恩格列净二甲双胍片项目信息
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101566-202301对照品来源中检院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%
110.109403094256945739445394532943690.24
210.149444294346943940.08
单位质量响应值RSD%判断
9343.479309.070.27数据可信
供试品溶液-2024112921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%
5min141724-4172440.26436.535.4040.2636.535.39
237499-3749936.18736.19
336869-3686935.57935.58
435826-3582634.57334.57
537094-3709435.79635.80
638102-3810236.76936.77
10min182732-8273279.83874.514.4779.9174.574.47
276279-7627973.61173.67
375083-7508372.45772.52
472675-7267570.13370.19
577627-7762774.91274.97
678876-7887676.11776.18
15min199951-9995196.45593.163.4796.6593.353.46
293955-9395590.66890.85
392217-9221788.99189.17
495422-9542292.08492.26
5100703-10070397.18097.36
697005-9700593.61293.80
20min1101572-10157298.01997.812.2498.3898.152.24
299731-9973196.24296.58
398456-9845695.01295.34
4100974-10097497.44297.77
5105006-105006101.333101.68
6102369-10236998.78899.13
30min1101755-10175598.19698.282.1198.7298.782.11
2100877-10087797.34897.84
398927-9892795.46695.95
4100893-10089397.36497.85
5104783-104783101.118101.63
6103844-103844100.211100.72
45min1102066-10206698.49698.281.7599.1898.951.75
2100776-10077697.25197.91
399961-9996196.46497.11
4100629-10062997.10997.76
5104743-104743101.079101.76
6102893-10289399.29499.97
60min1101254-10125497.71297.911.8998.5698.741.89
2101122-10112297.58598.40
398824-9882495.36796.17
4100473-10047396.95897.77
5104399-104399100.747101.60
6102678-10267899.08699.93
极限1101415-10141597.86798.321.5798.8899.311.57
2101550-10155097.99898.98
399620-9962096.13597.10
4101665-10166598.10999.08
5104481-104481100.826101.85
6102570-10257098.98299.99
恩格列净二甲双胍片项目信息
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100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
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%
110.081009028100917810109791010407101001710099220.09
210.111008293100834210083180.01
单位质量响应值RSD%判断
100190.6799734.720.33数据可信
供试品溶液-2024112921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%
5min1511580-51158046.06042.684.2546.0642.684.25
2474715-47471542.74142.74
3462166-46216641.61141.61
4452828-45282840.77040.77
5469261-46926142.24942.25
6474033-47403342.67942.68
10min1918719-91871982.71678.323.7082.7978.393.70
2858401-85840177.28577.36
3845321-84532176.10876.18
4829213-82921374.65774.73
5881213-88121379.33979.41
6886383-88638379.80579.88
15min11071806-107180696.49994.222.9296.7194.422.91
21025117-102511792.29592.50
31006993-100699390.66490.86
41034296-103429693.12293.31
51089034-108903498.05098.25
61051913-105191394.70894.91
20min11089054-108905498.05297.812.1698.4398.162.16
21071756-107175696.49596.85
31057662-105766295.22695.57
41079586-107958697.20097.55
51126423-1126423101.416101.78
61093404-109340498.44498.81
30min11089226-108922698.06798.122.0298.6198.642.02
21080588-108058897.29097.80
31062221-106222195.63696.14
41079505-107950597.19297.70
51126026-1126026101.381101.92
61101456-110145699.16999.69
45min11084253-108425397.62097.851.9498.3298.541.94
21082915-108291597.49998.18
31062166-106216695.63196.30
41074937-107493796.78197.45
51124389-1124389101.233101.94
61092486-109248698.36199.05
60min11081092-108109297.33597.541.9398.2098.391.93
21077593-107759397.02097.86
31058157-105815795.27096.09
41073654-107365496.66597.50
51120325-1120325100.867101.74
61089658-108965898.10698.96
极限11081428-108142897.36597.371.7998.3998.381.79
21076095-107609596.88597.89
31056068-105606895.08296.07
41074173-107417396.71297.71
51114760-1114760100.366101.41
61086453-108645397.81898.84
恩格列净二甲双胍片项目信息
