培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10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%
110.444342443421434924336543441434290.11
210.434339443452434230.10
单位质量响应值RSD%判断
4159.874163.280.06数据可信
供试品溶液-2022081501批-培哚普利-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%
5min135340-3534072.45468.226.8772.4568.226.87
230291-3029162.10262.10
335218-3521872.20372.20
433923-3392369.54869.55
534361-3436170.44670.45
630526-3052662.58462.58
10min144046-4404690.30392.863.2691.1193.623.24
243298-4329888.76989.46
345095-4509592.45393.26
447215-4721596.80097.57
545593-4559393.47494.26
646523-4652395.38196.08
15min144953-4495392.16293.682.6193.9795.482.55
245513-4551393.31094.99
344269-4426990.76092.59
447363-4736397.10398.95
545193-4519392.65494.48
646882-4688296.11797.87
20min145247-4524792.76593.811.7795.6096.641.74
245639-4563993.56896.28
344649-4464991.53994.38
446904-4690496.16299.09
545699-4569993.69196.54
646408-4640895.14597.97
30min143416-4341689.01191.261.9392.8795.131.89
244382-4438290.99194.74
344025-4402590.25994.11
445647-4564793.58597.58
544183-4418390.58394.48
645412-4541293.10396.98
45min143853-4385389.90792.111.7794.7697.001.73
245014-4501492.28797.05
344097-4409790.40795.27
445847-4584793.99599.03
545258-4525892.78797.69
645500-4550093.28498.20
极限144092-4409290.39792.081.6896.2598.001.66
244263-4426390.74796.54
344544-4454491.32497.19
445509-4550993.30299.38
545053-4505392.36798.30
646023-4602394.356100.31
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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2000
标示量(mg)10供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.988119981217808408091580912810170.22
213.998107581075810750.00
单位质量响应值RSD%判断
5795.215795.210.00数据可信
供试品溶液-2022081501批-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%
5min159147-5914766.16265.943.6066.1665.943.60
256498-5649863.19963.20
359685-5968566.76466.76
461836-6183669.17069.17
560059-6005967.18267.18
656448-5644863.14363.14
10min175353-7535384.29088.403.4585.0289.133.42
277400-7740086.58087.28
378050-7805087.30788.05
482247-8224792.00192.77
578986-7898688.35489.10
682114-8211491.85392.55
15min177259-7725986.42289.663.4388.0991.383.39
281867-8186791.57693.24
376960-7696086.08787.80
482765-8276592.58194.37
579078-7907888.45790.18
683020-8302092.86694.59
20min178141-7814187.40889.442.4990.0492.152.47
280814-8081490.39893.08
377620-7762086.82689.49
481874-8187491.58494.40
578975-7897588.34191.05
682314-8231492.07694.83
30min175786-7578684.77487.492.7688.3891.202.74
278893-7889388.25091.94
376465-7646585.53489.17
480268-8026889.78893.62
576865-7686585.98189.67
681002-8100290.60994.39
45min176074-7607485.09688.413.2489.6493.083.19
279714-7971489.16893.83
375914-7591484.91789.50
481458-8145891.11995.95
579202-7920288.59593.24
681838-8183891.54496.33
极限178060-7806087.31889.222.9692.8194.882.91
279517-7951788.94894.61
377001-7700186.13391.66
480970-8097090.57396.42
579318-7931888.72594.36
683701-8370193.62899.43
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10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%
110.444366543681438194372743770437320.15
210.434345543013432340.73
单位质量响应值RSD%判断
4188.894145.160.75数据可信
供试品溶液-2022081501批-培哚普利-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%
5min133038-3303867.64768.903.0267.6568.903.02
234884-3488471.42771.43
332936-3293667.43867.44
434954-3495471.57071.57
532662-3266266.87766.88
633413-3341368.41568.42
10min144133-4413390.36593.121.9891.1293.881.97
246227-4622794.65395.45
346262-4626294.72495.47
445374-4537492.90693.70
544719-4471991.56592.31
646150-4615094.49595.26
15min145366-4536692.89094.571.1794.6596.361.18
246497-4649795.20597.05
346823-4682395.87397.67
446491-4649195.19397.02
545759-4575993.69495.45
646170-4617094.53696.35
20min145679-4567993.53194.410.6796.3297.260.70
246378-4637894.96297.86
346249-4624994.69897.56
446401-4640195.00997.89
545777-4577793.73196.53
646165-4616594.52697.39
30min145033-4503392.20893.041.0096.0396.940.98
245450-4545093.06297.02
346013-4601394.21498.13
444923-4492391.98395.92
545282-4528292.71896.56
645925-4592594.03497.95
45min145171-4517192.49093.340.7897.3498.270.75
245315-4531592.78597.78
346156-4615694.50799.47
445460-4546093.08298.05
545760-4576093.69698.57
645643-4564393.45798.41
极限145073-4507392.29093.250.8298.1799.220.82
245615-4561593.39999.42
345438-4543893.03799.05
445933-4593394.051100.05
545206-4520692.56298.48
645980-4598094.147100.14
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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2000
标示量(mg)10供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.988132981489813108156881299813990.15
213.998111781016810660.09
单位质量响应值RSD%判断
5822.535794.570.35数据可信
供试品溶液-2022081501批-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%
5min157673-5767364.36566.072.3064.3766.072.29
261228-6122868.33368.33
358683-5868365.49265.49
460438-6043867.45167.45
558259-5825965.01965.02
658931-5893165.76965.77
10min176610-7661085.49987.881.7286.2188.621.71
279987-7998789.26890.03
380009-8000989.29390.02
478238-7823887.31688.07
578069-7806987.12887.85
679564-7956488.79689.53
15min177146-7714686.09889.211.8487.7690.921.83
280496-8049689.83691.59
381104-8110490.51592.23
479545-7954588.77590.49
580921-8092190.31192.00
680386-8038689.71491.43
20min179215-7921588.40789.071.1391.0391.771.11
280888-8088890.27493.02
380029-8002989.31592.04
478909-7890988.06590.77
580803-8080390.17992.87
679014-7901488.18290.90
30min177903-7790386.94387.891.2690.5591.581.23
279002-7900288.16991.92
379645-7964588.88792.60
477177-7717786.13289.82
579305-7930588.50792.20
679454-7945488.67392.37
45min178419-7841987.51888.661.1692.0993.331.14
279342-7934288.54893.28
380837-8083790.21794.92
478478-7847887.58492.23
579772-7977289.02893.71
679807-7980789.06793.75
极限180310-8031089.62989.990.6995.1795.640.68
280243-8024389.55495.27
381571-8157191.03696.74
480093-8009389.38795.00
580654-8065490.01395.68
680933-8093390.32495.99
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