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%
1 11.101941271938771938791939941939261939610.06
2 11.081933051934471933760.06
单位质量响应值RSD%判断
17473.9617452.710.09数据可信
供试品溶液-2025011721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%
5min179053-7905340.63538.5312.3640.6438.5312.37
259363-5936330.51430.51
368005-6800534.95634.96
483197-8319742.76542.77
580765-8076541.51541.52
679324-7932440.77540.77
10min1111523-11152357.32656.393.3857.3956.463.39
2103897-10389753.40653.46
3106755-10675554.87554.93
4113762-11376258.47758.55
5110127-11012756.60856.68
6112180-11218057.66357.73
15min1131889-13188967.79466.542.7867.9666.702.80
2124050-12405063.76563.90
3127281-12728165.42665.58
4133314-13331468.52768.70
5127930-12793065.75965.92
6132214-13221467.96168.13
20min1144839-14483974.45173.242.0674.7373.512.08
2137519-13751970.68870.93
3140587-14058772.26572.52
4145239-14523974.65774.94
5143349-14334973.68573.96
6143403-14340373.71373.99
30min1160387-16038782.44381.152.5682.8481.542.57
2151667-15166777.96178.32
3154843-15484379.59379.97
4162673-16267383.61884.03
5157740-15774081.08281.48
6159872-15987282.17882.58
45min1173018-17301888.93687.931.6789.4788.451.68
2166976-16697685.83086.32
3169086-16908686.91587.43
4174752-17475289.82790.37
5170105-17010587.43887.97
6172408-17240888.62289.16
60min1179472-17947292.25391.751.4792.9492.421.48
2174967-17496789.93890.57
3176423-17642390.68691.34
4182221-18222193.66694.36
5177916-17791691.45392.13
6179931-17993192.48993.17
极限1186656-18665695.94694.851.1296.7995.681.13
2182285-18228593.69994.49
3182502-18250293.81194.62
4187004-18700496.12596.98
5183537-18353794.34395.17
6185134-18513495.16496.00
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%
1 11.101938591934341938341937051935611936790.10
2 11.081935801933171934480.10
单位质量响应值RSD%判断
17448.5617459.210.05数据可信
供试品溶液-2025011721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%
5min172697-7269737.38838.873.9437.3938.873.94
273801-7380137.95637.96
374139-7413938.13038.13
480622-8062241.46441.46
574568-7456838.35138.35
677654-7765439.93839.94
10min1105946-10594654.48855.743.4754.5555.803.47
2104204-10420453.59353.66
3105510-10551054.26454.33
4113851-11385158.55458.62
5109595-10959556.36556.43
6111143-11114357.16157.23
15min1127429-12742965.53766.092.5865.6966.252.58
2124551-12455164.05764.21
3125221-12522164.40264.56
4132947-13294768.37568.54
5130080-13008066.90167.06
6130774-13077467.25867.42
20min1141674-14167472.86473.002.4073.1373.262.40
2138066-13806671.00871.27
3137753-13775370.84771.11
4145873-14587375.02375.30
5144315-14431574.22274.49
6143910-14391074.01374.29
30min1158810-15881081.67781.782.1982.0682.172.19
2155174-15517479.80780.18
3154579-15457979.50179.88
4162903-16290383.78284.19
5161393-16139383.00583.40
6161252-16125282.93383.33
45min1171296-17129688.09888.922.2488.6289.452.24
2168920-16892086.87687.39
3168599-16859986.71187.22
4175920-17592090.47691.02
5177972-17797291.53292.06
6174675-17467589.83690.37
60min1179881-17988192.51493.151.3093.1893.831.30
2178504-17850491.80592.46
3178765-17876591.94092.60
4183307-18330794.27694.97
5183623-18362394.43895.12
6182680-18268093.95394.64
极限1186484-18648495.90996.140.9596.7396.970.96
2184518-18451894.89895.71
3185395-18539595.34996.16
4188394-18839496.89297.75
5189053-18905397.23198.07
6187761-18776196.56697.41
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%
1 11.101940061936371941311938771934811938260.14
2 11.081932931932921932920.01
单位质量响应值RSD%判断
17461.8017445.130.07数据可信
供试品溶液-2025011721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%
5min1-0.0000.16111.100.000.16111.04
2643-6430.3310.33
3-0.0000.00
4708-7080.3640.36
5526-5260.2710.27
6-0.0000.00
10min11213-12130.6240.6112.170.620.6012.18
21404-14040.7220.72
31001-10010.5150.51
41203-12030.6190.62
51205-12050.6200.62
61044-10440.5370.54
15min11423-14230.7320.9024.340.730.9024.37
21865-18650.9590.96
31463-14630.7520.75
41529-15290.7860.79
51621-16210.8340.84
62544-25441.3081.31
20min11490-14900.7660.814.300.770.814.28
21624-16240.8350.84
31580-15800.8130.81
41505-15050.7740.78
51660-16600.8540.86
61542-15420.7930.80
30min11399-13990.7200.796.340.720.796.51
21676-16760.8620.87
31502-15020.7730.78
41487-14870.7650.77
51537-15370.7910.79
61612-16120.8290.83
45min11315-13150.6760.747.570.680.747.74
21507-15070.7750.78
31460-14600.7510.76
41398-13980.7190.72
51338-13380.6880.69
61603-16030.8240.83
60min11323-13230.6800.7519.310.690.7619.00
21226-12260.6310.64
31304-13040.6710.68
41367-13670.7030.71
51990-19901.0231.03
61576-15760.8110.82
极限11240-12400.6380.663.870.640.663.78
21308-13080.6730.68
31221-12210.6280.64
41342-13420.6900.70
51241-12410.6380.65
61312-13120.6750.68
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%
1 11.101944181948041945321946681942521945350.12
2 11.081942271940611941440.07
单位质量响应值RSD%判断
17525.6817522.020.02数据可信
供试品溶液-2025011721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%
5min1558-5580.2860.05244.950.290.05244.95
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min11495-14950.7660.6611.110.770.6611.14
21273-12730.6520.65
31221-12210.6250.63
41261-12610.6460.65
51070-10700.5480.55
61360-13600.6970.70
15min11795-17950.9190.7612.280.920.7612.29
21395-13950.7150.72
31270-12700.6510.65
41557-15570.7980.80
51386-13860.7100.71
61544-15440.7910.79
20min11691-16910.8660.7612.230.870.7712.37
21465-14650.7500.75
31273-12730.6520.65
41495-14950.7660.77
51320-13200.6760.68
61712-17120.8770.88
30min11545-15450.7910.9046.730.800.9146.36
21303-13030.6670.67
31385-13850.7090.71
43436-34361.7601.76
51461-14610.7480.75
61451-14510.7430.75
45min11529-15290.7830.776.330.790.786.21
21671-16710.8560.86
31411-14110.7230.73
41500-15000.7680.77
51414-14140.7240.73
61502-15020.7690.77
60min11402-14020.7180.667.170.730.677.62
21256-12560.6430.65
31185-11850.6070.61
41328-13280.6800.69
51203-12030.6160.62
61386-13860.7100.72
极限11241-12410.6360.657.820.640.667.66
21229-12290.6300.64
31448-14480.7420.75
41215-12150.6220.63
51169-11690.5990.61
61310-13100.6710.68
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