托伐普坦口崩片项目信息
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101242-202302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(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)7.5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%
116.482008882008652007232004612005592006990.10
216.552033682032902033290.03
单位质量响应值RSD%判断
12178.3412285.740.63数据可信
供试品溶液-2025051121批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min118926-189269.2749.906.499.279.906.49
219336-193369.4759.48
320408-2040810.00110.00
422590-2259011.07011.07
520374-203749.9849.98
619550-195509.5809.58
10min137755-3775518.50118.582.8718.5218.592.86
236788-3678818.02718.04
338183-3818318.71118.73
436724-3672417.99618.01
539606-3960619.40819.42
638401-3840118.81818.83
15min153882-5388226.40426.623.3626.4526.673.35
252009-5200925.48625.53
356904-5690427.88527.93
453328-5332826.13326.18
556084-5608427.48327.53
653790-5379026.35926.41
20min167913-6791333.28033.032.2133.3733.122.21
265713-6571332.20232.29
367874-6787433.26133.35
466174-6617432.42832.52
569849-6984934.22834.32
666901-6690132.78432.88
30min188978-8897843.60243.232.0843.7543.382.08
286092-8609242.18842.33
388096-8809643.17043.32
487217-8721742.73942.89
591408-9140844.79344.94
687522-8752242.88943.03
45min1112270-11227055.01655.613.7655.2355.833.75
2109334-10933453.57753.79
3113626-11362655.68155.90
4121199-12119959.39259.61
5114452-11445256.08556.31
6110070-11007053.93854.16
60min1131754-13175464.56463.132.4864.8763.442.47
2124301-12430160.91261.21
3130964-13096464.17764.49
4128477-12847762.95863.27
5131632-13163264.50464.82
6125822-12582261.65761.96
90min1152599-15259974.77974.421.3775.2074.831.38
2148947-14894772.98973.39
3153641-15364175.28975.71
4150993-15099373.99274.41
5154475-15447575.69876.13
6150503-15050373.75274.16
120min1170594-17059483.59781.931.8984.1482.481.89
2163195-16319579.97180.50
3169628-16962883.12383.67
4165383-16538381.04381.59
5169759-16975983.18883.74
6164629-16462980.67481.21
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限1176197-17619786.34386.161.5187.0286.841.52
2173531-17353185.03685.69
3178915-17891587.67488.36
4174314-17431485.42086.10
5178998-17899887.71588.41
6173019-17301984.78585.45
托伐普坦口崩片项目信息
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101242-202302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(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)7.5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%
116.482045442044762039842039502035632041030.20
216.552032962033872033420.04
单位质量响应值RSD%判断
12384.8912286.530.57数据可信
供试品溶液-2025051121批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min119757-197579.6009.613.529.609.613.54
219698-196989.5729.57
319341-193419.3989.40
419188-191889.3249.32
519541-195419.4959.50
621127-2112710.26610.27
10min137316-3731618.13217.792.0918.1517.802.08
237576-3757618.25918.27
336218-3621817.59917.61
436582-3658217.77617.79
535463-3546317.23217.25
636510-3651017.74117.76
15min153386-5338625.94126.052.4225.9926.102.41
253587-5358726.03926.09
355739-5573927.08427.13
451786-5178625.16425.21
554031-5403126.25426.30
653094-5309425.79925.85
20min167310-6731032.70731.871.6332.8031.961.63
265898-6589832.02132.11
364370-6437031.27831.37
465330-6533031.74531.83
564619-6461931.39931.49
665948-6594832.04532.13
30min188113-8811342.81541.941.6042.9642.081.60
287134-8713442.34042.48
384525-8452541.07241.21
485901-8590141.74141.88
585064-8506441.33441.47
687133-8713342.33942.48
45min1111827-11182754.33854.483.7154.5554.703.70
2110391-11039153.64153.85
3113734-11373455.26555.48
4109033-10903352.98153.19
5108185-10818552.56952.78
6119572-11957258.10258.32
60min1130924-13092463.61861.412.4863.9261.712.47
2125991-12599161.22161.52
3127828-12782862.11362.42
4123439-12343959.98160.28
5122435-12243559.49359.79
6127658-12765862.03162.34
90min1151689-15168973.70872.840.9174.1273.250.91
2149840-14984072.80973.21
3150501-15050173.13173.54
4148015-14801571.92372.32
5148734-14873472.27272.67
6150692-15069273.22373.64
120min1169763-16976382.49079.412.0483.0379.942.04
2160693-16069378.08378.61
3161557-16155778.50379.03
4162204-16220478.81779.33
5162005-16200578.72179.24
6164344-16434479.85780.39
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限1173709-17370984.40884.171.5885.0884.831.57
2172514-17251483.82784.48
3178372-17837286.67387.33
4172370-17237083.75784.41
5170580-17058082.88783.54
6171745-17174583.45384.12
托伐普坦口崩片项目信息
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101242-202302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(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)7.5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%
116.482052592051592055012055112049812052820.12
216.552046632051222048920.16
单位质量响应值RSD%判断
12456.4312380.180.44数据可信
供试品溶液-2025051021批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min119586-195869.4549.762.569.459.762.58
221145-2114510.20610.21
320126-201269.7149.71
420093-200939.6989.70
520351-203519.8239.82
620029-200299.6689.67
10min138019-3801918.35119.043.8318.3719.053.82
242148-4214820.34420.36
338825-3882518.74018.76
440138-4013819.37419.39
539085-3908518.86618.88
638423-3842318.54618.56
15min153531-5353125.83826.952.9325.8827.002.93
258321-5832128.15028.20
355968-5596827.01527.06
456798-5679827.41527.46
555053-5505326.57326.62
655327-5532726.70526.75
20min167072-6707232.37433.522.4232.4633.622.43
271657-7165734.58734.69
370090-7009033.83133.92
470722-7072234.13634.23
568541-6854133.08333.18
668620-6862033.12133.21
30min187784-8778442.37144.132.3742.5144.272.37
293018-9301844.89845.05
389996-8999643.43943.59
491726-9172644.27444.43
592458-9245844.62844.77
693525-9352545.14345.29
45min1109257-10925752.73654.642.0552.9554.862.05
2112697-11269754.39654.63
3113433-11343354.75254.97
4116399-11639956.18356.41
5113407-11340754.73954.96
6114012-11401255.03155.25
60min1129781-12978162.64363.281.7362.9463.601.73
2134178-13417864.76565.09
3129877-12987762.68963.00
4132878-13287864.13764.46
5128092-12809261.82762.14
6131841-13184163.63763.95
90min1152545-15254573.63074.541.2274.0474.961.22
2157350-15735075.95076.38
3153569-15356974.12574.54
4156154-15615475.37275.80
5153366-15336674.02774.44
6153653-15365374.16574.58
120min1167337-16733780.77081.681.0681.3082.221.06
2170439-17043982.26782.82
3167489-16748980.84381.38
4171467-17146782.76483.31
5168153-16815381.16481.70
6170502-17050282.29882.84
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限1175845-17584584.87785.290.4685.5485.970.46
2177038-17703885.45386.15
3175920-17592084.91385.59
4176596-17659685.23985.93
5176784-17678485.33086.00
6178028-17802885.93086.61
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