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%
110.991958851958481958651959141958641958750.02
210.971973521977631975580.15
单位质量响应值RSD%判断
17823.0218008.930.74数据可信
供试品溶液-2022082601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%
5min167640-6764033.89131.756.7333.8931.756.73
258535-5853529.32929.33
366372-6637233.25633.26
459359-5935929.74229.74
567540-6754033.84133.84
660763-6076330.44530.45
10min1144080-14408072.19269.893.7272.2569.953.72
2130229-13022965.25265.30
3137562-13756268.92668.98
4139368-13936869.83169.88
5143584-14358471.94372.00
6142130-14213071.21571.27
15min1170996-17099685.67883.721.8785.8583.891.87
2167967-16796784.16084.32
3161512-16151280.92681.10
4167171-16717183.76183.93
5166648-16664883.49983.68
6168249-16824984.30284.47
20min1188087-18808794.24190.452.8294.5690.762.82
2181723-18172391.05391.35
3172595-17259586.47986.78
4178593-17859389.48489.79
5182383-18238391.38391.70
6179745-17974590.06290.37
30min1192309-19230996.35794.971.9896.8395.431.98
2193388-19338896.89897.35
3183218-18321891.80292.25
4189423-18942394.91195.37
5187467-18746793.93194.40
6191455-19145595.92996.39
45min1196989-19698998.70297.982.2399.3498.602.22
2199371-19937199.895100.51
3188940-18894094.66995.27
4195529-19552997.97098.58
5192123-19212396.26496.89
6200303-200303100.362100.98
60min1198238-19823899.32898.602.04100.1399.382.03
2202479-202479101.453102.23
3190917-19091795.65996.42
4196316-19631698.36599.14
5194076-19407697.24298.03
6198698-19869899.558100.35
极限1197941-19794199.17999.691.56100.15100.631.54
2202726-202726101.576102.52
3201145-201145100.784101.70
4197954-19795499.185100.13
5193892-19389297.15098.10
6200081-200081100.251101.20
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%
110.991961271963711960941962101967361963080.14
210.971976141978761977450.10
单位质量响应值RSD%判断
17862.4218025.980.65数据可信
供试品溶液-24052101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%
5min1128219-12821964.14362.673.0364.1462.673.03
2122687-12268761.37661.38
3130152-13015265.11065.11
4127514-12751463.79063.79
5121647-12164760.85560.86
6121457-12145760.76060.76
10min1153073-15307376.57676.623.5176.6876.723.51
2149074-14907474.57674.68
3156865-15686578.47378.58
4161645-16164580.86580.97
5146967-14696773.52273.62
6151323-15132375.70175.80
15min1163267-16326781.67681.342.0581.9181.572.05
2160354-16035480.21980.45
3168586-16858684.33784.58
4163290-16329081.68881.93
5160415-16041580.24980.47
6159642-15964279.86380.09
20min1169070-16907084.57984.771.8484.9585.141.84
2167923-16792384.00584.37
3174876-17487687.48487.86
4171085-17108585.58785.96
5167513-16751383.80084.16
6166280-16628083.18383.54
30min1170199-17019985.14488.082.1185.6688.602.10
2175728-17572887.91088.41
3181526-18152690.81091.34
4177952-17795289.02289.54
5175469-17546987.78088.28
6175580-17558087.83688.34
45min1179991-17999190.04391.071.2890.7091.721.28
2180708-18070890.40191.05
3186535-18653593.31693.99
4181794-18179490.94491.61
5181915-18191591.00591.65
6181317-18131790.70691.35
60min1181953-18195391.02492.271.2291.8393.081.22
2182824-18282491.46092.26
3188442-18844294.27095.10
4184823-18482392.46093.28
5184330-18433092.21393.01
6184279-18427992.18892.98
极限1183744-18374491.92093.441.1192.8894.401.10
2185547-18554792.82293.77
3189588-18958894.84495.83
4186565-18656593.33194.31
5188388-18838894.24395.19
6186847-18684793.47294.42
