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%
110.041683738168312816830041681279168122216824740.07
210.271727988172868217283350.03
单位质量响应值RSD%判断
167577.09168289.680.31数据可信
供试品溶液-2025031121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%
5min17156-71560.1060.0817.860.110.0821.02
25017-50170.0750.07
36584-65840.0980.10
44644-46440.0690.07
54883-48830.0730.07
65459-54590.0810.08
15min113480-134800.2000.196.420.200.196.27
212916-129160.1920.19
313685-136850.2040.20
413426-134260.2000.20
513400-134000.1990.20
611398-113980.1700.17
30min116301-163010.2420.243.270.240.243.16
216093-160930.2390.24
315939-159390.2370.24
415146-151460.2250.23
516497-164970.2450.25
615398-153980.2290.23
45min117107-171070.2540.253.370.260.253.58
216542-165420.2460.25
315973-159730.2380.24
415967-159670.2370.24
517310-173100.2570.26
616902-169020.2510.25
60min117649-176490.2620.261.960.260.262.02
217356-173560.2580.26
316801-168010.2500.25
417610-176100.2620.26
517226-172260.2560.26
616975-169750.2520.25
90min117968-179680.2670.263.190.270.263.11
216758-167580.2490.25
317288-172880.2570.26
418229-182290.2710.27
517537-175370.2610.26
618091-180910.2690.27
120min117937-179370.2670.256.020.270.255.85
216308-163080.2430.24
315133-151330.2250.23
416721-167210.2490.25
517312-173120.2570.26
617577-175770.2610.26
极限118348-183480.2730.263.100.280.263.76
216994-169940.2530.26
316841-168410.2500.25
417253-172530.2570.26
517469-174690.2600.26
617564-175640.2610.26
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%
110.041699977169888917000831700801170012716999750.05
210.271716765171724117170030.02
单位质量响应值RSD%判断
169320.22167186.270.90数据可信
供试品溶液-2025031121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%
5min111622-116220.1730.166.440.170.166.21
211231-112310.1670.17
310802-108020.1600.16
410281-102810.1530.15
59910-99100.1470.15
610116-101160.1500.15
15min115383-153830.2280.215.570.230.215.68
214485-144850.2150.22
313283-132830.1970.20
413865-138650.2060.21
513525-135250.2010.20
614726-147260.2190.22
30min116966-169660.2520.243.740.250.243.16
216337-163370.2430.24
315784-157840.2340.23
416369-163690.2430.24
515203-152030.2260.23
616344-163440.2430.24
45min116962-169620.2520.2310.020.250.239.13
216007-160070.2380.24
315144-151440.2250.23
415894-158940.2360.24
512471-124710.1850.19
615501-155010.2300.23
60min117339-173390.2570.252.210.260.253.00
216357-163570.2430.24
316771-167710.2490.25
416450-164500.2440.25
516725-167250.2480.25
617109-171090.2540.26
90min116381-163810.2430.243.060.250.253.04
216855-168550.2500.25
315878-158780.2360.24
417069-170690.2530.26
516699-166990.2480.25
615859-158590.2350.24
120min116172-161720.2400.247.220.240.247.64
216557-165570.2460.25
317136-171360.2540.26
416372-163720.2430.25
517256-172560.2560.26
613986-139860.2080.21
极限117963-179630.2670.255.900.270.255.66
217312-173120.2570.26
316555-165550.2460.25
416697-166970.2480.25
515377-153770.2280.23
615710-157100.2330.24
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