阿齐沙坦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68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.662843622845082846712845532843752844940.05
210.712841632846182843900.12
单位质量响应值RSD%判断
26687.9926553.690.36数据可信
供试品溶液-2023101221批-阿齐沙坦-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%
5min157870-5787019.50626.8719.2319.5126.8719.22
289685-8968530.23030.23
371643-7164324.14924.15
4101610-10161034.25034.25
573684-7368424.83724.84
683782-8378228.24028.24
10min1233570-23357078.72987.537.2878.8487.687.29
2253201-25320185.34685.51
3249509-24950984.10284.24
4282190-28219095.11795.31
5258803-25880387.23487.37
6280851-28085194.66694.82
15min1265535-26553589.50495.174.4590.0595.814.47
2270976-27097691.33891.98
3279372-27937294.16894.77
4295978-29597899.765100.48
5287612-28761296.94597.57
6294671-29467199.324100.01
20min1277611-27761193.57498.013.1194.6299.183.14
2281221-28122194.79195.94
3293424-29342498.904100.03
4298170-298170100.504101.78
5297635-297635100.323101.48
6296594-29659499.973101.21
30min1291174-29117498.146100.061.4899.71101.771.52
2291342-29134298.20299.88
3298877-298877100.742102.42
4299469-299469100.942102.77
5299574-299574100.977102.70
6300634-300634101.334103.12
45min1294088-29408899.128100.291.38101.24102.561.41
2291139-29113998.134100.36
3299534-299534100.964103.20
4299148-299148100.833103.23
5299191-299191100.848103.13
6302142-302142101.843104.20
60min1291424-29142498.23099.761.31100.89102.591.35
2290890-29089098.050100.82
3298021-298021100.454103.25
4297344-297344100.225103.18
5297946-297946100.428103.27
6300202-300202101.189104.11
极限1291719-29171998.32999.361.18101.53102.731.21
2289340-28934097.528100.84
3298098-298098100.480103.83
4296008-29600899.775103.28
5296136-29613699.818103.22
6297326-297326100.219103.70
阿齐沙坦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100374-202106对照品来源中检院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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.786969669754695017004070166698310.39
214.796983669356695960.49
单位质量响应值RSD%判断
4724.704705.610.29数据可信
供试品溶液-2023101221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%
5min136274-3627449.87842.8421.9749.8842.8421.97
223265-2326531.99031.99
328495-2849539.18139.18
441573-4157357.16457.16
525693-2569335.32835.33
631647-3164743.51543.52
10min162505-6250585.94683.013.7886.2283.243.82
260320-6032082.94183.12
358535-5853580.48780.70
463235-6323586.94987.27
557244-5724478.71278.91
660363-6036383.00083.24
15min169227-6922795.18991.813.2495.9492.513.27
266850-6685091.92092.56
364499-6449988.68789.35
468549-6854994.25695.06
563904-6390487.86988.50
667611-6761192.96793.67
20min170501-7050196.94093.752.9398.2294.962.96
268361-6836193.99895.15
366886-6688691.97093.13
469438-6943895.47996.80
564923-6492389.27190.39
668973-6897394.83996.06
30min171835-7183598.77595.553.05100.6097.283.07
270319-7031996.69098.36
367626-6762692.98794.66
470761-7076197.29899.15
566227-6622791.06492.68
670163-7016396.47698.22
45min172928-72928100.27895.584.08102.6597.844.08
268755-6875594.54096.75
366573-6657391.53993.72
471152-7115297.836100.23
566039-6603990.80592.93
671610-7161098.465100.75
60min172193-7219399.26796.073.58102.1998.863.60
270187-7018796.50999.24
367749-6774993.15695.85
471793-7179398.717101.66
565952-6595290.68593.31
671315-7131598.060100.89
极限171838-7183898.77995.533.25102.2698.853.28
269457-6945795.50598.77
367869-6786993.32196.53
471053-7105397.699101.19
565858-6585890.55693.69
670763-7076397.301100.67
