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%
111.121971261969431970731965371968521969060.12
211.171982561981461982010.04
单位质量响应值RSD%判断
17707.3717744.050.15数据可信
供试品溶液-24042301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%
5min1123001-12300162.44663.835.7462.4563.835.74
2114582-11458258.17258.17
3133687-13368767.87167.87
4125649-12564963.79063.79
5123923-12392362.91462.91
6133571-13357167.81267.81
10min1154583-15458378.48078.903.1878.5879.013.19
2146029-14602974.13774.23
3159984-15998481.22281.33
4158303-15830380.36880.47
5156558-15655879.48279.59
6157050-15705079.73279.85
15min1166585-16658584.57385.022.3884.8185.262.38
2160042-16004281.25181.47
3170640-17064086.63286.88
4167595-16759585.08685.33
5170334-17033486.47686.71
6169627-16962786.11786.36
20min1174444-17444488.56388.482.1188.9488.862.11
2167764-16776485.17285.53
3176698-17669889.70790.10
4173234-17323487.94988.33
5178423-17842390.58390.96
6175060-17506088.87689.27
30min1181894-18189492.34592.022.2192.8792.552.21
2174000-17400088.33888.84
3184828-18482893.83594.38
4180733-18073391.75692.28
5184992-18499293.91894.45
6181070-18107091.92792.46
45min1187001-18700194.93894.781.7795.6295.461.77
2181827-18182792.31192.96
3190148-19014896.53697.23
4185572-18557294.21294.89
5190556-19055696.74397.43
6185092-18509293.96994.66
60min1187484-18748495.18395.881.8296.0296.721.82
2184966-18496693.90594.70
3191683-19168397.31598.17
4188343-18834395.61996.46
5194155-19415598.57099.42
6186540-18654094.70495.55
极限1190758-19075896.84596.582.4097.8497.582.39
2186437-18643794.65295.61
3194626-19462698.80999.83
4189408-18940896.16097.16
5195942-19594299.477100.49
6184206-18420693.51994.52
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%
111.121982311980181980581984781981971981960.10
211.171999432002902001160.13
单位质量响应值RSD%判断
17823.3817915.490.37数据可信
供试品溶液-24042302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%
5min1125058-12505862.98061.241.5962.9861.241.59
2120249-12024960.55860.56
3122063-12206361.47261.47
4121708-12170861.29361.29
5121024-12102460.94860.95
6119548-11954860.20560.21
10min1153348-15334877.22775.771.4277.3375.871.42
2149087-14908775.08175.18
3152654-15265476.87876.98
4149923-14992375.50275.60
5149945-14994575.51375.61
6147785-14778574.42574.53
15min1164469-16446982.82882.631.1083.0682.861.10
2163348-16334882.26382.49
3165711-16571183.45383.68
4165304-16530483.24883.48
5164810-16481082.99983.23
6160796-16079680.97881.20
20min1170963-17096386.09886.410.8886.4786.780.89
2171601-17160186.41986.78
3173123-17312387.18687.56
4173225-17322587.23787.60
5171484-17148486.36086.73
6169151-16915185.18685.54
30min1178338-17833889.81290.671.1090.3391.181.09
2179789-17978990.54391.05
3181778-18177891.54592.06
4182310-18231091.81292.32
5180769-18076991.03691.55
6177264-17726489.27189.77
45min1184291-18429192.81093.851.1693.4894.521.15
2186029-18602993.68594.34
3188320-18832094.83995.51
4188751-18875195.05695.72
5187281-18728194.31694.98
6183488-18348892.40693.06
60min1187685-18768594.51995.521.0895.3496.341.08
2187862-18786294.60895.42
3191290-19129096.33597.16
4192107-19210796.74697.57
5191102-19110296.24097.06
6187961-18796194.65895.46
极限1189098-18909895.23196.811.1396.2197.791.13
2190880-19088096.12897.10
3192815-19281597.10398.09
4194886-19488698.14699.13
5194230-19423097.81598.79
6191501-19150196.44197.40
