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(%)99.99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%
111.191936441937441935511933591934471935490.08
211.131936321934681935500.06
单位质量响应值RSD%判断
17296.6017389.940.39数据可信
稳定性考察-长期18月-供试品溶液-S0388207DD批-pH4.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min151689-5168926.82123.1415.2626.8223.1415.27
251374-5137426.65726.66
340627-4062721.08121.08
447816-4781624.81124.81
541384-4138421.47421.47
634658-3465817.98417.98
10min1122115-12211563.36458.309.5063.4158.349.50
2119767-11976762.14562.19
3101467-10146752.65052.68
4123623-12362364.14664.19
5106684-10668455.35755.39
6100493-10049352.14452.17
15min1155106-15510680.48280.822.1480.6380.962.14
2156886-15688681.40681.55
3149445-14944577.54577.67
4158934-15893482.46882.62
5156897-15689781.41281.54
6157273-15727381.60781.72
20min1165884-16588486.07586.801.7986.3687.071.78
2168281-16828187.31987.60
3161934-16193484.02584.28
4168967-16896787.67487.96
5168401-16840187.38187.64
6170237-17023788.33388.59
30min1176572-17657291.62192.351.3592.0592.771.35
2177884-17788492.30192.73
3174070-17407090.32290.71
4179147-17914792.95793.39
5179400-17940093.08893.50
6180814-18081493.82294.22
45min1184802-18480295.89196.390.9696.4796.960.96
2186926-18692696.99397.58
3182687-18268794.79495.34
4185891-18589196.45697.04
5187311-18731197.19397.76
6186978-18697897.02097.58
60min1188228-18822897.66998.180.8898.4198.910.89
2191424-19142499.327100.07
3186692-18669296.87297.57
4188851-18885197.99298.74
5189888-18988898.53099.26
6190218-19021898.70199.42
极限1189514-18951498.33698.781.0599.2499.681.05
2192363-19236399.814100.72
3186816-18681696.93697.80
4190654-19065498.92899.84
5191646-19164699.442100.33
6191265-19126599.245100.13
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(%)99.99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%
111.191939441943191938861938821941171940300.10
211.131947291949591948440.09
单位质量响应值RSD%判断
17339.5917506.200.68数据可信
稳定性考察-长期18月-供试品溶液-S0388207DD批-pH4.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min121046-2104610.87117.4945.9310.8717.4945.95
250812-5081226.24626.25
349224-4922425.42525.43
442267-4226721.83221.83
525409-2540913.12413.12
614387-143877.4317.43
10min1100556-10055651.93951.8416.2151.9651.8616.22
2119665-11966561.81061.85
3100597-10059751.96152.00
4114290-11429059.03359.07
593215-9321548.14848.17
673819-7381938.12938.14
15min1149182-14918277.05677.733.9677.1677.843.99
2157713-15771381.46281.61
3150100-15010077.53077.66
4156395-15639580.78180.92
5148061-14806176.47776.58
6141419-14141973.04673.12
20min1162626-16262684.00085.071.9484.2385.321.97
2168319-16831986.94087.22
3164179-16417984.80285.06
4168715-16871587.14587.41
5163689-16368984.54984.78
6160683-16068382.99683.19
30min1175423-17542390.61091.321.0890.9891.711.11
2179001-17900192.45892.89
3175717-17571790.76291.16
4178835-17883592.37292.79
5177410-17741091.63692.01
6174450-17445090.10790.44
45min1184179-18417995.13295.430.8095.6695.970.82
2186114-18611496.13296.71
3184810-18481095.45896.01
4185879-18587996.01196.58
5185404-18540495.76596.29
6182147-18214794.08394.57
60min1188117-18811797.16797.640.5397.8598.340.56
2190095-19009598.18898.93
3188965-18896597.60598.31
4189630-18963097.94898.68
5189783-18978398.02798.71
6187609-18760996.90497.55
极限1190614-19061498.45698.640.5999.3099.500.60
2192474-19247499.417100.32
3190620-19062098.45999.33
4190292-19029298.29099.18
5192198-19219899.274100.12
6189649-18964997.95898.76
