奥美沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号070220417对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.997727877109771517707477149771520.11
2 16.107774777812777800.06
单位质量响应值RSD%判断
4825.024831.060.09数据可信
供试品溶液-24121701批-氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min151608-5160869.22473.463.3569.2273.463.36
256033-5603375.15975.16
356044-5604475.17475.17
454616-5461673.25873.26
553860-5386072.24472.24
656430-5643075.69275.69
10min164596-6459686.64587.650.7586.7687.770.75
265563-6556387.94288.07
366056-6605688.60388.73
465369-6536987.68287.80
565377-6537787.69387.81
665113-6511387.33887.46
15min166734-6673489.51389.701.0389.7789.971.03
265689-6568988.11188.38
367777-6777790.91291.18
467141-6714190.05990.33
567064-6706489.95590.22
666850-6685089.66889.94
20min166573-6657389.29791.051.2889.7191.471.28
268254-6825491.55291.97
368347-6834791.67692.10
467569-6756990.63391.05
567480-6748090.51390.93
669077-6907792.65693.08
30min168238-6823891.53092.141.2392.0992.711.23
269076-6907692.65493.23
369327-6932792.99193.57
469778-6977893.59694.17
567516-6751690.56291.13
668224-6822491.51192.09
45min168596-6859692.01091.932.4892.7292.652.47
269375-6937593.05593.78
369883-6988393.73794.47
469909-6990993.77294.50
565410-6541087.73788.46
668041-6804191.26691.99
60min168260-6826091.56092.221.6892.4293.101.67
268023-6802391.24292.12
369595-6959593.35094.24
470600-7060094.69895.58
567453-6745390.47791.34
668605-6860592.02292.90
极限170713-7071394.85095.910.8495.8796.940.83
271565-7156595.99397.03
371463-7146395.85696.90
472551-7255197.31598.35
571358-7135895.71596.73
671364-7136495.72396.76
奥美沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号OM230503W对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.964518264518474516354516954523344518670.07
2 11.054561554569164565360.12
单位质量响应值RSD%判断
41228.7441315.480.15数据可信
供试品溶液-24121701批-奥美沙坦酯-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1203287-20328744.28546.503.5444.2946.503.54
2214031-21403146.62646.63
3226058-22605849.24649.25
4211004-21100445.96745.97
5210300-21030045.81345.81
6215939-21593947.04247.04
10min1291156-29115663.42766.132.5063.5066.212.50
2300957-30095765.56365.64
3311060-31106067.76467.85
4310901-31090167.72967.81
5300925-30092565.55665.63
6306477-30647766.76566.84
15min1326742-32674271.18073.532.0371.3673.722.04
2335308-33530873.04673.23
3344199-34419974.98375.18
4344299-34429975.00575.19
5333989-33398972.75972.94
6340756-34075674.23374.42
20min1342122-34212274.53076.871.9574.8377.181.95
2349734-34973476.18976.50
3358658-35865878.13378.45
4361168-36116878.67978.99
5350639-35063976.38676.69
6354748-35474877.28177.59
30min1355242-35524277.38879.852.2477.8180.292.24
2364164-36416479.33279.77
3371664-37166480.96681.42
4377778-37777882.29882.74
5360481-36048178.53078.96
6369983-36998380.60081.04
45min1360602-36060278.55681.032.0479.1181.602.04
2369338-36933880.45981.03
3376956-37695682.11982.70
4382501-38250183.32783.91
5368561-36856180.29080.86
6373693-37369381.40881.98
60min1359223-35922378.25680.902.1278.9481.612.12
2368363-36836380.24780.95
3375828-37582881.87382.60
4381828-38182883.18083.90
5368102-36810280.19080.89
6374922-37492281.67682.39
极限1380057-38005782.79485.231.9783.6186.071.97
2387736-38773684.46785.30
3397220-39722086.53387.39
4401805-40180587.53288.39
5388167-38816784.56185.39
6392513-39251385.50886.36
