盐酸司来吉兰片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号101298-201801对照品来源中检院对照品使用方法减压干燥3h
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)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%
110.172508892475112492302473452460392482030.76
210.082442352444232443290.06
单位质量响应值RSD%判断
24405.4124238.990.49数据可信
供试品溶液-24092701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%
5min183216-8321634.04334.8412.1034.0434.8412.10
274901-7490130.64230.64
375844-7584431.02731.03
484740-8474034.66734.67
5102981-10298142.12942.13
689255-8925536.51436.51
10min1127682-12768252.23459.999.3552.3460.109.34
2146600-14660059.97360.07
3151858-15185862.12562.22
4161607-16160766.11366.22
5158829-15882964.97665.10
6133252-13325254.51354.62
15min1148093-14809360.58467.949.0760.8468.229.07
2163420-16342066.85467.13
3173330-17333070.90971.19
4181757-18175774.35674.66
5180750-18075073.94474.27
6149058-14905860.97961.25
20min1165607-16560767.74973.127.7168.1973.617.71
2175732-17573271.89172.36
3185540-18554075.90476.40
4195630-19563080.03180.56
5189257-18925777.42477.97
6160703-16070365.74366.20
30min1175247-17524771.69376.966.0672.3477.676.07
2186424-18642476.26576.95
3193043-19304378.97379.69
4204595-20459583.69984.46
5193745-19374579.26080.04
6175746-17574671.89772.55
45min1188255-18825577.01480.955.3577.8781.895.37
2195485-19548579.97280.89
3200379-20037981.97482.93
4214335-21433587.68488.70
5203336-20333683.18484.20
6185449-18544975.86676.74
60min1195167-19516779.84282.843.9380.9384.023.97
2199306-19930681.53582.69
3205663-20566384.13685.34
4215137-21513788.01289.29
5205680-20568084.14385.41
6193971-19397179.35380.45
极限1220049-22004990.02190.101.4891.3591.531.48
2220332-22033290.13791.54
3221904-22190490.78092.24
4224922-22492292.01593.56
5215031-21503187.96889.48
6219194-21919489.67191.01
盐酸司来吉兰片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号101298-201801对照品来源中检院对照品使用方法减压干燥3h
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)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%
110.172501482491762476542478102472452484070.49
210.082508952482012495480.77
单位质量响应值RSD%判断
24425.4724756.750.96数据可信
供试品溶液-24092702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%
5min182125-8212533.23160.0733.0433.2360.0733.04
2162803-16280365.87665.88
3207721-20772184.05184.05
4117698-11769847.62547.62
5196789-19678979.62879.63
6123532-12353249.98649.99
10min1169011-16901168.38879.7916.0968.4979.9716.11
2197813-19781380.04280.24
3227741-22774192.15292.40
4209273-20927384.67984.82
5228666-22866692.52792.77
6150621-15062160.94761.10
15min1185326-18532674.99083.8513.0775.2984.2713.11
2210291-21029185.09185.53
3232882-23288294.23294.76
4219849-21984988.95989.36
5230418-23041893.23593.75
6164544-16454466.58066.91
20min1199349-19934980.66486.3511.4181.1987.0211.45
2214486-21448686.78987.48
3233384-23338494.43695.25
4223438-22343890.41191.07
5237374-23737496.05096.85
6172313-17231369.72470.26
30min1207005-20700583.76288.319.4984.5389.249.55
2220964-22096489.41090.36
3236204-23620495.57796.67
4227105-22710591.89592.83
5235973-23597395.48396.57
6182293-18229373.76274.50
45min1219063-21906388.64191.747.1289.6692.947.21
2228976-22897692.65293.87
3239651-23965196.97198.35
4232391-23239194.03495.24
5241984-24198497.91599.29
6198331-19833180.25281.21
60min1222133-22213389.88393.265.5391.1794.735.64
2232941-23294194.25695.76
3240050-24005097.13398.81
4234446-23444694.86596.36
5243948-24394898.710100.37
6209339-20933984.70685.91
极限1244374-24437498.883101.351.81100.44103.101.86
2257130-257130104.044105.83
3251935-251935101.942103.91
4253133-253133102.427104.20
5247654-247654100.210102.17
6248658-248658100.616102.07
盐酸司来吉兰片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号101298-201801对照品来源中检院对照品使用方法减压干燥3h
