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)0
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%
110.761628441629991626281637871631021630720.27
210.801632191624411628300.34
单位质量响应值RSD%判断
15155.3915076.850.37数据可信
供试品溶液-25110501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%
5min1164331-16433193.08818.51197.4593.0918.51197.45
25116-51162.8982.90
36363-63633.6043.60
45936-59363.3633.36
57182-71824.0684.07
67091-70914.0174.02
10min1175166-17516699.22696.914.5399.7497.014.58
2173613-17361398.34698.36
3169702-16970296.13196.15
4181369-181369102.740102.76
5168123-16812395.23795.26
6158453-15845389.75989.78
15min1176313-17631399.87696.703.79100.9497.343.88
2171105-17110596.92697.49
3169305-16930595.90696.46
4178416-178416101.067101.66
5168969-16896995.71696.27
6160101-16010190.69291.21
20min1176662-176662100.07496.443.89101.7097.623.98
2171598-17159897.20598.31
3165732-16573293.88294.97
4178125-178125100.902102.05
5168644-16864495.53296.62
6160735-16073591.05192.08
30min1175124-17512499.20295.613.88101.3897.323.98
2170767-17076796.73498.38
3165421-16542193.70695.31
4176261-17626199.846101.56
5166062-16606294.06995.68
6159029-15902990.08591.62
45min1171578-17157897.19494.503.8099.9296.743.88
2168842-16884295.64497.82
3164292-16429293.06695.20
4173895-17389598.506100.77
5166342-16634294.22896.36
6155985-15598588.36190.39
60min1171564-17156497.18694.863.44100.4697.633.53
2168714-16871495.57198.28
3164250-16425093.04395.69
4173084-17308498.047100.86
5169662-16966296.10898.77
6157426-15742689.17791.70
极限1172422-17242297.67293.863.88101.4897.163.98
2167244-16724494.73997.98
3162834-16283492.24095.40
4172554-17255497.747101.10
5163253-16325392.47895.67
6155856-15585688.28891.31
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)0
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%
111.681993271988622011631985131998671995460.52
211.721982061991721986890.35
单位质量响应值RSD%判断
17084.4216952.990.55数据可信
供试品溶液-25110501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%
5min183694-8369444.15077.7723.3344.1577.7723.33
2170240-17024089.80489.80
3165382-16538287.24287.24
4176751-17675193.23993.24
5136198-13619871.84771.85
6152338-15233880.36180.36
10min1156967-15696782.80379.2111.7783.0579.6511.74
2160049-16004984.42884.93
3154919-15491981.72282.21
4168709-16870988.99789.51
5118960-11896062.75363.15
6141391-14139174.58675.03
15min1178319-17831994.06690.155.8194.7791.025.81
2172443-17244390.96691.93
3175068-17506892.35193.29
4180156-18015695.03596.05
5153385-15338580.91381.66
6165967-16596787.55088.41
20min1182508-18250896.27693.972.7997.5095.342.82
2178960-17896094.40495.88
3176452-17645293.08194.53
4183141-18314196.61098.15
5169470-16947089.39890.60
6178305-17830594.05995.41
30min1185980-18598098.10795.821.7499.8797.711.75
2182980-18298096.52598.52
3180500-18050095.21797.19
4182675-18267596.36498.44
5176513-17651393.11394.81
6181180-18118095.57597.45
45min1179832-17983294.86494.860.5997.1797.290.49
2179350-17935094.61097.14
3178244-17824494.02796.52
4179621-17962194.75397.37
5181282-18128295.62997.84
6180665-18066595.30497.70
60min1180026-18002694.96795.220.9497.8098.170.82
2179146-17914694.50297.56
3178661-17866194.24697.27
4180036-18003694.97298.11
5182782-18278296.42099.16
6182332-18233296.18399.11
极限1181418-18141895.70194.280.9299.0697.760.89
2180021-18002194.96498.55
3177633-17763393.70497.25
4178231-17823194.02097.69
5177315-17731593.53696.81
6177751-17775193.76697.23
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)0