奥美沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号070220417对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.997719977239773697740077317773050.11
2 16.107807178046780580.03
单位质量响应值RSD%判断
4834.584848.320.21数据可信
供试品溶液-24122001批-氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min155339-5533974.02372.634.3174.0272.634.32
254518-5451872.92472.92
350039-5003966.93366.93
453685-5368571.81071.81
555339-5533974.02374.02
656874-5687476.07676.08
10min166218-6621888.57589.600.7688.7089.720.76
267140-6714089.80889.93
367155-6715589.82889.94
466625-6662589.11989.24
567056-6705689.69689.82
667699-6769990.55690.68
15min168619-6861991.78692.770.9692.0693.040.96
269379-6937992.80393.07
369314-6931492.71692.98
469317-6931792.72092.99
568931-6893192.20492.48
670576-7057694.40494.68
20min169494-6949492.95794.210.8793.3894.630.86
270787-7078794.68695.11
371327-7132795.40995.82
470389-7038994.15494.58
570268-7026893.99294.42
670317-7031794.05894.49
30min170110-7011093.78194.820.7194.3695.400.70
270881-7088194.81295.40
371608-7160895.78496.36
471100-7110095.10595.68
571000-7100094.97195.55
670640-7064094.49095.08
45min170413-7041394.18694.900.9394.9295.640.93
271124-7112495.13795.88
370151-7015193.83694.57
470741-7074194.62595.36
571271-7127195.33496.08
671970-7197096.26997.02
60min170235-7023593.94894.930.6294.8495.830.62
271448-7144895.57096.47
371244-7124495.29896.19
470784-7078494.68295.58
571236-7123695.28796.19
670860-7086094.78495.69
极限171390-7139095.49396.560.6996.5497.620.69
272660-7266097.19298.25
372331-7233196.75297.80
472349-7234996.77697.83
572598-7259897.10998.17
671797-7179796.03797.10
奥美沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号OM230503W对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.964530034530314533104537094530994532300.07
2 11.054573724574184573950.01
单位质量响应值RSD%判断
41353.1041393.210.07数据可信
供试品溶液-24122001批-奥美沙坦酯-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1198292-19829243.09242.384.2543.0942.384.25
2198579-19857943.15443.15
3179433-17943338.99338.99
4193206-19320641.98741.99
5197237-19723742.86342.86
6203267-20326744.17344.17
10min1284333-28433361.79063.021.8161.8663.091.81
2297385-29738564.62664.70
3290946-29094663.22763.29
4284433-28443361.81261.88
5288773-28877362.75562.83
6294037-29403763.89963.97
15min1324515-32451570.52271.861.6170.7072.041.61
2340204-34020473.93174.11
3328844-32884471.46371.63
4328026-32802671.28571.46
5330374-33037471.79571.97
6332042-33204272.15872.34
20min1346755-34675575.35576.601.4475.6576.901.44
2360829-36082978.41478.72
3353813-35381376.88977.18
4347720-34772075.56575.86
5353153-35315376.74577.04
6352617-35261776.62976.93
30min1367068-36706879.76981.501.5480.1981.921.53
2384407-38440783.53783.97
3375895-37589581.68882.11
4371583-37158380.75181.17
5375952-37595281.70082.12
6375221-37522181.54181.97
45min1380074-38007482.59683.971.3383.1584.531.33
2395385-39538585.92386.50
3386549-38654984.00384.56
4383424-38342483.32483.88
5387304-38730484.16784.73
6385672-38567283.81284.38
60min1381592-38159282.92684.131.3783.6184.831.37
2396521-39652186.17086.89
3388318-38831884.38785.08
4384280-38428083.51084.20
5388182-38818284.35885.06
6384025-38402583.45484.16
极限1397718-39771886.43087.240.9987.2688.080.99
2408242-40824288.71789.58
3401845-40184587.32788.16
4401227-40122787.19388.02
5402382-40238287.44488.28
6397251-39725186.32987.17
