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%
19.959460694519946209483094861946870.16
29.959399693854939250.11
单位质量响应值RSD%判断
9516.289439.700.58数据可信
供试品溶液-24071001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%
5min137846-3784635.57537.1013.3735.5737.1013.38
237687-3768735.42635.43
336065-3606533.90133.90
434386-3438632.32332.32
541862-4186239.35039.35
648965-4896546.02746.03
10min176421-7642171.83571.077.3071.8971.147.30
275510-7551070.97971.04
371776-7177667.46967.53
468818-6881864.68864.74
576036-7603671.47371.54
685111-8511180.00480.08
15min192470-9247086.92185.812.9287.1085.982.93
291911-9191186.39686.57
388203-8820382.91083.08
488873-8887383.54083.70
590720-9072085.27685.46
695527-9552789.79590.00
20min195367-9536789.64489.151.1489.9789.471.15
295017-9501789.31589.64
392951-9295187.37387.68
494596-9459688.92089.22
594882-9488289.18889.52
696208-9620890.43590.79
30min196094-9609490.32889.650.8890.8090.120.88
295182-9518289.47089.94
393834-9383488.20388.66
496037-9603790.27490.72
595439-9543989.71290.19
695639-9563989.90090.41
45min195759-9575990.01389.580.8290.6490.200.82
295292-9529289.57490.19
393765-9376588.13888.74
495798-9579890.04990.65
595638-9563889.89990.52
695552-9555289.81890.48
60min195647-9564789.90889.910.8290.6890.680.82
295994-9599490.23491.00
394141-9414188.49289.24
496240-9624090.46591.21
596174-9617490.40391.18
695714-9571489.97190.78
极限196056-9605690.29289.980.7491.2290.900.74
295473-9547389.74490.66
394465-9446588.79689.69
496437-9643790.65091.55
596166-9616690.39591.32
695765-9576590.01890.98
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)850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%
110.081081062108107910801971080198108327410811620.12
210.101073118107358810733530.04
单位质量响应值RSD%判断
107258.13106272.570.66数据可信
供试品溶液-24071001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%
5min1570151-57015156.54558.1610.5756.5458.1610.57
2564149-56414955.95055.95
3546477-54647754.19754.20
4524262-52426251.99451.99
5617536-61753661.24461.24
6695962-69596269.02269.02
10min1989355-98935598.11997.415.8698.2197.505.87
2979726-97972697.16497.26
3944484-94448493.66993.76
4909440-90944090.19490.28
5989127-98912798.09798.20
61080873-1080873107.196107.31
15min11142937-1142937113.351112.432.06113.61112.692.07
21143631-1143631113.420113.67
31105514-1105514109.639109.89
41110953-1110953110.179110.42
51130503-1130503112.118112.38
61168435-1168435115.880116.17
20min11168070-1168070115.843115.110.74116.29115.560.74
21163198-1163198115.360115.80
31144422-1144422113.498113.93
41159202-1159202114.964115.38
51164770-1164770115.516115.97
61164690-1164690115.508116.00
30min11165624-1165624115.601115.010.66116.24115.640.66
21158011-1158011114.846115.48
31145420-1145420113.597114.22
41162150-1162150115.256115.87
51165909-1165909115.629116.27
61160625-1160625115.105115.78
45min11163293-1163293115.370114.840.49116.20115.670.50
21156382-1156382114.684115.51
31147998-1147998113.853114.66
41160655-1160655115.108115.91
51162660-1162660115.307116.14
61156971-1156971114.743115.61
60min11163147-1163147115.355114.820.58116.38115.840.58
21160939-1160939115.136116.16
31145008-1145008113.556114.55
41158983-1158983114.942115.94
51161828-1161828115.224116.25
61156780-1156780114.724115.79
极限11159091-1159091114.953114.530.55116.17115.740.55
21157756-1157756114.821116.03
31142337-1142337113.291114.48
41156025-1156025114.649115.84
51158460-1158460114.890116.11
61155333-1155333114.580115.83
