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%
1 16.532018872003572026622016881993242011840.67
2 16.582030832037502034160.24
单位质量响应值RSD%判断
12170.8412268.760.57数据可信
中间条件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%
5min114922-149227.3207.104.427.327.104.43
213415-134156.5806.58
314618-146187.1707.17
414148-141486.9406.94
515241-152417.4767.48
614539-145397.1327.13
10min133159-3315916.26515.852.7716.2815.862.77
232094-3209415.74315.75
332310-3231015.84915.86
433165-3316516.26816.28
532414-3241415.90015.91
630736-3073615.07715.09
15min150357-5035724.70124.341.7524.7424.381.75
249457-4945724.26024.30
349129-4912924.09924.14
450478-5047824.76124.80
550135-5013524.59224.63
648223-4822323.65523.69
20min164907-6490731.83831.411.2331.9231.491.23
263825-6382531.30831.39
364221-6422131.50231.58
464688-6468831.73131.81
563921-6392131.35531.43
662697-6269730.75430.83
30min184482-8448241.44041.501.1041.5741.621.11
284530-8453041.46441.59
384809-8480941.60141.73
486143-8614342.25542.39
584345-8434541.37341.51
683251-8325140.83740.96
45min1108402-10840253.17452.721.1253.3852.921.12
2107212-10721252.59052.79
3106514-10651452.24852.45
4108596-10859653.26953.47
5108429-10842953.18753.39
6105694-10569451.84552.04
60min1125255-12525561.44060.941.0361.7361.221.03
2124568-12456861.10461.39
3124114-12411460.88161.17
4125596-12559661.60861.90
5123812-12381260.73361.02
6122030-12203059.85960.14
90min1146476-14647671.85071.770.7272.2472.160.72
2146890-14689072.05372.44
3145218-14521871.23371.62
4148044-14804472.61973.01
5145782-14578271.50971.90
6145525-14552571.38371.77
120min1159465-15946578.22178.490.8178.7379.000.80
2160005-16000578.48678.99
3159622-15962278.29878.81
4162533-16253379.72680.24
5159471-15947178.22478.73
6158963-15896377.97578.48
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1177604-17760487.11987.220.9087.7687.860.90
2178543-17854387.58088.22
3177468-17746887.05287.69
4180488-18048888.53489.18
5177094-17709486.86987.51
6175713-17571386.19186.82
240min1186515-18651591.49091.600.9192.2892.390.90
2188670-18867092.54793.33
3186569-18656991.51692.30
4188673-18867392.54993.34
5185618-18561891.05091.84
6184430-18443090.46791.24
极限1188669-18866992.54792.941.0093.4993.880.99
2190725-19072593.55594.49
3188058-18805892.24793.18
4192760-19276094.55395.50
5188571-18857192.49893.44
6188095-18809592.26593.19
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%
1 16.532015512029152010912037822027482024170.54
2 16.582033432029582031500.14
单位质量响应值RSD%判断
12245.4312252.710.05数据可信
中间条件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%
5min112518-125186.1266.012.636.136.002.63
212639-126396.1856.18
312066-120665.9045.90
411817-118175.7835.78
512494-124946.1146.11
612114-121145.9285.93
10min131404-3140415.36714.993.8115.3815.003.82
232301-3230115.80615.82
329744-2974414.55514.56
430677-3067715.01215.02
529014-2901414.19814.21
630677-3067715.01215.02
15min150110-5011024.52124.162.8924.5624.202.89
250973-5097324.94324.98
348860-4886023.90923.94
449839-4983924.38824.42
546828-4682822.91522.95
649646-4964624.29424.33
20min165961-6596132.27831.772.2932.3531.842.29
265785-6578532.19132.27
363592-6359231.11831.19
465020-6502031.81731.89
562689-6268930.67630.75
666469-6646932.52632.60
30min187078-8707842.61142.521.0042.7442.651.00
287755-8775542.94243.07
386841-8684142.49542.62
486522-8652242.33942.47
585439-8543941.80941.93
687740-8774042.93543.06
45min1109824-10982453.74253.860.6753.9454.060.68
2110359-11035954.00354.21
3110452-11045254.04954.25
4109211-10921153.44253.64
5109416-10941653.54253.73