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101566-202301对照品来源中检院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%
110.109432394543942199420294894944360.31
210.149500895037950220.03
单位质量响应值RSD%判断
9350.109371.010.16数据可信
供试品溶液-2024120221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%
5min139972-3997238.43242.0512.3438.4342.0512.34
251845-5184549.84849.85
337604-3760436.15636.16
448407-4840746.54346.54
543247-4324741.58141.58
641307-4130739.71639.72
10min184830-8483081.56381.207.8581.6381.277.86
292985-9298589.40389.49
374198-7419871.34071.40
489476-8947686.03086.11
584787-8478781.52181.59
680446-8044677.34777.41
15min1101388-10138897.48396.532.4897.6896.742.50
2102537-10253798.58898.82
395975-9597592.27892.46
4102015-10201598.08698.31
5101502-10150297.59297.80
698974-9897495.16295.36
20min1102489-10248998.54198.201.4598.9098.571.46
2102354-10235498.41298.81
3100006-10000696.15496.49
4102574-10257498.62399.01
5104330-104330100.312100.68
6101051-10105197.15997.51
30min1102078-10207898.14698.191.6198.6798.721.62
2102039-10203998.10998.67
399713-9971395.87296.37
4102403-10240398.45999.01
5104839-104839100.801101.34
6101669-10166997.75398.27
45min1102289-10228998.34997.951.4699.0498.641.46
2101615-10161597.70198.43
399474-9947495.64396.30
4102417-10241798.47299.19
5103987-10398799.982100.68
6101439-10143997.53298.21
60min1101898-10189897.97397.701.4398.8398.561.44
2101498-10149897.58998.48
399294-9929495.46996.28
4101813-10181397.89198.77
5103833-10383399.834100.70
6101336-10133697.43398.27
极限1101887-10188797.96397.761.4898.9898.781.48
2101423-10142397.51698.57
399378-9937895.55096.52
4101831-10183197.90998.95
5104072-104072100.063101.10
6101474-10147497.56698.57
恩格列净二甲双胍片项目信息
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100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
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%
110.081008235100802110096051007819100821410083790.07
210.111015091101418210146360.07
单位质量响应值RSD%判断
100037.60100359.640.23数据可信
供试品溶液-2024120221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%
5min1497042-49704244.64548.1210.3044.6548.1210.30
2618255-61825555.53355.53
3471390-47139042.34142.34
4583069-58306952.37252.37
5531665-53166547.75547.76
6513086-51308646.08646.09
10min1937469-93746984.20583.956.5284.2884.036.52
21012021-101202190.90290.99
3837206-83720675.19975.27
4978852-97885287.92288.01
5940240-94024084.45484.53
6901998-90199881.01981.10
15min11083527-108352797.32496.511.8997.5496.731.91
21088415-108841597.76398.01
31037368-103736893.17893.37
41085101-108510197.46697.70
51088176-108817697.74297.96
61064229-106422995.59195.80
20min11090293-109029397.93297.741.0798.3198.121.07
21089239-108923997.83798.24
31070838-107083896.18596.54
41089718-108971897.88098.28
51106265-110626599.36799.75
61082454-108245497.22897.60
30min11086433-108643397.58597.641.1798.1398.181.17
21086135-108613597.55998.13
31068627-106862795.98696.50
41088183-108818397.74398.30
51108210-110821099.541100.09
61084339-108433997.39797.93
45min11088904-108890497.80797.571.2098.5198.281.21
21084855-108485597.44498.18
31067886-106788695.91996.59
41084390-108439097.40298.12
51108372-110837299.556100.27
61083168-108316897.29297.99
60min11082817-108281797.26197.171.1698.1398.041.17
21080787-108078797.07897.97
31062724-106272495.45696.29
41081502-108150297.14298.03
51102219-110221999.00399.88
61080526-108052697.05597.91
极限11080063-108006397.01396.901.1498.0497.931.15
21077952-107795296.82497.88
31060095-106009595.22096.21
41078643-107864396.88697.93
51098791-109879198.69599.74
61077375-107737596.77297.79
恩格列净二甲双胍片项目信息
