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%
111.081703901700151700811701761701461701620.09
211.041722711731271726990.36
单位质量响应值RSD%判断
15357.5815643.031.31数据可信
加速6月-供试品溶液-2023122121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%
5min1157588-15758887.06380.4410.0087.0680.4410.00
2127381-12738170.37470.37
3160027-16002788.41088.41
4146201-14620180.77280.77
5128232-12823270.84570.84
6154136-15413685.15685.16
10min1178255-17825598.48195.883.1298.9696.323.14
2174475-17447596.39396.78
3179653-17965399.25399.74
4172816-17281695.47695.92
5164527-16452790.89791.29
6171529-17152994.76595.24
15min1180356-18035699.64296.082.86100.6797.062.88
2173881-17388196.06496.99
3178961-17896198.87199.91
4172971-17297195.56296.54
5168172-16817292.91093.81
6169134-16913493.44294.44
20min1180666-18066699.81397.173.37101.4098.683.37
2176686-17668697.61499.07
3183679-183679101.478103.07
4175782-17578297.11598.62
5168172-16817292.91094.33
6170309-17030994.09195.61
30min1175043-17504396.70695.732.3098.8597.782.32
2176081-17608197.28099.28
3178243-17824398.474100.63
4171485-17148594.74196.79
5167134-16713492.33794.27
6171641-17164194.82796.87
45min1177745-17774598.19995.242.21100.8897.822.23
2174178-17417896.22998.77
3175021-17502196.69499.40
4168717-16871793.21195.79
5168584-16858493.13895.58
6170042-17004293.94396.51
60min1177263-17726397.93395.302.52101.1598.412.53
2175518-17551896.969100.05
3175565-17556596.995100.23
4168177-16817792.91396.01
5166685-16668592.08995.05
6171728-17172894.87597.97
极限1174496-17449696.40494.902.46100.1798.542.45
2176973-17697397.773101.39
3174769-17476996.555100.33
4167484-16748492.53096.14
5166824-16682492.16695.64
6170092-17009293.97197.59
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ZT-705-231101-1-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(%)100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%
111.071851651849251852711846201848981849760.14
211.071859161866771862960.29
单位质量响应值RSD%判断
16709.6716828.910.51数据可信
加速6月-供试品溶液-2023122121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%
5min1105190-10519056.45651.7027.6456.4651.7027.64
256346-5634630.24130.24
3126324-12632467.79867.80
479306-7930642.56442.56
589377-8937747.96947.97
6121389-12138965.15065.15
10min1161939-16193986.91385.796.4987.2386.086.55
2140982-14098275.66575.83
3170421-17042191.46591.84
4160525-16052586.15486.39
5157672-15767284.62384.89
6167540-16754089.91990.28
15min1175396-17539694.13592.302.4894.9393.062.55
2163750-16375087.88588.47
3174752-17475293.79094.67
4173748-17374893.25193.97
5171935-17193592.27893.01
6172262-17226292.45393.31
20min1182552-18255297.97696.212.2499.3097.492.26
2175430-17543094.15495.23
3183394-18339498.42899.83
4182562-18256297.98199.21
5177017-17701795.00596.25
6174628-17462893.72395.10
30min1178844-17884495.98696.300.8197.8598.120.76
2180643-18064396.95298.55
3180735-18073597.00198.95
4180656-18065696.95898.74
5178309-17830995.69997.48
6177422-17742295.22397.12
45min1180181-18018196.70495.811.1799.1098.161.08
2180632-18063296.94699.08
3178063-17806395.56798.06
4176338-17633894.64196.96
5180028-18002896.62198.93
6175854-17585494.38196.81
60min1181603-18160397.46795.831.20100.4098.711.14
2180673-18067396.96899.64
3178211-17821195.64698.67
4176860-17686094.92197.76
5177760-17776095.40498.25
6176201-17620194.56797.52
极限1178651-17865195.88295.371.4299.3698.781.29
2182289-18228997.835101.05
3176739-17673994.85698.41
4175613-17561394.25297.62
5177215-17721595.11298.49
6175705-17570594.30197.78
