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%
113.811183190118337211812201184881118151511828360.13
213.761171391117524111733160.24
单位质量响应值RSD%判断
85650.6985270.060.32数据可信
影响因素30天-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%
5min11260472-126047296.79297.100.9896.7997.100.98
21255089-125508996.37996.38
31283548-128354898.56498.56
41274261-127426197.85197.85
51250257-125025796.00896.01
61263262-126326297.00697.01
10min11279388-127938898.24598.751.3598.4198.911.34
21269002-126900297.44797.61
31299049-129904999.75499.92
41314104-1314104100.911101.07
51272992-127299297.75497.91
61281032-128103298.37198.53
15min11271618-127161897.64898.381.1997.9798.701.18
21265855-126585597.20597.53
31303307-1303307100.081100.41
41295592-129559299.48999.82
51270246-127024697.54397.87
61280105-128010598.30098.63
30min11272944-127294497.75098.260.9698.2498.750.96
21265493-126549397.17897.66
31290903-129090399.12999.63
41287612-128761298.87699.37
51267863-126786397.36097.85
61292798-129279899.27499.76
极限11266969-126696997.29197.971.1097.9498.631.10
21261959-126195996.90697.55
31287829-128782998.89399.56
41296211-129621199.537100.20
51263968-126396897.06197.71
61278217-127821798.15598.81
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%
113.811178606117609711772371176655117775411772700.09
213.761178664117607111773680.16
单位质量响应值RSD%判断
85247.6585564.530.27数据可信
影响因素30天-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%
5min11260416-126041696.84998.180.9596.8598.180.95
21274045-127404597.89697.90
31269079-126907997.51597.51
41290013-129001399.12399.12
51281790-128179098.49298.49
61291027-129102799.20199.20
10min11319097-1319097101.358100.880.79101.52101.050.79
21293868-129386899.42099.58
31320074-1320074101.433101.60
41321561-1321561101.547101.71
51311920-1311920100.807100.97
61310943-1310943100.732100.90
15min11338152-1338152102.822101.260.97103.15101.600.96
21317189-1317189101.212101.54
31306674-1306674100.404100.74
41327743-1327743102.023102.36
51309568-1309568100.626100.96
61307888-1307888100.497100.83
30min11343691-1343691103.248100.831.40103.75101.331.39
21290411-129041199.15499.65
31302390-1302390100.074100.57
41319947-1319947101.423101.93
51305647-1305647100.325100.82
61311395-1311395100.766101.27
极限11333060-1333060102.431100.481.22103.10101.151.22
21289746-128974699.10399.77
31293332-129333299.378100.04
41316671-1316671101.172101.85
51309344-1309344100.609101.28
61304200-1304200100.213100.88
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%
113.811181630117767911794071179125117904911793780.13
213.761180300117794111791200.15
单位质量响应值RSD%判断
85400.2985691.860.25数据可信
影响因素30天-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%
5min11308510-1308510100.38098.151.23100.3898.151.23
21274600-127460097.77997.78
31284736-128473698.55698.56
41265579-126557997.08797.09
51268070-126807097.27897.28
61275238-127523897.82897.83
10min11328835-1328835101.93999.991.13102.11100.151.13
21299066-129906699.65699.82
31312951-1312951100.721100.89
41293529-129352999.23199.39
51293790-129379099.25199.41
61292288-129228899.13699.30
15min11330583-1330583102.073100.081.34102.41100.411.34
21302409-130240999.912100.24
31320694-1320694101.315101.65
41294958-129495899.34099.67
51286510-128651098.69299.02
61292414-129241499.14599.47
30min11328492-1328492101.913100.221.22102.42100.721.22
21296969-129696999.49599.99
31313554-1313554100.767101.27
41318080-1318080101.114101.61
51289757-128975798.94199.43
61291721-129172199.09299.59
极限11327919-1327919101.86999.701.26102.55100.371.26
21291369-129136999.06599.73
31309716-1309716100.473101.14
41284876-128487698.56799.23
51288540-128854098.84899.51
61295620-129562099.391100.05
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