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 11.101947231947271947881948261947351947600.03
2 11.081960691956171958430.17
单位质量响应值RSD%判断
17545.9517675.360.52数据可信
供试品溶液-2025011721批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1115454-11545458.85161.224.3558.8561.224.35
2114598-11459858.41458.41
3122727-12272762.55862.56
4123329-12332962.86562.86
5116877-11687759.57659.58
6127638-12763865.06165.06
10min1154153-15415378.57780.482.3978.6780.582.39
2154547-15454778.77878.87
3158606-15860680.84780.95
4160170-16017081.64481.75
5155945-15594579.49079.59
6163922-16392283.55683.66
15min1170420-17042086.86988.651.6387.1088.881.64
2172198-17219887.77588.00
3173670-17367088.52588.76
4173949-17394988.66788.91
5174371-17437188.88389.11
6178880-17888091.18191.43
20min1180327-18032791.91993.091.4092.2993.481.41
2180607-18060792.06192.44
3181716-18171692.62793.01
4182588-18258893.07193.46
5183191-18319193.37893.76
6187328-18732895.48795.89
30min1187596-18759695.62496.891.2596.1597.421.25
2188453-18845396.06196.59
3189377-18937796.53297.07
4189098-18909896.38996.93
5192185-19218597.96398.50
6193725-19372598.74899.31
45min1192063-19206397.90199.101.1098.5999.801.10
2194002-19400298.88999.58
3192954-19295498.35599.06
4193610-19361098.68999.39
5196118-19611899.968100.67
6197760-197760100.805101.53
60min1193158-19315898.45999.651.3699.31100.521.36
2194771-19477199.281100.13
3193108-19310898.43399.30
4194731-19473199.261100.13
5197346-197346100.594101.46
6199890-199890101.890102.78
极限1194568-19456899.178100.021.16100.19101.061.16
2195213-19521399.506100.53
3194568-19456899.178100.21
4195108-19510899.453100.49
5197672-197672100.760101.79
6200222-200222102.060103.12
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 11.101952611949761952111951561954011952010.08
2 11.081962621962271962440.02
单位质量响应值RSD%判断
17585.6817711.550.51数据可信
供试品溶液-2025011721批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1118304-11830460.17461.102.0660.1761.102.05
2120979-12097961.53461.53
3119361-11936160.71160.71
4123496-12349662.81462.81
5116750-11675059.38359.38
6121845-12184561.97561.97
10min1155372-15537279.02879.892.4979.1379.992.49
2156872-15687279.79179.89
3153966-15396678.31378.41
4164671-16467183.75883.86
5154657-15465778.66478.76
6156886-15688679.79879.90
15min1172126-17212687.54988.692.4087.7888.922.40
2172858-17285887.92288.16
3170672-17067286.81087.04
4176100-17610089.57189.82
5172347-17234787.66287.89
6182071-18207192.60892.84
20min1181151-18115192.14092.092.4392.5292.472.41
2180438-18043891.77792.16
3179947-17994791.52791.90
4185410-18541094.30694.70
5185689-18568994.44894.82
6173697-17369788.34888.74
30min1188489-18848995.87296.270.8896.4096.810.88
2188337-18833795.79596.33
3187560-18756095.40095.93
4192165-19216597.74298.29
5188979-18897996.12196.66
6190149-19014996.71797.25
45min1192891-19289198.11198.671.1498.8099.371.14
2192113-19211397.71698.41
3191830-19183097.57298.26
4196129-19612999.758100.47
5197185-197185100.295100.99
6193832-19383298.59099.29
60min1193798-19379898.57399.000.7999.4399.860.79
2193362-19336298.35199.21
3193442-19344298.39199.24
4197385-197385100.397101.28
5195220-19522099.296100.16
6194611-19461198.98699.85
极限1195322-19532299.34899.530.80100.37100.560.80
2193983-19398398.66799.69
3194376-19437698.86799.88
4198349-198349100.887101.93
5196135-19613599.761100.79
6195890-19589099.637100.67
