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%
5min1164331-16433193.08891.139.0393.0991.139.03
2170240-17024096.43696.44
3165382-16538293.68493.68
4176751-176751100.124100.12
5136198-13619877.15277.15
6152338-15233886.29586.29
10min1175166-17516699.22696.914.5399.7497.414.53
2173613-17361398.34698.88
3169702-16970296.13196.65
4181369-181369102.740103.30
5168123-16812395.23795.67
6158453-15845389.75990.24
15min1176313-17631399.87696.703.79100.9497.743.80
2171105-17110596.92698.01
3169305-16930595.90696.96
4178416-178416101.067102.19
5168969-16896995.71696.67
6160101-16010190.69291.67
20min1176662-176662100.07496.443.89101.7098.023.90
2171598-17159897.20598.83
3165732-16573293.88295.47
4178125-178125100.902102.59
5168644-16864495.53297.02
6160735-16073591.05192.53
30min1175124-17512499.20295.613.88101.3897.723.89
2170767-17076796.73498.89
3165421-16542193.70695.81
4176261-17626199.846102.10
5166062-16606294.06996.09
6159029-15902990.08592.07
45min1171578-17157897.19494.503.8099.9297.153.81
2168842-16884295.64498.34
3164292-16429293.06695.70
4173895-17389598.506101.31
5166342-16634294.22896.77
6155985-15598588.36190.85
60min1171564-17156497.18694.863.44100.4698.033.45
2168714-16871495.57198.80
3164250-16425093.04396.19
4173084-17308498.047101.40
5169662-16966296.10899.17
6157426-15742689.17792.16
极限1172422-17242297.67293.863.88101.4897.563.88
2167244-16724494.73998.50
3162834-16283492.24095.90
4172554-17255497.747101.64
5163253-16325392.47896.08
6155856-15585688.28891.76
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%
5min183694-8369444.15044.2630.2244.1544.2630.22
2102698-10269854.17554.17
387178-8717845.98845.99
4117343-11734361.90061.90
546178-4617824.36024.36
666324-6632434.98734.99
10min1156967-15696782.80379.2111.7783.0579.4611.83
2160049-16004984.42884.73
3154919-15491981.72281.98
4168709-16870988.99789.34
5118960-11896062.75362.89
6141391-14139174.58674.78
15min1178319-17831994.06690.155.8194.7790.835.89
2172443-17244390.96691.74
3175068-17506892.35193.06
4180156-18015695.03595.87
5153385-15338580.91381.40
6165967-16596787.55088.16
20min1182508-18250896.27693.972.7997.5095.162.89
2178960-17896094.40495.68
3176452-17645293.08194.30
4183141-18314196.61097.98
5169470-16947089.39890.33
6178305-17830594.05995.15
30min1185980-18598098.10795.821.7499.8797.521.84
2182980-18298096.52598.32
3180500-18050095.21796.96
4182675-18267596.36498.27
5176513-17651393.11394.54
6181180-18118095.57597.19
45min1179832-17983294.86494.860.5997.1797.110.47
2179350-17935094.61096.95
3178244-17824494.02796.30
4179621-17962194.75397.19
5181282-18128295.62997.58
6180665-18066595.30497.45
60min1180026-18002694.96795.220.9497.8097.980.79
2179146-17914694.50297.36
3178661-17866194.24697.04
4180036-18003694.97297.94
5182782-18278296.42098.90
6182332-18233296.18398.86
极限1181418-18141895.70194.280.9299.0697.580.98
2180021-18002194.96498.35
3177633-17763393.70497.02
4178231-17823194.02097.51
5177315-17731593.53696.55
6177751-17775193.76696.98
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%
5min1166530-16653093.64274.0427.4193.6474.0427.41
287037-8703748.94248.94
3155309-15530987.33387.33
498477-9847755.37555.38
5114314-11431464.28064.28
6168310-16831094.64394.64
10min1167816-16781694.36593.533.5394.8993.943.59
2155919-15591987.67687.95
3172025-17202596.73297.22
4169107-16910795.09195.40
5163342-16334291.85092.21
6169759-16975995.45895.98
15min1169609-16960995.37495.612.7596.4296.542.78
2166992-16699293.90294.66
3178148-178148100.175101.20
4171722-17172296.56297.40
5164563-16456392.53693.40
6169176-16917695.13096.19
20min1166941-16694193.87395.433.0995.4596.893.09
2169602-16960295.37096.65
3178318-178318100.271101.85
4171583-17158396.48497.86
5162533-16253391.39592.78
6169226-16922695.15896.74
30min1165808-16580893.23695.272.9895.3397.262.95
2172342-17234296.91098.72
3176016-17601698.976101.11
4170924-17092496.11398.02
5161713-16171390.93492.82
6169698-16969895.42497.54
45min1163058-16305891.69093.702.2094.3096.222.17
2168918-16891894.98597.33
3171351-17135196.35399.04
4168564-16856494.78697.23
5161920-16192091.05093.44
6166003-16600393.34695.99
60min1165475-16547593.04994.103.2096.1797.143.14
2172423-17242396.95699.83
3174309-17430998.017101.24
4166954-16695493.88196.85
5159571-15957189.72992.63
6165299-16529992.95096.11
极限1164672-16467292.59893.872.4396.2497.432.42
2168174-16817494.56797.98
3172556-17255697.031100.80
4169523-16952395.32598.82
5161019-16101990.54393.94
6165629-16562993.13696.81
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%
5min1103255-10325554.13628.3964.3654.1428.3964.35
238372-3837220.11820.12
338972-3897220.43320.43
422879-2287911.99512.00
528184-2818414.77714.78
693255-9325548.89348.89
10min1164234-16423486.10770.0622.6486.4170.2222.71
2146981-14698177.06177.17
3112831-11283159.15759.27
499395-9939552.11252.18
5109244-10924457.27657.36
6169105-16910588.66188.93
15min1181982-18198295.41287.948.4396.1988.498.57
2175310-17531091.91492.45
3162228-16222885.05585.50
4152799-15279980.11280.47
5151512-15151279.43779.84
6182586-18258695.72996.49
20min1180689-18068994.73493.153.6296.0494.183.77
2180682-18068294.73195.78
3177010-17701092.80593.72
4175759-17575992.14992.95
5166489-16648987.28988.13
6185356-18535697.18198.48
30min1183006-18300695.94996.561.7897.7898.111.85
2186288-18628897.67099.25
3185357-18535797.18298.61
4185384-18538497.19698.51
5178083-17808393.36894.69
6186891-18689197.98699.82
45min1178007-17800793.32895.401.3995.7097.491.32
2182099-18209995.47397.59
3181697-18169795.26397.23
4184838-18483896.91098.76
5180688-18068894.73496.58
6184410-18441096.68599.07
60min1182151-18215195.50195.970.7598.3998.580.79
2184963-18496396.97599.62
3183868-18386896.40198.90
4183280-18328096.09398.48
5181020-18102094.90897.28
6182949-18294995.91998.84
极限1179787-17978794.26195.671.6097.6898.831.43
2178987-17898793.84297.03
3183120-18312096.00999.04
4187149-18714998.121101.05
5182781-18278195.83198.73
6183065-18306595.98099.43
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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