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(%)99.74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%
110.941936521935811934051937501935501935880.07
211.031927781930171928980.09
单位质量响应值RSD%判断
17695.4317488.490.84数据可信
供试品溶液-2025111511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%
5min1100719-10071951.39535.0529.2851.4035.0529.28
275126-7512638.33638.34
347405-4740524.19024.19
473024-7302437.26337.26
569041-6904135.23135.23
646750-4675023.85623.86
10min1164798-16479884.09479.275.9184.1879.335.92
2155851-15585179.52879.59
3149102-14910276.08576.12
4158532-15853280.89680.96
5163288-16328883.32383.38
6140555-14055571.72371.76
15min1175984-17598489.80288.392.9790.0388.582.99
2175013-17501389.30689.50
3170855-17085587.18587.35
4176941-17694190.29090.49
5176744-17674490.19090.39
6163756-16375683.56283.72
20min1183588-18358893.68292.531.7694.0692.871.78
2182258-18225893.00493.35
3179308-17930891.49891.81
4184778-18477894.28994.64
5182017-18201792.88193.23
6176006-17600689.81390.11
30min1188778-18877896.33196.211.4696.8696.701.47
2189428-18942896.66297.16
3188101-18810195.98596.45
4192931-19293198.45098.95
5187476-18747695.66696.17
6184531-18453194.16394.61
45min1192971-19297198.47098.911.1599.1699.561.15
2194010-19401099.00099.66
3194526-19452699.26499.89
4197748-197748100.908101.58
5192277-19227798.11698.78
6191490-19149097.71498.32
60min1194002-19400298.99699.701.4599.85100.521.45
2195345-19534599.682100.51
3197192-197192100.624101.41
4200059-200059102.087102.92
5192538-19253898.24999.07
6193167-19316798.57099.34
极限1193349-19334998.66399.591.3699.68100.571.36
2195640-19564099.832100.82
3196286-196286100.162101.12
4199654-199654101.880102.89
5192348-19234898.15299.14
6193690-19369098.83799.77
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(%)99.74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%
110.941933861936011932201939191929841934220.19
211.031930001931251930620.05
单位质量响应值RSD%判断
17680.2617503.350.72数据可信
供试品溶液-2025111511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%
5min199867-9986750.96140.3132.2550.9640.3132.25
297207-9720749.60349.60
3100926-10092651.50151.50
474661-7466138.09838.10
564276-6427632.79932.80
637035-3703518.89818.90
10min1158880-15888081.07480.757.4481.1680.827.46
2167122-16712285.28085.36
3169628-16962886.55986.64
4159138-15913881.20681.27
5158458-15845880.85980.91
6136278-13627869.54169.57
15min1172328-17232887.93688.604.1188.1688.804.13
2179599-17959991.64791.87
3179329-17932991.50991.74
4177598-17759890.62690.82
5172101-17210187.82088.01
6160765-16076582.03682.18
20min1178377-17837791.02392.482.5691.3992.822.58
2186080-18608094.95495.33
3184693-18469394.24694.63
4184011-18401193.89894.25
5180365-18036592.03792.37
6173820-17382088.69888.98
30min1184741-18474194.27096.212.0094.7996.712.02
2192099-19209998.02598.56
3191394-19139497.66598.21
4191878-19187897.91298.42
5187361-18736195.60796.10
6183756-18375693.76894.20
45min1188767-18876796.32598.341.7197.0099.011.72
2196871-196871100.460101.16
3193260-19326098.61899.32
4196191-196191100.113100.78
5190736-19073697.33097.98
6190523-19052397.22197.81
60min1189107-18910796.49898.781.7197.3399.611.72
2196690-196690100.368101.23
3194525-19452599.263100.13
4197674-197674100.870101.71
5192210-19221098.08298.89
6191269-19126997.60298.35
极限1189391-18939196.64398.861.4697.6499.851.47
2197096-197096100.575101.61
3194115-19411599.054100.09
4196441-196441100.241101.25
5192781-19278198.37399.35
6192547-19254798.25499.17
