瑞舒伐他汀钙依折麦布片项目信息
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%
111.541711151709031719261711961701911710660.37
211.541715201716031715620.04
单位质量响应值RSD%判断
14823.7414866.720.21数据可信
供试品溶液-CLB05410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%
5min196132-9613255.44953.704.3155.4553.704.32
289153-8915351.42451.42
388096-8809650.81450.81
493470-9347053.91453.91
593126-9312653.71553.72
698627-9862756.88856.89
10min1131763-13176376.00176.751.2876.3177.051.28
2133395-13339576.94377.23
3132922-13292276.67076.95
4130656-13065675.36375.66
5135416-13541678.10878.41
6134197-13419777.40577.72
15min1150341-15034186.71787.231.1787.4587.961.17
2149331-14933186.13586.85
3151683-15168387.49188.20
4150302-15030286.69587.41
5151374-15137487.31388.05
6154386-15438689.05089.80
20min1157529-15752990.86391.250.9992.0892.460.98
2157944-15794491.10392.29
3160743-16074392.71793.91
4156055-15605590.01391.21
5158974-15897491.69792.91
6157991-15799191.13092.37
30min1164464-16446494.86396.111.1996.5897.821.16
2167641-16764196.69698.39
3169459-16945997.74599.45
4164587-16458794.93496.63
5167650-16765096.70198.43
6165955-16595595.72397.47
45min1167292-16729296.49596.771.2998.7499.021.27
2167626-16762696.68798.92
3168900-16890097.42299.67
4164675-16467594.98597.21
5167007-16700796.33098.59
6171145-17114598.717101.00
60min1167115-16711596.39295.681.5799.1798.471.54
2166030-16603095.76798.54
3168232-16823297.03799.83
4161218-16121892.99195.75
5164874-16487495.10097.90
6167793-16779396.78499.61
极限1161394-16139493.09395.231.9096.4198.551.86
2166041-16604195.77399.08
3169266-16926697.633100.97
4161561-16156193.18996.46
5165139-16513995.25398.58
6167175-16717596.42799.79
瑞舒伐他汀钙依折麦布片项目信息
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%
110.881829151825531835861825391825321828250.25
210.951823401825451824420.08
单位质量响应值RSD%判断
16803.7716661.370.61数据可信
供试品溶液-CLB05410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%
5min154636-5463629.31429.4410.2129.3129.4410.21
253842-5384228.88828.89
359534-5953431.94231.94
446455-4645524.92524.92
552348-5234828.08728.09
662405-6240533.48333.48
10min1139426-13942674.80776.814.8474.9776.984.84
2139352-13935274.76874.93
3146268-14626878.47878.66
4133265-13326571.50271.64
5150354-15035480.67180.83
6150324-15032480.65580.84
15min1177874-17787495.43695.901.5796.0196.491.59
2174260-17426093.49794.07
3179480-17948096.29896.91
4177601-17760195.29095.83
5181243-18124397.24497.85
6181947-18194797.62298.26
20min1180736-18073696.97298.361.3698.0899.481.34
2181518-18151897.39198.49
3184262-18426298.864100.01
4185748-18574899.661100.73
5186441-186441100.033101.18
6181208-18120897.22598.40
30min1182392-18239297.860100.341.9099.51102.001.86
2188571-188571101.176102.81
3186980-186980100.322102.02
4189149-189149101.486103.10
5191581-191581102.791104.49
6183368-18336898.384100.10
45min1183537-18353798.475100.081.03100.67102.301.03
2185819-18581999.699101.90
3185844-18584499.712101.97
4186897-186897100.277102.46
5188165-188165100.958103.23
6188866-188866101.334103.60
60min1183395-18339598.39899.260.94101.14102.040.95
2184730-18473099.115101.87
3187565-187565100.636103.44
4183157-18315798.271101.01
5186507-186507100.068102.90
6184634-18463499.063101.89
极限1178846-17884695.95899.151.6899.24102.491.66
2185610-18561099.587102.89
3186875-186875100.266103.63
4184859-18485999.184102.47
5187557-187557100.631104.02
6185061-18506199.292102.67
瑞舒伐他汀钙依折麦布片项目信息
