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100638-202104对照品来源中检院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%
113.481112410111579311124491113709112171411152150.35
213.521113621111474211141820.08
单位质量响应值RSD%判断
82731.0882409.910.28数据可信
中间条件6月-供试品溶液-2025020821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%
5min11292977-1292977102.763102.730.78102.76102.730.78
21293220-1293220102.782102.78
31293008-1293008102.765102.77
41289246-1289246102.466102.47
51277619-1277619101.542101.54
61309027-1309027104.039104.04
10min11310632-1310632104.166103.940.85104.34104.110.84
21306479-1306479103.836104.01
31314333-1314333104.460104.63
41307515-1307515103.918104.09
51287798-1287798102.351102.52
61320081-1320081104.917105.09
15min11306473-1306473103.836103.770.94104.18104.110.94
21304779-1304779103.701104.05
31304105-1304105103.647103.99
41300365-1300365103.350103.69
51290440-1290440102.561102.90
61327428-1327428105.501105.85
30min11291239-1291239102.625103.231.44103.14103.751.44
21301324-1301324103.426103.94
31300837-1300837103.388103.91
41296455-1296455103.039103.56
51273034-1273034101.178101.69
61330493-1330493105.745106.27
极限11301386-1301386103.431103.171.55104.12103.861.54
21284397-1284397102.081102.77
31319464-1319464104.868105.56
41289999-1289999102.526103.21
51271427-1271427101.050101.73
61321909-1321909105.062105.76
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100638-202104对照品来源中检院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%
113.481113058111730611201271118944112031111179490.27
213.521109010111305911110340.26
单位质量响应值RSD%判断
82933.9082177.070.65数据可信
中间条件6月-供试品溶液-NPA3053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%
5min11235142-123514298.18698.820.6498.1998.820.64
21235139-123513998.18698.19
31252049-125204999.53099.53
41243590-124359098.85898.86
51239642-123964298.54498.54
61252913-125291399.59999.60
10min11252293-125229399.54999.780.4699.7199.950.46
21254993-125499399.76499.93
31261976-1261976100.319100.48
41248934-124893499.28299.45
51250964-125096499.44499.61
61262323-1262323100.347100.51
15min11251819-125181999.51299.700.2499.84100.040.24
21253422-125342299.63999.97
31258324-1258324100.029100.36
41252855-125285599.59499.92
51251618-125161899.49699.83
61257360-125736099.952100.29
30min11249012-124901299.28999.640.2599.78100.140.26
21254045-125404599.689100.18
31256518-125651899.885100.39
41253906-125390699.678100.17
51250633-125063399.41799.91
61256748-125674899.903100.40
极限11249720-124972099.34599.520.39100.01100.180.39
21253769-125376999.667100.33
31249449-124944999.32399.99
41249731-124973199.346100.01
51247619-124761999.17899.84
61260880-1260880100.232100.90
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100638-202104对照品来源中检院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%
113.481115408112251011236921122817112483311218520.34
213.521119009112010811195580.07
单位质量响应值RSD%判断
83223.4482807.540.36数据可信
-供试品溶液-NPA3091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%
5min11206794-120679495.39995.950.8495.4095.950.84
21204693-120469395.23395.23
31206239-120623995.35695.36
41220254-122025496.46496.46
51214057-121405795.97495.97
61230723-123072397.29197.29
10min11211529-121152995.77496.550.9395.9396.710.93
21214067-121406795.97496.13
31218379-121837996.31596.47
41215650-121565096.10096.26
51226928-122692896.99197.15
61241874-124187498.17398.33
15min11214393-121439396.00096.430.6196.3296.750.62
21209970-120997095.65195.97
31221568-122156896.56796.89
41219975-121997596.44196.76
51221242-122124296.54296.86
61231873-123187397.38297.71
30min11207437-120743795.45096.220.8695.9396.700.86
21210728-121072895.71096.19
31214191-121419195.98496.46
41214629-121462996.01996.50
51218919-121891996.35896.84
61236769-123676997.76998.26
极限11210679-121067995.70796.070.8196.3496.720.81
21214550-121455096.01396.65
31205887-120588795.32895.97
41209767-120976795.63596.28
51217655-121765596.25896.90
61233426-123342697.50598.16