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(%)99.74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%
110.941934341932931923951930471924321929200.26
211.031935651931971933810.14
单位质量响应值RSD%判断
17634.3717532.280.42数据可信
供试品溶液-2025111611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%
5min1106324-10632454.28152.8016.1854.2852.7916.18
2119221-11922160.86560.86
380708-8070841.20341.20
4124991-12499163.81163.81
592989-9298947.47347.47
696256-9625649.14149.14
10min1164291-16429183.87482.023.4183.9682.103.42
2166230-16623084.86484.97
3151552-15155277.37177.44
4164184-16418483.82083.93
5157569-15756980.44280.52
6160093-16009381.73181.81
15min1178192-17819290.97189.702.3291.2089.922.33
2181237-18123792.52692.77
3169135-16913586.34786.54
4174636-17463689.15689.40
5174704-17470489.19089.40
6176258-17625889.98490.20
20min1186349-18634995.13593.262.2095.5293.632.21
2187384-18738495.66496.06
3176504-17650490.10990.45
4180315-18031592.05592.45
5181953-18195392.89193.25
6183493-18349393.67794.05
30min1193924-19392499.00297.021.8199.5497.541.81
2193800-19380098.93999.50
3186505-18650595.21595.71
4186036-18603694.97595.52
5189251-18925196.61797.13
6190676-19067697.34497.87
45min1196995-196995100.57098.891.82101.2899.581.82
2197828-197828100.996101.72
3191607-19160797.82098.47
4188361-18836196.16296.87
5192934-19293498.49799.17
6194516-19451699.30599.99
60min1197804-197804100.98399.311.70101.86100.171.70
2198027-198027101.097101.99
3192551-19255198.30299.11
4189411-18941196.69997.57
5193790-19379098.93499.78
6195552-19555299.834100.69
极限1197790-197790100.97699.181.96102.02100.201.96
2198427-198427101.301102.36
3192736-19273698.39699.37
4188363-18836396.16397.19
5192490-19249098.27099.28
6195820-19582099.970100.99
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(%)99.74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%
110.941926251927611929151925791927191927200.07
211.031944341940441942390.15
单位质量响应值RSD%判断
17616.0917610.060.03数据可信
供试品溶液-2025111611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%
5min148722-4872224.83142.0441.5724.8342.0441.57
2113545-11354557.86957.87
348310-4831024.62124.62
4100689-10068951.31751.32
559435-5943530.29130.29
6124211-12421163.30563.30
10min1132526-13252667.54377.318.3967.5877.388.42
2163305-16330583.22983.33
3144620-14462073.70673.75
4162370-16237082.75382.84
5145422-14542274.11574.17
6161857-16185782.49182.60
15min1159018-15901881.04486.364.2881.2086.564.31
2176406-17640689.90690.14
3165727-16572784.46484.63
4177557-17755790.49390.72
5165443-16544384.31984.49
6172485-17248587.90888.15
20min1169699-16969986.48890.603.1186.7890.953.14
2182665-18266593.09693.48
3176874-17687490.14590.45
4184730-18473094.14994.52
5174134-17413488.74889.06
6178548-17854890.99891.39
30min1181577-18157792.54295.022.0292.9795.512.05
2190777-19077797.23197.77
3186744-18674495.17595.63
4190852-19085297.26997.80
5184378-18437893.96994.43
6184323-18432393.94194.48
45min1187301-18730195.45997.301.8596.0597.961.87
2193978-19397898.86299.56
3191112-19111297.40198.01
4196099-19609999.943100.64
5189372-18937296.51497.13
6187665-18766595.64496.34
60min1189847-18984796.75798.211.6097.5099.021.61
2195220-19522099.495100.36
3194420-19442099.08799.86
4196462-196462100.128100.99
5191229-19122997.46198.24
6189037-18903796.34497.20
极限1189732-18973296.69897.961.5797.6198.941.58
2194251-19425199.001100.03
3193383-19338398.55999.50
4196550-196550100.173101.20
5190679-19067997.18198.12
6188694-18869496.16997.19