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%
111.081715261718631725641724971722691721440.26
211.041719941727211723580.30
单位质量响应值RSD%判断
15536.4615612.140.35数据可信
长期6月-供试品溶液-2023122121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%
5min1137758-13775875.74073.385.3575.7473.385.35
2123678-12367867.99968.00
3132144-13214472.65372.65
4127320-12732070.00170.00
5137072-13707275.36375.36
6142857-14285778.54378.54
10min1172464-17246494.82194.500.9495.2494.910.94
2172893-17289395.05795.44
3170937-17093793.98294.39
4171049-17104994.04394.43
5169774-16977493.34293.76
6174204-17420495.77896.21
15min1178855-17885598.33597.081.7199.2898.011.72
2177034-17703497.33498.24
3174236-17423695.79696.72
4173102-17310295.17296.08
5175077-17507796.25897.20
6181086-18108699.562100.53
20min1177059-17705997.34895.771.4598.8497.241.45
2175118-17511896.28197.73
3173583-17358395.43796.89
4171717-17171794.41195.85
5170993-17099394.01395.48
6176620-17662097.10698.63
30min1173990-17399095.66095.371.6797.7097.381.65
2175296-17529696.37898.36
3171182-17118294.11796.10
4175518-17551896.50198.47
5168776-16877692.79494.79
6176037-17603796.78698.85
45min1171089-17108994.06594.420.9496.6396.950.94
2171055-17105594.04796.56
3171485-17148594.28396.79
4172864-17286495.04197.54
5169652-16965293.27595.79
6174238-17423895.79798.40
60min1170854-17085493.93694.601.4797.0297.661.46
2170456-17045693.71796.76
3171402-17140294.23897.27
4171632-17163294.36497.39
5170900-17090093.96296.99
6177135-17713597.390100.52
极限1170567-17056793.77893.781.0197.3997.361.01
2168628-16862892.71296.27
3170743-17074393.87597.43
4172036-17203694.58698.14
5168628-16862892.71296.26
6172797-17279795.00498.68
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ZT-705-231101-1-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(%)100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%
111.071851861860671858961871021872131862930.46
211.071859211866521862860.28
单位质量响应值RSD%判断
16828.6416828.000.01数据可信
长期6月-供试品溶液-2023122121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%
5min192964-9296449.71845.578.3449.7245.578.34
279887-7988742.72542.72
387863-8786346.99046.99
475816-7581640.54740.55
581890-8189043.79643.80
692794-9279449.62749.63
10min1163557-16355787.47283.273.2887.7583.523.29
2151556-15155681.05481.29
3156505-15650583.70183.96
4154317-15431782.53182.76
5149437-14943779.92180.16
6158792-15879284.92485.20
15min1179852-17985296.18792.862.3996.9593.582.40
2171699-17169991.82792.51
3172246-17224692.11992.85
4169298-16929890.54391.23
5171084-17108491.49892.19
6177626-17762694.99795.74
20min1179477-17947795.98793.931.5297.2895.161.54
2174835-17483593.50494.70
3175122-17512293.65794.90
4173213-17321392.63793.82
5172943-17294392.49293.69
6178192-17819295.29996.57
30min1178222-17822295.31595.251.1497.1597.001.12
2178706-17870695.57497.29
3175441-17544193.82895.59
4181015-18101596.80998.51
5176181-17618194.22495.93
6179041-17904195.75397.56
45min1174365-17436593.25394.411.1295.6196.691.06
2174545-17454593.34995.60
3175649-17564993.93996.22
4178188-17818895.29797.54
5179073-17907395.77198.00
6177320-17732094.83397.17
60min1175515-17551593.86895.011.4796.7597.821.43
2174871-17487193.52396.29
3175994-17599494.12496.93
4178128-17812895.26598.03
5180692-18069296.63699.40
6180721-18072196.65299.52
极限1174878-17487893.52794.121.4596.9397.461.39
2172172-17217292.08095.37
3174947-17494793.56496.89
4178925-17892595.69198.99
5178531-17853195.48198.78
6176491-17649194.39097.79
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%
