洛索洛芬钠细粒剂项目信息
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T202103YY01对照品来源原料药对照品使用方法直接使用
对照品含量(%)88.1对照品水分(%)0对照品稀释倍数200
标示量(mg)60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%
115.111708352170821717063431703623170704717067160.12
215.111693340169196216926510.06
单位质量响应值RSD%判断
112952.75112021.910.59数据可信
供试品溶液-6批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11649105-164910596.87097.000.6096.8797.000.60
21658289-165828997.40997.41
31645662-164566296.66896.67
41639924-163992496.33196.33
51647784-164778496.79296.79
61667324-166732497.94097.94
15min11673337-167333798.29398.340.3298.4598.510.32
21673880-167388098.32598.49
31667230-166723097.93598.10
41678057-167805798.57198.73
51670731-167073198.14098.30
61682066-168206698.80698.97
30min11662816-166281697.67598.450.6498.0098.780.64
21678266-167826698.58398.91
31665983-166598397.86198.19
41688284-168828499.17199.50
51673189-167318998.28598.61
61687277-168727799.11299.44
洛索洛芬钠细粒剂项目信息
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T202103YY01对照品来源原料药对照品使用方法直接使用
对照品含量(%)88.1对照品水分(%)0对照品稀释倍数200
标示量(mg)60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%
115.111685729168742616875881687258168637716868760.05
215.111712984170757817102810.23
单位质量响应值RSD%判断
111639.71113188.680.98数据可信
供试品溶液-1批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11594275-159427593.71398.392.4593.7198.392.45
21685600-168560099.08199.08
31685764-168576499.09199.09
41692839-169283999.50799.51
51673178-167317898.35198.35
61711414-1711414100.599100.60
15min11692990-169299099.516100.590.7699.67100.750.77
21710891-1710891100.568100.73
31719439-1719439101.070101.24
41716161-1716161100.878101.04
51699605-169960599.904100.07
61728026-1728026101.575101.74
30min11682527-168252798.901100.591.2699.22100.921.26
21708754-1708754100.442100.77
31706426-1706426100.305100.64
41726624-1726624101.493101.83
51699026-169902699.870100.20
61743794-1743794102.502102.84
洛索洛芬钠细粒剂项目信息
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T202103YY01对照品来源原料药对照品使用方法直接使用
对照品含量(%)88.1对照品水分(%)0对照品稀释倍数200
标示量(mg)60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%
115.111693067169158916916781692562169069016919170.06
215.111692051169164616918480.02
单位质量响应值RSD%判断
111973.33111968.760.01数据可信
供试品溶液-2批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11567842-156784292.52095.636.9992.5295.636.99
21703382-1703382100.518100.52
31682062-168206299.26099.26
41411429-141142983.29083.29
51685461-168546199.46099.46
61672959-167295998.72398.72
15min11705168-1705168100.623100.241.44100.78100.401.45
21725189-1725189101.805101.97
31710572-1710572100.942101.11
41653653-165365397.58397.72
51704232-1704232100.568100.73
61692816-169281699.894100.06
30min11704280-1704280100.571100.810.59100.89101.140.59
21722601-1722601101.652101.99
31716046-1716046101.265101.60
41710423-1710423100.933101.23
51701160-1701160100.387100.72
61695576-1695576100.057100.39
洛索洛芬钠细粒剂项目信息
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T202103YY01对照品来源原料药对照品使用方法直接使用
对照品含量(%)88.1对照品水分(%)0对照品稀释倍数200
标示量(mg)60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%
115.111693077169335316931621693929169379516934630.03
215.111689184169157416903790.10
单位质量响应值RSD%判断
112075.65111871.540.13数据可信
供试品溶液-3批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11717817-1717817101.36899.421.38101.3799.421.38
21655937-165593797.71697.72
31664823-166482398.24098.24
41694386-169438699.98599.98
51676663-167666398.93998.94
61699353-1699353100.278100.28
15min11722442-1722442101.640100.311.06101.81100.481.06
21676190-167619098.91199.07
31706823-1706823100.719100.88
41716106-1716106101.267101.43
51687280-168728099.56699.73
61690879-169087999.77899.95
30min11718704-1718704101.420100.160.94101.76100.500.94
21679751-167975199.12199.45
31684549-168454999.40499.74
41714660-1714660101.181101.52
51695547-1695547100.053100.38
61691132-169113299.793100.13
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