依折麦布阿托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对照品来源自制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%
111.551921731920331920231921111923001921280.06
211.451924031932771928400.33
单位质量响应值RSD%判断
16634.4616841.920.88数据可信
长期24月-供试品溶液-2024011221批-依折麦布-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min166189-6618935.50233.3611.6535.5033.3611.64
251560-5156027.65527.66
361279-6127932.86832.87
456016-5601630.04530.05
569175-6917537.10337.10
668952-6895236.98436.98
10min1152118-15211881.59181.481.8781.7981.661.88
2150299-15029980.61680.77
3147449-14744979.08779.27
4151870-15187081.45881.63
5155321-15532183.30983.52
6154367-15436782.79883.00
15min1174266-17426693.47194.061.6194.1294.701.60
2177294-17729495.09595.70
3170209-17020991.29591.92
4176931-17693194.90095.52
5175766-17576694.27594.94
6177685-17768595.30595.97
20min1182270-18227097.76498.041.8298.9399.201.81
2183417-18341798.37999.51
3177189-17718995.03996.17
4187543-187543100.592101.74
5182866-18286698.08499.28
6183424-18342498.38399.58
30min1179737-17973796.40598.331.2098.12100.041.18
2181832-18183297.52999.21
3185141-18514199.304100.96
4185239-18523999.356101.06
5184715-18471599.075100.81
6183283-18328398.307100.05
45min1186612-186612100.093100.460.96102.34102.710.95
2187311-187311100.468102.69
3184860-18486099.153101.36
4190405-190405102.127104.38
5187143-187143100.378102.67
6187392-187392100.511102.80
60min1181778-18177897.50099.041.01100.30101.851.00
2184233-18423398.817101.59
3184098-18409898.744101.50
4187356-187356100.492103.32
5185718-18571899.613102.46
6184760-18476099.100101.95
极限1184114-18411498.75399.320.81102.10102.680.79
2186642-186642100.109103.43
3183908-18390898.643101.95
4186426-18642699.993103.38
5186453-186453100.008103.41
6183426-18342698.384101.78
依折麦布阿托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100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.321567091568071568771567571570471568390.09
211.301569361575781572570.29
单位质量响应值RSD%判断
13855.0413916.550.32数据可信
长期24月-供试品溶液-2024011221批-阿托伐他汀钙-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1108057-10805764.41465.5533.0964.4165.5533.09
2149454-14945489.09189.09
3150323-15032389.60989.61
455796-5579633.26133.26
5108278-10827864.54664.55
687855-8785552.37152.37
10min1144273-14427386.00289.559.4686.3689.919.55
2164709-16470998.18598.68
3170469-170469101.618102.12
4136157-13615781.16481.35
5147703-14770388.04788.41
6138011-13801182.27082.56
15min1157525-15752593.90295.924.5294.7496.784.64
2169111-169111100.809101.85
3170052-170052101.370102.43
4151339-15133990.21590.85
5158876-15887694.70795.56
6158551-15855194.51495.26
20min1162448-16244896.83798.221.8998.1999.612.03
2167630-16763099.926101.53
3169137-169137100.824102.45
4161282-16128296.14297.28
5162959-16295997.14198.52
6165132-16513298.43799.71
30min1158684-15868494.59397.842.7096.4999.782.76
2162787-16278797.03999.19
3171873-171873102.455104.64
4161819-16181996.46298.13
5165056-16505698.391100.30
6164615-16461598.12999.95
45min1164128-16412897.838100.011.27100.26102.491.27
2166678-16667899.358102.05
3170071-170071101.381104.14
4168748-168748100.592102.80
5167849-167849100.056102.52
6169112-169112100.809103.17
60min1160160-16016095.47398.762.0098.44101.801.98
2163445-16344597.431100.68
3169418-169418100.992104.31
4167076-16707699.596102.36
5166613-16661399.320102.34
6167290-16729099.723102.65
极限1163954-16395497.73599.941.22101.23103.531.21
2166754-16675499.404103.19
3169392-169392100.976104.86
4169088-169088100.795104.11
5168526-168526100.460104.03
6168253-168253100.297103.78
