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%
115.239247592503930419264392876927080.27
215.149252292384924530.11
单位质量响应值RSD%判断
6087.206106.540.23数据可信
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%
5min122466-2246623.88739.4019.8523.8939.4019.85
239698-3969842.20942.21
340120-4012042.65842.66
440062-4006242.59642.60
542715-4271545.41745.42
637274-3727439.63239.63
10min148845-4884551.93563.979.8551.9764.039.86
259260-5926063.00963.08
363855-6385567.89467.97
461413-6141365.29865.37
565374-6537469.50969.58
662228-6222866.16466.23
15min159276-5927663.02674.117.8763.1574.287.88
269265-6926573.64673.82
373271-7327177.90678.09
469435-6943573.82774.01
573435-7343578.08078.27
673510-7351078.16078.34
20min166665-6666570.88278.045.1671.1178.335.18
272441-7244177.02377.32
376609-7660981.45581.77
473554-7355478.20778.51
573876-7387678.54978.87
677225-7722582.11082.42
30min176990-7699081.86081.593.1882.2182.023.17
273527-7352778.17878.60
379297-7929784.31384.76
474056-7405678.74079.17
578884-7888483.87484.33
677679-7767982.59383.04
45min181450-8145086.60284.262.0087.0984.821.96
276922-7692281.78882.34
378255-7825583.20583.80
479041-7904184.04184.61
580297-8029785.37685.97
679528-7952884.55985.14
极限188973-8897394.60187.405.4295.2388.105.35
278959-7895983.95484.65
377954-7795482.88583.61
486471-8647191.94192.65
580194-8019485.26786.00
680626-8062685.72686.45
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%
111.433557243548303566513562373565323559950.21
211.393583383580993582180.05
单位质量响应值RSD%判断
31145.6731450.220.69数据可信
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%
5min1118127-11812731.24250.6419.0631.2450.6419.06
2204222-20422254.01254.01
3207565-20756554.89654.90
4213695-21369556.51856.52
5210060-21006055.55655.56
6195258-19525851.64151.64
10min1218110-21811057.68571.059.4457.7471.139.45
2270320-27032071.49471.58
3283851-28385175.07275.16
4274365-27436572.56372.66
5283422-28342274.95975.05
6281736-28173674.51374.60
15min1254694-25469467.36178.077.1267.5178.277.13
2293353-29335377.58577.79
3310496-31049682.11982.34
4296729-29672978.47878.69
5307321-30732181.28081.50
6308550-30855081.60581.81
20min1274070-27407072.48580.995.6172.7581.335.63
2302094-30209479.89780.24
3318505-31850584.23784.59
4307088-30708881.21881.56
5317706-31770684.02684.38
6317981-31798184.09984.45
30min1318301-31830184.18384.141.8984.5684.601.88
2308536-30853681.60182.07
3323807-32380785.64086.13
4313652-31365282.95483.44
5321551-32155185.04385.54
6322910-32291085.40285.89
45min1326910-32691086.46085.051.7486.9885.661.71
2311867-31186782.48283.09
3325541-32554186.09886.73
4318466-31846684.22784.85
5322733-32273385.35685.99
6323993-32399385.68986.32
极限1360808-36080895.42688.574.9196.0989.324.83
2321186-32118684.94685.69
3327706-32770686.67187.45
4350021-35002192.57393.33
5323306-32330685.50786.28
6326357-32635786.31487.09
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%
115.239189592249923729224291951921420.23
215.149184291586917140.20
单位质量响应值RSD%判断
6050.036057.730.09数据可信
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%
5min138809-3880941.55741.447.9041.5641.447.90
240609-4060943.48443.48
340124-4012442.96542.96
442526-4252645.53745.54
535271-3527137.76837.77
634872-3487237.34137.34
10min160767-6076765.06965.524.4365.1465.594.42
258340-5834062.47162.54
359603-5960363.82363.89
461605-6160565.96766.04
566214-6621470.90270.97
660591-6059164.88164.94
15min167920-6792072.72974.724.9172.9174.904.90
267028-6702871.77471.95
368989-6898973.87474.05
467725-6772572.52072.71
576240-7624081.63881.82
670791-7079175.80375.97
20min173265-7326578.45278.795.3878.7579.095.37
269591-6959174.51874.81
372602-7260277.74278.04
471364-7136476.41776.72
581089-8108986.83087.15
673550-7355078.75879.05
30min176449-7644981.86280.935.3582.2981.365.33
272295-7229577.41477.83
373423-7342378.62279.05
