908792.37792.620.9292.9993.240.91
299622-9962292.87693.50
399551-9955192.81093.46
498866-9886692.17192.81
5100816-10081693.98994.61
698115-9811591.47192.08
60min199486-9948692.74992.750.7593.5293.530.75
299901-9990193.13693.91
399344-9934492.61793.42
499032-9903292.32693.12
5100657-10065793.84194.62
698490-9849091.82092.59
极限1101141-10114194.29294.200.2395.2195.140.23
2100972-10097294.13495.07
3100837-10083794.00994.96
4100774-10077493.95094.89
5101401-10140194.53495.47
6101157-10115794.30795.23
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(%)100对照品水分(%)0对照品稀释倍数10
标示量(mg)1000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%
110.121096637109848910937181099223109299510962120.26
210.091096326109614710962360.02
单位质量响应值RSD%判断
108321.34108645.790.22数据可信
供试品溶液-24080502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%
5min1539051-53905144.72147.395.5644.7247.395.56
2567493-56749347.08047.08
3614193-61419350.95550.95
4605576-60557650.24050.24
5543515-54351545.09145.09
6557452-55745246.24746.25
10min1947490-94749078.60681.564.1178.6881.644.11
2973742-97374280.78480.86
31045615-104561586.74686.83
41020186-102018684.63784.72
5958804-95880479.54479.62
6953114-95311479.07279.15
15min11141555-114155594.70695.381.7994.9195.601.80
21139196-113919694.51094.72
31175434-117543497.51697.75
41166619-116661996.78597.01
51156621-115662195.95696.16
61118975-111897592.83293.04
20min11192734-119273498.95298.430.5799.3298.810.58
21182357-118235798.09198.46
31191367-119136798.83899.23
41188399-118839998.59298.98
51189207-118920798.65999.03
61174870-117487097.47097.83
30min11191557-119155798.85498.780.2199.3899.320.22
21189576-118957698.69099.22
31190974-119097498.80699.36
41192654-119265498.94599.50
51193036-119303698.97799.51
61186284-118628498.41798.94
45min11191150-119115098.82098.650.3799.5199.360.38
21188477-118847798.59999.30
31191563-119156398.85599.58
41191797-119179798.87499.59
51191125-119112598.81899.52
61180598-118059897.94598.63
60min11189890-118989098.71698.640.1699.5799.500.16
21188997-118899798.64299.50
31188365-118836598.58999.48
41190417-119041798.75999.64
51190418-119041898.76099.62
61185708-118570898.36999.22
极限11191635-119163598.86098.520.2799.8899.560.26
21187086-118708698.48399.51
31185561-118556198.35799.41
41186716-118671698.45299.50
51183333-118333398.17299.20
61191020-119102098.80999.83
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