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%
19.959420493976941679399893951940590.13
29.959413493944940390.15
单位质量响应值RSD%判断
9453.179451.160.02数据可信
供试品溶液-24071101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%
5min150301-5030147.41144.849.1347.4144.849.13
243616-4361641.11041.11
344663-4466342.09742.10
452151-5215149.15549.15
542802-4280240.34340.34
651919-5191948.93648.94
10min187408-8740882.38678.673.6582.4778.753.65
282708-8270877.95678.02
380416-8041675.79675.87
484444-8444479.59279.67
579814-7981475.22875.30
686017-8601781.07581.16
15min198160-9816092.52090.091.9492.7490.301.94
294628-9462889.19189.39
395029-9502989.56989.77
496096-9609690.57590.79
592841-9284187.50787.70
696761-9676191.20291.42
20min199430-9943093.71792.131.1294.0992.491.12
297628-9762892.01992.37
398191-9819192.55092.90
497262-9726291.67492.04
596126-9612690.60390.94
697864-9786492.24192.61
30min199212-9921293.51292.521.0094.0493.031.00
298344-9834492.69493.19
399154-9915493.45793.96
497147-9714791.56692.08
596882-9688291.31691.81
698201-9820192.55993.08
45min199495-9949593.77992.801.0994.4693.461.09
298845-9884593.16693.82
399563-9956393.84394.50
497305-9730591.71492.39
597062-9706291.48592.13
698440-9844092.78493.46
60min199204-9920493.50492.821.1094.3493.641.10
299082-9908293.38994.20
399891-9989194.15294.96
497325-9732591.73392.56
597258-9725891.67092.46
698091-9809192.45593.29
极限199885-9988594.14693.561.1395.1494.541.12
2100059-10005994.31095.28
3100631-10063194.84995.82
497759-9775992.14293.12
598232-9823292.58893.54
699040-9904093.35094.34
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)850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%
110.081074313107428410745531073458107352810740270.05
210.101073532107422810738800.05
单位质量响应值RSD%判断
106550.30106324.750.15数据可信
供试品溶液-24071101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%
5min1713057-71305770.93467.307.6670.9367.307.66
2629803-62980362.65262.65
3641800-64180063.84563.85
4732846-73284672.90272.90
5618678-61867861.54561.55
6723134-72313471.93671.94
10min11077430-1077430107.181103.542.77107.30103.652.78
21037509-1037509103.210103.31
31012012-1012012100.673100.78
41059078-1059078105.356105.48
51003103-100310399.78799.89
61055544-1055544105.004105.12
15min11164434-1164434115.836113.741.32116.13114.031.32
21136718-1136718113.079113.36
31148717-1148717114.273114.55
41148491-1148491114.250114.55
51119104-1119104111.327111.60
61142984-1142984113.702114.00
20min11170717-1170717116.461115.111.00116.95115.591.00
21162259-1162259115.620116.08
31167846-1167846116.176116.64
41152399-1152399114.639115.13
51141891-1141891113.594114.05
61147941-1147941114.195114.68
30min11169773-1169773116.367115.131.01117.05115.791.00
21160316-1160316115.427116.08
31171655-1171655116.555117.21
41149197-1149197114.320115.00
51144911-1144911113.894114.54
61148014-1148014114.203114.88
45min11166575-1166575116.049115.080.95116.93115.940.95
21158446-1158446115.240116.09
31172849-1172849116.673117.53
41149212-1149212114.322115.19
51146701-1146701114.072114.91
61147460-1147460114.148115.01
60min11165182-1165182115.911114.871.03116.98115.921.03
21156876-1156876115.084116.13
31171642-1171642116.553117.60
41146892-1146892114.091115.15
51142097-1142097113.614114.64
61145830-1145830113.985115.04
极限11164355-1164355115.828114.661.03117.09115.901.03
21154396-1154396114.838116.07
31168538-1168538116.244117.49
41144692-1144692113.872115.12
51140198-1140198113.425114.64
61143423-1143423113.746114.99
