苯磺酸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4000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.341683317134169661685916977169540.71
215.231690016903169020.02
单位质量响应值RSD%判断
1105.221109.780.30数据可信
供试品溶液-8167603批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min117859-1785950.90758.189.1650.9158.189.16
219601-1960155.87255.87
319221-1922154.78954.79
421038-2103859.96959.97
523001-2300165.56465.56
621748-2174861.99261.99
10min125190-2519071.80481.347.8571.8981.447.85
226640-2664075.93776.03
328338-2833880.77780.87
429881-2988185.17585.28
530508-3050886.96387.07
630662-3066287.40287.50
15min127954-2795479.68388.856.4179.8989.086.41
229483-2948384.04184.26
332213-3221391.82392.05
431784-3178490.60090.84
532709-3270993.23793.49
632870-3287093.69693.94
20min129990-2999085.48693.695.4385.8294.065.43
231264-3126489.11889.48
334091-3409197.17697.55
434044-3404497.04297.43
533903-3390396.64097.05
633906-3390696.64997.05
30min132664-3266493.10898.523.9593.5999.063.96
233173-3317394.55995.07
336213-36213103.225103.77
435133-35133100.146100.70
535366-35366100.810101.38
634823-3482399.26399.83
45min134274-3427497.698101.042.8598.33101.742.86
234339-3433997.88398.55
336704-36704104.624105.34
436021-36021102.677103.40
536152-36152103.051103.79
635188-35188100.303101.03
60min135079-3507999.992101.222.63100.79102.092.64
233974-3397496.84297.67
336681-36681104.559105.45
435931-35931102.421103.31
536009-36009102.643103.55
635393-35393100.887101.79
极限135155-35155100.209101.752.70101.17102.792.71
234027-3402796.99497.98
336517-36517104.091105.15
435779-35779101.988103.05
536258-36258103.353104.43
636443-36443103.880104.95
苯磺酸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4000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.341739117322173461737217347173560.16
215.231691616934169250.08
单位质量响应值RSD%判断
1131.421111.291.27数据可信
供试品溶液-8167603批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min119663-1966355.36157.675.8355.3657.685.83
219422-1942254.68254.68
319189-1918954.02654.03
421120-2112059.46359.46
521737-2173761.20061.20
621778-2177861.31561.32
10min130204-3020485.03982.105.6985.1382.205.69
226026-2602673.27673.37
328956-2895681.52581.61
429476-2947682.98983.09
529539-2953983.16683.27
630762-3076286.61086.71
15min133136-3313693.29489.305.2193.5389.535.21
228827-2882781.16281.37
331086-3108687.52287.75
432992-3299292.88893.13
531457-3145788.56688.81
632805-3280592.36292.61
20min134163-3416396.18593.224.0996.5793.604.09
230824-3082486.78487.13
332652-3265291.93192.30
434683-3468397.64998.04
532929-3292992.71193.10
633405-3340594.05194.45
30min135626-35626100.30497.833.76100.8598.363.76
232762-3276292.24192.73
333719-3371994.93595.46
436349-36349102.340102.89
534870-3487098.17698.72
635153-3515398.97299.53
45min135827-35827100.87099.693.52101.59100.393.52
233514-3351494.35895.00
335909-35909101.101101.78
437200-37200104.736105.46
534692-3469297.67498.38
635313-3531399.423100.15
60min135969-35969101.270100.533.57102.15101.393.57
233810-3381095.19196.00
335736-35736100.614101.47
437722-37722106.205107.11
535128-3512898.90299.77
635865-35865100.977101.86
极限136212-36212101.95499.703.06103.01100.743.06
233673-3367394.80595.77
335610-35610100.259101.28
436801-36801103.612104.69
535082-3508298.77299.81
635089-3508998.79299.85
苯磺酸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4000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.341695216840168771701716875169120.43
215.231683416859168460.11
单位质量响应值RSD%判断
1102.481106.110.24数据可信
供试品溶液-8167603批-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%
5min110640-1064030.41730.295.3930.4230.295.39
210365-1036529.63129.63
39655-965527.60127.60
410879-1087931.10031.10
511371-1137132.50732.51
610664-1066430.48630.49
10min117686-1768650.56052.336.6450.6152.386.64
217474-1747449.95450.00
317117-1711748.93348.98
418019-1801951.51251.56
520285-2028557.99058.04
619249-1924955.02855.08
15min120374-2037458.24461.285.4458.3861.425.44
220588-2058858.85658.99
320186-2018657.70757.83
422304-2230463.76263.90
522504-2250464.33464.48
622657-2265764.77164.91
20min122257-2225763.62766.345.5263.8666.585.52
222164-2216463.36263.59
322051-2205163.03963.26
423343-2334366.73266.98
524324-2432469.53769.79
625106-2510671.77272.02
30min124594-2459470.30873.715.4370.6574.065.43
223842-2384268.15968.49
325594-2559473.16773.50
426171-2617174.81775.17
527511-2751178.64779.02
626983-2698377.13877.51
45min126820-2682076.67280.053.5977.1380.523.60
227196-2719677.74778.20
327386-2738678.29078.74
428365-2836581.08981.57
529116-2911683.23683.74
629118-2911883.24183.74
60min128448-2844881.32683.842.5281.9184.452.53
228544-2854481.60082.18
329439-2943984.15984.74
429263-2926383.65684.27
530104-3010486.06086.70
630175-3017586.26386.90
极限133369-3336995.39498.542.9796.1199.292.96
233464-3346495.66696.38
335855-35855102.501103.22
433946-3394697.04497.80
535009-35009100.082100.87
635181-35181100.574101.36
苯磺酸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4000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.341697316928169161696216879169320.23
215.231702717093170600.28
单位质量响应值RSD%判断
1103.781120.161.05数据可信
供试品溶液-8167603批-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%
5min110656-1065630.25429.675.6830.2529.665.69
210533-1053329.90529.90
310677-1067730.31430.31
410078-1007828.61328.61
511245-1124531.92631.93
69508-950826.99526.99
10min118498-1849852.51951.631.1252.5751.681.13
218185-1818551.63051.68
318180-1818051.61651.67
417869-1786950.73350.78
518256-1825651.83251.89
618119-1811951.44351.49
15min122350-2235063.45560.632.9563.5960.772.95
221016-2101659.66859.80
321692-2169261.58761.72
421066-2106659.81059.94
520539-2053958.31458.45
621473-2147360.96561.10
20min124560-2456069.73067.382.4669.9767.612.46
223249-2324966.00866.24
324022-2402268.20368.44
422936-2293665.11965.35
523966-2396668.04468.28
623653-2365367.15567.39
30min127292-2729277.48775.192.0777.8575.542.07
225720-2572073.02373.37
326380-2638074.89775.25
426090-2609074.07474.41
526710-2671075.83476.18
626703-2670375.81476.16
45min130257-3025785.90581.923.5286.3982.393.50
227775-2777578.85879.33
328711-2871181.51581.99
429020-2902082.39382.86
527698-2769878.63979.12
629651-2965184.18484.65
60min130965-3096587.91585.382.5988.5585.992.59
229317-2931783.23683.83
330130-3013085.54486.16
430170-3017085.65886.26
529028-2902882.41583.02
630821-3082187.50688.12
极限135079-3507999.59597.623.44100.3798.373.42
233578-3357895.33496.07
335442-35442100.626101.38
434521-3452198.01198.75
532407-3240792.00992.75
635272-35272100.143100.90
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