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%
110.761638891642921647461645671660871647160.51
210.801641841630141635990.51
单位质量响应值RSD%判断
15308.1815148.060.75数据可信
供试品溶液-25110502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%
5min1166530-16653093.64232.57137.8693.6432.57137.86
26782-67823.8143.81
3155309-15530987.33387.33
46364-63643.5793.58
55937-59373.3383.34
66649-66493.7393.74
10min1167816-16781694.36593.533.5394.8993.713.65
2155919-15591987.67687.70
3172025-17202596.73297.22
4169107-16910795.09195.11
5163342-16334291.85091.87
6169759-16975995.45895.48
15min1169609-16960995.37495.612.7596.4296.322.91
2166992-16699293.90294.41
3178148-178148100.175101.20
4171722-17172296.56297.11
5164563-16456392.53693.07
6169176-16917695.13095.68
20min1166941-16694193.87395.433.0995.4596.663.19
2169602-16960295.37096.40
3178318-178318100.271101.85
4171583-17158396.48497.57
5162533-16253391.39592.44
6169226-16922695.15896.24
30min1165808-16580893.23695.272.9895.3397.023.02
2172342-17234296.91098.47
3176016-17601698.976101.11
4170924-17092496.11397.73
5161713-16171390.93492.48
6169698-16969895.42497.03
45min1163058-16305891.69093.702.2094.3095.992.23
2168918-16891894.98597.08
3171351-17135196.35399.04
4168564-16856494.78696.94
5161920-16192091.05093.11
6166003-16600393.34695.48
60min1165475-16547593.04994.103.2096.1796.913.25
2172423-17242396.95699.58
3174309-17430998.017101.24
4166954-16695493.88196.56
5159571-15957189.72992.29
6165299-16529992.95095.61
极限1164672-16467292.59893.872.4396.2497.202.51
2168174-16817494.56797.73
3172556-17255697.031100.80
4169523-16952395.32598.53
5161019-16101990.54393.60
6165629-16562993.13696.31
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)0
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%
111.682014632007422019742024302005522014320.40
211.721999061986171992620.46
单位质量响应值RSD%判断
17245.8917001.881.01数据可信
供试品溶液-25110502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%
5min1103255-10325554.13653.3441.1554.1453.3341.15
287037-8703745.63345.63
338972-3897220.43320.43
498477-9847751.63151.63
5114314-11431459.93459.93
6168310-16831088.24488.24
10min1164234-16423486.10770.0622.6486.4170.3622.63
2146981-14698177.06177.31
3112831-11283159.15759.27
499395-9939552.11252.40
5109244-10924457.27657.61
6169105-16910588.66189.15
15min1181982-18198295.41287.948.4396.1988.638.51
2175310-17531091.91492.60
3162228-16222885.05585.50
4152799-15279980.11280.69
5151512-15151279.43780.09
6182586-18258695.72996.71
20min1180689-18068994.73493.153.6296.0494.323.73
2180682-18068294.73195.92
3177010-17701092.80593.72
4175759-17575992.14993.17
5166489-16648987.28988.38
6185356-18535697.18198.70
30min1183006-18300695.94996.561.7897.7898.251.82
2186288-18628897.67099.39
3185357-18535797.18298.61
4185384-18538497.19698.73
5178083-17808393.36894.95
6186891-18689197.986100.04
45min1178007-17800793.32895.401.3995.7097.621.39
2182099-18209995.47397.73
3181697-18169795.26397.23
4184838-18483896.91098.98
5180688-18068894.73496.83
6184410-18441096.68599.28
60min1182151-18215195.50195.970.7598.3998.720.76
2184963-18496396.97599.77
3183868-18386896.40198.90
4183280-18328096.09398.70
5181020-18102094.90897.53
6182949-18294995.91999.06
极限1179787-17978794.26195.671.6097.6898.961.48
2178987-17898793.84297.17
3183120-18312096.00999.04
4187149-18714998.121101.27
5182781-18278195.83198.98
6183065-18306595.98099.65
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)0
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%
