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%
112.114825448265482384818348243482370.07
212.184835248312483320.06
单位质量响应值RSD%判断
3983.243968.140.27数据可信
供试品溶液-24042901批-左氨氯地平-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%
5min140021-4002181.35481.679.0081.3581.669.00
239146-3914679.57579.58
333705-3370568.51568.51
444099-4409989.64389.64
542099-4209985.57885.58
641976-4197685.32885.33
10min147162-4716295.87095.552.3096.3296.002.31
245140-4514091.76092.20
346677-4667794.88495.26
447561-4756196.68197.18
548382-4838298.35098.83
647098-4709895.74096.21
15min147872-4787297.31396.081.9998.3097.062.00
245412-4541292.31293.26
347355-4735596.26297.17
447685-4768596.93397.97
547903-4790397.37698.40
647368-4736896.28997.29
20min146296-4629694.10995.793.7895.6397.303.75
244508-4450890.47591.94
347039-4703995.62097.06
449951-49951101.539103.11
547571-4757196.70198.26
647363-4736396.27897.82
30min147038-4703895.61895.572.4597.6797.622.45
244821-4482191.11193.08
347451-4745196.45798.43
448098-4809897.77299.91
547679-4767996.92199.02
647007-4700795.55597.63
45min145736-4573692.97195.302.8295.5597.882.81
244820-4482091.10993.58
347429-4742996.41398.92
448252-4825298.086100.77
547791-4779197.14899.79
647270-4727096.08998.70
60min147799-4779997.16596.042.06100.2699.162.07
245409-4540992.30695.29
347218-4721895.98499.03
447979-4797997.531100.76
547946-4794697.463100.64
647132-4713295.80998.95
极限148506-4850698.60295.912.53102.2499.552.50
244934-4493491.34194.83
347291-4729196.13299.71
447235-4723596.01899.79
547559-4755996.677100.40
647555-4755596.669100.34
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(%)99.7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%
111.373961153963913962823960223961413961900.04
211.383976043973013974520.06
单位质量响应值RSD%判断
34845.2134925.480.17数据可信
供试品溶液-24042901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%
5min128862-288627.4248.4352.627.428.4352.62
246218-4621811.88811.89
311231-112312.8892.89
458087-5808714.94114.94
533039-330398.4988.50
619161-191614.9284.93
10min1138681-13868135.67137.6927.0435.7137.7327.06
2191469-19146949.24949.31
395058-9505824.45024.47
4188147-18814748.39448.48
5155317-15531739.95040.00
6110429-11042928.40428.43
15min1257511-25751166.23661.239.5666.4761.489.62
2256482-25648265.97166.31
3199338-19933851.27351.42
4245638-24563863.18263.53
5246613-24661363.43263.70
6222618-22261857.26157.45
20min1309544-30954479.61974.365.1480.2374.955.09
2280415-28041572.12772.83
3273717-27371770.40470.84
4282328-28232872.61973.32
5282536-28253672.67273.29
6305928-30592878.68979.19
30min1335843-33584386.38482.237.7887.4383.247.60
2297822-29782276.60477.71
3329655-32965584.79285.62
4290513-29051374.72475.83
5308894-30889479.45280.48
6355491-35549191.43792.38
45min1357211-35721191.88086.448.5893.4187.918.39
2308331-30833179.30780.84
3349861-34986189.98991.29
4305032-30503278.45979.98
5320686-32068682.48583.95
6375350-37535096.54597.99
60min1363628-36362893.53088.128.8795.5790.068.69
2312140-31214080.28782.26
3357250-35725091.89093.69
4313119-31311980.53982.50
5324079-32407983.35885.28
6385231-38523199.087101.07
极限1403541-403541103.79798.655.38106.36101.095.31
2379687-37968797.661100.08
3392988-392988101.082103.39
4363271-36327193.43995.84
5356417-35641791.67694.06
6405321-405321104.254106.79
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%
