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%
111.154672546713467864674046757467440.07
211.094664646626466360.04
单位质量响应值RSD%判断
4192.294205.230.22数据可信
供试品溶液-2024052421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%
5min143745-4374584.19984.904.4684.2084.904.46
245516-4551687.60887.61
340286-4028677.54277.54
445117-4511786.84086.84
544898-4489886.41986.42
645080-4508086.76986.77
10min147691-4769191.79591.721.1892.2692.201.16
247816-4781692.03592.52
348592-4859293.52993.96
446978-4697890.42290.90
547204-4720490.85791.34
647646-4764691.70892.19
15min146542-4654289.58391.041.3390.5692.021.31
247567-4756791.55692.55
347547-4754791.51792.47
446476-4647689.45690.44
547820-4782092.04393.03
647842-4784292.08593.08
20min145652-4565287.87089.661.9789.3591.151.93
245997-4599788.53490.04
347378-4737891.19292.65
445812-4581288.17889.66
546759-4675990.00191.50
647892-4789292.18193.68
30min146513-4651389.52790.512.2391.4992.502.19
247686-4768691.78593.78
348055-4805592.49594.46
445219-4521987.03789.01
547691-4769191.79593.79
646985-4698590.43692.45
45min145600-4560087.77090.692.4390.2393.182.39
247517-4751791.46093.97
347060-4706090.58093.06
445988-4598888.51790.97
548524-4852493.39895.90
648010-4801092.40994.93
60min147112-4711290.68092.261.3993.6395.251.37
248194-4819492.76395.78
348026-4802692.43995.42
447662-4766291.73994.69
549043-4904394.39797.42
647545-4754591.51494.54
极限150362-5036296.93695.681.96100.3999.191.90
251112-5111298.379101.91
348795-4879593.92097.42
448556-4855693.46096.92
549436-4943695.15398.70
650010-5001096.25899.80
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%
111.473971183973353974223974013972823973120.04
211.343966443965843966140.02
单位质量响应值RSD%判断
34639.2334974.780.69数据可信
供试品溶液-2024052421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%
5min1131590-13159033.92430.799.2633.9230.799.26
2109019-10901928.10528.10
3127010-12701032.74332.74
4103359-10335926.64626.65
5125681-12568132.40032.40
6119910-11991030.91330.91
10min1288434-28843474.35875.092.6774.5575.262.68
2286608-28660873.88774.04
3298410-29841076.93077.11
4281319-28131972.52472.67
5302281-30228177.92878.11
6290498-29049874.89075.06
15min1314155-31415580.98982.532.8081.5983.122.80
2315687-31568781.38481.95
3322827-32282783.22483.83
4315329-31532981.29181.84
5337261-33726186.94687.56
6315564-31556481.35281.94
20min1314575-31457581.09783.352.6582.1584.402.65
2319429-31942982.34883.37
3326860-32686084.26485.34
4320439-32043982.60983.61
5338855-33885587.35688.45
6319762-31976282.43483.47
30min1324186-32418683.57585.542.7085.0887.052.69
2324808-32480883.73585.21
3334411-33441186.21187.75
4329240-32924084.87886.34
5348371-34837189.81091.39
6329798-32979885.02286.52
45min1334484-33448486.23088.022.0888.2090.012.08
2340070-34007087.67089.61
3340406-34040687.75689.78
4338058-33805887.15189.08
5355104-35510491.54593.63
6340525-34052587.78789.76
60min1336350-33635086.71188.952.0789.1691.432.06
2344054-34405488.69791.13
3346118-34611889.22991.74
4348215-34821589.76992.19
5356443-35644391.89194.48
6339089-33908987.41789.87
极限1382096-38209698.50499.980.90101.43102.940.91
2390443-390443100.656103.58
3386099-38609999.536102.54
4388059-388059100.041102.96
5392065-392065101.074104.17
6388078-388078100.046102.99
