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%
114.959491194426946249452494486945940.21
214.979546795397954320.06
单位质量响应值RSD%判断
6327.366374.880.53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%
5min157540-5754058.73153.0516.0358.7353.0516.03
248814-4881449.82549.82
364281-6428165.61265.61
452676-5267653.76753.77
548441-4844149.44449.44
640087-4008740.91740.92
10min180761-8076182.43375.3311.1382.5375.4211.13
271784-7178473.27073.35
381072-8107282.75082.86
479034-7903480.67080.76
570219-7021971.67371.76
659964-5996461.20561.27
15min188331-8833190.16083.389.7690.3983.599.76
281175-8117582.85583.06
387709-8770989.52589.77
486530-8653088.32188.55
579043-7904380.67980.88
667330-6733068.72468.89
20min190556-9055692.43186.719.3792.8287.069.37
284556-8455686.30686.65
388637-8863790.47290.87
492950-9295094.87495.25
582175-8217583.87684.21
670832-7083272.29872.58
30min191345-9134593.23688.248.4793.7888.748.48
282215-8221583.91784.40
390864-9086492.74593.29
494217-9421796.16796.70
585692-8569287.46687.94
674385-7438575.92576.33
45min192197-9219794.10690.376.8394.8091.016.85
288455-8845590.28690.91
391652-9165293.54994.25
494646-9464696.60597.30
586599-8659988.39289.01
677653-7765379.26179.79
极限192532-9253294.44894.441.3095.3095.241.33
292395-9239594.30895.09
391436-9143693.32994.19
494560-9456096.51897.37
592983-9298394.90895.68
691247-9124793.13693.80
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%
114.959492394875948889473794815948480.08
214.979513695200951680.05
单位质量响应值RSD%判断
6344.356357.250.15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%
5min154198-5419855.32252.1516.2055.3252.1516.20
255985-5598557.14657.15
354461-5446155.59155.59
455332-5533256.48056.48
552160-5216053.24253.24
634410-3441035.12435.12
10min177865-7786579.48078.146.3379.5778.226.33
279173-7917380.81580.91
379953-7995381.61181.70
477615-7761579.22579.32
577845-7784579.46079.55
666851-6685168.23868.30
15min180914-8091482.59287.224.6282.8287.444.63
288146-8814689.97490.20
389290-8929091.14291.37
487118-8711888.92589.15
587192-8719289.00089.22
680020-8002081.68081.85
20min190432-9043292.30892.672.8792.6793.032.88
293178-9317895.11195.49
391835-9183593.74094.12
490089-9008991.95892.33
593016-9301694.94595.31
686169-8616987.95688.26
30min191278-9127893.17196.572.9593.6997.092.96
297445-9744599.466100.00
397305-9730599.32399.86
494564-9456496.52597.05
595763-9576397.74998.28
691289-9128993.18293.64
45min192832-9283294.75797.552.2495.4398.222.25
296587-9658798.59099.29
398523-98523100.566101.27
496995-9699599.00799.70
594200-9420096.15496.84
694259-9425996.21496.82
极限192863-9286394.78997.802.3395.6298.642.33
295369-9536997.34798.22
399099-99099101.154102.02
497641-9764199.666100.52
595367-9536797.34598.20
694552-9455296.51397.28
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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