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%
110.041659240165879016580951658915165976716589610.04
210.271689362169028216898220.04
单位质量响应值RSD%判断
165235.16164539.630.30数据可信
供试品溶液-2025031221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%
5min13947-39470.0600.0619.810.060.0616.86
23931-39310.0600.06
32408-24080.0360.04
44618-46180.0700.07
54104-41040.0620.06
64121-41210.0620.06
15min112098-120980.1830.182.350.180.183.13
211960-119600.1810.18
311716-117160.1770.18
411468-114680.1740.17
511435-114350.1730.17
611512-115120.1740.17
30min115367-153670.2330.245.360.230.245.78
216890-168900.2560.26
315383-153830.2330.23
414387-143870.2180.22
515548-155480.2360.24
616127-161270.2440.24
45min115454-154540.2340.243.990.230.245.28
215273-152730.2310.23
316196-161960.2450.25
415548-155480.2360.24
515263-152630.2310.23
616831-168310.2550.26
60min117062-170620.2580.253.960.260.254.91
215361-153610.2330.23
316672-166720.2530.25
416017-160170.2430.24
516011-160110.2430.24
616999-169990.2570.26
90min114475-144750.2190.245.660.220.245.62
216612-166120.2520.25
316477-164770.2500.25
415979-159790.2420.24
515807-158070.2390.24
617058-170580.2580.26
120min117247-172470.2610.255.000.260.254.71
216811-168110.2550.26
314967-149670.2270.23
416205-162050.2450.25
516388-163880.2480.25
615634-156340.2370.24
极限116577-165770.2510.253.120.250.253.04
216126-161260.2440.25
316146-161460.2450.25
416009-160090.2420.24
515672-156720.2370.24
617128-171280.2590.26
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%
110.041674615167362916725441673843167351616736290.05
210.271735192173498817350900.01
单位质量响应值RSD%判断
166696.12168947.420.95数据可信
供试品溶液-2025031221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%
5min13014-30140.0450.0617.820.040.0622.27
24034-40340.0600.06
32726-27260.0410.04
44059-40590.0600.06
53951-39510.0590.06
64446-44460.0660.07
15min111153-111530.1660.185.150.170.184.23
212049-120490.1790.18
311480-114800.1710.17
411798-117980.1760.18
512288-122880.1830.18
612925-129250.1920.19
30min115331-153310.2280.222.560.230.223.66
214995-149950.2230.22
314335-143350.2130.21
415251-152510.2270.23
514959-149590.2230.22
615314-153140.2280.23
45min115901-159010.2370.2212.010.240.2212.18
216417-164170.2440.25
314789-147890.2200.22
413992-139920.2080.21
511878-118780.1770.18
616613-166130.2470.25
60min113905-139050.2070.227.560.210.238.22
216446-164460.2450.25
314542-145420.2160.22
416495-164950.2450.25
514735-147350.2190.22
614172-141720.2110.21
90min115706-157060.2340.246.820.240.247.23
214244-142440.2120.21
315926-159260.2370.24
415320-153200.2280.23
516752-167520.2490.25
617322-173220.2580.26
120min115645-156450.2330.236.200.230.226.13
214903-149030.2220.22
316308-163080.2430.24
415645-156450.2330.23
513600-136000.2020.20
615019-150190.2240.23
极限115842-158420.2360.242.610.240.243.36
216358-163580.2430.25
316250-162500.2420.24
416549-165490.2460.25
515386-153860.2290.23
616349-163490.2430.25
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