依折麦布阿托伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.231728871707521729201714091702381716410.72
210.161740531727221733880.55
单位质量响应值RSD%判断
16778.2017065.751.21数据可信
供试品溶液-2023121221批-依折麦布-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min126349-2634913.98018.5227.4213.9818.5227.43
249053-4905326.02626.03
344990-4499023.87023.87
430655-3065516.26416.26
528743-2874315.25015.25
629702-2970215.75915.76
10min1109158-10915857.91561.518.6557.9961.628.67
2132080-13208070.07770.22
3121156-12115664.28164.41
4105054-10505455.73855.83
5118753-11875363.00663.09
6109442-10944258.06658.15
15min1155461-15546182.48283.434.7682.8883.874.75
2160722-16072285.27385.81
3157811-15781183.72884.22
4144483-14448376.65777.06
5157690-15769083.66484.10
6167270-16727088.74789.16
20min1169316-16931689.83390.802.9890.6991.712.98
2170262-17026290.33491.34
3172394-17239491.46692.42
4163146-16314686.55987.38
5178604-17860494.76095.66
6173163-17316391.87492.78
30min1176268-17626893.52193.461.9194.8894.881.89
2172984-17298491.77993.29
3175902-17590293.32794.79
4172641-17264191.59792.90
5181868-18186896.49297.92
6177305-17730594.07195.48
45min1178707-17870794.81594.932.3896.6996.862.32
2172247-17224791.38893.41
3178752-17875294.83996.82
4178491-17849194.70096.52
5185640-18564098.493100.46
6179653-17965395.31797.25
60min1178236-17823694.56594.811.8696.9797.271.81
2173579-17357992.09494.62
3181935-18193596.52899.04
4179717-17971795.35197.69
5182223-18222396.68199.19
6176541-17654193.66696.13
极限1178173-17817394.53294.422.0097.4697.411.96
2173331-17333191.96395.00
3178142-17814294.51597.56
4177476-17747694.16297.03
5184222-18422297.741100.79
6176460-17646093.62396.61
依折麦布阿托伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.732987322974782988642975992949142975170.54
210.713015142996853006000.44
单位质量响应值RSD%判断
27727.5928067.230.87数据可信
供试品溶液-2023121221批-阿托伐他汀-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1189434-18943456.09162.8313.3056.0962.8313.30
2266088-26608878.78878.79
3189685-18968556.16556.16
4212192-21219262.82962.83
5205313-20531360.79260.79
6210541-21054162.34062.34
10min1303323-30332389.81389.332.2490.1289.682.27
2314027-31402792.98293.42
3296982-29698287.93588.25
4299472-29947288.67289.02
5301422-30142289.25089.59
6294970-29497087.33987.69
15min1317983-31798394.15393.742.1994.9694.582.18
2319921-31992194.72795.68
3315713-31571393.48194.28
4313604-31360492.85793.70
5305766-30576690.53691.37
6326537-32653796.68697.52
20min1320256-32025694.82695.800.5596.1697.170.57
2324750-32475096.15797.64
3323101-32310195.66996.99
4323932-32393295.91597.27
5325016-32501696.23697.57
6324296-32429696.02397.39
30min1319464-31946494.59294.800.4496.4596.700.43
2319376-31937694.56696.58
3319610-31961094.63596.49
4319707-31970794.66496.55
5319860-31986094.70996.58
6322970-32297095.63097.53
45min1320294-32029494.83895.361.0197.2297.780.95
2317215-31721593.92696.47
3320704-32070494.95997.34
4323285-32328595.72398.14
5325666-32566696.42898.83
6325131-32513196.27098.70
60min1319703-31970394.66395.201.0197.5898.160.95
2318684-31868494.36197.42
3327352-32735296.92899.83
4323200-32320095.69898.65
5319856-31985694.70897.64
6320366-32036694.85997.83
极限1316698-31669893.77394.651.0397.2198.140.98
2316404-31640493.68697.27
3319860-31986094.70998.15
4318636-31863694.34797.83
5325259-32525996.30899.77
6321143-32114395.08998.58
