坎地沙坦酯氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.971736911745961755611746681746581746350.38
215.951735991738201737100.09
单位质量响应值RSD%判断
10935.1910890.910.29数据可信
加速1月-供试品溶液-2024042711批-pH6.5(内含0.35%Tween)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min156854-5685429.24628.676.0729.2528.676.07
260333-6033331.03631.04
352620-5262027.06827.07
456114-5611428.86628.87
557426-5742629.54029.54
651041-5104126.25626.26
10min1109017-10901756.07956.222.3856.4056.542.38
2110176-11017656.67657.02
3104467-10446753.73954.04
4112176-11217657.70458.03
5110293-11029356.73657.06
6109647-10964756.40356.70
15min1137358-13735870.65871.042.2271.6171.982.23
2138908-13890871.45672.43
3132218-13221868.01468.91
4140193-14019372.11773.08
5140067-14006772.05273.01
6139805-13980571.91772.84
20min1149658-14965876.98578.402.1178.7280.142.12
2154190-15419079.31781.09
3147375-14737575.81177.46
4155007-15500779.73781.50
5155335-15533579.90681.66
6152922-15292278.66480.38
30min1165800-16580085.28985.701.3687.8888.301.36
2165876-16587685.32887.98
3162905-16290583.80086.30
4168882-16888286.87489.52
5167307-16730786.06488.71
6168785-16878586.82589.42
45min1162597-16259783.64186.932.0687.1890.491.97
2171151-17115188.04291.64
3170917-17091787.92191.35
4167731-16773186.28289.90
5169573-16957387.23090.83
6172011-17201188.48492.04
60min1168881-16888186.87488.801.5491.3493.321.49
2171805-17180588.37892.95
3173880-17388089.44593.85
4175559-17555990.30994.88
5175040-17504090.04294.61
6170531-17053187.72392.26
极限1166004-16600485.39488.161.7790.8293.671.71
2173670-17367089.33794.90
3172718-17271888.84894.25
4174245-17424589.63395.21
5170063-17006387.48293.05
6171603-17160388.27493.79
坎地沙坦酯氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.971743741747101750761751541751361748900.20
215.951741971742811742390.04
单位质量响应值RSD%判断
10951.1610924.080.18数据可信
加速1月-供试品溶液-2024042711批-pH6.5(内含0.35%Tween)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min162748-6274832.20628.6012.8532.2128.6012.86
258866-5886630.21330.21
356856-5685629.18129.18
445754-4575423.48323.48
548145-4814524.71124.71
661969-6196931.80631.81
10min1112972-11297257.98355.624.6458.3455.944.68
2110952-11095256.94657.28
3110264-11026456.59356.92
4102395-10239552.55452.82
5101616-10161652.15552.43
6112013-11201357.49157.84
15min1138220-13822070.94269.602.0671.9470.532.12
2138230-13823070.94771.92
3136151-13615169.88070.83
4132385-13238567.94768.79
5131971-13197167.73468.59
6136645-13664570.13371.13
20min1148863-14886376.40476.471.7778.1978.181.78
2146462-14646275.17276.93
3153026-15302678.54180.27
4147162-14716275.53177.13
5147176-14717675.53877.15
6151244-15124477.62679.40
30min1162728-16272883.52184.311.5286.1686.871.55
2166501-16650185.45788.05
3167248-16724885.84088.44
4162080-16208083.18885.63
5161405-16140582.84285.29
6165606-16560684.99887.63
45min1164990-16499084.68286.732.1788.2590.232.14
2168717-16871786.59490.14
3174022-17402289.31792.87
4167747-16774786.09789.46
5165788-16578885.09188.46
6172665-17266588.62192.20
60min1166705-16670585.56287.381.1990.0791.841.16
2171050-17105087.79292.30
3172087-17208788.32492.87
4171142-17114287.83992.16
5169013-16901386.74691.06
6171456-17145688.00092.56
极限1164237-16423784.29586.111.3589.7591.541.33
2167623-16762386.03391.51
3170771-17077187.64993.18
4167461-16746185.95091.25
5166967-16696785.69690.97
6169548-16954887.02192.56
