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%
116.584023064052154029223991404025474024260.54
216.533989103992353990720.06
单位质量响应值RSD%判断
24271.7724142.290.38数据可信
中间条件6月-供试品溶液-2025050421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%
5min132091-320917.9468.304.237.958.304.23
231414-314147.7797.78
334403-344038.5198.52
434637-346378.5778.58
533765-337658.3618.36
634737-347378.6018.60
10min167909-6790916.81517.502.9616.8317.522.96
269715-6971517.26317.28
372869-7286918.04418.06
470058-7005817.34717.36
570108-7010817.36017.37
673460-7346018.19018.20
15min1101099-10109925.03425.972.7925.0726.012.80
2102657-10265725.41925.46
3107393-10739326.59226.64
4105022-10502226.00526.05
5104097-10409725.77625.82
6108933-10893326.97427.02
20min1127974-12797431.68832.571.8131.7732.661.82
2129959-12995932.18032.26
3133148-13314832.97033.06
4131267-13126732.50432.59
5132281-13228132.75532.84
6134669-13466933.34633.44
30min1163396-16339640.45941.581.7540.6041.721.75
2167999-16799941.59941.74
3169921-16992142.07542.22
4165613-16561341.00841.15
5169297-16929741.92142.06
6171289-17128942.41442.56
45min1200591-20059149.66950.571.2149.8750.781.21
2204156-20415650.55250.76
3207501-20750151.38151.59
4203341-20334150.35050.56
5203358-20335850.35550.56
6206427-20642751.11551.33
60min1228505-22850556.58157.090.6256.8757.380.62
2230755-23075557.13957.43
3229418-22941856.80857.11
4230766-23076657.14157.43
5231251-23125157.26157.56
6232545-23254557.58257.88
90min1261259-26125964.69264.961.2365.0765.351.23
2265386-26538665.71466.10
3263717-26371765.30065.69
4256474-25647463.50763.90
5262621-26262165.02965.42
6264609-26460965.52165.92
120min1280887-28088769.55270.381.0670.0470.881.06
2284751-28475170.50971.00
3285384-28538470.66671.17
4280993-28099369.57870.07
5284567-28456770.46370.96
6288891-28889171.53472.04
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
180min1312042-31204277.26777.210.6477.8777.830.64
2315159-31515978.03878.65
3312196-31219677.30577.93
4310085-31008576.78277.39
5309534-30953476.64677.26
6311981-31198177.25177.88
240min1327037-32703780.98080.790.5981.7181.530.59
2327578-32757881.11381.86
3327541-32754181.10481.85
4322572-32257279.87480.61
5326942-32694280.95681.70
6325920-32592080.70381.46
极限1327434-32743481.07881.650.6781.9582.530.67
2331659-33165982.12483.00
3329631-32963181.62282.51
4326943-32694380.95681.83
5330597-33059781.86182.74
6332299-33229982.28283.17
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%
116.584061634062594024424050624032124046280.43
216.534038174009994024080.50
单位质量响应值RSD%判断
24404.5824344.100.18数据可信
中间条件6月-供试品溶液-2025050621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%
5min127673-276736.8056.423.526.816.423.55
225643-256436.3066.31
326352-263526.4806.48
426224-262246.4496.45
524982-249826.1436.14
625666-256666.3126.31
10min164109-6410915.76514.528.7815.7814.538.78
263086-6308615.51415.52
352103-5210312.81312.82
462662-6266215.41015.42
553466-5346613.14813.16
658904-5890414.48514.50
15min198005-9800524.10123.254.5724.1423.284.57
295814-9581423.56223.60
393899-9389923.09123.12
498088-9808824.12124.16
586402-8640221.24821.28
694963-9496323.35323.39
20min1125670-12567030.90430.372.5330.9830.442.53
2123744-12374430.43030.51
3123130-12313030.27930.35
4127016-12701631.23531.31
5117885-11788528.99029.06
6123556-12355630.38430.46
30min1162835-16283540.04439.661.1240.1739.781.13
2162004-16200439.83939.97
3161011-16101139.59539.72
4163194-16319440.13240.26
5158419-15841938.95839.07
6160108-16010839.37339.50
45min1201557-20155749.56649.110.6249.7649.300.62
2200328-20032849.26449.46
3198769-19876948.88049.07
4200301-20030149.25749.45