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 11.101947381948271945671946801946171946860.06
2 11.081948521945681947100.11
单位质量响应值RSD%判断
17539.2817573.100.14数据可信
供试品溶液-2025011721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%
5min1106074-10607454.23657.323.1754.2457.323.16
2110799-11079956.65256.65
3111318-11131856.91856.92
4113613-11361358.09158.09
5115665-11566559.14059.14
6115120-11512058.86258.86
10min1140319-14031971.74673.871.6971.8473.971.69
2145386-14538674.33774.43
3144923-14492374.10074.20
4146197-14619774.75274.85
5146971-14697175.14775.25
6143061-14306173.14873.25
15min1157941-15794180.75682.361.2680.9782.581.26
2160212-16021281.91882.14
3161622-16162282.63982.86
4162663-16266383.17183.39
5163667-16366783.68483.91
6160410-16041082.01982.24
20min1168463-16846386.13687.661.1286.4888.021.12
2170579-17057987.21887.57
3171356-17135687.61687.97
4173101-17310188.50888.87
5173868-17386888.90089.26
6171321-17132187.59887.95
30min1179995-17999592.03393.560.8692.5294.060.87
2182607-18260793.36893.87
3184109-18410994.13694.64
4184236-18423694.20194.71
5183531-18353193.84194.35
6183367-18336793.75794.26
45min1187861-18786196.05597.490.8196.7098.150.82
2191450-19145097.89098.55
3191028-19102897.67498.33
4192476-19247698.41499.08
5190604-19060497.45798.13
6190588-19058897.44998.11
60min1191942-19194298.14199.030.7698.9499.850.76
2194211-19421199.301100.12
3192744-19274498.55199.37
4196145-196145100.290101.12
5193114-19311498.74199.57
6193965-19396599.176100.00
极限1194250-19425099.321100.201.02100.29101.181.02
2198106-198106101.293102.28
3195579-195579100.001100.99
4198618-198618101.555102.55
5193750-19375099.066100.06
6195461-19546199.941100.93
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 11.101961591964321956561956061958431959390.18
2 11.081950921950571950740.02
单位质量响应值RSD%判断
17652.1617605.960.19数据可信
供试品溶液-2025011721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%
5min1110586-11058656.31056.195.0956.3156.185.08
2104740-10474053.33353.33
3105397-10539753.66853.67
4107225-10722554.59854.60
5116184-11618459.16059.16
6117917-11791760.04360.04
10min1145444-14544474.05973.943.3674.1574.043.36
2139120-13912070.83970.93
3141707-14170772.15672.25
4143314-14331472.97573.07
5149875-14987576.31576.41
6151829-15182977.31077.41
15min1163317-16331783.16082.842.2983.3883.062.30
2157791-15779180.34680.55
3164085-16408583.55183.76
4158636-15863680.77780.99
5165035-16503584.03584.26
6167280-16728085.17885.41
20min1173086-17308688.13487.852.0788.4988.202.07
2167416-16741685.24785.59
3170712-17071286.92687.27
4171090-17109087.11887.47
5175662-17566289.44689.81
6177169-17716990.21390.58
30min1182782-18278293.07293.731.2793.5794.241.27
2181520-18152092.42992.91
3182637-18263792.99893.49
4183668-18366893.52394.02
5187078-18707895.25995.77
6186820-18682095.12895.65
45min1190266-19026696.88298.020.9297.5498.680.92
2192882-19288298.21498.85
3191111-19111197.31397.96
4191815-19181597.67198.32
5194181-19418198.87699.55
6194759-19475999.17099.85
60min1192703-19270398.12399.461.4398.94100.281.43
2193306-19330698.43099.23
3193703-19370398.63299.44
4195295-19529599.443100.25
5196821-196821100.220101.06
6200091-200091101.885102.73
极限1195085-19508599.336100.190.70100.32101.180.71
2196577-196577100.096101.06
3195655-19565599.626100.60
4196508-196508100.061101.04
5198460-198460101.055102.06
6198285-198285100.966101.98
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