472552-7255277.68978.12
583071-8307188.95389.41
675704-7570481.06481.49
45min177144-7714482.60681.814.6383.1782.384.62
274415-7441579.68480.23
374137-7413779.38679.95
472682-7268277.82878.39
582546-8254688.39189.00
677504-7750482.99283.55
极限178162-7816283.69686.909.8184.4087.609.74
283685-8368589.61090.29
370664-7066475.66776.36
474775-7477580.06980.76
589528-8952895.86796.62
690103-9010396.48397.18
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%
111.433561483574563576173569733560973568580.20
211.393579663578493579080.03
单位质量响应值RSD%判断
31221.1731423.000.46数据可信
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%
5min1196343-19634351.88853.576.9451.8953.576.94
2213162-21316256.33256.33
3210470-21047055.62155.62
4220094-22009458.16458.16
5193015-19301551.00851.01
6183156-18315648.40348.40
10min1269134-26913471.12472.873.3971.2172.963.38
2264833-26483369.98770.08
3281245-28124574.32574.42
4277091-27709173.22773.32
5290649-29064976.81076.89
6271517-27151771.75471.83
15min1294532-29453277.83679.524.3178.0479.734.30
2284701-28470175.23875.45
3305132-30513280.63780.85
4295054-29505477.97478.19
5322788-32278885.30385.52
6303210-30321080.12980.33
20min1304603-30460380.49882.074.5780.8382.424.56
2293016-29301677.43577.77
3315428-31542883.35883.71
4302807-30280780.02380.37
5334517-33451788.40388.76
6312986-31298682.71383.05
30min1311914-31191482.43083.554.4582.9084.034.44
2298533-29853378.89379.36
3321920-32192085.07485.56
4307081-30708181.15281.63
5339375-33937589.68790.19
6318021-31802184.04384.52
45min1313379-31337982.81783.873.9783.4284.493.96
2302414-30241479.91980.52
3319777-31977784.50885.14
4310062-31006281.94082.56
5339494-33949489.71890.37
6319155-31915584.34384.95
极限1319531-31953184.44388.847.6485.1989.607.59
2343366-34336690.74191.47
3310626-31062682.08982.86
4312236-31223682.51583.27
5364476-36447696.32097.12
6366879-36687996.95597.71
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%
115.239209691970919939216492211920870.12
215.149121991157911880.05
单位质量响应值RSD%判断
6046.426022.990.28数据可信
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%
5min145546-4554648.92645.988.7548.9345.988.75
237448-3744840.22740.23
343359-4335946.57746.58
447912-4791251.46851.47
542469-4246945.62145.62
640099-4009943.07543.07
10min165980-6598070.87670.823.2170.9670.903.21
266485-6648571.41971.49
367824-6782472.85772.93
466969-6696971.93972.02
566517-6651771.45371.53
661812-6181266.39966.47
15min174274-7427479.78680.003.5279.9980.203.51
277307-7730783.04483.23
377706-7770683.47383.67
473909-7390979.39479.60
572631-7263178.02178.22
671014-7101476.28476.47
20min176801-7680182.50084.234.2082.8384.564.19
281129-8112987.15087.47
383181-8318189.35489.69
477917-7791783.69984.04
577566-7756683.32283.65
673897-7389779.38179.69
30min179495-7949585.39486.112.9785.8686.582.97
282822-8282288.96889.44
382888-8288889.03989.53
479525-7952585.42785.90
579641-7964185.55186.02
676620-7662082.30682.75
45min180611-8061186.59387.622.9687.2188.232.95
283778-8377889.99590.61
385341-8534191.67492.31
479770-7977085.69086.31
580448-8044886.41887.02
679459-7945985.35685.93
极限180559-8055986.53789.584.9987.2990.334.96
289059-8905995.66896.44
384729-8472991.01791.80
486242-8624292.64293.40
577463-7746383.21183.96
682287-8228788.39389.11
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%
111.433596583592753590313599283596653595110.10
211.393552413552923552660.02
单位质量响应值RSD%判断
31453.2831191.040.60数据可信
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%
5min1225992-22599259.72357.837.1359.7257.837.13
2196276-19627651.87051.87
3220077-22007758.16058.16
4238261-23826162.96662.97
5227687-22768760.17160.17
6204716-20471654.10154.10
10min1288319-28831976.19477.052.8776.2977.142.87
2293280-29328077.50677.59
3299715-29971579.20679.30
4298265-29826578.82378.93
5292984-29298477.42777.53