依折麦布阿托伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.231765021766161766661767571768471766780.08
210.161779071780731779900.07
单位质量响应值RSD%判断
17270.5817518.701.01数据可信
供试品溶液-2023121421批-依折麦布-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min134455-3445517.78319.4529.8917.7819.4529.90
232244-3224416.64216.64
329401-2940115.17515.17
450430-5043026.02926.03
553120-5312027.41727.42
626506-2650613.68113.68
10min1111401-11140157.49860.639.2857.6060.739.31
2119672-11967261.76761.86
3113818-11381858.74558.83
4117351-11735160.56960.71
5137232-13723270.83070.98
6105290-10529054.34454.42
15min1145659-14565975.17978.635.9275.6079.085.96
2153885-15388579.42579.86
3147402-14740276.07976.49
4156446-15644680.74781.23
5167586-16758686.49787.04
6143122-14312273.87074.25
20min1160848-16084883.01986.663.7083.8587.543.75
2170387-17038787.94288.82
3167100-16710086.24687.08
4169850-16985087.66588.59
5177545-17754591.63792.66
6161654-16165483.43584.22
30min1171114-17111488.31891.692.5089.6193.062.56
2179113-17911392.44693.81
3176274-17627490.98192.29
4178215-17821591.98393.40
5184732-18473295.34696.88
6176481-17648191.08892.34
45min1177201-17720191.45993.211.1493.2595.081.20
2182581-18258194.23696.12
3179623-17962392.70994.53
4182033-18203393.95395.88
5182099-18209993.98796.05
6179975-17997592.89194.65
60min1177111-17711191.41392.341.4193.7194.731.44
2179439-17943992.61495.02
3175593-17559390.62992.96
4182914-18291494.40896.86
5179788-17978892.79595.38
6178606-17860692.18594.46
极限1174557-17455790.09591.621.4592.9094.521.43
2178242-17824291.99794.91
3174710-17471090.17493.01
4180223-18022393.01995.99
5176961-17696191.33694.44
6180335-18033593.07795.86
依折麦布阿托伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.732987762986142993382986442992202989180.12
210.713029753024223026980.13
单位质量响应值RSD%判断
27858.1528263.121.03数据可信
供试品溶液-2023121421批-阿托伐他汀-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1187947-18794755.32762.0917.9855.3362.0917.98
2187469-18746955.18755.19
3174187-17418751.27751.28
4254447-25444774.90474.90
5263023-26302377.42877.43
6198482-19848258.42958.43
10min1288422-28842284.90588.962.5485.2189.302.57
2303107-30310789.22889.53
3301345-30134588.70988.99
4304025-30402589.49889.91
5311883-31188391.81192.24
6304319-30431989.58589.91
15min1313086-31308692.16693.400.9792.9494.241.03
2316810-31681093.26294.06
3315181-31518192.78293.56
4319884-31988494.16795.08
5321455-32145594.62995.57
6317212-31721293.38094.20
20min1314214-31421492.49894.331.4393.7995.691.42
2317884-31788493.57894.90
3327142-32714296.30397.60
4318544-31854493.77295.21
5323562-32356295.25096.72
6321257-32125794.57195.91
30min1311851-31185191.80294.541.6593.6196.421.66
2320280-32028094.28396.12
3324178-32417895.43197.26
4319845-31984594.15596.11
5326884-32688496.22798.22
6323956-32395695.36597.23
45min1316547-31654793.18494.590.9695.5097.000.95
2322161-32216194.83797.20
3323963-32396395.36897.73
4323508-32350895.23497.71
5318440-31844093.74296.27
6323314-32331495.17697.57
60min1317145-31714593.36093.520.8696.1996.450.87
2317109-31710993.35096.24
3315955-31595593.01095.90
4323089-32308995.11098.12
5315750-31575092.95096.00
6317063-31706393.33696.26
极限1308990-30899090.96092.581.4594.3196.041.42
2314586-31458692.60796.02
3314198-31419892.49395.90
4318237-31823793.68297.22
5310160-31016091.30494.87
6320835-32083594.44797.89
