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(%)99.74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%
111.111977331983601976671980971979851979680.15
211.151996221993881995050.09
单位质量响应值RSD%判断
17818.9017892.830.30数据可信
供试品溶液-24050902-2-1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%
5min1133228-13322866.97768.334.4366.9868.334.44
2124807-12480762.74462.74
3138646-13864669.70169.70
4140075-14007570.42070.42
5138399-13839969.57769.58
6140348-14034870.55770.56
10min1159823-15982380.34781.342.3980.4681.462.40
2155280-15528078.06478.17
3162723-16272381.80581.92
4166389-16638983.64883.77
5162279-16227981.58281.70
6164284-16428482.59082.71
15min1169355-16935585.13986.031.4785.3986.281.47
2167413-16741384.16384.40
3172029-17202986.48486.74
4173979-17397987.46487.72
5170614-17061485.77286.02
6173379-17337987.16287.42
20min1174549-17454987.75188.450.9088.1488.850.91
2173806-17380687.37787.75
3176759-17675988.86289.26
4177883-17788389.42789.83
5175607-17560788.28388.68
6177084-17708489.02589.43
30min1179386-17938690.18291.060.7690.7291.600.76
2181539-18153991.26591.79
3181140-18114091.06491.61
4183134-18313492.06792.62
5179854-17985490.41890.96
6181749-18174991.37091.92
45min1183794-18379492.39892.760.8093.0893.460.80
2185498-18549893.25593.93
3183849-18384992.42693.12
4186673-18667393.84694.55
5182491-18249191.74392.44
6184801-18480192.90593.61
60min1184385-18438592.69593.650.7393.5394.500.72
2187993-18799394.50995.34
3186050-18605093.53394.38
4187655-18765594.33995.20
5186067-18606793.54194.39
6185554-18555493.28394.14
极限1185497-18549793.25493.921.0094.2594.930.98
2189844-18984495.44096.43
3186763-18676393.89194.90
4187833-18783394.42995.45
5184562-18456292.78493.79
6186481-18648193.74994.76
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(%)99.74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%
111.111982861984201984031984801983801983940.04
211.151998951999071999010.01
单位质量响应值RSD%判断
17857.2517928.340.29数据可信
供试品溶液-24051001-1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%
5min1131254-13125465.84963.665.2165.8563.665.22
2130018-13001865.22965.23
3114299-11429957.34357.34
4129174-12917464.80564.81
5125017-12501762.72062.72
6131626-13162666.03566.04
10min1157266-15726678.89977.352.7879.0177.462.78
2156009-15600978.26878.38
3146198-14619873.34673.44
4156055-15605578.29178.40
5152447-15244776.48176.59
6157082-15708278.80678.92
15min1168442-16844284.50683.262.0184.7583.502.02
2165466-16546683.01383.25
3160076-16007680.30980.53
4168153-16815384.36184.60
5164802-16480282.68082.91
6168853-16885384.71284.95
20min1173957-17395787.27286.761.3287.6587.131.33
2173892-17389287.24087.62
3169054-16905484.81385.16
4174120-17412087.35487.73
5171356-17135685.96886.34
6175176-17517687.88488.27
30min1180666-18066690.63890.241.4391.1790.761.43
2180971-18097190.79191.31
3177322-17732288.96189.45
4181183-18118390.89891.42
5176199-17619988.39788.91
6182925-18292591.77292.30
45min1184961-18496192.79393.240.5493.4793.900.55
2185970-18597093.29993.97
3184721-18472192.67393.31
4186969-18696993.80094.48
5185412-18541293.01993.68
6187033-18703393.83394.51
60min1184937-18493792.78194.120.8593.6194.940.85
2189301-18930194.97095.80
3187797-18779794.21695.01
4188176-18817694.40695.24
5186627-18662793.62994.44
6188739-18873994.68895.53
极限1187724-18772494.17994.830.4995.1795.810.48
2190243-19024395.44396.43
3189532-18953295.08696.04
4189368-18936895.00495.99
5188197-18819794.41795.39
6189068-18906894.85495.85
