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%
110.001738451741831746341744741746411743550.20
210.011753221760611756920.30
单位质量响应值RSD%判断
17435.5017551.650.47数据可信
供试品溶液-2023120823批-依折麦布-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min113802-138027.0836.515.067.086.515.05
212287-122876.3066.31
312471-124716.4006.40
412943-129436.6426.64
512675-126756.5056.50
611948-119486.1326.13
10min116429-164298.4318.442.718.478.482.72
216504-165048.4708.50
317234-172348.8448.88
416411-164118.4228.46
516229-162298.3298.36
615881-158818.1508.18
15min116582-165828.5108.362.408.608.442.39
216788-167888.6168.70
316405-164058.4198.50
416192-161928.3108.39
516109-161098.2678.35
615679-156798.0468.13
20min116378-163788.4058.494.828.548.624.75
216644-166448.5428.67
316034-160348.2298.36
416365-163658.3988.53
518043-180439.2609.39
615774-157748.0958.22
30min116410-164108.4228.302.138.608.482.10
215982-159828.2028.38
315796-157968.1068.28
416006-160068.2148.39
516747-167478.5948.77
616143-161438.2848.45
45min115922-159228.1718.223.038.408.442.97
216762-167628.6028.83
315287-152877.8458.07
415805-158058.1118.33
516173-161738.3008.53
616118-161188.2728.49
60min115860-158608.1398.121.768.418.381.77
215949-159498.1858.46
315895-158958.1578.42
415564-155647.9878.25
516197-161978.3128.59
615427-154277.9178.18
极限115563-155637.9878.173.648.308.493.48
215871-158718.1458.46
317072-170728.7619.07
415677-156778.0458.36
515834-158348.1268.45
615535-155357.9728.28
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%
111.211589581588971592041589891590991590290.08
211.241610721613361612040.12
单位质量响应值RSD%判断
14186.3514341.990.78数据可信
供试品溶液-2023120823批-阿托伐他汀钙-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min136021-3602120.85920.6524.1120.8620.6524.12
230572-3057217.70417.70
345319-4531926.24426.24
442971-4297124.88424.88
537373-3737321.64221.64
621732-2173212.58512.58
10min175227-7522743.56342.2913.0643.6842.4013.08
276200-7620044.12744.23
379878-7987846.25746.40
477175-7717544.69144.83
575802-7580243.89644.02
653853-5385331.18631.26
15min198222-9822256.87954.0510.6457.2454.4010.67
299098-9909857.38757.73
399103-9910357.39057.79
494191-9419154.54554.93
595967-9596755.57455.94
673462-7346242.54142.78
20min1112056-11205664.89161.259.2865.5661.909.31
2112463-11246365.12665.79
3108599-10859962.88963.61
4104668-10466860.61261.30
5110275-11027563.85964.53
686601-8660150.15050.63
30min1125490-12549072.67068.427.4373.7069.417.47
2123410-12341071.46672.49
3120281-12028169.65470.72
4115813-11581367.06668.09
5122363-12236370.85971.89
6101566-10156658.81659.57
45min1135186-13518678.28571.547.3079.7272.907.32
2129088-12908874.75476.17
3122911-12291171.17772.63
4118300-11830068.50669.91
5126438-12643873.21974.64
6109265-10926563.27464.36
60min1137536-13753679.64674.097.4881.5275.857.51
2133634-13363477.38679.22
3132589-13258976.78178.63
4121643-12164370.44272.22
5130550-13055075.60077.43
6111665-11166564.66466.10
极限1140591-14059181.41578.643.9883.7380.824.10
2140467-14046781.34383.61
3138633-13863380.28182.56
4132368-13236876.65378.82
5135920-13592078.71080.96
6126786-12678673.42175.22
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%
110.001770931772281772921774911772811772770.09
210.011752361755071753720.11
单位质量响应值RSD%判断
17727.7017519.680.84数据可信
供试品溶液-2023120823批-依折麦布-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min114080-140807.1736.586.587.176.586.58
213763-137637.0117.01
312672-126726.4556.46
412370-123706.3016.30
511846-118466.0356.03
612738-127386.4896.49
10min116353-163538.3318.242.428.378.282.43
215810-158108.0548.09
316765-167658.5408.58
416438-164388.3748.41
515878-158788.0898.12
615865-158658.0828.12
15min116378-163788.3438.301.808.438.391.80
215783-157838.0408.12
316516-165168.4148.50
416540-165408.4268.51
516445-164458.3778.46
616133-161338.2188.30
20min116506-165068.4088.241.328.548.371.31
215906-159068.1038.23
316245-162458.2758.41
416015-160158.1588.29
516287-162878.2978.42
616124-161248.2148.34
30min115974-159748.1378.120.698.328.300.70
216025-160258.1638.34
316083-160838.1938.37
415887-158878.0938.27
515852-158528.0758.25
615798-157988.0488.22
45min115451-154517.8718.031.698.108.251.61
215616-156167.9558.17
316182-161828.2438.46
415632-156327.9638.18
515971-159718.1368.35
615754-157548.0258.24
60min115562-155627.9288.064.228.208.324.07
217178-171788.7519.01
315646-156467.9708.24
415427-154277.8598.12
515611-156117.9538.21
615533-155337.9138.17
极限115878-158788.0898.011.758.408.321.70
215526-155267.9098.22
315542-155427.9178.23
415931-159318.1168.42
515408-154087.8498.15
616096-160968.2008.51
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%
111.211618521617281619761620051620291619180.08
211.241611121612971612040.09
单位质量响应值RSD%判断
14444.0714341.990.51数据可信
供试品溶液-2023120823批-阿托伐他汀钙-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min133640-3364019.30618.6718.7019.3118.6718.70
237217-3721721.35921.36
327015-2701515.50415.50
423483-2348313.47713.48
534608-3460819.86119.86
639261-3926122.53222.53
10min169155-6915539.68840.977.2039.8041.087.21
272302-7230241.49441.61
367649-6764938.82438.91
467350-6735038.65238.73
581164-8116446.58046.69
670744-7074440.60040.72
15min188692-8869250.90052.537.2151.2352.867.18
289356-8935651.28151.63
389272-8927251.23351.53
491151-9115152.31152.60
5104575-10457560.01560.38
686139-8613949.43549.79
20min1101920-10192058.49158.586.7659.1059.216.75
299363-9936357.02457.66
399660-9966057.19457.78
4101178-10117858.06658.65
5115296-11529666.16866.87
695068-9506854.55955.18
30min1112573-11257364.60563.995.3165.5464.945.30
2109107-10910762.61663.57
3107490-10749061.68862.59
4113882-11388265.35666.26
5121406-12140669.67470.74
6104575-10457560.01560.94
45min1116545-11654566.88565.925.7268.1867.225.69
2108777-10877762.42763.73
3110073-11007363.17064.42
4119705-11970568.69869.96
5124779-12477971.61073.07
6109303-10930362.72963.99
60min1121456-12145669.70367.295.7071.3768.965.67
2112965-11296564.83066.48
3109742-10974262.98164.58
4122311-12231170.19471.84
5125626-12562672.09673.95
6111356-11135663.90765.52
极限1131858-13185875.67374.573.5077.7376.613.50
2124181-12418171.26773.27
3124725-12472571.57973.53
4134678-13467877.29179.33
5134034-13403476.92279.18
6130110-13011074.67076.64
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