110.761623181619241627411626541617061622690.28
210.801639731640941640340.06
单位质量响应值RSD%判断
15080.7615188.330.51数据可信
供试品溶液-25110503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%
5min1166014-16601493.92886.0512.4493.9386.0512.44
2149408-14940884.53384.53
3122994-12299469.58869.59
4154704-15470487.52987.53
5142121-14212180.41080.41
6177271-177271100.297100.30
10min1178068-178068100.74897.835.94101.2798.315.95
2160721-16072190.93391.40
3159024-15902489.97390.36
4177110-177110100.206100.69
5181489-181489102.683103.13
6181081-181081102.453103.01
15min1172848-17284897.79498.624.6498.8899.644.65
2167398-16739894.71195.69
3162895-16289592.16393.05
4177798-177798100.595101.64
5183395-183395103.762104.78
6181471-181471102.673103.80
20min1172348-17234897.51299.374.0499.14100.944.06
2172523-17252397.61199.11
3164896-16489693.29594.69
4178583-178583101.039102.64
5184358-184358104.307105.90
6181119-181119102.474104.17
30min1171138-17113896.82798.344.2298.99100.464.24
2171312-17131296.92598.97
3161833-16183391.56293.48
4176528-17652899.877102.04
5180824-180824102.307104.48
6181190-181190102.514104.78
45min1169286-16928695.77998.024.3198.48100.694.32
2169366-16936695.82498.41
3162403-16240391.88594.31
4176795-176795100.028102.75
5181872-181872102.900105.64
6179760-179760101.705104.54
60min1161339-16133991.28395.914.7594.5299.124.73
2170482-17048296.45699.57
3158017-15801789.40392.34
4174079-17407998.491101.76
5177705-177705100.542103.86
6175499-17549999.294102.69
极限1164215-16421592.91096.184.7996.6599.924.77
2167610-16761094.83198.48
3157939-15793989.35992.79
4179088-179088101.325105.15
5176270-17627099.731103.60
6174857-17485798.931102.88
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)0
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%
111.681989861990991986561985801997181990080.23
211.722013252013052013150.01
单位质量响应值RSD%判断
17038.3617177.050.58数据可信
供试品溶液-25110503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%
5min174963-7496339.33924.8537.0039.3424.8537.00
243407-4340722.77922.78
332323-3232316.96216.96
446455-4645524.37824.38
527684-2768414.52814.53
659315-5931531.12731.13
10min1154758-15475881.21372.6810.2481.4372.8210.29
2135079-13507970.88671.01
3119527-11952762.72462.82
4141662-14166274.34074.48
5126636-12663666.45566.54
6153277-15327780.43680.61
15min1177591-17759193.19592.203.5993.8692.743.63
2176015-17601592.36892.89
3163992-16399286.05886.50
4177149-17714992.96393.51
5176358-17635892.54893.00
6183108-18310896.09096.71
20min1184951-18495197.05797.452.2698.2498.502.29
2189459-18945999.423100.46
3178270-17827093.55194.47
4184836-18483696.99798.06
5187129-18712998.20099.16
6189589-18958999.491100.64
30min1187370-18737098.32798.851.95100.05100.451.98
2191260-191260100.368101.95
3181995-18199595.50696.95
4187731-18773198.516100.12
5189662-18966299.529101.04
6192219-192219100.871102.58
45min1186730-18673097.99198.571.70100.26100.721.72
2188809-18880999.082101.23
3183099-18309996.08598.06
4185973-18597397.59399.74
5191357-191357100.419102.48
6191069-191069100.268102.53
60min1179377-17937794.13296.752.2796.9599.442.21
2191341-191341100.410103.10
3181365-18136595.17597.68
4183008-18300896.03898.73
5185384-18538497.28499.90
6185693-18569397.447100.27
极限1178748-17874893.80296.922.7697.14100.162.71
2185615-18561597.406100.66
3178493-17849393.66896.70
4191302-191302100.390103.62
5186682-18668297.966101.13
6187349-18734998.316101.68
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