阿齐沙坦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68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.662842602842322843462842192841722842460.03
210.712830772834462832620.10
单位质量响应值RSD%判断
26664.7326448.370.58数据可信
供试品溶液-2023101221批-阿齐沙坦-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%
5min130352-3035210.25621.1553.0410.2621.1453.04
240026-4002613.52413.52
3108201-10820136.56036.56
455052-5505218.60118.60
599955-9995533.77433.77
641917-4191714.16314.16
10min1206116-20611669.64480.289.2569.7080.399.31
2225125-22512576.06776.14
3266322-26632289.98790.19
4235050-23505079.42179.52
5258239-25823987.25687.44
6234652-23465279.28679.36
15min1271607-27160791.77392.123.3892.2292.683.42
2278836-27883694.21594.71
3283410-28341095.76196.46
4267077-26707790.24290.79
5276940-27694093.57594.25
6257878-25787887.13487.65
20min1277472-27747293.75595.072.8994.7196.142.93
2288620-28862097.52198.54
3288905-28890597.61898.85
4275565-27556593.11094.16
5287663-28766397.19898.39
6269938-26993891.20992.21
30min1287409-28740997.11297.772.7898.5999.372.83
2294134-29413499.384100.95
3297699-297699100.589102.37
4279442-27944294.42095.98
5296666-296666100.240101.97
6280743-28074394.86096.37
45min1292103-29210398.69898.742.04100.71100.892.08
2297340-297340100.468102.58
3295875-29587599.973102.31
4282761-28276195.54297.63
5297574-297574100.547102.84
6287753-28775397.22899.27
60min1293338-29333899.11699.250.99101.68101.941.05
2297369-297369100.478103.15
3296172-296172100.073102.96
4290149-29014998.038100.66
5294571-29457199.532102.38
6290780-29078098.251100.83
极限1289877-28987797.94697.830.84101.06101.080.91
2291354-29135498.445101.68
3293016-29301699.007102.45
4287144-28714497.023100.19
5289083-28908397.678101.08
6286742-28674296.887100.01
阿齐沙坦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100374-202106对照品来源中检院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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.786979169566697246955869623696520.15
214.796992069449696840.48
单位质量响应值RSD%判断
4712.584711.560.02数据可信
供试品溶液-2023101221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%
5min134827-3482747.91950.217.8447.9250.217.83
239548-3954854.41554.41
337741-3774151.92851.93
438600-3860053.11053.11
536526-3652650.25750.26
631721-3172143.64543.65
10min162165-6216585.53484.605.7385.8084.875.72
266684-6668491.75192.05
359651-5965182.07582.36
463466-6346687.32487.62
556363-5636377.55177.83
660568-6056883.33683.58
15min169514-6951495.64592.025.5796.3992.765.56
271529-7152998.41899.23
364920-6492089.32490.07
468144-6814493.76094.54
560987-6098783.91384.62
666160-6616091.03191.74
20min169687-6968795.88393.685.3397.1694.945.32
272585-7258599.871101.23
365894-6589490.66591.91
469532-6953295.67096.97
562116-6211685.46686.64
668684-6868494.50395.71
30min171177-7117797.93394.725.1399.7496.495.12
273115-73115100.600102.51
366963-6696392.13593.88
469679-6967995.87297.70
562993-6299386.67388.32
669102-6910295.07896.81
45min170897-7089797.54894.474.9799.9096.784.97
272873-72873100.267102.74
367216-6721692.48394.74
469086-6908695.05697.42
562908-6290886.55688.69
668993-6899394.92897.19
60min171413-7141398.25895.305.70101.1598.135.68
274067-74067101.910104.94
368157-6815793.77896.55
470625-7062597.174100.07
562411-6241185.87288.49
668889-6888994.78597.58
极限170834-7083497.46293.635.64100.9096.995.62
271830-7183098.832102.43
367027-6702792.22395.51
469669-6966995.85999.29
561140-6114084.12387.21
667782-6778293.26296.58
