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对照品来源工作对照品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%
110.031667171669121670641671211671111669850.11
210.091683311685451684380.09
单位质量响应值RSD%判断
16648.5516693.560.20数据可信
供试品溶液-2023121621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%
5min19695-96955.2175.524.115.225.534.08
210008-100085.3855.39
310646-106465.7285.73
410311-103115.5485.55
510102-101025.4365.44
610833-108335.8295.83
10min116684-166848.9778.951.929.018.981.90
216322-163228.7828.81
316830-168309.0569.09
416291-162918.7668.80
517122-171229.2139.24
616512-165128.8858.92
15min116582-165828.9229.011.299.009.091.26
216994-169949.1449.22
316741-167419.0089.09
416883-168839.0849.16
516897-168979.0929.17
616427-164278.8398.92
20min116243-162438.7408.573.588.878.703.54
216572-165728.9179.05
315241-152418.2018.33
415292-152928.2288.36
516404-164048.8278.96
615844-158448.5258.66
30min115437-154378.3068.511.728.488.691.71
216223-162238.7298.91
315954-159548.5848.76
415854-158548.5318.71
515818-158188.5118.69
615618-156188.4048.58
45min116147-161478.6888.392.738.918.612.65
215019-150198.0818.31
315791-157918.4978.72
415619-156198.4048.63
515799-157998.5018.73
615165-151658.1608.38
60min115781-157818.4918.312.578.768.582.48
215983-159838.6008.87
315380-153808.2768.55
415247-152478.2048.47
515417-154178.2968.57
614860-148607.9968.27
极限115414-154148.2948.211.778.618.531.72
215013-150138.0788.40
315340-153408.2548.57
415400-154008.2868.60
515564-155648.3758.70
614863-148637.9978.31
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%
110.732910222913952916082916532915542914460.09
210.782929102930482929790.04
单位质量响应值RSD%判断
27161.7927178.010.05数据可信
供试品溶液-2023121621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%
5min132807-328079.97415.6221.259.9715.6221.26
253965-5396516.40616.41
350781-5078115.43815.44
449555-4955515.06515.07
554664-5466416.61916.62
666548-6654820.23120.23
10min1134516-13451640.89542.1712.2440.9542.2612.22
2142436-14243643.30243.39
3134766-13476640.97141.06
4110529-11052933.60233.69
5160805-16080548.88748.98
6149171-14917145.35045.46
15min1178103-17810354.14653.357.1854.4353.677.19
2175421-17542153.33053.66
3172626-17262652.48152.79
4158177-15817748.08848.36
5197015-19701559.89560.26
6171552-17155252.15452.52
20min1201687-20168761.31556.9910.9861.9057.6110.93
2187382-18738256.96757.59
3173143-17314352.63853.24
4161618-16161849.13449.67
5219209-21920966.64267.34
6181714-18171455.24355.90
30min1212445-21244564.58661.489.2765.5162.419.25
2195398-19539859.40460.35
3196589-19658959.76660.66
4181706-18170655.24156.05
5234724-23472471.35972.43
6192408-19240858.49559.46
45min1230846-23084670.18063.0211.8071.4664.2911.70
2187313-18731356.94658.22
3204269-20426962.10063.33
4183367-18336755.74656.86
5243231-24323173.94575.41
6194650-19465059.17660.46
60min1230668-23066870.12663.9911.5271.8065.6211.44
2202004-20200461.41263.00
3204885-20488562.28863.86
4184023-18402355.94557.37
5248240-24824075.46877.34
6193170-19317058.72660.34
极限1245644-24564474.67971.916.2376.7473.906.27
2221458-22145867.32669.26
3239295-23929572.74974.67
4227679-22767969.21770.96
5260124-26012479.08181.37
6225104-22510468.43570.38
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