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%
113.781149295114853511493381149322114704011487060.09
213.781148783114454311466630.27
单位质量响应值RSD%判断
83360.3883212.120.13数据可信
供试品溶液-NBA3053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%
5min11275717-1275717100.52098.653.03100.5298.653.03
21259911-125991199.27499.27
31249579-124957998.46098.46
41286615-1286615101.378101.38
51260521-126052199.32299.32
61179367-117936792.92892.93
10min11282766-1282766101.075100.501.17101.24100.661.17
21265996-126599699.75499.92
31256831-125683199.03199.20
41299347-1299347102.382102.55
51269383-1269383100.021100.19
61278193-1278193100.715100.87
15min11278285-1278285100.722100.671.58101.06101.001.57
21312678-1312678103.432103.76
31254987-125498798.88699.22
41285476-1285476101.289101.63
51266314-126631499.779100.11
61267973-126797399.909100.23
30min11275672-1275672100.51699.990.93101.02100.490.92
21262837-126283799.505100.01
31252135-125213598.66199.16
41285696-1285696101.306101.81
51264331-126433199.622100.12
61273100-1273100100.313100.80
极限11283758-1283758101.15399.701.25101.82100.361.25
21262199-126219999.454100.12
31247376-124737698.28698.94
41284844-1284844101.239101.92
51251742-125174298.63099.30
61261940-126194099.434100.09
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%
113.781147897114826911476001148257114898211482010.05
213.781147484114715011473170.03
单位质量响应值RSD%判断
83323.7383259.580.06数据可信
供试品溶液-NBA3053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%
5min11151667-115166790.73994.784.8590.7494.784.85
21118616-111861688.13588.14
31209179-120917995.27195.27
41230393-123039396.94296.94
51279073-1279073100.777100.78
61228900-122890096.82496.82
10min11154039-115403990.92695.293.0091.0895.453.00
21174508-117450892.53992.69
31224059-122405996.44396.60
41235974-123597497.38297.54
51242577-124257797.90298.07
61225290-122529096.54096.70
15min11203175-120317594.79797.862.2095.1098.182.21
21211506-121150695.45495.75
31256034-125603498.96299.28
41257848-125784899.10599.43
51266899-126689999.818100.15
61256924-125692499.03299.35
30min11248771-124877198.39099.691.0898.85100.171.09
21248180-124818098.34398.80
31270622-1270622100.112100.60
41268638-126863899.955100.44
51280060-1280060100.855101.35
61275294-1275294100.480100.97
极限11247698-124769898.305100.191.1298.93100.841.12
21267619-126761999.875100.50
31276364-1276364100.564101.22
41267702-126770299.882100.54
51284775-1284775101.227101.89
61285726-1285726101.302101.96
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%
113.781149268114801611493271147980114770611484590.07
213.781147328114995911486440.17
单位质量响应值RSD%判断
83342.4583355.880.02数据可信
供试品溶液-NBA3053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%
5min11314210-1314210103.474102.232.20103.47102.232.20
21314699-1314699103.513103.51
31259653-125965399.17999.18
41270301-1270301100.017100.02
51297691-1297691102.174102.17
61333828-1333828105.019105.02
10min11271312-1271312100.09799.290.81100.2799.460.81
21264206-126420699.53799.71
31244639-124463997.99798.16
41264477-126447799.55999.73
51253111-125311198.66498.83
61268517-126851799.877100.05
15min11274740-1274740100.36799.451.08100.7199.791.08
21271389-1271389100.103100.44
31246398-124639898.13598.46
41274142-1274142100.320100.65
51245458-124545898.06198.40
61266745-126674599.737100.08
30min11269946-126994699.98999.150.60100.5099.650.60
21258981-125898199.12699.63
31249974-124997498.41798.91
41264260-126426099.542100.04
51251956-125195698.57399.07
61260283-126028399.22899.74
极限11273092-1273092100.23798.920.98100.9199.590.98
21259385-125938599.15899.83
31245282-124528298.04798.70
41260685-126068599.26099.93
51239146-123914697.56498.23
61260614-126061499.25499.93
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%
113.781147123114979511482631148739114825811484360.09
213.781144760114630311455320.10
单位质量响应值RSD%判断
83340.7883130.040.18数据可信
供试品溶液-NBA3053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%
5min11279329-1279329100.866100.880.42100.87100.880.42
21285564-1285564101.357101.36
31275241-1275241100.544100.54
41278608-1278608100.809100.81
51285751-1285751101.372101.37
61272524-1272524100.329100.33
10min11288375-1288375101.579101.450.55101.75101.620.55
21292932-1292932101.938102.11
31281427-1281427101.031101.20
41282177-1282177101.090101.26
51296302-1296302102.204102.37
61278965-1278965100.837101.00
15min11281847-1281847101.064101.130.54101.40101.470.54
21291119-1291119101.795102.13
31277986-1277986100.760101.10
41281423-1281423101.031101.37
51290160-1290160101.720102.06
61273608-1273608100.415100.75
30min11281486-1281486101.036100.940.57101.54101.440.57
21287083-1287083101.477101.99
31275000-1275000100.525101.03
41278811-1278811100.825101.33
51288949-1288949101.624102.13
61269991-1269991100.130100.63
极限11281437-1281437101.032100.940.73101.71101.610.73
21295672-1295672102.154102.83
31272513-1272513100.328101.00
41278519-1278519100.802101.47
51284005-1284005101.235101.91
61269375-1269375100.081100.75
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