阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.029730097263973129707997005971920.15
212.089723097296972630.05
单位质量响应值RSD%判断
8085.868051.570.31数据可信
供试品溶液-2024030121批-左氨氯地平-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%
5min163099-6309963.20165.493.2563.2065.493.25
265445-6544565.55065.55
364867-6486764.97164.97
468783-6878368.89468.89
563439-6343963.54163.54
666658-6665866.76566.77
10min173418-7341873.53675.181.9173.8975.551.92
275121-7512175.24275.61
374381-7438174.50174.86
477494-7749477.61978.00
574220-7422074.33974.69
675743-7574375.86576.24
15min176576-7657676.69978.832.0677.4679.622.06
277202-7720277.32678.11
378639-7863978.76679.54
480644-8064480.77481.59
578885-7888579.01279.78
680292-8029280.42181.21
20min178676-7867678.80381.242.4379.9982.462.43
281296-8129681.42782.64
381150-8115081.28182.49
483552-8355283.68684.95
579077-7907779.20480.41
682934-8293483.06784.31
30min177928-7792878.05383.193.3779.6884.863.34
281755-8175581.88783.55
383863-8386383.99885.66
484960-8496085.09786.82
585094-8509485.23186.88
684711-8471184.84786.55
45min182213-8221382.34585.722.0284.4087.852.02
285408-8540885.54587.66
386194-8619486.33388.46
486216-8621686.35588.56
586943-8694387.08389.20
686532-8653286.67188.84
60min181738-8173881.87086.792.9884.3889.402.94
286598-8659886.73789.33
388435-8843588.57791.19
486619-8661986.75889.44
587620-8762087.76190.36
688883-8888389.02691.68
极限191191-9119191.33894.631.9194.3197.721.90
295421-9542195.57598.65
394185-9418594.33797.44
494324-9432494.47697.64
595379-9537995.53298.62
696371-9637196.52699.67
阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.073806823800113799283801763800603801710.08
210.033799963803003801480.06
单位质量响应值RSD%判断
37752.8337901.100.28数据可信
供试品溶液-2024030121批-阿齐沙坦-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%
5min186534-8653420.52719.585.7720.5319.585.76
274599-7459917.69617.70
382758-8275819.63119.63
481118-8111819.24219.24
588209-8820920.92420.92
682132-8213219.48319.48
10min1241513-24151357.29056.043.4857.4056.153.48
2238603-23860356.60056.70
3230307-23030754.63254.74
4226060-22606053.62453.73
5248559-24855958.96159.08
6232541-23254155.16255.27
15min1406290-40629096.37788.124.8596.8188.544.84
2361159-36115985.67186.08
3358735-35873585.09685.51
4362618-36261886.01886.42
5375350-37535089.03889.48
6364831-36483186.54386.96
20min1393801-39380193.41593.422.0594.3894.332.01
2395265-39526593.76294.65
3392934-39293493.20994.09
4404696-40469695.99996.88
5379830-37983090.10091.04
6396515-39651594.05894.95
30min1395460-39546093.80892.680.9095.2994.100.91
2387315-38731591.87693.29
3390008-39000892.51593.92
4394575-39457593.59895.01
5389162-38916292.31493.75
6387579-38757991.93993.36
45min1387582-38758291.93991.981.0393.9593.931.01
2385825-38582591.52393.44
3385432-38543291.42993.35
4395718-39571893.86995.81
5385831-38583191.52493.48
6386250-38625091.62393.55
60min1384484-38448491.20491.590.6593.7294.050.62
2386511-38651191.68594.11
3388420-38842092.13894.56
4389432-38943292.37894.84
5382816-38281690.80993.27
6385103-38510391.35193.79
极限1386373-38637391.65391.751.1794.6894.721.14
2387823-38782391.99794.93
3382515-38251590.73793.67
4394614-39461493.60796.58
5382229-38222990.67093.63
6387248-38724891.86094.81
阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.029708197183970169695697080970630.09
212.089666496767967160.08
单位质量响应值RSD%判断
8075.128006.290.61数据可信
供试品溶液-2024030221批-左氨氯地平-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%
5min164647-6464764.97765.272.4964.9865.272.48
264476-6447664.80664.81
365627-6562765.96265.96
465390-6539065.72465.72
562313-6231362.63262.63
667200-6720067.54367.54
10min177382-7738277.77877.062.6778.1477.432.67
276224-7622476.61476.97
377248-7724877.64378.01
478980-7898079.38479.75
572913-7291373.28673.63
677287-7728777.68278.06
15min178984-7898479.38879.992.8780.1880.782.87
277982-7798278.38179.17
380893-8089381.30682.10
482977-8297783.40184.21
576486-7648676.87777.63
680154-8015480.56481.37
20min181875-8187582.29482.152.3683.5383.382.36
279762-7976280.17081.39
383312-8331283.73884.99
484399-8439984.83086.10
579490-7949079.89681.08
681549-8154981.96683.22
30min183430-8343083.85683.172.3385.5584.872.32
279112-7911279.51681.18
384489-8448984.92186.64
483825-8382584.25385.99
582242-8224282.66284.29
683411-8341183.83785.55
45min186697-8669787.14086.232.4489.3088.382.40
281548-8154881.96584.07
386607-8660787.05089.24
486347-8634786.78889.00
586933-8693387.37789.46
686611-8661187.05489.23
60min185781-8578186.21986.352.2088.8688.982.16
282531-8253182.95385.52
387915-8791588.36491.03
485520-8552085.95788.65
587325-8732587.77190.34
686404-8640486.84689.50
极限192138-9213892.60993.621.3995.7396.731.39
292056-9205692.52795.55
392670-9267093.14496.30
495365-9536595.85299.02
592612-9261293.08596.14
694000-9400094.48097.62
阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.073797183800993795913797803795753797530.06
210.033787433789753788590.05
单位质量响应值RSD%判断
37711.3237772.580.12数据可信
供试品溶液-2024030221批-阿齐沙坦-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%
5min188605-8860521.06620.4314.6721.0720.4314.66
273806-7380617.54717.55
367542-6754216.05816.06
4100530-10053023.90123.90
593366-9336622.19722.20
691628-9162821.78421.78
10min1257123-25712361.13056.836.9561.2556.946.96
2229465-22946554.55454.65
3211556-21155650.29750.39
4238144-23814456.61856.75
5250731-25073159.61059.73
6247198-24719858.77058.89
15min1368005-36800587.49284.743.5687.9585.183.55
2346567-34656782.39582.80
3357347-35734784.95885.33
4336907-33690780.09880.55
5369642-36964287.88188.34
6360211-36021185.63986.09
20min1383698-38369891.22391.471.4992.1792.381.46
2386458-38645891.87992.74
3392392-39239293.29094.13
4375382-37538289.24690.14
5387891-38789192.22093.16
6382704-38270490.98691.91
30min1378246-37824689.92790.661.5791.3892.071.53
2387888-38788892.21993.59
3385421-38542191.63292.99
4371433-37143388.30789.69
5384401-38440191.39092.84
6380613-38061390.48991.92
45min1378282-37828289.93590.631.0891.8892.541.07
2381119-38111990.61092.49
3384847-38484791.49693.36
4374682-37468289.07990.96
5385144-38514491.56793.53
6383223-38322391.11093.04
60min1368399-36839987.58588.981.4690.0391.401.41
2378028-37802889.87592.26
3380926-38092690.56492.94
4367140-36714087.28689.66
5375959-37595989.38391.85
6375257-37525789.21691.65
极限1366438-36643887.11988.351.4190.0591.261.38
2374662-37466289.07491.96
3376822-37682289.58892.47
4364202-36420286.58889.45
5375984-37598489.38992.36
6371589-37158988.34491.28
阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.029752697344973489716597139973040.17
212.089698696848969170.11
单位质量响应值RSD%判断
8095.178022.930.64数据可信
供试品溶液-2024030321批-左氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min197121-9712197.39597.561.7697.4097.561.77
299366-9936699.64799.65
395483-9548395.75395.75
499411-9941199.69299.69
596279-9627996.55196.55
696053-9605396.32496.32
10min1100835-100835101.12098.552.38101.6699.092.38
2100910-100910101.195101.75
396514-9651496.78797.32
499086-9908699.36699.92
596793-9679397.06697.60
695473-9547395.74396.28
15min1100255-100255100.53898.581.53101.6499.671.53
2100170-100170100.453101.57
396963-9696397.23798.31
497685-9768597.96199.07
597560-9756097.83698.91
697191-9719197.46698.53
20min198567-9856798.84598.041.48100.5199.681.48
2100269-100269100.552102.23
396728-9672897.00198.61
497651-9765197.92799.58
596942-9694297.21698.84
696456-9645696.72998.34
30min198151-9815198.42897.661.63100.6499.841.62
299347-9934799.628101.86
395725-9572595.99598.14
497624-9762497.900100.09
598226-9822698.504100.66
695262-9526295.53197.68
45min199517-9951799.79898.122.90102.56100.842.87
2102732-102732103.022105.81
395527-9552795.79798.48
497555-9755597.831100.57
595601-9560195.87198.58
696105-9610596.37799.05
60min197863-9786398.14096.961.54101.45100.231.54
298831-9883199.110102.47
395039-9503995.30898.52
496752-9675297.025100.31
595203-9520395.47298.71
696445-9644596.71799.93
极限196328-9632896.60095.611.24100.4699.421.23
295512-9551295.78299.69
393484-9348493.74897.49
496755-9675597.028100.85
595286-9528695.55599.32
694684-9468494.95298.70
阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.073805813805623805013810553808673807130.07
210.033793043795573794300.05
单位质量响应值RSD%判断
37806.6537829.510.05数据可信
供试品溶液-2024030321批-阿齐沙坦-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15436-54361.2901.6326.361.291.6426.19
26392-63921.5171.52
35165-51651.2251.23
410216-102162.4242.42
56979-69791.6561.66
67115-71151.6881.69
10min123614-236145.6035.774.765.615.784.80
225065-250655.9475.96
322400-224005.3155.32
425660-256606.0886.10
524705-247055.8625.87
624368-243685.7825.79
15min138251-382519.0769.272.859.119.312.89
239498-394989.3729.41
337437-374378.8838.92
440666-406669.6499.70
539378-393789.3439.38
639148-391489.2899.33
20min146571-4657111.05011.311.3611.1411.401.38
248055-4805511.40211.50
347322-4732211.22811.31
448441-4844111.49311.59
547770-4777011.33411.43
647727-4772711.32411.42
30min154880-5488013.02113.051.0513.1713.201.05
254425-5442512.91313.07
354810-5481013.00513.15
455570-5557013.18513.35
555822-5582213.24513.40
654496-5449612.93013.09
45min160578-6057814.37314.261.4914.6014.481.47
261569-6156914.60814.84
359920-5992014.21714.44
459991-5999114.23414.47
559149-5914914.03414.26
659292-5929214.06814.30
60min162238-6223814.76714.760.7815.0715.070.79
261924-6192414.69315.00
362407-6240714.80715.11
462844-6284414.91115.23
561429-6142914.57514.88
662380-6238014.80115.11
极限163010-6301014.95014.911.6815.3315.301.65
261317-6131714.54914.94
363383-6338315.03915.42
464002-6400215.18615.59
563523-6352315.07215.46
661802-6180214.66415.05
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