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100638-202104对照品来源中检院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%
113.481121054110735711145821120145112025411166780.53
213.521111863111525711135600.22
单位质量响应值RSD%判断
82839.6182363.910.41数据可信
-供试品溶液-NPA3091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%
5min11143999-114399990.88991.801.2490.8991.801.24
21146915-114691591.12091.12
31142536-114253690.77290.77
41170983-117098393.03293.03
51175379-117537993.38293.38
61152724-115272491.58291.58
10min11213649-121364996.42296.600.7796.5796.760.77
21210945-121094596.20796.36
31204918-120491895.72895.88
41212006-121200696.29296.45
51230308-123030897.74697.90
61223621-122362197.21497.37
15min11230395-123039597.75397.220.5398.0697.540.52
21218860-121886096.83697.15
31216621-121662196.65896.97
41218543-121854396.81197.13
51228606-122860697.61097.93
61229492-122949297.68198.00
30min11232665-123266597.93397.340.6298.4197.820.62
21218388-121838896.79997.27
31218215-121821596.78597.26
41218527-121852796.81097.29
51233487-123348797.99898.48
61229937-122993797.71698.19
极限11234870-123487098.10897.280.7298.7597.910.72
21230437-123043797.75698.39
31218217-121821796.78597.42
41210553-121055396.17696.81
51225164-122516497.33797.98
61227080-122708097.48998.13
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100638-202104对照品来源中检院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%
113.481110650112206611190361119521111489011172330.41
213.521108574110781811081960.05
单位质量响应值RSD%判断
82880.7981967.160.79数据可信
-供试品溶液-NPA3091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%
5min11228360-122836097.80496.221.1497.8096.221.14
21220275-122027597.16097.16
31190338-119033894.77694.78
41206695-120669596.07996.08
51201240-120124095.64495.64
61203660-120366095.83795.84
10min11249364-124936499.47698.141.1399.6498.301.13
21248304-124830499.39299.55
31235545-123554598.37698.53
41222094-122209497.30597.46
51218526-121852697.02197.18
61221770-122177097.27997.44
15min11248418-124841899.40198.170.9399.7398.490.93
21244991-124499199.12899.46
31225784-122578497.59897.92
41225381-122538197.56697.89
51220432-122043297.17297.49
61232452-123245298.12998.45
30min11245622-124562299.17898.061.1399.6798.541.13
21249898-124989899.518100.01
31222322-122232297.32397.81
41227607-122760797.74498.23
51213706-121370696.63797.12
61230062-123006297.93998.42
极限11245055-124505599.13397.590.8299.7998.240.82
21220258-122025897.15897.82
31226508-122650897.65698.30
41220185-122018597.15397.80
51217693-121769396.95497.60
61224683-122468397.51198.16
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100638-202104对照品来源中检院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%
113.481115284111479611166961120098111785811169460.20
213.521108892110833311086120.04
单位质量响应值RSD%判断
82859.5081997.930.74数据可信
-供试品溶液-NPA3091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%
5min11251053-125105399.60499.020.8999.6099.020.89
21235466-123546698.36398.36
31261498-1261498100.436100.44
41245058-124505899.12799.13
51234519-123451998.28898.29
61234895-123489598.31898.32
10min11258819-1258819100.22399.840.79100.39100.010.79
21244626-124462699.09399.26
31267206-1267206100.890101.06
41254711-125471199.896100.06
51240512-124051298.76598.93
61258292-1258292100.181100.34
15min11256837-1256837100.06599.600.95100.4099.930.95
21238798-123879898.62998.96
31266331-1266331100.821101.16
41254334-125433499.866100.20
51234944-123494498.32298.65
61254464-125446499.876100.21
30min11257872-1257872100.14799.670.86100.65100.170.86
21246036-124603699.20599.70
31268546-1268546100.997101.50
41255269-125526999.940100.44
51240748-124074898.78499.28
61242612-124261298.93299.43
极限11256518-1256518100.03999.270.96100.7199.940.96
21233378-123337898.19798.86
31263641-1263641100.607101.28
41249524-124952499.483100.15
51235264-123526498.34799.00
61243079-124307998.97099.63
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