氨氯地平阿托伐他汀钙片项目信息
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)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%
114.939491194426946249452494486945940.21
214.979546795397954320.06
单位质量响应值RSD%判断
6335.836374.880.44数据可信
供试品溶液-24090901批-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%
5min157540-5754058.69253.0116.0358.6953.0116.03
248814-4881449.79149.79
364281-6428165.56865.57
452676-5267653.73053.73
548441-4844149.41149.41
640087-4008740.88940.89
10min180761-8076182.37875.2811.1382.4875.3711.14
271784-7178473.22173.30
381072-8107282.69582.80
479034-7903480.61680.71
570219-7021971.62571.71
659964-5996461.16461.23
15min188331-8833190.09983.329.7690.3383.549.76
281175-8117582.80083.00
387709-8770989.46589.71
486530-8653088.26288.49
579043-7904380.62580.83
667330-6733068.67868.85
20min190556-9055692.36986.659.3792.7587.009.37
284556-8455686.24986.59
388637-8863790.41190.81
492950-9295094.81195.18
582175-8217583.82084.16
670832-7083272.25072.53
30min191345-9134593.17388.188.4793.7188.688.48
282215-8221583.86184.35
390864-9086492.68393.23
494217-9421796.10396.63
585692-8569287.40787.88
674385-7438575.87476.28
45min192197-9219794.04290.316.8394.7490.956.85
288455-8845590.22690.85
391652-9165293.48794.19
494646-9464696.54197.23
586599-8659988.33288.95
677653-7765379.20779.74
极限192532-9253294.38494.381.3095.2495.171.33
292395-9239594.24495.02
391436-9143693.26694.12
494560-9456096.45397.30
592983-9298394.84495.61
691247-9124793.07393.74
氨氯地平阿托伐他汀钙片项目信息
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100590-202005 对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.623646203660753657123662453654243656150.18
211.683703143701213702180.04
单位质量响应值RSD%判断
31464.2931696.750.53数据可信
供试品溶液-24090901批-阿托伐他汀钙-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%
5min1268795-26879570.30562.3413.9470.3162.3413.94
2226951-22695159.36159.36
3283825-28382574.23674.24
4233266-23326661.01261.01
5225769-22576959.05259.05
6191386-19138650.05850.06
10min1327570-32757085.67878.8610.6185.8078.9710.61
2300020-30002078.47278.57
3329164-32916486.09586.22
4317789-31778983.12083.22
5290208-29020875.90676.00
6244330-24433063.90663.99
15min1346682-34668290.67784.619.6190.9484.849.62
2326244-32624485.33185.56
3343613-34361389.87490.14
4344134-34413490.01190.25
5314760-31476082.32882.55
6265382-26538269.41369.60
20min1352476-35247692.19386.878.8492.6087.258.85
2336579-33657988.03588.41
3348676-34867691.19991.62
4353450-35345092.44792.84
5325185-32518585.05485.42
6276488-27648872.31772.62
30min1354874-35487492.82088.277.6993.3888.797.71
2343229-34322989.77490.29
3350247-35024791.61092.18
4356946-35694693.36293.91
5331742-33174286.77087.27
6287909-28790975.30575.73
45min1355276-35527692.92589.046.3493.6489.716.36
2344867-34486790.20290.87
3350621-35062191.70792.43
4357472-35747293.49994.20
5334539-33453987.50188.15
6299755-29975578.40378.95
极限1354882-35488292.82294.052.1593.7094.872.08
2359913-35991394.13894.96
3350024-35002491.55192.43
4356312-35631293.19694.05
5371756-37175697.23598.03
6364563-36456395.35496.04
氨氯地平阿托伐他汀钙片项目信息
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)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%
114.939492394875948889473794815948480.08
214.979513695200951680.05
单位质量响应值RSD%判断
6352.856357.250.05数据可信
供试品溶液-24090902批-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%
5min154198-5419855.28552.1216.2055.2952.1216.20
255985-5598557.10857.11
354461-5446155.55355.55
455332-5533256.44256.44
552160-5216053.20653.21
634410-3441035.10035.10
10min177865-7786579.42778.096.3379.5278.186.34
279173-7917380.76180.86
379953-7995381.55781.65
477615-7761579.17279.27
577845-7784579.40679.50
666851-6685168.19268.25
15min180914-8091482.53787.164.6282.7687.384.63
288146-8814689.91490.14
389290-8929091.08191.31
487118-8711888.86589.09
587192-8719288.94189.16
680020-8002081.62581.80
20min190432-9043292.24692.612.8792.6192.972.88
293178-9317895.04795.43
391835-9183593.67794.06
490089-9008991.89692.27
593016-9301694.88295.25
686169-8616987.89788.21
30min191278-9127893.10996.502.9593.6297.022.96
297445-9744599.39999.94
397305-9730599.25799.79
494564-9456496.46196.99
595763-9576397.68498.21
691289-9128993.12093.57
45min192832-9283294.69497.482.2495.3698.162.25
296587-9658798.52499.23
398523-98523100.499101.20
496995-9699598.94099.63
594200-9420096.08996.78
694259-9425996.15096.76
极限192863-9286394.72697.742.3395.5598.582.33
295369-9536997.28298.15
399099-99099101.087101.96
497641-9764199.599100.45
595367-9536797.28098.13
694552-9455296.44897.22
氨氯地平阿托伐他汀钙片项目信息
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100590-202005 对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.621829151830031827381818481822741825560.27
211.681843041841451842240.07
单位质量响应值RSD%判断
15710.5015772.600.28数据可信
供试品溶液-24090902批-阿托伐他汀钙-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%
5min1115547-11554760.63153.9317.5760.6353.9317.57
2112393-11239358.97658.98
3104899-10489955.04355.04
4107798-10779856.56556.56
5109355-10935557.38257.38
666701-6670135.00035.00
10min1154697-15469781.17476.446.5181.2776.536.52
2151537-15153779.51679.61
3143666-14366675.38675.48
4144626-14462675.88975.98
5151167-15116779.32279.42
6128406-12840667.37867.44
15min1171056-17105689.75886.253.6489.9986.473.65
2168618-16861888.47988.71
3160639-16063984.29284.51
4161856-16185684.93085.15
5168552-16855288.44488.67
6155549-15554981.62181.79
20min1179634-17963494.25991.302.6494.6491.672.65
2176966-17696692.85993.24
3169321-16932188.84789.21
4171381-17138189.92890.29
5177525-17752593.15293.53
6169202-16920288.78589.09
30min1184331-18433196.72495.151.8197.2795.671.82
2183389-18338996.22996.76
3176322-17632292.52193.03
4178513-17851393.67194.18
5184053-18405396.57897.11
6181430-18143095.20195.66
45min1185946-18594697.57196.451.8498.2897.121.83
2184916-18491697.03197.72
3178201-17820193.50794.17
4181207-18120795.08495.75
5186017-18601797.60898.30
6186585-18658597.90698.52
极限1185463-18546397.31896.551.7698.1897.381.75
2184679-18467996.90697.76
3178639-17863993.73794.55
4181844-18184495.41996.25
5185802-18580297.49698.35
6187606-18760698.44299.22
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