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%
110.239345593162928869272992956930380.31
210.219289592899928970.01
单位质量响应值RSD%判断
9094.629098.630.04数据可信
供试品溶液-24090902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%
5min136762-3676236.00439.2214.4336.0039.2214.44
239525-3952538.71038.71
351068-5106850.01550.02
440832-4083239.99039.99
536884-3688436.12436.12
635187-3518734.46234.46
10min174816-7481673.27477.038.3073.3377.108.30
274998-7499873.45273.52
391096-9109689.21889.30
479892-7989278.24578.31
577716-7771676.11476.17
673416-7341671.90371.96
15min192580-9258090.67192.852.4690.8593.042.48
292997-9299791.08091.27
398476-9847696.44696.68
495721-9572193.74893.94
596024-9602494.04494.23
693041-9304191.12391.30
20min195004-9500493.04694.941.6593.3895.281.66
295414-9541493.44793.79
399073-9907397.03197.42
496741-9674194.74795.10
598390-9839096.36296.71
696977-9697794.97895.31
30min196154-9615494.17295.381.9994.6695.881.99
294638-9463892.68793.18
399361-9936197.31397.87
497697-9769795.68396.19
599674-9967497.61998.12
696802-9680294.80695.29
45min197388-9738895.38096.231.5396.0396.901.54
296183-9618394.20094.85
399922-9992297.86298.58
498503-9850396.47297.14
599952-9995297.89298.56
697602-9760295.59096.24
60min196926-9692694.92896.301.8795.7397.121.88
295474-9547493.50694.31
3100239-10023998.17399.05
498683-9868396.64997.48
5100019-10001997.95798.79
698621-9862196.58897.39
极限199009-9900996.96898.341.8297.9399.331.82
297875-9787595.85796.82
3102034-10203499.931100.97
499929-9992997.86998.86
5102632-102632100.516101.51
6100985-10098598.90399.87
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%
110.175002174990964980844998884972244989020.26
210.205002904990664996780.18
单位质量响应值RSD%判断
49056.2448988.040.10数据可信
供试品溶液-24090902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%
5min1255392-25539246.88849.8611.3646.8949.8611.36
2270870-27087049.72949.73
3329955-32995560.57760.58
4275483-27548350.57650.58
5253248-25324846.49446.49
6244530-24453044.89344.89
10min1455472-45547283.62086.116.2483.7086.196.25
2449816-44981682.58282.66
3525381-52538196.45596.56
4471416-47141686.54886.63
5466023-46602385.55785.63
6445939-44593981.87081.95
15min1534052-53405298.04798.881.3498.2699.101.36
2530202-53020297.34097.56
3549181-549181100.824101.09
4537587-53758798.69698.92
5545216-545216100.097100.32
6535205-53520598.25998.47
20min1536328-53632898.46599.551.0598.8599.941.05
2537689-53768998.71599.10
3549503-549503100.884101.31
4539124-53912498.97899.37
5548691-548691100.735101.12
6542173-54217399.53899.91
30min1535259-53525998.26999.401.5298.8199.961.52
2531119-53111997.50898.06
3548716-548716100.739101.34
4542576-54257699.612100.17
5552607-552607101.453102.01
6538147-53814798.79999.34
45min1535525-53552598.31799.331.0399.03100.051.04
2536954-53695498.58099.29
3545702-545702100.186100.95
4540556-54055699.24199.97
5549658-549658100.912101.64
6537781-53778198.73299.44
60min1531685-53168597.61299.101.3398.4999.991.33
2531694-53169497.61498.49
3546866-546866100.399101.33
4538156-53815698.80099.69
5547728-547728100.558101.45
6542678-54267899.631100.50
极限1534654-53465498.15799.051.3699.19100.111.36
2532324-53232497.73098.77
3546441-546441100.321101.42
4534101-53410198.05699.11
5550257-550257101.022102.08
6539408-53940899.030100.07
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%