奥美沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号070220417对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.997753877600777157739377704775900.18
2 16.107839378342783680.05
单位质量响应值RSD%判断
4852.414867.580.23数据可信
供试品溶液-24122002批-氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min158621-5862178.11477.550.8878.1177.550.88
258721-5872178.24778.25
358054-5805477.35877.36
457541-5754176.67576.67
558559-5855978.03178.03
657691-5769176.87476.87
10min166744-6674488.93888.131.1689.0788.261.16
264833-6483386.39186.52
365918-6591887.83787.97
466905-6690589.15289.28
566538-6653888.66388.79
665888-6588887.79787.93
15min170067-7006793.36692.341.3093.6492.621.29
268722-6872291.57391.85
368661-6866191.49291.77
470753-7075394.28094.56
568622-6862291.44091.72
668963-6896391.89592.17
20min169198-6919892.20892.941.6092.6493.371.59
268935-6893591.85792.28
369745-6974592.93793.36
471816-7181695.69696.13
569981-6998193.25193.68
668808-6880891.68892.12
30min171080-7108094.71694.361.1695.3094.941.16
270631-7063194.11794.70
370163-7016393.49494.08
472080-7208096.04896.64
571147-7114794.80595.39
669756-6975692.95193.53
45min172565-7256596.69495.051.4697.4495.791.45
271578-7157895.37996.12
370091-7009193.39894.14
472358-7235896.41897.17
571143-7114394.79995.54
670249-7024993.60894.34
60min168851-6885191.74593.751.4592.6594.651.44
269843-6984393.06793.96
370558-7055894.02094.91
471877-7187795.77896.69
570859-7085994.42195.32
670134-7013493.45594.35
极限170961-7096194.55796.191.3195.6297.251.30
271839-7183995.72796.78
372745-7274596.93497.99
473642-7364298.12999.20
572351-7235196.40997.47
671584-7158495.38796.43
奥美沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号OM230503W对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.964532894535014542134539174543184538480.10
2 11.054575624577104576360.03
单位质量响应值RSD%判断
41409.4941415.020.01数据可信
供试品溶液-24122002批-奥美沙坦酯-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1207963-20796345.15144.952.0045.1544.942.00
2210940-21094045.79745.80
3209153-20915345.40945.41
4205014-20501444.51144.51
5209405-20940545.46445.46
6199629-19962943.34143.34
10min1304546-30454666.12065.301.0566.2065.381.05
2298259-29825964.75564.83
3298743-29874364.86064.94
4303826-30382665.96466.04
5302226-30222665.61665.69
6297143-29714364.51364.58
15min1344575-34457574.81174.251.6975.0074.441.69
2336229-33622972.99973.18
3338705-33870573.53673.72
4352077-35207776.43976.62
5342218-34221874.29974.48
6338221-33822173.43173.61
20min1361816-36181678.55478.911.7678.8679.221.76
2358081-35808177.74378.05
3358732-35873277.88478.19
4375245-37524581.46981.78
5365777-36577779.41479.72
6361072-36107278.39278.69
30min1382855-38285583.12283.341.6183.5683.781.61
2381352-38135282.79583.23
3378545-37854582.18682.62
4395636-39563685.89686.34
5384729-38472983.52883.97
6379968-37996882.49582.93
45min1393330-39333085.39685.321.6485.9885.901.64
2389390-38939084.54085.11
3386543-38654383.92284.50
4404756-40475687.87688.47
5394220-39422085.58986.17
6389535-38953584.57285.14
60min1389030-38903084.46285.201.5785.1885.921.56
2389537-38953784.57285.29
3386846-38684683.98884.70
4403773-40377387.66388.40
5394693-39469385.69286.41
6390811-39081184.84985.56
极限1400884-40088487.03687.581.4787.9088.441.47
2399658-39965886.77087.62
3401408-40140887.15088.00
4414570-41457090.00790.89
5405083-40508387.94788.81
6398649-39864986.55187.40