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101566-202301对照品来源中检院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%
110.109469494698945639432694548945660.17
210.149465694784947200.10
单位质量响应值RSD%判断
9362.979341.220.17数据可信
供试品溶液-2024120221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%
5min131964-3196430.76137.8715.0530.7637.8715.05
234656-3465633.35133.35
338909-3890937.44437.44
441481-4148139.91939.92
549011-4901147.16647.17
640089-4008938.58038.58
10min168461-6846165.88475.089.0665.9375.149.07
272715-7271569.97770.03
376117-7611773.25173.31
482195-8219579.10179.17
588180-8818084.86084.94
680416-8041677.38977.45
15min190589-9058987.17994.024.6987.3494.214.70
296528-9652892.89493.07
395003-9500391.42691.61
4103019-10301999.14199.34
5101303-10130397.48997.71
699777-9977796.02196.21
20min198985-9898595.25898.582.6695.5698.932.67
2104300-104300100.373100.70
399017-9901795.28995.63
4105081-105081101.125101.49
5103416-10341699.52399.91
6103847-10384799.937100.29
30min1100952-10095297.15199.562.0997.62100.062.09
2105190-105190101.230101.72
3100702-10070296.91197.41
4105572-105572101.597102.13
5103440-10344099.546100.09
6104848-104848100.901101.42
45min1101450-10145097.63199.292.0698.2699.972.06
2105112-105112101.155101.82
3100012-10001296.24796.90
4105236-105236101.274101.98
5102918-10291899.04399.76
6104334-104334100.406101.09
60min1100847-10084797.05099.152.2197.8499.992.21
2104839-104839100.892101.72
399821-9982196.06396.88
4105250-105250101.288102.16
5102824-10282498.95399.83
6104592-104592100.654101.51
极限1101370-10137097.55499.282.1698.51100.292.16
2104759-104759100.815101.81
399966-9996696.20397.18
4105877-105877101.891102.93
5102776-10277698.90799.95
6104244-104244100.319101.34
恩格列净二甲双胍片项目信息
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100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
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%
110.081012242101144910106991010984100962010109990.10
210.111007645100833410079900.05
单位质量响应值RSD%判断
100297.5299702.270.43数据可信
供试品溶液-2024120221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%
5min1410099-41009936.90944.1912.7836.9144.1912.78
2439619-43961939.56639.57
3488346-48834643.95243.95
4515884-51588446.43046.43
5589656-58965653.07053.07
6502340-50234045.21145.21
10min1782280-78228070.40678.587.3070.4778.657.30
2823844-82384474.14774.21
3863779-86377977.74177.81
4913326-91332682.20082.28
5958943-95894386.30686.39
6896200-89620080.65980.73
15min1993827-99382789.44594.613.5489.6294.813.56
21041799-104179993.76393.95
31029872-102987292.68992.89
41098330-109833098.85199.07
51075279-107527996.77697.01
61068072-106807296.12796.34
20min11063824-106382495.74598.111.9796.0798.481.98
21107888-110788899.711100.06
31065351-106535195.88396.24
41114506-1114506100.307100.69
51089890-108989098.09198.48
61099460-109946098.95299.32
30min11078635-107863597.07898.651.6497.5799.171.65
21108746-110874699.788100.30
31073400-107340096.60797.12
41119220-1119220100.731101.28
51091365-109136598.22498.78
61104945-110494599.44699.98
45min11079285-107928597.13798.421.6797.7999.111.67
21107498-110749899.676100.35
31069024-106902496.21396.89
41115890-1115890100.431101.15
51085951-108595197.73798.46
61103373-110337399.305100.01
60min11075120-107512096.76298.071.6997.5798.931.69
21102797-110279799.253100.10
31065371-106537195.88496.72
41113488-1113488100.215101.10
51082455-108245597.42298.31
61098942-109894298.90699.77
极限11072448-107244896.52197.841.6897.4998.861.68
21103431-110343199.310100.32
31063213-106321395.69096.69
41109103-110910399.820100.87
51079615-107961597.16698.21
61094755-109475598.52999.56
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