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%
111.311711761714641714001727421709821715530.41
211.361695511707571701540.51
单位质量响应值RSD%判断
15168.2614978.350.90数据可信
供试品溶液-23112301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%
5min1116938-11693866.43268.006.9366.4368.006.93
2118458-11845867.29667.30
3124480-12448070.71770.72
4119948-11994868.14268.14
5131669-13166974.80174.80
6106728-10672860.63260.63
10min1160918-16091891.41791.131.1591.7991.511.15
2157731-15773189.60789.98
3159445-15944590.58090.97
4159769-15976990.76491.14
5162980-16298092.58893.00
6161640-16164091.82792.16
15min1168724-16872495.85296.280.5496.7397.160.56
2169495-16949596.29097.16
3168822-16882295.90796.80
4169906-16990696.52397.41
5171082-17108297.19198.12
6168837-16883795.91696.76
20min1177622-177622100.90798.881.08102.32100.301.06
2172267-17226797.86499.27
3173019-17301998.29299.72
4173631-17363198.639100.06
5173525-17352598.579100.05
6174239-17423998.985100.36
30min1174818-17481899.31498.411.14101.28100.381.13
2173362-17336298.486100.44
3172185-17218597.81899.79
4170116-17011696.64298.61
5175662-17566299.793101.81
6173207-17320798.398100.33
45min1171008-17100897.14997.921.0499.67100.441.02
2172460-17246097.974100.47
3169581-16958196.33998.86
4173527-17352798.580101.08
5174409-17440999.081101.65
6173218-17321898.405100.88
60min1171771-17177197.58396.301.15100.6499.361.13
2169355-16935596.21099.25
3166505-16650594.59197.64
4170706-17070696.978100.03
5170674-17067496.959100.08
6168104-16810495.49998.52
极限1169917-16991796.52995.811.41100.1399.411.37
2169111-16911196.07299.65
3170595-17059596.915100.49
4164180-16418093.27096.86
5170136-17013696.654100.31
6168002-16800295.44199.00
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%
111.081908821881231897531879751886791890820.65
211.171869531865431867480.16
单位质量响应值RSD%判断
17065.1616718.711.46数据可信
供试品溶液-23112301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%
5min193025-9302549.44555.0814.9549.4455.0814.95
2114674-11467460.95260.95
3114879-11487961.06161.06
4110217-11021758.58358.58
5112193-11219359.63359.63
676776-7677640.80840.81
10min1161058-16105885.60687.593.2285.8887.903.26
2169251-16925189.96190.30
3170569-17056990.66191.00
4167155-16715588.84789.17
5164134-16413487.24187.57
6156574-15657483.22383.45
15min1176173-17617393.64093.931.7594.3994.721.77
2178470-17847094.86195.70
3177864-17786494.53995.38
4181075-18107596.24597.06
5174130-17413092.55493.37
6172591-17259191.73692.43
20min1185513-18551398.60497.531.7699.8798.841.75
2184984-18498498.32399.69
3183974-18397497.78699.15
4186378-18637899.064100.42
5177441-17744194.31495.64
6182681-18268197.09998.30
30min1185125-18512598.39897.360.81100.2299.220.80
2184903-18490398.280100.19
3182832-18283297.17999.09
4181649-18164996.55198.45
5182088-18208896.78498.64
6182463-18246396.98398.72
45min1183002-18300297.27098.251.3499.63100.651.31
2187336-18733699.573102.03
3180912-18091296.15998.61
4187017-18701799.404101.84
5185586-18558698.643101.03
6185250-18525098.465100.74
60min1186447-18644799.10197.991.35102.01100.941.33
2185292-18529298.487101.50
3180881-18088196.14299.13
4187498-18749899.659102.65
5183208-18320897.379100.32
6182831-18283197.179100.00
极限1186315-18631599.03198.281.00102.49101.771.00
2187010-18701099.400102.96
3186345-18634599.047102.57
4182937-18293797.235100.78
5183745-18374597.665101.15
6183086-18308697.314100.68
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%
