替米沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.107711327716497706057712047708597710900.06
211.167690077694307692180.04
单位质量响应值RSD%判断
69467.5768926.340.56数据可信
加速6月-供试品溶液-2024070321批-pH7.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1295001-29500138.36940.182.8738.3740.182.87
2304683-30468339.62939.63
3320473-32047341.68241.68
4315574-31557441.04541.05
5307780-30778040.03240.03
6310192-31019240.34540.35
10min1542029-54202970.49970.484.9170.7170.704.90
2497212-49721264.67064.89
3525227-52522768.31468.55
4559244-55924472.73872.97
5562758-56275873.19573.42
6564802-56480273.46173.69
15min1685378-68537889.14490.511.7389.7591.131.72
2689141-68914189.63390.21
3698404-69840490.83891.45
4710340-71034092.39193.02
5682955-68295588.82989.46
6709244-70924492.24892.88
20min1742979-74297996.63694.713.1697.7495.833.14
2687718-68771889.44890.53
3713309-71330992.77793.89
4742366-74236696.55697.70
5743784-74378496.74197.86
6738921-73892196.10897.25
30min1751836-75183697.78896.191.9299.4297.841.88
2744835-74483596.87798.45
3713864-71386492.84994.48
4737121-73712195.87497.56
5751897-75189797.79699.46
6737782-73778295.96097.64
45min1740445-74044596.30695.182.1698.4997.362.14
2721435-72143593.83495.95
3707936-70793692.07894.23
4732224-73222495.23797.45
5753781-75378198.041100.24
6734972-73497295.59597.81
60min1729495-72949594.88295.221.2997.6097.941.27
2735187-73518795.62298.26
3717948-71794893.38096.04
4726806-72680694.53297.28
5739153-73915396.13898.89
6744184-74418496.79399.54
极限1750494-75049497.61394.911.89100.8698.151.81
2742166-74216696.53099.70
3719315-71931593.55896.74
4728221-72822194.71697.99
5722231-72223193.93797.22
6715977-71597793.12496.40
替米沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.107694667698387698107702547694967697730.05
211.167665977683897674930.17
单位质量响应值RSD%判断
69348.9268771.770.60数据可信
加速6月-供试品溶液-2024070321批-pH7.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1308477-30847740.20238.373.7740.2038.363.77
2283394-28339436.93336.93
3295199-29519938.47138.47
4295024-29502438.44838.45
5280241-28024136.52236.52
6303994-30399439.61739.62
10min1522663-52266368.11568.411.9368.3468.621.92
2507123-50712366.09066.30
3530586-53058669.14869.36
4524307-52430768.32968.54
5527848-52784868.79168.99
6536975-53697569.98070.20
15min1642850-64285083.77885.532.3784.3886.122.36
2639955-63995583.40183.97
3662340-66234086.31886.92
4669228-66922887.21687.81
5646055-64605584.19684.78
6677429-67742988.28588.89
20min1730158-73015895.15692.992.4596.2294.052.43
2714833-71483393.15994.19
3701680-70168091.44592.52
4733842-73384295.63796.71
5687274-68727489.56890.62
6713259-71325992.95494.05
30min1715604-71560493.26091.304.2294.8692.894.17
2711521-71152192.72894.28
3712005-71200592.79194.38
4727298-72729894.78496.39
5644879-64487984.04385.59
6692202-69220290.21091.83
45min1718048-71804893.57891.171.6995.6993.261.64
2690127-69012789.93992.01
3697456-69745690.89593.00
4697071-69707190.84492.98
5708250-70825092.30194.32
6686284-68628489.43991.56
60min1707198-70719892.16491.982.8894.8094.582.82
2677442-67744288.28690.85
3688729-68872989.75792.36
4724786-72478694.45697.10
5706382-70638292.05894.59
6730179-73017995.15997.77
极限1714806-71480693.15691.002.6496.3094.112.58
2698218-69821890.99494.05
3702911-70291191.60694.71
4718462-71846293.63296.80
5686238-68623889.43392.47
6669118-66911887.20290.34
