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101242-201201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%
116.514043344039684039154037274037494039390.07
216.494034934033304034120.03
单位质量响应值RSD%判断
24466.3224464.040.01数据可信
供试品溶液-1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%
5min131722-317227.7809.0512.697.789.0512.70
238405-384059.4199.42
330722-307227.5347.53
441350-4135010.14110.14
541578-4157810.19710.20
637675-376759.2409.24
10min169757-6975717.10817.122.8217.1217.142.83
271903-7190317.63417.65
367502-6750216.55516.57
471555-7155517.54917.57
570765-7076517.35517.37
667436-6743616.53816.55
15min1106597-10659726.14326.191.2626.1826.241.27
2108515-10851526.61326.66
3104922-10492225.73225.77
4107568-10756826.38126.43
5107549-10754926.37626.42
6105644-10564425.90925.95
20min1134563-13456333.00133.421.4933.0933.511.50
2137766-13776633.78733.88
3133990-13399032.86132.94
4137397-13739733.69633.79
5138956-13895634.07834.17
6134987-13498733.10533.19
30min1172614-17261442.33343.171.4142.4743.321.42
2177055-17705543.42243.57
3174238-17423842.73142.87
4177306-17730643.48443.63
5179611-17961144.04944.20
6175435-17543543.02543.17
45min1211407-21140751.84752.681.3252.0652.891.32
2215728-21572852.90753.12
3212276-21227652.06052.27
4216099-21609952.99853.22
5219174-21917453.75253.97
6214054-21405452.49652.71
60min1236218-23621857.93259.181.5658.2359.481.56
2242566-24256659.48859.79
3238993-23899358.61258.91
4243221-24322159.64959.96
5246997-24699760.57560.88
6239912-23991258.83859.14
90min1269135-26913566.00467.051.7366.4067.451.73
2275489-27548967.56367.97
3266915-26691565.46065.85
4276417-27641767.79068.20
5279505-27950568.54868.96
6272904-27290466.92967.33
120min1290344-29034471.20672.161.1771.7172.671.17
2295452-29545272.45972.98
3290396-29039671.21971.72
4296662-29666272.75573.27
5298840-29884073.28973.81
6293740-29374072.03972.55
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1313895-31389576.98278.001.4077.6078.631.40
2318841-31884178.19578.83
3312012-31201276.52077.14
4320998-32099878.72479.36
5323984-32398479.45680.10
6318597-31859778.13578.76
240min1328552-32855280.57681.211.1781.3381.981.17
2332960-33296081.65782.43
3327503-32750380.31981.07
4334354-33435481.99982.77
5336216-33621682.45683.24
6327306-32730680.27181.03
极限1331663-33166381.33982.101.3682.2283.001.37
2336472-33647282.51983.42
3327555-32755580.33281.21
4339767-33976783.32784.24
5338459-33845983.00683.92
6334652-33465282.07282.97
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101242-201201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%
116.514048234047604050624048824046024048260.05
216.494050034051204050620.03
单位质量响应值RSD%判断
24520.0524564.100.13数据可信
供试品溶液-1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%
5min132869-328698.0368.8017.228.048.8017.19
245580-4558011.14311.14
333579-335798.2098.21
429233-292337.1477.15
541523-4152310.15110.15
633135-331358.1018.10
10min171013-7101317.36117.624.9117.3717.644.92
275865-7586518.54718.57
370504-7050417.23717.25
467968-6796816.61716.63
576961-7696118.81518.83
670122-7012217.14317.16
15min1109403-10940326.74726.783.4626.7926.833.46
2111167-11116727.17827.23
3104609-10460925.57525.62
4107877-10787726.37426.41
5115898-11589828.33528.38
6108335-10833526.48626.53
20min1139463-13946334.09634.082.8534.1834.172.85
2141317-14131734.54934.64
3133574-13357432.65632.74
4138923-13892333.96434.05
5145508-14550835.57435.67
6137609-13760933.64233.73
30min1179991-17999144.00443.752.8844.1543.892.89
2181089-18108944.27244.42
3169307-16930741.39241.53
4179331-17933143.84343.98
5184769-18476945.17245.33
6179161-17916143.80143.94
45min1219420-21942053.64353.133.1753.8653.353.17
2219590-21959053.68553.91
3203500-20350049.75149.96
4220710-22071053.95954.17
5222151-22215154.31154.54
6218556-21855653.43253.65
60min1245731-24573160.07659.254.3260.3859.554.31
2244903-24490359.87360.19
3221342-22134254.11354.40
4245440-24544060.00560.31
5250024-25002461.12561.45
6246567-24656760.28060.58
90min1278386-27838668.05967.074.5968.4767.484.58
2277357-27735767.80868.22
3248923-24892360.85661.24
4279666-27966668.37268.78
5282686-28268669.11169.53
6279023-27902368.21568.62
120min1298311-29831172.93171.705.0573.4572.225.04
2297624-29762472.76373.29
3263176-26317664.34164.82
4300317-30031773.42173.94
5300916-30091673.56774.11
6299275-29927573.16673.68
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1320323-32032378.31277.215.5178.9577.855.49
2322337-32233778.80479.45
3280472-28047268.56969.16
4324537-32453779.34279.98
5323882-32388279.18279.84
6323404-32340479.06579.71
240min1334244-33424481.71580.305.2382.4981.075.22
2332791-33279181.36082.14
3293582-29358271.77472.48
4336324-33632482.22483.00
5336430-33643082.25083.04
6337357-33735782.47683.25
极限1337281-33728182.45881.005.4683.3781.905.44
2336870-33687082.35783.27
3294550-29455072.01172.84
4339280-33928082.94783.86
5340176-34017683.16684.09
