地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号2.0对照品来源EP对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数100
标示量(mg)360供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.041704102170109817031451701576170138017022600.08
210.271766871171811617424941.98
单位质量响应值RSD%判断
169547.81169668.350.06数据可信
供试品溶液-2025031021批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17487-74870.1100.1117.910.110.1119.96
28504-85040.1250.13
38007-80070.1180.12
47758-77580.1140.11
54934-49340.0730.07
68685-86850.1280.13
15min114594-145940.2150.213.410.220.213.83
214134-141340.2080.21
314637-146370.2160.22
414887-148870.2190.22
513537-135370.1990.20
614271-142710.2100.21
30min116559-165590.2440.238.130.240.237.78
213623-136230.2010.20
315336-153360.2260.23
416587-165870.2440.24
516884-168840.2490.25
614800-148000.2180.22
45min114934-149340.2200.234.330.220.244.47
215746-157460.2320.23
316036-160360.2360.24
416418-164180.2420.24
516872-168720.2480.25
615414-154140.2270.23
60min116827-168270.2480.248.430.250.248.85
216856-168560.2480.25
313614-136140.2000.20
416617-166170.2450.25
517367-173670.2560.26
615938-159380.2350.24
90min116973-169730.2500.252.870.250.253.00
217009-170090.2500.25
316936-169360.2490.25
417272-172720.2540.26
517718-177180.2610.26
616245-162450.2390.24
120min116564-165640.2440.247.140.250.246.72
216103-161030.2370.24
314632-146320.2150.22
417634-176340.2600.26
517656-176560.2600.26
615810-158100.2330.23
极限116706-167060.2460.248.480.250.248.47
215940-159400.2350.24
314560-145600.2140.22
416848-168480.2480.25
518698-186980.2750.28
615655-156550.2310.23
地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号2.0对照品来源EP对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数100
标示量(mg)360供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.041712367171244217098771709851170967117108420.09
210.271731180173268017319300.07
单位质量响应值RSD%判断
170402.59168639.730.74数据可信
供试品溶液-2025031021批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113421-134210.1980.189.610.200.1810.29
210316-103160.1520.15
312993-129930.1910.19
412605-126050.1860.19
511877-118770.1750.17
611236-112360.1660.17
15min114226-142260.2100.234.530.210.234.56
215391-153910.2270.23
314737-147370.2170.22
415799-157990.2330.23
516052-160520.2360.24
615718-157180.2320.23
30min115957-159570.2350.248.820.240.249.52
214928-149280.2200.22
315366-153660.2260.23
415053-150530.2220.22
518742-187420.2760.28
615869-158690.2340.23
45min117066-170660.2510.228.800.250.227.89
213250-132500.1950.20
314888-148880.2190.22
414887-148870.2190.22
513922-139220.2050.21
614372-143720.2120.21
60min116511-165110.2430.232.420.240.242.34
215454-154540.2280.23
315875-158750.2340.24
415738-157380.2320.23
516043-160430.2360.24
615477-154770.2280.23
90min115805-158050.2330.234.650.230.244.47
216926-169260.2490.25
316305-163050.2400.24
415317-153170.2260.23
514826-148260.2180.22
616109-161090.2370.24
120min114678-146780.2160.238.370.220.247.87
214511-145110.2140.22
315919-159190.2350.24
415957-159570.2350.24
518200-182000.2680.27
615563-155630.2290.23
极限115900-159000.2340.234.670.240.233.89
215327-153270.2260.23
315773-157730.2320.23
414526-145260.2140.22
514453-144530.2130.22
616169-161690.2380.24
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