阿齐沙坦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68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.662841622839272843292841432841402841400.06
210.712848772847412848090.04
单位质量响应值RSD%判断
26654.7826592.810.17数据可信
供试品溶液-2024010621批-阿齐沙坦-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%
5min183516-8351628.14734.1924.2828.1534.1924.28
286597-8659729.18629.19
3107010-10701036.06636.07
4147021-14702149.55049.55
581896-8189627.60127.60
6102676-10267634.60534.60
10min1280595-28059594.56995.622.0494.7395.802.07
2282548-28254895.22795.39
3287362-28736296.85097.05
4292552-29255298.59998.87
5275763-27576392.94093.09
6283383-28338395.50995.70
15min1294255-29425599.17399.391.9199.85100.111.94
2295912-29591299.731100.42
3299159-299159100.825101.56
4298418-298418100.576101.40
5284023-28402395.72496.39
6297698-297698100.333101.06
20min1293959-29395999.07399.591.99100.31100.872.01
2296499-29649999.929101.17
3303943-303943102.438103.74
4298415-298415100.575101.96
5286190-28619096.45597.66
6294003-29400399.088100.37
30min1291988-29198898.409100.062.70100.19101.882.69
2303230-303230102.198104.00
3307527-307527103.646105.51
4296354-29635499.880101.82
5284979-28497996.04697.78
6297189-297189100.162101.99
45min1292388-29238898.54399.492.28100.87101.872.29
2297319-297319100.205102.57
3304161-304161102.511104.95
4297382-297382100.227102.72
5283937-28393795.69597.97
6295956-29595699.746102.13
60min1290911-29091198.04698.792.25100.92101.722.25
2295997-29599799.760102.68
3300380-300380101.237104.25
4293540-29354098.932101.98
5281366-28136694.82997.63
6296534-29653499.941102.88
极限1290244-29024497.82198.951.23101.24102.441.27
2295222-29522299.499102.98
3298754-298754100.689104.26
4296170-29617099.818103.42
5290603-29060397.942101.27
6290617-29061797.947101.44
阿齐沙坦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100374-202106对照品来源中检院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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.786993369843700046998069988699500.10
214.796968869940698140.26
单位质量响应值RSD%判断
4732.754720.350.19数据可信
供试品溶液-2024010621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%
5min138900-3890053.35957.2410.3253.3657.2410.32
244483-4448361.01761.02
343342-4334259.45259.45
446346-4634663.57363.57
534511-3451147.33947.34
642784-4278458.68758.69
10min165396-6539689.70489.252.6490.0089.572.66
266247-6624790.87191.21
365067-6506789.25389.58
467125-6712592.07692.43
562150-6215085.25185.51
664423-6442388.36988.70
15min167278-6727892.28593.961.5393.0894.771.55
269593-6959395.46196.30
367643-6764392.78693.61
469679-6967995.57996.44
567832-6783293.04593.78
668972-6897294.60995.43
20min168862-6886294.45894.850.8595.7796.190.84
269672-6967295.56996.94
368531-6853194.00495.35
469567-6956795.42596.82
569756-6975695.68596.94
668494-6849493.95395.30
30min170239-7023996.34796.310.8698.1898.170.86
271391-7139197.92799.83
369758-6975895.68797.55
469899-6989995.88197.81
569919-6991995.90897.69
670061-7006196.10397.97
45min171628-7162898.25296.851.58100.6299.251.53
270991-7099197.37999.83
369581-6958195.44497.84
471147-7114797.593100.05
571420-7142097.967100.28
668882-6888294.48696.88
60min171104-7110497.53496.151.89100.4599.091.86
270828-7082897.155100.15
369620-6962095.49898.42
470016-7001696.04199.04
567743-6774392.92395.79
671268-7126897.759100.68
极限170561-7056196.78995.751.85100.2499.211.78
269714-6971495.62799.16
368728-6872894.27497.73
470510-7051096.719100.25
571381-7138197.914101.29
667907-6790793.14896.61
