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%
114.999202491873922509223291934920630.19
214.999133491532914330.16
单位质量响应值RSD%判断
6141.636099.600.49数据可信
中间条件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%
5min147645-4764550.46351.537.5250.4651.537.53
245688-4568848.39048.39
347372-4737250.17450.17
451849-5184954.91554.92
545023-4502347.68647.69
654314-5431457.52657.53
10min166355-6635570.27973.675.0570.3673.765.06
268724-6872472.78872.87
367859-6785971.87271.96
472745-7274577.04777.14
566691-6669170.63570.71
674977-7497779.41179.51
15min172621-7262176.91682.524.0077.1282.734.00
278076-7807682.69382.90
377432-7743282.01182.21
480867-8086785.64985.87
577250-7725081.81982.02
681240-8124086.04586.27
20min173454-7345477.79886.105.6178.1386.455.60
282044-8204486.89687.24
380273-8027385.02085.36
484409-8440989.40189.76
580749-8074985.52585.86
686823-8682391.95892.33
30min175124-7512479.56788.015.2480.0388.505.23
283186-8318688.10688.59
383488-8348888.42588.91
486204-8620491.30291.81
582869-8286987.77088.25
687702-8770292.88993.41
45min175114-7511479.55688.635.4580.1589.275.44
284923-8492389.94590.58
384471-8447189.46790.10
485485-8548590.54191.20
583436-8343688.37088.99
688676-8867693.92094.60
极限176462-7646280.98489.905.7481.7190.695.73
287607-8760792.78893.57
385471-8547190.52691.30
488538-8853893.77494.59
582035-8203586.88787.66
689186-8918694.46095.30
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%
1 11.613664843651263660283650063643013653890.24
2 11.653652593654043653320.03
单位质量响应值RSD%判断
31471.9231358.970.26数据可信
中间条件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%
5min1220220-22022058.02458.776.0358.0258.776.03
2215920-21592056.89156.89
3214807-21480756.59856.60
4231076-23107660.88560.88
5209976-20997655.32555.33
6246320-24632064.90164.90
10min1278725-27872573.43976.034.8273.5476.144.82
2283331-28333174.65374.75
3279115-27911573.54273.64
4295105-29510577.75577.86
5281073-28107374.05874.15
6314089-31408982.75782.87
15min1297512-29751278.38982.404.3878.6182.624.38
2310058-31005881.69581.91
3304618-30461880.26280.48
4319916-31991684.29284.52
5307976-30797681.14681.36
6336311-33631188.61288.86
20min1303254-30325479.90284.734.2480.2585.094.24
2319929-31992984.29684.65
3316042-31604283.27283.62
4328831-32883186.64187.01
5317717-31771783.71384.06
6343703-34370390.56090.95
30min1304957-30495780.35185.894.1680.8386.394.16
2326684-32668486.07686.57
3322099-32209984.86885.36
4332004-33200487.47787.99
5323756-32375685.30485.79
6346388-34638891.26791.81
45min1304447-30444780.21786.354.3480.8386.994.34
2330760-33076087.15087.79
3324817-32481785.58486.21
4332769-33276987.67988.34
5325370-32537085.72986.36
6348162-34816291.73592.43
极限1307604-30760481.04887.484.5781.8088.274.57
2335482-33548288.39489.18
3327449-32744986.27787.05
4344060-34406090.65491.46
5326765-32676586.09786.87
6350637-35063792.38793.24
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%
114.999225291961925779227892348922830.24
214.999175891713917360.04
单位质量响应值RSD%判断
6156.306119.810.43数据可信
中间条件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%
5min140830-4083043.12247.1110.3343.1247.1110.33
246926-4692649.56049.56
342691-4269145.08745.09
449597-4959752.38152.38
549116-4911651.87351.87
638483-3848340.64340.64
10min164566-6456668.19072.454.9068.2672.524.90
270102-7010274.03774.12
364128-6412867.72767.80
469986-6998673.91474.00
571731-7173175.75775.84
671064-7106475.05375.12
15min173265-7326577.37781.334.4777.5681.524.46
280524-8052485.04485.25
372816-7281676.90377.09
476660-7666080.96381.17
578020-7802082.39982.61
680736-8073685.26785.46
20min176625-7662580.92684.904.3481.2485.244.34
284275-8427589.00589.35
376982-7698281.30381.62
478762-7876283.18383.53
581220-8122085.77986.13
684469-8446989.21089.54
30min180519-8051985.03887.363.3385.4987.843.32
286001-8600190.82891.32
380623-8062385.14885.60
480495-8049585.01385.50
582396-8239687.02187.51
686287-8628791.13091.61
45min182321-8232186.94188.143.7787.5388.763.75
287209-8720992.10492.75
380967-8096785.51186.11
479631-7963184.10084.73
583556-8355688.24688.88
687069-8706991.95692.59
极限184018-8401888.73489.804.9989.4790.564.97
290973-9097396.07996.88
381234-8123485.79386.53
481437-8143786.00886.77
582832-8283287.48188.27
689651-8965194.68395.47
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%
1 11.613678203666103673733666013668603670530.15
