阿齐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100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.195148451365512825143751474514080.17
212.235159751511515540.12
单位质量响应值RSD%判断
4217.234215.370.04数据可信
中间条件3月-供试品溶液-24051503批-左氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min150146-5014696.11896.340.9796.1296.340.97
249678-4967895.22195.22
350562-5056296.91696.92
450877-5087797.51997.52
549740-4974095.34095.34
650557-5055796.90696.91
10min153051-53051101.68698.932.52102.2299.472.50
252022-5202299.714100.24
352290-52290100.228100.77
450874-5087497.51498.06
549386-4938694.66195.19
652056-5205699.779100.32
15min151927-5192799.53298.361.42100.6399.441.42
251407-5140798.53599.62
351749-5174999.191100.29
450673-5067397.12898.21
550187-5018796.19797.25
651945-5194599.566100.66
20min151198-5119898.13597.572.1699.7999.202.14
250771-5077197.31698.95
350491-5049196.77998.43
450495-5049596.78798.41
549595-4959595.06296.65
652872-52872101.343102.99
30min151351-5135198.42896.591.44100.6298.771.44
250057-5005795.94898.12
350054-5005495.94298.13
450305-5030596.42398.58
549447-4944794.77896.90
651153-5115398.048100.26
45min149502-4950294.88494.152.1697.6396.862.13
249318-4931894.53197.24
349484-4948494.84997.57
449040-4904093.99896.69
547129-4712990.33592.98
650257-5025796.33199.08
60min149443-4944394.77193.602.3598.0496.832.32
248452-4845292.87196.10
349208-4920894.32097.56
448748-4874893.43996.66
546880-4688089.85893.00
650268-5026896.35299.64
极限149293-4929394.48392.812.6098.2896.562.56
248094-4809492.18595.93
348833-4883393.60197.37
448289-4828992.55996.30
546208-4620888.57092.22
649806-4980695.46699.29
阿齐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%
111.293935363938013935273937233937793936730.04
211.343936773938083937420.03
单位质量响应值RSD%判断
34869.1834721.520.31数据可信
中间条件3月-供试品溶液-24051503批-阿齐沙坦-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min14146-41461.0691.1614.791.071.1614.79
24356-43561.1231.12
34166-41661.0741.07
45600-56001.4441.44
54948-49481.2761.28
63765-37650.9710.97
10min115147-151473.9064.155.823.914.165.80
215509-155093.9994.01
315634-156344.0324.04
417744-177444.5764.58
516555-165554.2694.28
616050-160504.1394.14
15min122081-220815.6946.306.285.726.326.29
223435-234356.0436.07
324057-240576.2046.23
426307-263076.7846.82
525248-252486.5116.54
625365-253656.5416.57
20min126904-269046.9387.747.027.007.817.00
228475-284757.3437.41
329445-294457.5937.66
432014-320148.2568.33
531109-311098.0228.09
632158-321588.2938.36
30min134422-344228.8779.796.498.979.906.52
235783-357839.2289.33
337678-376789.7169.82
440523-4052310.45010.57
539309-3930910.13710.25
640117-4011710.34510.46
45min140441-4044110.42911.696.4310.5811.866.41
243476-4347611.21211.37
346261-4626111.93012.09
447640-4764012.28512.46
545949-4594911.84912.02
648242-4824212.44112.61
60min145419-4541911.71313.076.7111.9213.306.69
247703-4770312.30212.52
352223-5222313.46713.69
453737-5373713.85814.10
551361-5136113.24513.48
653677-5367713.84214.08
极限150694-5069413.07314.426.1113.3414.726.12
252825-5282513.62313.91
357320-5732014.78215.08
459002-5900215.21515.54
556780-5678014.64214.95
658973-5897315.20815.52
阿齐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100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.195132951387513685128251303513340.09
212.235164451670516570.04
单位质量响应值RSD%判断
4211.164223.790.22数据可信
中间条件3月-供试品溶液-24051503批-左氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min149681-4968195.20195.101.6095.2095.101.60
250126-5012696.05396.05
349869-4986995.56195.56
449139-4913994.16294.16
550608-5060896.97796.98
648357-4835792.66392.66
10min150554-5055496.87397.450.8097.4097.980.79
251199-5119998.10998.64
350333-5033396.45096.98
451294-5129498.29198.81
551130-5113097.97798.52
650612-5061296.98597.50
15min149930-4993095.67896.401.2896.7497.461.28
250681-5068197.11798.20
350141-5014196.08297.15
449510-4951094.87395.94
551363-5136398.42499.51
650201-5020196.19797.25
20min150127-5012796.05595.752.0497.6597.362.01
250499-5049996.76898.39
350685-5068597.12498.72
448005-4800591.98993.59
550667-5066797.09098.72
649835-4983595.49697.08
30min149939-4993995.69594.741.9797.8396.881.95
249781-4978195.39297.55
350305-5030596.39698.54
