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RSF-703-230318-D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(%)98.9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0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.541740911740901740801737271743191740610.13
211.661736841729821733330.29
单位质量响应值RSD%判断
15083.2814865.611.03数据可信
长期24月-供试品溶液-CLB01071批-阿托伐他汀-pH4.5(内含0.2%Tween80)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1104409-10440959.70764.9114.9059.7164.9114.90
2130359-13035974.54674.55
385086-8508648.65748.66
4123475-12347570.61070.61
5111879-11187963.97963.98
6125854-12585471.97071.97
10min1155339-15533988.83189.653.2389.1690.013.27
2163087-16308793.26293.68
3148204-14820484.75185.02
4159850-15985091.41191.80
5158271-15827190.50890.86
6155836-15583689.11689.52
15min1167289-16728995.66595.502.1596.4996.362.17
2163915-16391593.73694.67
3161749-16174992.49793.24
4170682-17068297.60598.51
5167784-16778495.94896.81
6170610-17061097.56498.46
20min1167341-16734195.69596.621.6997.0598.011.70
2168490-16849096.35297.80
3168044-16804496.09797.35
4169396-16939696.87098.31
5166163-16616395.02196.41
6174309-17430999.680101.12
30min1162806-16280693.10196.413.0794.9998.343.02
2167398-16739895.72797.72
3168434-16843496.32098.11
4176126-176126100.719102.70
5172984-17298498.922100.84
6163808-16380893.67495.67
45min1164783-16478394.23296.451.9896.6498.911.89
2167152-16715295.58798.11
3174805-17480599.963102.29
4168515-16851596.36698.91
5168737-16873796.49398.96
6167977-16797796.05998.57
60min1162884-16288493.14695.651.5596.0898.651.55
2167373-16737395.71398.76
3166769-16676995.36898.25
4168440-16844096.32399.40
5167309-16730995.67798.68
6170779-17077997.661100.71
极限1164332-16433293.97495.051.7897.4298.581.72
2166534-16653495.23398.82
3166303-16630395.10198.51
4165591-16559194.69498.30
5171596-17159698.128101.66
6162950-16295093.18496.77
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%
111.091860101863091865771861891862001862570.12
211.101859021855151857080.15
单位质量响应值RSD%判断
16795.0416730.450.28数据可信
长期24月-供试品溶液-CLB01071批-依折麦布-pH4.5(内含0.2%Tween80)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min154384-5438429.12631.3815.2629.1331.3815.25
273427-7342739.32539.32
347270-4727025.31625.32
460354-6035432.32332.32
561932-6193233.16933.17
654211-5421129.03329.03
10min1139504-13950474.71379.855.6374.8880.025.63
2150323-15032380.50880.73
3138415-13841574.13074.27
4152567-15256781.70981.89
5159194-15919485.25985.44
6154562-15456282.77882.94
15min1179191-17919195.96895.513.2896.5596.133.27
2171496-17149691.84792.51
3170886-17088691.52092.07
4183535-18353598.29598.93
5180758-18075896.80897.47
6184197-18419798.64999.27
20min1181967-18196797.45597.552.2198.5798.702.18
2178662-17866295.68596.86
3181778-18177897.35498.41
4184123-18412398.61099.79
5177596-17759695.11496.31
6188778-188778101.103102.27
30min1177439-17743995.03097.403.2196.6899.093.16
2177134-17713494.86796.57
3183582-18358298.32099.92
4191958-191958102.806104.53
5183632-18363298.347100.07
6177418-17741895.01996.75
45min1180400-18040096.61697.262.1998.8099.492.10
2179412-17941296.08798.32
3189167-189167101.311103.46
4181979-18197997.46299.76
5177828-17782895.23897.51
6180803-18080396.83299.09
60min1177034-17703494.81395.911.7197.5398.681.68
2176617-17661794.59097.36
3179755-17975596.27098.98
4181624-18162497.271100.11
5175941-17594194.22897.03
6183532-18353298.293101.09
极限1177380-17738094.99894.981.4798.2498.281.42
2174180-17418093.28596.58
3179263-17926396.00799.25
4179076-17907695.90799.29
5179967-17996796.38499.71
6174180-17418093.28596.63
