托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101242-201201对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数10000
标示量(mg)15供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.459714897317973749722797032972200.14
216.539753397545975390.01
单位质量响应值RSD%判断
5910.035900.730.12数据可信
供试品溶液-2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%
5min17335-73357.4538.6110.117.458.6010.13
27965-79658.0938.09
38835-88358.9778.98
48560-85608.6978.70
59862-986210.02010.02
68259-82598.3918.39
10min117788-1778818.07320.035.6418.1120.075.65
219337-1933719.64719.69
320513-2051320.84220.89
419767-1976720.08420.13
521001-2100121.33821.39
619854-1985420.17220.22
15min127706-2770628.15029.633.3228.2929.793.33
228753-2875329.21429.37
330408-3040830.89531.06
429081-2908129.54729.71
530056-3005630.53830.71
628996-2899629.46129.62
20min133710-3371034.25036.403.2834.5536.723.29
235448-3544836.01636.33
337068-3706837.66238.00
436057-3605736.63536.96
536612-3661237.19937.54
636039-3603936.61636.94
30min142970-4297043.65945.132.3944.1545.652.40
243200-4320043.89244.41
345520-4552046.24946.80
444824-4482445.54246.07
545050-4505045.77246.32
644918-4491845.63846.16
45min152109-5210952.94454.261.6953.6855.041.71
253121-5312153.97254.73
354782-5478255.66056.46
453268-5326854.12254.90
553972-5397254.83755.64
653190-5319054.04254.82
60min158649-5864959.58960.510.9160.6161.590.94
259666-5966660.62261.68
360151-6015161.11562.23
460007-6000760.96962.05
559598-5959860.55361.66
659283-5928360.23361.31
90min166440-6644067.50568.071.5968.8669.491.57
268130-6813069.22270.62
368341-6834169.43670.89
467106-6710668.18169.60
566259-6625967.32168.77
665708-6570866.76168.18
120min168749-6874969.85171.742.1671.5873.542.13
269168-6916870.27672.06
370368-7036871.49673.33
472578-7257873.74175.54
570773-7077371.90773.73
672033-7203373.18774.97
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min175827-7582777.04278.621.5679.1680.811.55
277799-7779979.04681.22
376242-7624277.46479.70
479100-7910080.36782.58
578036-7803679.28681.51
677283-7728378.52180.71
240min179537-7953780.81182.271.7983.3684.901.75
283391-8339184.72787.34
381730-8173083.04085.71
480911-8091182.20784.86
580609-8060981.90184.56
679634-7963480.91083.54
极限178920-7892080.18582.801.8383.1885.881.81
281530-8153082.83685.92
382359-8235983.67986.81
483317-8331784.65287.76
580967-8096782.26485.38
681851-8185183.16386.24
托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101242-201201对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数10000
标示量(mg)15供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.454939049323493774920449225493040.18
216.534986250041499520.26
单位质量响应值RSD%判断
2997.203021.900.59数据可信
供试品溶液-2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%
5min13997-39977.9699.2211.617.979.2211.59
24623-46239.2179.22
34198-41988.3698.37
45282-528210.53110.53
55244-524410.45510.45
64404-44048.7808.78
10min110154-1015420.24421.263.1920.2921.313.19
210747-1074721.42621.48
310644-1064421.22121.27
410460-1046020.85420.91
511160-1116022.25022.31
610805-1080521.54221.59
15min114876-1487629.65831.413.2029.8131.583.21
216028-1602831.95532.13
315805-1580531.51031.67
415524-1552430.95031.12
516309-1630932.51532.70
615988-1598831.87532.04
20min118663-1866337.20839.072.8037.5339.422.80
219827-1982739.52939.88
320017-2001739.90840.25
419207-1920738.29338.64
520022-2002239.91840.28
619852-1985239.57939.92
30min123758-2375847.36649.322.2447.8949.882.26
224918-2491849.67950.25
325133-2513350.10750.67
424476-2447648.79749.36
525291-2529150.42251.01
624843-2484349.52950.09
45min129906-2990659.62360.491.6660.4161.321.67
230258-3025860.32561.17
330842-3084261.48962.33
429705-2970559.22260.05
530985-3098561.77462.64
630344-3034460.49661.34
60min132854-3285465.50166.220.9866.6267.390.99
233138-3313866.06767.25
333396-3339666.58167.76
432900-3290065.59266.75
533278-3327866.34667.55
633720-3372067.22768.40
90min137475-3747574.71376.311.8176.2077.851.80
237419-3741974.60276.15
338616-3861676.98878.54
438759-3875977.27378.80
538297-3829776.35277.93
639097-3909777.94779.50
120min141391-4139182.52181.511.0884.4283.481.04
240696-4069681.13583.10
341326-4132682.39184.37
440399-4039980.54382.50
541067-4106781.87583.87
640435-4043580.61582.60
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min143913-4391387.54988.881.0189.9191.291.02
244600-4460088.91891.33
344818-4481889.35391.79
444257-4425788.23590.63
545194-4519490.10392.56
644688-4468889.09491.52
240min146312-4631292.33291.760.9595.1894.670.92
245676-4567691.06493.97
345996-4599691.70294.63
445472-4547290.65793.55
546022-4602291.75394.71
646680-4668093.06595.99
极限144752-4475289.22191.001.3292.5894.421.30
245781-4578191.27394.68
346624-4662492.95496.40
445527-4552790.76794.16
545588-4558890.88894.35
645606-4560690.92494.37
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