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%
116.792014462012952014972015752014512014530.06
216.802035802037832036820.08
单位质量响应值RSD%判断
11998.3912123.930.74数据可信
供试品溶液-2025050921批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min115401-154017.6549.8112.777.659.8112.79
221095-2109510.48410.48
320423-2042310.15010.15
420184-2018410.03110.03
518578-185789.2339.23
622750-2275011.30611.31
10min135906-3590617.84519.475.7517.8619.485.75
239092-3909219.42819.45
339574-3957419.66819.68
440168-4016819.96319.98
537719-3771918.74618.76
642545-4254521.14421.16
15min151597-5159725.64327.384.0425.6927.434.03
255110-5511027.38927.44
355273-5527327.47027.52
455899-5589927.78127.83
554242-5424226.95727.00
658413-5841329.03029.08
20min165006-6500632.30733.822.6732.3933.922.68
268535-6853534.06134.16
368549-6854934.06834.16
468391-6839133.98934.09
567360-6736033.47733.57
670511-7051135.04335.15
30min185790-8579042.63644.142.5842.7844.292.58
288897-8889744.18044.33
388639-8863944.05244.20
488956-8895644.20944.36
587828-8782843.64943.80
692805-9280546.12246.28
45min1108793-10879354.06855.301.9554.2855.531.95
2111654-11165455.49055.72
3109849-10984954.59354.82
4111283-11128355.30555.53
5110922-11092255.12655.35
6115130-11513057.21757.46
60min1125632-12563262.43764.001.7762.7464.321.78
2129177-12917764.19864.52
3129403-12940364.31164.63
4127604-12760463.41763.74
5128302-12830263.76464.08
6132510-13251065.85566.19
90min1149874-14987474.48475.151.3574.8975.571.36
2149642-14964274.36974.79
3151488-15148875.28775.71
4150134-15013474.61475.04
5150968-15096875.02875.45
6155118-15511877.09177.53
120min1163448-16344881.23081.251.2481.7681.801.23
2165540-16554082.27082.82
3165709-16570982.35482.90
4163606-16360681.30981.86
5160369-16036979.70080.24
6162297-16229780.65881.23
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1183070-18307090.98290.490.7091.6591.170.69
2183581-18358191.23691.92
3182727-18272790.81291.50
4181800-18180090.35191.04
5180552-18055289.73190.41
6180709-18070989.80990.51
240min1191163-19116395.00494.141.6495.8294.981.62
2191971-19197195.40696.24
3190650-19065094.74995.59
4190995-19099594.92195.76
5188122-18812293.49394.32
6183694-18369491.29292.15
极限1192286-19228695.56295.461.0096.5496.450.99
2194772-19477296.79897.80
3193799-19379996.31497.31
4191155-19115595.00095.99
5190637-19063794.74395.72
6189842-18984294.34895.36
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%
116.792031692029332027142028262024152028110.14
216.802047262049972048620.10
单位质量响应值RSD%判断
12079.2712194.170.67数据可信
供试品溶液-2025051021批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min121646-2164610.69110.195.2410.6910.195.21
221549-2154910.64310.64
319064-190649.4159.42
419534-195349.6489.65
521119-2111910.43010.43
620868-2086810.30610.31
10min139593-3959319.55419.721.7219.5719.741.72
240837-4083720.16920.19
339280-3928019.40019.42
439410-3941019.46419.48
539708-3970819.61119.63
640753-4075320.12720.14
15min155846-5584627.58127.622.3427.6327.672.34
256784-5678428.04528.10
355030-5503027.17827.23
454612-5461226.97227.02
555182-5518227.25427.30
658087-5808728.68828.74
20min169303-6930334.22834.113.4434.3234.203.43
269382-6938234.26734.36
368450-6845033.80633.90
468162-6816233.66433.76
565911-6591132.55232.65
673163-7316336.13436.23
30min188440-8844043.67944.120.9643.8344.280.96
290819-9081944.85445.01
389598-8959844.25144.40
488736-8873643.82543.97
589550-8955044.22744.38
688912-8891243.91244.07
45min1111164-11116454.90255.430.8755.1355.660.86
2113457-11345756.03556.26
3112682-11268255.65255.88
4113069-11306955.84356.07
5111768-11176855.20055.42
6111262-11126254.95155.18
