比索洛尔左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.154280542836428254282842803428190.04
210.164276642773427700.02
单位质量响应值RSD%判断
4218.624209.650.16数据可信
加速3月-供试品溶液-G01QCM批-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min126012-2601255.44269.3019.3755.4469.3019.37
237197-3719779.28279.28
330862-3086265.77965.78
424462-2446252.13852.14
538205-3820581.43081.43
638359-3835981.75881.76
10min130596-3059665.21281.8216.5865.3081.9416.58
241695-4169588.86989.00
339562-3956284.32384.43
430939-3093965.94366.03
546594-4659499.31199.45
640949-4094987.27987.42
15min133225-3322570.81684.9812.2271.0285.2412.23
242881-4288191.39791.68
341540-4154088.53888.79
434312-3431273.13373.33
544909-4490995.71996.02
642370-4237090.30790.59
20min134671-3467173.89887.4310.6074.2287.8210.62
243470-4347092.65293.08
342993-4299391.63592.03
436438-3643877.66477.98
545296-4529696.54497.00
643253-4325392.19092.62
30min136993-3699378.84790.308.1979.2990.848.22
243925-4392593.62294.21
344688-4468895.24895.80
439047-3904783.22583.67
545440-4544096.85197.47
644101-4410193.99794.58
45min139588-3958884.37892.405.5184.9593.095.56
244094-4409493.98294.73
345201-4520196.34197.05
441204-4120487.82288.41
545370-4537096.70297.48
644644-4464495.15495.90
极限144225-4422594.26195.081.6294.9895.931.67
243997-4399793.77594.67
345608-4560897.20998.08
443848-4384893.45894.19
545307-4530796.56797.51
644683-4468395.23796.14
比索洛尔左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.154289342909429094290842879429000.04
210.164287842874428760.01
单位质量响应值RSD%判断
4226.604220.080.11数据可信
长期3月-供试品溶液-G01QCM批-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min124549-2454952.21067.3013.3452.2167.3013.34
232557-3255769.24169.24
335826-3582676.19376.19
433258-3325870.73270.73
528867-2886761.39361.39
634823-3482374.06074.06
10min133952-3395272.20881.429.2872.2981.539.29
238084-3808480.99581.11
343175-4317591.82391.95
438279-3827981.41081.53
534921-3492174.26874.37
641291-4129187.81687.94
15min138095-3809581.01986.777.0281.2387.027.03
240543-4054386.22586.48
344646-4464694.95195.23
440815-4081586.80387.06
537317-3731779.36479.59
643378-4337892.25492.52
20min140473-4047386.07689.974.9986.4290.365.01
242122-4212289.58389.98
344875-4487595.43895.88
442375-4237590.12190.52
539532-3953284.07584.43
644434-4443494.50094.92
30min142777-4277790.97692.543.6591.4693.083.67
243895-4389593.35493.90
344951-4495195.60096.20
443829-4382993.21493.76
540719-4071986.59987.10
644894-4489495.47896.06
45min144056-4405693.69694.092.2394.3394.792.26
244281-4428194.17594.87
345135-4513595.99196.75
444466-4446694.56895.27
542436-4243690.25190.89
645085-4508595.88596.62
极限144540-4454094.72694.980.6895.5295.830.72
244283-4428394.17995.04
345056-4505695.82396.74
444611-4461194.87795.74
544470-4447094.57795.37
644987-4498795.67696.58
比索洛尔左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.154289842913429464289342851429000.09
210.164374343765437540.04
单位质量响应值RSD%判断
4226.604306.501.33数据可信
中间条件3月-供试品溶液-G01QCM批-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min138753-3875381.59164.6125.8381.5964.6125.83
235409-3540974.55074.55
334143-3414371.88571.88
433199-3319969.89769.90
525365-2536553.40353.40
617264-1726436.34836.35
10min144036-4403692.71378.8817.8692.8578.9917.87
239829-3982983.85683.98
339645-3964583.46983.59
439729-3972983.64583.76
536921-3692177.73377.82
624632-2463251.86051.92
15min145251-4525195.27185.0513.3195.5685.2913.33
242044-4204488.51988.78
341956-4195688.33488.59
442383-4238389.23389.49
540908-4090886.12886.35
629835-2983562.81562.96
20min145771-4577196.36688.609.8296.8288.989.85
243111-4311190.76691.18
343425-4342591.42791.83
443420-4342091.41691.82
542845-4284590.20690.57
633929-3392971.43471.69
30min145930-4593096.70191.865.8097.3192.395.85
244399-4439993.47894.04
343928-4392892.48693.04
444055-4405592.75393.31
544794-4479494.30994.82
638679-3867981.43581.81
45min145901-4590196.64093.593.0197.4194.283.08
244957-4495794.65295.37
343998-4399892.63393.35
444566-4456693.82994.54
545245-4524595.25995.93
642058-4205888.54989.06
极限145869-4586996.57394.651.7397.5095.491.75
245159-4515995.07895.95
343872-4387292.36893.24
444647-4464794.00094.87
545729-4572996.27897.11
644458-4445893.60294.26
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