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%
110.032493022496752487682491752489072491650.15
210.102485692486562486120.03
单位质量响应值RSD%判断
24841.9724615.050.65数据可信
供试品溶液-24101401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%
5min161786-6178624.86143.4943.4124.8643.4943.42
289504-8950436.01436.01
379299-7929931.90831.91
4180701-18070172.71072.71
585498-8549834.40334.40
6151759-15175961.06461.06
10min1140777-14077756.64671.7219.2356.7271.8619.26
2140444-14044456.51256.62
3168093-16809367.63767.73
4207909-20790983.65883.88
5190309-19030976.57676.68
6221969-22196989.31589.50
15min1166193-16619366.87277.4814.4867.1277.8314.52
2158467-15846763.76464.04
3181823-18182373.16273.46
4214009-21400986.11386.58
5207114-20711483.33883.67
6227766-22776691.64892.10
20min1175752-17575270.71980.2312.6271.1680.8012.68
2168182-16818267.67368.14
3189235-18923576.14476.66
4217523-21752387.52688.25
5215615-21561586.75987.34
6229988-22998892.54293.27
30min1186246-18624674.94183.3610.6975.6084.1810.75
2179354-17935472.16872.84
3198226-19822679.76280.51
4223291-22329189.84790.84
5223807-22380790.05590.90
6232065-23206593.37894.38
45min1196690-19669079.14486.678.7080.0387.748.79
2193026-19302677.66978.56
3206642-20664283.14884.13
4231656-23165693.21394.47
5231237-23123793.04594.16
6233092-23309293.79195.07
60min1205694-20569482.76788.616.4883.8989.946.59
2202139-20213981.33682.46
3215883-21588386.86788.10
4230499-23049992.74894.29
5233786-23378694.07095.46
6233288-23328893.87095.44
极限1240493-24049396.76996.581.5998.1498.171.39
2243649-24364998.03999.40
3243793-24379398.09799.59
4234054-23405494.17896.00
5240938-24093896.94898.62
6237154-23715495.42697.27
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%
110.032485832490392491702487982485862488350.11
210.102486402488172487280.06
单位质量响应值RSD%判断
24809.0724626.530.53数据可信
供试品溶液-24101402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%
5min1121399-12139948.86949.5034.1848.8749.5034.18
2123308-12330849.63849.64
348147-4814719.38219.38
4128197-12819751.60651.61
5139818-13981856.28456.28
6176984-17698471.24571.24
10min1195282-19528278.61170.6018.3978.7670.7518.42
2187156-18715675.34075.49
3120932-12093248.68148.74
4153290-15329061.70761.86
5187741-18774175.57575.74
6207947-20794783.70983.92
15min1208111-20811183.77574.7015.9184.1675.0615.95
2196323-19632379.03079.40
3136967-13696755.13655.34
4163681-16368165.89066.23
5194188-19418878.17078.57
6214171-21417186.21486.68
20min1214804-21480486.46977.0614.3187.1077.6514.35
2199725-19972580.39981.01
3146972-14697259.16359.53
4171081-17108168.86969.41
5198239-19823979.80180.43
6217802-21780287.67688.40
30min1226332-22633291.11080.2412.4992.0081.0512.55
2205161-20516182.58783.44
3159591-15959164.24364.79
4181641-18164173.11973.86
5203213-20321381.80382.67
6220021-22002188.56989.56
45min1232918-23291893.76183.9310.0494.9384.9910.12
2213599-21359985.98487.09
3175287-17528770.56271.30
4194012-19401278.09979.06
5210937-21093784.91386.03
6224210-22421090.25691.51
60min1234086-23408694.23186.038.0795.6887.348.17
2217859-21785987.69989.06
3186119-18611974.92275.87
4202139-20213981.37182.57
5216162-21616287.01688.39
6225976-22597690.96692.49
极限1236664-23666495.26994.381.6697.0095.941.62
2229445-22944592.36393.98
3238517-23851796.01597.19
4229821-22982192.51493.96
5237123-23712395.45497.08
6235168-23516894.66796.46
