盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSZJ-4057-240226对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.992127632126012118782126842123072124470.18
216.002125422124992125200.02
单位质量响应值RSD%判断
13286.2413282.500.02数据可信
供试品溶液-2024042521批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min14397-43972.21810.1858.002.2210.1857.99
239904-3990420.12720.13
323687-2368711.94711.95
417240-172408.6968.70
520660-2066010.42110.42
615162-151627.6487.65
10min1104536-10453652.72752.8912.6052.7452.9512.63
2123927-12392762.50862.62
3115246-11524658.12958.20
499662-9966250.26850.32
586246-8624643.50243.56
699595-9959550.23550.28
15min1132652-13265266.90865.516.6867.2165.866.71
2139601-13960170.41370.87
3134772-13477267.97868.37
4126032-12603263.56963.90
5114650-11465057.82858.13
6131608-13160866.38266.70
20min1148172-14817274.73672.365.3575.4173.075.38
2149992-14999275.65476.50
3145649-14564973.46474.23
4140354-14035470.79371.47
5129304-12930465.22065.84
6147263-14726374.27874.97
30min1149423-14942375.36774.164.8276.4675.284.85
2153775-15377577.56378.83
3150731-15073176.02777.20
4139136-13913670.17971.25
5137125-13712569.16470.15
6152025-15202576.68077.78
45min1156018-15601878.69475.135.2680.2076.665.25
2154815-15481578.08779.79
3146265-14626573.77575.37
4143056-14305672.15673.62
5137546-13754669.37770.74
6155997-15599778.68380.21
60min1153255-15325577.30076.343.9279.2578.283.97
2155366-15536678.36580.50
3154690-15469078.02480.03
4146089-14608973.68675.55
5141941-14194171.59473.35
6156707-15670779.04181.01
极限1163004-16300482.21880.894.4184.6083.264.44
2165886-16588683.67186.24
3163291-16329182.36284.80
4153610-15361077.47979.75
5149605-14960575.45977.61
6166823-16682384.14486.55
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSZJ-4057-240226对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.992109852109792107672109052106862108640.07
216.002106452107442106940.04
单位质量响应值RSD%判断
13187.2413168.380.11数据可信
供试品溶液-2024042521批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min144231-4423122.49012.9743.2122.4912.9743.20
230335-3033515.42415.42
315883-158838.0768.08
416538-165388.4098.41
518137-181379.2229.22
627891-2789114.18214.18
10min1111227-11122756.55554.788.9756.6854.858.97
298798-9879850.23650.32
393768-9376847.67847.72
4113145-11314557.53157.58
5109609-10960955.73355.78
6119819-11981960.92461.00
15min1136381-13638169.34568.145.8869.7868.525.90
2126853-12685364.50164.87
3122672-12267262.37562.68
4138164-13816470.25270.62
5135844-13584469.07269.43
6144203-14420373.32373.74
20min1148855-14885575.68874.664.2076.5175.424.22
2138638-13863870.49371.22
3140344-14034471.36172.02
4149311-14931175.92076.68
5148960-14896075.74276.49
6154913-15491378.76879.59
30min1151964-15196477.26976.054.7978.5177.224.81
2143325-14332572.87673.99
3138873-13887370.61371.67
4153876-15387678.24179.42
5151075-15107576.81777.98
6158285-15828580.48381.75
45min1151206-15120676.88476.653.4078.5678.243.45
2145450-14545073.95775.48
3143899-14389973.16874.61
4154470-15447078.54380.16
5152375-15237577.47879.07
6157028-15702879.84481.55
60min1163584-16358483.17778.444.4685.2880.464.47
2147907-14790775.20677.14
3145626-14562674.04675.90
4156004-15600479.32381.37
5152824-15282477.70679.73
6159623-15962381.16383.32
极限1157968-15796880.32281.205.2382.8983.665.21
2154065-15406578.33780.69
3148282-14828275.39777.66
4163840-16384083.30885.80
5161618-16161882.17884.63
6172436-17243687.67890.28
