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%
116.444990349747498684970249888498220.19
216.395025150257502540.01
单位质量响应值RSD%判断
3030.543066.140.83数据可信
供试品溶液-2J95SDC1批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min11089-10892.1442.209.082.142.209.16
21011-10111.9901.99
31074-10742.1142.11
41309-13092.5772.58
51138-11382.2402.24
61097-10972.1592.16
10min17391-739114.54814.492.3114.5614.502.31
27286-728614.34114.35
37334-733414.43614.45
47574-757414.90814.92
57485-748514.73314.75
67085-708513.94613.96
15min111832-1183223.29023.542.2923.3823.642.29
211747-1174723.12223.21
312086-1208623.79023.88
412287-1228724.18524.28
512211-1221124.03624.13
611603-1160322.83922.93
20min115294-1529430.10430.191.6130.3330.411.61
214952-1495229.43129.65
315234-1523429.98630.21
415579-1557930.66530.90
515623-1562330.75230.98
615342-1534230.19830.41
30min120776-2077640.89540.041.8741.2840.431.85
220286-2028639.93040.31
319854-1985439.08039.47
420809-2080940.95941.36
520225-2022539.81040.21
620105-2010539.57439.96
45min125873-2587350.92751.612.6451.5452.232.62
225529-2552950.25050.85
325768-2576850.72151.33
427399-2739953.93154.56
526643-2664352.44353.06
626121-2612151.41552.02
60min130771-3077160.56860.211.8561.4761.111.84
230235-3023559.51360.40
330121-3012159.28960.18
431086-3108661.18862.12
531352-3135261.71262.62
629967-2996758.98659.88
90min135286-3528669.45569.352.0970.6970.582.08
234343-3434367.59968.81
334435-3443567.78069.00
436094-3609471.04672.31
535955-3595570.77272.03
635271-3527169.42670.64
120min140131-4013178.99277.672.7880.6179.292.76
238771-3877176.31577.90
338533-3853375.84777.44
440406-4040679.53381.20
540741-4074180.19381.84
638166-3816675.12476.73
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
180min143150-4315084.93483.983.4287.0086.043.37
240922-4092280.54982.56
341070-4107080.84082.86
442864-4286484.37286.48
544772-4477288.12790.22
643220-4322085.07287.09
240min144688-4468887.96287.862.2190.4990.382.21
243748-4374886.11288.57
343623-4362385.86588.33
446001-4600190.54693.12
545605-4560589.76792.35
644164-4416486.93089.42
300min144210-4421087.02187.683.5190.0490.683.45
243228-4322885.08888.03
342722-4272284.09287.04
445123-4512388.81891.90
547114-4711492.73795.82
644859-4485988.29891.27
360min144671-4467187.92889.072.8191.4392.562.77
244064-4406486.73490.15
343684-4368485.98689.40
446111-4611190.76394.33
546669-4666991.86195.46
646299-4629991.13394.60
极限143484-4348485.59286.813.1589.5990.803.10
243072-4307284.78188.68
342425-4242583.50787.40
445582-4558289.72193.80
545876-4587690.30094.41
644188-4418886.97890.95
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%
116.445031650215502485016650074502040.19
216.395072050744507320.04
单位质量响应值RSD%判断
3053.773095.300.96数据可信
供试品溶液-3B85SDC1批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min11227-12272.3952.585.212.392.585.31
21398-13982.7282.73
31397-13972.7262.73
41322-13222.5802.58
51265-12652.4692.47
61335-13352.6052.61
10min18102-810215.81215.942.3015.8315.962.30
28210-821016.02316.04
38152-815215.90915.92
48049-804915.70815.72
58513-851316.61416.63
67980-798015.57415.59
15min113301-1330125.95825.851.7826.0625.951.78
213625-1362526.59126.69
312954-1295425.28125.38
413121-1312125.60725.71
513350-1335026.05426.16
613108-1310825.58225.68
20min116625-1662532.44532.610.9432.6932.850.95
216881-1688132.94533.20
316770-1677032.72832.97
416744-1674432.67832.92
516789-1678932.76533.02
616438-1643832.08032.32
30min121886-2188642.71342.350.8743.1442.780.87
221765-2176542.47742.91
321596-2159642.14742.57
421453-2145341.86842.29
521924-2192442.78743.22
621579-2157942.11442.53
45min126719-2671952.14554.292.5452.8154.962.51
227973-2797354.59255.26
328108-2810854.85655.52
427580-2758053.82554.48
528863-2886356.32957.00
627670-2767054.00154.66
60min131987-3198762.42664.252.6463.3865.212.61
232273-3227362.98463.96
333757-3375765.88066.84
432726-3272663.86864.83
534194-3419466.73367.72
632584-3258463.59164.55
90min137311-3731172.81673.532.1674.1274.852.14
237581-3758173.34374.67
337537-3753773.25774.59
436508-3650871.24972.56
538889-3888975.89677.25
638234-3823474.61875.93
120min141381-4138180.75982.072.1682.4683.802.14
241799-4179981.57583.31
343011-4301183.94085.68
441069-4106980.15081.86
543312-4331284.52886.30
641734-4173481.44883.17
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
180min144545-4454586.93486.691.8689.0988.871.84
243788-4378885.45787.64
343883-4388385.64287.85
443835-4383585.54887.70
545944-4594489.66491.91
644512-4451286.87089.05
240min145407-4540788.61690.872.2191.2593.542.17
245472-4547288.74391.40
347872-4787293.42796.11
447330-4733092.36995.00
547121-4712191.96194.71
646179-4617990.12392.78
300min146142-4614290.05190.192.7493.1893.362.68
244298-4429886.45289.60
346194-4619490.15293.35
445700-4570089.18892.33
548139-4813993.94897.20
646802-4680291.33994.50
360min145827-4582789.43691.103.1593.0694.773.08
244789-4478987.41091.04
346321-4632190.40094.10
447085-4708591.89195.53
549161-4916195.94399.72
646890-4689091.51195.18
极限145067-4506787.95389.781.5592.0893.961.53
245244-4524488.29892.42
346077-4607789.92494.13
446799-4679991.33395.48
546648-4664891.03895.35
646188-4618890.14194.32
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