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(%)99.99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%
111.191940241941101936771940751941231940020.10
211.131941751942371942060.03
单位质量响应值RSD%判断
17337.0917448.880.46数据可信
稳定性考察-中间条件18月-供试品溶液-S0388207DD批-pH4.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min156786-5678629.38127.188.7029.3827.188.70
248269-4826924.97524.97
349672-4967225.70025.70
450430-5043026.09326.09
559653-5965330.86530.86
650346-5034626.04926.05
10min1132668-13266868.64361.359.0868.6961.409.08
2110396-11039657.11957.16
3105316-10531654.49154.53
4112470-11247058.19258.24
5127528-12752865.98366.03
6123080-12308063.68263.73
15min1156656-15665681.05479.901.7581.2280.041.75
2153203-15320379.26879.40
3151541-15154178.40878.54
4151783-15178378.53378.67
5155237-15523780.32080.48
6158124-15812481.81481.96
20min1166454-16645486.12486.051.2186.4286.331.22
2165563-16556385.66385.93
3164051-16405184.88185.14
4165060-16506085.40385.67
5166867-16686786.33886.63
6169866-16986687.88988.18
30min1178479-17847992.34692.500.7692.7992.920.76
2179464-17946492.85593.27
3177043-17704391.60392.01
4177964-17796492.07992.49
5178696-17869692.45892.90
6180977-18097793.63894.07
45min1185698-18569896.08196.630.8496.6897.210.83
2188355-18835597.45698.02
3185362-18536295.90796.47
4186860-18686096.68297.25
5185382-18538295.91796.51
6188920-18892097.74898.34
60min1188677-18867797.62298.450.8798.3899.190.87
2189943-18994398.27799.01
3189629-18962998.11598.83
4190484-19048498.55799.29
5189486-18948698.04198.79
6193422-193422100.077100.83
极限1191503-19150399.08499.540.63100.00100.440.62
2193833-193833100.290101.18
3191422-19142299.04299.92
4192163-19216399.426100.32
5191462-19146299.06399.98
6193948-193948100.349101.27
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(%)99.99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%
111.191944031945571945211944771942201944360.07
211.131941271941601941440.02
单位质量响应值RSD%判断
17375.8717443.310.28数据可信
稳定性考察-中间条件18月-供试品溶液-S0388207DD批-pH4.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min160742-6074231.39823.6431.5131.4023.6431.52
254533-5453328.18828.19
345631-4563123.58723.59
453141-5314127.46927.47
540166-4016620.76220.76
620241-2024110.46310.46
10min1120612-12061262.34562.0611.3962.4062.1011.40
2124769-12476964.49464.54
3131486-13148667.96668.01
4131086-13108667.75967.81
5117886-11788660.93660.97
694467-9446748.83148.85
15min1156204-15620480.74380.432.9680.9080.572.98
2158292-15829281.82281.98
3159476-15947682.43482.59
4158277-15827781.81481.97
5154306-15430679.76279.90
6146985-14698575.97876.08
20min1167992-16799286.83686.221.9987.1386.492.02
2168915-16891587.31387.60
3169258-16925887.49187.78
4169023-16902387.36987.66
5164483-16448385.02285.29
6161090-16109083.26983.49
30min1180347-18034793.22392.771.1593.6693.191.17
2181425-18142593.78094.22
3181059-18105993.59194.03
4180157-18015793.12493.57
5177306-17730691.65192.06
6176509-17650991.23991.60
45min1188674-18867497.52797.050.8898.1297.620.91
2189517-18951797.96398.56
3188788-18878897.58698.18
4188076-18807697.21897.81
5185528-18552895.90196.46
6185870-18587096.07796.59
60min1192475-19247599.49298.901.07100.2599.631.07
2193204-19320499.868100.62
3192470-19247099.489100.24
4191261-19126198.86499.62
5187538-18753896.94097.66
6191011-19101198.73599.41
极限1194259-194259100.41499.880.95101.33100.780.96
2195391-195391100.999101.92
3193661-193661100.105101.02
4192801-19280199.660100.58
5189966-18996698.19599.08
6193310-19331099.923100.76
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