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%
115.159186991731917549164791617917240.11
215.169129691245912700.04
单位质量响应值RSD%判断
6054.396020.450.40数据可信
供试品溶液-第3批-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%
5min183723-8372389.89688.701.3689.9088.701.36
282608-8260888.69988.70
381483-8148387.49187.49
10min183328-8332889.47289.180.6289.6289.330.63
283385-8338589.53389.68
382468-8246888.54888.69
15min191412-9141298.15297.300.7798.4597.600.77
290120-9012096.76597.06
390325-9032596.98597.28
20min190285-9028596.94296.441.4297.4096.901.41
288381-8838194.89795.36
390783-9078397.47697.93
30min193763-93763100.67699.850.72101.30100.470.72
292589-9258999.416100.03
392624-9262499.453100.07
45min191909-9190998.68698.661.2599.4899.451.24
290734-9073497.42498.21
393019-9301999.877100.66
极限193725-93725100.635100.780.13101.59101.740.13
293935-93935100.861101.81
393931-93931100.857101.81
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%
111.603544783541143539603532083529423537400.19
211.613550003549703549850.01
单位质量响应值RSD%判断
30494.8330575.800.19数据可信
供试品溶液-第3批-阿托伐他汀钙-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%
5min1174215-17421547.12646.391.7747.1346.391.77
2168252-16825245.51345.51
3172053-17205346.54246.54
10min1164730-16473044.56143.892.0144.6443.972.00
2163487-16348744.22444.30
3158587-15858742.89942.98
15min1254887-25488768.94968.281.5269.1068.431.52
2248027-24802767.09367.24
3254338-25433868.80068.95
20min1239456-23945664.77563.951.2265.0464.221.22
2236080-23608063.86164.12
3233736-23373663.22763.49
30min1299160-29916080.92580.360.8481.3080.730.85
2294317-29431779.61579.98
3297783-29778380.55280.92
45min1279207-27920775.52775.030.6076.0475.540.61
2275967-27596774.65175.15
3276940-27694074.91475.42
极限1318529-31852986.16486.530.3886.8087.160.37
2320459-32045986.68687.31
3320698-32069886.75187.38
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%
115.159075690580906359050090479905900.13
215.169191491192915530.56
单位质量响应值RSD%判断
5979.546039.120.71数据可信
供试品溶液-第3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%
5min144552-4455248.06147.602.4048.0647.602.41
242923-4292346.30446.30
344908-4490848.44548.45
10min147070-4707050.77854.618.8650.8654.698.84
255659-5565960.04360.12
349149-4914953.02053.10
15min164847-6484769.95568.842.9070.1269.002.88
261677-6167766.53566.71
364903-6490370.01570.18
20min158618-5861863.23567.529.3463.5267.809.31
269299-6929974.75875.05
359843-5984364.55764.84
30min172240-7224077.93075.103.6078.3275.493.57
267254-6725472.55172.96
369346-6934674.80875.20
45min161396-6139666.23272.0012.1566.7572.5212.08
276066-7606682.05882.59
362753-6275367.69668.21
极限174077-7407779.91277.143.1580.5477.793.10
269898-6989875.40476.07
370558-7055876.11676.75
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%
111.603547793553843555183555003551573552680.09
211.613612803582003597400.61
单位质量响应值RSD%判断
30626.5530985.360.83数据可信
供试品溶液-第3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%
5min1207198-20719855.55855.565.5655.5655.575.57
2195711-19571152.47852.48
3218749-21874958.65558.66
10min1222694-22269459.71362.334.6059.8162.434.59
2243878-24387865.39365.48
3230826-23082661.89361.99
15min1266193-26619371.37770.034.0971.5770.224.08
2248916-24891666.74466.94
3268360-26836071.95872.16
20min1256795-25679568.85772.637.0269.1772.946.98
2292467-29246778.42278.73
3263287-26328770.59870.92
30min1287207-28720777.01174.683.9377.4475.123.90
2266248-26624871.39271.83
3282128-28212875.65076.09
45min1269662-26966272.30776.067.4072.8676.627.34
2307773-30777382.52683.08
3273553-27355373.35073.91
极限1295009-29500979.10376.144.1879.7876.834.13
2271457-27145772.78873.48
3285410-28541076.53077.22
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%
115.159062190601906099063990610906160.02
215.169007689976900260.08
单位质量响应值RSD%判断
5981.255938.390.51数据可信
供试品溶液批-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%
5min174152-7415280.65686.746.0880.6686.746.08
282677-8267789.92989.93
382408-8240889.63789.64
10min150357-5035754.77452.685.4554.9152.835.43
249516-4951653.85954.01
345429-4542949.41449.56
15min182447-8244789.67995.004.8689.9095.234.85
289593-8959397.45297.69
389967-8996797.85998.09
20min163558-6355869.13365.757.1369.5166.147.08
262249-6224967.70968.11
355535-5553560.40660.80
30min184442-8444291.84997.284.9192.3497.784.89
291235-9123599.23899.75
392637-92637100.763101.26
45min168227-6822774.21270.146.9674.8670.816.89
265716-6571671.48072.16
359518-5951864.73965.40
极限184793-8479392.23197.764.9793.0098.544.93
291716-9171699.761100.56
393122-93122101.290102.06
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%