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%
19.959425794192942589418594058941900.09
29.959409393744939180.27
单位质量响应值RSD%判断
9466.339438.990.21数据可信
供试品溶液-24071102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%
5min138657-3865736.43442.1517.0136.4342.1517.01
241436-4143639.05339.05
352870-5287049.83049.83
451369-5136948.41548.42
549610-4961046.75746.76
634372-3437232.39632.40
10min173183-7318368.97575.117.3369.0475.187.33
280968-8096876.31276.38
386381-8638181.41481.50
483990-8399079.16079.24
581648-8164876.95377.03
671991-7199167.85167.91
15min187563-8756382.52886.993.0582.7087.183.06
292914-9291487.57187.76
395006-9500689.54389.76
493495-9349588.11988.33
594383-9438388.95689.16
690404-9040485.20685.37
20min193137-9313787.78189.361.0988.0989.701.11
294874-9487489.41989.76
395821-9582190.31190.68
494900-9490089.44389.80
595869-9586990.35690.71
694251-9425188.83189.14
30min195302-9530289.82290.190.7290.2890.680.73
295553-9555390.05990.55
396871-9687191.30191.82
494871-9487189.41689.92
596017-9601790.49691.00
695542-9554290.04890.51
45min195611-9561190.11390.200.4190.7290.840.41
295630-9563090.13190.77
396112-9611290.58591.26
495018-9501889.55490.21
595995-9599590.47591.13
695871-9587190.35890.97
60min196270-9627090.73490.270.5691.4991.060.55
295659-9565990.15890.95
396296-9629690.75991.58
494868-9486889.41390.22
595959-9595990.44191.25
695627-9562790.12890.89
极限197572-9757291.96191.670.4892.8792.600.46
297408-9740891.80792.74
397209-9720991.61992.59
496360-9636090.81991.77
597427-9742791.82592.78
697575-9757591.96492.87
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)850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%
110.081075302107579110751741075530107500910753610.03
210.101070583107056510705740.01
单位质量响应值RSD%判断
106682.64105997.430.46数据可信
供试品溶液-24071102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%
5min1572408-57240856.99564.2213.9957.0064.2213.99
2604760-60476060.21660.22
3740653-74065373.74773.75
4724070-72407072.09672.10
5704676-70467670.16570.17
6523183-52318352.09452.09
10min1944540-94454094.048100.225.6794.14100.335.68
21022531-1022531101.814101.91
31070273-1070273106.568106.69
41048397-1048397104.390104.51
51024652-1024652102.025102.14
6928833-92883392.48492.57
15min11077793-1077793107.317111.402.15107.57111.672.17
21124546-1124546111.972112.24
31141407-1141407113.651113.95
41127393-1127393112.255112.55
51137876-1137876113.299113.59
61103648-1103648109.891110.13
20min11127292-1127292112.245113.110.54112.68113.570.55
21135039-1135039113.017113.47
31142923-1142923113.802114.29
41134240-1134240112.937113.42
51143031-1143031113.812114.29
61133424-1133424112.856113.28
30min11141669-1141669113.677113.510.37114.29114.160.37
21137438-1137438113.255113.90
31145172-1145172114.026114.71
41133318-1133318112.845113.51
51142574-1142574113.767114.43
61139905-1139905113.501114.11
45min11135775-1135775113.090113.230.30113.90114.070.30
21138356-1138356113.347114.18
31138281-1138281113.339114.21
41130938-1130938112.608113.47
51140192-1140192113.530114.38
61139470-1139470113.458114.26
60min11140261-1140261113.537113.170.32114.53114.200.31
21135636-1135636113.076114.10
31137774-1137774113.289114.35
41129920-1129920112.507113.55
51137897-1137897113.301114.35
61138034-1138034113.315114.31
极限11132690-1132690112.783112.830.29113.97114.040.28
21133279-1133279112.841114.05
31134440-1134440112.957114.20
41127114-1127114112.227113.46
51135877-1135877113.100114.33
61135581-1135581113.071114.25
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%