依折麦布阿托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对照品来源自制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%
111.551930261930811930651928101928841929730.07
211.451923121928891926000.22
单位质量响应值RSD%判断
16707.6216820.960.48数据可信
长期24月-供试品溶液-2024011221批-依折麦布-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min151700-5170027.68634.0712.3527.6934.0712.34
274823-7482340.06940.07
360777-6077732.54732.55
460459-6045932.37732.38
567086-6708635.92635.93
666871-6687135.81135.81
10min1133335-13333571.40377.945.3771.5678.135.37
2153184-15318482.03382.26
3153422-15342282.16082.34
4147729-14772979.11279.29
5140014-14001474.98075.18
6145574-14557477.95878.16
15min1162773-16277387.16891.222.6887.7291.842.69
2172096-17209692.16192.84
3176484-17648494.51195.15
4172103-17210392.16492.78
5168937-16893790.46991.09
6169642-16964290.84791.48
20min1175494-17549493.98096.251.8595.0297.381.86
2181534-18153497.21598.41
3182649-18264997.81298.97
4183409-18340998.21999.35
5178849-17884995.77796.90
6176465-17646594.50095.64
30min1185331-18533199.24898.492.98100.81100.152.93
2184423-18442398.762100.49
3189530-189530101.497103.20
4185227-18522799.193100.87
5185585-18558599.384101.04
6173380-17338092.84894.51
45min1181412-18141297.15099.291.1899.26101.511.21
2186466-18646699.856102.14
3185566-18556699.374101.64
4187387-187387100.349102.58
5186934-186934100.107102.31
6184739-18473998.931101.11
60min1177387-17738794.99498.291.7997.64101.051.80
2184327-18432798.711101.54
3186024-18602499.619102.44
4186126-18612699.674102.46
5184736-18473698.930101.69
6182644-18264497.809100.54
极限1181685-18168597.29698.901.46100.47102.211.47
2184587-18458798.850102.23
3186129-18612999.676103.05
4187588-187588100.457103.80
5186883-186883100.079103.39
6181257-18125797.067100.34
依折麦布阿托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100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.321574471574561574681571481573051573650.09
211.301564791570921567860.28
单位质量响应值RSD%判断
13901.5013874.870.14数据可信
长期24月-供试品溶液-2024011221批-阿托伐他汀钙-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1148718-14871888.63787.498.2188.6487.498.21
2155274-15527492.54492.54
3146485-14648587.30687.31
4123233-12323373.44773.45
5154819-15481992.27392.27
6152246-15224690.73990.74
10min1168185-168185100.239100.741.51100.73101.231.54
2171417-171417102.165102.68
3167563-16756399.868100.35
4165076-16507698.38698.79
5170398-170398101.558102.07
6171533-171533102.234102.74
15min1171040-171040101.941101.701.40102.99102.741.43
2169289-169289100.897101.98
3170028-170028101.337102.38
4167046-16704699.560100.51
5173072-173072103.152104.23
6173328-173328103.304104.38
20min1172428-172428102.768102.240.82104.38103.840.83
2170484-170484101.609103.25
3169700-169700101.142102.74
4170916-170916101.867103.37
5172297-172297102.690104.34
6173394-173394103.344104.99
30min1174597-174597104.061101.342.27106.25103.522.23
2168280-168280100.296102.50
3172445-172445102.778104.94
4167814-167814100.018102.09
5172726-172726102.945105.17
6164365-16436597.962100.18
45min1168949-168949100.694101.281.28103.46104.031.27
2168490-168490100.421103.18
3168405-168405100.370103.11
4168528-168528100.443103.07
5171755-171755102.367105.16
6173514-173514103.415106.18
60min1164747-16474798.190100.131.43101.51103.441.40
2166202-16620299.057102.38
3169227-169227100.860104.15
4167204-16720499.654102.84
5169409-169409100.968104.33
6171260-171260102.072105.41
极限1168412-168412100.374100.510.88104.24104.370.87
2166214-16621499.064102.94
3169896-169896101.259105.11
4167899-167899100.069103.81
