盐酸鲁拉西酮片项目信息
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N877-220209对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
111.23 1987501988871984561981571977741984050.23
211.262003412001862002640.06
单位质量响应值RSD%判断
17667.4117785.440.48数据可信
长期24月-供试品溶液-2022082801批-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min173125-7312537.03138.7510.0537.0338.7410.05
278933-7893339.97239.97
378641-7864139.82439.82
462713-6271331.75831.76
581575-8157541.31041.31
684083-8408342.58042.58
10min1130616-13061666.14468.012.4166.2168.082.41
2132683-13268367.19167.26
3132621-13262167.16067.23
4133487-13348767.59867.65
5137310-13731069.53469.60
6139132-13913270.45770.53
15min1150343-15034376.13476.991.4076.3177.171.40
2150365-15036576.14576.32
3150147-15014776.03576.21
4152299-15229977.12577.29
5153988-15398877.98078.16
6155098-15509878.54278.73
20min1160488-16048881.27181.841.2681.5782.151.26
2159589-15958980.81681.12
3159462-15946280.75281.06
4162574-16257482.32882.62
5163539-16353982.81783.13
6164054-16405483.07783.40
30min1171539-17153986.86887.750.8787.3088.190.87
2172150-17215087.17787.62
3172134-17213487.16987.61
4175007-17500788.62489.06
5174497-17449788.36688.82
6174325-17432588.27988.74
45min1180785-18078591.55092.310.8992.1392.900.88
2181338-18133891.83092.42
3181271-18127191.79692.38
4185119-18511993.74594.32
5183149-18314992.74793.35
6182085-18208592.20892.81
60min1185596-18559693.98694.341.1394.7295.081.12
2185258-18525893.81594.55
3184818-18481893.59294.33
4190488-19048896.46497.20
5185661-18566194.01994.77
6185952-18595294.16794.93
极限1189601-18960196.01496.261.0596.9097.161.04
2188873-18887395.64696.54
3188715-18871595.56696.46
4193791-19379198.13699.03
5190809-19080996.62697.54
6188690-18869095.55396.47
盐酸鲁拉西酮片项目信息
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N877-220209对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
111.23 2004482004642004092002332003302003770.05
211.262036972036552036760.02
单位质量响应值RSD%判断
17843.0118088.450.97数据可信
长期24月-供试品溶液-2022082801批-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min178596-7859639.27236.416.8539.2736.416.85
275543-7554337.74737.75
366994-6699433.47533.48
477666-7766638.80838.81
569053-6905334.50434.50
669345-6934534.65034.65
10min1136934-13693468.42266.652.9968.4966.712.99
2135526-13552667.71967.78
3126429-12642963.17363.23
4136676-13667668.29468.36
5133002-13300266.45866.52
6131720-13172065.81765.87
15min1154347-15434777.12375.651.6177.3075.821.62
2152851-15285176.37676.55
3147210-14721073.55773.72
4151721-15172175.81175.99
5151833-15183375.86776.04
6150402-15040275.15275.32
20min1163488-16348881.69180.791.4282.0081.091.43
2163500-16350081.69782.00
3157429-15742978.66378.95
4162469-16246981.18281.49
5162298-16229881.09681.39
6160902-16090280.39980.69
30min1175044-17504487.46586.331.4487.9186.761.44
2175552-17555287.71988.16
3169510-16951084.70085.11
4170493-17049385.19185.63
5174007-17400786.94787.38
6172045-17204585.96786.39
45min1182429-18242991.15591.080.8191.7591.650.81
2183896-18389691.88892.47
3180052-18005289.96790.52
4181583-18158390.73291.31
5183824-18382491.85292.43
6181834-18183490.85891.43
60min1186097-18609792.98893.240.6993.7393.970.69
2188210-18821094.04494.78
3184745-18474592.31293.02
4185893-18589392.88693.62
5187675-18767593.77694.50
6187007-18700793.44394.16
极限1189886-18988694.88195.200.7295.7896.080.72
2191755-19175595.81596.71
3188849-18884994.36395.22
4189411-18941194.64495.53
5192294-19229496.08496.97
6190950-19095095.41396.29
盐酸鲁拉西酮片项目信息