112.114815448118481664809048126481310.07
212.184832248318483200.01
单位质量响应值RSD%判断
3974.483967.160.14数据可信
供试品溶液-24042902批-左氨氯地平-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%
5min115160-1516030.85564.3243.5130.8564.3243.52
243871-4387189.28989.29
334935-3493571.10271.10
437652-3765276.63276.63
513783-1378328.05228.05
644218-4421889.99590.00
10min143834-4383489.21495.335.4489.3995.685.57
249816-49816101.389101.88
347772-4777297.22997.62
447298-4729896.26496.69
543657-4365788.85389.01
648652-4865299.02099.52
15min145007-4500791.60197.714.1892.2798.604.31
250657-50657103.100104.16
348683-4868399.083100.02
447970-4797097.63298.59
546541-4654194.72395.37
649199-49199100.133101.18
20min146141-4614193.90998.803.0995.09100.223.22
250707-50707103.202104.83
349061-4906199.852101.34
448793-4879399.307100.81
547879-4787997.44698.62
648670-4867099.056100.66
30min147036-4703695.73198.542.0097.43100.522.12
248390-4839098.486100.69
349398-49398100.538102.58
448121-4812197.93999.99
547932-4793297.55499.27
649623-49623100.996103.15
45min146885-4688595.42398.072.7397.65100.592.78
249511-49511100.768103.52
349426-49426100.595103.19
446365-4636594.36596.96
548179-4817998.057100.32
648738-4873899.195101.91
60min145514-4551492.63399.234.1095.39102.304.16
251690-51690105.203108.52
349598-49598100.945104.10
448707-4870799.132102.25
548503-4850398.716101.52
648506-4850698.722101.99
极限147113-4711395.88798.091.4399.16101.711.52
248888-4888899.500103.40
348841-4884199.404103.12
448027-4802797.748101.42
548500-4850098.710102.06
647803-4780397.292101.11
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(%)99.7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%
111.373952553955543958903952803950713954100.09
211.383969743969033969380.02
单位质量响应值RSD%判断
34776.6134880.320.22数据可信
供试品溶液-24042902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%
5min113345-133453.4386.7636.343.446.7636.31
227061-270616.9726.97
315667-156674.0364.04
435546-355469.1589.16
532235-322358.3058.30
633497-334978.6308.63
10min166500-6650017.13333.8932.1417.1533.9332.15
2143004-14300436.84336.88
396790-9679024.93624.96
4183498-18349847.27547.33
5151529-15152939.03939.09
6147883-14788338.10038.15
15min1127368-12736832.81459.1324.1232.9359.3524.14
2255079-25507965.71765.96
3203466-20346652.42052.58
4268631-26863169.20969.52
5263309-26330967.83868.10
6259107-25910766.75567.01
20min1225646-22564658.13473.7111.2458.4374.2611.35
2308035-30803579.36179.97
3273724-27372470.52170.97
4305990-30599078.83479.53
5301599-30159977.70278.34
6301648-30164877.71578.35
30min1310959-31095980.11484.994.4180.7385.954.53
2341696-34169688.03389.08
3322392-32239283.05983.90
4332343-33234385.62386.76
5321386-32138682.80083.87
6350508-35050890.30391.37
45min1367322-36732294.63591.714.6095.7093.154.49
2345034-34503488.89390.43
3352592-35259290.84092.15
4359912-35991292.72694.34
5332471-33247185.65687.19
6378530-37853097.52299.09
60min1375268-37526896.68293.885.3598.2795.825.22
2353919-35391991.18293.21
3368325-36832594.89396.70
4359650-35965092.65894.79
5335994-33599486.56488.57
6393157-393157101.291103.40
极限1394019-394019101.51398.233.53103.64100.703.37
2368577-36857794.95897.50
3388206-388206100.015102.35
4370509-37050995.45698.10
5368916-36891695.04697.53
6397448-397448102.396105.06
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%