111.311699891707701728251714151709671711930.62
211.361702401705801704100.15
单位质量响应值RSD%判断
15136.4315000.880.64数据可信
供试品溶液-23112301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%
5min1131196-13119674.55488.178.3074.5588.178.30
2164470-16447093.46293.46
3159779-15977990.79690.80
4150177-15017785.34085.34
5160558-16055891.23991.24
6164737-16473793.61493.61
10min1174441-17444199.12898.871.2399.5499.361.22
2171677-17167797.55798.08
3177913-177913101.101101.61
4173818-17381898.77499.25
5173009-17300998.31498.82
6173105-17310598.36998.89
15min1177758-177758101.013101.172.01101.98102.212.00
2175887-17588799.950101.01
3185010-185010105.134106.20
4177916-177916101.103102.13
5175189-17518999.553100.61
6176476-176476100.285101.35
20min1175715-17571599.852100.160.51101.38101.760.53
2174922-17492299.401101.02
3177547-177547100.893102.54
4176394-176394100.238101.82
5176236-176236100.148101.75
6176764-176764100.448102.07
30min1173815-17381598.77299.571.23100.85101.721.22
2172376-17237697.955100.12
3177688-177688100.973103.18
4177689-177689100.974103.12
5175427-17542799.688101.85
6174294-17429499.045101.23
45min1172268-17226897.89399.581.56100.52102.291.56
2172436-17243697.989100.70
3179508-179508102.007104.78
4176496-176496100.296103.00
5174722-17472299.288102.00
6176000-176000100.014102.75
60min1170730-17073097.01997.901.22100.19101.161.20
2170191-17019196.71399.97
3173786-17378698.756102.09
4175719-17571999.854103.11
5172011-17201197.747101.02
6171272-17127297.327100.61
极限1168756-16875695.89897.371.3899.61101.171.37
2168481-16848195.74199.54
3173130-17313098.383102.27
4171645-17164597.539101.35
5171574-17157497.499101.31
6174452-17445299.134102.96
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%
111.081874581885961888411890111881111884030.34
211.171868481879391873940.42
单位质量响应值RSD%判断
17003.8816776.540.96数据可信
供试品溶液-23112301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%
5min192349-9234949.08849.1812.8049.0949.1812.80
2104829-10482955.72155.72
399494-9949452.88652.89
470327-7032737.38237.38
595348-9534850.68250.68
692767-9276749.31049.31
10min1152391-15239181.00381.877.3881.2882.147.40
2162885-16288586.58186.89
3164193-16419387.27687.57
4133505-13350570.96471.17
5159796-15979684.93985.22
6151375-15137580.46380.74
15min1175872-17587293.48493.234.5294.2193.964.56
2181074-18107496.24997.04
3184080-18408097.84798.63
4161062-16106285.61286.21
5175527-17552793.30094.05
6174737-17473792.88193.60
20min1180651-18065196.02494.861.8497.2796.111.90
2181447-18144796.44797.77
3180130-18013095.74797.07
4172447-17244791.66392.74
5178542-17854294.90396.17
6177555-17755594.37895.62
30min1178844-17884495.06494.950.8796.8496.720.92
2178625-17862594.94796.81
3181547-18154796.50098.35
4177373-17737394.28295.87
5177895-17789594.55996.36
6177503-17750394.35196.11
45min1178176-17817694.70995.200.8097.0197.500.81
2178695-17869594.98497.37
3181730-18173096.59898.99
4179420-17942095.37097.48
5177640-17764094.42496.75
6178949-17894995.11997.40
60min1177216-17721694.19894.050.5597.0396.880.47
2176009-17600993.55796.47
3177453-17745394.32497.25
4178465-17846594.86297.50
5176466-17646693.80096.65
6176025-17602593.56596.38
极限1174610-17461092.81393.220.7496.1796.580.72
2174662-17466292.84196.28
3176339-17633993.73297.18
4175303-17530393.18196.35
5173937-17393792.45595.83
6177447-17744794.32197.65
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