6111188-11118854.40954.61
60min1125166-12516661.24961.720.5761.5462.000.57
2126004-12600461.65961.95
3126649-12664961.97562.26
4125392-12539261.36061.65
5126582-12658261.94262.22
6126917-12691762.10662.40
90min1146975-14697571.92172.410.8372.3172.800.82
2149424-14942473.12073.52
3148362-14836272.60072.99
4146206-14620671.54571.94
5148993-14899372.90973.29
6147878-14787872.36372.76
120min1161126-16112678.84679.380.5379.3679.900.52
2163141-16314179.83280.35
3162374-16237479.45779.97
4161835-16183579.19379.70
5163221-16322179.87180.38
6161638-16163879.09679.61
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1180001-18000188.08287.681.1488.7388.321.13
2180563-18056388.35789.01
3176127-17612786.18786.83
4179086-17908687.63588.28
5181682-18168288.90589.54
6177599-17759986.90787.55
240min1185614-18561490.82991.490.7091.6292.280.69
2186755-18675591.38792.19
3188883-18888392.42993.22
4186197-18619791.11491.90
5188181-18818192.08592.87
6186117-18611791.07591.87
极限1189959-18995992.95592.790.8293.9093.740.82
2189509-18950992.73593.69
3189352-18935292.65893.60
4188798-18879892.38793.33
5192391-19239194.14595.09
6187740-18774091.86992.81
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%
1 16.532043132039112027232040182035872037100.30
2 16.582025352033682029520.30
单位质量响应值RSD%判断
12323.6512240.770.48数据可信
中间条件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%
5min111768-117685.7435.871.965.745.861.95
212160-121605.9345.93
312378-123786.0416.04
411852-118525.7845.78
512117-121175.9135.91
611856-118565.7865.79
10min130734-3073414.99915.063.1715.0115.073.17
231186-3118615.22015.23
332344-3234415.78515.79
429447-2944714.37114.38
531198-3119815.22615.24
630271-3027114.77314.78
15min149159-4915923.99124.052.3924.0324.082.38
249616-4961624.21424.25
351367-5136725.06925.10
448163-4816323.50523.54
549137-4913723.98024.02
648199-4819923.52223.56
20min164990-6499031.71731.620.7931.7931.700.79
265063-6506331.75331.83
364425-6442531.44131.52
465086-6508631.76431.84
565289-6528931.86331.94
663953-6395331.21131.28
30min187402-8740242.65542.541.2642.7842.671.26
287254-8725442.58242.71
388202-8820243.04543.18
488087-8808742.98943.11
586929-8692942.42442.55
685169-8516941.56541.69
45min1110622-11062253.98753.720.7854.1953.920.78
2110050-11005053.70853.91
3110666-11066654.00854.21
4111021-11102154.18154.38
5108981-10898153.18653.38
6109132-10913253.26053.45
60min1127637-12763762.29061.851.0162.5862.141.01
2126848-12684861.90562.19
3126720-12672061.84362.14
4128149-12814962.54062.83
5126570-12657061.77062.06
6124457-12445760.73961.02
90min1152764-15276474.55372.671.5474.9573.061.54
2147693-14769372.07872.47
3148880-14888072.65873.05
4149993-14999373.20173.59
5147998-14799872.22772.62
6146108-14610871.30571.69
120min1165479-16547980.75879.661.1081.2880.171.10
2163304-16330479.69780.21
3163086-16308679.59180.11
4164459-16445980.26180.77
5162817-16281779.45979.97
6160182-16018278.17378.68
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1183905-18390589.75188.281.0890.4088.921.07
2181630-18163088.64189.29
3179618-17961887.65988.31
4181842-18184288.74489.39
5179745-17974587.72188.36
6178591-17859187.15787.79
240min1192278-19227893.83792.381.0294.6493.171.02
2189859-18985992.65793.45
3188031-18803191.76492.56
4190400-19040092.92193.72
5188090-18809091.79392.58
6187035-18703591.27892.06
极限1195145-19514595.23693.411.1196.1994.361.11
2191656-19165693.53494.48
3189828-18982892.64193.59
4192264-19226493.83094.78
5189779-18977992.61893.56
6189804-18980492.63093.56
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