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSZJ-4057-240226对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.992118482120922123402123472123192121890.11
216.002113192116612114900.12
单位质量响应值RSD%判断
13270.1113218.120.28数据可信
供试品溶液-2024042621批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min150142-5014225.36819.7222.8825.3719.7222.88
229305-2930514.82614.83
331092-3109215.73015.73
439735-3973520.10320.10
548892-4889224.73624.74
634717-3471717.56417.56
10min1126365-12636563.93159.519.1664.0759.629.15
2117691-11769159.54359.63
3128801-12880165.16465.25
4100468-10046850.82950.94
5122574-12257462.01362.15
6109875-10987555.58855.69
15min1146210-14621073.97172.105.3074.4772.545.30
2144362-14436273.03673.45
3150279-15027976.03076.48
4128379-12837964.95065.34
5144759-14475973.23773.72
6141050-14105071.36171.77
20min1154644-15464478.23876.654.5579.1577.494.56
2152534-15253477.17177.99
3161260-16126081.58582.46
4140233-14023370.94771.70
5150366-15036676.07476.96
6149962-14996275.86976.67
30min1152151-15215176.97778.193.7078.3279.463.70
2156702-15670279.27980.53
3160402-16040281.15182.48
4144252-14425272.98174.13
5155966-15596678.90780.22
6157789-15778979.82981.05
45min1159715-15971580.80480.223.4582.5781.923.45
2159535-15953580.71382.40
3162837-16283782.38384.16
4148149-14814974.95276.51
5158141-15814180.00781.76
6163030-16303082.48184.15
60min1161769-16176981.84380.832.6984.0682.972.72
2162677-16267782.30284.44
3161444-16144481.67983.91
4151245-15124576.51978.49
5161769-16176981.84384.04
6159654-15965480.77382.90
极限1168712-16871285.35683.832.2988.0386.432.34
2167460-16746084.72287.32
3166872-16687284.42587.11
4158160-15816080.01782.41
5166762-16676284.36987.02
6166245-16624584.10786.68
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSZJ-4057-240226对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.992119122124492125222126572126622124400.15
216.002118732117352118040.05
单位质量响应值RSD%判断
13285.8013237.750.26数据可信
供试品溶液-2024042621批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min155207-5520727.89322.1719.8727.8922.1719.86
244586-4458622.52722.53
347352-4735223.92523.92
428435-2843514.36714.37
544438-4443822.45222.45
643265-4326521.86021.86
10min1124768-12476863.03961.513.4863.1961.643.48
2115526-11552658.37058.49
3119475-11947560.36560.50
4119999-11999960.63060.71
5123437-12343762.36762.49
6127284-12728464.31064.43
15min1146116-14611673.82573.072.4974.3373.542.47
2139431-13943170.44870.90
3142049-14204971.77072.24
4148522-14852275.04175.46
5143530-14353072.51972.99
6148118-14811874.83775.32
20min1153455-15345577.53377.993.0078.4578.862.97
2146160-14616073.84774.69
3153696-15369677.65578.52
4159014-15901480.34281.18
5155597-15559778.61579.49
6158215-15821579.93880.83
30min1155987-15598778.81380.132.7280.1681.442.69
2152393-15239376.99778.25
3161053-16105381.37282.67
4163719-16371982.71984.00
5156513-15651379.07880.39
6161933-16193381.81783.16
45min1160583-16058381.13581.152.2282.9282.902.19
2155171-15517178.40080.08
3160821-16082181.25583.01
4166172-16617283.95985.70
5161588-16158881.64283.39
6159311-15931180.49282.29
60min1156966-15696679.30781.032.8381.5483.222.77
2154558-15455878.09180.20
3164254-16425482.98985.19
4166742-16674284.24786.45
5160514-16051481.10083.30
6159192-15919280.43282.67
极限1163163-16316382.43883.391.7385.1186.041.71
2161783-16178381.74184.29
3163957-16395782.83985.50
4169538-16953885.65988.33
5164640-16464083.18485.84
6167197-16719784.47687.16
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