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%
111.531755991759371762011755581751191756830.24
211.691766311780231773270.56
单位质量响应值RSD%判断
15237.0315169.120.32数据可信
长期36月-供试品溶液-CLB01071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%
5min1135745-13574576.45567.5313.8876.4667.5313.88
290508-9050850.97750.98
3114851-11485164.68764.69
4119049-11904967.05267.05
5134842-13484275.94775.95
6124342-12434270.03370.03
10min1167619-16761994.40891.612.6394.8391.992.67
2157860-15786088.91189.19
3158939-15893989.51989.88
4160595-16059590.45290.82
5167688-16768894.44794.87
6163234-16323491.93892.33
15min1178279-178279100.41298.861.15101.3699.751.20
2173292-17329297.60398.38
3173331-17333197.62598.48
4176804-17680499.581100.46
5176500-17650099.410100.36
6174962-17496298.54499.44
20min1179045-179045100.84399.661.55102.35101.091.53
2178744-178744100.674101.99
3171991-17199196.87098.27
4179052-179052100.847102.28
5176335-17633599.317100.82
6176478-17647899.397100.84
30min1175713-17571398.96799.810.92101.03101.800.86
2178346-178346100.450102.33
3177768-177768100.124102.06
4179370-179370101.026103.01
5177018-17701899.702101.75
6175084-17508498.612100.61
45min1177075-17707599.73499.221.38102.35101.771.33
2179269-179269100.969103.41
3173917-17391797.955100.45
4178465-178465100.517103.07
5174524-17452498.297100.90
6173764-17376497.869100.42
60min1176429-17642999.37099.661.26102.54102.751.19
2177624-177624100.043103.04
3180012-180012101.388104.43
4178468-178468100.518103.63
5173975-17397597.988101.14
6175138-17513898.643101.73
极限1173482-17348297.71099.071.14101.43102.711.08
2177087-17708799.740103.29
3177693-177693100.082103.68
4177016-17701699.700103.37
5176861-17686199.613103.31
6173190-17319097.546101.18
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%
111.001860631876671872441864341870451868910.35
211.141904961908341906650.13
单位质量响应值RSD%判断
16990.0917115.350.52数据可信
长期36月-供试品溶液-CLB01071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%
5min172730-7273038.29031.6629.9638.2931.6629.96
261301-6130132.27332.27
342761-4276122.51222.51
433731-3373117.75817.76
572643-7264338.24438.24
677650-7765040.88040.88
10min1160247-16024784.36475.8515.1084.5876.0215.14
2148125-14812577.98278.16
3124680-12468065.63965.76
4110035-11003557.92958.03
5161881-16188185.22485.44
6159428-15942883.93384.16
15min1191532-191532100.83496.604.91101.5297.204.99
2178915-17891594.19294.80
3178391-17839193.91694.41
4170164-17016489.58590.01
5192296-192296101.237101.92
6189654-18965499.846100.54
20min1193626-193626101.937100.102.34103.18101.232.45
2187121-18712198.51299.65
3186585-18658598.23099.24
4184762-18476297.27098.19
5193786-193786102.021103.27
6194888-194888102.601103.85
30min1189206-18920699.610100.871.49101.42102.561.45
2188055-18805599.004100.69
3195784-195784103.073104.63
4190839-190839100.470101.93
5193496-193496101.868103.68
6192174-192174101.172102.99
45min1190182-190182100.124100.000.78102.49102.250.75
2187461-18746198.691100.92
3191762-191762100.956103.09
4190133-190133100.098102.11
5190823-190823100.461102.84
6189327-18932799.674102.05
60min1190866-190866100.484100.141.77103.40102.951.66
2184622-18462297.19799.98
3194116-194116102.195104.89
4192915-192915101.563104.14
5188859-18885999.427102.37
6189921-18992199.986102.92
极限1189574-18957499.804100.032.07103.28103.401.96
2185203-18520397.502100.82
3196667-196667103.538106.80
4190804-190804100.451103.59
5190680-190680100.386103.88
6187116-18711698.510102.00
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%