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%
111.541715021718391717921722801724301719690.23
211.541715701711731713720.17
单位质量响应值RSD%判断
14901.9914850.260.25数据可信
供试品溶液-CLB05410批-瑞舒伐他汀钙-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%
5min1128903-12890374.19768.416.7574.2068.416.75
2117618-11761867.70267.70
3108438-10843862.41862.42
4124250-12425071.51971.52
5123026-12302670.81570.81
6110891-11089163.83063.83
10min1160135-16013592.17591.151.4492.5991.531.46
2157935-15793590.90891.28
3157989-15798990.93991.29
4157814-15781490.83991.24
5161432-16143292.92193.31
6154785-15478589.09589.45
15min1174326-174326100.34396.812.12101.2797.702.12
2163231-16323193.95794.84
3168056-16805696.73497.59
4167434-16743496.37697.28
5168586-16858697.03997.95
6167514-16751496.42297.27
20min1170150-17015097.93996.961.8099.4298.391.78
2169317-16931797.46098.86
3169248-16924897.42098.81
4162342-16234293.44594.88
5170278-17027898.01399.46
6169394-16939497.50498.89
30min1170540-17054098.16499.152.25100.19101.112.21
2169749-16974997.70999.65
3176567-176567101.633103.56
4169047-16904797.30499.26
5177793-177793102.339104.33
6169814-16981497.74699.67
45min1169611-16961197.62996.741.19100.2099.261.15
2168197-16819796.81599.30
3170167-17016797.949100.44
4167311-16731196.30598.80
5164567-16456794.72697.29
6168594-16859497.04499.51
60min1169906-16990697.79996.611.85100.9199.661.82
2170162-17016297.946100.97
3168063-16806396.73899.78
4167944-16794496.67099.70
5169179-16917997.380100.47
6161787-16178793.12696.13
极限1166790-16679096.00595.980.7399.6699.570.70
2164996-16499694.97398.54
3168298-16829896.873100.45
4165832-16583295.45499.02
5166930-16693096.08699.71
6167680-16768096.518100.04
瑞舒伐他汀钙依折麦布片项目信息
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%
110.881834591834941838771827841830501833330.24
210.951823351819031821190.17
单位质量响应值RSD%判断
16850.4616631.870.93数据可信
供试品溶液-CLB05410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%
5min158466-5846631.35431.586.0131.3531.586.01
255859-5585929.95629.96
358500-5850031.37231.37
458113-5811331.16531.16
556622-5662230.36530.37
665773-6577335.27235.27
10min1156284-15628483.81180.732.7783.9980.912.77
2147134-14713478.90479.07
3153039-15303982.07182.25
4145422-14542277.98678.16
5148501-14850179.63779.81
6152847-15284781.96882.16
15min1186423-18642399.97496.022.31100.6196.642.30
2174001-17400193.31393.92
3177344-17734495.10595.74
4177784-17778495.34195.95
5179915-17991596.48497.10
6178824-17882495.89996.55
20min1184666-18466699.03297.511.80100.2398.661.80
2181273-18127397.21298.34
3182675-18267597.96499.12
4175542-17554294.13995.27
5183254-18325498.27599.42
6183510-18351098.41299.60
30min1184291-18429198.83199.522.02100.58101.221.99
2183124-18312498.20599.87
3189870-189870101.823103.53
4182320-18232097.77499.43
5190797-190797102.320104.01
6183085-18308598.18499.91
45min1182490-18249097.86596.901.05100.1699.151.05
2179313-17931396.16198.37
3183423-18342398.365100.63
4179981-17998196.51998.72
5178504-17850495.72797.99
6180452-18045296.77299.05
60min1182779-18277998.02096.501.94100.8699.291.88
2180822-18082296.97099.71
3181351-18135197.254100.07
4179007-17900795.99798.74
5182336-18233697.782100.58
6173385-17338592.98295.80
极限1180175-18017596.62395.980.94100.0199.310.95
2176707-17670794.76498.05
3180454-18045496.773100.13
4176971-17697194.90598.18
5179538-17953896.28299.62
6179998-17999896.52999.86
瑞舒伐他汀钙依折麦布片项目信息