447832-4783291.65793.76
550109-5010996.02198.19
648688-4868893.29895.42
45min148574-4857493.07992.652.3995.7495.322.36
248860-4886093.62796.31
349297-4929794.46597.14
447090-4709090.23692.85
549520-4952094.89297.59
646770-4677089.62292.26
60min148531-4853192.99792.281.7996.1895.461.78
248922-4892293.74696.95
348483-4848392.90596.11
446719-4671989.52592.64
548782-4878293.47896.71
647516-4751691.05294.19
极限147725-4772591.45291.941.7395.1595.641.71
248785-4878593.48497.21
348154-4815492.27495.99
446457-4645789.02392.64
548532-4853292.99996.75
648236-4823692.43296.07
阿齐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%
111.293931623929913931323923643929223929140.09
211.343962053960103961080.04
单位质量响应值RSD%判断
34801.9534930.160.27数据可信
中间条件3月-供试品溶液-24051503批-阿齐沙坦-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min14785-47851.2311.2117.301.231.2117.41
24332-43321.1151.11
34252-42521.0941.09
43880-38800.9991.00
56214-62141.5991.60
64750-47501.2221.22
10min116320-163204.2004.2114.254.214.2214.21
214584-145843.7533.76
314429-144293.7133.72
415657-156574.0294.03
520810-208105.3565.36
616435-164354.2304.24
15min124611-246116.3346.2513.516.366.2813.52
221578-215785.5535.58
321620-216205.5645.59
422950-229505.9065.93
530392-303927.8227.86
624462-244626.2956.33
20min131176-311768.0237.7312.508.097.7912.49
226611-266116.8496.91
327352-273527.0397.10
427953-279537.1947.25
536800-368009.4719.55
630218-302187.7777.84
30min139543-3954310.1779.6911.1310.299.8011.14
233741-337418.6838.78
334607-346078.9069.00
435377-353779.1059.21
545022-4502211.58711.72
637634-376349.6859.79
45min147519-4751912.22911.589.9512.4011.7410.01
240252-4025210.35910.50
341843-4184310.76910.91
442838-4283811.02511.18
552524-5252413.51713.72
644936-4493611.56511.73
60min153972-5397213.89012.928.8614.1213.158.91
246494-4649411.96612.17
346465-4646511.95812.16
447406-4740612.20012.41
557200-5720014.72115.00
649785-4978512.81313.04
极限157962-5796214.91714.366.1015.2314.666.19
252538-5253813.52113.79
352311-5231113.46313.74
454137-5413713.93314.21
560945-6094515.68516.04
656815-5681514.62214.92
阿齐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100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.195157851543517455140851542515630.24
212.235110451411512580.43
单位质量响应值RSD%判断
4229.944191.170.66数据可信
中间条件3月-供试品溶液-2024052421批-左氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min148648-4864893.37693.690.7293.3893.690.72
248330-4833092.76692.77
348653-4865393.38693.39
449086-4908694.21794.22
549317-4931794.66094.66
648837-4883793.73993.74
10min150857-5085797.61696.841.1898.1397.361.17
250809-5080997.52498.04
349584-4958495.17395.69
449960-4996095.89496.42
550379-5037996.69997.22
651132-5113298.14498.66
15min150703-5070397.32096.131.0698.3897.191.05
250287-5028796.52297.58
349273-4927394.57695.62
449626-4962695.25396.31
550304-5030496.55597.62
650315-5031596.57697.64
20min150389-5038996.71895.441.1198.3297.031.10
249768-4976895.52697.12
348757-4875793.58595.16
450021-5002196.01197.60
549553-4955395.11396.71
649847-4984795.67797.28
30min150033-5003396.03494.971.4398.1797.101.41
249001-4900194.05496.18
348574-4857493.23495.33
449029-4902994.10796.23
549910-4991095.79897.93
650336-5033696.61698.75
45min148977-4897794.00893.911.0296.6896.561.00
248407-4840792.91395.56
348740-4874093.55396.16
448512-4851293.11595.76
549753-4975395.49798.16
649177-4917794.39197.06
60min147421-4742191.02192.521.1494.2295.691.10
247785-4778591.72094.88
348148-4814892.41695.55
448810-4881093.68796.85
548787-4878793.64396.83
648248-4824892.60895.80
极限149337-4933794.69893.581.9498.4097.261.89
247741-4774191.63595.31
348118-4811892.35996.00
447873-4787391.88895.57
549658-4965895.31599.03
649792-4979295.57299.28
阿齐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%
111.293935223936873938463941893940793938650.07
211.343928183930113929140.04
单位质量响应值RSD%判断
34886.1834648.500.49数据可信
中间条件3月-供试品溶液-2024052421批-阿齐沙坦-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17719-77191.9921.945.281.991.935.14
28036-80362.0742.07
37533-75331.9441.94
47442-74421.9211.92
56839-68391.7651.77
67419-74191.9151.91
10min117848-178484.6064.545.604.624.555.63
219183-191834.9514.96
318041-180414.6564.67