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%
111.121983601983281985821988331988411985890.13
211.172003802011222007510.27
单位质量响应值RSD%判断
17858.7217972.340.45数据可信
供试品溶液-1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%
5min1129842-12984265.22161.694.2365.2261.704.22
2118669-11866959.60959.61
3116257-11625758.39758.40
4127612-12761264.10164.10
5123032-12303261.80061.80
6121515-12151561.03861.04
10min1157861-15786179.29676.462.4779.4076.562.47
2148575-14857574.63174.73
3148977-14897774.83374.93
4154738-15473877.72777.83
5153525-15352577.11777.22
6149619-14961975.15575.26
15min1169265-16926585.02482.581.8585.2682.811.85
2161341-16134181.04481.27
3163159-16315981.95782.18
4165896-16589683.33283.57
5165278-16527883.02183.25
6161486-16148681.11681.34
20min1174482-17448287.64485.631.5988.0386.001.60
2167980-16798084.37884.74
3169432-16943285.10885.47
4171433-17143386.11386.49
5172104-17210486.45086.82
6167358-16735884.06684.43
30min1180251-18025190.54289.101.1291.0789.611.13
2175440-17544088.12688.63
3177417-17741789.11989.62
4177932-17793289.37789.90
5178346-17834689.58590.10
6174837-17483787.82388.33
45min1184088-18408892.47091.591.3593.1592.241.35
2180132-18013290.48391.13
3185104-18510492.98093.63
4181448-18144891.14491.81
5184118-18411892.48593.15
6179072-17907289.95090.60
60min1187474-18747494.17092.811.2395.0093.631.23
2183150-18315091.99892.80
3185405-18540593.13193.94
4182998-18299891.92292.74
5187250-18725094.05894.88
6182357-18235791.60092.40
极限1189148-18914895.01193.601.3596.0094.561.34
2185424-18542493.14194.09
3188021-18802194.44595.40
4184669-18466992.76293.73
5188117-18811794.49395.47
6182626-18262691.73592.69
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%
111.122018222017452021202022222012252018270.20
211.172045942046252046100.02
单位质量响应值RSD%判断
18149.9118317.820.66数据可信
供试品溶液-2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%
5min1118253-11825358.36463.545.7358.3663.545.74
2127610-12761062.98262.98
3124607-12460761.50061.50
4140370-14037069.27969.28
5130854-13085464.58364.58
6130729-13072964.52164.52
10min1154194-15419476.10278.273.0476.2078.383.04
2157380-15738077.67577.78
3154062-15406276.03776.14
4166598-16659882.22482.34
5161679-16167979.79679.90
6157620-15762077.79377.90
15min1167156-16715682.50084.392.3782.7284.632.38
2169726-16972683.76884.00
3166878-16687882.36282.59
4177719-17771987.71387.97
5172479-17247985.12785.37
6171970-17197084.87585.11
20min1174386-17438686.06887.242.0886.4387.622.09
2175728-17572886.73087.10
3173654-17365485.70786.07
4183505-18350590.56990.97
5178332-17833288.01588.40
6175015-17501586.37886.76
30min1182268-18226889.95890.661.7690.4691.181.77
2180700-18070089.18489.70
3182020-18202089.83690.34
4189058-18905893.30993.86
5186199-18619991.89892.43
6181862-18186289.75890.28
45min1188028-18802892.80193.351.2993.4694.021.30
2188041-18804192.80793.47
3188665-18866593.11593.77
4193438-19343895.47196.18
5190219-19021993.88294.56
6186418-18641892.00692.68
60min1191674-19167494.60094.771.1995.4195.601.19
2191286-19128694.40995.23
3190560-19056094.05194.86
4195990-19599096.73197.59
5193046-19304695.27896.12
6189558-18955893.55694.38
极限1194732-19473296.11095.471.2597.0896.461.25
2192937-19293795.22496.20
3193201-19320195.35496.33
4195967-19596796.71997.74
5194751-19475196.11997.12
6189075-18907593.31894.30
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