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%
110.189396393806941339428493902940180.21
2 10.219429294244942680.04
单位质量响应值RSD%判断
9235.569232.910.03数据可信
供试品溶液-311952B批-恩格列净-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min120167-2016719.45720.6214.8219.4620.6214.82
223322-2332222.50122.50
316986-1698616.38816.39
420081-2008119.37419.37
521438-2143820.68320.68
626271-2627125.34625.35
10min144319-4431942.75945.1013.4642.7945.1413.46
249694-4969447.94447.98
338017-3801736.67836.71
446215-4621544.58844.62
545274-4527443.68043.71
656973-5697354.96755.01
15min164835-6483562.55265.9011.5662.6666.0011.56
271950-7195069.41769.53
357219-5721955.20455.29
470573-7057368.08868.19
564848-6484862.56562.67
680390-8039077.55977.69
20min182014-8201479.12681.358.2479.3381.578.25
288577-8857785.45885.69
373328-7332870.74670.93
488490-8849085.37485.59
580959-8095978.10878.32
692571-9257189.31289.57
30min1102511-10251198.90296.322.4999.2496.682.50
2101100-10110097.54097.92
397774-9777494.33194.63
4100461-10046196.92497.29
595908-9590892.53192.87
6101256-10125697.69198.10
45min1104073-104073100.40998.750.96100.9199.270.94
2101892-10189298.30498.84
3102501-10250198.89299.35
4102535-10253598.92599.45
5101185-10118597.62298.12
6101956-10195698.36698.94
60min1104067-104067100.40398.940.85101.0799.620.83
2102141-10214198.54599.25
3102883-10288399.26199.88
4102671-10267199.05699.74
5101832-10183298.24798.91
6101724-10172498.14298.88
极限1103804-103804100.14998.940.79100.9999.790.77
2101792-10179298.20899.07
3103064-10306499.435100.22
4102795-10279599.176100.03
5102057-10205798.46499.29
6101804-10180498.22099.12
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%
1 10.098906648911688908608910868910728909700.03
210.158903618913408908500.08
单位质量响应值RSD%判断
88302.2887768.470.43数据可信
供试品溶液-311952B批-二甲双胍-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1266634-26663427.25927.7811.4027.2627.7811.41
2291845-29184529.83629.84
3227076-22707623.21523.21
4256689-25668926.24226.24
5270340-27034027.63827.64
6317982-31798232.50832.51
10min1474706-47470648.53050.4610.8648.5850.5110.86
2517434-51743452.89952.95
3417962-41796242.72942.77
4490331-49033150.12850.17
5480673-48067349.14049.19
6580382-58038259.33459.39
15min1636659-63665965.08767.769.3865.2167.899.39
2689213-68921370.46070.60
3571895-57189558.46658.58
4682726-68272669.79769.92
5639933-63993365.42265.55
6756355-75635577.32477.48
20min1764770-76477078.18479.896.5878.4280.146.59
2810916-81091682.90283.16
3697658-69765871.32371.53
4812943-81294383.10983.35
5761104-76110477.81078.05
6841549-84154986.03486.32
30min1906515-90651592.67590.731.8093.0491.111.82
2892415-89241591.23491.63
3868782-86878288.81889.14
4893012-89301291.29591.68
5867136-86713688.65089.02
6897189-89718991.72292.15
45min1914925-91492593.53592.290.7494.0592.820.74
2896274-89627491.62892.17
3898564-89856491.86392.34
4905197-90519792.54193.07
5900268-90026892.03792.55
6901524-90152492.16592.74
60min1912598-91259893.29792.350.6093.9793.030.59
2896815-89681591.68492.38
3900954-90095492.10792.73
4905358-90535892.55793.25
5903584-90358492.37693.04
6900442-90044292.05492.79
极限1910327-91032793.06592.200.6193.9093.040.60
2894606-89460691.45892.31
3899122-89912291.92092.70
4903807-90380792.39993.24
5904018-90401892.42093.24
6899245-89924591.93292.82
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%