阿齐沙坦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68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.662847852848102848642845642849352847920.05
210.712843022844862843940.05
单位质量响应值RSD%判断
26715.9526554.060.43数据可信
供试品溶液-2024010621批-阿齐沙坦-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%
5min1109182-10918236.78232.5520.9036.7832.5520.89
275918-7591825.57625.58
397192-9719232.74332.74
469162-6916223.30023.30
5120567-12056740.61840.62
6107728-10772836.29336.29
10min1281659-28165994.88896.041.9695.0996.221.98
2287010-28701096.69196.83
3288770-28877097.28497.47
4276528-27652893.16093.29
5292352-29235298.49198.72
6284175-28417595.73695.94
15min1291323-29132398.14499.761.1898.88100.481.20
2294618-29461899.25499.93
3299322-299322100.839101.56
4294452-29445299.19899.85
5300887-300887101.366102.14
6296119-29611999.760100.49
20min1291522-29152298.21199.991.2399.49101.261.24
2295924-29592499.694100.92
3296794-29679499.987101.27
4296200-29620099.787100.99
5302826-302826102.019103.36
6297565-297565100.247101.53
30min1292578-29257898.56799.821.41100.39101.641.40
2292284-29228498.468100.25
3303530-303530102.256104.09
4296565-29656599.910101.66
5297881-297881100.353102.26
6294862-29486299.336101.18
45min1288845-28884597.30999.051.3799.68101.431.38
2293605-29360598.913101.24
3294328-29432899.156101.56
4292058-29205898.392100.70
5301068-301068101.427103.89
6294150-29415099.096101.49
60min1288600-28860097.22798.660.97100.14101.590.98
2291935-29193598.350101.23
3292050-29205098.389101.35
4293303-29330398.811101.67
5297168-297168100.113103.14
6294043-29404399.060102.01
极限1289855-28985597.64998.570.95101.10102.050.96
2290941-29094198.015101.44
3292507-29250798.543102.05
4293020-29302098.716102.12
5297759-297759100.312103.89
6291515-29151598.209101.71
阿齐沙坦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100374-202106对照品来源中检院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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.786964769830698816968969714697520.15
214.796959669822697090.23
单位质量响应值RSD%判断
4719.354713.250.10数据可信
供试品溶液-2024010621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%
5min140466-4046655.62856.4315.1855.6356.4315.18
235547-3554748.86648.87
335351-3535148.59648.60
437540-3754051.60651.61
549623-4962368.21668.22
647769-4776965.66765.67
10min164136-6413688.16789.892.4288.4890.202.45
264257-6425788.33388.60
364723-6472388.97489.24
464933-6493389.26289.55
565930-6593090.63391.01
668337-6833793.94294.31
15min168597-6859794.29995.641.8895.1096.451.89
268538-6853894.21894.98
370417-7041796.80197.57
469384-6938495.38196.16
568692-6869294.43095.31
671806-7180698.71099.60
20min169222-6922295.15896.991.8996.4898.331.90
269171-6917195.08896.37
371044-7104497.66398.96
471281-7128197.98999.30
570015-7001596.24897.66
672583-7258399.779101.21
30min170616-7061697.07598.182.2098.93100.072.18
269949-6994996.15897.97
373038-73038100.404102.25
472140-7214099.170101.03
569613-6961395.69697.64
673179-73179100.598102.59
45min170018-7001896.25298.391.7498.64100.821.75
270438-7043896.83099.18
372319-7231999.416101.82
471835-7183598.750101.16
571417-7141798.176100.65
673397-73397100.898103.45
60min170448-7044896.84498.641.8799.77101.621.85
270981-7098197.576100.46
372603-7260399.806102.76
472757-72757100.018102.97
570312-7031296.65799.68
673431-73431100.944104.05
极限170709-7070997.20298.491.94100.67102.021.91
270336-7033696.690100.12
373265-73265100.716104.23
472690-7269099.926103.44
570175-7017596.468100.02
672708-7270899.950103.62
