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%
113.781154416115468811543891154418115389411543610.03
213.781153893115351411537040.03
单位质量响应值RSD%判断
83770.7583723.080.05数据可信
供试品溶液-2024120721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%
5min11244680-124468097.534100.184.2697.53100.184.26
21183443-118344392.73692.74
31321990-1321990103.593103.59
41319032-1319032103.361103.36
51308558-1308558102.540102.54
61292690-1292690101.297101.30
10min11327682-1327682104.039102.773.92104.20102.943.92
21210476-121047694.85495.01
31344748-1344748105.376105.55
41347802-1347802105.615105.79
51328980-1328980104.140104.31
61309549-1309549102.618102.79
15min11350631-1350631105.837102.983.85106.17103.323.85
21215125-121512595.21995.53
31343803-1343803105.302105.65
41337245-1337245104.788105.14
51329071-1329071104.147104.49
61309091-1309091102.582102.92
30min11340525-1340525105.045102.663.95105.56103.173.95
21207050-120705094.58695.06
31341048-1341048105.086105.61
41334290-1334290104.556105.08
51326029-1326029103.909104.43
61311631-1311631102.781103.29
极限11346537-1346537105.516102.733.79106.20103.413.78
21222121-122212195.76796.40
31343086-1343086105.246105.94
41336798-1336798104.753105.45
51335526-1335526104.653105.34
61282164-1282164100.472101.15
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%
113.781153791115415211535661153538115276011535610.05
213.781153757115438811540720.04
单位质量响应值RSD%判断
83712.7083749.780.04数据可信
供试品溶液-2024120721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%
5min1961536-96153675.36175.421.7875.3675.421.78
2944338-94433874.01374.01
3978551-97855176.69576.69
4987049-98704977.36177.36
5952978-95297874.69074.69
6949277-94927774.40074.40
10min11062503-106250383.27483.731.1083.4083.861.10
21089791-108979185.41385.54
31073098-107309884.10584.23
41058473-105847382.95983.09
51060569-106056983.12383.25
61065331-106533183.49683.62
15min11174701-117470192.06892.961.7892.3393.221.77
21222808-122280895.83996.10
31186537-118653792.99693.26
41174210-117421092.03092.30
51163378-116337891.18191.44
61194472-119447293.61893.88
30min11271603-127160399.663100.671.27100.08101.091.27
21308007-1308007102.516102.94
31286826-1286826100.856101.28
41283155-1283155100.568100.99
51262338-126233898.93799.35
61294625-1294625101.467101.89
极限11301016-1301016101.968102.581.06102.55103.171.06
21324093-1324093103.777104.37
31318295-1318295103.322103.91
41307509-1307509102.477103.07
51286218-1286218100.808101.39
61316083-1316083103.149103.74
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%
113.781154960115630311545011155504115542211553380.06
213.781153043115390111534720.06
单位质量响应值RSD%判断
83841.6583706.240.12数据可信
供试品溶液-2024120721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%
5min11294172-1294172101.380101.551.20101.38101.551.20
21302258-1302258102.014102.01
31267483-126748399.28999.29
41311757-1311757102.758102.76
51296319-1296319101.548101.55
61305743-1305743102.287102.29
10min11324463-1324463103.753102.771.27103.92102.941.28
21319234-1319234103.343103.51
31286624-1286624100.789100.95
41332064-1332064104.348104.52
51301002-1301002101.915102.08
61308397-1308397102.494102.66
15min11325273-1325273103.816102.741.20104.16103.081.20
21317170-1317170103.182103.52
31289577-1289577101.020101.35
41330375-1330375104.216104.56
51299025-1299025101.760102.10
61308156-1308156102.476102.82
30min11319084-1319084103.332102.431.18103.85102.941.18
21313903-1313903102.926103.44
31284019-1284019100.585101.09
41325856-1325856103.862104.38
51296549-1296549101.566102.07
61306281-1306281102.329102.84
极限11315587-1315587103.058102.450.96103.74103.130.96
21313021-1313021102.857103.54
31290226-1290226101.071101.74
41325284-1325284103.817104.51
51301312-1301312101.939102.62
61301416-1301416101.948102.63
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%
113.781154523115360511551271154298115329411541690.07
213.781153239115441411538260.08
单位质量响应值RSD%判断
83756.8283731.930.03数据可信
供试品溶液-2024120721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%
5min11275670-127567099.966102.361.2499.97102.361.24
21322524-1322524103.638103.64
31313128-1313128102.901102.90
41311200-1311200102.750102.75
51311244-1311244102.754102.75
61303912-1303912102.179102.18
10min11304665-1304665102.238104.100.93102.40104.270.93
21336500-1336500104.733104.91
31338607-1338607104.898105.07
41332707-1332707104.436104.61
51329974-1329974104.221104.39
61328325-1328325104.092104.26
15min11305173-1305173102.278103.880.78102.61104.220.78
21333331-1333331104.484104.83
31329989-1329989104.223104.57
41330355-1330355104.251104.60
51327498-1327498104.027104.37
61327134-1327134103.999104.34
30min11300511-1300511101.913103.580.82102.42104.090.82
21329562-1329562104.189104.71
31323860-1323860103.742104.26
41328300-1328300104.090104.61
51326200-1326200103.926104.44
61321948-1321948103.592104.11
极限11296434-1296434101.593103.300.85102.27103.980.85
21327403-1327403104.020104.71
31323885-1323885103.744104.44
41322684-1322684103.650104.34
51320043-1320043103.443104.13
61318582-1318582103.329104.02
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