60min1129155-12915563.78863.740.8064.1164.060.80
2130374-13037464.39064.71
3130199-13019964.30364.62
4127884-12788463.16063.48
5128342-12834263.38663.70
6128446-12844663.43763.76
90min1149431-14943173.80275.001.1674.2375.421.15
2151799-15179974.97175.40
3153808-15380875.96376.39
4153803-15380375.96176.38
5151788-15178874.96675.39
6150483-15048374.32174.75
120min1169172-16917283.55182.202.0284.1082.762.01
2170026-17002683.97384.53
3161497-16149779.76180.31
4163280-16328080.64181.19
5167478-16747882.71583.26
6167210-16721082.58283.14
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1188179-18817992.93991.321.7093.6292.011.69
2189370-18937093.52794.22
3183014-18301490.38891.07
4181560-18156089.67090.35
5184101-18410190.92591.61
6183216-18321690.48791.18
240min1194225-19422595.92594.900.9796.7795.740.96
2194303-19430395.96396.81
3190357-19035794.01494.85
4189980-18998093.82894.66
5192268-19226894.95895.79
6191766-19176694.71095.55
极限1198465-19846598.01995.562.3999.0296.562.38
2199267-19926798.41599.43
3192090-19209094.87095.86
4187538-18753892.62293.61
5193396-19339695.51596.51
6190122-19012293.89894.90
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101242-202302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%
116.792032922032542031092035802037682034010.14
216.802046272045252045760.04
单位质量响应值RSD%判断
12114.4112177.140.37数据可信
供试品溶液-2025051121批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12026-20261.0008.2143.481.008.2243.47
218358-183589.0609.06
321385-2138510.55410.55
419443-194439.5959.60
518859-188599.3079.31
619789-197899.7669.77
10min136893-3689318.20719.074.5518.2119.084.57
237206-3720618.36118.38
341723-4172320.59120.61
438620-3862019.05919.08
538066-3806618.78618.80
639337-3933719.41319.43
15min152551-5255125.93426.723.4325.9726.763.43
253549-5354926.42726.47
357806-5780628.52828.58
453874-5387426.58726.64
553517-5351726.41126.46
653533-5353326.41926.47
20min166371-6637132.75533.482.8832.8333.572.89
266848-6684832.99033.08
371714-7171435.39135.49
467220-6722033.17433.27
567728-6772833.42433.52
667132-6713233.13033.22
30min186817-8681742.84543.442.0442.9743.592.05
287277-8727743.07243.22
391656-9165645.23345.39
487583-8758343.22343.37
587399-8739943.13243.28
687457-8745743.16143.31
45min1110065-11006554.31854.741.7854.5254.961.78
2111704-11170455.12755.34
3114043-11404356.28156.51
4109510-10951054.04454.26
5111665-11166555.10855.33
6108524-10852453.55753.78
60min1128442-12844263.38763.461.3863.6863.771.38
2129328-12932863.82464.13
3130809-13080964.55564.88
4126279-12627962.32062.63
5129867-12986764.09064.40
6126781-12678162.56762.88
90min1152919-15291975.46774.741.2975.8675.151.28
2151903-15190374.96575.38
3152770-15277075.39375.83
4148593-14859373.33273.75
5153041-15304175.52775.94
6149441-14944173.75074.16
120min1165911-16591181.87881.381.2582.4081.921.25
2165662-16566281.75682.30
3166505-16650582.17282.73
4161334-16133479.62080.16
5166444-16644482.14182.68
6163506-16350680.69281.23
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1182064-18206489.85090.361.3490.5191.031.33
2185837-18583791.71292.39
3184399-18439991.00291.70
4180217-18021788.93989.61
5185375-18537591.48492.16
6180662-18066289.15889.83
240min1191863-19186394.68694.231.1995.5095.061.18
2193768-19376895.62696.45
3191553-19155394.53395.38
4187824-18782492.69393.51
5192054-19205494.78095.61
6188627-18862793.08993.91
极限1193345-19334595.41794.981.5996.3895.961.58
2196551-19655197.00097.99
3192993-19299395.24496.25
4187270-18727092.41993.39
5193207-19320795.34996.34
6191395-19139594.45595.43
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