依折麦布瑞舒伐他汀钙片项目信息
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%
111.311705521716831700211700931712331707160.43
211.361727711726951727330.04
单位质量响应值RSD%判断
15094.2515205.370.52数据可信
供试品溶液-23112302批-瑞舒伐他汀钙-pH2.0(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%
5min1104662-10466259.15667.109.4359.1667.109.43
2127458-12745872.04172.04
3126213-12621371.33771.34
4111948-11194863.27563.27
5131961-13196174.58674.59
6110082-11008262.22062.22
10min1146441-14644182.77089.143.9783.1089.523.99
2161281-16128191.15891.56
3161531-16153191.29991.70
4155642-15564287.97188.32
5163765-16376592.56292.98
6157626-15762689.09289.44
15min1168376-16837695.16896.221.8495.9697.081.86
2170796-17079696.53697.44
3169975-16997596.07296.98
4172014-17201497.22598.06
5174674-17467498.72899.66
6165551-16555193.57294.41
20min1174815-17481598.80898.541.34100.1299.941.36
2173838-17383898.25699.70
3176482-17648299.750101.19
4172813-17281397.67699.06
5177167-177167100.137101.61
6170914-17091496.60397.96
30min1177599-177599100.381100.051.80102.25102.001.80
2174422-17442298.586100.57
3176208-17620899.595101.59
4176457-17645799.736101.66
5182981-182981103.423105.46
6174361-17436198.551100.45
45min1175118-17511898.97998.502.19101.40101.002.16
2169057-16905795.55398.09
3174209-17420998.465101.01
4174004-17400498.349100.83
5180691-180691102.129104.74
6172506-17250697.50399.95
60min1172800-17280097.66997.972.33100.64101.022.28
2180106-180106101.798104.87
3172853-17285397.699100.79
4173894-17389498.287101.31
5172846-17284697.695100.87
6167475-16747594.65997.65
极限1173098-17309897.83797.351.62101.35100.951.60
2168846-16884695.43499.07
3171171-17117196.748100.38
4172185-17218597.321100.89
5177132-177132100.117103.84
6171010-17101096.657100.17
依折麦布瑞舒伐他汀钙片项目信息
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%
111.081892101893111899541881281895901892390.37
211.171931211929441930320.07
单位质量响应值RSD%判断
17079.3317281.290.84数据可信
供试品溶液-23112302批-依折麦布-pH2.0(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%
5min1113825-11382559.48157.5818.4459.4857.5818.45
2121759-12175963.62763.63
3124173-12417364.88864.89
4102554-10255453.59153.59
5126157-12615765.92565.93
672666-7266637.97337.97
10min1171528-17152889.63486.305.6089.9686.625.65
2171726-17172689.73890.09
3169338-16933888.49088.85
4162620-16262084.97985.28
5168198-16819887.89488.26
6147530-14753077.09477.30
15min1182931-18293195.59393.583.5296.4294.383.56
2182461-18246195.34896.20
3176422-17642292.19293.04
4182096-18209695.15795.93
5183260-18326095.76596.62
6167335-16733587.44388.08
20min1188095-18809598.29295.612.6599.6596.922.70
2183386-18338695.83197.21
3183840-18384096.06897.43
4185336-18533696.85098.15
5183302-18330295.78797.17
6173793-17379390.81891.94
30min1184242-18424296.27897.241.5598.1899.091.60
2187794-18779498.134100.05
3186111-18611197.25599.15
4185205-18520596.78198.62
5190699-19069999.652101.57
6182489-18248995.36296.99
45min1185176-18517696.76696.881.6899.2199.271.69
2181416-18141694.80197.26
3186324-18632497.36699.80
4185618-18561896.99799.37
5190572-19057299.586102.06
6183273-18327395.77297.93
60min1185650-18565097.01496.862.7299.9999.792.70
2194334-194334101.552104.54
3184487-18448796.40699.39
4185649-18564997.01399.93
5182753-18275395.50098.53
6179205-17920593.64696.34
极限1186463-18646397.43996.681.06100.96100.141.09
2183215-18321595.74299.29
3183666-18366695.97799.49
4185046-18504696.698100.15
5188147-18814798.319101.87
6183512-18351295.89799.11
依折麦布瑞舒伐他汀钙片项目信息