2 11.653683713676953680330.13
单位质量响应值RSD%判断
31615.2531590.820.06数据可信
中间条件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%
5min1184716-18471648.38054.4111.0248.3854.4111.02
2218601-21860157.25657.26
3198686-19868652.03952.04
4231031-23103160.51160.51
5232593-23259360.92060.92
6180795-18079547.35447.35
10min1266453-26645369.78974.324.7469.8774.414.74
2293217-29321776.79976.89
3267348-26734870.02370.11
4288217-28821775.48975.59
5297444-29744477.90678.01
6289842-28984275.91575.99
15min1294872-29487277.23281.404.2577.4381.624.25
2326075-32607585.40585.63
3296444-29644477.64477.85
4307677-30767780.58680.81
5318860-31886083.51583.75
6320842-32084284.03484.24
20min1310056-31005681.20984.204.0781.5384.554.07
2340195-34019589.10389.47
3307745-30774580.60480.94
4313766-31376682.18182.54
5324904-32490485.09885.47
6332092-33209286.98187.33
30min1320245-32024583.87885.573.6484.3486.063.64
2345003-34500390.36390.88
3313688-31368882.16182.63
4317734-31773483.22083.72
5328013-32801385.91386.42
6335497-33549787.87388.36
45min1321411-32141184.18386.043.6984.7886.673.69
2346915-34691590.86391.53
3317277-31727783.10183.70
4317603-31760383.18683.82
5329389-32938986.27386.93
6338368-33836888.62589.26
极限1324451-32445184.98087.485.3585.7288.265.33
2363602-36360295.23496.05
3319793-31979383.76084.50
4318720-31872083.47984.25
5330225-33022586.49287.29
6347198-34719890.93791.72
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%
114.999131891911921209216492130919290.39
214.999281592442926280.29
单位质量响应值RSD%判断
6132.696179.320.54数据可信
中间条件6月-供试品溶液-2025021221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%
5min144801-4480147.17850.9610.4547.1850.9610.45
246783-4678349.26549.27
343184-4318445.47545.48
455107-5510758.03158.03
554316-5431657.19857.20
646155-4615548.60448.60
10min171112-7111274.88576.735.4874.9676.825.49
271431-7143175.22175.30
367234-6723470.80170.88
477347-7734781.45181.55
577618-7761881.73681.83
672446-7244676.29076.37
15min181187-8118785.49485.514.5085.7085.724.50
280802-8080285.08985.30
374553-7455378.50878.70
484179-8417988.64588.88
584820-8482089.32089.55
681682-8168286.01686.22
20min185318-8531889.84488.415.3790.1988.775.37
282923-8292387.32287.67
375450-7545079.45379.78
487980-8798092.64893.03
586870-8687091.47991.86
685216-8521689.73790.09
30min187175-8717591.80090.624.4392.3091.134.43
286147-8614790.71791.21
378525-7852582.69183.15
488941-8894193.66094.19
587550-8755092.19592.73
688014-8801492.68393.18
45min187424-8742492.06291.314.3392.7191.974.34
287127-8712791.74992.40
379272-7927283.47884.07
489600-8960094.35495.04
588628-8862893.33094.02
688232-8823292.91393.57
极限188029-8802992.69991.424.8093.5092.224.80
285247-8524789.77090.57
379588-7958883.81084.54
492052-9205296.93697.78
588434-8843493.12693.97
687510-8751092.15392.96
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%
1 11.613670383694073699023692313688693688890.30
2 11.653745033727533736280.34
单位质量响应值RSD%判断
31773.3932071.070.66数据可信
中间条件6月-供试品溶液-2025021221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%
5min1207334-20733453.76357.917.5853.7657.917.58
2217918-21791856.50756.51
3208718-20871854.12254.12
4249751-24975164.76264.76
5237864-23786461.67961.68
6218431-21843156.64056.64
10min1293022-29302275.98278.144.2076.0778.244.20
2299465-29946577.65377.75
3283427-28342773.49473.58
4320019-32001982.98283.09
5308438-30843879.97980.08
6303791-30379178.77478.87
15min1325699-32569984.45584.493.8384.6784.723.83
2327792-32779284.99885.22
3303349-30334978.66078.87
4341858-34185888.64588.89
5327880-32788085.02185.26
6328417-32841785.16085.39
20min1337250-33725087.45186.514.0287.8186.884.02
2337535-33753587.52487.89
3308170-30817079.91080.25
4347703-34770390.16190.56
5332813-33281386.30086.68
6338324-33832487.72988.10
30min1342009-34200988.68587.744.1689.1988.254.15
2342699-34269988.86489.37
3312276-31227680.97581.45
4350859-35085990.97991.52
5333984-33398486.60487.13
6348287-34828790.31390.83
45min1342700-34270088.86488.023.8689.5188.683.86
2343590-34359089.09589.75
3314784-31478481.62582.24
4351172-35117291.06191.76
5336376-33637687.22487.89
6348081-34808190.25990.92
极限1345695-34569589.64088.684.6590.4489.494.65
2341566-34156688.57089.38
3314624-31462481.58482.33
4363118-36311894.15895.01
5338546-33854687.78788.60
6348502-34850290.36891.18
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