110.239324993394929349305592921931110.23
210.219312093236931780.09
单位质量响应值RSD%判断
9101.769126.150.19数据可信
供试品溶液-24091001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%
5min135779-3577934.97540.3619.1334.9740.3619.14
236372-3637235.55535.55
337788-3778836.93936.94
440729-4072939.81439.81
556897-5689755.61855.62
640187-4018739.28439.28
10min170735-7073569.14576.7611.8069.2076.8311.80
272159-7215970.53770.60
377758-7775876.01076.07
478905-7890577.13277.20
596312-9631294.14794.24
675299-7529973.60773.67
15min190702-9070288.66394.364.0988.8494.554.11
293907-9390791.79691.97
398384-9838496.17396.36
499830-9983097.58697.78
5101114-10111498.84199.09
695231-9523193.09193.28
20min197963-9796395.76197.831.9396.0898.181.94
298758-9875896.53896.87
399794-9979497.55197.90
4103483-103483101.157101.51
5100776-10077698.51198.93
699687-9968797.44797.79
30min197703-9770395.50798.112.0695.9998.632.07
299441-9944197.20697.70
399631-9963197.39297.90
4103819-103819101.486102.01
5101304-10130499.02799.61
6100299-10029998.04598.55
45min198979-9897996.75498.351.9797.3999.021.98
298867-9886796.64597.30
399854-9985497.61098.28
4104109-104109101.769102.46
5101601-10160199.317100.06
6100230-10023097.97798.65
60min199161-9916196.93298.381.8997.7399.221.90
299294-9929497.06297.88
399754-9975497.51298.35
4104160-104160101.819102.68
5101377-10137799.099100.01
6100116-10011697.86698.70
极限198669-9866996.45198.432.0297.4199.442.03
299305-9930597.07398.05
399671-9967197.43198.43
4104306-104306101.962103.00
5101366-10136699.088100.16
6100838-10083898.57299.57
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%
110.174998845004274992535009904993984999900.15
210.205013215013505013360.01
单位质量响应值RSD%判断
49163.2349150.590.02数据可信
供试品溶液-24091001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%
5min1227372-22737241.62947.0316.6141.6347.0316.60
2231913-23191342.46042.46
3236804-23680443.35643.36
4253015-25301546.32446.32
5341392-34139262.50562.50
6250762-25076245.91145.91
10min1406475-40647574.42081.4710.3174.4981.5510.31
2415478-41547876.06976.14
3440965-44096580.73580.81
4445623-44562381.58881.67
5533501-53350197.67797.78
6427717-42771778.31078.39
15min1506082-50608292.65796.973.2192.8597.183.22
2518206-51820694.87795.07
3536409-53640998.21098.42
4542256-54225699.28099.49
5551973-551973101.059101.33
6522753-52275395.70995.92
20min1534119-53411997.79099.491.6798.1499.871.68
2537930-53793098.48898.84
3540004-54000498.86899.24
4558807-558807102.310102.69
5549140-549140100.541100.98
6540391-54039198.93999.31
30min1532652-53265297.52299.431.6098.0399.971.62
2539935-53993598.85599.38
3537534-53753498.41698.95
4555666-555666101.735102.28
5551212-551212100.920101.52
6541532-54153299.14899.68
45min1539199-53919998.72099.611.3099.39100.321.31
2539373-53937398.75299.44
3539396-53939698.75799.46
4556048-556048101.805102.52
5549259-549259100.562101.33
6540997-54099799.05099.75
60min1537778-53777898.46099.491.3999.30100.371.40
2538002-53800298.50199.35
3539049-53904998.69399.56
4556282-556282101.848102.74
5548732-548732100.466101.40
6540712-54071298.99799.86
极限1532600-53260097.51299.291.6698.51100.331.67
2537476-53747698.40599.42
3536862-53686298.29399.32
4556131-556131101.820102.88
5550076-550076100.712101.82
6540682-54068298.992100.02
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