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%
114.691673656167419316746621677212167393916747320.09
214.861674833167562316752280.04
单位质量响应值RSD%判断
114004.90112734.050.80数据可信
供试品溶液-24061802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%
5min11689161-168916198.45299.441.5098.4599.441.50
21733778-1733778101.053101.05
31674798-167479897.61597.62
41710993-171099399.72599.72
51690725-169072598.54398.54
61737020-1737020101.242101.24
15min11696593-169659398.885100.171.6499.05100.331.63
21752168-1752168102.125102.29
31683940-168394098.14898.31
41726373-1726373100.621100.79
51704541-170454199.34999.51
61747833-1747833101.872102.04
30min11696551-169655198.883100.101.4799.21100.441.47
21748297-1748297101.899102.24
31685868-168586898.26098.59
41724579-1724579100.517100.85
51707064-170706499.49699.83
61742611-1742611101.568101.91
45min11690491-169049198.53099.801.5599.02100.301.55
21745444-1745444101.733102.24
31679756-167975697.90498.39
41719244-1719244100.206100.71
51700205-170020599.09699.59
61738348-1738348101.319101.83
极限11684741-168474198.19599.571.6098.85100.241.60
21741724-1741724101.516102.19
31675499-167549997.65698.31
41716141-1716141100.025100.69
51695931-169593198.84799.51
61735977-1735977101.181101.86
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%
114.691675498167612716755681673837167440516750870.06
214.861666259166234016643000.17
单位质量响应值RSD%判断
114029.07111998.651.28数据可信
供试品溶液-24061901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%
5min11702372-170237299.53999.286.7099.5499.286.70
21676236-167623698.01198.01
31633804-163380495.53095.53
41528933-152893389.39889.40
51817373-1817373106.264106.26
61829388-1829388106.966106.97
15min11822974-1822974106.591107.310.96106.76107.480.97
21833091-1833091107.183107.35
31829291-1829291106.960107.12
41822958-1822958106.590106.74
51833933-1833933107.232107.41
61869846-1869846109.332109.51
30min11819272-1819272106.375107.531.00106.72107.871.00
21834773-1834773107.281107.62
31840291-1840291107.604107.94
41840467-1840467107.614107.94
51826749-1826749106.812107.17
61872402-1872402109.481109.84
45min11814352-1814352106.087107.160.92106.61107.680.92
21829783-1829783106.989107.51
31830020-1830020107.003107.52
41831955-1831955107.116107.62
51825782-1825782106.755107.29
61864331-1864331109.009109.55
极限11814733-1814733106.109107.090.87106.81107.790.87
21827031-1827031106.828107.53
31827971-1827971106.883107.58
41831466-1831466107.088107.77
51825842-1825842106.759107.47
61861741-1861741108.858109.58
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%
114.691674284167392616746421675016167472416745180.03
214.861671926167245016721880.03
单位质量响应值RSD%判断
113990.33112529.480.92数据可信
供试品溶液-24061902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%
5min11699222-169922299.13599.930.7599.1499.930.75
21705810-170581099.52099.52
31714837-1714837100.046100.05
41734817-1734817101.212101.21
51704679-170467999.45499.45
61717546-1717546100.205100.20
15min11723439-1723439100.548100.940.61100.71101.110.61
21721159-1721159100.415100.58
31730591-1730591100.966101.13
41750442-1750442102.124102.29
51726071-1726071100.702100.87
61729380-1729380100.895101.06
30min11715991-1715991100.114100.730.67100.45101.060.67
21722078-1722078100.469100.80
31727339-1727339100.776101.11
41747991-1747991101.981102.32
51718590-1718590100.265100.60
61727057-1727057100.759101.09
45min11708245-170824599.662100.420.78100.16100.920.78
21717692-1717692100.213100.71
31723753-1723753100.567101.07
41746227-1746227101.878102.39
51712964-171296499.937100.44
61718828-1718828100.279100.78
极限11706664-170666499.570100.160.76100.24100.830.76
21710563-171056399.797100.46
31712250-171225099.896100.57
41742372-1742372101.653102.33
51711512-171151299.853100.52
61717178-1717178100.183100.85
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%
114.691674237167282716743381675839167382416742130.07
214.861663604166269116631480.04
单位质量响应值RSD%判断
113969.57111921.131.29数据可信
供试品溶液-24062501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%
5min11721551-1721551100.722100.520.29100.72100.520.29
21726286-1726286100.999101.00
31714108-1714108100.287100.29
41715104-1715104100.345100.34
51714351-1714351100.301100.30
61717574-1717574100.489100.49
15min11733619-1733619101.428101.690.37101.60101.860.37
21748939-1748939102.324102.49
31735876-1735876101.560101.73
41735406-1735406101.533101.70
51732596-1732596101.368101.54
61742644-1742644101.956102.12
30min11730824-1730824101.265101.460.30101.60101.800.30
21743085-1743085101.982102.32
31733045-1733045101.394101.73
41734147-1734147101.459101.80
51727959-1727959101.097101.43
61735826-1735826101.557101.89
45min11719264-1719264100.588101.160.60101.09101.660.60
21736578-1736578101.601102.11
31723651-1723651100.845101.35
41743996-1743996102.035102.54
51718129-1718129100.522101.03
61732379-1732379101.356101.86
极限11716051-1716051100.400100.940.71101.07101.610.70
21742759-1742759101.963102.64
31713456-1713456100.248100.92
41735149-1735149101.518102.19
51715612-1715612100.375101.05
61728384-1728384101.122101.80
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