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DJ333-221017对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.67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%
19.921654061661581659921657421657131658020.18
210.111683141697951690540.62
单位质量响应值RSD%判断
16713.9116721.460.04数据可信
供试品溶液-2024011221批-依折麦布-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19855-98555.2886.5717.275.296.5717.25
210190-101905.4685.47
312966-129666.9576.96
414745-147457.9127.91
514422-144227.7387.74
611288-112886.0576.06
10min117102-171029.1779.442.189.219.482.24
217206-172069.2329.26
317673-176739.4839.52
418140-181409.7339.78
517772-177729.5369.58
617656-176569.4749.51
15min118491-184919.9229.820.8410.009.910.76
218434-184349.8919.97
318102-181029.7139.80
418281-182819.8099.91
518169-181699.7499.85
618369-183699.8569.94
20min118734-1873410.05210.090.6310.1910.240.69
218759-1875910.06610.20
318777-1877710.07510.22
419036-1903610.21410.37
518833-1883310.10510.26
618723-1872310.04610.19
30min113123-131237.0417.080.897.237.280.95
213171-131717.0677.26
313083-130837.0207.22
413417-134177.1997.41
513200-132007.0837.29
613179-131797.0727.27
45min114876-148767.9828.001.518.218.241.45
214740-147407.9098.14
314956-149568.0258.27
414854-148547.9708.22
514676-146767.8758.12
615314-153148.2178.45
60min116752-167528.9899.112.539.269.392.44
217284-172849.2749.55
316653-166538.9369.22
416773-167739.0009.29
516707-167078.9659.25
617721-177219.5099.79
极限118396-183969.87110.022.9110.2010.362.80
219439-1943910.43010.76
318273-182739.80510.14
418339-183399.84010.18
518329-183299.83510.17
619323-1932310.36810.70
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DJ333-221017对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.67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%
19.921691281684881680001672821674491680690.46
210.111726351732041729200.24
单位质量响应值RSD%判断
16942.4417103.860.68数据可信
供试品溶液-2024011221批-依折麦布
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min112635-126356.6586.463.326.666.463.31
211551-115516.0876.09
312130-121306.3926.39
412251-122516.4566.46
512346-123466.5066.51
612657-126576.6706.67
10min116806-168068.8568.981.868.899.011.88
216632-166328.7648.80
316940-169408.9278.96
417035-170358.9779.01
517290-172909.1119.15
617495-174959.2199.26
15min117201-172019.0649.160.939.159.250.90
217611-176119.2809.36
317328-173289.1319.22
417489-174899.2169.30
517479-174799.2119.30
617238-172389.0849.17
20min117914-179149.4409.470.919.589.610.90
217938-179389.4539.59
318257-182579.6219.76
417983-179839.4769.61
517763-177639.3609.50
618023-180239.4979.64
30min112857-128576.7756.534.106.966.723.99
211526-115266.0746.26
312089-120896.3706.56
412405-124056.5376.73
512626-126266.6536.84
612811-128116.7516.94
45min113839-138397.2937.422.677.527.652.62
213742-137427.2417.46
313868-138687.3087.53
414488-144887.6357.86
513947-139477.3497.58
614629-146297.7097.94
60min115654-156548.2498.371.968.528.641.94
215625-156258.2348.49
315915-159158.3878.65
416060-160608.4638.73
515650-156508.2478.51
616407-164078.6468.92
极限116784-167848.8449.273.569.169.583.46
217077-170778.9999.31
317278-172789.1059.42
418187-181879.5849.90
517883-178839.4249.74
618298-182989.6429.96
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DJ333-221017对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.67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%
19.921645241648201644131643601642781644790.13
210.111637101645591641340.37
单位质量响应值RSD%判断
16580.5416234.821.49数据可信
供试品溶液-2024011222批-依折麦布
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min114941-149418.1698.1910.328.178.1910.34
213672-136727.4757.48
316169-161698.8418.84
416270-162708.8968.90
512609-126096.8946.89
616216-162168.8668.87
10min121742-2174211.88812.292.2911.9312.332.31
222373-2237312.23312.27
323069-2306912.61412.66
422917-2291712.53012.58
522047-2204712.05512.09
622669-2266912.39512.44
15min123989-2398913.11712.941.9113.2313.051.89
223203-2320312.68712.80
324350-2435013.31413.43
423228-2322812.70012.82
523727-2372712.97313.08
623476-2347612.83612.95
20min125048-2504813.69613.561.1813.8813.741.17
224708-2470813.51013.69
325149-2514913.75113.94
424694-2469413.50213.69
524881-2488113.60413.78
624333-2433313.30513.49
30min114207-142077.7687.851.748.038.121.68
213974-139747.6417.90
314589-145897.9778.25
414327-143277.8348.10
514635-146358.0028.25
614451-144517.9018.16
45min116392-163928.9638.921.639.279.221.58
216197-161978.8569.15
316499-164999.0219.34
416271-162718.8979.20
516615-166159.0859.38
615864-158648.6748.98
60min119359-1935910.58510.291.8110.9410.641.73
218848-1884810.30610.65
318681-1868110.21410.58
418889-1888910.32810.69
518808-1880810.28410.63
618309-1830910.01110.37
极限122027-2202712.04411.512.7112.4611.922.63
220939-2093911.44911.85
321031-2103111.49911.92
420911-2091111.43411.85
521176-2117611.57811.98
620261-2026111.07811.49
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DJ333-221017对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.67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%
19.921696231708811712811706341697161704270.43
210.111708951718341713640.39
单位质量响应值RSD%判断
17180.1416949.950.96数据可信
供试品溶液-2024011222批-依折麦布
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min115380-153808.0857.847.398.087.847.39
215207-152077.9947.99
315771-157718.2908.29
415975-159758.3988.40
513961-139617.3397.34
613183-131836.9306.93
10min121641-2164111.37611.431.1411.4211.481.15
221722-2172211.41911.46
322150-2215011.64411.69
421938-2193811.53211.58
521545-2154511.32611.37
621514-2151411.30911.35
15min122583-2258311.87111.891.8311.9812.001.80
222806-2280611.98912.10
323066-2306612.12512.24
422061-2206111.59711.71
522207-2220711.67411.78
622983-2298312.08212.18
20min123634-2363412.42412.312.7112.6012.482.68
223608-2360812.41012.58
323804-2380412.51312.69
423107-2310712.14712.32
522295-2229511.72011.89
624069-2406912.65312.82
30min112397-123976.5176.411.306.766.651.22
212042-120426.3306.57
312091-120916.3566.60
412047-120476.3336.58
512253-122536.4416.67
612348-123486.4916.73
45min113807-138077.2587.194.237.547.474.06
213045-130456.8577.14
313359-133597.0237.31
414668-146687.7117.99
513309-133096.9967.27
613863-138637.2877.56
60min115300-153008.0437.922.338.368.242.27
214804-148047.7828.10
314962-149627.8658.19
415271-152718.0288.35
514575-145757.6627.97
615509-155098.1538.47
极限116603-166038.7288.702.289.099.062.21
216495-164958.6719.03
316416-164168.6309.00
417155-171559.0189.38
515995-159958.4088.76
616644-166448.7499.11
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