111.603553813553973554033548383543973550830.13
211.613558803555993557400.06
单位质量响应值RSD%判断
30610.6030640.830.07数据可信
供试品溶液批-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%
5min1155835-15583542.03043.303.8142.0343.303.80
2167454-16745445.16445.16
3158378-15837842.71642.72
10min1219430-21943059.18259.721.2859.2559.791.28
2220192-22019259.38859.46
3224660-22466060.59360.66
15min1229889-22988962.00363.783.1962.1763.963.19
2244685-24468565.99466.17
3234898-23489863.35463.53
20min1265614-26561471.63871.460.2571.9171.730.24
2264310-26431071.28771.57
3264881-26488171.44171.72
30min1268715-26871572.47574.182.6472.8774.582.64
2282951-28295176.31476.72
3273404-27340473.73974.14
45min1283564-28356476.48075.281.4276.9975.801.40
2275964-27596474.43074.96
3277827-27782774.93275.45
极限1287718-28771877.60079.352.6578.2479.992.64
2302834-30283481.67782.33
3292015-29201578.75979.40
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%
115.159008490271901119008990035901180.10
215.169020390236902200.03
单位质量响应值RSD%判断
5948.385951.190.04数据可信
供试品溶液批-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%
5min157060-5706062.16961.860.9062.1761.860.90
257078-5707862.18962.19
356188-5618861.21961.22
10min157435-5743562.57862.431.4562.6862.531.45
256410-5641061.46161.56
358048-5804863.24563.35
15min176090-7609082.90382.231.5983.1182.441.58
274096-7409680.73080.94
376240-7624083.06683.27
20min173335-7333579.90182.473.1480.2582.823.13
278087-7808785.07985.42
375664-7566482.43982.78
30min181841-8184189.16988.721.6189.6589.201.60
279961-7996187.12087.60
382476-8247689.86190.34
45min178466-7846685.49289.544.4886.1290.174.45
285814-8581493.49894.13
382271-8227189.63790.27
极限184307-8430791.85690.581.4292.6391.371.40
281954-8195489.29290.08
383157-8315790.60391.39
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%
111.603528483529313523663525953526703526820.07
211.613585333587753586540.05
单位质量响应值RSD%判断
30403.6230891.821.13数据可信
供试品溶液批-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%
5min1268720-26872072.42872.100.7272.4372.110.72
2265299-26529971.50671.51
3268540-26854072.38072.38
10min1260233-26023370.14167.674.1370.2667.794.12
2239815-23981564.63864.76
3253125-25312568.22568.35
15min1318568-31856885.86485.290.9886.1085.520.99
2312897-31289784.33684.56
3317866-31786685.67585.91
20min1310602-31060283.71783.870.6584.1084.250.65
2309511-30951183.42383.79
3313412-31341284.47484.85
30min1333681-33368189.93889.101.1990.4689.621.20
2326172-32617287.91488.42
3331912-33191289.46189.98
45min1328116-32811688.43889.631.1889.1190.301.16
2335432-33543290.40991.06
3334106-33410690.05290.72
极限1337547-33754790.98090.161.1491.8090.981.14
2330270-33027089.01889.82
3335738-33573890.49291.31
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%
115.159168191472916059150291451915420.11
215.169021190226902180.02
单位质量响应值RSD%判断
6042.385951.061.08数据可信
供试品溶液批-氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min148557-4855752.49448.2117.3852.4948.2117.38
249566-4956653.58453.58
335672-3567238.56438.56
10min168467-6846774.01877.543.9574.1177.623.93
273497-7349779.45679.54
373214-7321479.15079.21
15min175884-7588482.03686.855.5582.2587.075.53
280341-8034186.85487.08
384799-8479991.67491.87
20min177818-7781884.12790.277.1584.4790.637.13
282981-8298189.70990.07
389715-8971596.98897.34
30min180725-8072587.27092.726.3387.7693.226.30
285068-8506891.96592.48
391504-9150498.92299.43
45min182998-8299889.72793.204.4690.3693.864.44
285183-8518392.08992.76
390465-9046597.79998.47
极限187402-8740294.48896.213.5795.2797.033.56
286939-8693993.98794.81
392648-92648100.159101.00
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100590-202005 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%
111.603614433609233612823609783609773611210.07
211.613561593561103561340.01
单位质量响应值RSD%判断
31131.1230674.761.05数据可信
供试品溶液批-阿托伐他汀钙
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1204856-20485654.75952.7814.1654.7652.7714.16
2220923-22092359.05359.05
3166529-16652944.51444.51
10min1283939-28393975.89880.076.5275.9980.166.52
2321442-32144285.92286.02
3293231-29323178.38278.46
15min1311872-31187283.36488.495.6583.5888.715.65
2349222-34922293.34893.59
3332007-33200788.74688.95
20min1324506-32450686.74192.065.3787.1092.435.36
2360973-36097396.48996.89
3347724-34772492.94893.30
30min1336775-33677590.02194.824.6990.5295.344.69
2369560-36956098.78599.34
3357793-35779395.63996.15
45min1346381-34638192.58996.453.8193.2497.133.82
2373703-37370399.892100.61
3362437-36243796.88197.55
极限1371039-37103999.18099.622.7299.99100.462.73
2383514-383514102.514103.40
3363492-36349297.16397.99
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