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%
110.032478722483552488472489252488432485680.19
210.102495582495642495610.01
单位质量响应值RSD%判断
24782.4524709.010.21数据可信
供试品溶液-24101401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%
5min1166260-16626066.85266.7118.1866.8566.7118.18
2155403-15540362.48662.49
3122733-12273349.35049.35
4153773-15377361.83161.83
5186715-18671575.07675.08
6210558-21055884.66384.66
10min1217584-21758487.48890.036.2487.6990.236.24
2239326-23932696.23196.42
3222181-22218189.33789.48
4204016-20401682.03382.22
5219645-21964588.31788.54
6240654-24065496.76597.02
15min1235164-23516494.55794.682.8095.0295.152.81
2244235-24423598.20598.68
3234513-23451394.29594.71
4225910-22591090.83691.27
5231795-23179593.20393.69
6241240-24124097.00097.54
20min1237237-23723795.39195.950.9796.1496.700.99
2241569-24156997.13397.90
3238501-23850195.89996.60
4235007-23500794.49495.20
5239246-23924696.19996.97
6240150-24015096.56297.40
30min1239348-23934896.24096.640.9097.2797.680.87
2242963-24296397.69398.76
3242284-24228497.42098.41
4239190-23919096.17697.16
5241056-24105696.92697.98
6237245-23724595.39496.52
45min1237432-23743295.46996.510.7896.7997.840.76
2242430-24243097.47998.83
3241437-24143797.08098.36
4239732-23973296.39497.67
5240505-24050596.70598.05
6238520-23852095.90797.32
60min1238278-23827895.80996.280.6597.4297.900.61
2241031-24103196.91698.56
3240949-24094996.88398.45
4239350-23935096.24097.81
5239932-23993296.47498.11
6237119-23711995.34397.04
极限1237534-23753495.51096.451.1697.4198.361.12
2240824-24082496.83398.77
3243002-24300297.70999.57
4239588-23958896.33698.19
5242398-24239897.46699.39
6235885-23588594.84796.83
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%
110.032495992484212490622487142494202490430.20
210.102475232469982472600.16
单位质量响应值RSD%判断
24829.8124481.191.00数据可信
供试品溶液-24101402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%
5min1175279-17527970.73965.1629.4570.7465.1629.45
2193726-19372678.18478.18
393594-9359437.77337.77
4175348-17534870.76770.77
5114199-11419946.08946.09
6216513-21651387.38187.38
10min1217124-21712487.62787.148.3687.8487.348.40
2233770-23377094.34594.58
3185582-18558274.89775.01
4219691-21969188.66388.88
5206599-20659983.37983.52
6232778-23277893.94594.21
15min1228458-22845892.20192.014.0592.6892.464.10
2237350-23735095.79096.31
3210603-21060384.99585.33
4233052-23305294.05594.53
5227514-22751491.82092.21
6230869-23086993.17493.72
20min1233568-23356894.26493.512.5095.0294.242.55
2237499-23749995.85096.66
3220824-22082489.12089.71
4234495-23449594.63895.40
5233168-23316894.10294.77
6230657-23065793.08993.91
30min1233274-23327494.14594.200.9995.1895.210.96
2236444-23644495.42496.52
3233621-23362194.28595.15
4232093-23209393.66894.71
5235127-23512794.89395.84
6229881-22988192.77693.88
45min1232013-23201393.63694.281.3894.9595.581.30
2235412-23541295.00896.39
3236592-23659295.48496.63
4232734-23273493.92795.25
5236535-23653595.46196.69
6228347-22834792.15793.54
60min1233353-23335394.17794.411.3695.7795.981.28
2236012-23601295.25096.91
3236808-23680895.57197.00
4231785-23178593.54495.15
5236692-23669295.52497.04
6228895-22889592.37894.04
极限1230454-23045493.00793.601.4094.8995.461.31
2233381-23338194.18896.14
3236632-23663295.50097.22
4231597-23159793.46895.36
5232500-23250093.83395.64
6226917-22691791.57993.51
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