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101566-202301对照品来源中检所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1000
标示量(mg)10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%
110.065580905567795575765567575582445574890.13
210.005546675543025544840.05
单位质量响应值RSD%判断
55416.4055448.400.05数据可信
供试品溶液-2024053011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%
5min1582951-58295194.64891.762.0594.6591.762.05
2561578-56157891.17891.18
3552374-55237489.68389.68
4554414-55441490.01590.01
5572420-57242092.93892.94
6567186-56718692.08892.09
10min1629773-629773102.250100.231.57102.41100.381.57
2627592-627592101.896102.05
3607040-60704098.55998.71
4611417-61141799.27099.42
5618839-618839100.475100.63
6609371-60937198.93799.09
15min1631928-631928102.600101.111.57102.93101.441.57
2632387-632387102.674103.00
3607260-60726098.59598.91
4618135-618135100.360100.68
5627748-627748101.921102.24
6619233-619233100.539100.86
20min1633589-633589102.869101.411.47103.37101.901.47
2633929-633929102.925103.42
3610750-61075099.16199.64
4619697-619697100.614101.10
5628941-628941102.115102.61
6620754-620754100.786101.27
30min1635461-635461103.173101.671.54103.84102.331.54
2635579-635579103.193103.86
3610906-61090699.18799.83
4622388-622388101.051101.70
5630931-630931102.438103.10
6622084-622084101.002101.66
45min1646632-646632104.987102.211.88105.83103.041.87
2636872-636872103.402104.24
3612509-61250999.447100.26
4624852-624852101.451102.27
5632093-632093102.627103.46
6624101-624101101.329102.15
60min1636321-636321103.313101.891.48104.33102.891.48
2636517-636517103.345104.35
3611903-61190399.349100.32
4626329-626329101.691102.68
5630781-630781102.414103.42
6623636-623636101.253102.24
极限1634408-634408103.002101.931.40104.19103.101.40
2636475-636475103.338104.52
3611948-61194899.356100.50
4626359-626359101.696102.85
5630746-630746102.408103.58
6626789-626789101.765102.93
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101566-202301对照品来源中检所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1000
标示量(mg)10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%
110.065575595571205577085575865572505574450.05
210.005597605595885596740.03
单位质量响应值RSD%判断
55412.0355967.400.71数据可信
供试品溶液-202829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%
5min1482423-48242377.96677.615.4277.9777.615.42
2503027-50302781.29681.30
3429827-42982769.46669.47
4485448-48544878.45578.46
5496815-49681580.29280.29
6483810-48381078.19078.19
10min1604188-60418897.64595.311.7397.7895.441.74
2591575-59157595.60795.74
3572287-57228792.48992.61
4588935-58893595.18095.31
5590654-59065495.45895.59
6590917-59091795.50095.63
15min1620567-620567100.29298.081.21100.5898.361.21
2603928-60392897.60397.90
3598849-59884996.78297.05
4605117-60511797.79598.08
5605640-60564097.88098.17
6607092-60709298.11498.40
20min1622923-622923100.67398.381.20101.1398.831.20
2604725-60472597.73298.19
3602466-60246697.36797.80
4607832-60783298.23498.69
5606448-60644898.01098.47
6607847-60784798.23698.69
30min1621428-621428100.43198.291.13101.0698.911.13
2603606-60360697.55198.17
3602566-60256697.38397.98
4607936-60793698.25198.87
5606461-60646198.01298.63
6607139-60713998.12298.74
45min1620340-620340100.25598.551.20101.0599.341.18
2603394-60339497.51798.30
3617573-61757399.808100.56
4607676-60767698.20998.99
5605532-60553297.86298.65
6604387-60438797.67798.46
60min1618477-61847799.95498.021.10100.9298.961.10
2600595-60059597.06498.01
3601328-60132897.18398.11
4608513-60851398.34499.29
5603220-60322097.48998.43
6606945-60694598.09199.03
极限1618934-618934100.02897.811.20101.1698.921.20
2600473-60047397.04598.15
3599710-59971096.92198.01
4607303-60730398.14999.26
5602121-60212197.31198.42
6602814-60281497.42398.53
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101566-202301对照品来源中检所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1000