5170152-170152101.411105.33
6169288-169288100.896104.80
依折麦布阿托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对照品来源自制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%
111.551930941933581935321935051935601934100.10
211.451927631930971929300.13
单位质量响应值RSD%判断
16745.4516849.780.44数据可信
长期24月-供试品溶液-2024011222批-依折麦布-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min163318-6331833.84129.2225.4333.8429.2225.43
241999-4199922.44722.45
351731-5173127.64827.65
478115-7811541.74941.75
550688-5068827.09127.09
642161-4216122.53322.53
10min1139670-13967074.64772.768.5474.8472.928.58
2128179-12817968.50668.63
3130521-13052169.75869.91
4158175-15817584.53884.77
5132450-13245070.78970.94
6127842-12784268.32668.45
15min1169602-16960290.64588.103.9091.2588.673.96
2163014-16301487.12487.63
3160177-16017785.60886.15
4175585-17558593.84294.54
5161539-16153986.33586.88
6159159-15915985.06385.57
20min1177714-17771494.98093.282.1196.0994.342.18
2174862-17486293.45694.45
3171884-17188491.86492.88
4179900-17990096.14997.37
5172417-17241792.14993.17
6170417-17041791.08092.06
30min1185460-18546099.12097.351.61100.7598.921.66
2181301-18130196.89798.41
3182337-18233797.45198.98
4184413-18441398.561100.32
5182260-18226097.41098.95
6177070-17707094.63696.12
45min1185304-18530499.03798.931.29101.22101.041.27
2184483-18448398.598100.64
3189095-189095101.063103.13
4184311-18431198.506100.81
5185634-18563499.213101.29
6181796-18179697.16299.17
60min1182773-18277397.68497.930.96100.42100.600.91
2185246-18524699.006101.60
3184725-18472598.727101.36
4181628-18162897.07299.92
5184180-18418098.436101.06
6180888-18088896.67799.23
极限1185273-18527399.02098.400.84102.30101.610.76
2185602-18560299.196102.34
3184144-18414498.417101.60
4181370-18137096.934100.33
5184787-18478798.761101.94
6183482-18348298.063101.15
依折麦布阿托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100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.321576111575341577551578141577401576910.08
211.301565581567931566760.11
单位质量响应值RSD%判断
13930.3013865.130.34数据可信
长期24月-供试品溶液-2024011222批-阿托伐他汀钙-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1130707-13070777.84973.2519.6877.8573.2519.68
2137124-13712481.67181.67
3124731-12473174.29074.29
4150451-15045189.60889.61
580034-8003447.66847.67
6114892-11489268.42968.43
10min1161073-16107395.93594.192.3396.3794.602.37
2160501-16050195.59496.05
3155726-15572692.75093.16
4161864-16186496.40696.90
5157382-15738293.73694.00
6152362-15236290.74791.13
15min1166734-16673499.30696.951.69100.2797.881.67
2162178-16217896.59397.58
3162312-16231296.67397.60
4161801-16180196.36897.40
5164891-16489198.20998.99
6158766-15876694.56195.45
20min1163863-16386397.59796.521.4099.1197.991.35
2162127-16212796.56398.08
3161697-16169796.30697.77
4160121-16012195.36896.94
5165293-16529398.44899.78
6159224-15922494.83496.24
30min1163907-16390797.62396.181.5299.6898.181.48
2160317-16031795.48597.54
3161428-16142896.14698.15
4160617-16061795.66397.76
5164623-16462398.04999.93
6157985-15798594.09696.03
45min1161055-16105595.92496.171.6698.5398.711.59
2161202-16120296.01298.60
3163794-16379497.555100.09
4159522-15952295.01197.64
5165213-16521398.401100.82
6157993-15799394.10096.56
60min1158157-15815794.19894.811.7497.3397.881.66
2160969-16096995.87398.99
3159359-15935994.91497.99
4156950-15695093.47996.64
5163551-16355197.411100.38
6156075-15607592.95895.94
极限1159862-15986295.21495.001.4598.8798.601.38
2160883-16088395.82299.48
3158832-15883294.60098.20
4156560-15656093.24796.92
5163050-16305097.112100.62
6157812-15781293.99397.49
