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%
114.799207791993922619209091889920620.15
214.829289193012929520.10
单位质量响应值RSD%判断
6224.616272.060.54数据可信
长期12月-供试品溶液-2025021321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%
5min149708-4970851.57245.517.2851.5745.517.28
244650-4465046.32446.32
340817-4081742.34742.35
443966-4396645.61445.61
541846-4184643.41543.41
642200-4220043.78243.78
10min180037-8003783.03877.974.3483.1278.054.34
278288-7828881.22381.30
372931-7293175.66575.74
474577-7457777.37377.45
573012-7301275.74975.82
672079-7207974.78174.85
15min190790-9079094.19489.983.0694.4290.193.06
289203-8920392.54792.76
384434-8443487.60087.80
484693-8469387.86888.07
586189-8618989.42089.62
685069-8506988.25888.46
20min195250-9525098.82195.681.6999.2096.041.69
292340-9234095.80296.17
391626-9162695.06195.40
491197-9119794.61694.97
591843-9184395.28695.63
691083-9108394.49894.84
30min198222-98222101.90599.521.68102.45100.031.69
297282-97282100.929101.46
395987-9598799.586100.09
495430-9543099.00899.52
594714-9471498.26598.77
693890-9389097.41097.91
45min1100614-100614104.386100.922.20105.10101.602.20
297867-97867101.536102.23
397969-97969101.642102.31
494303-9430397.83998.51
596972-96972100.608101.28
695894-9589499.489100.15
极限199999-99999103.748100.821.67104.64101.671.68
298156-98156101.836102.70
395763-9576399.353100.19
496740-96740100.367101.20
596001-9600199.600100.44
696387-96387100.001100.83
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%
111.821840681837001838561834361833621836840.16
211.881853991856511855250.10
单位质量响应值RSD%判断
15540.1015616.580.35数据可信
长期12月-供试品溶液-2025021321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%
5min1101989-10198954.19150.616.0554.1950.616.05
299786-9978653.02153.02
389192-8919247.39247.39
499507-9950752.87252.87
590294-9029447.97747.98
690757-9075748.22348.22
10min1144356-14435676.70374.582.8076.7974.662.80
2142410-14241075.66975.76
3139685-13968574.22174.30
4144146-14414676.59176.68
5135974-13597472.24972.33
6135604-13560472.05272.13
15min1165919-16591988.16086.552.2088.3886.762.20
2164788-16478887.55987.77
3163317-16331786.77886.98
4166329-16632988.37888.59
5159154-15915484.56684.77
6157863-15786383.88084.08
20min1175491-17549193.24692.242.1793.6192.592.17
2173708-17370892.29992.66
3175956-17595693.49393.84
4178078-17807894.62194.98
5170307-17030790.49290.83
6168045-16804589.29089.63
30min1181855-18185596.62896.042.3097.1596.552.30
2179662-17966295.46295.98
3184786-18478698.18598.69
4185583-18558398.60899.13
5177764-17776494.45494.95
6174816-17481692.88793.38
45min1184592-18459298.08297.402.2898.7698.062.28
2182298-18229896.86397.54
3187209-18720999.472100.14
4188161-18816199.978100.66
5180213-18021395.75596.40
6177340-17734094.22994.87
极限1185336-18533698.47797.682.0299.3298.512.02
2182541-18254196.99297.83
3187155-18715599.444100.28
4188391-188391100.100100.95
5180247-18024795.77396.58
6179381-17938195.31396.11
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%
114.799341293538936159350493414934970.10
214.829421494277942460.05
单位质量响应值RSD%判断
6321.646359.380.43数据可信
长期12月-供试品溶液-2025021321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%
5min146337-4633747.37544.5311.7747.3844.5311.78
240639-4063941.55041.55
349819-4981950.93550.94
439976-3997640.87240.87
547748-4774848.81848.82
636807-3680737.63237.63
10min173973-7397375.63075.603.4475.7175.683.45
272043-7204373.65773.73
378563-7856380.32380.41
472094-7209473.70973.78
574848-7484876.52576.61
672169-7216973.78673.85
15min187081-8708189.03288.072.0789.2488.272.08
284758-8475886.65786.85
389323-8932391.32491.54
484758-8475886.65786.85
585668-8566887.58787.80
685250-8525087.16087.35
20min192228-9222894.29493.912.2294.6594.262.22
290208-9020892.22992.57
395278-9527897.41397.78
490293-9029392.31692.65
590223-9022392.24492.60
692898-9289894.97995.31
30min195675-9567597.81997.832.2998.3398.332.28
296297-9629798.45598.94