依折麦布阿托伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.231762751772661764801768051766891767030.22
210.161763611775681769640.49
单位质量响应值RSD%判断
17273.0217417.720.59数据可信
供试品溶液-2023121621批-依折麦布-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min141038-4103821.24123.4816.5721.2423.4816.56
240395-4039520.90820.91
337475-3747519.39619.40
449746-4974625.74825.75
557911-5791129.97429.97
645653-4565323.62923.63
10min1114430-11443059.22762.376.5459.3462.506.55
2115735-11573559.90260.02
3119617-11961761.91262.02
4115330-11533059.69359.84
5135293-13529370.02570.19
6122576-12257663.44363.57
15min1156063-15606380.77579.983.6181.2280.463.62
2154628-15462880.03380.48
3153199-15319979.29379.74
4144787-14478774.93975.41
5161676-16167683.68184.24
6156795-15679581.15481.64
20min1169046-16904687.49586.971.7788.3987.891.78
2169688-16968887.82888.72
3166292-16629286.07086.96
4162850-16285084.28885.18
5170923-17092388.46789.49
6169370-16937087.66388.60
30min1174205-17420590.16590.290.8291.5591.700.86
2175697-17569790.93892.32
3172705-17270589.38990.76
4172998-17299889.54190.90
5176266-17626691.23292.74
6174810-17481090.47991.90
45min1177190-17719091.71092.210.8493.5994.120.83
2180512-18051293.43095.32
3177435-17743591.83793.70
4176923-17692391.57293.43
5177330-17733091.78393.80
6179560-17956092.93794.86
60min1177622-17762291.93492.050.4694.3394.470.41
2178756-17875692.52194.93
3177889-17788992.07294.45
4178853-17885392.57194.94
5176958-17695891.59094.12
6177042-17704291.63494.07
极限1178578-17857892.42991.150.7095.3394.080.66
2175943-17594391.06593.98
3175778-17577890.98093.87
4175615-17561590.89593.77
5175285-17528590.72493.76
6175478-17547890.82493.77
依折麦布阿托伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.733052353055413052563051963039973050450.20
210.713049323063803056560.34
单位质量响应值RSD%判断
28429.1728539.310.28数据可信
供试品溶液-2023121621批-阿托伐他汀-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1211272-21127261.26660.0313.1661.2760.0313.16
2221463-22146364.22164.22
3183789-18378953.29653.30
4174214-17421450.52050.52
5249860-24986072.45672.46
6201404-20140458.40458.40
10min1299253-29925386.77986.402.2487.1286.732.27
2305613-30561388.62488.98
3290217-29021784.15984.45
4289527-28952783.95984.24
5299955-29995586.98387.39
6303055-30305587.88288.21
15min1316113-31611391.66891.131.9892.4991.941.98
2320201-32020192.85493.70
3307355-30735589.12989.89
4309535-30953589.76190.51
5309981-30998189.89090.78
6322387-32238793.48894.30
20min1320503-32050392.94192.551.2294.2793.871.23
2324849-32484994.20295.57
3314531-31453191.21092.47
4317249-31724991.99893.24
5316097-31609791.66493.05
6321629-32162993.26894.60
30min1317874-31787492.17992.050.7894.0393.890.79
2321104-32110493.11695.00
3315579-31557991.51493.28
4316261-31626191.71193.47
5314519-31451991.20693.10
6319324-31932492.60094.45
45min1320038-32003892.80792.631.3195.1794.981.29
2324886-32488694.21296.62
3318635-31863592.40094.67
4317593-31759392.09894.36
5312907-31290790.73993.14
6322563-32256393.53995.90
60min1317938-31793892.19892.090.8195.0794.950.78
2319104-31910492.53695.46
3318481-31848192.35595.14
4317492-31749292.06894.85
5312610-31261090.65393.56
6319826-31982692.74595.63
极限1320645-32064592.98391.231.2696.3794.601.21
2314829-31482991.29694.74
3314456-31445691.18894.49
4314200-31420091.11494.40
5308233-30823389.38392.79
6315224-31522491.41194.81
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