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(%)99.74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%
111.111993881995971995001994571992831994450.06
211.151994501997891996200.13
单位质量响应值RSD%判断
17951.8517903.140.20数据可信
供试品溶液-24051601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%
5min1127379-12737963.78165.763.0963.7865.763.09
2133005-13300566.59866.60
3125086-12508662.63362.63
4133397-13339766.79466.79
5134600-13460067.39767.40
6134462-13446267.32867.33
10min1155224-15522477.72377.144.6977.8377.254.69
2158408-15840879.31879.43
3150651-15065175.43475.54
4160286-16028680.25880.37
5141069-14106970.63670.75
6158684-15868479.45679.57
15min1165590-16559082.91484.011.8383.1584.251.83
2169988-16998885.11685.36
3162681-16268181.45781.69
4170665-17066585.45585.70
5168559-16855984.40184.63
6169248-16924884.74684.99
20min1172500-17250086.37487.001.5086.7587.381.51
2175371-17537187.81188.20
3169260-16926084.75285.12
4176550-17655088.40288.79
5173770-17377087.01087.38
6175067-17506787.65988.05
30min1178324-17832489.29090.101.3989.8190.621.39
2181677-18167790.96991.50
3176477-17647788.36588.87
4183599-18359991.93192.47
5179716-17971689.98790.50
6179810-17981090.03490.57
45min1183593-18359391.92892.351.2792.6093.021.27
2185813-18581393.04093.72
3180896-18089690.57891.23
4187527-18752793.89894.59
5183293-18329391.77892.44
6185487-18548792.87793.56
60min1185082-18508292.67493.041.2793.4993.871.28
2188049-18804994.16095.00
3182775-18277591.51992.32
4188965-18896594.61895.46
5184085-18408592.17592.99
6185934-18593493.10093.94
极限1185685-18568592.97694.241.4293.9595.221.42
2191078-19107895.67696.67
3185347-18534792.80793.76
4191683-19168395.97996.98
5187390-18739093.83094.80
6188087-18808794.17995.17
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%
111.111996271997461998271998411999001997880.06
211.152036332039072037700.10
单位质量响应值RSD%判断
17982.7218275.341.15数据可信
供试品溶液-24051602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%
5min1123136-12313660.97562.813.0760.9762.813.07
2122116-12211660.47060.47
3125271-12527162.03262.03
4129878-12987864.31364.31
5131607-13160765.17065.17
6129049-12904963.90363.90
10min1150814-15081474.68175.882.2174.7875.982.21
2148997-14899773.78173.88
3151851-15185175.19475.30
4156812-15681277.65177.76
5157529-15752978.00678.11
6153363-15336375.94376.05
15min1162103-16210380.27179.396.5480.5079.626.53
2160233-16023379.34579.57
3139682-13968269.16869.40
4166949-16694982.67082.91
5167140-16714082.76583.00
6165795-16579582.09982.33
20min1168394-16839483.38684.401.4083.7584.771.40
2167600-16760082.99383.35
3169289-16928983.82984.17
4172691-17269185.51485.89
5173423-17342385.87686.25
6171281-17128184.81585.19
30min1174559-17455986.43986.303.8286.9486.803.80
2175199-17519986.75687.25
3176187-17618787.24587.73
4161363-16136379.90480.42
5180108-18010889.18689.71
6178262-17826288.27288.78
45min1181712-18171289.98190.490.6990.6291.130.70
2181777-18177790.01390.65
3181842-18184290.04590.67
4183668-18366890.94991.60
5184773-18477391.49692.16
6182629-18262990.43591.09
60min1183995-18399591.11191.790.6091.9092.590.60
2184485-18448591.35492.14
3185527-18552791.87092.65
4186194-18619492.20093.00
5186963-18696392.58193.40
6185088-18508891.65292.46
极限1188289-18828993.23792.960.3394.1893.920.34
2186824-18682492.51293.45
3187163-18716392.68093.61
4187949-18794993.06994.02
5187935-18793593.06294.04
6188261-18826193.22494.19
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