坎地沙坦片项目信息
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100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.067446375176747607492374829748300.35
216.077527475157752160.11
单位质量响应值RSD%判断
4659.404680.520.32数据可信
供试品溶液-12423607批-pH1.2(内含0.1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17852-78529.4399.7331.789.449.7431.79
213057-1305715.69615.70
38373-837310.06510.07
46285-62857.5557.56
56421-64217.7197.72
66591-65917.9237.92
10min123997-2399728.84731.0420.8628.8631.0620.87
236644-3664444.05044.08
323987-2398728.83528.85
423305-2330528.01528.03
522057-2205726.51526.53
624952-2495229.99530.01
15min139971-3997148.04953.3318.0748.1153.3918.08
260140-6014072.29572.39
340820-4082049.07049.13
441631-4163150.04550.10
538654-3865446.46646.52
644955-4495554.04154.10
20min154355-5435565.34071.7912.9865.4871.9412.99
274213-7421389.21289.43
356637-5663768.08468.23
457324-5732468.90969.05
553452-5345264.25564.39
662319-6231974.91475.07
30min173699-7369988.59493.544.7888.8593.824.81
282910-8291099.666100.04
378829-7882994.76195.02
477696-7769693.39993.66
573453-7345388.29888.54
680286-8028696.51296.79
45min182809-8280999.54599.270.9099.9599.700.92
283190-83190100.003100.54
383489-83489100.362100.78
482405-8240599.05999.47
581487-8148797.95698.34
682103-8210398.69699.14
60min184469-84469101.540100.830.92102.11101.420.90
283587-83587100.480101.18
385003-85003102.182102.77
483658-83658100.566101.14
583735-83735100.658101.21
682799-8279999.533100.14
极限184010-84010100.989100.281.15101.72101.041.13
283714-83714100.633101.50
382340-8234098.98199.74
483519-83519100.398101.14
584671-84671101.783102.50
682249-8224998.87299.64
坎地沙坦片项目信息
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100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.067397174677749327532975057747930.70
216.077434975139747440.75
单位质量响应值RSD%判断
4657.104651.150.10数据可信
供试品溶液-12423607批-pH1.2(内含0.05%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17125-71258.5947.9110.148.597.9110.10
26109-61097.3697.37
35943-59437.1687.17
47623-76239.1959.19
56278-62787.5727.57
66257-62577.5477.55
10min125681-2568130.97628.625.4230.9928.635.42
223813-2381328.72328.74
321717-2171726.19526.21
423690-2369028.57528.59
523281-2328128.08128.09
624178-2417829.16329.18
15min146096-4609655.60052.035.0655.6752.095.06
244114-4411453.21053.27
340077-4007748.34048.40
441982-4198250.63850.70
541978-4197850.63350.69
644563-4456353.75153.81
20min163844-6384477.00871.835.8877.1771.985.88
261080-6108073.67473.82
354128-5412865.28965.42
458188-5818870.18670.33
557941-5794169.88870.03
662131-6213174.94275.09
30min179662-7966296.08794.562.6796.3794.832.68
278684-7868494.90895.18
374860-7486090.29590.54
478249-7824994.38394.65
577817-7781793.86294.12
681106-8110697.82998.10
45min183498-83498100.714100.791.29101.16101.221.30
284176-84176101.532101.96
382651-8265199.693100.09
482260-8226099.22199.64
583531-83531100.754101.17
685254-85254102.832103.27
60min184231-84231101.598101.560.91102.21102.150.91
284456-84456101.870102.47
383733-83733100.998101.56
483378-83378100.570101.16
583845-83845101.133101.72
685537-85537103.174103.78
极限184661-84661102.117101.300.98102.90102.060.99
283549-83549100.776101.54
383245-83245100.409101.14
483441-83441100.646101.40
583666-83666100.917101.67
685324-85324102.917103.70
坎地沙坦片项目信息
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100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.067409674569746357478075127746410.51
216.077472075487751040.73
单位质量响应值RSD%判断
4647.634673.550.40数据可信
供试品溶液-12423607批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min13528-35284.2504.304.084.254.304.05
23475-34754.1864.19
33579-35794.3114.31
43378-33784.0694.07
53740-37404.5054.50
63742-37424.5074.51
15min16483-64837.8097.645.007.827.655.02
25907-59077.1157.12
36418-64187.7317.74
46033-60337.2677.27
56441-64417.7587.77
66768-67688.1528.16
20min19014-901410.85810.684.4810.8810.704.49
28456-845610.18510.20
38759-875910.55010.57
48394-839410.11110.13
59252-925211.14411.16
69327-932711.23511.26
30min113259-1325915.97115.871.9316.0115.911.93
213059-1305915.73015.77
313214-1321415.91715.95
412727-1272715.33015.37
513406-1340616.14816.19
613389-1338916.12716.17
45min117249-1724920.77720.800.6320.8420.860.63
217134-1713420.63820.70
317346-1734620.89420.96
417217-1721720.73820.80
517220-1722020.74220.81
617437-1743721.00321.07
60min119433-1943323.40823.450.3323.5123.550.33
219447-1944723.42423.52
319509-1950923.49923.60
419385-1938523.35023.45
519567-1956723.56923.67
619449-1944923.42723.53
极限120724-2072424.96324.690.7925.1024.830.78
220391-2039124.56124.70
320652-2065224.87625.01
420477-2047724.66524.80
520299-2029924.45124.59
620454-2045424.63724.78
坎地沙坦片项目信息
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100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.067461475378754687573375549753480.58
216.077626176149762050.11
单位质量响应值RSD%判断
4691.664742.070.76数据可信
供试品溶液-12423607批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110631-1063112.65311.4911.8412.6511.4911.81
211430-1143013.60413.60
39043-904310.76310.76
49449-944911.24611.25
58928-892810.62610.63
68441-844110.04610.05
10min128988-2898834.50133.424.6434.5233.444.64
229369-2936934.95434.98
327146-2714632.30932.33
429026-2902634.54634.56
527921-2792133.23133.25
626035-2603530.98631.00
15min146560-4656055.41554.743.0855.4954.823.08
245080-4508053.65353.73
345122-4512253.70353.78
447623-4762356.68056.76
547417-4741756.43556.51
644151-4415152.54852.62
20min160638-6063872.17071.642.6772.3471.812.66
257341-5734168.24668.42
359843-5984371.22471.39
461394-6139473.07073.24
561899-6189973.67173.84
660048-6004871.46871.62
30min174120-7412088.21688.932.3488.5189.222.33
272523-7252386.31586.60
373012-7301286.89787.18
475967-7596790.41490.71
576703-7670391.29091.58
676001-7600190.45590.73
45min179458-7945894.56995.051.9195.0195.481.90
279137-7913794.18794.62
377725-7772592.50792.93
480398-8039895.68896.13
580164-8016495.41095.85
682293-8229397.94398.37
60min178942-7894293.95595.301.4494.5595.891.43
280137-8013795.37795.96
379437-7943794.54495.12
479782-7978294.95595.56
579868-7986895.05795.66
682269-8226997.91598.50
极限179774-7977494.94594.262.1695.7095.022.15
280049-8004995.27396.02
377228-7722891.91592.65
477348-7734892.05892.82
579112-7911294.15794.92
681690-8169097.22697.98
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