6276687-27668773.12073.21
15min1310374-31037482.02383.613.1182.2583.833.11
2326120-32612086.18486.40
3327575-32757586.56986.80
4318082-31808284.06084.30
5314539-31453983.12483.35
6301505-30150579.67979.89
20min1317119-31711983.80685.963.4184.1786.323.40
2337182-33718289.10889.47
3338346-33834689.41589.79
4325775-32577586.09386.47
5322952-32295285.34785.71
6310161-31016181.96782.31
30min1321566-32156684.98187.152.9285.4887.662.91
2340955-34095590.10590.61
3341732-34173290.31090.83
4329279-32927987.01987.54
5325913-32591386.13086.64
6319270-31927084.37484.86
45min1323599-32359985.51887.882.5686.1688.532.55
2342433-34243390.49591.15
3343282-34328290.72091.39
4331924-33192487.71888.38
5328252-32825286.74887.40
6325627-32562786.05486.68
极限1323991-32399185.62290.744.8186.4191.544.78
2365803-36580396.67197.48
3347974-34797491.96092.78
4357890-35789094.58095.39
5331072-33107287.49388.29
6333532-33353288.14388.91
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%
115.239171692066919299193991979919260.15
215.149209892292921950.15
单位质量响应值RSD%判断
6035.856089.500.63数据可信
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%
5min130529-3052932.64442.6614.9532.6442.6614.95
242285-4228545.21445.21
343322-4332246.32346.32
447670-4767050.97250.97
536541-3654139.07239.07
639014-3901441.71741.72
10min154695-5469558.48467.097.6558.5467.167.65
267341-6734172.00672.08
360184-6018464.35364.43
467377-6737772.04472.13
563585-6358567.99068.05
663304-6330467.68967.76
15min163774-6377468.19276.828.6468.3477.008.64
278418-7841883.85084.05
364492-6449268.95969.14
476328-7632881.61581.82
574560-7456079.72579.90
673508-7350878.60078.78
20min172267-7226777.27380.899.2277.5481.209.21
281914-8191487.58887.92
363082-6308267.45267.75
477552-7755282.92483.27
579037-7903784.51284.82
680066-8006685.61285.93
30min178379-7837983.80883.839.1284.2084.279.10
282447-8244788.15888.64
364219-6421968.66769.08
480961-8096186.56987.05
581077-8107786.69387.15
683290-8329089.06089.52
45min180233-8023385.79185.216.9886.3285.806.98
283795-8379589.60090.23
368820-6882073.58774.11
481834-8183487.50388.13
579945-7994585.48386.08
683509-8350989.29489.90
极限182065-8206587.75092.214.8288.4392.944.84
289462-8946295.65996.44
380547-8054786.12786.78
490822-9082297.11397.88
588486-8848694.61595.35
686051-8605192.01292.77
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%
111.433575683586553578573579933579383580020.12
211.393609723612943611330.07
单位质量响应值RSD%判断
31321.2631706.150.87数据可信
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%
5min1155201-15520140.76751.9613.8140.7751.9613.81
2200884-20088452.76652.77
3221252-22125258.11658.12
4232128-23212860.97360.97
5186610-18661049.01749.02
6190742-19074250.10250.10
10min1232317-23231761.02372.157.8261.0972.247.82
2282628-28262874.23874.33
3277622-27762272.92373.02
4292936-29293676.94677.05
5284052-28405274.61274.69
6278550-27855073.16773.25
15min1264327-26432769.43179.396.6269.6079.596.62
2311794-31179481.89982.11
3295227-29522777.54777.77
4315262-31526282.81083.04
5314062-31406282.49582.70
6312701-31270182.13782.34
20min1293373-29337377.06082.475.1077.3582.815.10
2320463-32046384.17684.52
3293626-29362677.12777.47
4324037-32403785.11585.48
5325961-32596185.62085.96
6326444-32644485.74786.09
30min1314179-31417982.52684.314.8382.9484.794.82
2325273-32527385.44085.93
3293176-29317677.00977.48
4326195-32619585.68286.19
5330379-33037986.78187.27
6336673-33667388.43488.92
45min1318702-31870283.71485.163.8384.2685.783.82
2326586-32658685.78486.42
3302528-30252879.46580.07
4327749-32774986.09086.74
5331522-33152287.08187.71
6338224-33822488.84189.47
极限1321639-32163984.48590.904.0885.1891.664.08
2346440-34644091.00091.77
3343782-34378290.30191.04
4362678-36267895.26596.06
5356734-35673493.70394.48
6345207-34520790.67691.46
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