奥美沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号070220417对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.997850478527784007842678421784560.08
2 16.107814078240781900.10
单位质量响应值RSD%判断
4906.574856.520.73数据可信
供试品溶液-24122003批-氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min155902-5590274.16372.894.8674.1672.884.87
256045-5604574.35374.35
357739-5773976.60176.60
454212-5421271.92171.92
555751-5575173.96373.96
649993-4999366.32466.32
10min165148-6514886.43086.671.9686.5586.801.96
266230-6623087.86587.99
366951-6695188.82288.95
463811-6381184.65684.78
565935-6593587.47487.60
663910-6391084.78784.90
15min167670-6767089.77690.331.6890.0490.591.68
268173-6817390.44390.71
369285-6928591.91892.19
466064-6606487.64587.91
568399-6839990.74391.01
668922-6892291.43791.69
20min168346-6834690.67391.421.6591.0991.841.65
268970-6897091.50091.92
369947-6994792.79693.23
467062-6706288.96989.38
568935-6893591.45491.87
670185-7018593.11293.52
30min169015-6901591.56092.711.4392.1393.281.42
270989-7098994.17994.75
370741-7074193.85094.43
468439-6843990.79691.35
570238-7023893.18393.76
669879-6987992.70693.27
45min168921-6892191.43593.382.1292.1694.102.11
271085-7108594.30695.04
372018-7201895.54496.28
468370-6837090.70491.41
570240-7024093.18593.91
671682-7168295.09895.81
60min170011-7001192.88193.821.5293.7594.701.52
271730-7173095.16296.05
372001-7200195.52196.42
469167-6916791.76292.62
570426-7042693.43294.32
670970-7097094.15495.03
极限171623-7162395.02095.230.9696.0596.270.96
271975-7197595.48796.53
372625-7262596.34997.41
470988-7098894.17895.19
571064-7106494.27895.32
672423-7242396.08197.11
奥美沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号OM230503W对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.964587344587644587844585654593984588490.07
2 11.054579424576334577880.05
单位质量响应值RSD%判断
41865.7841428.780.75数据可信
供试品溶液-24122003批-奥美沙坦酯-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1193864-19386441.85341.445.7941.8541.445.79
2195409-19540942.18742.19
3201661-20166143.53743.54
4187860-18786040.55740.56
5201041-20104143.40343.40
6171762-17176237.08237.08
10min1285387-28538761.61261.832.5761.6861.902.58
2292084-29208463.05863.13
3291068-29106862.83962.91
4281629-28162960.80160.87
5293709-29370963.40963.48
6274593-27459359.28259.34
15min1325437-32543770.25970.410.9970.4370.581.00
2328625-32862570.94771.12
3328445-32844570.90871.09
4323565-32356569.85570.02
5329295-32929571.09271.27
6321372-32137269.38169.54
20min1346769-34676974.86475.361.0675.1575.651.06
2349020-34902075.35075.64
3353327-35332776.28076.58
4345436-34543674.57674.86
5353801-35380176.38276.68
6346157-34615774.73275.01
30min1360971-36097177.93079.781.6778.3480.201.67
2371740-37174080.25580.67
3376791-37679181.34681.77
4364479-36447978.68879.10
5375143-37514380.99081.41
6368230-36823079.49779.90
45min1372816-37281680.48782.381.7081.0382.931.70
2387002-38700283.55084.10
3388384-38838483.84884.41
4374520-37452080.85581.40
5383754-38375482.84983.41
6383047-38304782.69683.23
60min1377093-37709381.41182.841.3682.0983.521.36
2389340-38934084.05584.75
3388627-38862783.90184.60
4377993-37799381.60582.28
5385279-38527983.17883.87
6383922-38392282.88583.56
极限1394896-39489685.25485.630.7886.0786.450.78
2400076-40007686.37387.20
3398080-39808085.94286.78
4391900-39190084.60785.42
5399196-39919686.18387.02
6395630-39563085.41386.22
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