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%
111.541719731720451727791724661733391725200.33
211.541722721715941719330.28
单位质量响应值RSD%判断
14949.7414898.870.25数据可信
供试品溶液-CLB05410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%
5min1145179-14517983.29687.875.6483.3087.875.64
2156872-15687290.00590.00
3159695-15969591.62591.62
4157137-15713790.15790.16
5139587-13958780.08880.09
6160407-16040792.03392.03
10min1167399-16739996.04598.351.9396.5198.841.93
2174460-174460100.096100.60
3171623-17162398.46898.98
4175994-175994100.976101.48
5170043-17004397.56298.01
6168971-16897196.94797.46
15min1164131-16413194.17097.112.4295.1798.152.39
2171813-17181398.57799.63
3165155-16515594.75795.81
4169324-16932497.14998.21
5175006-175006100.409101.40
6170157-17015797.62798.68
20min1163833-16383393.99998.483.0795.52100.063.04
2173133-17313399.335100.94
3179547-179547103.015104.60
4168910-16891096.91298.51
5173796-17379699.715101.26
6170676-17067697.92599.52
30min1165445-16544594.92497.612.4796.9799.732.44
2168962-16896296.94299.10
3176763-176763101.417103.57
4167215-16721595.93998.08
5168968-16896896.94599.04
6173399-17339999.487101.62
45min1166464-16646495.50896.661.3098.0899.331.29
2171422-17142298.353101.05
3169850-16985097.451100.17
4166634-16663495.60698.28
5169918-16991897.490100.13
6166554-16655495.56098.25
60min1163847-16384794.00795.681.5997.1198.881.57
2165664-16566495.04998.29
3170390-17039097.761101.02
4165651-16565195.04298.25
5169710-16971097.371100.55
6165298-16529894.83998.06
极限1159878-15987891.73095.542.7595.3599.272.69
2162466-16246693.21496.98
3172371-17237198.897102.70
4168286-16828696.554100.29
5169029-16902996.980100.70
6167045-16704595.84299.59
瑞舒伐他汀钙依折麦布片项目信息
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%
110.881837151841171845451839531832171839090.27
210.951823311834041828680.42
单位质量响应值RSD%判断
16903.4016700.270.86数据可信
供试品溶液-CLB05410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%
5min168608-6860836.66033.408.3036.6633.418.30
260814-6081432.49532.50
358557-5855731.28931.29
469575-6957537.17637.18
559437-5943731.75931.76
658112-5811231.05131.05
10min1150097-15009780.20279.213.0680.4179.403.06
2149164-14916479.70479.88
3144711-14471177.32477.50
4153135-15313581.82682.03
5151323-15132380.85781.03
6141009-14100975.34675.52
15min1171580-17158091.68194.311.9892.3394.931.97
2179325-17932595.82096.44
3173001-17300192.44193.04
4177345-17734594.76295.42
5180359-18035996.37297.00
6177358-17735894.76995.36
20min1175665-17566593.86498.132.9395.0299.282.88
2185430-18543099.082100.24
3192306-192306102.756103.87
4182388-18238897.45698.64
5182777-18277797.66498.83
6183330-18333097.96099.08
30min1177567-17756794.88097.632.4096.5699.322.35
2182628-18262897.58599.29
3188743-188743100.852102.54
4180340-18034096.36298.09
5179907-17990796.13197.83
6187086-18708699.967101.63
45min1179022-17902295.65897.011.0697.8799.241.05
2184023-18402398.330100.58
3183151-18315197.864100.11
4180711-18071196.56098.82
5182312-18231297.41699.65
6180079-18007996.22398.44
60min1176352-17635294.23195.661.3496.9798.441.32
2178907-17890795.59698.39
3183424-18342498.010100.80
4178026-17802695.12697.93
5179418-17941895.87098.65
6178062-17806295.14597.90
极限1171009-17100991.37695.182.6394.6498.492.56
2174094-17409493.02596.35
3183846-18384698.236101.57
4180201-18020196.28899.62
5179557-17955795.94499.26
6180052-18005296.20899.49
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