依折麦布瑞舒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RSF-703-230318-D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(%)98.9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0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.311688971689051689011699141683481689930.34
211.361709371717221713300.33
单位质量响应值RSD%判断
14941.9115081.870.66数据可信
供试品溶液-2023122121批-瑞舒伐他汀钙-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min183679-8367947.73145.964.5747.7345.964.57
277000-7700043.92243.92
380533-8053345.93745.94
478404-7840444.72344.72
586219-8621949.18049.18
677628-7762844.28044.28
10min1126989-12698972.43673.423.3072.7073.683.30
2124048-12404870.75871.00
3132950-13295075.83676.09
4123998-12399870.73070.98
5133016-13301675.87476.15
6131306-13130674.89875.14
15min1148962-14896284.97083.952.8285.6484.612.82
2144269-14426982.29382.93
3148475-14847584.69285.37
4140831-14083180.33280.97
5152819-15281987.17087.86
6147701-14770184.25084.91
20min1158314-15831490.30487.343.6391.4488.463.58
2153318-15331887.45488.55
3158347-15834790.32391.47
4148684-14868484.81185.90
5144495-14449582.42283.60
6155501-15550188.70089.83
30min1155961-15596188.96291.042.6390.6092.662.61
2156022-15602288.99790.58
3163161-16316193.06994.72
4155782-15578288.86090.42
5165162-16516294.21095.85
6161544-16154492.14693.77
45min1156036-15603689.00591.362.4991.1493.482.47
2157164-15716489.64891.72
3163441-16344193.22995.39
4156982-15698289.54491.60
5165612-16561294.46796.63
6161795-16179592.29094.42
60min1164178-16417893.64990.852.3396.2893.482.30
2156887-15688789.49092.06
3159504-15950490.98393.67
4155764-15576488.85091.40
5163241-16324193.11495.80
6156041-15604189.00891.66
极限1158865-15886590.61891.112.1693.7794.242.15
2158139-15813990.20493.27
3161428-16142892.08095.27
4154799-15479988.29991.34
5165071-16507194.15897.36
6160069-16006991.30594.45
依折麦布瑞舒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%
111.081851751856301860721877731871221863540.58
211.171907461897511902480.37
单位质量响应值RSD%判断
16818.9517032.050.90数据可信
供试品溶液-2023122121批-依折麦布-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min114263-142637.5667.794.387.577.794.40
214865-148657.8857.88
315676-156768.3158.32
415097-150978.0088.01
514052-140527.4547.45
614135-141357.4987.50
10min120622-2062210.93911.494.8510.9811.544.83
220971-2097111.12411.17
320741-2074111.00211.05
422232-2223211.79311.84
522154-2215411.75111.79
623252-2325212.33412.38
15min123553-2355312.49312.802.2512.6012.912.21
224784-2478413.14613.25
323549-2354912.49112.60
423982-2398212.72112.83
524709-2470913.10613.21
624234-2423412.85512.96
20min125545-2554513.55013.584.5313.7213.764.48
225858-2585813.71613.89
325430-2543013.48913.67
426408-2640814.00814.19
523511-2351112.47112.65
626862-2686214.24914.43
30min126309-2630913.95514.906.5714.2015.156.47
227111-2711114.38114.64
328678-2867815.21215.46
427801-2780114.74715.01
527146-2714614.39914.65
631489-3148916.70316.96
45min128475-2847515.10415.964.3115.4316.294.27
228673-2867315.20915.54
331392-3139216.65116.99
430303-3030316.07416.41
530156-3015615.99616.32
631512-3151216.71517.07
60min131178-3117816.53816.152.2816.9516.582.17
231212-3121216.55616.98
329652-2965215.72816.16
430073-3007315.95216.38
530777-3077716.32516.74
629820-2982015.81816.26
极限130550-3055016.20515.2921.3116.7115.8120.57
231772-3177216.85317.36
330180-3018016.00816.52
432641-3264117.31417.83
531421-3142116.66717.18
616418-164188.7099.24
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