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%
113.481120162112085611205121121137112068611206710.04
213.521124275112499311246340.05
单位质量响应值RSD%判断
83135.8383182.990.05数据可信
中间条件6月-供试品溶液-2025020621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%
5min11253691-125369198.93598.441.6398.9398.441.63
21273887-1273887100.528100.53
31218322-121832296.14496.14
41238889-123888997.76797.77
51263601-126360199.71799.72
61236334-123633497.56597.56
10min11283869-1283869101.316101.001.21101.48101.171.21
21301659-1301659102.720102.89
31266816-126681699.970100.13
41269455-1269455100.179100.34
51293275-1293275102.058102.22
61264343-126434399.77599.94
15min11271457-1271457100.337100.671.52100.67101.001.52
21302801-1302801102.810103.15
31252548-125254898.84499.17
41274034-1274034100.540100.87
51293368-1293368102.066102.40
61259638-125963899.40499.73
30min11270443-1270443100.257100.601.53100.76101.101.53
21303182-1303182102.840103.35
31259567-125956799.39899.89
41267464-1267464100.022100.52
51293926-1293926102.110102.62
61254195-125419598.97499.47
极限11268475-1268475100.101100.531.44100.77101.201.44
21299566-1299566102.555103.24
31252878-125287898.87199.53
41275864-1275864100.684101.35
51289849-1289849101.788102.46
61256772-125677299.17899.84
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%
113.481123912112513411236251124201112412811242000.06
213.521125261112465311249570.04
单位质量响应值RSD%判断
83397.6383206.880.17数据可信
中间条件6月-供试品溶液-2025020721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%
5min11250588-125058898.52199.444.9998.5299.444.99
21233181-123318197.14997.15
31329076-1329076104.704104.70
41332663-1332663104.987104.99
51165169-116516991.79191.79
61262567-126256799.46499.46
10min11263561-126356199.543102.183.5699.71102.353.56
21287819-1287819101.454101.62
31347803-1347803106.179106.35
41357738-1357738106.962107.14
51242829-124282997.90998.06
61282440-1282440101.030101.20
15min11262404-126240499.452102.543.1099.78102.883.10
21284301-1284301101.177101.51
31346511-1346511106.077106.43
41358337-1358337107.009107.36
51275793-1275793100.506100.82
61282424-1282424101.029101.36
30min11263695-126369599.553102.513.09100.05103.023.09
21285599-1285599101.279101.78
31344347-1344347105.907106.44
41359169-1359169107.075107.61
51277059-1277059100.606101.09
61277153-1277153100.613101.12
极限11262982-126298299.497102.312.84100.16102.982.85
21284143-1284143101.164101.83
31342181-1342181105.736106.44
41348461-1348461106.231106.94
51277589-1277589100.648101.30
61276575-1276575100.568101.24
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%
113.481123801112410411233691122360112338211234030.06
213.521120903112116711210350.02
单位质量响应值RSD%判断
83338.5082916.790.36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%
5min11230295-123029597.12697.280.3497.1397.280.34
21227337-122733796.89396.89
31236066-123606697.58297.58
41231157-123115797.19497.19
51238399-123839997.76697.77
61230304-123030497.12797.13
10min11240444-124044497.92798.100.4298.0998.260.42
21238329-123832997.76097.92
31248788-124878898.58698.75
41249577-124957798.64898.81
51240098-124009897.90098.06
61238220-123822097.75297.91
15min11239092-123909297.82198.100.5898.1598.420.58
21234520-123452097.46097.78
31250832-125083298.74799.07
41249342-124934298.63098.96
51235351-123535197.52597.85
61246552-124655298.41098.73
30min11234718-123471897.47597.780.4697.9698.270.45
21235187-123518797.51298.00
31245933-124593398.36198.85
41245724-124572498.34498.83
51235412-123541297.53098.02
61234774-123477497.48097.97
极限11235516-123551697.53897.570.4198.1998.220.41
21230432-123043297.13797.79
31240713-124071397.94998.60
41243265-124326598.15098.80
51233034-123303497.34297.99