19.959507894713952519506195002950210.21
29.959490394485946940.32
单位质量响应值RSD%判断
9549.859516.980.25数据可信
供试品溶液-24071103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%
5min130789-3078928.77337.5916.7928.7737.5916.80
241059-4105938.37038.37
340528-4052837.87437.87
450246-5024646.95646.96
543633-4363340.77640.78
635108-3510832.80932.81
10min165451-6545161.16572.2210.1761.2172.2910.17
277839-7783972.74272.81
379414-7941474.21474.28
485983-8598380.35280.43
584135-8413578.62578.69
670886-7088666.24466.30
15min186945-8694581.25184.832.9281.4085.012.94
291064-9106485.10185.29
389974-8997484.08284.27
493869-9386987.72287.93
593562-9356287.43587.63
689230-8923083.38783.55
20min194536-9453688.34587.890.6588.6388.220.66
293375-9337587.26087.59
393490-9349087.36887.69
494410-9441088.22888.59
594814-9481488.60588.95
693667-9366787.53387.84
30min195514-9551489.25988.650.4589.6989.120.42
294800-9480088.59289.06
394311-9431188.13588.61
494535-9453588.34488.85
594943-9494388.72689.22
695067-9506788.84289.29
45min195445-9544589.19588.620.3789.7889.240.35
294920-9492088.70489.32
394465-9446588.27988.90
494605-9460588.41089.06
594864-9486488.65289.29
694660-9466088.46189.06
60min195510-9551089.25688.560.4489.9989.330.42
294861-9486188.64989.42
394430-9443088.24689.01
494432-9443288.24889.05
594860-9486088.64889.44
694523-9452388.33389.08
极限196470-9647090.15389.721.2991.0390.631.26
296178-9617889.88090.80
395207-9520788.97289.89
494686-9468688.48689.43
595340-9534089.09790.03
698129-9812991.70392.60
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)850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%
110.081078061107795010783201078011107735810779400.04
210.101076342107721610767790.06
单位质量响应值RSD%判断
106938.49106611.780.22数据可信
供试品溶液-24071103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%
5min1478054-47805447.40658.9214.2447.4158.9214.24
2599423-59942359.44159.44
3592005-59200558.70658.71
4720299-72029971.42871.43
5643435-64343563.80663.81
6531746-53174652.73052.73
10min1872060-87206086.47797.837.8186.5697.937.82
2997677-99767798.93499.03
31002418-100241899.40499.50
41068865-1068865105.993106.11
51057696-1057696104.885104.99
6920592-92059291.29091.38
15min11080192-1080192107.116110.051.84107.34110.311.86
21115389-1115389110.607110.87
31102782-1102782109.356109.62
41133353-1133353112.388112.68
51129802-1129802112.036112.32
61097261-1097261108.809109.05
20min11146657-1146657113.707112.530.57114.11112.970.55
21130393-1130393112.094112.54
31130066-1130066112.062112.51
41132024-1132024112.256112.74
51137342-1137342112.783113.25
61131950-1131950112.249112.67
30min11150598-1150598114.098112.860.61114.69113.490.59
21139040-1139040112.952113.59
31133121-1133121112.365113.00
41130899-1130899112.145112.81
51136413-1136413112.691113.35
61138506-1138506112.899113.51
45min11148574-1148574113.897112.650.59114.68113.470.57
21136116-1136116112.662113.49
31131476-1131476112.202113.02
41130473-1130473112.102112.96
51136323-1136323112.682113.53
61132865-1132865112.340113.14
60min11151036-1151036114.141112.530.73115.11113.540.70
21133065-1133065112.359113.37
31131303-1131303112.185113.19
41127887-1127887111.846112.89
51133648-1133648112.417113.45
61131682-1131682112.222113.21
极限11148058-1148058113.846112.821.07115.01114.021.04
21132908-1132908112.344113.54
31127629-1127629111.820113.01
41126874-1126874111.745112.98
51133810-1133810112.433113.65
61157052-1157052114.738115.91
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