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%
111.142029662029932021722021502020432024650.24
211.112002932004792003860.07
单位质量响应值RSD%判断
18174.6018036.540.54数据可信
供试品溶液-T0704607DD批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min116268-162688.08615.7642.648.0915.7642.64
239594-3959419.68019.68
338264-3826419.01919.02
440991-4099120.37420.37
512563-125636.2446.24
642531-4253121.14021.14
10min156009-5600927.83945.5133.1827.8545.5333.18
2112018-11201855.67855.71
3107240-10724053.30353.33
4111041-11104155.19255.23
549082-4908224.39624.41
6113927-11392756.62756.66
15min1123215-12321561.24374.0612.3161.3074.1612.35
2158706-15870678.88479.01
3159869-15986979.46279.58
4162277-16227780.65980.78
5127723-12772363.48463.53
6162269-16226980.65580.78
20min1162682-16268280.86085.874.7881.0286.104.83
2174165-17416586.56786.82
3178331-17833188.63888.89
4180825-18082589.87890.14
5162296-16229680.66880.82
6178323-17832388.63488.90
30min1185733-18573392.31793.762.0592.6194.132.10
2187518-18751893.20493.61
3190137-19013794.50694.91
4193172-19317296.01596.42
5183168-18316891.04291.33
6192099-19209995.48195.89
45min1195034-19503496.94097.011.4197.3997.541.43
2192202-19220295.53296.09
3197093-19709397.96498.52
4199333-19933399.07799.65
5192383-19238395.62296.07
6195010-19501096.92897.50
60min1196814-19681497.82597.811.4598.4498.501.47
2193978-19397896.41597.13
3198599-19859998.71299.43
4201378-201378100.093100.83
5194117-19411796.48497.09
6195839-19583997.34098.07
极限1197605-19760598.21898.011.4298.9998.861.44
2193691-19369196.27397.15
3198438-19843898.63299.52
4201623-201623100.215101.12
5194853-19485396.85097.61
6196921-19692197.87898.77
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%
111.141986761984031986041987261985301985880.07
211.112007482007332007400.01
单位质量响应值RSD%判断
17826.5718068.410.96数据可信
供试品溶液-T0704607DD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%
5min178611-7861139.41828.6021.1539.4228.6021.15
256913-5691328.53828.54
353631-5363126.89226.89
442444-4244421.28321.28
551375-5137525.76125.76
659294-5929429.73229.73
10min1120427-12042760.38658.4213.7660.4558.4713.76
2115374-11537457.85357.90
3121002-12100260.67560.72
486464-8646443.35643.39
5121366-12136660.85760.90
6134432-13443267.40967.46
15min1168769-16876984.62784.363.9184.7984.513.92
2164526-16452682.49982.64
3168478-16847884.48184.63
4157742-15774279.09779.21
5175669-17566988.08788.23
6174252-17425287.37687.54
20min1180580-18058090.54990.971.7290.8691.251.74
2178824-17882489.66989.95
3181307-18130790.91491.20
4177937-17793789.22489.46
5186439-18643993.48793.78
6183381-18338191.95492.26
30min1188743-18874394.64295.541.3395.1095.971.32
2187594-18759494.06694.50
3190404-19040495.47595.91
4191256-19125695.90396.29
5194923-19492397.74198.19
6190225-19022595.38695.85
45min1193468-19346897.01297.350.8997.6397.940.87
2191637-19163796.09496.68
3193948-19394897.25297.85
4196379-19637998.47199.02
5195779-19577998.17198.78
6193624-19362497.09097.71
60min1194825-19482597.69297.941.1898.4798.701.17
2192682-19268296.61897.37
3194203-19420397.38098.14
4197526-19752699.04799.76
5198673-19867399.622100.40
6193973-19397397.26598.05
极限1194936-19493697.74897.421.1298.6998.341.11
2190742-19074295.64596.55
3193755-19375597.15698.08
4196270-19627098.41799.29
5196628-19662898.59699.54
6193313-19331396.93497.88
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%
111.142122592122792116072110292115082117360.26
211.112083772086472085120.10
单位质量响应值RSD%判断
19006.8218767.960.90数据可信
供试品溶液-T0704607DD批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min112111-121115.7714.8630.245.774.8630.25
212105-121055.7685.77
312610-126106.0086.01
44573-45732.1792.18
511105-111055.2915.29
68759-87594.1734.17
10min137610-3761017.92016.2314.7817.9316.2414.78
239489-3948918.81618.83
338613-3861318.39818.41
428361-2836113.51313.52
530745-3074514.64914.66
629556-2955614.08314.09
15min162026-6202629.55429.658.6629.5929.688.63
260503-6050328.82828.87
361329-6132929.22229.26
472476-7247634.53334.56
556463-5646326.90326.94
660556-6055628.85428.88
20min189830-8983042.80238.8312.8342.8938.9112.81
282462-8246239.29139.38
391191-9119143.45143.54
487389-8738941.63941.72
573325-7332534.93835.02
664754-6475430.85430.93
30min182001-8200139.07238.7510.7039.2338.9010.68
272108-7210834.35834.51
395973-9597345.72945.89
485755-8575540.86141.01
574839-7483935.65935.80
677234-7723436.80036.93
45min193679-9367944.63641.288.4344.8641.508.38
285789-8578940.87741.09
385542-8554240.75941.00
473715-7371535.12435.34
593496-9349644.54944.74
687619-8761941.74941.94
60min174444-7444435.47142.229.9435.7742.509.87
295416-9541645.46445.74
393661-9366144.62844.93
497978-9797846.68546.96
584127-8412740.08540.35
685960-8596040.95841.22
极限194634-9463445.09142.498.5245.4542.848.46
283581-8358139.82540.18
393629-9362944.61244.99
492627-9262744.13544.49
576185-7618536.30136.64
694336-9433644.94945.28
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