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)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%
110.172472742466952485022468312470542472710.30
210.082439392490692465041.48
单位质量响应值RSD%判断
24313.7724454.760.41数据可信
供试品溶液-24092701批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1223811-22381191.32783.605.7991.3383.615.79
2191643-19164378.20178.20
3198935-19893581.17681.18
4209526-20952685.49885.50
5195584-19558479.80979.81
6209819-20981985.61785.62
10min1232134-23213494.72392.471.8695.0092.721.86
2227014-22701492.63492.87
3226250-22625092.32292.57
4230342-23034293.99294.25
5221813-22181390.51290.75
6222098-22209890.62890.88
15min1229602-22960293.69092.341.3694.2592.871.36
2225815-22581592.14592.66
3228066-22806693.06393.58
4225783-22578392.13292.67
5227727-22772792.92593.44
6220769-22076990.08690.61
20min1240135-24013597.98893.602.7598.8394.412.74
2226131-22613192.27493.06
3225755-22575592.12092.92
4233745-23374595.38096.20
5226925-22692592.59893.39
6223609-22360991.24492.04
30min1222933-22293390.96991.761.2692.1092.841.25
2223293-22329391.11592.18
3225090-22509091.84992.92
4228937-22893793.41994.52
5227351-22735192.77193.84
6221566-22156690.41191.48
45min1228087-22808793.07291.631.9794.4892.991.96
2218339-21833989.09490.43
3224738-22473891.70593.06
4228262-22826293.14394.52
5227892-22789292.99294.34
6219939-21993989.74791.09
60min1224979-22497991.80391.511.1993.4993.141.19
2225708-22570892.10193.71
3224591-22459191.64593.27
4227088-22708892.66494.32
5223818-22381891.33092.95
6219310-21931089.49091.10
极限1222879-22287990.94789.961.3092.9191.871.30
2220685-22068590.05191.93
3217566-21756688.77990.68
4223308-22330891.12293.06
5221925-22192590.55792.46
6216436-21643688.31790.20
盐酸司来吉兰片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号101298-201801对照品来源中检院对照品使用方法减压干燥3h
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)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%
110.172502772488242494302472502490492489660.45
210.082473452472832473140.02
单位质量响应值RSD%判断
24480.4324535.120.16数据可信
供试品溶液-24092702批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1172803-17280370.15756.8320.1770.1656.8320.17
2138097-13809756.06756.07
397690-9769039.66239.66
4117601-11760147.74547.75
5161657-16165765.63265.63
6152009-15200961.71561.71
10min1230410-23041093.54584.2311.3493.7684.4011.36
2215751-21575187.59487.76
3162988-16298866.17266.29
4202720-20272082.30382.45
5218452-21845288.69088.89
6214491-21449187.08287.27
15min1252073-252073102.34094.796.48102.8395.226.51
2233997-23399795.00195.43
3207386-20738684.19784.51
4228554-22855492.79293.18
5242539-24253998.46998.93
6236373-23637395.96696.41
20min1255922-255922103.90399.074.53104.7099.784.57
2247981-247981100.679101.39
3223786-22378690.85691.43
4240582-24058297.67598.34
5248213-248213100.773101.53
6247619-247619100.532101.27
30min1253674-253674102.990101.031.48104.10102.031.55
2251140-251140101.961102.98
3242795-24279598.57399.42
4247867-247867100.633101.59
5247976-247976100.677101.74
6249562-249562101.321102.36
45min1255074-255074103.559101.591.22104.98102.901.28
2247915-247915100.652101.98
3247008-247008100.284101.42
4250345-250345101.639102.90
5248628-248628100.942102.30
6252382-252382102.466103.81
60min1254169-254169103.191101.600.81104.92103.220.85
2249753-249753101.398103.02
3249638-249638101.352102.79
4248967-248967101.079102.65
5248597-248597100.929102.59
6250421-250421101.669103.32
极限1249320-249320101.222101.090.80103.26103.010.82
2249285-249285101.208103.14
3246983-246983100.274102.02
4249975-249975101.488103.36
5246508-246508100.081102.05
6251876-251876102.260104.21
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