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(%)99.74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%
111.151981091985621984891981451988421984290.16
211.181979221973141976180.22
单位质量响应值RSD%判断
17796.3217676.030.48数据可信
供试品溶液-25010301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%
5min1106210-10621053.75554.173.0653.7654.173.07
2107791-10779154.55654.56
3102787-10278752.02352.02
4105613-10561353.45353.45
5112712-11271257.04657.05
6107094-10709454.20354.20
10min1140163-14016370.94070.562.1671.0370.652.16
2141062-14106271.39571.49
3135837-13583768.75068.84
4138680-13868070.18970.28
5144015-14401572.88972.98
6136701-13670169.18869.28
15min1158008-15800879.97279.681.5080.1879.891.50
2157120-15712079.52279.73
3157055-15705579.48979.69
4155971-15597178.94179.15
5161683-16168381.83282.05
6154788-15478878.34278.55
20min1167998-16799885.02884.872.3685.3785.212.36
2170178-17017886.13186.47
3161394-16139481.68582.02
4170868-17086886.48086.82
5171175-17117586.63686.99
6164510-16451083.26283.60
30min1181466-18146691.84491.371.2092.3391.861.20
2179823-17982391.01391.50
3178066-17806690.12390.59
4180754-18075491.48491.97
5184146-18414693.20193.70
6178929-17892990.56091.04
45min1190911-19091196.62596.210.8497.2696.850.85
2188849-18884995.58196.22
3188828-18882895.57096.19
4190215-19021596.27296.91
5192823-19282397.59298.25
6188961-18896195.63896.26
60min1193187-19318797.77798.340.8498.5799.140.84
2195598-19559898.99799.79
3192432-19243297.39498.17
4194667-19466798.52699.32
5196659-19665999.534100.35
6193311-19331197.83998.62
极限1198054-198054100.24099.780.66101.20100.740.66
2195815-19581599.107100.07
3196001-19600199.201100.14
4197034-19703499.724100.68
5199188-199188100.814101.80
6196766-19676699.588100.54
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(%)99.74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%
111.151974381976681974851971901973701974300.09
211.181977861971871974860.22
单位质量响应值RSD%判断
17706.7317664.220.17数据可信
供试品溶液-25010301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%
5min1112175-11217556.93756.512.2756.9456.512.27
2109412-10941255.53455.53
3109752-10975255.70755.71
4108832-10883255.24055.24
5112294-11229456.99757.00
6115535-11553558.64258.64
10min1144232-14423273.20873.381.9173.3073.481.92
2144037-14403773.10973.20
3142886-14288672.52572.62
4141635-14163571.89071.98
5144996-14499673.59673.69
6149671-14967175.96876.07
15min1160850-16085081.64381.781.5281.8681.991.52
2161263-16126381.85282.07
3160330-16033081.37981.59
4157775-15777580.08280.29
5161127-16112781.78382.00
6165329-16532983.91684.14
20min1170358-17035886.46987.381.6586.8287.731.65
2172784-17278487.70088.05
3170723-17072386.65487.00
4168383-16838385.46685.81
5175356-17535689.00589.36
6175327-17532788.99189.35
30min1183541-18354193.16093.231.1293.6693.731.12
2184613-18461393.70494.20
3182959-18295992.86493.36
4181460-18146092.10492.59
5182280-18228092.52093.02
6187249-18724995.04295.55
45min1192008-19200897.45797.700.8498.1198.360.85
2192947-19294797.93498.59
3192218-19221897.56498.21
4191001-19100196.94697.59
5191330-19133097.11397.77
6195472-19547299.21699.89
60min1196833-19683399.906100.080.62100.72100.900.63
2198227-198227100.614101.43
3196098-19609899.533100.34
4195824-19582499.394100.20
5197085-197085100.034100.85
6198969-198969100.991101.83
极限1199680-199680101.352100.920.97102.33101.910.97
2200334-200334101.683102.67
3197572-197572100.282101.26
4197432-197432100.211101.18
5196571-19657199.774100.76
6201426-201426102.238103.24