111.531804251802991801991800351794751800870.21
211.691845201833441839320.46
单位质量响应值RSD%判断
15618.9915734.130.52数据可信
中间条件36月-供试品溶液-CLB01071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%
5min1130920-13092071.51170.096.9171.5170.096.91
2126647-12664769.17769.18
3133768-13376873.06773.07
4112853-11285361.64361.64
5126841-12684169.28369.28
6138894-13889475.86775.87
10min1167124-16712491.28790.442.9491.6890.832.96
2169902-16990292.80493.19
3164380-16438089.78890.19
4157303-15730385.92286.26
5164124-16412489.64890.03
6170598-17059893.18493.61
15min1179705-17970598.15996.602.4099.0697.502.40
2180655-18065598.67899.58
3171272-17127293.55294.46
4171659-17165993.76494.58
5179195-17919597.88098.76
6178665-17866597.59198.53
20min1181840-18184099.32598.443.68100.7799.863.65
2184974-184974101.037102.48
3168999-16899992.31193.74
4175766-17576696.00797.35
5183198-183198100.067101.49
6186490-186490101.865103.35
30min1178778-17877897.65298.193.2699.65100.163.24
2181926-18192699.372101.38
3170585-17058593.17795.11
4177071-17707196.72098.59
5182111-18211199.473101.46
6188050-188050102.717104.76
45min1180625-18062598.66198.123.34101.21100.643.32
2184320-184320100.680103.24
3169498-16949892.58395.04
4175967-17596796.11798.53
5181862-18186299.337101.87
6185578-185578101.367103.98
60min1173308-17330894.66597.563.8597.76100.623.80
2185173-185173101.145104.27
3169931-16993192.82095.79
4175444-17544495.83198.78
5180453-18045398.567101.65
6187328-187328102.323105.50
极限1177551-17755196.98297.552.72100.60101.162.72
2183008-18300899.963103.65
3170370-17037093.06096.54
4176530-17653096.42599.90
5181204-18120498.978102.61
6182902-18290299.905103.65
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)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%
111.001915531913291928181908281908661914790.43
211.141937911953261945580.56
单位质量响应值RSD%判断
17407.1817464.810.24数据可信
中间条件36月-供试品溶液-CLB01071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%
5min158214-5821429.97333.8015.0329.9733.8015.03
255379-5537928.51428.51
380259-8025941.32441.32
460475-6047531.13831.14
574856-7485638.54238.54
664708-6470833.31733.32
10min1160170-16017082.46982.193.6982.6482.383.71
2157538-15753881.11481.27
3170069-17006987.56687.80
4152171-15217178.35078.52
5157765-15776581.23181.44
6160110-16011082.43882.62
15min1193762-19376299.76597.291.84100.3997.931.84
2187504-18750496.54397.15
3190860-19086098.27198.99
4185967-18596795.75296.36
5190917-19091798.30098.97
6184692-18469295.09595.74
20min1193401-19340199.57999.550.95100.76100.740.91
2193699-19369999.733100.88
3189927-18992797.79099.05
4193322-19332299.539100.68
5194487-194487100.138101.35
6195241-195241100.527101.70
30min1187856-18785696.72498.781.9798.46100.521.92
2188528-18852897.07098.77
3192080-19208098.899100.70
4198445-198445102.176103.87
5191889-19188998.801100.57
6192322-19232299.024100.75
45min1188199-18819996.90198.561.1799.17100.841.14
2191080-19108098.384100.62
3191023-19102398.355100.71
4195176-195176100.493102.75
5191675-19167598.690101.01
6191365-19136598.531100.81
60min1184802-18480295.15297.711.4297.96100.541.39
2190034-19003497.846100.63
3191250-19125098.472101.37
4192664-19266499.200102.02
5189253-18925397.443100.31
6190574-19057498.124100.95
极限1185493-18549395.50797.211.5298.84100.591.47
2189121-18912197.375100.70
3187817-18781796.704100.15
4194107-19410799.943103.31
5188206-18820696.904100.31
6188104-18810496.852100.22
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