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%
116.643930693929543928153932783926863929600.06
216.863967993981943974960.25
单位质量响应值RSD%判断
23615.3823576.280.12数据可信
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%
5min133358-333588.4828.553.848.488.553.81
235361-353618.9928.99
332504-325048.2658.27
433000-330008.3918.39
535087-350878.9228.92
632431-324318.2478.25
10min168767-6876717.48617.463.6117.5017.473.61
272854-7285418.52518.54
367458-6745817.15317.17
468883-6888317.51617.53
568689-6868917.46617.48
665260-6526016.59416.61
15min1101724-10172425.86725.573.1725.9125.623.17
2105840-10584026.91326.96
397785-9778524.86524.91
4101074-10107425.70125.74
5100018-10001825.43325.48
696932-9693224.64824.69
20min1126184-12618432.08631.813.1232.1731.893.12
2131422-13142233.41833.51
3121192-12119230.81730.90
4125977-12597732.03432.12
5124966-12496631.77731.86
6120790-12079030.71530.80
30min1159931-15993140.66840.771.8340.8140.911.83
2164896-16489641.93042.08
3158172-15817240.22040.36
4162451-16245141.30841.45
5159621-15962140.58940.73
6156867-15686739.88940.02
45min1195019-19501949.59049.451.6449.8049.661.65
2199227-19922750.66050.88
3191426-19142648.67648.88
4196563-19656349.98350.19
5193860-19386049.29549.50
6190759-19075948.50748.71
60min1217498-21749855.30655.861.2455.6056.151.24
2222658-22265856.61856.92
3215767-21576754.86655.15
4221423-22142356.30456.60
5218863-21886355.65355.94
6221762-22176256.39056.67
90min1250363-25036363.66363.711.2464.0564.101.24
2253092-25309264.35764.75
3246294-24629462.62863.00
4253992-25399264.58664.97
5247503-24750362.93663.32
6252120-25212064.11064.48
120min1270258-27025868.72268.450.7669.2168.940.76
2270407-27040768.76069.26
3266068-26606867.65668.14
4270900-27090068.88569.38
5267124-26712467.92568.41
6270302-27030268.73369.21
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1291883-29188374.22174.591.1074.8275.191.10
2297271-29727175.59176.21
3289824-28982473.69774.29
4296890-29689075.49476.10
5290356-29035673.83274.43
6293759-29375974.69875.29
240min1308698-30869878.49678.110.7879.2278.840.79
2310735-31073579.01479.76
3304238-30423877.36278.08
4308000-30800078.31979.05
5305975-30597577.80478.53
6305483-30548377.67978.40
极限1312159-31215979.37779.150.6080.2380.010.60
2314014-31401479.84880.72
3309080-30908078.59479.44
4311670-31167079.25280.12
5309331-30933178.65779.51
6311416-31141679.18880.04
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%
116.643961313958373961763964033978433964780.20
216.863972743981883977310.17
单位质量响应值RSD%判断
23826.8023590.210.71数据可信
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%
5min128485-284857.2097.143.077.217.143.09
227031-270316.8416.84
328311-283117.1657.16
429384-293847.4377.44
528711-287117.2667.27
627411-274116.9376.94
10min163781-6378116.14215.662.4616.1515.672.46
262712-6271215.87115.88
361642-6164215.60015.61
462806-6280615.89515.91
559790-5979015.13215.14
660470-6047015.30415.32
15min192996-9299623.53523.231.9623.5723.261.95
291840-9184023.24323.28
391005-9100523.03223.07
492313-9231323.36323.40
588675-8867522.44222.48
693795-9379523.73823.77
20min1116480-11648029.47929.201.6529.5629.281.65
2115712-11571229.28429.36
3117876-11787629.83229.91
4115281-11528129.17529.25
5112203-11220328.39628.47
6114810-11481029.05629.13
30min1149958-14995837.95138.011.9238.0838.141.91
2152064-15206438.48438.61
3152041-15204138.47938.60
4148429-14842937.56437.69
5145463-14546336.81436.94
6153177-15317738.76638.89
45min1186805-18680547.27747.081.0447.4747.271.04
2187783-18778347.52447.71
3187782-18778247.52447.71
4184707-18470746.74646.93