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(%)99.74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%
111.151978851978621977401976351972661976780.13
211.181972811973931973370.05
单位质量响应值RSD%判断
17728.9717650.890.32数据可信
供试品溶液-25010301批-pH6.8(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min164921-6492132.94432.814.7432.9432.814.75
265561-6556133.26933.27
359079-5907929.97929.98
465389-6538933.18133.18
564570-6457032.76632.77
668453-6845334.73634.74
10min199808-9980850.64750.663.6250.7050.713.62
2103177-10317752.35752.41
394501-9450147.95448.00
499669-9966950.57650.63
597510-9751049.48149.54
6104320-10432052.93752.99
15min1120893-12089361.34662.053.3061.4962.193.31
2126016-12601663.94664.09
3116745-11674559.24259.37
4125266-12526663.56563.71
5118801-11880160.28560.42
6125989-12598963.93264.08
20min1136242-13624269.13569.572.7969.3869.822.79
2141290-14129071.69771.95
3132286-13228667.12867.36
4137273-13727369.65869.90
5133867-13386767.93068.17
6141650-14165071.87972.13
30min1156674-15667479.50379.612.1879.8679.972.18
2161047-16104781.72282.09
3152584-15258477.42877.77
4156842-15684279.58879.95
5153767-15376778.02878.38
6160428-16042881.40881.78
45min1173593-17359388.08988.331.7188.5888.821.72
2178140-17814090.39690.90
3170506-17050686.52286.99
4173668-17366888.12788.62
5171577-17157787.06687.55
6176940-17694089.78790.30
60min1184413-18441393.57993.331.3494.2293.971.35
2187594-18759495.19395.85
3181069-18106991.88292.50
4183040-18304092.88293.52
5181788-18178892.24792.87
6185646-18564694.20594.86
极限1191668-19166897.26196.781.0998.0597.571.10
2193399-19339998.13998.95
3188416-18841695.61196.38
4190316-19031696.57597.37
5188298-18829895.55196.33
6192172-19217297.51698.33
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(%)99.74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%
111.151983391979311980281974851975911978750.18
211.181995291992281993780.11
单位质量响应值RSD%判断
17746.6417833.450.35数据可信
供试品溶液-25010301批-pH6.8(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min166539-6653933.57532.845.6633.5732.845.66
261221-6122130.89130.89
370212-7021235.42835.43
461435-6143530.99931.00
563260-6326031.92031.92
667879-6787934.25134.25
10min1102032-10203251.48450.783.4351.5450.843.43
2101069-10106950.99851.05
3105707-10570753.33953.40
496189-9618948.53648.59
597337-9733749.11549.17
6101490-10149051.21151.27
15min1126216-12621663.68761.853.2363.8361.993.23
2122861-12286161.99462.13
3127335-12733564.25264.40
4116994-11699459.03459.17
5119235-11923560.16560.30
6122857-12285761.99262.13
20min1138687-13868769.98069.192.5570.2369.442.56
2138173-13817369.72169.96
3142156-14215671.73071.99
4132658-13265866.93867.17
5133641-13364167.43467.67
6137452-13745269.35769.60
30min1157337-15733779.39078.822.0879.7579.182.08
2157478-15747879.46279.82
3160891-16089181.18481.56
4151959-15195976.67777.02
5153140-15314077.27377.62
6156447-15644778.94179.30
45min1173655-17365587.62487.201.5888.1287.691.58
2175830-17583088.72289.21
3175389-17538988.49989.01
4169490-16949085.52385.99
5169727-16972785.64286.12
6172832-17283287.20987.70
60min1182813-18281392.24592.251.0892.8992.881.08
2184910-18491093.30393.94
3184192-18419292.94193.60
4179505-17950590.57691.19
5183721-18372192.70493.32
6181758-18175891.71392.35
极限1189718-18971895.73095.231.0196.5396.021.02
2190859-19085996.30597.10
3190502-19050296.12596.94
4186295-18629594.00294.77
5186973-18697394.34495.12
6188061-18806194.89395.68
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