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%
111.311708761712181726491715381711481714860.41
211.361701061696891698980.18
单位质量响应值RSD%判断
15162.3314955.810.97数据可信
供试品溶液-23112302批-瑞舒伐他汀钙-pH6.6(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%
5min1174265-17426599.09494.095.4999.0994.095.49
2162089-16208992.17092.17
3149877-14987785.22685.23
4170961-17096197.21597.21
5163405-16340592.91892.92
6172230-17223097.93797.94
10min1174519-17451999.23899.872.8699.79100.392.83
2168031-16803195.54996.06
3183552-183552104.375104.85
4175143-17514399.593100.13
5177430-177430100.893101.41
6175098-17509899.567100.11
15min1173595-17359598.71399.611.2399.81100.681.23
2172366-17236698.01499.06
3176031-176031100.098101.15
4174149-17414999.028100.12
5176869-176869100.574101.65
6178016-178016101.227102.32
20min1174427-17442799.18699.791.98100.84101.421.97
2169821-16982196.56798.15
3178719-178719101.626103.24
4174567-17456799.265100.91
5179432-179432102.032103.67
6176003-176003100.082101.74
30min1175594-17559499.84999.532.03102.05101.722.01
2168530-16853095.83397.96
3176704-176704100.481102.65
4173798-17379898.828101.02
5177297-177297100.818103.02
6178287-178287101.381103.60
45min1173012-17301298.38199.210.91101.14101.950.92
2172368-17236898.015100.67
3174374-17437499.156101.89
4174947-17494799.482102.23
5176657-176657100.454103.22
6175466-17546699.777102.56
60min1168518-16851895.82696.891.5599.13100.181.52
2167183-16718395.06798.27
3173332-17333298.563101.85
4173135-17313598.451101.75
5168595-16859595.87099.19
6171593-17159397.574100.91
极限1173875-17387598.87298.263.19102.71102.093.12
2162467-16246792.38596.11
3176504-176504100.367104.20
4171809-17180997.697101.54
5178002-178002101.219105.07
6174174-17417499.042102.92
依折麦布瑞舒伐他汀钙片项目信息
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%
111.081889811892921895291891881899761893930.21
211.171895881898501897190.10
单位质量响应值RSD%判断
17093.2316984.690.46数据可信
供试品溶液-23112302批-依折麦布-pH6.6(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%
5min1102700-10270054.11147.5420.0554.1147.5420.05
282604-8260443.52343.52
374377-7437739.18839.19
4115985-11598561.11161.11
568746-6874636.22136.22
696965-9696551.09051.09
10min1164713-16471386.78583.535.8387.0983.805.87
2148186-14818678.07778.32
3159027-15902783.78984.01
4170046-17004689.59589.93
5146929-14692977.41577.62
6162312-16231285.52085.80
15min1177366-17736693.45292.721.8494.2393.451.89
2173379-17337991.35192.03
3176659-17665993.07993.76
4177521-17752193.53394.37
5171026-17102690.11190.74
6179968-17996894.82395.58
20min1180390-18039095.04595.451.5096.3596.701.47
2176573-17657393.03494.22
3184375-18437597.14598.34
4180478-18047895.09196.45
5182465-18246596.13897.27
6182726-18272696.27697.56
30min1182150-18215095.97295.901.6597.8097.681.64
2176819-17681993.16394.86
3183351-18335196.60598.35
4180979-18097995.35597.24
5183070-18307096.45798.12
6185740-18574097.86499.68
45min1181252-18125295.49996.230.5597.8698.540.57
2182507-18250796.16098.38
3181915-18191595.84898.13
4183430-18343096.64799.06
5182716-18271696.27198.47
6183995-18399596.94499.31
60min1175683-17568392.56593.971.4495.4696.811.44
2178527-17852794.06396.82
3179738-17973894.70197.51
4182426-18242696.11899.07
5175717-17571792.58395.32
6178019-17801993.79696.70
极限1180869-18086995.29794.682.2798.7198.042.20
2172196-17219690.72894.00
3182340-18234096.07299.41
4180210-18021094.95098.44
5183813-18381396.849100.10
6178763-17876394.18897.61
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