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%
113.781147945114215711514761150139114664911476730.32
213.781146980114501311459960.13
单位质量响应值RSD%判断
83285.4183163.720.11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%
5min11266817-126681799.89299.182.5699.8999.182.56
21197739-119773994.44594.45
31273297-1273297100.403100.40
41259206-125920699.29299.29
51256906-125690699.11199.11
61292788-1292788101.940101.94
10min11278050-1278050100.778100.272.07100.94100.432.07
21223882-122388296.50796.66
31284476-1284476101.285101.45
41268508-1268508100.026100.19
51271970-1271970100.299100.46
61302541-1302541102.709102.88
15min11276608-1276608100.664100.152.08101.00100.482.08
21224259-122425996.53696.85
31277806-1277806100.759101.09
41270649-1270649100.194100.53
51266085-126608599.835100.17
61305288-1305288102.926103.27
30min11282250-1282250101.10999.872.18101.61100.372.18
21214170-121417095.74196.22
31275435-1275435100.572101.08
41267547-126754799.950100.45
51266427-126642799.862100.36
61293407-1293407101.989102.50
极限11265163-126516399.76299.511.94100.43100.181.94
21216662-121666295.93796.58
31277155-1277155100.707101.38
41267101-126710199.915100.58
51258551-125855199.24099.91
61287218-1287218101.501102.18
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%
113.781139888113552811461951144679114197911416540.37
213.781143093113780111404470.33
单位质量响应值RSD%判断
82848.6282761.030.08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%
5min11117449-111744988.56192.993.6088.5692.993.60
21143685-114368590.64090.64
31173291-117329192.98692.99
41195731-119573194.76594.76
51239603-123960398.24298.24
61170208-117020892.74292.74
10min11141413-114141390.46094.964.1290.6195.114.12
21134198-113419889.88890.04
31227416-122741697.27697.43
41220680-122068096.74296.90
51256100-125610099.54999.71
61209016-120901695.81895.97
15min11186961-118696194.07097.303.1394.3797.613.13
21178357-117835793.38893.69
31255442-125544299.49799.81
41235654-123565497.92998.25
51276557-1276557101.171101.50
61233325-123332597.74498.06
30min11216267-121626796.39299.002.2696.8599.482.27
21220447-122044796.72497.18
31266749-1266749100.393100.88
41247914-124791498.90099.38
51290998-1290998102.315102.81
61252609-125260999.27399.75
极限11244061-124406198.59599.911.6699.21100.551.67
21230421-123042197.51498.13
31274288-1274288100.991101.64
41262703-1262703100.073100.72
51288719-1288719102.134102.80
61263578-1263578100.142100.78
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%
113.781145959114368711484831143884114769211459410.19
213.781141568114354111425540.13
单位质量响应值RSD%判断
83159.7282913.930.21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%
5min11248287-124828798.654100.343.3598.65100.343.35
21208909-120890995.54295.54
31270627-1270627100.419100.42
41325835-1325835104.783104.78
51255587-125558799.23199.23
61308505-1308505103.413103.41
10min11245950-124595098.46999.771.0198.6399.941.01
21252366-125236698.97699.14
31256248-125624899.28399.45
41273077-1273077100.613100.79
51269421-1269421100.324100.49
61277681-1277681100.977101.15
15min11251624-125162498.91899.731.1099.25100.071.10
21240975-124097598.07698.40
31263681-126368199.870100.20
41271930-1271930100.522100.86
51264178-126417899.910100.24
61279360-1279360101.110101.45
30min11245462-124546298.43199.540.9598.92100.040.95
21243537-124353798.27898.77
31262464-126246499.774100.27
41266265-1266265100.075100.58
51268394-1268394100.243100.74
61270730-1270730100.428100.94
极限11248208-124820898.64899.681.1699.31100.351.16
21245390-124539098.42599.08
31257708-125770899.398100.06
41267496-1267496100.172100.85
51263791-126379199.879100.55
61285271-1285271101.577102.25
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%
113.781143894114618311394771146818114224011437220.27
213.781143060114026411416620.18
单位质量响应值RSD%判断
82998.6982849.200.13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%
5min11255694-125569499.37499.710.5099.3799.710.50
21256776-125677699.46099.46
31259443-125944399.67199.67
41254997-125499799.31999.32
51261134-126113499.80599.80
61271629-1271629100.635100.64
10min11264623-1264623100.081100.420.98100.25100.590.98
21259453-125945399.67299.84
31282150-1282150101.468101.63
41252167-125216799.09599.26
51272402-1272402100.696100.86
61282659-1282659101.508101.68
15min11266932-1266932100.264100.240.66100.60100.580.66
21262494-126249499.912100.24
31275396-1275396100.933101.27
41252391-125239199.11399.44
51272621-1272621100.714101.05
61270223-1270223100.524100.86
30min11262565-126256599.91899.910.55100.42100.420.55
21259399-125939999.667100.17
31273648-1273648100.795101.30
41252607-125260799.13099.63
51262303-126230399.897100.40
61264441-1264441100.066100.57
极限11265218-1265218100.12899.920.77100.79100.590.77
21253460-125346099.19799.86
31273717-1273717100.800101.47
41248343-124834398.79299.45
51266795-1266795100.253100.92
61268385-1268385100.379101.05
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