阿齐沙坦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68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.662847232852052849822850302844792848840.10
210.712850792851012850900.01
单位质量响应值RSD%判断
26724.5826619.050.28数据可信
供试品溶液-2024010721批-阿齐沙坦-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%
5min178797-7879726.50935.3618.6626.5135.3618.66
2127034-12703442.73742.74
3128967-12896743.38843.39
4104300-10430035.08935.09
594725-9472531.86831.87
696724-9672432.54032.54
10min1280963-28096394.52397.452.2794.6797.642.29
2288632-28863297.10397.34
3299184-299184100.653100.89
4288518-28851897.06497.26
5285534-28553496.06096.24
6295092-29509299.27699.46
15min1293890-29389098.872100.251.6399.54100.991.64
2295767-29576799.503100.28
3302289-302289101.697102.50
4294611-29461199.11499.85
5295644-29564499.462100.17
6305763-305763102.866103.60
20min1296343-29634399.697100.741.57100.92102.041.58
2297884-297884100.215101.54
3303402-303402102.072103.44
4298110-298110100.291101.58
5294206-29420698.978100.24
6306753-306753103.199104.50
30min1295316-29531699.351100.491.87101.13102.351.87
2295461-29546199.400101.29
3303311-303311102.041103.97
4295623-29562399.455101.30
5294546-29454699.092100.91
6307948-307948103.601105.48
45min1287946-28794696.87298.621.3799.20101.031.39
2291471-29147198.058100.50
3297886-297886100.216102.72
4291950-29195098.219100.61
5291556-29155698.086100.45
6297968-297968100.244102.70
60min1289565-28956597.41798.841.54100.28101.801.53
2288041-28804196.90499.89
3296522-29652299.757102.81
4297440-297440100.066103.01
5292213-29221398.307101.22
6299072-299072100.615103.62
极限1293362-29336298.69499.361.30102.10102.871.30
2290730-29073097.809101.33
3298736-298736100.502104.11
4292332-29233298.347101.84
5296354-29635499.701103.16
6300504-300504101.097104.67
阿齐沙坦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100374-202106对照品来源中检院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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.786977969870701646989769616698650.29
214.796995570154700540.21
单位质量响应值RSD%判断
4727.004736.580.15数据可信
供试品溶液-2024010721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%
5min136738-3673850.33861.3212.3050.3461.3212.29
246030-4603063.07063.07
353558-5355873.38473.38
442959-4295958.86258.86
546140-4614063.22063.22
643094-4309459.04759.05
10min164288-6428888.08692.592.9988.3792.933.01
268599-6859993.99394.34
369349-6934995.02195.43
467180-6718092.04992.38
566445-6644591.04291.39
669569-6956995.32295.65
15min169157-6915794.75896.472.3895.5397.322.38
271683-7168398.21999.09
370411-7041196.47697.41
469876-6987695.74396.58
568378-6837893.69094.55
672933-7293399.932100.79
20min169564-6956495.31597.532.9396.6198.922.92
273213-73213100.315101.73
371307-7130797.70499.18
470641-7064196.79198.16
568475-6847593.82395.20
673869-73869101.214102.63
30min170962-7096297.23197.493.0499.0699.433.02
272246-7224698.990100.97
371531-7153198.011100.02
470597-7059796.73198.64
567524-6752492.52094.42
674065-74065101.483103.46
45min170118-7011896.07596.282.1198.4498.762.11
271618-7161898.130100.66
370476-7047696.56599.12
469518-6951895.25297.70
567902-6790293.03895.45
671974-7197498.618101.16
60min170809-7080997.02196.322.1199.9299.332.09
271629-7162998.145101.22
369738-6973895.55498.65
469396-6939695.08598.06
568142-6814293.36796.30
672077-7207798.759101.85
极限170482-7048296.57396.841.68100.01100.391.68
271972-7197298.615102.23
370366-7036696.414100.04
469372-6937295.05298.56
569653-6965395.43798.89
672230-7223098.968102.60
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