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N877-220209对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
111.23 1998032000991997621997111990701996890.19
211.262041282041802041540.02
单位质量响应值RSD%判断
17781.7518130.911.38数据可信
中间条件24月-供试品溶液-2022082801批-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min174943-7494337.46936.382.8337.4736.382.82
273677-7367736.83636.84
371428-7142835.71135.71
469717-6971734.85634.86
574739-7473937.36737.37
672056-7205636.02536.03
10min1127698-12769863.84462.801.7763.9162.861.77
2124805-12480562.39862.46
3127574-12757463.78263.84
4121830-12183060.91060.97
5126638-12663863.31463.38
6125103-12510362.54762.61
15min1146697-14669773.34372.091.3773.5172.261.37
2143734-14373471.86172.03
3145764-14576472.87673.04
4140993-14099370.49170.65
5144215-14421572.10272.27
6143788-14378871.88872.05
20min1156563-15656378.27577.131.1678.5777.411.16
2153595-15359576.79177.08
3156058-15605878.02378.31
4151792-15179275.89076.17
5154142-15414277.06577.35
6153427-15342776.70776.99
30min1170249-17024985.11883.911.1985.5484.331.20
2168129-16812984.05884.47
3169561-16956184.77485.19
4165103-16510382.54582.95
5168032-16803284.00984.43
6165954-16595482.97083.38
45min1180960-18096090.47389.350.9791.0489.900.98
2178572-17857289.27989.83
3180292-18029290.13990.70
4176496-17649688.24188.78
5178824-17882489.40589.96
6177149-17714988.56789.12
60min1186485-18648593.23592.050.9493.9592.750.94
2184399-18439992.19292.89
3185737-18573792.86193.57
4182151-18215191.06891.76
5182954-18295491.47092.18
6182961-18296191.47392.17
极限1192238-19223896.11194.680.9496.9895.540.94
2189407-18940794.69695.55
3190514-19051495.24996.11
4187531-18753193.75894.60
5187830-18783093.90894.77
6188726-18872694.35595.21
盐酸鲁拉西酮片项目信息
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N877-220209对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
111.23 2032692033002031962033212030542032280.06
211.262073882073992073940.01
单位质量响应值RSD%判断
18096.8818418.651.25数据可信
中间条件24月-供试品溶液-2022082801批-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min177188-7718837.95338.305.3937.9538.305.39
271428-7142835.12135.12
381236-8123639.94439.94
483190-8319040.90440.90
578834-7883438.76238.76
675538-7553837.14237.14
10min1128492-12849263.17963.621.8663.2463.681.87
2125424-12542461.67161.73
3129375-12937563.61363.68
4132356-13235665.07965.15
5129401-12940163.62663.69
6131273-13127364.54764.61
15min1145833-14583371.70672.131.3871.8772.301.38
2143466-14346670.54270.70
3146811-14681172.18772.36
4148871-14887173.19973.38
5146399-14639971.98472.15
6148753-14875373.14173.31
20min1156547-15654776.97476.981.0177.2677.261.02
2153963-15396375.70375.98
3156167-15616776.78777.08
4158010-15801077.69377.99
5156237-15623776.82177.11
6158384-15838477.87778.17
30min1169030-16903083.11283.330.8883.5383.750.88
2167199-16719982.21182.62
3168970-16897083.08283.50
4170847-17084784.00584.43
5169532-16953283.35883.78
6171306-17130684.23184.65
45min1179014-17901488.02188.250.8488.5888.810.84
2178360-17836087.69988.24
3177499-17749987.27687.84
4180702-18070288.85189.42
5179736-17973688.37688.93
6181571-18157189.27889.84
60min1183998-18399890.47190.790.6591.1791.490.65
2183600-18360090.27690.96
3184663-18466390.79891.50
4184875-18487590.90391.62
5183866-18386690.40691.11
6186841-18684191.86992.58
极限1190040-19004093.44293.540.6594.2994.400.66
2188677-18867792.77293.61
3189725-18972593.28794.14
4190814-19081493.82394.69
5189891-18989193.36994.22
6192346-19234694.57695.44
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