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%
114.939375693282933909341493635934950.21
214.979333493579934560.19
单位质量响应值RSD%判断
6262.226242.890.22数据可信
供试品溶液-24090906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%
5min146817-4681748.53947.323.4248.5447.323.43
246228-4622847.92847.93
343871-4387145.48545.48
10min178775-7877581.67282.190.6381.7582.260.63
279768-7976882.70282.78
379272-7927282.18882.26
15min167813-6781370.30771.543.8270.5271.753.81
272016-7201674.66574.88
367168-6716869.63869.85
20min190024-9002493.33592.561.0893.6792.891.08
289605-8960592.90193.24
388196-8819691.44091.77
30min176197-7619779.00081.885.6379.4982.365.60
284092-8409287.18587.68
376624-7662479.44279.92
45min193452-9345296.88995.711.2097.5196.331.19
292229-9222995.62196.26
391259-9125994.61695.23
极限179645-7964582.57487.245.7683.3688.035.72
289269-8926992.55293.35
383522-8352286.59487.37
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%
111.621805901808061808211803671802701805710.14
211.681820481823501821990.12
单位质量响应值RSD%判断
15539.6715599.230.28数据可信
供试品溶液-24090906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%
5min194271-9427150.01348.343.2150.0148.343.20
288517-8851746.96146.96
390542-9054248.03548.04
10min167530-6753035.82737.774.4835.9137.854.46
273316-7331638.89638.97
372736-7273638.58838.67
15min1129142-12914268.51369.792.5868.6669.942.57
2135419-13541971.84471.99
3130096-13009669.02069.16
20min1112846-11284659.86861.572.6160.1361.832.59
2118838-11883863.04763.31
3116468-11646861.79062.05
30min1144787-14478776.81480.244.7077.1780.604.69
2158851-15885184.27584.64
3150076-15007679.62079.98
45min1139808-13980874.17275.641.9474.6676.141.94
2145332-14533277.10377.61
3142575-14257575.64076.14
极限1153414-15341481.39085.785.4882.0086.405.46
2171030-17103090.73691.37
3160610-16061085.20885.83
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%
114.939511194878949789499294601949120.21
214.979321893273932460.05
单位质量响应值RSD%判断
6357.136228.861.45数据可信
供试品溶液-24090906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%
5min143652-4365244.97141.7415.3844.9741.7415.38
244550-4455045.89645.90
333339-3333934.34734.35
10min173338-7333875.55481.256.1175.6381.326.10
282161-8216184.64484.72
381096-8109683.54783.60
15min170316-7031672.44171.197.4372.6471.397.42
273514-7351475.73675.95
363477-6347765.39565.59
20min185510-8551088.09490.872.6588.4291.192.64
289432-8943292.13592.48
389657-8965792.36792.67
30min182742-8274285.24382.314.7985.7182.784.78
281388-8138883.84884.35
375548-7554877.83178.29
45min188473-8847391.14794.483.0691.7695.093.04
293478-9347896.30396.94
393166-9316695.98296.57
极限187687-8768790.33787.023.7191.1087.793.68
284286-8428686.83387.63
381444-8144483.90584.65
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%
111.621829621829891829301832241833891830990.11
211.681830401830451830420.01
单位质量响应值RSD%判断
15757.2315671.400.39数据可信
供试品溶液-24090906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%
5min182760-8276043.50242.6411.8643.5042.6411.86
289817-8981747.21147.21
370796-7079637.21337.21
10min156052-5605229.46333.3110.1629.5433.3810.14
268158-6815835.82735.91
365891-6589134.63534.70
15min1130188-13018868.43268.887.9368.5569.017.93
2141825-14182574.54974.69
3121109-12110963.66063.78
20min1108181-10818156.86458.383.4557.1058.623.46
2115405-11540560.66160.92
3109586-10958657.60357.83
30min1151303-15130379.53179.454.5979.8679.794.59
2158010-15801083.05683.42
3144159-14415975.77676.10
45min1136276-13627671.63273.563.4872.1074.033.48
2145444-14544476.45176.95
3138083-13808372.58273.03
极限1162279-16227985.30084.802.4285.8885.392.43
2164664-16466486.55487.18
3157053-15705382.55383.12
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%
114.939332993128930799336693397932600.16
214.979422194595944080.29
单位质量响应值RSD%判断
6246.486306.480.68数据可信
供试品溶液-24090906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%
5min146041-4604147.55345.513.9247.5545.513.92
242854-4285444.26244.26
343299-4329944.72144.72
10min173726-7372676.14877.741.9676.2377.811.95
276662-7666279.18079.25
375402-7540277.87977.95
15min166555-6655568.74164.006.4968.9564.216.47
259091-5909161.03261.24
360244-6024462.22362.43
20min186534-8653489.37790.171.0689.7090.481.05
288322-8832291.22391.53
387052-8705289.91290.22
30min174856-7485677.31570.588.2977.7871.048.24
264747-6474766.87467.33
365393-6539367.54168.00
45min190646-9064693.62494.240.6994.2294.820.68
291898-9189894.91795.49
391176-9117694.17194.74
极限177805-7780580.36173.298.3781.1274.028.31
267531-6753169.74970.48
367529-6752969.74770.47
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%
