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%
116.373981803983953983253982263977193981690.07
216.344019813976323998060.77
单位质量响应值RSD%判断
24323.0924467.930.42数据可信
供试品溶液-2025032921批-SHUI(内含0.22%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1370270-37027091.06884.0311.1191.0784.0311.11
2370032-37003291.00991.01
3367489-36748990.38490.38
4346345-34634585.18385.18
5274863-27486367.60267.60
6321036-32103678.95978.96
10min1421676-421676103.71199.964.96103.86100.104.96
2414341-414341101.907102.06
3426450-426450104.885105.04
4412987-412987101.574101.72
5376797-37679792.67392.79
6386245-38624594.99795.13
15min1425614-425614104.679103.132.26105.00103.442.26
2420618-420618103.451103.77
3414826-414826102.026102.35
4417884-417884102.778103.09
5404649-40464999.52399.79
6432321-432321106.329106.62
20min1448087-448087110.207108.081.22110.71108.561.23
2438322-438322107.805108.30
3432869-432869106.464106.96
4439558-439558108.109108.59
5435423-435423107.092107.52
6442305-442305108.784109.25
30min1446550-446550109.829105.953.12110.51106.603.09
2412983-412983101.573102.25
3415838-415838102.275102.95
4436025-436025107.240107.90
5439656-439656108.133108.74
6433519-433519106.624107.27
45min1443510-443510109.081106.361.74109.95107.201.73
2431362-431362106.093106.94
3420471-420471103.414104.26
4430600-430600105.906106.75
5435554-435554107.124107.92
6433249-433249106.557107.38
60min1440386-440386108.313105.901.79109.36106.911.78
2432007-432007106.252107.27
3417202-417202102.610103.63
4432839-432839106.456107.47
5433116-433116106.524107.49
6427961-427961105.257106.26
极限1438473-438473107.842105.351.57109.07106.541.57
2430916-430916105.983107.18
3419833-419833103.258104.44
4429255-429255105.575106.77
5429533-429533105.643106.79
6421945-421945103.777104.96
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%
116.373976074050693986893978844001963998890.77
216.344020214057484038840.66
单位质量响应值RSD%判断
24428.1624717.500.84数据可信
供试品溶液-2025032921批-SHUI(内含0.22%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1343058-34305883.76873.949.2383.7773.949.23
2325250-32525079.42079.42
3278053-27805367.89567.90
4306370-30637074.81074.81
5293969-29396971.78271.78
6270025-27002565.93565.93
10min1412000-412000100.60297.192.39100.7497.312.40
2406029-40602999.14499.28
3386052-38605294.26694.38
4397002-39700296.94097.06
5395152-39515296.48896.61
6391871-39187195.68795.80
15min1416329-416329101.659103.012.51101.97103.302.50
2413444-413444100.955101.25
3415148-415148101.371101.64
4418061-418061102.082102.37
5427072-427072104.283104.56
6441147-441147107.720107.99
20min1418872-418872102.280104.003.00102.76104.462.99
2413281-413281100.915101.38
3413858-413858101.056101.50
4442599-442599108.074108.53
5427589-427589104.409104.86
6439296-439296107.268107.72
30min1419002-419002102.312104.732.56102.96105.362.54
2415602-415602101.482102.12
3439488-439488107.314107.92
4441973-441973107.921108.56
5424066-424066103.549104.18
6433199-433199105.779106.41
45min1420917-420917102.780104.322.45103.60105.132.43
2414369-414369101.181101.98
3438373-438373107.042107.83
4440900-440900107.659108.48
5421742-421742102.981103.78
6427105-427105104.291105.09
60min1420216-420216102.609104.261.49103.60105.241.48
2428720-428720104.685105.66
3431069-431069105.259106.22
4435802-435802106.414107.41
5419394-419394102.408103.38
6426647-426647104.179105.16
极限1445126-445126108.691104.132.63109.85105.282.61
2416794-416794101.773102.92
3427887-427887104.482105.62
4430117-430117105.026106.20
5413507-413507100.970102.11