110.189427994227944219427594066942540.14
2 10.219490794895949010.01
单位质量响应值RSD%判断
9258.749294.910.28数据可信
供试品溶液-311952B批-恩格列净-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min120818-2081819.99318.869.2219.9918.869.23
218027-1802717.31217.31
321594-2159420.73820.74
418331-1833117.60417.60
521363-2136320.51620.52
617669-1766916.96916.97
10min145970-4597044.14841.428.8444.1841.468.83
240143-4014338.55238.58
349363-4936347.40647.44
441142-4114239.51139.54
542584-4258440.89640.93
639597-3959738.02838.06
15min170498-7049867.70461.969.0767.8162.069.07
260168-6016857.78357.88
372990-7299070.09770.21
461663-6166359.21959.31
563119-6311960.61760.72
658653-5865356.32856.42
20min185408-8540882.02379.077.5182.2479.277.51
277040-7704073.98674.18
391889-9188988.24788.48
480179-8017977.00177.19
584425-8442581.07981.28
675063-7506372.08872.27
30min1102155-10215598.10697.252.4998.4697.592.50
299369-9936995.43095.74
3102172-10217298.12298.50
4101626-10162697.59897.92
5104766-104766100.614100.95
697522-9752293.65793.96
45min1103359-10335999.262100.080.7999.78100.580.78
2103718-10371899.607100.08
3103502-10350299.40099.94
4105327-105327101.152101.64
5105022-105022100.859101.37
6104326-104326100.191100.65
60min1103391-10339199.293100.010.8399.98100.670.80
2103934-10393499.815100.45
3103007-10300798.92499.63
4105279-105279101.106101.76
5104754-104754100.602101.28
6104440-104440100.300100.93
极限1103202-10320299.11299.940.8499.96100.770.82
2103429-10342999.330100.13
3103275-10327599.182100.05
4104700-104700100.550101.37
5104577-104577100.432101.27
6105212-105212101.042101.84
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%
1 10.099847559849759855399840899835599845830.08
210.159861329895199878260.25
单位质量响应值RSD%判断
97580.0897322.760.19数据可信
供试品溶液-311952B批-二甲双胍-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1289465-28946526.73325.517.6426.7325.507.65
2257502-25750223.78123.78
3301295-30129527.82627.83
4261311-26131124.13324.13
5294203-29420327.17127.17
6253309-25330923.39423.39
10min1543169-54316950.16447.547.5750.2147.587.57
2487615-48761545.03345.07
3579665-57966553.53453.58
4496948-49694845.89545.94
5503776-50377646.52646.57
6477540-47754044.10344.14
15min1756866-75686669.90065.557.6370.0365.677.62
2674286-67428662.27362.39
3795267-79526773.44673.58
4686675-68667563.41763.53
5689578-68957863.68563.81
6655929-65592960.57860.69
20min1896671-89667182.81179.986.2683.0680.216.27
2827692-82769276.44176.66
3952427-95242787.96088.22
4853804-85380478.85279.07
5867678-86767880.13380.36
6797794-79779473.67973.89
30min11027492-102749294.89393.951.7095.2894.311.72
21009010-100901093.18693.53
31029056-102905695.03795.44
41021531-102153194.34294.70
51030574-103057495.17795.54
6985880-98588091.05091.39
45min11034119-103411995.50595.690.4796.0596.220.46
21039594-103959496.01196.51
31036248-103624895.70296.26
41043726-104372696.39296.90
51030866-103086695.20495.73
61032428-103242895.34995.84
60min11034608-103460895.55095.740.4696.2596.420.44
21040051-104005196.05396.71
31033776-103377695.47396.20
41043191-104319196.34397.01
51030180-103018095.14195.82
61037865-103786595.85196.50
极限11030902-103090295.20895.460.4496.0796.300.43
21035082-103508295.59496.42
31032675-103267595.37296.25
41039783-103978396.02896.86
51026967-102696794.84495.68
61036602-103660295.73496.54
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