397472-9747299.656100.19
495225-9522597.35997.85
591695-9169593.74994.26
697751-9775199.941100.43
45min196459-9645998.62098.912.5999.2999.582.58
294459-9445996.57597.23
398759-98759100.972101.67
497314-9731499.494100.15
593442-9344295.53696.20
6100020-100020102.261102.92
极限196283-9628398.44099.231.6699.28100.061.65
295817-9581797.96498.78
398433-98433100.638101.51
497170-9717099.347100.16
595227-9522797.36198.18
699401-99401101.628102.45
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%
111.821863331866001867101860201855941862510.25
211.881879441878301878870.05
单位质量响应值RSD%判断
15757.2815815.400.27数据可信
长期12月-供试品溶液-2025021321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%
5min198747-9874751.77749.037.9951.7849.037.99
284987-8498744.56244.56
3101155-10115553.04053.04
485496-8549644.82944.83
5100279-10027952.58052.58
690340-9034047.36947.37
10min1143479-14347975.23272.853.3875.3272.943.38
2134018-13401870.27170.35
3142126-14212674.52374.61
4133674-13367470.09170.17
5143655-14365575.32475.41
6136685-13668571.67071.75
15min1165179-16517986.61084.781.7986.8284.981.79
2158307-15830783.00783.20
3162029-16202984.95985.17
4158290-15829082.99883.19
5164137-16413786.06486.28
6162201-16220185.04985.25
20min1175846-17584692.20390.841.1792.5691.181.18
2171442-17144289.89490.22
3172097-17209790.23890.59
4171303-17130389.82190.15
5173170-17317090.80091.16
6175569-17556992.05892.40
30min1182981-18298195.94594.711.3396.4595.201.32
2179968-17996894.36594.84
3178476-17847693.58294.09
4179411-17941194.07394.55
5178706-17870693.70394.21
6184205-18420596.58697.08
45min1185052-18505297.03096.201.4097.7096.851.39
2182214-18221495.54296.18
3181608-18160895.22595.89
4182983-18298395.94696.58
5181062-18106294.93895.60
6187835-18783598.49099.14
极限1184505-18450596.74496.471.1797.5897.291.17
2183191-18319196.05596.85
3182741-18274195.81996.64
4183385-18338596.15696.95
5182061-18206195.46296.28
6188065-18806598.61099.43
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%
114.799408794055941589417593919940790.11
214.829448294467944740.02
单位质量响应值RSD%判断
6360.996374.760.16数据可信
长期12月-供试品溶液-2025021421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%
5min149877-4987750.77553.416.0450.7753.416.04
251418-5141852.34452.34
358073-5807359.11959.12
454152-5415255.12755.13
549847-4984750.74450.74
651416-5141652.34252.34
10min172399-7239973.70275.772.1473.7975.862.14
274368-7436875.70775.79
376891-7689178.27578.37
474627-7462775.97176.06
573097-7309774.41374.50
675192-7519276.54676.63
15min182639-8263984.12786.994.1684.3387.204.16
284143-8414385.65885.87
391930-9193093.58593.81
486857-8685788.42188.64
582491-8249183.97684.18
684636-8463686.16086.37
20min186514-8651488.07291.893.7888.4292.253.77
291956-9195693.61293.97
395998-9599897.72698.11
488134-8813489.72190.09
588395-8839589.98690.33
690580-9058092.21192.57
30min190110-9011091.73296.503.7392.2397.013.72
294989-9498996.69997.21
3100790-100790102.605103.15
492988-9298894.66295.18
595652-9565297.37497.87
694228-9422895.92496.44
45min191008-9100892.64697.383.6693.2998.053.66
295170-9517096.88397.56
3101850-101850103.684104.40
495424-9542497.14297.82
595695-9569597.41898.08
694776-9477696.48297.15
极限191334-9133492.97897.223.3893.7898.063.38
294973-9497396.68397.52
3101106-101106102.926103.82
494607-9460796.31097.15
596513-9651398.25199.07
694468-9446896.16997.00
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%
111.821877181878421876111874581864511874160.30
211.881886531885161885840.06
单位质量响应值RSD%判断
15855.8415874.070.09数据可信
长期12月-供试品溶液-2025021421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%
5min198604-9860451.44654.033.5851.4554.033.58
2104495-10449554.51954.52
3109107-10910756.92656.93
4105227-10522754.90154.90
5100451-10045152.40952.41
6103414-10341453.95553.96
10min1138705-13870572.36875.713.1172.4575.803.12
2147272-14727276.83876.93
3150842-15084278.70178.80
4146367-14636776.36676.46