6339757-33975783.06383.97
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101242-201201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%
116.512019472018362014202014012018162016840.13
216.492036522036402036460.01
单位质量响应值RSD%判断
12215.8712349.670.78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%
5min111991-119915.8586.329.695.866.329.69
212293-122936.0056.01
314999-149997.3277.33
412519-125196.1166.12
513954-139546.8176.82
611897-118975.8125.81
10min137743-3774318.43818.572.3818.4518.582.38
236609-3660917.88417.89
339349-3934919.22219.23
438194-3819418.65818.67
538418-3841818.76718.78
637782-3778218.45718.47
15min157767-5776728.21927.981.0428.2628.021.04
257343-5734328.01228.05
357845-5784528.25728.30
456602-5660227.65027.69
557621-5762128.14828.19
656502-5650227.60127.64
20min173561-7356135.93535.281.1036.0235.361.10
272375-7237535.35535.44
372447-7244735.39135.48
471466-7146634.91135.00
572026-7202635.18535.27
671403-7140334.88134.97
30min195121-9512146.46745.601.2246.6145.751.22
293980-9398045.91046.06
393443-9344345.64745.80
492944-9294445.40345.55
592785-9278545.32645.47
691809-9180944.84944.99
45min1117351-11735157.32656.340.9657.5556.560.95
2115539-11553956.44156.66
3115280-11528056.31556.54
4114983-11498356.17056.39
5114132-11413255.75455.98
6114744-11474456.05356.27
60min1132602-13260264.77763.980.9265.1064.300.92
2131538-13153864.25764.57
3131797-13179764.38364.70
4130545-13054563.77264.09
5129463-12946363.24363.56
6129908-12990863.46163.77
90min1153125-15312574.80273.581.1975.2374.001.19
2150853-15085373.69274.12
3151740-15174074.12674.55
4150197-15019773.37273.79
5150020-15002073.28573.71
6147815-14781572.20872.63
120min1166215-16621581.19780.230.7981.7580.780.80
2163720-16372079.97880.52
3165452-16545280.82481.38
4163589-16358979.91480.46
5163670-16367079.95380.50
6162823-16282379.54080.08
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1180720-18072088.28287.310.9588.9787.990.95
2178741-17874187.31687.99
3180794-18079488.31989.00
4176948-17694886.44087.12
5178063-17806386.98487.66
6177166-17716686.54687.22
240min1186381-18638191.04890.211.2791.8891.041.26
2181439-18143988.63489.46
3188010-18801091.84492.68
4183131-18313189.46090.28
5184891-18489190.32091.14
6184149-18414989.95790.77
极限1188932-18893292.29491.750.8593.2892.720.85
2186413-18641391.06392.04
3190478-19047893.04994.04
4187500-18750091.59492.56
5186762-18676291.23492.21
6186813-18681391.25992.22
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101242-201201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%
116.511985981989271989161986851981361986520.17
216.491997542000421998980.11
单位质量响应值RSD%判断
12032.2212122.380.53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%
5min115220-152207.5617.215.167.567.215.13
213438-134386.6766.68
314973-149737.4397.44
414084-140846.9977.00
514086-140866.9987.00
615266-152667.5847.58
10min141531-4153120.63320.184.5720.6520.194.57
241427-4142720.58120.59
342845-4284521.28621.30
440726-4072620.23320.24
537478-3747818.61918.63
639704-3970419.72519.74
15min159439-5943929.53029.352.5629.5829.392.57
259775-5977529.69729.74
361539-6153930.57330.62
458287-5828728.95729.00
557342-5734228.48828.53
658026-5802628.82828.87
20min174049-7404936.78836.811.0236.8836.901.03
274476-7447637.00037.10
375374-7537437.44637.55
473736-7373636.63336.73
573242-7324236.38736.48
673636-7363636.58336.68
30min194441-9444146.91947.140.8447.0847.300.84
296012-9601247.69947.86
395478-9547847.43447.60
493831-9383146.61646.77
595096-9509647.24447.40
694516-9451646.95647.11
45min1114300-11430056.78557.680.9757.0257.910.97
2116720-11672057.98758.22
3115826-11582657.54357.78
4115720-11572057.49057.72
5117646-11764658.44758.68
6116343-11634357.80058.03
60min1131402-13140265.28165.540.7865.6165.870.78
2132835-13283565.99366.33
3131818-13181865.48865.82
4131396-13139665.27865.61
5133403-13340366.27666.60
6130633-13063364.89965.23
90min1150874-15087474.95575.190.8275.3975.630.82
2152929-15292975.97676.42
3150068-15006874.55575.00
4150542-15054274.79075.23
5152885-15288575.95476.39
6150811-15081174.92475.36
120min1164508-16450881.72981.600.7982.2982.160.79
2165063-16506382.00482.57
3163461-16346181.20981.78
4163776-16377681.36581.93
5166171-16617182.55583.12
6162484-16248480.72381.29
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1178633-17863388.74688.640.4889.4589.340.48
2179270-17927089.06389.77
3177084-17708487.97788.68
4178076-17807688.46989.17
5179320-17932089.08789.79
6178142-17814288.50289.20
240min1185479-18547992.14791.720.7693.0092.580.75
2186115-18611592.46393.32
3182474-18247490.65491.51
4184244-18424491.53492.38
5185698-18569892.25693.11
6183761-18376191.29492.14
极限1187529-18752993.16692.820.7494.1793.830.74
2188359-18835993.57894.59
3184643-18464391.73292.73
4185822-18582292.31893.31
5187744-18774493.27294.28
6186959-18695992.88293.88
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