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RSF-703-230318-D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(%)98.9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0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.541750061750281752821752381749541751020.09
211.661751091755391753240.18
单位质量响应值RSD%判断
15173.4815036.360.65数据可信
中间条件24月-供试品溶液-CLB01071批-阿托伐他汀-pH4.5(内含0.2%Tween80)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1126522-12652271.72567.227.4671.7267.227.46
2124129-12412970.36870.37
3109781-10978162.23562.23
4106251-10625160.23360.23
5118044-11804466.91966.92
6126778-12677871.87071.87
10min1154899-15489987.81288.192.1988.2188.562.20
2161927-16192791.79692.19
3154965-15496587.84988.19
4152166-15216686.26286.60
5153354-15335486.93687.31
6156083-15608388.48388.88
15min1162429-16242992.08193.531.8692.9794.401.85
2167972-16797295.22396.12
3166316-16631694.28495.12
4164529-16452993.27194.08
5160579-16057991.03291.89
6168128-16812895.31196.20
20min1164428-16442893.21495.953.7394.6197.343.66
2169061-16906195.84097.27
3170883-17088396.87398.23
4166004-16600494.10795.44
5180947-180947102.578103.94
6164242-16424293.10894.53
30min1164178-16417893.07295.422.9894.9997.342.93
2173987-17398798.633100.60
3175244-17524499.345101.24
4165259-16525993.68595.54
5164236-16423693.10595.04
6166982-16698294.66296.60
45min1161854-16185491.75594.921.8994.1997.371.86
2169422-16942296.04598.56
3170762-17076296.80499.25
4167440-16744094.92197.30
5168937-16893795.77098.22
6166221-16622194.23096.69
60min1160637-16063791.06594.162.5494.0197.142.49
2171507-17150797.227100.27
3170607-17060796.71799.70
4165829-16582994.00896.91
5163629-16362992.76195.74
6164422-16442293.21096.20
极限1164853-16485393.45593.983.0796.9097.483.01
2175150-17515099.292102.88
3167203-16720394.78798.31
4161981-16198191.82795.25
5161052-16105291.30094.79
6164490-16449093.24996.75
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%
111.091867251871391879881876331869371872840.28
211.101873111875421874260.09
单位质量响应值RSD%判断
16887.6516885.230.02数据可信
中间条件24月-供试品溶液-CLB01071批-依折麦布-pH4.5(内含0.2%Tween80)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min174412-7441239.56036.0027.4339.5636.0027.43
267376-6737635.82035.82
338473-3847320.45420.45
461324-6132432.60232.60
569029-6902936.69936.70
695672-9567250.86350.86
10min1161515-16151585.86880.179.2086.0980.379.25
2155788-15578882.82383.02
3126530-12653067.26867.38
4145407-14540777.30477.49
5150442-15044279.98180.18
6165094-16509487.77188.05
15min1178586-17858694.94394.053.6995.6494.703.76
2177965-17796594.61395.27
3167632-16763289.12089.61
4174191-17419192.60793.22
5175526-17552693.31793.96
6187542-18754299.705100.47
20min1178778-17877895.04597.555.7396.2798.725.67
2180031-18003195.71296.90
3178437-17843794.86495.85
4178716-17871695.01396.14
5204886-204886108.926110.09
6180094-18009495.74597.07
30min1178740-17874095.02596.821.6596.7898.531.64
2184186-18418697.92199.64
3183083-18308397.33498.84
4178105-17810594.68896.34
5185485-18548598.611100.38
6183089-18308997.33799.19
45min1174103-17410392.56096.053.0694.8498.303.04
2180469-18046995.94498.20
3177912-17791294.58596.64
4179484-17948495.42197.60
5190665-190665101.365103.68
6181408-18140896.44498.84
60min1173799-17379992.39894.842.0695.1997.622.03
2181046-18104696.25199.04
3178040-17804094.65397.23
4176202-17620293.67696.39
5184088-18408897.868100.75
6177170-17717094.19197.12
极限1178499-17849994.89794.552.7898.2097.862.78
2184983-18498398.344101.67
3171473-17147391.16294.26
4173207-17320792.08495.31
5180656-18065696.04499.47
6178244-17824494.76298.22
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