5140755-14075573.43873.53
6146734-14673476.55776.65
15min1157222-15722282.02986.002.5982.2486.222.59
2166493-16649386.86687.09
3169877-16987788.63288.86
4166017-16601786.61886.84
5163408-16340885.25785.47
6166000-16600086.60986.83
20min1165161-16516186.17190.442.6086.5190.802.60
2174754-17475491.17691.54
3178908-17890893.34493.72
4174433-17443391.00991.37
5173714-17371490.63490.99
6173048-17304890.28690.65
30min1170603-17060389.01193.522.6289.5094.032.62
2179850-17985093.83594.35
3184762-18476296.39896.93
4180393-18039394.11994.63
5181016-18101694.44494.95
6178875-17887593.32793.84
45min1172094-17209489.78994.352.6590.4295.012.65
2180892-18089294.37995.05
3186537-18653797.32498.01
4181968-18196894.94095.61
5182888-18288895.42096.08
6180619-18061994.23694.90
极限1172594-17259490.05094.522.5790.8395.342.57
2181627-18162794.76295.59
3186591-18659197.35298.20
4182019-18201994.96795.80
5183218-18321895.59396.41
6180872-18087294.36895.19
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%
114.799345493517935029346393640935150.08
214.829400694225941160.17
单位质量响应值RSD%判断
6322.856350.610.31数据可信
长期12月-供试品溶液-2025021421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%
5min142553-4255343.53253.2011.5043.5353.2011.50
258649-5864959.99960.00
354158-5415855.40455.40
447045-4704548.12848.13
555121-5512156.38956.39
654521-5452155.77655.78
10min171253-7125372.89376.535.8672.9776.625.86
281138-8113883.00583.11
375381-7538177.11677.21
470042-7004271.65471.73
578610-7861080.41980.51
672448-7244874.11574.21
15min184465-8446586.40987.383.3086.6087.593.31
288775-8877590.81891.06
384941-8494186.89687.12
480945-8094582.80883.01
588100-8810090.12790.36
685237-8523787.19887.41
20min186461-8646188.45191.353.6188.7991.713.62
294303-9430396.47396.86
388331-8833190.36490.73
485919-8591987.89688.23
591814-9181493.92794.30
688948-8894890.99591.36
30min193169-9316995.31394.193.6795.8094.713.66
297442-9744299.684100.23
393248-9324895.39495.91
489315-8931591.37091.85
587881-8788189.90390.44
691399-9139993.50294.02
45min194522-9452296.69795.663.2197.3496.333.21
298405-98405100.669101.39
393982-9398296.14596.82
489371-8937191.42792.06
592275-9227594.39895.08
692495-9249594.62395.29
极限194507-9450796.68296.043.6897.4996.873.68
299607-99607101.899102.78
392281-9228194.40495.24
490025-9002592.09792.89
595509-9550997.70798.55
691364-9136493.46694.29
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%
111.821865961867081866681864211862951865380.10
211.881880061881631880840.06
单位质量响应值RSD%判断
15781.5615831.990.23数据可信
长期12月-供试品溶液-2025021421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%
5min188120-8812046.14554.289.2146.1554.289.21
2109138-10913857.15257.15
3109248-10924857.20957.21
495697-9569750.11350.11
5112264-11226458.78958.79
6107510-10751056.29956.30
10min1137050-13705071.76875.955.2371.8476.045.24
2149741-14974178.41478.51
3149025-14902578.03978.13
4135716-13571671.07071.15
5154896-15489681.11381.21
6143825-14382575.31675.41
15min1159673-15967383.61585.543.8783.8185.763.87
2167728-16772887.83388.06
3166594-16659487.23987.46
4154215-15421580.75780.96
5171376-17137689.74389.98
6160526-16052684.06284.28
20min1169983-16998389.01489.863.4589.3590.223.45
2176153-17615392.24592.62
3174550-17455091.40591.78
4162695-16269585.19785.53
5178524-17852493.48793.87
6167717-16771787.82788.19
30min1176812-17681292.59092.692.9793.0793.202.97
2181857-18185795.23295.76
3179863-17986394.18894.71
4168845-16884588.41888.90
5181709-18170995.15495.69
6172896-17289690.53991.05
45min1178901-17890193.68493.482.9194.3294.152.92
2183180-18318095.92596.61
3180912-18091294.73795.42
4170409-17040989.23789.86
5183391-18339196.03596.73
6174322-17432291.28691.94
极限1179909-17990994.21293.912.8795.0194.732.87
2183718-18371896.20697.05
3181174-18117494.87495.71
4171401-17140189.75690.53
5184650-18465096.69497.55
6175132-17513291.71092.52
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