6425270-425270103.843104.99
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%
116.374038204015684039344010963989054018650.53
216.344017184029484023330.22
单位质量响应值RSD%判断
24548.8724622.580.22数据可信
供试品溶液-3A75SDB1批-SHUI(内含0.22%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1271573-27157366.27667.201.2466.2867.201.24
2273239-27323966.68266.68
3275888-27588867.32967.33
4273629-27362966.77866.78
5281174-28117468.61968.62
6276735-27673567.53667.54
10min1358092-35809287.39087.980.9887.5088.090.98
2355516-35551686.76286.87
3360581-36058187.99888.11
4361098-36109888.12488.24
5361715-36171588.27588.39
6365938-36593889.30589.42
15min1390184-39018495.22294.571.3695.4894.831.36
2380629-38062992.89093.15
3384921-38492193.93894.20
4384297-38429793.78694.04
5389651-38965195.09295.35
6395413-39541396.49896.76
20min1400748-40074897.80097.291.4998.2297.701.49
2392236-39223695.72396.13
3391879-39187995.63696.05
4402343-40234398.19098.60
5397751-39775197.06997.49
6406982-40698299.32299.74
30min1415567-415567101.41799.991.67101.99100.571.66
2402221-40222198.16098.73
3409242-40924299.873100.45
4411770-411770100.490101.07
5401449-40144997.97198.55
6418043-418043102.021102.61
45min1414054-414054101.048100.411.20101.79101.161.20
2407424-40742499.430100.16
3409806-409806100.011100.75
4410267-410267100.123100.87
5407042-40704299.336100.08
6420078-420078102.518103.28
60min1412964-412964100.782100.942.22101.70101.852.21
2403321-40332198.42899.33
3411123-411123100.332101.24
4429427-429427104.799105.71
5407168-40716899.367100.28
6417619-417619101.918102.85
极限1418359-418359102.098100.582.01103.18101.662.00
2403466-40346698.46499.53
3407966-40796699.562100.64
4416501-416501101.645102.73
5403618-40361898.50199.58
6423004-423004103.232104.33
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%
116.374054534033674081374086464022494055700.70
216.344089944060234075080.52
单位质量响应值RSD%判断
24775.2024939.290.47数据可信
供试品溶液-3A75SDB1批-SHUI(内含0.22%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1285667-28566768.95566.002.5968.9566.002.58
2264799-26479963.91763.92
3276119-27611966.65066.65
4272249-27224965.71665.72
5269609-26960965.07865.08
6272162-27216265.69565.69
10min1367634-36763488.74087.362.2888.8587.472.28
2347971-34797183.99484.10
3355957-35595785.92186.03
4368770-36877089.01489.12
5364450-36445087.97188.08
6366693-36669388.51388.62
15min1402760-40276097.21994.712.4497.4894.972.43
2377761-37776191.18491.43
3384909-38490992.91093.16
4396877-39687795.79996.06
5399943-39994396.53996.79
6391995-39199594.62094.88
20min1410645-41064599.12297.881.6199.5598.291.61
2395062-39506295.36095.76
3403252-40325297.33797.75
4408505-40850598.60599.02
5412838-41283899.651100.07
6402592-40259297.17897.59
30min1417703-417703100.82699.921.39101.42100.501.39
2406520-40652098.12698.68
3413991-41399199.930100.50
4412682-41268299.614100.20
5422817-422817102.060102.64
6409968-40996898.95899.54
45min1421161-421161101.66099.921.20102.42100.661.20
2410363-41036399.05499.77
3411121-41112199.23799.97
4408811-40881198.67999.43
5418791-418791101.088101.84
6413456-41345699.800100.54
60min1418576-418576101.036100.400.61101.96101.310.61
2414556-414556100.066100.95
3413907-41390799.909100.81
4412794-41279499.641100.55
5418552-418552101.030101.95
6417246-417246100.715101.62
极限1417024-417024100.66299.720.76101.76100.800.77
2408082-40808298.50399.56
3412235-41223599.506100.58
4413110-41311099.717100.80
5415794-415794100.365101.45
6412516-41251699.574100.65
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