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%
115.399224591734921389176492045919850.25
215.459108191416912480.26
单位质量响应值RSD%判断
5976.935906.020.85数据可信
供试品溶液-GF9440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%
5min156563-5656361.71659.675.5861.7259.675.58
250532-5053255.13555.14
353601-5360158.48458.48
452109-5210956.85656.86
557433-5743362.66562.67
657893-5789363.16763.17
10min179808-7980887.07887.172.9887.1887.272.98
279117-7911786.32586.42
379459-7945986.69886.80
476228-7622883.17283.27
583345-8334590.93891.04
681368-8136888.78188.89
15min185546-8554693.33994.152.3293.5994.402.32
285230-8523092.99493.23
386145-8614593.99394.23
483791-8379191.42491.66
589528-8952897.68497.94
687497-8749795.46895.72
20min187875-8787595.88097.291.8596.2897.701.85
288988-8898897.09597.49
388968-8896897.07397.47
487093-8709395.02795.41
591464-9146499.796100.22
690631-9063198.88799.30
30min189197-8919797.32399.291.6197.8999.861.62
291517-9151799.854100.41
391319-9131999.638100.20
489223-8922397.35197.90
592678-92678101.121101.71
692064-92064100.451101.03
45min189440-8944097.58899.351.4798.31100.081.47
290165-9016598.37999.10
391630-9163099.977100.70
490074-9007498.28098.99
592456-92456100.879101.63
692554-92554100.986101.73
极限190567-9056798.81899.561.0599.71100.451.06
291400-9140099.726100.61
391392-9139299.718100.61
489918-8991898.10998.98
592749-92749101.198102.12
691435-9143599.765100.68
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%
111.331731521723711732461728991737301730800.29
211.301727651735271731460.32
单位质量响应值RSD%判断
15276.2615322.650.22数据可信
供试品溶液-GF9440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%
5min1102474-10247455.32552.706.7755.3252.706.77
290246-9024648.72348.72
394349-9434950.93850.94
490718-9071848.97848.98
5104946-10494656.65956.66
6102934-10293455.57355.57
10min1147750-14775079.76980.032.5679.8680.122.56
2147200-14720079.47279.55
3146234-14623478.95079.04
4144422-14442277.97278.05
5155423-15542383.91184.01
6148421-14842180.13180.22
15min1163088-16308888.05090.662.1488.2790.882.14
2168679-16867991.06891.28
3167797-16779790.59290.81
4165881-16588189.55789.77
5173912-17391293.89394.13
6168146-16814690.78091.01
20min1169388-16938891.45194.812.2191.8295.182.20
2177136-17713695.63496.00
3176949-17694995.53395.90
4173661-17366193.75894.12
5180902-18090297.66798.06
6175570-17557094.78895.17
30min1173071-17307193.43997.742.3293.9698.272.31
2183113-18311398.86199.39
3182387-18238798.46999.00
4183375-18337599.00299.52
5184380-18438099.545100.10
6179857-17985797.10397.64
45min1174435-17443594.17698.292.1894.8698.982.17
2185129-18512999.949100.64
3183110-18311098.85999.55
4182718-18271898.64899.33
5185126-18512699.948100.67
6181770-18177098.13698.83
极限1178433-17843396.33498.501.3497.1799.361.34
2184384-18438499.547100.40
3183312-18331298.96899.82
4182129-18212998.33099.18
5185154-18515499.963100.85
6181246-18124697.85398.71
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%
115.399141290988912879088591117911380.24
215.459034490436903900.08
单位质量响应值RSD%判断
5921.905850.490.86数据可信
供试品溶液-GF9440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%
5min154063-5406359.54254.7311.4759.5454.7411.47
242678-4267847.00347.00
345673-4567350.30250.30
455083-5508360.66660.67
545451-4545150.05750.06
655237-5523760.83560.84
10min179895-7989587.99285.283.8288.0985.373.82
273881-7388181.36981.45
373786-7378681.26481.35
478260-7826086.19286.29
578102-7810286.01886.10
680671-8067188.84788.95
15min186626-8662695.40593.342.2695.6593.572.26
283636-8363692.11292.33
381718-8171890.00090.22
484407-8440792.96293.21
586692-8669295.47895.70
685401-8540194.05694.31
20min189220-8922098.26296.701.7298.6797.091.72
288206-8820697.14697.51
385709-8570994.39694.76
486340-8634095.09095.49
589420-8942098.48398.87
687931-8793196.84397.25
30min190674-9067499.86498.971.88100.4399.521.87
291178-91178100.419100.95
388314-8831497.26597.79
