依折麦布阿托伐他汀钙片片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号R075K0对照品来源USP对照品使用方法直接使用
对照品含量(%)99.8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%
110.181665031666921672791668651663731667420.22
210.131682391665881674140.70
单位质量响应值RSD%判断
16379.3716526.550.64数据可信
0天-供试品溶液-2023120823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%
5min19553-95535.2156.5313.845.226.5313.85
212095-120956.6036.60
314224-142247.7657.77
412844-128447.0127.01
512419-124196.7806.78
610629-106295.8035.80
10min114826-148268.0949.015.248.129.055.28
216906-169069.2309.27
317292-172929.4409.48
416795-167959.1699.21
516493-164939.0049.04
616733-167339.1359.17
15min116511-165119.0149.232.379.099.322.38
216561-165619.0419.13
317583-175839.5999.69
416959-169599.2589.35
516761-167619.1509.24
617122-171229.3479.43
20min117308-173089.4499.692.339.579.832.31
218248-182489.96210.10
317602-176029.6099.76
417773-177739.7039.84
517373-173739.4849.62
618240-182409.95810.09
30min123256-2325612.69612.861.9212.8713.061.92
223479-2347912.81813.01
323980-2398013.09113.29
424040-2404013.12413.32
522872-2287212.48712.68
623750-2375012.96613.16
45min114482-144827.9068.342.938.158.612.95
215188-151888.2928.56
315355-153558.3838.66
415821-158218.6378.91
515507-155078.4668.73
615339-153398.3748.64
60min114828-148288.0958.655.208.398.965.07
215097-150978.2428.55
315638-156388.5378.86
416695-166959.1149.43
516855-168559.2029.51
615966-159668.7169.03
极限116738-167389.13810.147.929.4710.497.72
217097-170979.3349.69
318388-1838810.03910.41
419699-1969910.75411.12
518943-1894310.34210.70
620523-2052311.20411.56
依折麦布阿托伐他汀钙片片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号R075K0对照品来源USP对照品使用方法直接使用
对照品含量(%)99.8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%
110.181675241669571672171687521668751674650.46
210.131686081678751682420.31
单位质量响应值RSD%判断
16450.3916608.290.68数据可信
0天-供试品溶液-第3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%
5min112667-126676.8837.3812.776.887.3812.78
214402-144027.8267.83
315683-156838.5228.52
414804-148048.0458.04
510864-108645.9045.90
613099-130997.1187.12
10min119448-1944810.56811.143.4310.6111.183.43
220512-2051211.14611.19
321483-2148311.67411.72
420784-2078411.29411.34
520756-2075611.27911.31
620008-2000810.87310.91
15min122094-2209412.00612.322.5812.1012.422.55
221982-2198211.94512.05
322478-2247812.21512.33
423176-2317612.59412.70
523414-2341412.72312.82
622899-2289912.44412.54
20min119237-1923710.45410.581.3210.6210.761.32
219518-1951810.60610.78
319702-1970210.70610.89
419566-1956610.63210.81
519101-1910110.38010.55
619738-1973810.72610.89
30min122741-2274112.35812.541.4812.5812.771.50
223238-2323812.62812.86
323356-2335612.69212.93
423105-2310512.55512.79
522580-2258012.27012.49
623413-2341312.72312.95
45min112512-125126.7997.082.237.097.382.21
212967-129677.0467.35
313259-132597.2057.52
413094-130947.1157.42
513027-130277.0797.37
613330-133307.2447.54
60min116009-160098.6998.873.369.039.213.31
216009-160098.6999.04
316575-165759.0079.36
417336-173369.4219.77
515976-159768.6829.01
616030-160308.7119.05
极限118299-182999.94410.608.1710.3210.997.93
218443-1844310.02210.41
319111-1911110.38510.79
422188-2218812.05712.46
520659-2065911.22611.61
618318-183189.95410.34
依折麦布阿托伐他汀钙片片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号R075K0对照品来源USP对照品使用方法直接使用
对照品含量(%)99.8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%
110.181678511686301678121689321694881685430.43
210.131679861678421679140.07
单位质量响应值RSD%判断
16556.2916575.910.09数据可信
0天-供试品溶液-2023120823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%
5min111090-110906.0135.719.076.015.709.08
210351-103515.6125.61
311659-116596.3216.32
49426-94265.1115.11
511219-112196.0836.08
69415-94155.1055.10
10min118194-181949.86510.154.839.9010.184.85
219826-1982610.74910.78
319462-1946210.55210.59
418001-180019.7609.79
519209-1920910.41510.45
617589-175899.5379.56
15min120848-2084811.30411.282.2711.3911.372.30
221387-2138711.59611.69
320872-2087211.31711.41
420156-2015610.92811.01
521218-2121811.50411.60
620391-2039111.05611.14
20min122414-2241412.15312.232.0612.3012.382.05
222432-2243212.16212.32
323411-2341112.69312.85
422634-2263412.27212.42
522050-2205011.95512.11
622351-2235112.11912.26
30min111894-118946.4496.524.146.676.744.10
211579-115796.2786.50
312784-127846.9317.16
411752-117526.3726.58
512502-125026.7787.00
611643-116436.3136.52
45min115168-151688.2248.064.698.488.314.55
214057-140577.6227.88
314697-146977.9698.23
414156-141567.6757.92
515863-158638.6018.86
615252-152528.2708.51
60min117431-174319.45110.227.409.7510.527.20
217052-170529.2459.55
319785-1978510.72711.04
418512-1851210.03710.33
520158-2015810.93011.24
620175-2017510.93911.23
极限121997-2199711.92712.288.4212.2812.638.18
219556-1955610.60310.95
322121-2212111.99412.36
424037-2403713.03313.38
523086-2308612.51712.89
625051-2505113.58213.93
依折麦布阿托伐他汀钙片片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号R075K0对照品来源USP对照品使用方法直接使用
对照品含量(%)99.8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%
110.181676711675791687551699971690851686170.61
210.131660731666721663720.26
单位质量响应值RSD%判断
16563.5616423.690.60数据可信
0天-供试品溶液-第3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%
5min110998-109985.9895.5012.695.995.5012.74
211182-111826.0906.09
38013-80134.3644.36
49152-91524.9844.98
511082-110826.0356.04
610136-101365.5205.52
10min117100-171009.3129.281.189.359.321.21
217159-171599.3459.38
316761-167619.1289.15
416872-168729.1889.22
517314-173149.4299.46
617078-170789.3009.33
15min118964-1896410.32710.231.3510.4110.311.32
218403-1840310.02210.11
318512-1851210.08110.16
418900-1890010.29310.37
518942-1894210.31610.40
618946-1894610.31810.40
20min118443-1844310.04410.743.3010.1910.883.22
219881-1988110.82710.97
319811-1981110.78910.92
420171-2017110.98511.12
519877-1987710.82510.97
620189-2018910.99511.13
30min111047-110476.0166.111.566.216.311.48
211053-110536.0196.22
311509-115096.2686.46
411277-112776.1416.34
511183-111836.0906.29
611294-112946.1516.35
45min113333-133337.2617.371.977.497.601.87
213296-132967.2417.48
314038-140387.6457.87
413533-135337.3707.60
513470-134707.3367.57
613543-135437.3757.61
60min117045-170459.2828.942.529.559.212.41
215885-158858.6518.93
316743-167439.1189.39
416237-162378.8429.11
516239-162398.8439.12
616344-163448.9019.18
极限119599-1959910.67310.324.4711.0010.644.32
219191-1919110.45110.77
320095-2009510.94311.26
417920-179209.75910.08
518716-1871610.19210.52
618127-181279.87210.20
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