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%
114.999185492152918059222291720919510.25
214.999221491923920680.23
单位质量响应值RSD%判断
6134.166141.960.09数据可信
长期6月-供试品溶液-2025021021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%
5min148808-4880851.54746.8213.6651.5546.8213.66
246889-4688949.52049.52
332508-3250834.33234.33
448380-4838051.09551.09
544937-4493747.45947.46
644487-4448746.98446.98
10min169794-6979473.71167.5612.2073.8067.6412.20
270056-7005673.98774.07
349003-4900351.75351.81
465661-6566169.34669.43
562984-6298466.51966.60
666307-6630770.02870.11
15min175102-7510279.31775.559.7579.5375.749.76
276282-7628280.56380.77
357973-5797361.22661.37
472908-7290876.99977.20
570780-7078074.75274.94
676161-7616180.43580.63
20min178208-7820882.59778.578.5182.9478.898.52
279110-7911083.54983.89
362084-6208465.56865.81
475271-7527179.49579.82
574037-7403778.19278.51
677682-7768282.04182.37
30min179465-7946583.92480.746.9284.4081.196.94
280906-8090685.44685.93
366385-6638570.11070.47
476512-7651280.80681.27
575930-7593080.19180.64
679511-7951183.97384.44
45min179171-7917183.61482.641.8984.2383.221.93
280395-8039584.90785.53
376236-7623680.51480.99
478075-7807582.45683.05
577128-7712881.45682.03
678484-7848482.88883.49
极限179690-7969084.16285.654.6584.9286.374.56
281957-8195786.55687.32
387810-8781092.73893.34
478276-7827682.66983.40
577233-7723381.56782.28
681646-8164686.22886.97
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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%
111.613604873619523596843612843592063605230.32
211.653600503586183593340.29
单位质量响应值RSD%判断
31052.8030844.120.48数据可信
长期6月-供试品溶液-2025021021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%
5min1217442-21744258.15753.7815.0058.1653.7815.00
2215793-21579357.71657.72
3142363-14236338.07738.08
4223103-22310359.67159.67
5211443-21144356.55356.55
6196227-19622752.48352.48
10min1282484-28248475.55370.3412.5775.6570.4312.57
2287524-28752476.90177.00
3197457-19745752.81252.88
4274271-27427173.35773.46
5269749-26974972.14772.24
6266471-26647171.27171.36
15min1300535-30053580.38176.1310.6280.6076.3410.63
2307491-30749182.24282.47
3224434-22443460.02760.18
4294777-29477778.84179.06
5289600-28960077.45777.67
6291037-29103777.84178.05
20min1304811-30481181.52578.129.4481.8878.459.46
2313507-31350783.85184.21
3237121-23712163.42163.67
4302206-30220680.82881.18
5296866-29686679.40079.74
6297906-29790679.67880.01
30min1307438-30743882.22879.667.7782.7280.127.79
2317343-31734384.87785.38
3252060-25206067.41667.77
4305935-30593581.82682.31
5301037-30103780.51680.99
6303128-30312881.07581.54
45min1307777-30777782.31881.493.7082.9582.083.75
2318357-31835785.14885.79
3284351-28435176.05376.52
4309427-30942782.76083.38
5303939-30393981.29281.90
6304179-30417981.35681.96
极限1310577-31057783.06784.103.1783.8384.843.09
2319983-31998385.58386.37
3332071-33207188.81689.41
4311291-31129183.25884.02
5305995-30599581.84282.59
6306824-30682482.06382.80
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%
114.999190292273919059225291875920410.22
214.999192591763918440.13
单位质量响应值RSD%判断
6140.166127.020.16数据可信
长期6月-供试品溶液-2025021121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%
5min146160-4616048.78647.1810.4248.7947.1810.42
240715-4071543.03143.03
351148-5114854.05854.06
438308-3830840.48740.49
547412-4741250.10950.11
644118-4411846.62846.63
10min168116-6811671.99170.476.4872.0770.556.48
266986-6698670.79770.87
372175-7217576.28176.37
459364-5936462.74162.81
568617-6861772.52172.60
664804-6480468.49168.57
15min176699-7669981.06279.574.4481.2679.764.45
277628-7762882.04482.23
378815-7881583.29983.52
469715-6971573.68173.85
575719-7571980.02780.23
673134-7313477.29477.49
20min180905-8090585.50884.113.1785.8484.443.18
282451-8245187.14187.47
381581-8158186.22286.58
476439-7643980.78781.08
579310-7931083.82284.16
676794-7679481.16381.48
30min182844-8284487.55786.422.1188.0486.892.12
283744-8374488.50888.98
382896-8289687.61288.11
480891-8089185.49385.92
581230-8123085.85186.33
679031-7903183.52783.98
45min183257-8325787.99387.282.1788.6287.892.16
285057-8505789.89690.51
383261-8326187.99888.64
482509-8250987.20387.77
581660-8166086.30586.93
679737-7973784.27384.87
极限184833-8483389.65988.182.6890.4388.942.67
285927-8592790.81591.58
384423-8442389.22690.02
484008-8400888.78789.50
581195-8119585.81486.58
680204-8020484.76785.50
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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%
111.613593873605173591693608453595523598940.21
211.653603513597913600710.11
单位质量响应值RSD%判断
30998.6230907.380.21数据可信
长期6月-供试品溶液-2025021121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%
5min1216613-21661357.92656.609.6857.9356.609.68
2196543-19654352.55952.56
3237405-23740563.48763.49
4184062-18406249.22249.22
5230847-23084761.73361.73
6204422-20442254.66654.67
10min1285447-28544776.33474.196.5476.4374.286.54
2280785-28078575.08775.17
3295644-29564479.06179.17
4247061-24706166.06966.15
5290335-29033577.64177.74
6265322-26532270.95271.04
15min1309921-30992182.87981.014.9883.1081.224.99
2314774-31477484.17784.39
3314103-31410383.99784.23
4278150-27815074.38374.57
5310129-31012982.93483.17
6290442-29044277.67077.88
20min1318360-31836085.13684.163.8185.5084.523.81
2327537-32753787.59087.94
3322825-32282586.33086.71
4298356-29835679.78680.10
5319907-31990785.54985.92
6301364-30136480.59180.93
30min1323069-32306986.39585.812.8786.9086.312.88
2332498-33249888.91689.42
3325293-32529386.99087.51
4313359-31335983.79884.25
5324253-32425386.71187.22
6306877-30687782.06582.54
45min1325234-32523486.97486.452.6587.6287.092.66
2333527-33352789.19289.84
3326206-32620687.23487.90
4317910-31791085.01585.60
5327738-32773887.64388.30
6309141-30914182.67083.28
极限1328492-32849287.84586.962.6188.6487.742.62
2336007-33600789.85590.65
3327358-32735887.54288.35
4320128-32012885.60886.34
5327936-32793687.69688.50
6311268-31126883.23983.99
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