111.081720791728681727861738821737311730690.43
211.041760101762631761360.11
单位质量响应值RSD%判断
15619.9515954.351.50数据可信
中间条件6月-供试品溶液-2023122121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%
5min1129477-12947770.23579.008.1870.2379.008.18
2159145-15914586.32886.33
3142626-14262677.36777.37
4134741-13474173.09073.09
5154163-15416383.62683.63
6153627-15362783.33583.33
10min1169407-16940791.89593.601.9992.2894.042.01
2177952-17795296.53097.01
3172299-17229993.46393.89
4169408-16940891.89592.30
5171013-17101392.76693.23
6175202-17520295.03895.50
15min1171489-17148993.02495.362.2493.9296.312.26
2182682-18268299.096100.11
3173197-17319793.95194.90
4174213-17421394.50295.42
5175893-17589395.41396.39
6177244-17724496.14697.14
20min1173144-17314493.92295.361.7695.3496.851.78
2178407-17840796.77798.34
3172713-17271393.68895.16
4174240-17424094.51695.96
5175791-17579195.35896.87
6180448-18044897.88499.41
30min1175468-17546895.18294.031.0397.1296.051.02
2175609-17560995.25997.36
3172756-17275693.71195.70
4172082-17208293.34695.31
5171319-17131992.93294.97
6172859-17285993.76795.84
45min1171209-17120992.87293.420.8895.3495.960.90
2174246-17424694.52097.15
3171077-17107792.80195.31
4171396-17139692.97495.46
5174061-17406194.41996.98
6171298-17129892.92095.51
60min1170321-17032192.39093.530.7895.3796.590.79
2171758-17175893.17096.33
3171931-17193193.26496.29
4173259-17325993.98496.99
5173293-17329394.00397.08
6173982-17398294.37697.48
极限1169300-16930091.83793.401.0295.3396.981.03
2173675-17367594.21097.89
3172518-17251893.58297.13
4173441-17344194.08397.61
5170872-17087292.68996.29
6173329-17332994.02297.65
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ZT-705-231101-1-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(%)100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%
111.071866531874021877381879721887061876940.41
211.071910981922521916750.43
单位质量响应值RSD%判断
16955.1917314.811.49数据可信
中间条件6月-供试品溶液-2023122121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%
5min179501-7950141.76254.3216.9641.7654.3216.96
2118625-11862562.31462.31
397090-9709051.00151.00
488210-8821046.33746.34
5120156-12015663.11863.12
6116921-11692161.41861.42
10min1149872-14987278.72883.223.9278.9683.533.96
2162866-16286685.55385.90
3155396-15539681.62981.91
4153853-15385380.81981.08
5164374-16437486.34586.70
6164231-16423186.27086.61
15min1165055-16505586.70389.992.7187.3790.762.76
2175001-17500191.92892.75
3166972-16697287.71088.45
4170145-17014589.37790.08
5176212-17621292.56493.39
6174518-17451891.67492.49
20min1173169-17316990.96592.472.2992.1293.732.32
2175357-17535792.11593.45
3171124-17112489.89191.12
4175057-17505791.95793.16
5179475-17947594.27895.62
6181980-18198095.59496.92
30min1179437-17943794.25892.371.4195.9194.141.36
2173024-17302490.88992.73
3173064-17306490.91092.63
4175993-17599392.44994.16
5176863-17686392.90694.77
6176685-17668592.81294.67
45min1176874-17687492.91292.281.7895.0994.571.75
2171997-17199790.35092.70
3172563-17256390.64792.88
4176721-17672192.83195.06
5180438-18043894.78497.17
6175411-17541192.14394.52
60min1175568-17556892.22692.122.0594.9294.932.02
2169351-16935188.96091.81
3173348-17334891.05993.79
4176785-17678592.86595.61
5179367-17936794.22197.13
6177834-17783493.41696.30
极限1175586-17558692.23592.601.0495.4495.921.00
2173203-17320390.98394.33
3176429-17642992.67895.92
4178721-17872193.88297.14
5176780-17678092.86296.30
6176944-17694492.94896.36
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