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%
110.534218442174422494219042206422010.07
210.494198341919419510.11
单位质量响应值RSD%判断
4007.693999.140.16数据可信
供试品溶液-G01QCM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%
5min133478-3347875.11153.2430.6975.1153.2430.69
224991-2499156.06956.07
317077-1707738.31438.31
417611-1761139.51239.51
531144-3114469.87469.87
618085-1808540.57540.58
10min140121-4012190.01567.8324.1990.1467.9224.20
232412-3241272.71972.81
323542-2354252.81852.88
423409-2340952.52052.59
536972-3697282.95083.07
624938-2493855.95156.02
15min142815-4281596.05975.7420.7296.3375.9420.73
236603-3660382.12282.34
326873-2687360.29260.44
426661-2666159.81659.97
540013-4001389.77390.03
629586-2958666.37966.54
20min143867-4386798.41980.4518.2898.8580.7818.31
239208-3920887.96788.32
329143-2914365.38565.64
428874-2887464.78165.03
541651-4165193.44893.85
632399-3239972.69072.96
30min144446-4444699.71886.0614.46100.3286.5214.50
241985-4198594.19794.70
332486-3248672.88573.25
432201-3220172.24672.61
543286-4328697.11697.68
635742-3574280.19080.58
45min144864-44864100.65690.8810.78101.4291.4910.84
244070-4407098.87599.53
335667-3566780.02280.50
435564-3556479.79180.27
544083-4408398.90499.63
638800-3880087.05187.58
极限145922-45922103.030101.221.39103.96101.981.44
245773-45773102.696103.52
344599-44599100.062100.68
444995-44995100.950101.56
544353-4435399.510100.40
645053-45053101.080101.75
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%
110.534183141860418514182641837418410.04
210.494198541957419710.05
单位质量响应值RSD%判断
3973.504001.050.49数据可信
供试品溶液-G01QCM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%
5min131859-3185971.76965.8515.9471.7765.8515.94
234009-3400976.61276.61
320874-2087447.02347.02
428041-2804163.16863.17
531911-3191171.88671.89
628699-2869964.65064.65
10min138769-3876987.33580.6411.7687.4580.7411.76
239565-3956589.12889.26
328226-2822663.58463.66
434203-3420377.04977.15
538155-3815585.95186.07
635854-3585480.76880.88
15min140913-4091392.16487.578.8892.4387.828.89
241826-4182694.22194.50
332651-3265173.55373.74
437134-3713483.65183.89
540824-4082491.96492.23
639906-3990689.89690.14
20min142497-4249795.73392.017.3596.1592.407.37
243255-4325597.44097.87
335424-3542479.79980.11
439221-3922188.35388.73
542373-4237395.45395.87
642304-4230495.29895.69
30min143713-4371398.47296.544.5299.0597.094.55
244276-4427699.740100.34
339408-3940888.77489.21
441704-4170493.94694.47
543867-4386798.81999.39
644174-4417499.510100.06
45min144230-4423099.63799.732.71100.38100.442.75
244879-44879101.099101.86
341909-4190994.40895.00
444925-44925101.202101.88
545123-45123101.648102.39
644562-44562100.384101.10
极限145138-45138101.682102.070.87102.59102.950.89
245819-45819103.216104.15
345248-45248101.930102.68
445200-45200101.822102.67
545709-45709102.968103.88
644760-44760100.831101.71
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%
110.534193841992419844196041888419520.10
210.494175841764417610.02
单位质量响应值RSD%判断
3984.053981.030.06数据可信
供试品溶液-G01QCM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%
5min113769-1376931.05462.7724.9331.0562.7824.94
231844-3184471.81971.82
330326-3032668.39668.40
429754-2975467.10667.11
531364-3136470.73770.74
629945-2994567.53667.54
10min124459-2445955.16479.6315.3655.2279.7415.37
238675-3867587.22687.35
338764-3876487.42687.54
436333-3633381.94382.06
536341-3634181.96282.08
637272-3727284.06184.17
15min129709-2970967.00487.0111.8767.1587.2511.88
242371-4237195.56195.83
341649-4164993.93394.19
438978-3897887.90988.16
538778-3877887.45887.71
640000-4000090.21490.47
20min132998-3299874.42291.039.6674.6891.419.68
244139-4413999.54999.97
342816-4281696.56596.98
440304-4030490.89991.29
540384-4038491.08091.48
641531-4153193.66794.07
30min136863-3686383.13995.506.7183.5296.046.75
245005-45005101.502102.09
343771-4377198.71999.30
442917-4291796.79397.34
542261-4226195.31395.87
643257-4325797.56098.12
45min139933-3993390.06398.574.4590.5899.264.50
245410-45410102.415103.17
344261-4426199.824100.57
444717-44717100.852101.56
543599-4359998.33199.04
644301-4430199.914100.64
极限146032-46032103.818102.990.61104.49103.850.55
245789-45789103.270104.20
345312-45312102.194103.10
445377-45377102.341103.22
545804-45804103.304104.18
645671-45671103.004103.89
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%
110.534189841882418724186641910418860.05
210.494196641992419790.05
单位质量响应值RSD%判断
3977.784001.810.43数据可信
供试品溶液-G01QCM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%
5min118565-1856541.79553.3528.0841.7953.3528.08
215853-1585335.68935.69
331452-3145270.80770.81
420475-2047546.09546.09
524225-2422554.53754.54
631607-3160771.15671.16
10min126382-2638259.39370.2220.0359.4670.3120.04
224243-2424354.57754.64
339328-3932888.53888.66
428055-2805563.15963.24
531056-3105669.91570.01
638090-3809085.75185.87
15min130663-3066369.03177.8315.6769.2078.0415.69
229113-2911365.54165.69
341796-4179694.09494.36
431265-3126570.38670.57
533868-3386876.24676.45
640729-4072991.69291.95
20min133166-3316674.66582.6313.7574.9582.9713.78
231895-3189571.80472.06
342918-4291896.62097.04
433403-3340375.19975.50
535727-3572780.43180.77
643126-4312697.08897.50
30min139558-3955889.05689.639.7489.4690.109.78
235450-3545079.80780.19
344253-4425399.625100.21
436331-3633181.79182.22
538678-3867887.07487.54
644603-44603100.413100.99
45min139156-3915688.15192.877.4688.7193.507.52
238360-3836086.35886.87
345145-45145101.633102.38
438930-3893087.64288.20
540952-4095292.19492.81
644977-44977101.255102.00
极限146397-46397104.452101.691.47105.16102.471.46
244413-4441399.985100.64
345216-45216101.793102.71
445075-45075101.476102.18
544984-44984101.271102.04
644936-44936101.163102.08
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