487709-8770996.59897.16
591988-91988101.311101.86
689297-8929798.34798.91
45min191335-91335100.59299.511.73101.33100.231.72
291497-91497100.770101.47
389378-8937898.43699.13
487722-8772296.61397.33
591763-91763101.063101.78
690447-9044799.614100.35
极限190743-9074399.94098.682.42100.8499.562.41
291228-91228100.474101.34
386555-8655595.32796.18
487454-8745496.31797.20
591980-91980101.302102.19
689628-8962898.71299.61
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%
111.331724741718691724691721211726161723100.18
211.301714761714991714880.01
单位质量响应值RSD%判断
15208.3015175.930.16数据可信
供试品溶液-GF9440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%
5min196956-9695652.71549.4114.2252.7249.4214.21
275594-7559441.10141.10
384728-8472846.06746.07
4104035-10403556.56456.56
578766-7876642.82542.83
6105224-10522457.21157.21
10min1148957-14895780.98878.675.0981.0878.755.10
2136334-13633474.12574.19
3139217-13921775.69375.77
4149783-14978381.43881.53
5139310-13931075.74375.81
6154559-15455984.03484.13
15min1170024-17002492.44390.802.7092.6791.012.71
2163821-16382189.07089.26
3163379-16337988.83089.03
4167493-16749391.06791.30
5163022-16302288.63688.83
6174253-17425394.74294.98
20min1178318-17831896.95295.601.6897.3395.961.70
2175080-17508095.19295.53
3173177-17317794.15794.51
4174472-17447294.86195.24
5173415-17341594.28694.63
6180536-18053698.15898.55
30min1183384-18338499.70798.801.37100.2599.321.37
2182650-18265099.30899.81
3180387-18038798.07798.59
4177753-17775396.64597.18
5181314-18131498.58199.08
6184771-184771100.461101.02
45min1183648-18364899.85099.321.29100.55100.011.29
2184449-184449100.286100.95
3182821-18282199.400100.07
4178762-17876297.19497.89
5181221-18122198.53199.20
6185136-185136100.659101.38
极限1182897-18289799.44299.291.39100.31100.151.38
2185055-185055100.615101.45
3182342-18234299.14099.98
4178504-17850497.05397.92
5181524-18152498.69599.53
6185428-185428100.818101.71
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%
115.399009590469901919056890555903760.25
215.458972689945898360.18
单位质量响应值RSD%判断
5872.385814.630.70数据可信
供试品溶液-LC1771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%
5min148264-4826453.54359.556.0453.5459.556.04
252084-5208457.78157.78
357843-5784364.17064.17
454604-5460460.57760.58
554100-5410060.01760.02
655155-5515561.18861.19
10min177949-7794986.47586.062.6486.5686.162.64
276327-7632784.67684.77
380538-8053889.34789.45
476486-7648684.85284.95
575001-7500183.20583.30
679175-7917587.83587.94
15min185601-8560194.96492.923.3895.2093.163.38
284246-8424693.46193.70
385596-8559694.95895.21
483727-8372792.88593.13
578190-7819086.74286.98
685165-8516594.48094.73
20min190005-9000599.85097.512.62100.2497.912.62
287418-8741896.98097.37
389749-8974999.56699.98
486499-8649995.96096.36
584188-8418893.39693.78
689523-8952399.31599.72
30min191711-91711101.74299.401.96102.3099.961.95
289863-8986399.692100.25
389566-8956699.36399.94
490025-9002599.872100.43
586374-8637495.82296.36
690039-9003999.887100.46
45min191529-91529101.54099.711.85102.27100.431.84
290464-90464100.359101.08
390725-90725100.649101.39
487396-8739696.95597.68
588234-8823497.88598.58
690907-90907100.850101.59
极限191329-91329101.31999.991.46102.22100.881.46
290134-9013499.993100.88
389987-8998799.830100.74
490795-90795100.726101.61
587656-8765697.24498.11
690877-90877100.817101.72
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%
111.331709501720061712971720901719741716630.30
211.301711871710531711200.06
单位质量响应值RSD%判断
15151.1915143.360.04数据可信
供试品溶液-LC1771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%
5min175532-7553241.18947.307.7941.1947.307.79
284435-8443546.04346.04
395522-9552252.08952.09
485666-8566646.71546.71
588736-8873648.38948.39
690568-9056849.38849.39
10min1139827-13982776.24977.534.2976.3277.604.29
2138610-13861075.58675.66
3149033-14903381.27081.36
4134559-13455973.37773.45
