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%
111.181981811971511971641971711975001974330.23
211.221974631968761971700.22
单位质量响应值RSD%判断
17659.4817573.080.35数据可信
供试品溶液-25010302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%
5min1103245-10324552.61053.005.6952.6153.005.69
299848-9984850.87950.88
3104638-10463853.32053.32
4109227-10922755.65855.66
595525-9552548.67648.68
6111596-11159656.86556.87
10min1145298-14529874.03973.522.3974.1373.612.39
2143118-14311872.92873.01
3145476-14547674.13074.22
4146266-14626674.53274.62
5137931-13793170.28570.37
6147580-14758075.20275.30
15min1164878-16487884.01684.861.3484.2385.061.35
2165626-16562684.39784.60
3168020-16802085.61785.83
4168590-16859085.90886.12
5163339-16333983.23283.43
6168692-16869285.96086.18
20min1176578-17657889.97890.650.9590.3391.000.95
2178328-17832890.87091.22
3177931-17793190.66891.02
4178787-17878791.10491.46
5175494-17549489.42689.76
6180249-18024991.84992.21
30min1187148-18714895.36496.240.5895.8796.740.58
2189042-18904296.32996.83
3189135-18913596.37796.88
4189985-18998596.81097.32
5188074-18807495.83696.32
6189828-18982896.73097.25
45min1193420-19342098.56099.480.6399.22100.140.63
2195371-19537199.554100.21
3196245-196245100.000100.67
4196119-19611999.936100.61
5194064-19406498.88899.53
6196149-19614999.951100.63
60min1195940-19594099.844101.040.67100.67101.870.66
2197752-197752100.768101.59
3199325-199325101.569102.40
4198908-198908101.357102.20
5199476-199476101.646102.46
6198334-198334101.064101.91
极限1206572-206572105.262102.761.21106.25103.761.19
2200378-200378102.106103.10
3200989-200989102.417103.42
4200962-200962102.403103.41
5200846-200846102.344103.32
6200195-200195102.013103.03
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%
111.181970161974031974651971241984681974950.30
211.221976781974021975400.10
单位质量响应值RSD%判断
17665.0317606.060.24数据可信
供试品溶液-25010302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%
5min1106922-10692254.42453.724.1554.4253.724.15
2113065-11306557.55157.55
3102787-10278752.31952.32
4105249-10524953.57353.57
5100111-10011150.95750.96
6105116-10511653.50553.50
10min1147079-14707974.86474.222.2774.9674.312.27
2151652-15165277.19277.29
3145325-14532573.97274.06
4144938-14493873.77573.86
5142134-14213472.34772.43
6143758-14375873.17473.26
15min1169293-16929386.17185.131.0286.3985.351.02
2168331-16833185.68285.91
3167136-16713685.07385.28
4168253-16825385.64285.85
5165470-16547084.22584.43
6165056-16505684.01584.23
20min1180088-18008891.66690.970.8192.0391.320.81
2177983-17798390.59590.96
3178781-17878191.00191.35
4180031-18003191.63791.99
5179167-17916791.19791.54
6176286-17628689.73190.08
30min1190698-19069897.06796.360.6797.5896.860.67
2188255-18825595.82396.34
3189201-18920196.30596.81
4189965-18996596.69497.20
5190273-19027396.85097.35
6187421-18742195.39995.90
45min1197027-197027100.28899.770.64100.96100.440.64
2195250-19525099.384100.06
3197812-197812100.688101.35
4194924-19492499.21899.89
5196325-19632599.931100.59
6194742-19474299.12599.78
60min1199926-199926101.764101.040.61102.60101.870.60
2196650-196650100.096100.94
3198001-198001100.784101.62
4198674-198674101.127101.96
5199659-199659101.628102.45
6198092-198092100.830101.66
极限1200676-200676102.146101.850.37103.16102.850.36
2199010-199010101.298102.31
3201024-201024102.323103.32
4200051-200051101.827102.83
5200152-200152101.879102.87
6199622-199622101.609102.60