112.114825748251482804827548304482730.05
212.184835248279483160.11
单位质量响应值RSD%判断
3986.213966.830.35数据可信
供试品溶液-24042903批-左氨氯地平-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%
5min138504-3850478.25460.4047.5978.2560.4047.59
240415-4041582.13882.14
335939-3593973.04173.04
410299-1029920.93120.93
540242-4024281.78681.79
612927-1292726.27226.27
10min143727-4372788.86988.974.7689.3089.304.89
244636-4463690.71691.17
345932-4593293.35093.76
440015-4001581.32581.44
545129-4512991.71892.17
643210-4321087.81887.96
15min144625-4462590.69492.451.4591.6293.281.50
245530-4553092.53393.49
346643-4664394.79595.72
445212-4521291.88792.46
545540-4554092.55493.52
645376-4537692.22092.85
20min144669-4466990.78392.621.4192.2293.971.44
245544-4554492.56294.04
346439-4643994.38195.83
445690-4569092.85893.94
546033-4603393.55595.03
645073-4507391.60492.75
30min145075-4507591.60894.011.9293.5595.861.87
246154-4615493.80195.79
347702-4770296.94798.92
446359-4635994.21895.81
545675-4567592.82894.83
646564-4656494.63596.29
45min144782-4478291.01393.822.1993.4696.202.06
245859-4585993.20295.71
347301-4730196.13398.65
446725-4672594.96297.08
545291-4529192.04794.56
647009-4700995.53997.72
60min145179-4517991.82094.451.7194.7797.351.64
246867-4686795.25098.28
347299-4729996.12899.18
447036-4703695.59498.24
545909-4590993.30396.33
646553-4655394.61297.32
极限143975-4397589.37393.952.6492.8397.382.52
246341-4634194.18197.74
347406-4740696.34699.93
447078-4707895.67998.86
545967-4596793.42196.96
646606-4660694.72097.96
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(%)99.7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%
111.373965713968483969603966873969983968130.05
211.383969463967333968400.04
单位质量响应值RSD%判断
34900.0034871.700.06数据可信
供试品溶液-24042903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%
5min172723-7272318.70512.7234.6018.7112.7234.60
263879-6387916.43016.43
341010-4101010.54810.55
426656-266566.8566.86
539089-3908910.05410.05
653300-5330013.70913.71
10min1274724-27472470.66260.9115.1370.7760.9815.14
2278844-27884471.72271.81
3237496-23749661.08661.15
4189191-18919148.66248.70
5234365-23436560.28160.34
6206209-20620953.03953.12
15min1333182-33318285.69883.564.2986.1983.964.33
2334565-33456586.05486.54
3314027-31402780.77181.17
4306223-30622378.76479.07
5342343-34234388.05488.44
6318834-31883482.00782.38
20min1348389-34838989.60990.592.4590.5891.462.44
2346307-34630789.07490.04
3353568-35356890.94191.79
4341543-34154387.84888.59
5365267-36526793.95094.83
6358183-35818392.12892.95
30min1363878-36387893.59395.333.5495.0696.713.49
2359483-35948392.46393.93
3385392-38539299.127100.48
4354074-35407491.07192.31
5379150-37915097.52198.92
6381777-38177798.19799.54
45min1376950-37695096.95597.583.0598.9599.493.02
2368697-36869794.83396.81
3391081-391081100.590102.49
4363465-36346593.48795.23
5386039-38603999.293101.24
6390075-390075100.331102.22
60min1382826-38282698.46799.262.57101.00101.712.57
2380176-38017697.785100.29
3392274-392274100.897103.36
4371012-37101295.42897.69
5398847-398847102.588105.08
6390258-390258100.378102.82
极限1391993-391993100.825100.941.65103.90103.941.67
2393617-393617101.242104.29
3395063-395063101.614104.64
4385159-38515999.067101.86
5402782-402782103.600106.66
6386071-38607199.301102.30
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