洛索洛芬钠细颗粒项目信息
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%
114.991718969171992017181341714701171751517178480.12
214.931716020171545117157360.03
单位质量响应值RSD%判断
114599.60114918.690.20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%
5min11746007-1746007100.53098.975.97100.5398.975.97
21609143-160914392.65092.65
31709483-170948398.42798.43
41785472-1785472102.803102.80
51863928-1863928107.320107.32
61599578-159957892.09992.10
15min11745084-1745084100.47799.195.83100.6499.355.84
21620059-162005993.27893.43
31714736-171473698.73098.89
41782196-1782196102.614102.79
51869955-1869955107.667107.85
61604056-160405692.35792.51
30min11740638-1740638100.22199.075.93100.5699.405.94
21615450-161545093.01393.32
31707829-170782998.33298.66
41789551-1789551103.037103.38
51867727-1867727107.539107.90
61602267-160226792.25492.56
洛索洛芬钠细颗粒项目信息
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%
114.991713492171406017128351715716171451017141230.07
214.931714317171291417136160.06
单位质量响应值RSD%判断
114351.10114776.690.27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%
5min11825449-1825449105.284102.584.56105.28102.584.56
21795223-1795223103.540103.54
31903328-1903328109.775109.78
41673192-167319296.50296.50
51725910-172591099.54399.54
61747974-1747974100.815100.82
15min11862862-1862862107.441103.314.90107.62103.494.90
21805038-1805038104.106104.28
31915885-1915885110.500110.68
41678317-167831796.79896.96
51735673-1735673100.106100.27
61750098-1750098100.938101.11
30min11852563-1852563106.847102.994.81107.20103.344.81
21802006-1802006103.931104.28
31908557-1908557110.077110.44
41674021-167402196.55096.87
51731356-173135699.857100.19
61745832-1745832100.692101.03
洛索洛芬钠细颗粒项目信息
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%
114.991714443171545417146021713513171361917143260.05
214.931716130171229017142100.16
单位质量响应值RSD%判断
114364.64114816.480.28数据可信
供试品溶液-24100901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%
5min11686438-168643897.24396.380.9997.2496.380.99
21656288-165628895.50595.50
31665333-166533396.02796.03
41676207-167620796.65496.65
51651533-165153395.23195.23
61692584-169258497.59897.60
15min11696254-169625497.80996.850.9697.9797.010.96
21668100-166810096.18696.35
31675764-167576496.62896.79
41682379-168237997.00997.17
51656831-165683195.53695.69
61698157-169815797.91998.08
30min11691519-169151997.53696.700.9797.8697.020.97
21663665-166366595.93096.25
31670908-167090896.34896.67
41682665-168266597.02697.35
51656246-165624695.50395.82
61697209-169720997.86598.19
洛索洛芬钠细颗粒项目信息
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%
114.991711288171358717132401712293171196917124750.06
214.931713907171156417127360.10
单位质量响应值RSD%判断
114241.16114717.750.30数据可信
供试品溶液-24100902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%
5min11720748-172074899.318100.002.5299.32100.002.52
21681758-168175897.06897.07
31727206-172720699.69199.69
41699355-169935598.08398.08
51798955-1798955103.832103.83
61767708-1767708102.029102.03
15min11727320-172732099.698100.542.5799.86100.712.57
21695040-169504097.83498.00
31739705-1739705100.412100.58
41702773-170277398.28198.44
51812226-1812226104.598104.77
61774642-1774642102.429102.60
30min11724111-172411199.512100.272.5999.84100.602.59
21689195-168919597.49797.82
31735097-1735097100.146100.48
41697340-169734097.96798.29
51807453-1807453104.323104.67
61770173-1770173102.171102.51
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