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%
114.691684366168266716834091682525168523316836400.07
214.861680272168065216804620.02
单位质量响应值RSD%判断
114611.30113086.270.95数据可信
供试品溶液-24061801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%
5min11729822-1729822100.399101.731.14100.40101.731.14
21767571-1767571102.590102.59
31781031-1781031103.371103.37
41746888-1746888101.390101.39
51757668-1757668102.015102.02
61733365-1733365100.605100.60
15min11737472-1737472100.843102.411.29101.01102.581.29
21781581-1781581103.403103.57
31796728-1796728104.282104.45
41761112-1761112102.215102.38
51767961-1767961102.613102.78
61742371-1742371101.127101.30
30min11734592-1734592100.676102.261.39101.01102.601.38
21775647-1775647103.059103.40
31798903-1798903104.409104.75
41761726-1761726102.251102.59
51764093-1764093102.388102.73
61736383-1736383100.780101.12
45min11732172-1732172100.535101.961.32101.04102.471.32
21770233-1770233102.745103.26
31793943-1793943104.121104.64
41753311-1753311101.762102.27
51756726-1756726101.961102.47
61734283-1734283100.658101.16
极限11717103-171710399.661101.201.22100.33101.881.22
21757454-1757454102.003102.69
31775006-1775006103.022103.72
41741678-1741678101.087101.77
51746062-1746062101.342102.02
61724602-1724602100.096100.77
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%
114.691682863168050716811181682518168154016817090.06
214.861673855167696416754100.14
单位质量响应值RSD%判断
114479.85112746.301.08数据可信
供试品溶液-24061801批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min11659874-165987496.54096.351.2396.5496.351.23
21648740-164874095.89395.89
31621026-162102694.28194.28
41665844-166584496.88896.89
51680819-168081997.75997.76
61663330-166333096.74196.74
15min11711815-171181599.56199.741.3399.7299.901.33
21705093-170509399.17099.33
31677901-167790197.58997.75
41729646-1729646100.598100.76
51743911-1743911101.428101.59
61721255-1721255100.110100.27
30min11715757-171575799.791100.011.28100.12100.341.28
21714510-171451099.718100.04
31682998-168299897.88598.21
41732220-1732220100.748101.08
51749051-1749051101.727102.06
61723126-1723126100.219100.55
45min11717680-171768099.90399.891.29100.40100.381.29
21708688-170868899.38099.87
31679131-167913197.66098.14
41730255-1730255100.634101.13
51742823-1742823101.365101.87
61726351-1726351100.407100.90
极限11705004-170500499.16599.161.3499.8299.821.34
21703306-170330699.06699.72
31664017-166401796.78197.43
41714336-171433699.708100.37
51733129-1733129100.801101.47
61709982-170998299.455100.12
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%
114.691676355167784516793221680973167911516787220.11
214.861679354168058516799700.06
单位质量响应值RSD%判断
114276.51113053.160.77数据可信
供试品溶液-24061801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%
5min11828610-1828610106.303103.492.54106.30103.492.54
21742079-1742079101.272101.27
31826945-1826945106.206106.21
41790424-1790424104.083104.08
51777661-1777661103.341103.34
61716030-171603099.75899.76
15min11755770-1755770102.068101.211.03102.25101.381.03
21738793-1738793101.081101.25
31737671-1737671101.016101.19
41765243-1765243102.619102.79
51734645-1734645100.840101.01
61713938-171393899.63799.80
30min11750961-1750961101.789100.980.99102.14101.320.99
21731352-1731352100.649100.99
31734067-1734067100.807101.15
41761373-1761373102.394102.74
51732777-1732777100.732101.07
61712012-171201299.52599.86
45min11744831-1744831101.432100.710.98101.95101.220.98
21729222-1729222100.525101.03
31728590-1728590100.488101.00
41756622-1756622102.118102.63
51727619-1727619100.432100.94
61707223-170722399.24699.74
极限11744021-1744021101.385100.500.98102.07101.180.98
21725059-1725059100.283100.96
31725817-1725817100.327101.01
41751441-1751441101.817102.50
51722643-1722643100.143100.82
61704023-170402399.06099.72
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%
114.691679620168068916809321681538168327316812100.09
214.861682117168397916830480.08
单位质量响应值RSD%判断
114445.88113260.300.74数据可信
供试品溶液-24061801批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min11741475-1741475101.070100.441.70101.07100.441.70
21770590-1770590102.760102.76
31725150-1725150100.122100.12
41732681-1732681100.559100.56
51733178-1733178100.588100.59
61680335-168033597.52197.52
15min11755034-1755034101.857101.371.76102.03101.541.76
21788180-1788180103.780103.95
31744980-1744980101.273101.44
41745095-1745095101.280101.45
51753282-1753282101.755101.92
61693218-169321898.26998.43
30min11751229-1751229101.636101.301.40101.97101.641.40
21785473-1785473103.623103.97
31736376-1736376100.774101.11
41742141-1742141101.108101.44
51747666-1747666101.429101.77
61710114-171011499.25099.58
45min11749577-1749577101.540101.011.37102.05101.511.38
21776111-1776111103.080103.60
31733145-1733145100.586101.09
41737866-1737866100.860101.37
51742757-1742757101.144101.65
61702868-170286898.82999.32
极限11741915-1741915101.095100.781.31101.77101.451.31
21774832-1774832103.006103.69
31727997-1727997100.288100.96
41733437-1733437100.603101.28
51735820-1735820100.742101.42
61704852-170485298.94499.60
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