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1000
标示量(mg)15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%
116.531989031986651986841992341979221986820.25
216.581987271992541989900.19
单位质量响应值RSD%判断
12019.4812001.810.11数据可信
加速6月-供试品溶液-2025050921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%
5min110341-103415.1615.465.565.165.465.57
211963-119635.9705.97
311112-111125.5465.55
410996-109965.4885.49
510299-102995.1405.14
610967-109675.4735.47
10min122934-2293411.44511.923.2211.4511.933.23
225146-2514612.54912.56
323812-2381211.88411.89
424092-2409212.02312.03
523275-2327511.61611.62
624054-2405412.00412.01
15min136095-3609518.01318.812.6018.0418.842.61
238942-3894219.43419.47
338393-3839319.16019.19
437823-3782318.87618.91
537319-3731918.62418.65
637547-3754718.73818.77
20min149245-4924524.57625.361.7524.6325.421.75
251797-5179725.85025.91
351324-5132425.61425.67
451082-5108225.49325.55
550455-5045525.18025.24
651006-5100625.45525.52
30min169334-6933434.60235.351.4934.7035.461.50
271457-7145735.66135.77
371519-7151935.69235.80
471207-7120735.53635.64
569698-6969834.78334.88
671822-7182235.84335.95
45min191044-9104445.43646.611.3445.5946.771.35
293950-9395046.88647.05
394487-9448747.15447.32
493722-9372246.77346.94
593034-9303446.42946.59
694142-9414246.98247.14
60min1106586-10658653.19354.691.5353.4254.931.54
2110247-11024755.02055.26
3110842-11084255.31755.56
4110263-11026355.02855.27
5108677-10867754.23654.47
6110897-11089755.34455.58
90min1129697-12969764.72665.981.1965.0566.321.18
2133681-13368166.71567.05
3131616-13161665.68466.02
4132723-13272366.23666.57
5131685-13168565.71866.05
6133883-13388366.81567.15
120min1144138-14413871.93373.271.3372.3673.711.33
2147785-14778573.75374.20
3147319-14731973.52173.96
4147187-14718773.45573.90
5144956-14495672.34172.78
6149478-14947874.59875.04
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1162394-16239481.04482.821.2481.5983.391.24
2166705-16670583.19583.77
3166333-16633383.01083.58
4166757-16675783.22183.79
5165132-16513282.41082.97
6168443-16844384.06384.63
240min1173494-17349486.58388.151.0487.2788.851.04
2176887-17688788.27788.99
3176590-17659088.12988.83
4177352-17735288.50989.21
5176337-17633788.00288.70
6179146-17914689.40490.11
极限1176584-17658488.12689.871.0688.9590.721.06
2181416-18141690.53791.39
3180143-18014389.90290.75
4179965-17996589.81390.66
5180307-18030789.98490.82
6182089-18208990.87391.73
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1000
标示量(mg)15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%
116.531986321999661988091987651996291991600.30
216.581994571981091987830.48
单位质量响应值RSD%判断
12048.4011989.320.35数据可信
加速6月-供试品溶液-2025051021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%
5min110635-106355.3045.384.745.305.384.76
210263-102635.1185.12
310624-106245.2985.30
411301-113015.6365.64
510409-104095.1915.19
611545-115455.7585.76
10min124057-2405711.99812.222.9812.0112.232.99
223849-2384911.89411.90
324451-2445112.19412.20
425463-2546312.69912.71
523847-2384711.89311.90
625329-2532912.63212.64
15min138987-3898719.44419.491.8619.4719.521.86
238316-3831619.10919.14
338720-3872019.31019.34
439300-3930019.60019.63
538735-3873519.31819.35
640404-4040420.15020.18
20min152668-5266826.26726.312.2526.3326.372.24
251926-5192625.89625.96
352176-5217626.02126.08
453973-5397326.91726.98
551385-5138525.62725.69
654374-5437427.11727.18
30min173308-7330836.56036.721.2536.6736.821.25
272578-7257836.19636.30
373264-7326436.53836.64
474729-7472937.26937.38
573062-7306236.43736.54
674781-7478137.29537.40
45min197270-9727048.51047.811.3348.6847.981.33
294528-9452847.14347.31
394695-9469547.22647.39
