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%
116.643953563917783929823934053927883932620.34
216.863928423902373915400.48
单位质量响应值RSD%判断
23633.5323223.011.24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%
5min133643-336438.6178.503.378.628.503.37
232093-320938.2208.22
332705-327058.3768.38
432892-328928.4248.42
532546-325468.3368.34
635213-352139.0199.02
10min172818-7281818.65017.972.6918.6617.982.69
269830-6983017.88517.90
368993-6899317.67117.68
469842-6984217.88817.90
567628-6762817.32117.33
671790-7179018.38718.40
15min1105371-10537126.98826.182.1427.0326.222.14
2102596-10259626.27726.32
3101401-10140125.97126.01
4102747-10274726.31626.36
598663-9866325.27025.31
6102541-10254126.26326.31
20min1129952-12995233.28333.021.6533.3733.111.64
2129116-12911633.06933.16
3126560-12656032.41532.50
4130780-13078033.49533.58
5126119-12611932.30232.39
6131041-13104133.56233.65
30min1165915-16591542.49442.261.6942.6442.411.68
2164552-16455242.14542.29
3162447-16244741.60641.75
4169769-16976943.48143.62
5162108-16210841.51941.66
6165289-16528942.33442.48
45min1200826-20082651.43651.051.0351.6551.261.03
2200018-20001851.22951.44
3199073-19907350.98751.20
4201459-20145951.59851.81
5195672-19567250.11650.32
6198797-19879750.91651.13
60min1225367-22536757.72157.430.8158.0257.730.81
2225201-22520157.67957.98
3222515-22251556.99157.29
4226606-22660658.03858.34
5221937-22193756.84357.13
6223702-22370257.29557.60
90min1254844-25484465.27164.781.5665.6765.171.56
2254436-25443665.16665.56
3246275-24627563.07663.47
4257085-25708565.84566.24
5250202-25020264.08264.47
6254622-25462265.21465.61
120min1277452-27745271.06170.560.6371.5771.060.63
2277120-27712070.97671.48
3274506-27450670.30770.80
4275759-27575970.62871.14
5272780-27278069.86570.36
6275411-27541170.53871.04
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1301447-30144777.20776.850.7277.8377.470.72
2298801-29880176.52977.15
3297719-29771976.25276.86
4301748-30174877.28477.91
5297964-29796476.31576.92
6302605-30260577.50378.13
240min1314842-31484280.63779.910.9181.3980.660.91
2312934-31293480.14980.90
3313433-31343380.27781.02
4312858-31285880.12980.88
5306725-30672578.55979.30
6311184-31118479.70180.45
极限1319520-31952081.83681.270.6882.7282.150.68
2316188-31618880.98281.86
3315064-31506480.69481.57
4319253-31925381.76782.66
5314981-31498180.67381.54
6318891-31889181.67582.56
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%
116.643909363908273905013908323902643906720.08
216.863984433971053977740.24
单位质量响应值RSD%判断
23477.8823592.760.35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%
5min128654-286547.3057.165.447.307.165.40
229856-298567.6117.61
329386-293867.4927.49
426893-268936.8566.86
527921-279217.1187.12
625832-258326.5866.59
10min164532-6453216.45216.062.4616.4616.072.46
265286-6528616.64416.66
362160-6216015.84715.86
461420-6142015.65815.67
562510-6251015.93615.95
662017-6201715.81015.82
15min195171-9517124.26323.831.6024.3023.871.60
295144-9514424.25624.30
393399-9339923.81123.85
491880-9188023.42423.46
591783-9178323.39923.44
693513-9351323.84023.88
20min1119714-11971430.52030.201.2430.6030.271.24
2120748-12074830.78330.86
3117729-11772930.01430.09
4117142-11714229.86429.94
5118087-11808730.10530.18
6117268-11726829.89629.97
30min1153165-15316539.04739.181.1239.1839.311.13
2157129-15712940.05840.19
3153314-15331439.08539.21
4153278-15327839.07639.20
5152492-15249238.87639.00
6152719-15271938.93439.06
45min1190152-19015248.47748.420.8548.6748.610.85
2192649-19264949.11349.31
3190488-19048848.56348.76
4189215-18921548.23848.43