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%
111.154669546709467224674846777467300.07
211.094708747091470890.01
单位质量响应值RSD%判断
4191.034246.080.93数据可信
供试品溶液-2024052421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%
5min139242-3924275.18181.113.7675.1881.113.76
243212-4321282.78782.79
343502-4350283.34283.34
443000-4300082.38082.38
542077-4207780.61280.61
642978-4297882.33882.34
10min146779-4677989.62090.742.4490.0491.202.44
247539-4753991.07691.54
349166-4916694.19394.66
448162-4816292.27092.73
546175-4617588.46388.91
646375-4637588.84689.30
15min147480-4748090.96389.853.4391.8890.803.39
249405-4940594.65195.62
347169-4716990.36791.35
444703-4470385.64386.61
545730-4573087.61188.55
646904-4690489.86090.81
20min148052-4805292.05992.641.0593.4894.101.04
248278-4827892.49293.98
348699-4869993.29994.79
448891-4889193.66795.11
547541-4754191.08092.51
648671-4867193.24594.70
30min146433-4643388.95792.432.4690.8994.402.42
248398-4839892.72294.73
349136-4913694.13696.14
449815-4981595.43797.40
547621-4762191.23393.17
648070-4807092.09494.06
45min148063-4806392.08093.122.1294.5195.602.10
249868-4986895.53898.06
348722-4872293.34395.87
449615-4961595.05497.55
547108-4710890.25192.69
648260-4826092.45894.94
60min147829-4782991.63292.471.6594.5795.471.64
249225-4922594.30697.36
348955-4895593.78996.84
448698-4869893.29796.32
547336-4733690.68793.63
647555-4755591.10794.10
极限147324-4732490.66495.283.0494.1198.792.96
250768-5076897.263100.84
349166-4916694.19397.76
450610-5061096.960100.50
549081-4908194.03197.47
651457-5145798.583102.08
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%
111.473985433986433990143987283981473986150.08
211.344016054010954013500.09
单位质量响应值RSD%判断
34752.8335392.421.29数据可信
供试品溶液-2024052421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%
5min1115950-11595029.66728.0514.8029.6728.0514.79
2130543-13054333.40133.40
3124575-12457531.87431.87
498055-9805525.08925.09
592119-9211923.57023.57
696461-9646124.68124.68
10min1285307-28530772.99971.816.1873.1671.976.19
2302767-30276777.46777.65
3295341-29534175.56675.74
4278469-27846971.25071.39
5262038-26203867.04667.18
6260072-26007266.54266.68
15min1313885-31388580.31179.804.4980.8880.354.47
2323960-32396082.88983.50
3313190-31319080.13380.73
4285527-28552773.05573.59
5311408-31140879.67780.18
6323294-32329482.71983.23
20min1324000-32400082.89983.842.3383.9284.842.29
2323246-32324682.70683.78
3327911-32791183.90084.94
4319119-31911981.65082.59
5330954-33095484.67885.62
6340827-34082787.20588.17
30min1335798-33579885.91886.171.4587.3987.641.41
2330986-33098684.68786.22
3335714-33571485.89687.40
4334015-33401585.46286.86
5339104-33910486.76488.18
6345163-34516388.31489.76
45min1339830-33983086.95088.171.8988.9090.111.86
2342360-34236087.59789.60
3343484-34348487.88489.87
4338795-33879586.68588.55
5346566-34656688.67390.57
6356637-35663791.25093.19
60min1347436-34743688.89689.082.1991.3391.512.14
2342573-34257387.65190.14
3347310-34731088.86391.34
4338242-33824286.54388.89
5354233-35423390.63593.03
6359137-35913791.88994.34
极限1363104-36310492.90497.993.5295.84100.913.41
2382050-38205097.752100.73
3376574-37657496.35199.32
4379856-37985697.191100.02
5397546-397546101.717104.61
6398641-398641101.997104.96
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