5182878-18287846.28346.47
6186317-18631747.15347.34
60min1209875-20987553.11553.451.1253.3853.721.12
2212528-21252853.78754.06
3213874-21387454.12754.40
4210728-21072853.33153.60
5207409-20740952.49152.75
6212759-21275953.84554.11
90min1242940-24294061.48361.410.8861.8461.770.88
2242613-24261361.40061.76
3245698-24569862.18162.54
4243587-24358761.64762.00
5239241-23924160.54760.90
6241887-24188761.21761.57
120min1264985-26498567.06267.381.3467.5267.841.34
2267381-26738167.66968.13
3266290-26629067.39367.86
4262621-26262166.46466.92
5263642-26364266.72367.17
6272585-27258568.98669.45
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1290736-29073673.57973.220.6374.1573.790.63
2288735-28873573.07373.65
3291094-29109473.67074.25
4288567-28856773.03173.60
5286320-28632072.46273.02
6290441-29044173.50574.08
240min1301032-30103276.18576.550.6676.8877.240.67
2303695-30369576.85977.55
3304576-30457677.08277.78
4303953-30395376.92477.62
5299363-29936375.76376.44
6302279-30227976.50177.20
极限1305941-30594177.42877.590.7478.2578.410.74
2307924-30792477.92978.75
3309765-30976578.39579.22
4304608-30460877.09077.91
5303654-30365476.84977.66
6307510-30751077.82578.65
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%
116.643969813960763956403959783943773958100.24
216.863980523973603977060.13
单位质量响应值RSD%判断
23786.6623588.730.60数据可信
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%
5min133548-335488.4987.757.638.507.757.65
231038-310387.8627.86
327094-270946.8636.86
431396-313967.9537.95
531898-318988.0808.08
628669-286697.2627.26
10min164594-6459416.36215.972.8916.3815.982.89
264783-6478316.41016.42
364039-6403916.22116.23
461162-6116215.49215.51
563244-6324416.02016.03
660480-6048015.32015.33
15min194767-9476724.00523.832.4924.0523.872.50
296449-9644924.43124.47
395910-9591024.29424.33
492908-9290823.53423.57
594507-9450723.93923.98
690029-9002922.80422.84
20min1116473-11647329.50329.772.6929.5829.852.69
2121084-12108430.67130.75
3119356-11935630.23330.31
4117265-11726529.70329.78
5119025-11902530.14930.23
6112002-11200228.37028.45
30min1153182-15318238.80138.512.1838.9338.642.19
2157075-15707539.78739.92
3147475-14747537.35537.48
4152856-15285638.71938.85
5152265-15226538.56938.70
6149451-14945137.85637.98
45min1188161-18816147.66147.392.0247.8647.582.02
2191108-19110848.40848.61
3180870-18087045.81446.01
4190063-19006348.14348.34
5187687-18768747.54147.74
6184602-18460246.76046.95
60min1212339-21233953.78653.941.3854.0654.211.38
2217775-21777555.16355.44
3210416-21041653.29853.57
4214819-21481954.41454.69
5212269-21226953.76854.04
6209961-20996153.18353.45
90min1245287-24528762.13161.283.9362.5061.643.92
2248008-24800862.82163.19
3223432-22343256.59556.95
4249088-24908863.09463.46
5244921-24492162.03962.40
6240897-24089761.01961.37
120min1267675-26767567.80267.261.6168.2767.721.61
2267115-26711567.66068.14
3258102-25810265.37765.83
4270073-27007368.41068.88
5267009-26700967.63468.10
6263142-26314266.65467.11
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1292679-29267974.13672.573.5874.7273.153.56
2292785-29278574.16374.75
3266720-26672067.56068.12
4293597-29359774.36874.95
5288070-28807072.96873.55
6285206-28520672.24372.81
240min1303907-30390776.98076.661.5877.6877.361.58
2308899-30889978.24478.96
3294738-29473874.65775.33
4305363-30536377.34978.05
5301682-30168276.41677.12
6301281-30128176.31577.00
极限1308752-30875278.20776.823.7679.0477.653.74
2310885-31088578.74779.59
3280759-28075971.11671.91
4310289-31028978.59679.43
5305591-30559177.40678.23
6303456-30345676.86677.68
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