依折麦布阿托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对照品来源自制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%
111.551926491932271933451936251936151932920.21
211.451940691940981940840.02
单位质量响应值RSD%判断
16735.2416950.570.91数据可信
长期24月-供试品溶液-2024011222批-依折麦布-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min171866-7186638.30730.3033.5738.3130.3033.57
279098-7909842.16242.16
360488-6048832.24232.24
431991-3199117.05217.05
535788-3578819.07619.08
661868-6186832.97832.98
10min1152124-15212481.08876.119.9181.3076.289.96
2158521-15852184.49784.73
3138256-13825673.69573.87
4135447-13544772.19872.29
5120301-12030164.12564.23
6152051-15205181.04981.23
15min1173322-17332292.38790.604.3693.0591.194.42
2176347-17634793.99994.70
3167558-16755889.31489.90
4169818-16981890.51991.01
5156611-15661183.47983.94
6176151-17615193.89594.53
20min1181820-18182096.91795.832.2798.0996.922.35
2184160-18416098.16499.39
3176698-17669894.18695.27
4179951-17995195.92096.92
5173328-17332892.39093.32
6182689-18268997.38098.53
30min1186638-18663899.48598.850.91101.20100.480.98
2186374-18637499.344101.12
3182993-18299397.54299.15
4186426-18642699.372100.90
5183587-18358797.85899.30
6186667-18666799.500101.20
45min1185596-18559698.92999.220.58101.20101.400.55
2185775-18577599.025101.35
3184824-18482498.518100.67
4185799-18579999.037101.12
5187375-18737599.878101.86
6187519-18751999.954102.20
60min1184770-18477098.48999.040.42101.31101.760.32
2185529-18552998.894101.77
3185658-18565898.962101.66
4186901-18690199.625102.26
5186462-18646299.391101.93
6185445-18544598.849101.65
极限1183563-18356397.84698.120.78101.21101.400.74
2183112-18311297.605101.03
3183157-18315797.629100.88
4182887-18288797.485100.67
5185618-18561898.941102.03
6186148-18614899.224102.58
依折麦布阿托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100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.321570811574531570751574381576531573400.17
211.301581231582721581980.07
单位质量响应值RSD%判断
13899.2913999.820.51数据可信
长期24月-供试品溶液-2024011222批-阿托伐他汀钙-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1146862-14686287.14676.4413.9987.1576.4413.99
2151776-15177690.06290.06
3114414-11441467.89267.89
4128302-12830276.13376.13
5126328-12632874.96274.96
6105226-10522662.44062.44
10min1161315-16131595.72393.444.2396.2193.864.25
2162692-16269296.54097.04
3145374-14537486.26386.64
4162486-16248696.41796.84
5158098-15809893.81494.23
6154851-15485191.88792.23
15min1161714-16171495.95995.891.8096.9896.841.82
2163194-16319496.83897.87
3157808-15780893.64294.50
4166020-16602098.51499.47
5159268-15926894.50895.45
6161599-16159995.89196.75
20min1162573-16257396.46996.751.3398.0298.231.35
2164968-16496897.89099.46
3160180-16018095.04996.43
4165420-16542098.15899.66
5160973-16097395.52096.98
6164181-16418197.42398.81
30min1162702-16270296.54696.701.0398.6398.721.05
2163665-16366597.11799.24
3160760-16076095.39397.30
4165295-16529598.084100.14
5161458-16145895.80797.80
6163892-16389297.25299.18
45min1160504-16050495.24196.180.9297.8698.730.90
2162277-16227796.29398.95
3160459-16045995.21597.65
4162633-16263396.50599.10
5162174-16217496.23298.76
6164456-16445697.586100.06
60min1160010-16001094.94895.970.9098.1099.060.88
2162051-16205196.15999.35
3160694-16069495.35498.32
4163751-16375197.168100.30
5160955-16095595.50998.57
6162977-16297796.70999.72
极限1158537-15853794.07495.081.5397.7598.701.46
2159860-15986094.85998.59
3158195-15819593.87197.36
4160158-16015895.03698.71
5159695-15969594.76198.35
6164947-16494797.878101.43
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