坎地沙坦酯氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.971728201729241728361727391727881728210.04
215.951747251748811748030.07
单位质量响应值RSD%判断
10821.6010959.440.90数据可信
加速1月-供试品溶液-2024042711批-pH6.8(内含0.1%Tween)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min125291-2529113.03712.4011.6513.0412.4011.66
228862-2886214.87814.88
321193-2119310.92510.92
423920-2392012.33112.33
521626-2162611.14811.15
623385-2338512.05512.05
10min157518-5751829.65029.934.0629.7930.074.09
262435-6243532.18532.35
356463-5646329.10629.23
457353-5735329.56529.70
555877-5587728.80428.93
658721-5872130.27030.40
15min181396-8139641.95942.891.4742.4343.361.49
284607-8460743.61444.14
383299-8329942.94043.38
484164-8416443.38643.85
582154-8215442.35042.79
683552-8355243.07043.54
20min1103029-10302953.11152.991.2354.0553.941.27
2104646-10464653.94454.95
3101089-10108952.11153.03
4103272-10327253.23654.18
5101684-10168452.41753.33
6103097-10309753.14654.09
30min1126574-12657465.24865.801.5066.7867.341.49
2130123-13012367.07768.68
3128106-12810666.03867.54
4124541-12454164.20065.74
5128712-12871266.35067.85
6127839-12783965.90067.44
45min1148411-14841176.50576.871.5078.7679.141.47
2151511-15151178.10380.45
3150599-15059977.63379.87
4146103-14610375.31577.57
5150947-15094777.81280.05
6147115-14711575.83778.11
60min1159632-15963282.28982.111.2185.3985.231.21
2161900-16190083.45886.68
3160271-16027182.61885.72
4156244-15624480.54383.63
5159484-15948482.21385.31
6158130-15813081.51584.63
极限1167468-16746886.32885.101.4090.3589.131.32
2163387-16338784.22588.37
3166045-16604585.59589.61
4164823-16482384.96588.95
5161530-16153083.26787.28
6167204-16720486.19290.21
坎地沙坦酯氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.971723201729091731301730681729741728800.19
215.951722791724711723750.08
单位质量响应值RSD%判断
10825.3010807.210.12数据可信
加速1月-供试品溶液-2024042711批-pH6.8(内含0.1%Tween)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min125491-2549113.23014.568.1013.2314.568.11
227861-2786114.46014.46
327959-2795914.51114.51
431186-3118616.18616.19
530062-3006215.60315.60
625747-2574713.36313.36
10min156589-5658929.37031.454.3029.5231.614.31
261196-6119631.76131.92
359458-5945830.85931.02
462901-6290132.64632.83
563756-6375633.09033.26
659659-5965930.96431.11
15min181911-8191142.51344.192.8542.9944.702.85
287628-8762845.48045.99
382395-8239542.76443.27
485978-8597844.62445.17
587167-8716745.24145.78
685752-8575244.50645.00
20min199856-9985651.82653.413.0952.7754.413.09
2106428-10642855.23756.26
398544-9854451.14552.12
4102634-10263453.26854.31
5105739-10573954.88055.92
6104204-10420454.08355.07
30min1124871-12487164.80966.282.5766.3367.882.55
2130551-13055167.75769.39
3125301-12530165.03366.58
4124272-12427264.49966.13
5129429-12942967.17568.83
6131839-13183968.42670.01
45min1145036-14503675.27576.751.6577.5279.081.63
2148254-14825476.94579.33
3148798-14879877.22879.50
4145799-14579975.67178.02
5147500-14750076.55478.95
6151903-15190378.83981.19
60min1157123-15712381.54981.742.5884.6384.932.50
2159634-15963482.85286.09
3158836-15883682.43885.57
4149557-14955777.62280.81
5159284-15928482.67085.92
6160536-16053683.32086.54
极限1159419-15941982.74084.821.6586.7288.921.66
2165736-16573686.01990.18
3163000-16300084.59988.64
4161509-16150983.82587.88
5164328-16432885.28889.46
6166616-16661686.47690.63
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