5141020-14102076.90076.98
6149973-14997381.78281.86
15min1163372-16337289.08988.873.7389.2889.073.73
2160874-16087487.72787.93
3168898-16889892.10292.32
4154892-15489284.46584.66
5158873-15887386.63586.84
6170881-17088193.18493.40
20min1173234-17323494.46793.922.7794.8194.282.77
2170710-17071093.09093.44
3175682-17568295.80296.18
4165175-16517590.07290.41
5169886-16988692.64192.99
6178753-17875397.47697.85
30min1179180-17918097.70996.782.3198.2197.302.31
2176642-17664296.32596.83
3179348-17934897.80198.34
4171398-17139893.46593.96
5175022-17502295.44295.95
6183270-18327099.939100.48
45min1179860-17986098.08097.781.7098.7498.461.71
2177808-17780896.96197.63
3180151-18015198.23998.94
4175999-17599995.97496.62
5177439-17743996.76097.43
6184656-184656100.695101.40
极限1179662-17966297.97297.791.6998.8098.631.70
2178180-17818097.16497.99
3180742-18074298.56199.42
4175596-17559695.75596.56
5177498-17749896.79297.62
6184312-184312100.508101.38
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%
115.398992990485903069006590169901910.24
215.458995790069900130.09
单位质量响应值RSD%判断
5860.365826.080.42数据可信
供试品溶液-LC1771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%
5min159107-5910765.57461.485.4865.5761.485.47
253107-5310758.91858.92
356341-5634162.50662.51
450897-5089756.46656.47
555250-5525061.29561.30
657803-5780364.12864.13
10min182540-8254091.57186.803.4191.6886.903.41
278627-7862787.23087.33
378287-7828786.85386.96
476593-7659384.97485.07
574537-7453782.69382.79
678853-7885387.48187.59
15min190073-9007399.92895.812.27100.1996.052.28
286381-8638195.83296.08
385848-8584895.24195.49
484359-8435993.58993.82
585325-8532594.66194.90
686156-8615695.58395.84
20min192804-92804102.95898.772.17103.3999.182.17
289308-8930899.08099.48
388308-8830897.97098.38
487743-8774397.34397.74
587877-8787797.49297.89
688141-8814197.78598.20
30min193219-93219103.419100.401.68104.02100.981.69
291226-91226101.208101.78
389904-8990499.741100.31
488973-8897398.70899.26
589956-8995699.799100.36
689723-8972399.540100.12
45min194058-94058104.349101.081.98105.12101.821.98
292199-92199102.287103.02
390070-9007099.925100.66
489089-8908998.83799.56
590055-9005599.908100.64
691216-91216101.196101.94
极限193205-93205103.403100.481.91104.35101.391.91
291155-91155101.129102.04
388984-8898498.72099.62
488362-8836298.03098.91
590773-90773100.705101.60
690961-90961100.914101.82
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%
111.331710671720141715451711971714121714470.22
211.301714851718251716550.15
单位质量响应值RSD%判断
15132.1315190.710.28数据可信
供试品溶液-LC1771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%
5min196185-9618552.40249.105.6452.4049.105.64
286439-8643947.09247.09
394631-9463151.55651.56
483185-8318545.32045.32
587860-8786047.86747.87
692398-9239850.33950.34
10min1154281-15428184.05379.672.9984.1479.752.99
2143476-14347678.16778.25
3148021-14802180.64380.73
4143847-14384778.36978.44
5145097-14509779.05079.13
6142641-14264177.71277.80
15min1176366-17636696.08591.292.9196.3191.502.91
2164418-16441889.57689.78
3168986-16898692.06592.28
4167794-16779491.41591.62
5164975-16497589.87990.09
6162836-16283688.71488.93
20min1182866-18286699.62795.612.45100.0195.982.45
2173766-17376694.66995.03
3176604-17660496.21596.59
4176461-17646196.13796.50
5172934-17293494.21594.58
6170371-17037192.81993.18
30min1185902-185902101.28198.471.92101.8399.001.92
2179096-17909697.57398.09
3181510-18151098.88899.42
4182708-18270899.540100.06
5179407-17940797.74298.26
6175836-17583695.79796.31
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2181812-18181299.05299.73
3182728-18272899.551100.25
4183113-18311399.761100.45
5181221-18122198.73099.41
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2182151-18215199.237100.08
3181376-18137698.81599.68
4182966-18296699.681100.53
5180980-18098098.59999.44
6177825-17782596.88097.72
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