依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.001749341748651749541747521746671748340.08
210.011773661771761772710.08
单位质量响应值RSD%判断
17483.4017709.390.91数据可信
供试品溶液-2023120823批-依折麦布-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%
5min112806-128066.5346.355.076.536.355.06
213012-130126.6396.64
312867-128676.5656.56
411564-115645.9005.90
511739-117395.9895.99
612734-127346.4976.50
10min117115-171158.7328.892.408.778.922.40
218128-181289.2499.29
317597-175978.9789.01
417136-171368.7438.78
517024-170248.6868.72
617491-174918.9248.96
15min117165-171658.7588.921.088.849.011.09
217500-175008.9299.02
317475-174758.9169.00
417457-174578.9078.99
517583-175838.9719.05
617740-177409.0519.14
20min117241-172418.7979.002.348.939.142.29
217604-176048.9829.12
317903-179039.1349.27
417299-172998.8268.96
518329-183299.3529.48
617475-174758.9169.05
30min116613-166138.4768.580.988.668.770.96
216878-168788.6118.80
317106-171068.7288.91
416838-168388.5918.77
516761-167618.5528.73
616760-167608.5518.74
45min116774-167748.5588.600.588.798.830.59
216978-169788.6628.90
316854-168548.5998.83
416902-169028.6248.85
516932-169328.6398.87
616722-167228.5328.76
60min116639-166398.4898.561.238.778.841.17
216715-167158.5288.81
317054-170548.7018.98
416587-165878.4638.74
517023-170238.6858.96
616655-166558.4988.78
极限116130-161308.2308.471.568.558.801.53
216879-168798.6128.94
316579-165798.4598.79
416580-165808.4598.78
516670-166708.5058.83
616768-167688.5558.88
依折麦布阿托伐他汀钙片项目信息
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2500
标示量(mg)20供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.211573211570381574661573961573991573240.11
211.241600821596661598740.19
单位质量响应值RSD%判断
14034.2614223.670.95数据可信
供试品溶液-2023120823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%
5min173704-7370443.09035.6715.0843.0935.6715.08
263964-6396437.39637.40
368607-6860740.11040.11
456456-5645633.00733.01
551253-5125329.96529.96
652093-5209330.45630.46
10min1134339-13433978.54072.496.0078.7872.696.03
2125912-12591273.61373.82
3130172-13017276.10476.33
4118111-11811169.05369.24
5115073-11507367.27667.44
6120310-12031070.33870.51
15min1151256-15125688.43083.334.3289.1183.934.34
2141847-14184782.93083.55
3144838-14483884.67885.32
4135046-13504678.95379.52
5136260-13626079.66380.20
6145964-14596485.33785.90
20min1160658-16065893.92788.034.7495.0989.104.74
2150949-15094988.25189.33
3151675-15167588.67589.79
4140456-14045682.11683.12
5144992-14499284.76885.75
6154746-15474690.47191.50
30min1162284-16228494.87890.063.7996.5791.623.81
2153397-15339789.68291.25
3155377-15537790.84092.45
4145632-14563285.14286.60
5150005-15000587.69989.15
6157599-15759992.13993.68
45min1167600-16760097.98692.983.53100.2095.043.54
2160053-16005393.57495.64
3157748-15774892.22694.34
4150379-15037987.91889.85
5157558-15755892.11594.06
6160929-16092994.08696.13
60min1167885-16788598.15294.093.72100.9196.663.71
2160284-16028493.70996.29
3159897-15989793.48296.11
4150281-15028187.86090.28
5162920-16292095.25097.70
6164359-16435996.09198.66
极限1166481-16648197.33296.242.21100.6499.342.21
2165228-16522896.59999.71
3161113-16111394.19397.34
4159413-15941393.19996.11
5166429-16642997.301100.28
6169050-16905098.834101.94
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.001743501746321746341746091746321745710.08
210.011759051762871760960.16
单位质量响应值RSD%判断
17457.1017592.010.55数据可信
供试品溶液-2023120823批-依折麦布-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%
5min113412-134126.8716.801.986.876.801.97
213644-136446.9906.99
313216-132166.7706.77
413398-133986.8646.86
513100-131006.7116.71
612902-129026.6106.61
10min117317-173178.8718.961.308.919.001.29
217648-176489.0419.08
317667-176679.0519.09
417393-173938.9108.95
517771-177719.1049.14
617203-172038.8138.85
15min117382-173828.9059.041.258.999.131.27
217990-179909.2169.31
317654-176549.0449.13
417641-176419.0379.12
517795-177959.1169.20
617463-174638.9469.03
20min117424-174248.9268.920.929.069.060.90
217731-177319.0839.22
317388-173888.9089.05
417365-173658.8969.03
517314-173148.8709.01
617299-172998.8629.00
30min117425-174258.9278.863.219.119.053.17
217858-178589.1489.34
317368-173688.8979.09
417792-177929.1159.30
516390-163908.3968.58
616933-169338.6758.86
45min117086-170868.7538.791.898.999.031.89
217712-177129.0749.32
317206-172068.8149.05
416898-168988.6578.89
517266-172668.8459.08
616802-168028.6078.84
60min117033-170338.7268.772.579.019.052.51
217943-179439.1929.48
317087-170878.7539.04
417053-170538.7369.02
516933-169338.6758.96
616632-166328.5208.80
极限116846-168468.6308.693.548.969.033.45
217961-179619.2019.54
316876-168768.6458.98
417082-170828.7519.09
516970-169708.6949.03
616088-160888.2428.57
依折麦布阿托伐他汀钙片项目信息
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2500
标示量(mg)20供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.211571411573381573611573021569481572180.12
211.241587641588791588220.06
单位质量响应值RSD%判断
14024.8014130.070.53数据可信
供试品溶液-2023120823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%
5min183173-8317348.80340.5714.2748.8040.5714.27
265802-6580238.61038.61
378498-7849846.06046.06
457118-5711833.51533.51
567738-6773839.74639.75
662509-6250936.67836.68
10min1136236-13623679.93875.664.9980.2175.895.01
2118827-11882769.72369.94
3132150-13215077.54177.80
4124548-12454873.08073.27
5133581-13358178.38078.60
6128373-12837375.32575.53
15min1153040-15304089.79886.774.6290.5187.424.62
2135414-13541479.45680.06
3148093-14809386.89587.58
4145691-14569185.48686.08
5153725-15372590.20090.86
6151299-15129988.77789.40
20min1159802-15980293.76690.663.5894.9891.793.59
2144512-14451284.79485.84
3153626-15362690.14291.31
4153429-15342990.02691.09
5157459-15745992.39193.55
6158253-15825392.85793.97
30min1166007-16600797.40794.982.2999.1496.612.31
2155536-15553691.26392.78
3162767-16276795.50697.18
4162906-16290695.58797.15
5159897-15989793.82295.49
6164131-16413196.30697.94
45min1166678-16667897.80097.392.25100.0899.552.27
2160084-16008493.93195.95
3165625-16562597.18399.38
4164454-16445496.49698.59
5171320-171320100.524102.72
6167739-16773998.423100.59
60min1168892-16889299.10098.271.53101.92100.971.56
2163740-16374096.07798.62
3165986-16598697.394100.14
4167235-16723598.127100.76
5171250-171250100.483103.23
6167726-16772698.415101.13
极限1169308-16930899.34498.591.46102.71101.831.47
2166190-16619097.514100.59
3165336-16533697.013100.29
4168316-16831698.762101.94
5172059-172059100.958104.27
6166904-16690497.933101.19
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