5198658-19865848.85349.03
6198555-19855548.82849.02
60min1226178-22617855.62055.720.2555.9055.990.24
2225957-22595755.56655.84
3227503-22750355.94656.21
4226420-22642055.68055.96
5226970-22697055.81556.08
6226483-22648355.69555.97
90min1259079-25907963.71164.040.4664.0864.410.46
2261504-26150464.30864.68
3261809-26180964.38364.74
4260820-26082064.13964.51
5260315-26031564.01564.37
6259013-25901363.69564.06
120min1281456-28145669.21469.460.4769.6969.930.46
2282810-28281069.54770.02
3284594-28459469.98670.45
4282902-28290269.57070.05
5281969-28196969.34069.80
6280930-28093069.08569.56
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
180min1309372-30937276.07976.250.7976.6776.840.79
2311027-31102776.48677.08
3309736-30973676.16976.75
4312559-31255976.86377.46
5312013-31201376.72977.31
6305767-30576775.19375.78
240min1323250-32325079.49279.421.4880.2180.141.46
2326828-32682880.37281.09
3325490-32549080.04380.76
4322653-32265379.34580.07
5325801-32580180.11980.82
6313839-31383977.17877.89
极限1322734-32273479.36580.471.0080.2281.320.99
2331108-33110881.42482.28
3330078-33007881.17182.02
4325529-32552980.05280.91
5328808-32880880.85981.70
6325081-32508179.94280.78
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%
116.584062814017894024634063864052744044390.54
216.534061964070474066220.15
单位质量响应值RSD%判断
24393.1824599.030.60数据可信
中间条件6月-供试品溶液-2025050821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%
5min126478-264786.4796.744.576.486.744.55
226812-268126.5616.56
326607-266076.5116.51
427096-270966.6306.63
528665-286657.0147.01
629519-295197.2237.22
10min161418-6141815.02915.382.7715.0415.392.77
261491-6149115.04715.06
363043-6304315.42615.44
461272-6127214.99315.00
564540-6454015.79315.80
665268-6526815.97115.98
15min196049-9604923.50323.632.1123.5423.672.11
294740-9474023.18323.22
397013-9701323.73923.78
493976-9397622.99623.03
598892-9889224.19924.24
698724-9872424.15724.20
20min1123466-12346630.21230.151.5330.2930.221.52
2122238-12223829.91129.99
3123728-12372830.27630.35
4119961-11996129.35429.43
5125118-12511830.61630.69
6124661-12466130.50430.58
30min1163751-16375140.06939.431.7440.1939.551.74
2162946-16294639.87240.00
3160756-16075639.33639.46
4155847-15584738.13538.26
5162022-16202239.64639.78
6161399-16139939.49439.62
45min1201765-20176549.37148.621.2849.5648.811.28
2197474-19747448.32148.51
3200305-20030549.01449.21
4194737-19473747.65147.84
5200143-20014348.97449.17
6197743-19774348.38748.58
60min1228105-22810555.81655.150.8956.0955.420.89
2226531-22653155.43155.70
3225178-22517855.10055.37
4223152-22315254.60454.87
5226268-22626855.36755.64
6223058-22305854.58154.86
90min1260406-26040663.72063.181.1064.0963.551.10
2261844-26184464.07264.44
3259044-25904463.38763.75
4254143-25414362.18862.55
5256022-25602262.64863.02
6257736-25773663.06763.43
120min1282780-28278069.19568.820.7869.6769.290.78
2282436-28243669.11169.58
3282891-28289169.22269.69
4278130-27813068.05768.52
5282460-28246069.11769.59
6278797-27879768.22168.69
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
180min1308238-30823875.42575.670.9876.0176.260.98
2311717-31171776.27676.86
3311747-31174776.28376.87
4304162-30416274.42775.00
5311508-31150876.22576.81
6308110-30811075.39375.98
240min1326035-32603579.78079.640.9280.4980.350.92
2328004-32800480.26180.97
3327453-32745380.12780.84
4321906-32190678.76979.47
5327883-32788380.23280.95
6321591-32159178.69279.40
极限1329285-32928580.57580.220.8281.4281.070.82
2328817-32881780.46081.31
3330173-33017380.79281.64
4324308-32430879.35780.19
5329941-32994180.73581.59
6324603-32460379.42980.27
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