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(%)99.74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%
110.941946661943341943491947261940521944250.15
211.031929481933211931340.14
单位质量响应值RSD%判断
17771.9417509.881.06数据可信
供试品溶液-2025111711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%
5min1117498-11749859.79250.1016.4859.7950.1016.48
2102796-10279652.31152.31
374228-7422837.77337.77
4108473-10847355.20055.20
583745-8374542.61642.62
6103911-10391152.87852.88
10min1167371-16737185.17282.162.6785.2782.242.68
2162507-16250782.69682.78
3156917-15691779.85279.91
4163420-16342083.16183.25
5155931-15593179.35079.42
6162543-16254382.71582.80
15min1181649-18164992.43790.051.7192.6890.271.73
2177928-17792890.54490.77
3175448-17544889.28289.48
4177038-17703890.09190.32
5172438-17243887.75087.95
6177241-17724190.19490.42
20min1187564-18756495.44793.791.0895.8494.161.09
2184584-18458493.93194.31
3184175-18417593.72394.07
4184101-18410193.68594.07
5181345-18134592.28392.63
6184102-18410293.68694.06
30min1192570-19257097.99597.160.7498.5597.690.74
2191600-19160097.50198.03
3192252-19225297.83398.33
4190000-19000096.68797.22
5189091-18909196.22596.73
6190079-19007996.72797.26
45min1195243-19524399.35598.980.61100.0799.660.62
2195249-19524999.358100.05
3195165-19516599.31599.98
4194940-19494099.20199.90
5192223-19222397.81898.48
6194181-19418198.81599.51
60min1198367-198367100.94599.770.82101.83100.620.83
2195228-19522899.348100.21
3197570-197570100.539101.37
4195507-19550799.489100.35
5194046-19404698.74699.57
6195614-19561499.544100.40
极限1196995-196995100.24799.850.71101.30100.870.71
2197242-197242100.372101.40
3197190-197190100.346101.34
4196188-19618899.836100.87
5193591-19359198.51499.51
6196115-19611599.799100.82
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(%)99.74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%
110.941940891941531942771938961942071941240.08
211.031931381933301932340.08
单位质量响应值RSD%判断
17744.4217518.950.91数据可信
供试品溶液-2025111711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%
5min178417-7841739.92540.5823.1239.9340.5823.12
288516-8851645.06745.07
3105096-10509653.50853.51
448578-4857824.73324.73
577681-7768139.55039.55
679947-7994740.70440.70
10min1153498-15349878.15279.253.8278.2279.323.84
2163258-16325883.12183.20
3161507-16150782.22982.32
4146907-14690774.79674.84
5154237-15423778.52878.59
6154479-15447978.65178.72
15min1178385-17838590.82388.432.6091.0288.632.61
2178540-17854090.90291.12
3175314-17531489.25989.49
4167279-16727985.16885.33
5171871-17187187.50687.70
6170713-17071386.91787.12
20min1188712-18871296.08192.582.4896.4392.922.49
2185319-18531994.35394.72
3181670-18167092.49592.87
4176310-17631089.76690.07
5180062-18006291.67692.02
6178922-17892291.09691.44
30min1198204-198204100.91396.812.51101.4297.312.51
2193264-19326498.39898.92
3187964-18796495.70096.23
4186391-18639194.89995.36
5189257-18925796.35896.85
6185770-18577094.58395.08
45min1202352-202352103.02598.842.43103.7099.502.43
2196950-196950100.275100.96
3191350-19135097.42498.11
4191799-19179997.65298.27
5192780-19278098.15298.81
6189586-18958696.52597.18
60min1204331-204331104.03399.672.40104.88100.502.40
2197673-197673100.643101.50
3192645-19264598.08398.93
4193622-19362298.58099.36
5194703-19470399.13199.95
6191563-19156397.53298.35
极限1205092-205092104.42099.552.68105.44100.552.67
2197891-197891100.754101.78
3193202-19320298.36799.38
4191596-19159697.54998.49
5193901-19390198.72299.71
6191533-19153397.51798.49
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