111.623705333707803707173705953706603706570.03
211.683728123729743728930.04
单位质量响应值RSD%判断
31898.1931925.770.07数据可信
供试品溶液-24090906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%
5min1215971-21597155.90154.222.7355.9054.222.73
2205215-20521553.11753.12
3207232-20723253.63953.64
10min1143510-14351037.14637.442.0137.2437.532.00
2147948-14794838.29438.38
3142500-14250036.88436.97
15min1271425-27142570.25566.514.8970.4166.664.88
2250073-25007364.72864.88
3249324-24932464.53464.69
20min1231499-23149959.92160.371.5860.1960.641.58
2237478-23747861.46861.73
3230758-23075859.72959.99
30min1293656-29365676.00970.786.4276.3871.156.39
2264821-26482168.54568.91
3261934-26193467.79868.16
45min1280434-28043472.58773.311.3973.0973.791.37
2287725-28772574.47474.95
3281519-28151972.86873.34
极限1301903-30190378.14472.436.8778.7673.036.83
2270589-27058970.03870.64
3267003-26700369.11069.70
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%
114.939406494051941819406094442941600.18
214.979369393706937000.01
单位质量响应值RSD%判断
6306.766259.190.54数据可信
供试品溶液-24090906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%
5min138120-3812039.33139.354.8539.3339.354.85
236302-3630237.45537.46
339999-3999941.27041.27
10min170484-7048472.72375.793.6272.7975.853.62
275606-7560678.00878.07
374266-7426676.62676.69
15min158549-5854960.40961.151.0860.6061.351.08
259758-5975861.65761.85
359506-5950661.39761.59
20min183065-8306585.70488.723.0085.9989.013.00
287940-8794090.73491.03
386956-8695689.71990.02
30min166533-6653368.64769.681.3869.0870.131.38
268357-6835770.52970.98
367721-6772169.87370.32
45min187099-8709989.86692.902.8490.4193.452.84
291742-9174294.65795.22
391262-9126294.16294.73
极限168424-6842470.59872.852.6971.2973.562.69
271543-7154373.81674.54
371856-7185674.13974.86
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%
111.623728593730033732433729993731903730590.05
211.683717003714173715580.06
单位质量响应值RSD%判断
32104.9131811.470.65数据可信
供试品溶液-24090906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%
5min1183142-18314247.33647.894.3647.3447.894.36
2178483-17848346.13246.13
3194180-19418050.18950.19
10min1129009-12900933.34534.613.5033.4234.683.49
2138345-13834535.75835.83
3134324-13432434.71834.80
15min1244530-24453063.20364.381.5963.3464.521.59
2251139-25113964.91165.05
3251569-25156965.02365.16
20min1214947-21494755.55758.023.9655.8058.273.95
2232532-23253260.10260.35
3226002-22600258.41458.66
30min1265395-26539568.59670.242.0568.9370.592.05
2275555-27555571.22271.57
3274370-27437070.91671.26
45min1264304-26430468.31471.363.9668.7671.813.95
2285866-28586673.88774.35
3278056-27805671.86972.33
极限1272765-27276570.50172.552.4671.0673.132.46
2285015-28501573.66774.25
3284311-28431173.48574.07
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%
114.939346693481936409367593641935810.11
214.979437694059942180.24
单位质量响应值RSD%判断
6267.986293.790.30数据可信
供试品溶液-24090906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%
5min175600-7560078.02777.620.9478.0377.620.94
275617-7561778.04578.04
374388-7438876.77676.78
10min138719-3871939.96240.957.8940.0941.087.87
243178-4317844.56444.69
337142-3714238.33438.46
15min185220-8522087.95688.680.7388.1588.880.73
286401-8640189.17589.38
386147-8614788.91389.10
20min158069-5806959.93364.566.9260.2864.916.89
266706-6670668.84869.20
362889-6288964.90865.25
30min189177-8917792.04092.270.3292.4892.720.32
289293-8929392.16092.63
389718-8971892.59893.05
45min166855-6685569.00175.377.3369.6075.987.28
276239-7623978.68779.31
375987-7598778.42779.03
极限190135-9013593.02993.630.8193.7494.360.81
290473-9047393.37894.13
391536-9153694.47595.21
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%
111.623734883735623726133730793734093732300.11
211.683757053764373760710.14
单位质量响应值RSD%判断
32119.6232197.860.18数据可信
供试品溶液-24090906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%
5min1147995-14799538.01337.503.7338.0137.503.73
2150182-15018238.57438.57
3139866-13986635.92535.92
10min1177501-17750145.59146.566.4045.6546.626.39
2194268-19426849.89849.96
3172029-17202944.18644.25
15min1233722-23372260.03259.921.0760.1760.061.07
2235529-23552960.49660.64
3230616-23061659.23459.37
20min1243454-24345462.53166.515.6362.7766.755.62
2272376-27237669.96070.21
3260949-26094967.02567.26
30min1282601-28260172.58672.120.6472.9372.470.64
2280726-28072672.10572.47
3279027-27902771.66872.01
45min1265280-26528068.13874.187.0868.6074.657.05
2299083-29908376.82077.30
3302092-30209277.59378.06
极限1310677-31067779.79879.320.6180.3879.920.59
2308796-30879679.31579.93
3306966-30696678.84579.44
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