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%
113.761157183115622811550121156003115450811557870.10
213.741153765115196511528650.12
单位质量响应值RSD%判断
83996.1583905.750.08数据可信
供试品溶液-2025020621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%
5min11045231-104523181.70680.282.0081.7180.282.00
21009542-100954278.91778.92
31019493-101949379.69479.69
41004928-100492878.55678.56
51057393-105739382.65782.66
61025562-102556280.16980.17
10min11165539-116553991.11189.561.2891.2589.691.28
21134665-113466588.69888.83
31141875-114187589.26189.39
41129755-112975588.31488.44
51161617-116161790.80490.94
61140469-114046989.15189.28
15min11221870-122187095.51494.640.8295.8094.920.82
21207888-120788894.42194.70
31208739-120873994.48894.77
41198587-119858793.69493.97
51223363-122336395.63195.92
61203831-120383194.10494.39
30min11264427-126442798.84199.120.5699.2999.560.56
21268696-126869699.17599.61
31266760-126676099.02399.46
41259413-125941398.44998.88
51280541-1280541100.101100.55
61268518-126851899.16199.60
极限11271371-127137199.38499.890.67100.00100.500.67
21271999-127199999.433100.04
31275169-127516999.681100.28
41271287-127128799.37799.98
51290655-1290655100.891101.51
61286469-1286469100.564101.17
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%
113.761153754115341111539231153064115345811535220.03
213.741155446115611511557800.05
单位质量响应值RSD%判断
83831.5484117.900.25数据可信
供试品溶液-2025020621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%
5min11057700-105770082.65883.041.1882.6683.041.18
21058658-105865882.73382.73
31043030-104303081.51181.51
41074330-107433083.95883.96
51064780-106478083.21183.21
61077319-107731984.19184.19
10min11179272-117927292.15992.070.5892.3092.200.58
21170798-117079891.49691.63
31177522-117752292.02292.16
41190203-119020393.01393.15
51177958-117795892.05692.19
61172910-117291091.66191.80
15min11236115-123611596.60196.410.5796.8996.700.57
21226930-122693095.88396.17
31239528-123952896.86897.16
41242064-124206497.06697.36
51232980-123298096.35696.65
61224264-122426495.67595.97
30min11276091-127609199.72599.530.78100.1899.980.77
21269836-126983699.23699.69
31286721-1286721100.556101.01
41273106-127310699.49299.95
51278531-127853199.916100.37
61257305-125730598.25798.71
极限11283324-1283324100.29099.900.67100.91100.520.67
21275013-127501399.641100.26
31290498-1290498100.851101.47
41278469-127846999.911100.53
51278081-127808199.880100.50
61264857-126485798.84799.46
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%
113.761152866115505011547711156147115677911551230.13
213.741154415115156011529880.18
单位质量响应值RSD%判断
83947.8983914.700.03数据可信
供试品溶液-2025020721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%
5min11145591-114559189.57390.611.1889.5790.611.18
21160486-116048690.73790.74
31181174-118117492.35592.35
41144062-114406289.45389.45
51158288-115828890.56590.57
61163840-116384090.99991.00
10min11231829-123182996.31597.351.1796.4697.501.17
21257865-125786598.35198.50
31267325-126732599.09199.24
41232168-123216896.34296.49
51238158-123815896.81096.96
61242784-124278497.17297.32
15min11271013-127101399.379100.341.1999.69100.651.19
21301687-1301687101.778102.09
31303148-1303148101.892102.21
41268821-126882199.20899.52
51277662-127766299.899100.21
61277191-127719199.862100.18
30min11284776-1284776100.455101.581.33100.93102.061.33
21318283-1318283103.075103.56
31323961-1323961103.519104.01
41287733-1287733100.686101.16
51289050-1289050100.789101.27
61291244-1291244100.961101.44
极限11285249-1285249100.492101.531.28101.14102.181.28
21315720-1315720102.875103.53
31323416-1323416103.477104.14
41287597-1287597100.676101.32
51289501-1289501100.825101.47
61289462-1289462100.822101.47
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%
113.761153251115358311536211153346115317811533960.02
213.741152240115264511524420.03
单位质量响应值RSD%判断
83822.3883874.960.05数据可信
供试品溶液-2025020721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%
5min11181098-118109892.44090.851.8192.4490.851.81
21144463-114446389.57389.57
31130325-113032588.46688.47
41181396-118139692.46392.46
51154874-115487490.38790.39
61172329-117232991.75491.75
10min11265584-126558499.05297.221.5499.2197.371.54
21226467-122646795.99196.14
31214935-121493595.08895.24
41254959-125495998.22198.37
51238453-123845396.92997.08
61252340-125234098.01698.17
15min11309023-1309023102.452100.431.46102.77100.741.46
21266472-126647299.12299.43
31260344-126034498.64298.95
41294277-1294277101.298101.62
51275548-127554899.832100.14
61293357-1293357101.226101.54
30min11326895-1326895103.851101.811.42104.34102.301.42
21287893-1287893100.798101.27
31277752-1277752100.005100.47
41307659-1307659102.345102.83
51291215-1291215101.058101.54
61313879-1313879102.832103.32
极限11329146-1329146104.027101.751.47104.69102.401.47
21288791-1288791100.869101.51
31276024-127602499.869100.51
41307861-1307861102.361103.02
51288954-1288954100.881101.53
61309473-1309473102.487103.14
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%
113.761156095115626611556981157289115462311559940.09
213.741154439115494011546900.04
单位质量响应值RSD%判断
84011.1984038.570.03数据可信
供试品溶液-NPA3080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%
5min11290527-1290527100.793100.780.71100.79100.780.71
21297037-1297037101.301101.30
31286544-1286544100.481100.48
41304693-1304693101.899101.90
51282492-1282492100.165100.17
61280808-1280808100.033100.03
10min11297864-1297864101.366101.350.63101.53101.520.63
21303905-1303905101.837102.01
31293786-1293786101.047101.21
41309913-1309913102.307102.48
51293725-1293725101.042101.21
61287029-1287029100.519100.69
15min11293997-1293997101.064101.160.60101.40101.500.60
21300077-1300077101.538101.88
31293748-1293748101.044101.38
41307330-1307330102.105102.45
51291918-1291918100.901101.24
61284705-1284705100.338100.67
30min11291736-1291736100.887100.900.58101.39101.400.58
21295655-1295655101.193101.70
31288817-1288817100.659101.16
41303558-1303558101.810102.32
51290074-1290074100.757101.26
61281355-1281355100.076100.58
极限11287048-1287048100.521100.650.60101.19101.330.60
21292501-1292501100.947101.62
31287108-1287108100.526101.20
41301455-1301455101.646102.33
51285436-1285436100.395101.07
61278806-127880699.877100.55
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