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%
110.121684606168233716822451681845168216216826390.07
210.241685890167511516805020.46
单位质量响应值RSD%判断
166268.68164111.520.93数据可信
供试品溶液-ACSB24025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%
5min114062-140620.2130.2929.730.210.2930.15
226606-266060.4020.40
318117-181170.2740.27
426528-265280.4010.40
515327-153270.2320.23
615353-153530.2320.23
15min114349-143490.2170.237.920.220.237.51
216747-167470.2530.25
315349-153490.2320.23
416872-168720.2550.26
514235-142350.2150.22
614402-144020.2180.22
30min114477-144770.2190.2639.170.220.2638.71
215841-158410.2400.24
313747-137470.2080.21
414072-140720.2130.21
514921-149210.2260.23
631200-312000.4720.47
45min113911-139110.2100.224.320.210.224.63
215734-157340.2380.24
314373-143730.2170.22
415021-150210.2270.23
514670-146700.2220.22
614507-145070.2190.22
60min113316-133160.2010.228.160.200.228.89
215634-156340.2360.24
315098-150980.2280.23
412624-126240.1910.19
515123-151230.2290.23
614701-147010.2220.22
90min116110-161100.2440.228.120.250.228.89
213269-132690.2010.20
314336-143360.2170.22
415041-150410.2270.23
514076-140760.2130.21
612973-129730.1960.20
120min114672-146720.2220.222.620.220.221.87
214531-145310.2200.22
314391-143910.2180.22
414482-144820.2190.22
514319-143190.2160.22
613641-136410.2060.21
极限113201-132010.2000.216.370.200.226.42
215752-157520.2380.24
314441-144410.2180.22
413672-136720.2070.21
513795-137950.2090.21
613657-136570.2060.21
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%
110.121676096167559916754991676332167691316760880.04
210.241721841172174417217920.01
单位质量响应值RSD%判断
165621.34168143.751.07数据可信
供试品溶液-ACSB24025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%
5min166565-665650.9960.4073.071.000.4073.66
217416-174160.2610.26
319006-190060.2840.28
424251-242510.3630.36
517297-172970.2590.26
616695-166950.2500.25
15min120732-207320.3100.2414.300.310.2414.16
215125-151250.2260.23
315588-155880.2330.23
416440-164400.2460.25
514528-145280.2170.22
614836-148360.2220.22
30min118416-184160.2760.2314.160.280.2314.51
215147-151470.2270.23
313503-135030.2020.20
414813-148130.2220.22
516730-167300.2500.25
612493-124930.1870.19
45min116366-163660.2450.226.340.250.226.75
214379-143790.2150.22
314973-149730.2240.23
413747-137470.2060.21
514105-141050.2110.21
614339-143390.2150.22
60min114018-140180.2100.2114.660.210.2114.77
212130-121300.1820.18
317986-179860.2690.27
412426-124260.1860.19
514201-142010.2130.21
614250-142500.2130.21
90min114420-144200.2160.2210.350.220.2210.39
217360-173600.2600.26
313732-137320.2060.21
414034-140340.2100.21
513503-135030.2020.20
613462-134620.2010.20
120min114086-140860.2110.206.480.210.206.60
212006-120060.1800.18
312642-126420.1890.19
413956-139560.2090.21
513705-137050.2050.21
613998-139980.2100.21
极限115388-153880.2300.2112.360.230.2112.11
212846-128460.1920.19
313608-136080.2040.21
416603-166030.2480.25
513956-139560.2090.21
611777-117770.1760.18
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%
110.121700883169733216975321695573169641216975460.12
210.241738400174009617392480.07
单位质量响应值RSD%判断
167741.70169848.440.89数据可信
供试品溶液-ACSB24005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%
5min113060-130600.1930.188.330.190.189.30
213322-133220.1970.20
311932-119320.1770.18
410857-108570.1610.16
511085-110850.1640.16
612543-125430.1860.19
15min114360-143600.2120.206.100.210.205.96
214230-142300.2110.21
312694-126940.1880.19
414757-147570.2180.22
513009-130090.1920.19
613280-132800.1960.20
30min114540-145400.2150.221.990.220.222.88
214646-146460.2170.22
314640-146400.2170.22
415236-152360.2250.23
514702-147020.2180.22
614340-143400.2120.21
45min114051-140510.2080.218.890.210.208.59
214107-141070.2090.21
311472-114720.1700.17
414296-142960.2120.21
515096-150960.2230.22
614308-143080.2120.21
60min113705-137050.2030.2112.040.200.2112.31
215360-153600.2270.23
314653-146530.2170.22
410677-106770.1580.16
514511-145110.2150.22
614645-146450.2170.22
90min113646-136460.2020.208.560.200.208.62
214579-145790.2160.22
314381-143810.2130.21
414173-141730.2100.21
514157-141570.2090.21
611403-114030.1690.17
120min114350-143500.2120.213.030.210.222.55
213951-139510.2060.21
314590-145900.2160.22
414986-149860.2220.22
513830-138300.2050.21
614522-145220.2150.22
极限113273-132730.1960.2010.440.200.209.64
213533-135330.2000.20
313761-137610.2040.21
411997-119970.1780.18
513072-130720.1930.20
616298-162980.2410.24
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