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%
111.181982221968401966431972541974341972790.32
211.221974371975151974760.03
单位质量响应值RSD%判断
17645.7117600.360.19数据可信
供试品溶液-25010302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%
5min163256-6325632.22133.142.3132.2233.142.32
267075-6707534.16634.17
365995-6599533.61633.62
464681-6468132.94632.95
565808-6580833.52133.52
663519-6351932.35532.35
10min1100501-10050151.19251.472.2451.2551.522.24
2104339-10433953.14753.20
3101245-10124551.57151.63
4100611-10061151.24851.30
5102130-10213052.02252.08
697448-9744849.63749.69
15min1122684-12268462.49162.971.9862.6363.111.98
2127253-12725364.81964.96
3123765-12376563.04263.18
4123426-12342662.86963.01
5124772-12477263.55563.70
6119824-11982461.03561.17
20min1137442-13744270.00970.932.0070.2571.172.00
2143475-14347573.08273.34
3138609-13860970.60370.85
4139649-13964971.13371.38
5140820-14082071.72971.98
6135458-13545868.99869.24
30min1157351-15735180.15081.361.8480.5181.721.84
2163936-16393683.50483.88
3158828-15882880.90281.27
4160614-16061481.81282.18
5161669-16166982.34982.72
6155951-15595179.43779.79
45min1174749-17474989.01290.381.6289.5190.881.62
2181769-18176992.58793.10
3176379-17637989.84290.34
4178315-17831590.82891.33
5179161-17916191.25991.76
6174231-17423188.74889.23
60min1185372-18537294.42395.651.2695.0696.301.27
2191070-19107097.32597.99
3187025-18702595.26595.91
4188540-18854096.03696.69
5189529-18952996.54097.20
6185103-18510394.28694.92
极限1192732-19273298.17299.141.1698.9799.951.16
2197929-197929100.819101.65
3193262-19326298.44299.25
4195750-19575099.709100.52
5195897-19589799.784100.60
6192190-19219097.89698.69
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(%)99.74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%
111.181974121975321972181973421971101973230.09
211.221976121974221975170.07
单位质量响应值RSD%判断
17649.6417604.010.19数据可信
供试品溶液-25010302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%
5min157773-5777329.42131.466.5329.4231.466.53
258243-5824329.66129.66
363328-6332832.25032.25
468823-6882335.04935.05
561390-6139031.26331.26
661103-6110331.11731.12
10min193797-9379747.76750.053.4347.8250.113.43
295295-9529548.53048.58
399830-9983050.83950.89
4103241-10324152.57652.63
599074-9907450.45450.51
698502-9850250.16350.21
15min1116715-11671559.43861.542.1459.5761.672.14
2118893-11889360.54760.68
3122068-12206862.16462.30
4123878-12387863.08663.23
5122030-12203062.14562.28
6121423-12142361.83661.97
20min1133220-13322067.84369.771.6868.0770.011.68
2135361-13536168.93469.16
3138090-13809070.32470.57
4139202-13920270.89071.14
5138755-13875570.66270.90
6137436-13743669.99070.23
30min1154115-15411578.48480.241.3578.8380.601.35
2156018-15601879.45479.80
3159005-15900580.97581.33
4158975-15897580.95981.33
5159578-15957881.26681.62
6157735-15773580.32880.68
45min1172833-17283388.01789.671.1088.4990.161.10
2175303-17530389.27589.75
3177027-17702790.15390.65
4176523-17652389.89690.40
5178562-17856290.93491.43
6176241-17624189.75290.24
60min1183489-18348993.44395.271.3894.0695.901.38
2186120-18612094.78395.41
3186458-18645894.95595.60
4187777-18777795.62796.28
5191375-19137597.45998.10
6187183-18718395.32595.96
极限1190001-19000196.76098.481.0297.5399.271.02
2193428-19342898.50599.29
3193472-19347298.52799.33
4193519-19351998.55199.36
5196135-19613599.883100.69
6193681-19368198.63499.43
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