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2000
标示量(mg)7.5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%
116.641959451956811957161955351954551956660.10
216.861956791957541957160.03
单位质量响应值RSD%判断
11758.7711608.300.92数据可信
供试品溶液-2025050921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%
5min114971-149717.6897.983.547.697.983.56
215131-151317.7717.77
315678-156788.0528.05
415848-158488.1398.14
515197-151977.8057.80
616429-164298.4378.44
10min135597-3559718.28118.896.7418.2918.906.75
234525-3452517.73117.74
340485-4048520.79220.81
439143-3914320.10220.12
534631-3463117.78517.80
636305-3630518.64518.66
15min152974-5297427.20627.733.4627.2527.773.46
251618-5161826.50926.55
355716-5571628.61428.66
456496-5649629.01429.06
552831-5283127.13227.17
654300-5430027.88727.93
20min171491-7149136.71535.893.1436.8035.983.14
266407-6640734.10434.19
370639-7063936.27836.37
472579-7257937.27437.37
568718-6871835.29135.38
669517-6951735.70135.79
30min188331-8833145.36446.672.7445.5146.822.74
288220-8822045.30745.45
392103-9210347.30147.46
493672-9367248.10748.26
589542-8954245.98646.13
693392-9339247.96348.11
45min1109693-10969356.33457.521.6256.5657.751.63
2110263-11026356.62756.85
3113314-11331458.19458.43
4114437-11443758.77159.01
5111717-11171757.37457.60
6112588-11258857.82158.05
60min1125133-12513364.26465.421.1864.5865.751.18
2126398-12639864.91465.23
3127650-12765065.55665.89
4129501-12950166.50766.84
5127494-12749465.47665.80
6128163-12816365.82066.15
90min1145331-14533174.63775.020.5075.0675.450.51
2145077-14507774.50674.93
3146206-14620675.08675.53
4146610-14661075.29475.74
5146289-14628975.12975.56
6146944-14694475.46575.90
120min1157004-15700480.63282.091.1381.1882.641.13
2158891-15889181.60182.15
3162216-16221683.30883.87
4160373-16037382.36282.93
5159622-15962281.97682.53
6160904-16090482.63583.20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1171241-17124187.94389.240.8788.6389.940.86
2174493-17449389.61390.30
3173298-17329889.00089.70
4173406-17340689.05589.76
5174570-17457089.65390.34
6175603-17560390.18390.88
240min1179953-17995392.41793.160.6093.2594.010.60
2180653-18065392.77793.61
3181051-18105192.98193.83
4181593-18159393.26094.12
5182278-18227893.61194.45
6182912-18291293.93794.79
极限1183120-18312094.04494.560.4695.0395.560.46
2183889-18388994.43995.42
3183335-18333594.15495.16
4185240-18524095.13396.15
5184423-18442394.71395.71
6184766-18476694.88995.90
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2000
标示量(mg)7.5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%
116.641975051974881975631976391975511975490.03
216.862041212046202043700.18
单位质量响应值RSD%判断
11871.9412121.591.48数据可信
供试品溶液-2025051021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%
5min115566-155667.7867.967.867.797.967.83
215485-154857.7457.75
314657-146577.3317.33
418321-183219.1649.16
515595-155957.8007.80
615807-158077.9067.91
10min135651-3565117.83218.325.3717.8518.335.38
234821-3482117.41717.43
335399-3539917.70617.72
440286-4028620.15120.17
536496-3649618.25518.27
637047-3704718.53118.54
15min152422-5242226.22126.674.2326.2626.714.24
251135-5113525.57725.62
352139-5213926.07926.12
457456-5745628.73928.79
552566-5256626.29326.34
654179-5417927.10027.14
20min166498-6649833.26233.993.3033.3534.083.30
268205-6820534.11534.20
365979-6597933.00233.09
472038-7203836.03336.13
566531-6653133.27833.37
668524-6852434.27534.36
30min186011-8601143.02243.712.4943.1643.852.49
284910-8491042.47142.61
389106-8910644.57044.71
490571-9057145.30345.46
585901-8590142.96743.11
687819-8781943.92644.07
45min1106912-10691253.47653.961.9853.6954.181.99
2106237-10623753.13953.35
3107349-10734953.69553.91
4112035-11203556.03956.27