标示量(mg)10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%
110.061407689140771514089521408454140746414080550.05
210.001409803141176214107820.10
单位质量响应值RSD%判断
139965.71141078.200.56数据可信
供试品溶液-2024052511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%
5min11343456-134345686.04686.411.7386.0586.411.73
21369328-136932887.70387.70
31358327-135832786.99887.00
41314874-131487484.21584.21
51332818-133281885.36485.36
61376282-137628288.14888.15
10min11490456-149045695.46195.571.4195.6095.711.41
21520445-152044597.38197.53
31499126-149912696.01696.16
41465581-146558193.86794.01
51470823-147082394.20394.35
61506173-150617396.46796.61
15min11523712-152371297.59197.591.4297.8997.891.43
21549821-154982199.26399.57
31540733-154073398.68198.99
41495872-149587295.80896.10
51500619-150061996.11296.41
61531425-153142598.08598.39
20min11529962-152996297.99197.941.2998.4698.401.29
21556208-155620899.672100.15
31535011-153501198.31498.78
41504154-150415496.33896.79
51509012-150901296.64997.11
61540310-154031098.65499.12
30min11535150-153515098.32398.441.3198.9599.061.31
21565766-1565766100.284100.92
31543800-154380098.87799.51
41515255-151525597.04997.67
51513698-151369896.94997.57
61547888-154788899.13999.77
45min11544529-154452998.92498.851.3599.7299.641.35
21573652-1573652100.789101.60
31547279-154727999.10099.90
41518420-151842097.25298.03
51521537-152153797.45198.23
61554678-155467899.574100.37
60min11546399-154639999.04498.821.38100.0099.781.38
21573835-1573835100.801101.78
31547106-154710699.089100.05
41516359-151635997.12098.06
51521563-152156397.45398.40
61552489-155248999.434100.40
极限11542728-154272898.80998.821.3699.9399.941.36
21571664-1571664100.662101.80
31544408-154440898.916100.04
41516186-151618697.10998.21
51523127-152312797.55398.66
61558859-155885999.842100.97
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101566-202301对照品来源中检所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1000
标示量(mg)10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%
110.061404061140765814096221410405140850914080510.18
210.001417406141893114181680.08
单位质量响应值RSD%判断
139965.31141816.800.93数据可信
供试品溶液-E36577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%
5min11108145-110814570.79071.443.8070.7971.443.80
21044650-104465066.73466.73
31131378-113137872.27572.27
41127287-112728772.01372.01
51123907-112390771.79771.80
61174799-117479975.04875.05
10min11430851-143085191.40590.541.0391.5290.661.03
21410014-141001490.07490.19
31406987-140698789.88190.00
41413114-141311490.27290.39
51403144-140314489.63689.76
61439756-143975691.97492.10
15min11508560-150856096.37095.470.8896.6495.740.87
21503096-150309696.02196.28
31481911-148191194.66794.94
41483331-148333194.75895.03
51482895-148289594.73095.00
61507113-150711396.27796.56
20min11561511-156151199.75297.291.45100.1897.721.45
21526512-152651297.51697.94
31511114-151111496.53396.96
41502147-150214795.96096.39
51505588-150558896.18096.61
61530905-153090597.79798.24
30min11560541-156054199.69097.551.38100.2998.141.37
21533190-153319097.94398.53
31511990-151199096.58997.18
41506336-150633696.22896.82
51511435-151143596.55397.14
61538562-153856298.28698.89
45min11529830-152983097.72897.170.8798.4997.920.87
21531950-153195097.86498.61
31509638-150963896.43997.19
41505945-150594596.20396.95
51512229-151222996.60497.35
61536605-153660598.16198.93
60min11526424-152642497.51196.990.7898.4497.910.77
21530916-153091697.79898.71
31517008-151700896.90997.82
41499466-149946695.78996.70
51510791-151079196.51297.42
61525042-152504297.42398.35
极限11529332-152933297.69796.860.8498.7997.940.84
21525332-152533297.44198.51
31503038-150303896.01797.09
41500829-150082995.87696.94
51512059-151205996.59397.66
61526968-152696897.54698.64
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