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(%)99.99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%
111.051942811942351942881942011943571942720.04
211.201956481956381956430.01
单位质量响应值RSD%判断
17581.1817468.120.46数据可信
供试品溶液-2022082801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%
5min1-0.0000.10156.270.000.10156.16
2509-5090.2610.26
3-0.0000.00
4-0.0000.00
5631-6310.3240.32
6-0.0000.00
10min11378-13780.7080.676.250.710.686.04
21296-12960.6660.67
31340-13400.6880.69
41318-13180.6770.68
51389-13890.7130.71
61162-11620.5970.60
15min11414-14140.7260.724.660.730.724.97
21330-13300.6830.68
31458-14580.7490.75
41370-13700.7040.70
51498-14980.7690.77
61350-13500.6930.69
20min11551-15510.7960.759.300.800.769.02
21277-12770.6560.66
31435-14350.7370.74
41408-14080.7230.73
51432-14320.7350.74
61676-16760.8610.86
30min11483-14830.7620.697.610.770.707.80
21287-12870.6610.66
31424-14240.7310.73
41286-12860.6600.66
51416-14160.7270.73
61220-12200.6260.63
45min11414-14140.7260.676.280.730.686.27
21223-12230.6280.63
31345-13450.6910.70
41312-13120.6740.68
51334-13340.6850.69
61194-11940.6130.62
60min11425-14250.7320.657.550.740.657.54
21174-11740.6030.61
31216-12160.6240.63
41268-12680.6510.66
51289-12890.6620.67
61174-11740.6030.61
极限11360-13600.6980.646.620.710.656.90
21192-11920.6120.62
31319-13190.6770.68
41200-12000.6160.62
51262-12620.6480.66
61144-11440.5870.59
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(%)99.99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%
111.051961861960021962911964071962601962290.08
211.201950031947121948580.11
单位质量响应值RSD%判断
17758.2817398.041.45数据可信
供试品溶液-2022082801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%
5min11096-10960.5611.0681.370.561.0681.23
24744-47442.4292.43
31119-11190.5730.57
43640-36401.8641.86
5833-8330.4260.43
6987-9870.5050.51
10min11574-15740.8060.9823.160.810.9823.11
22482-24821.2711.27
31705-17050.8730.87
42470-24701.2651.27
51513-15130.7750.78
61741-17410.8910.89
15min11782-17820.9120.959.640.910.9510.04
22070-20701.0601.07
31775-17750.9090.91
42099-20991.0751.08
51698-16980.8690.87
61722-17220.8820.88
20min11729-17290.8851.0746.210.891.0846.21
21807-18070.9250.93
31654-16540.8470.85
44061-40612.0792.09
51645-16450.8420.85
61657-16570.8480.85
30min13066-30661.5701.2136.081.581.2235.98
22915-29151.4921.50
33380-33801.7311.74
41693-16930.8670.88
51554-15540.7960.80
61538-15380.7870.79
45min11487-14870.7610.8115.800.770.8215.65
21517-15170.7770.79
31502-15020.7690.78
41548-15480.7930.80
51399-13990.7160.72
62093-20931.0721.08
60min11469-14690.7520.733.330.760.733.63
21466-14660.7510.76
31396-13960.7150.72
41444-14440.7390.75
51361-13610.6970.70
61375-13750.7040.71
极限11413-14130.7230.713.310.730.723.63
21434-14340.7340.75
31423-14230.7290.74
41376-13760.7050.72
51318-13180.6750.68
61348-13480.6900.70
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(%)99.99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%
111.051946461946171945791945341941541945060.11
211.201945161944541944850.03
单位质量响应值RSD%判断
17602.3517364.730.97数据可信
供试品溶液-S0388207DD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%
5min11593-15930.8201.0378.210.821.0378.30
21029-10290.5300.53
35071-50712.6102.61
41205-12050.6200.62
52088-20881.0751.07
6993-9930.5110.51
10min11730-17300.8911.1938.570.891.1938.45
21781-17810.9170.92
32694-26941.3871.39
43948-39482.0322.03
52046-20461.0531.05
61643-16430.8460.85
15min11852-18520.9531.006.750.961.016.76
21907-19070.9820.98
32185-21851.1251.13
41930-19300.9931.00
51989-19891.0241.03
61818-18180.9360.94
20min12154-21541.1090.977.441.110.987.24
21824-18240.9390.94
31923-19230.9901.00
41876-18760.9660.97
51790-17900.9210.93
61776-17760.9140.92
30min11599-15990.8230.9728.120.830.9727.78
21623-16230.8350.84
31688-16880.8690.88
42946-29461.5161.52
51790-17900.9210.93
61621-16210.8340.84
45min11553-15530.7990.804.260.810.804.22
21451-14510.7470.75
31567-15670.8070.82
41486-14860.7650.78
51616-16160.8320.84
61607-16070.8270.83
60min11479-14790.7611.1173.230.771.1272.45
25383-53832.7712.78
31524-15240.7840.80
41558-15580.8020.81
51494-14940.7690.78
61511-15110.7780.79
极限11392-13920.7170.7931.110.730.8030.34
2959-9590.4940.51
31448-14480.7450.76
41500-15000.7720.78
52412-24121.2421.25
61474-14740.7590.77
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(%)99.99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%
111.051941001939701936971937141941431939250.11
211.201946291951251948770.18
单位质量响应值RSD%判断
17549.7717399.730.61数据可信
供试品溶液-S0388207DD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%
5min11082-10820.5571.1883.780.561.1883.61
21044-10440.5380.54
31270-12700.6540.65
45458-54582.8112.81
5981-9810.5050.51
63887-38872.0022.00
10min11782-17820.9181.0423.670.921.0423.86
21654-16540.8520.85
31724-17240.8880.89
42841-28411.4631.47
51764-17640.9080.91
62381-23811.2261.23
15min11895-18950.9761.2150.260.981.2150.26
21722-17220.8870.89
31846-18460.9510.95
44748-47482.4452.45
51787-17870.9200.92
62106-21061.0851.09
20min11916-19160.9870.956.950.990.966.95
21714-17140.8830.89
31730-17300.8910.90
41980-19801.0201.03
51779-17790.9160.92
62003-20031.0321.04
30min11763-17630.9080.886.740.910.897.07
21586-15860.8170.82
31557-15570.8020.81
41851-18510.9530.97
51714-17140.8830.89
61780-17800.9170.93
45min11651-16510.8500.833.810.860.844.33
21546-15460.7960.80
31597-15970.8220.83
41714-17140.8830.90
51566-15660.8060.81
61615-16150.8320.84
60min11590-15900.8190.802.780.830.813.39
21504-15040.7750.78
31524-15240.7850.79
41614-16140.8310.85
51523-15230.7840.79
61540-15400.7930.80
极限11571-15710.8090.774.250.820.784.47
21403-14030.7230.73
31470-14700.7570.77
41564-15640.8050.82
51483-14830.7640.77
61533-15330.7890.80
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