497385-9738548.56848.74
595171-9517147.46447.63
696182-9618247.96848.14
60min1115103-11510357.40456.281.2957.6556.521.29
2110956-11095655.33655.58
3111736-11173655.72555.97
4113525-11352556.61756.87
5112618-11261856.16556.41
6113133-11313356.42256.67
90min1137932-13793268.78967.751.2569.1368.091.24
2133375-13337566.51766.85
3134507-13450767.08167.42
4137230-13723068.43968.78
5136101-13610167.87668.21
6135921-13592167.78668.13
120min1154807-15480777.20575.381.4877.6675.831.48
2148554-14855474.08774.53
3150026-15002674.82175.27
4152361-15236175.98576.44
5151404-15140475.50875.96
6149737-14973774.67775.14
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1174126-17412686.84084.781.6787.4385.361.67
2167033-16703383.30383.87
3167834-16783483.70284.28
4171962-17196285.76186.35
5171132-17113285.34785.92
6167862-16786283.71684.30
240min1185251-18525192.38890.261.6993.1290.991.68
2177333-17733388.43989.15
3178587-17858789.06589.78
4183284-18328491.40792.14
5182088-18208890.81191.53
6179411-17941189.47690.20
极限1188322-18832293.92091.761.7094.8092.631.69
2180059-18005989.79990.65
3181491-18149190.51391.37
4186261-18626192.89293.77
5185136-18513692.33193.20
6182720-18272091.12692.00
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1000
标示量(mg)15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%
116.532007671996441993202001831999881999800.28
216.582003562003562003560.00
单位质量响应值RSD%判断
12098.0012084.200.09数据可信
加速6月-供试品溶液-2025051121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%
5min19064-90644.4934.747.114.494.747.11
29101-91014.5124.51
310872-108725.3905.39
49533-95334.7264.73
59536-95364.7274.73
69209-92094.5654.57
10min118584-185849.21310.198.129.2210.208.11
219640-196409.7369.74
323047-2304711.42511.43
420520-2052010.17310.18
522000-2200010.90610.91
619600-196009.7169.72
15min127268-2726813.51815.179.7513.5415.199.75
228435-2843514.09614.12
334752-3475217.22817.26
430199-3019914.97115.00
533663-3366316.68816.71
629240-2924014.49514.52
20min137376-3737618.52920.198.4418.5720.248.45
238308-3830818.99119.04
345729-4572922.67022.73
439826-3982619.74319.79
544257-4425721.94021.99
638817-3881719.24319.29
30min152935-5293526.24228.477.5326.3228.557.54
254790-5479027.16127.24
363731-6373131.59431.69
456081-5608127.80127.88
561848-6184830.66030.75
655151-5515127.34027.42
45min172999-7299936.18838.835.9836.3138.965.99
276159-7615937.75537.88
384628-8462841.95342.10
477167-7716738.25538.38
583559-8355941.42341.56
675475-7547537.41637.54
60min190810-9081045.01847.255.0645.2047.445.07
293228-9322846.21746.40
3101910-10191050.52150.74
492749-9274945.97946.17
5100936-10093650.03850.25
692223-9222345.71845.91
90min1115788-11578857.40059.483.7957.6659.753.80
2118500-11850058.74559.01
3126196-12619662.56062.86
4117672-11767258.33458.60
5125202-12520262.06762.36
6116490-11649057.74858.01
120min1133726-13372666.29368.163.2266.6468.533.24
2137015-13701567.92368.29
3143736-14373671.25571.66
4135063-13506366.95667.32
5142101-14210170.44570.84
6133314-13331466.08966.45
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1156999-15699977.83079.302.5578.2979.792.57
2160693-16069379.66180.14
3165320-16532081.95582.48
4156617-15661777.64178.12
5164218-16421881.40981.92
6155986-15598677.32877.80
240min1170673-17067384.60986.021.6385.2086.641.65
2173682-17368286.10186.71
3177157-17715787.82388.48
4171889-17188985.21285.82
5176678-17667887.58688.24
6171086-17108684.81485.41
极限1175851-17585187.17688.251.5487.9189.021.56
2178753-17875388.61489.37
3181493-18149389.97390.78
4175817-17581787.15987.91
5180851-18085189.65490.45
6175345-17534586.92587.67
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