5106635-10663553.33853.55
6108107-10810754.07454.29
60min1122814-12281461.43061.441.7661.7361.751.76
2120608-12060860.32760.63
3122318-12231861.18261.49
4126759-12675963.40363.73
5121288-12128860.66760.97
6123271-12327161.65961.97
90min1145584-14558472.82071.501.3673.2271.911.35
2140635-14063570.34470.75
3143517-14351771.78672.19
4144621-14462172.33872.77
5141687-14168770.87071.27
6141634-14163470.84471.26
120min1155663-15566377.86177.741.3678.3978.271.36
2152962-15296276.51077.03
3156597-15659778.32878.85
4158765-15876579.41379.96
5153636-15363676.84777.37
6154922-15492277.49078.02
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1170959-17095985.51285.560.9786.1786.220.97
2169945-16994585.00585.65
3172946-17294686.50687.16
4173120-17312086.59387.28
5169149-16914984.60685.26
6170180-17018085.12285.78
240min1178503-17850389.28590.101.0190.0890.901.01
2180290-18029090.17990.97
3181366-18136690.71791.52
4181416-18141690.74291.57
5177388-17738888.72889.52
6181864-18186490.96691.77
极限1181140-18114090.60490.601.0891.5591.551.08
2179280-17928089.67490.61
3183460-18346091.76592.72
4183560-18356091.81592.79
5179954-17995490.01190.95
6179426-17942689.74790.70
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2000
标示量(mg)7.5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%
116.641958231958411962121957831957401958800.10
216.861980641982631981640.08
单位质量响应值RSD%判断
11771.6311753.500.11数据可信
供试品溶液-2025051121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%
5min122839-2283911.6507.8024.7311.657.8024.74
214770-147707.5347.53
313534-135346.9046.90
413853-138537.0667.07
514377-143777.3347.33
612412-124126.3316.33
10min135972-3597218.34917.762.1318.3717.782.13
234706-3470617.70317.72
334854-3485417.77917.79
435131-3513117.92017.93
534574-3457417.63617.65
633709-3370917.19517.21
15min153844-5384427.46526.721.6227.5226.771.63
251980-5198026.51526.56
352426-5242626.74226.78
452673-5267326.86826.91
552070-5207026.56126.60
651342-5134226.18926.23
20min167408-6740834.38434.171.0634.4834.251.06
266906-6690634.12834.21
367444-6744434.40334.49
467651-6765134.50834.59
566747-6674734.04734.13
665721-6572133.52433.61
30min187670-8767044.72044.890.9644.8745.040.96
287613-8761344.69144.83
389408-8940845.60645.75
488521-8852145.15445.30
587830-8783044.80144.94
687016-8701644.38644.52
45min1109348-10934855.77855.711.1656.0155.931.15
2107882-10788255.03055.25
3111400-11140056.82457.04
4109604-10960455.90856.13
5108835-10883555.51655.73
6108186-10818655.18555.40
60min1126459-12645964.50664.050.9664.8364.360.97
2124379-12437963.44563.75
3127264-12726464.91665.23
4126121-12612164.33364.65
5124624-12462463.57063.88
6124577-12457763.54663.85
90min1147242-14724275.10774.431.0075.5474.851.00
2144361-14436173.63874.05
3148061-14806175.52575.95
4145217-14521774.07474.49
5145817-14581774.38074.80
6144791-14479173.85774.27
120min1161489-16148982.37481.501.2182.9382.041.21
2157991-15799180.59081.13
3162793-16279383.04083.59
4158809-15880981.00781.55
5159249-15924981.23281.77
6158340-15834080.76881.30
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1176710-17671090.13988.820.9590.8389.500.96
2172618-17261888.05188.72
3175689-17568989.61890.30
4173178-17317888.33789.01
5173307-17330788.40389.08
6173293-17329388.39689.06
240min1185040-18504094.38892.791.2395.2393.621.23
2179505-17950591.56492.38
3184335-18433594.02894.86
4181107-18110792.38193.21
5180547-18054792.09692.92
6180923-18092392.28893.10
极限1186742-18674295.25693.871.3196.2594.851.30
2181729-18172992.69993.67
3187197-18719795.48896.48
4181993-18199392.83393.81
5182690-18269093.18994.16
6183817-18381793.76494.73
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