盐酸鲁拉西酮口崩片项目信息
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N877-220209对照品来源自制对照品使用方法直接使用
对照品含量(%)99.99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%
111.332017532017552016682018112017912017560.03
211.322019042016572017800.09
单位质量响应值RSD%判断
17807.2417825.090.08数据可信
高温10天-供试品溶液-24041201批-pH3.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1120526-12052660.87958.483.6560.8858.483.66
2121510-12151061.37661.38
3111543-11154356.34156.34
4114575-11457557.87357.87
5114267-11426757.71757.72
6112292-11229256.72056.72
10min1147708-14770874.60972.372.7374.7172.462.73
2148762-14876275.14175.24
3140640-14064071.03971.13
4141669-14166971.55871.65
5140844-14084471.14271.24
6139995-13999570.71370.81
15min1159997-15999780.81679.002.0681.0479.222.06
2160945-16094581.29581.52
3154332-15433277.95478.17
4155406-15540678.49778.71
5153775-15377577.67377.89
6153975-15397577.77477.99
20min1165976-16597683.83682.821.4984.2083.171.49
2167838-16783884.77685.14
3162608-16260882.13582.48
4163392-16339282.53182.88
5162558-16255882.10982.45
6161443-16144381.54681.89
30min1174406-17440688.09487.381.0088.5987.861.01
2175167-17516788.47888.98
3171908-17190886.83287.31
4173499-17349987.63688.12
5172470-17247087.11687.60
6170448-17044886.09586.57
45min1180654-18065491.25091.170.5691.9091.800.57
2181667-18166791.76292.41
3180937-18093791.39392.02
4180944-18094491.39692.03
5179992-17999290.91691.54
6178762-17876290.29490.92
60min1184300-18430093.09293.230.3493.8994.010.34
2184836-18483693.36294.17
3184878-18487893.38494.16
4185112-18511293.50294.28
5184866-18486693.37794.16
6183430-18343092.65293.42
极限1187005-18700594.45895.630.7795.4196.570.76
2189322-18932295.62896.59
3190883-19088396.41797.35
4190522-19052296.23497.17
5189833-18983395.88696.82
6188337-18833795.13196.06
盐酸鲁拉西酮口崩片项目信息
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N877-220209对照品来源自制对照品使用方法直接使用
对照品含量(%)99.99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%
111.332027702028722027162027932027992027900.03
211.322011502008742010120.10
单位质量响应值RSD%判断
17898.5017757.240.57数据可信
高温10天-供试品溶液-24041501批-pH3.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1104569-10456952.78552.684.8252.7852.684.82
2106317-10631753.66753.67
398739-9873949.84249.84
4108423-10842354.73054.73
5110148-11014855.60155.60
697973-9797349.45549.46
10min1135149-13514968.22166.893.2068.3166.973.21
2132026-13202666.64566.73
3127836-12783664.53064.61
4135485-13548568.39168.48
5137360-13736069.33769.43
6127186-12718664.20264.28
15min1149410-14941075.42073.822.4375.6274.012.43
2144839-14483973.11373.31
3142321-14232171.84172.03
4148396-14839674.90875.11
5150122-15012275.77975.99
6142298-14229871.83072.02
20min1158080-15808079.79677.741.9380.1278.061.93
2153082-15308277.27377.60
3150536-15053675.98876.30
4154966-15496678.22578.55
5156262-15626278.87979.21
6151088-15108876.26776.58
30min1169857-16985785.74183.501.8986.2083.961.89
2162993-16299382.27682.73
3162785-16278582.17182.61
4166020-16602083.80484.26
5168237-16823784.92485.39
6162662-16266282.10982.55
45min1178725-17872590.21888.431.4590.8289.021.45
2172239-17223986.94487.53
3173312-17331287.48588.06
4176204-17620488.94589.55
5177062-17706289.37889.99
6173543-17354387.60288.17
60min1183687-18368792.72291.461.2593.4892.201.25
2177615-17761589.65790.39
3180048-18004890.88691.61
4182285-18228592.01592.76
5182983-18298392.36793.12
6180451-18045191.08991.81
极限1191807-19180796.82195.111.2797.7396.001.27
2184569-18456993.16894.05
3187390-18739094.59295.46
4189106-18910695.45896.36
5189237-18923795.52496.43
6188400-18840095.10195.97
盐酸鲁拉西酮口崩片项目信息
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N877-220209对照品来源自制对照品使用方法直接使用
对照品含量(%)99.99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%
111.332016582015022014372016202016382015710.05
211.322016182012172014180.15
单位质量响应值RSD%判断
17790.9117793.110.01数据可信
高温10天-供试品溶液-24041502批-pH3.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1101688-10168851.43353.564.1551.4353.564.15
2103385-10338552.29252.29
3101663-10166351.42151.42
4111315-11131556.30356.30
5106484-10648453.85953.86
6110872-11087256.07856.08
10min1133554-13355467.55169.692.6167.6469.782.61
2137641-13764169.61869.71
3134192-13419267.87467.96
4142471-14247172.06172.15
5137704-13770469.65069.74
6141183-14118371.41071.50
15min1149976-14997675.85778.392.3976.0678.602.39
2154327-15432778.05878.26
3151391-15139176.57376.77
4158792-15879280.31680.53
5158128-15812879.98080.19
6157335-15733579.57979.79
20min1159971-15997180.91283.262.0681.2483.592.06
2163501-16350182.69883.03
3161659-16165981.76682.09
4167940-16794084.94385.29
5167785-16778584.86585.20
6166759-16675984.34684.69
30min1171283-17128386.63488.851.8587.0989.321.86
2174335-17433588.17888.65
3173380-17338087.69588.16
4179443-17944390.76191.25
5179060-17906090.56891.05
6176455-17645589.25089.74
45min1181677-18167791.89193.141.0192.5093.761.02
2183327-18332792.72693.34
3183358-18335892.74193.35
4187016-18701694.59295.23
5185429-18542993.78994.42
6184046-18404693.08993.72
60min1187276-18727694.72395.120.7895.4895.900.78
2186824-18682494.49595.27
3188721-18872195.45496.22
4190542-19054296.37597.17
5188324-18832495.25396.04
6186681-18668194.42295.21
极限1191671-19167196.94697.550.5597.8698.490.55
2191665-19166596.94397.87
3193491-19349197.86798.79
4193715-19371597.98098.94
5194051-19405198.15099.10
6192609-19260997.42198.37
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