替米沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.107759887749407735607743407738777745410.13
211.167724687724317724500.01
单位质量响应值RSD%判断
69778.4769215.950.58数据可信
加速6月-供试品溶液-2024070421批-pH7.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1322088-32208841.71241.291.3241.7141.291.32
2313669-31366940.62140.62
3317185-31718541.07741.08
4315477-31547740.85540.86
5324805-32480542.06342.06
6319810-31981041.41741.42
10min1523919-52391967.84970.392.3568.0870.622.34
2541328-54132870.10470.33
3560211-56021172.54972.78
4537061-53706169.55169.78
5545400-54540070.63170.87
6553338-55333871.65971.89
15min1675725-67572587.50989.331.7888.1289.951.76
2699899-69989990.64091.25
3673841-67384187.26587.90
4693986-69398689.87490.49
5702763-70276391.01091.64
6692492-69249289.68090.31
20min1690210-69021089.38594.853.0790.4895.973.05
2747331-74733196.78297.90
3747771-74777196.83997.96
4741152-74115295.98297.09
5723907-72390793.74994.88
6744086-74408696.36297.49
30min1716359-71635992.77192.822.0294.3694.461.99
2718325-71832593.02694.68
3714366-71436692.51394.17
4704127-70412791.18792.83
5703758-70375891.13992.79
6743268-74326896.25697.92
45min1717865-71786592.96693.671.2095.0795.831.19
2722591-72259193.57895.75
3713900-71390092.45394.62
4729329-72932994.45196.60
5718664-71866493.07095.23
6737374-73737495.49397.69
60min1701134-70113490.79992.052.1693.4294.732.09
2716390-71639092.77595.47
3711720-71172092.17094.85
4723924-72392493.75196.43
5725966-72596694.01596.69
6685474-68547488.77191.50
极限1720695-72069593.33392.113.0296.4695.302.92
2726046-72604694.02697.23
3669834-66983486.74689.94
4718357-71835793.03096.23
5707166-70716691.58194.78
6725503-72550393.95597.18
替米沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.107671137677897679767700627699267685730.18
211.167699717689537694620.10
单位质量响应值RSD%判断
69240.8168948.210.30数据可信
加速6月-供试品溶液-2024070421批-pH7.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1321700-32170041.90440.594.7241.9040.604.72
2320965-32096541.80841.81
3284664-28466437.07937.08
4316277-31627741.19741.20
5304855-30485539.70939.71
6321419-32141941.86741.87
10min1551805-55180571.87670.723.2172.1170.943.21
2551772-55177271.87272.10
3511341-51134166.60666.81
4544963-54496370.98571.21
5537012-53701269.95070.17
6560748-56074873.04173.27
15min1659936-65993685.96186.643.6386.5987.263.61
2656080-65608085.45986.09
3626427-62642781.59682.17
4689580-68958089.82390.45
5691369-69136990.05690.66
6667637-66763786.96487.60
20min1738467-73846796.19095.231.4097.3096.331.40
2725926-72592694.55795.66
3720694-72069493.87594.90
4748005-74800597.43398.56
5727839-72783994.80695.92
6725450-72545094.49595.62
30min1725215-72521594.46493.501.5396.1195.121.54
2706700-70670092.05393.68
3703339-70333991.61593.17
4731001-73100195.21896.88
5723929-72392994.29795.93
6716452-71645293.32394.97
45min1726207-72620794.59494.572.2696.7696.722.20
2724360-72436094.35396.50
3738764-73876496.22998.29
4733887-73388795.59497.79
5694817-69481790.50592.66
6737950-73795096.12398.29
60min1704846-70484691.81189.705.6594.5192.375.47
2716630-71663093.34696.01
3719542-71954293.72596.32
4645425-64542584.07186.79
5632839-63283982.43285.09
6712474-71247492.80595.50
极限1715333-71533393.17793.152.1396.3896.322.05
2733748-73374895.57698.76
3705595-70559591.90995.02
4726825-72682594.67497.86
5718061-71806193.53296.65
6691319-69131990.04993.26
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