61232389-123238997.29197.94
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%
113.481121992112280511215801121397112152111218590.06
213.521122291112233111223110.01
单位质量响应值RSD%判断
83223.9683011.170.19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%
5min11172810-117281092.59992.491.7392.6092.491.73
21167683-116768392.19492.19
31134968-113496889.61189.61
41186683-118668393.69493.69
51173605-117360592.66192.66
61192835-119283594.18094.18
10min11214350-121435095.87896.401.2396.0396.551.23
21221221-122122196.42196.57
31194916-119491694.34494.49
41234311-123431197.45497.61
51226291-122629196.82196.98
61234714-123471497.48697.64
15min11250052-125005298.69797.371.3199.0197.691.30
21233543-123354397.39497.71
31202755-120275594.96395.27
41240762-124076297.96498.28
51235871-123587197.57897.89
61236628-123662897.63797.96
30min11219922-121992296.31896.871.0196.8097.341.01
21226740-122674096.85797.33
31205667-120566795.19395.66
41236959-123695997.66498.15
51235677-123567797.56298.04
61236151-123615197.60098.08
极限11215684-121568495.98496.971.1896.6297.601.18
21236739-123673997.64698.28
31204524-120452495.10395.73
41237766-123776697.72798.37
51237328-123732897.69398.33
61236801-123680197.65198.30
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%
113.481119312111957811187581118966111965611192540.04
213.521116448111772011170840.09
单位质量响应值RSD%判断
83030.7182624.560.35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%
5min11215922-121592296.33996.610.8996.3496.610.89
21217168-121716896.43896.44
31202168-120216895.24995.25
41234879-123487997.84197.84
51221029-122102996.74496.74
61224784-122478497.04197.04
10min11231893-123189397.60497.850.7597.7798.010.75
21240756-124075698.30798.47
31219517-121951796.62496.78
41233553-123355397.73697.90
51237572-123757298.05498.22
61246515-124651598.76398.92
15min11245134-124513498.65498.050.8498.9898.380.84
21242014-124201498.40698.73
31218546-121854696.54796.87
41233946-123394697.76798.09
51238925-123892598.16298.49
61246490-124649098.76199.09
30min11231519-123151997.57597.780.7598.0698.270.75
21242942-124294298.48098.97
31218369-121836996.53397.01
41232128-123212897.62398.11
51236744-123674497.98998.48
61242965-124296598.48298.97
极限11231910-123191097.60697.680.9298.2698.330.92
21247040-124704098.80599.46
31213936-121393696.18296.82
41228627-122862797.34698.00
51235669-123566997.90498.56
61239569-123956998.21398.87
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%
113.481114784111489211144191114217111303011142680.07
213.521116237111502311156300.08
单位质量响应值RSD%判断
82660.8382517.010.13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%
5min11230663-123066397.78899.351.2397.7999.351.23
21244978-124497898.92698.93
31253918-125391899.63699.64
41238608-123860898.42098.42
51272657-1272657101.125101.13
61261036-1261036100.202100.20
10min11243109-124310998.777100.261.3598.94100.421.34
21251329-125132999.43099.60
31265904-1265904100.589100.75
41248924-124892499.23999.40
51286759-1286759102.246102.41
61274652-1274652101.284101.45
15min11241368-124136898.639100.051.3198.97100.391.31
21250917-125091799.39899.73
31263250-1263250100.378100.71
41245428-124542898.96299.29
51284914-1284914102.099102.44
61269119-1269119100.844101.18
30min11239165-123916598.46499.861.2798.96100.361.27
21249030-124903099.24899.74
31261932-1261932100.273100.77
41243582-124358298.81599.31
51281799-1281799101.852102.36
61265066-1265066100.522101.03
极限11237664-123766498.34599.671.2899.00100.341.28
21247327-124732799.11299.77
31257950-125795099.957100.62
41238973-123897398.44999.11
51278239-1278239101.569102.25
61265906-1265906100.589101.26
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