417168-171684.4314.44
516332-163324.2154.22
617060-170604.4034.41
15min125352-253526.5436.413.916.586.453.91
226391-263916.8116.85
325228-252286.5116.55
424023-240236.2006.24
523927-239276.1756.21
624214-242146.2496.28
20min130184-301847.7907.703.437.867.783.42
231472-314728.1238.20
330360-303607.8367.91
429288-292887.5597.63
528789-287897.4307.50
628976-289767.4787.55
30min137315-373159.6319.552.669.759.662.66
238320-383209.89010.01
337788-377889.7539.87
435777-357779.2349.35
536120-361209.3229.43
636703-367039.4739.58
45min143988-4398811.35311.432.9111.5211.592.91
245783-4578311.81611.99
345791-4579111.81811.99
442648-4264811.00711.17
544123-4412311.38811.55
643293-4329311.17311.34
60min147722-4772212.31712.572.8512.5512.802.86
249731-4973112.83513.08
350870-5087013.12913.37
447952-4795212.37612.60
548663-4866312.55912.78
647187-4718712.17812.40
极限155765-5576514.39214.341.6714.6914.641.67
255439-5543914.30814.62
356995-5699514.71015.02
454191-5419113.98614.28
555933-5593314.43614.73
655146-5514614.23314.53
阿齐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100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.195140351533514295146051418514490.11
212.235133651416513760.12
单位质量响应值RSD%判断
4220.594200.820.34数据可信
中间条件3月-供试品溶液-2024052421批-左氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min148749-4874993.56593.061.4193.5793.071.42
248245-4824592.59892.60
348921-4892193.89593.90
448392-4839292.88092.88
547324-4732490.83090.83
649297-4929794.61794.62
10min149421-4942194.85596.322.1695.3796.832.16
249773-4977395.53196.04
351701-5170199.23199.75
449740-4974095.46795.98
549089-4908994.21894.72
651367-5136798.59099.12
15min149012-4901294.07095.292.5595.1296.342.54
250442-5044296.81597.86
350564-5056497.04998.12
449912-4991295.79796.84
547373-4737390.92491.95
650590-5059097.09998.17
20min148510-4851093.10694.601.2594.6896.181.26
249338-4933894.69696.28
349972-4997295.91297.52
449420-4942094.85396.43
548609-4860993.29694.83
649871-4987195.71997.33
30min146716-4671689.66393.482.5391.7595.582.50
249054-4905494.15196.26
349626-4962695.24897.39
448346-4834692.79294.90
548258-4825892.62394.67
650219-5021996.38798.53
45min144855-4485586.09191.283.1288.6893.913.07
248040-4804092.20494.84
347576-4757691.31493.99
448299-4829992.70195.32
547342-4734290.86593.43
649253-4925394.53297.21
60min144458-4445885.32990.533.4088.3993.663.34
246768-4676889.76392.91
348924-4892493.90197.08
448006-4800692.13995.28
546583-4658389.40892.48
648269-4826992.64495.85
极限143665-4366583.80790.624.0587.3494.263.96
247325-4732590.83294.48
347497-4749791.16294.87
447924-4792491.98295.63
547424-4742491.02294.59
649452-4945294.91498.63
阿齐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%
111.293930093934353934803934213931203932930.06
211.343936593932753934670.07
单位质量响应值RSD%判断
34835.5234697.270.29数据可信
中间条件3月-供试品溶液-2024052421批-阿齐沙坦-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17635-76351.9711.935.941.971.935.89
27618-76181.9661.97
36923-69231.7871.79
47680-76801.9821.98
56943-69431.7921.79
68032-80322.0732.07
10min116856-168564.3504.473.794.364.483.76
217984-179844.6424.65
316800-168004.3364.35
416888-168884.3594.37
516998-169984.3874.40
618283-182834.7194.73
15min124037-240376.2046.242.556.246.282.57
225275-252756.5236.56
323704-237046.1186.15
423820-238206.1486.18
523752-237526.1306.16
624549-245496.3366.37
20min129491-294917.6117.502.577.687.582.55
230100-301007.7697.84
328390-283907.3277.40
428059-280597.2427.31
529289-292897.5597.63
629117-291177.5157.59
30min136438-364389.4049.332.549.529.442.55
237089-370899.5729.69
335722-357229.2209.33
434526-345268.9119.02
536354-363549.3839.49
636776-367769.4929.61
45min143015-4301511.10211.012.2711.2711.182.28
243496-4349611.22611.40
341422-4142210.69110.85
441467-4146710.70210.86
543039-4303911.10811.27
643523-4352311.23311.40
60min147565-4756512.27612.181.4412.5012.401.44
247433-4743312.24212.47
347879-4787912.35712.58
445931-4593111.85512.07
546999-4699912.13012.35
647231-4723112.19012.42
极限153827-5382713.89213.881.7814.1914.181.78
254746-5474614.13014.43
352508-5250813.55213.84
452791-5279113.62513.91
554224-5422413.99514.29
654689-5468914.11514.41
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