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%
110.991987911990931991441986381969951985320.45
210.971970261970751970500.02
单位质量响应值RSD%判断
18064.7917962.630.41数据可信
供试品溶液-24052102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%
5min1121710-12171060.65158.613.4060.6558.613.40
2111912-11191255.76855.77
3118358-11835858.98158.98
4119755-11975559.67759.68
5120489-12048960.04360.04
6113488-11348856.55456.55
10min1144774-14477472.14470.882.1172.2570.982.11
2139136-13913669.33569.43
3142120-14212070.82270.92
4146592-14659273.05073.15
5139174-13917469.35469.45
6141598-14159870.56270.66
15min1157444-15744478.45879.946.1978.6880.166.17
2153265-15326576.37676.58
3180077-18007789.73789.95
4159899-15989979.68279.90
5154340-15434076.91177.13
6157497-15749778.48578.70
20min1164371-16437181.91081.671.4682.2682.021.45
2161007-16100780.23480.57
3162884-16288481.16981.53
4167714-16771483.57683.93
5162249-16224980.85381.20
6165076-16507682.26182.60
30min1172258-17225885.84086.391.2286.3386.881.22
2171598-17159885.51185.98
3172394-17239485.90886.41
4176361-17636187.88588.38
5171855-17185585.64086.12
6175757-17575787.58488.06
45min1179344-17934489.37290.190.9590.0090.820.95
2180023-18002389.71090.32
3180450-18045089.92390.57
4183272-18327291.32991.97
5179787-17978789.59290.21
6183032-18303291.20991.84
60min1182475-18247590.93291.661.2991.7192.441.28
2184362-18436291.87292.63
3183572-18357291.47892.27
4186041-18604192.70993.50
5180372-18037289.88490.65
6186789-18678993.08293.86
极限1185561-18556192.47093.100.4993.4094.030.48
2187912-18791293.64194.56
3186753-18675393.06494.01
4186164-18616492.77093.72
5186803-18680393.08994.01
6187756-18775693.56394.50
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%
110.991992331990551989541990511984141989410.16
210.971984721983141983930.06
单位质量响应值RSD%判断
18102.0018085.050.07数据可信
供试品溶液-24052103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%
5min1119011-11901159.04457.186.3959.0457.186.39
2103571-10357151.38451.38
3116109-11610957.60457.60
4109400-10940054.27654.28
5120605-12060559.83559.83
6122787-12278760.91760.92
10min1149040-14904073.94272.793.3274.0472.893.32
2138133-13813368.53168.62
3148780-14878073.81373.91
4143820-14382071.35271.44
5150935-15093574.88274.98
6149624-14962474.23274.33
15min1162879-16287980.80880.012.0681.0380.222.07
2155289-15528977.04277.24
3162723-16272380.73180.95
4159476-15947679.12079.33
5163985-16398581.35781.58
6163227-16322780.98181.21
20min1171244-17124484.95884.141.8685.3184.491.86
2164046-16404681.38781.72
3169538-16953884.11284.47
4168289-16828983.49283.83
5172540-17254085.60185.96
6171942-17194285.30485.66
30min1180328-18032889.46589.081.4289.9689.571.43
2175961-17596187.29887.76
3179134-17913488.87289.37
4177520-17752088.07288.55
5181655-18165590.12390.63
6182757-18275790.67091.17
45min1186279-18627992.41791.890.8993.0692.530.90
2182592-18259290.58891.20
3185510-18551092.03692.68
4184360-18436091.46592.09
5187381-18738192.96493.62
6185171-18517191.86792.52
60min1189275-18927593.90493.310.6394.7094.100.63
2186986-18698692.76893.53
3188282-18828293.41194.21
4186531-18653192.54293.32
5189403-18940393.96794.77
6188042-18804293.29294.10
极限1191862-19186295.18794.451.0396.1495.401.03
2189280-18928093.90694.82
3189568-18956894.04995.00
4187631-18763193.08894.02
5193030-19303095.76696.73
6190947-19094794.73395.70
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