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100638-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)87.5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%
113.761166545116416411602361157476115988411616610.32
213.741155919115998011579500.25
单位质量响应值RSD%判断
84423.0484275.840.13数据可信
供试品溶液-2025020821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%
5min11289420-1289420100.319101.701.13100.32101.701.13
21302285-1302285101.320101.32
31308135-1308135101.775101.77
41294657-1294657100.726100.73
51324219-1324219103.026103.03
61324250-1324250103.029103.03
10min11287626-1287626100.179102.121.20100.35102.291.20
21307734-1307734101.744101.91
31312311-1312311102.100102.27
41309817-1309817101.906102.07
51324431-1324431103.043103.21
61333604-1333604103.756103.93
15min11295855-1295855100.819102.431.19101.15102.761.19
21308032-1308032101.767102.11
31314459-1314459102.267102.61
41312459-1312459102.111102.45
51327955-1327955103.317103.66
61340210-1340210104.270104.61
30min11290859-1290859100.431102.261.17100.93102.771.17
21308150-1308150101.776102.28
31316508-1316508102.426102.94
41308636-1308636101.814102.32
51330702-1330702103.530104.05
61331137-1331137103.564104.08
极限11288074-1288074100.214101.971.13100.88102.651.13
21304634-1304634101.502102.18
31313304-1313304102.177102.86
41305379-1305379101.560102.24
51322784-1322784102.914103.60
61329768-1329768103.458104.15
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100638-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)87.5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%
113.761165084115984211623231163038116343911627450.17
213.741156865116061711587410.23
单位质量响应值RSD%判断
84501.8284333.410.15数据可信
供试品溶液-2025020821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%
5min11285846-128584699.960100.571.7199.96100.581.71
21321133-1321133102.703102.70
31277953-127795399.34699.35
41267446-126744698.52998.53
51319780-1319780102.598102.60
61290300-1290300100.306100.31
10min11289019-1289019100.207100.731.50100.37100.901.50
21299665-1299665101.034101.21
31294847-1294847100.660100.83
41274637-127463799.08899.25
51331301-1331301103.493103.66
61285374-128537499.923100.09
15min11297151-1297151100.839101.331.39101.17101.671.39
21308556-1308556101.725102.06
31306898-1306898101.596101.93
41283931-128393199.811100.14
51334676-1334676103.756104.10
61289724-1289724100.261100.60
30min11291784-1291784100.421101.011.62100.92101.521.62
21298217-1298217100.922101.43
31303684-1303684101.347101.85
41272513-127251398.92399.42
51336530-1336530103.900104.42
61293482-1293482100.553101.05
极限11290830-1290830100.347100.611.45101.02101.281.45
21295115-1295115100.680101.36
31291342-1291342100.387101.06
41274883-127488399.10899.77
51329502-1329502103.354104.04
61283597-128359799.785100.45
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100638-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)87.5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%
113.761159922115825711608941159996116043711599010.09
213.741158863115843611586500.03
单位质量响应值RSD%判断
84295.1384326.780.03数据可信
供试品溶液-NPA3080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%
5min11262882-126288298.29998.281.3598.3098.281.35
21269185-126918598.78998.79
31282162-128216299.79999.80
41241319-124131996.62096.62
51276683-127668399.37399.37
61243553-124355396.79496.79
10min11269609-126960998.82298.191.0998.9998.351.09
21272265-127226599.02999.19
31262969-126296998.30698.47
41257679-125767997.89498.05
51270589-127058998.89999.06
61235738-123573896.18696.35
15min11283276-128327699.88698.341.21100.2198.661.21
21269550-126955098.81899.15
31258899-125889997.98998.32
41257845-125784597.90798.23
51272010-127201099.00999.34
61238756-123875696.42196.74
30min11268626-126862698.74697.900.9999.2498.390.99
21265572-126557298.50899.00
31256272-125627297.78498.28
41252809-125280997.51598.00
51267119-126711998.62999.12
61235996-123599696.20696.69
极限11266032-126603298.54497.801.0099.2098.451.00
21265926-126592698.53699.19
31253642-125364297.58098.24
41252855-125285597.51898.17
51265714-126571498.51999.18
61234308-123430896.07596.72
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100638-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)87.5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%
113.761158387115532611598871156907115828811577590.15
213.741153989115385011539200.01
单位质量响应值RSD%判断
84139.4683982.530.14数据可信
供试品溶液-NPA3080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%
5min11289316-1289316100.65597.961.74100.6597.961.74
21242261-124226196.98196.98
31269941-126994199.14299.14
41257528-125752898.17398.17
51233173-123317396.27296.27
61236628-123662896.54296.54
10min11268977-126897799.06798.070.8999.2398.230.89
21245898-124589897.26597.43
31270239-127023999.16599.33
41256650-125665098.10598.27
51248105-124810597.43897.60
61247198-124719897.36797.53
15min11263476-126347698.63897.940.7298.9798.270.72
21245232-124523297.21397.54
31266468-126646898.87199.20
41254764-125476497.95798.28
51252297-125229797.76598.09
61245352-124535297.22397.55
30min11260050-126005098.37097.720.6698.8798.210.66
21239979-123997996.80397.29
31262061-126206198.52799.02
41249596-124959697.55498.04
51251397-125139797.69598.18
61247454-124745497.38797.87
极限11255799-125579998.03897.570.6798.7098.230.67
21239670-123967096.77997.43
31263070-126307098.60699.27
41248057-124805797.43498.09
51247977-124797797.42898.08
61244566-124456697.16197.81
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