5188055-18805547.94248.13
6188907-18890748.15948.35
60min1216456-21645655.18355.100.5455.4655.380.54
2218191-21819155.62555.91
3215713-21571354.99355.27
4214872-21487254.77955.05
5216189-21618955.11555.39
6215452-21545254.92755.20
90min1249621-24962163.63863.330.5464.0163.700.54
2248728-24872863.41063.78
3249955-24995563.72364.09
4247441-24744163.08263.45
5248250-24825063.28863.65
6246453-24645362.83063.19
120min1270253-27025368.89868.671.0269.3769.151.01
2272583-27258369.49269.97
3269895-26989568.80669.28
4269664-26966468.74769.22
5264298-26429867.37967.85
6269577-26957768.72569.19
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1295220-29522075.26374.970.7275.8575.560.72
2296503-29650375.59076.18
3295063-29506375.22375.81
4290392-29039274.03274.61
5293635-29363574.85975.44
6293702-29370274.87675.46
240min1309614-30961478.93278.660.5879.6579.380.58
2308796-30879678.72479.44
3310077-31007779.05079.76
4308961-30896178.76679.47
5305110-30511077.78478.49
6308836-30883678.73479.44
极限1312735-31273579.72879.240.6580.5780.080.65
2310791-31079179.23280.08
3313377-31337779.89280.74
4307906-30790678.49779.33
5310209-31020979.08479.92
6309899-30989979.00579.84
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%
116.643976243979413984033987623981253981710.11
216.863966453970763968600.08
单位质量响应值RSD%判断
23928.5523538.551.17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%
5min133123-331238.3748.364.678.378.364.68
235311-353118.9278.93
331559-315597.9797.98
431814-318148.0438.04
534501-345018.7238.72
632088-320888.1138.11
10min169427-6942717.55316.766.9617.5716.786.95
273703-7370318.63418.65
366184-6618416.73316.75
463794-6379416.12916.14
560918-6091815.40215.42
663778-6377816.12516.14
15min197664-9766424.69224.242.1124.7324.282.11
297981-9798124.77224.82
397279-9727924.59424.64
495008-9500824.02024.06
593467-9346723.63123.67
693841-9384123.72523.77
20min1126281-12628131.92731.042.1932.0131.122.19
2124303-12430331.42731.51
3123170-12317031.14031.22
4123439-12343931.20831.29
5118726-11872630.01730.10
6120692-12069230.51430.59
30min1158392-15839240.04540.132.3440.1840.262.34
2157208-15720839.74639.89
3166089-16608941.99142.13
4157367-15736739.78639.92
5155794-15579439.38839.52
6157449-15744939.80739.94
45min1200262-20026250.63149.451.3150.8449.661.31
2193927-19392749.02949.24
3195928-19592849.53549.74
4196171-19617149.59749.80
5193694-19369448.97049.17
6193594-19359448.94549.14
60min1225123-22512356.91655.792.0057.2156.082.00
2219201-21920155.41955.71
3227020-22702057.39657.68
4218915-21891555.34755.63
5218318-21831855.19655.47
6215538-21553854.49354.77
90min1258804-25880465.43263.891.6265.8264.271.61
2247885-24788562.67163.05
3249708-24970863.13263.51
4256138-25613864.75865.13
5252267-25226763.77964.15
6251429-25142963.56763.94
120min1275421-27542169.63368.971.6470.1369.451.63
2270092-27009268.28668.77
3272443-27244368.88069.37
4280432-28043270.90071.38
5269616-26961668.16568.64
6268713-26871367.93768.41
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1302836-30283676.56475.261.4077.1775.861.40
2296978-29697875.08375.68
3298743-29874375.52976.13
4301002-30100276.10076.70
5295254-29525474.64775.24
6291283-29128373.64374.23
240min1314094-31409479.41078.900.8180.1579.630.80
2309758-30975878.31479.04
3310491-31049178.50079.23
4316057-31605779.90780.63
5310208-31020878.42879.14
6311961-31196178.87179.58
极限1312546-31254679.01979.701.5279.8980.561.50
2312205-31220578.93379.79
3315571-31557179.78480.64
4324215-32421581.96982.83
5315792-31579279.84080.68
6311183-31118378.67479.52
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