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%
113.761165365116502511652541166036116513011653620.04
213.741163993116366911638310.02
单位质量响应值RSD%判断
84692.0184703.860.01数据可信
供试品溶液-2025020621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%
5min11194260-119426092.53392.921.0992.5392.921.09
21197440-119744092.77992.78
31220387-122038794.55794.56
41185775-118577591.87591.88
51189104-118910492.13392.13
61208786-120878693.65893.66
10min11266068-126606898.09797.991.1598.2598.151.15
21261136-126113697.71497.87
31291522-1291522100.069100.23
41248693-124869396.75096.90
51257072-125707297.39997.55
61263826-126382697.92398.08
15min11282577-128257799.37699.201.1799.6999.511.17
21275056-127505698.79399.11
31307500-1307500101.307101.63
41263989-126398997.93598.25
51271498-127149898.51798.83
61280902-128090299.24699.57
30min11281401-128140199.28599.121.2399.7799.601.23
21274231-127423198.72999.21
31308224-1308224101.363101.86
41262365-126236597.81098.29
51270275-127027598.42298.90
61279258-127925899.11899.60
极限11279034-127903499.10198.891.2499.7599.541.23
21271250-127125098.49899.14
31305771-1305771101.173101.83
41260287-126028797.64998.29
51267849-126784998.23598.88
61273900-127390098.70399.35
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%
113.761164550116357711641161163934116301911638390.05
213.741162345116395711631510.10
单位质量响应值RSD%判断
84581.3284654.370.07数据可信
供试品溶液-2025020621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%
5min11168230-116823090.60291.841.1990.6091.841.19
21194337-119433792.62692.63
31171435-117143590.85090.85
41188012-118801292.13692.14
51204622-120462293.42493.42
61178489-117848991.39791.40
10min11244021-124402196.48097.470.9296.6397.620.92
21263594-126359497.99798.15
31244944-124494496.55196.70
41257884-125788497.55597.71
51274562-127456298.84899.00
61255414-125541497.36397.52
15min11257100-125710097.49498.741.0797.8199.051.07
21284466-128446699.61699.93
31261084-126108497.80398.12
41269542-126954298.45998.77
51292537-1292537100.242100.56
61274026-127402698.80799.12
30min11257399-125739997.51798.651.0897.9999.131.09
21285857-128585799.724100.21
31257928-125792897.55898.03
41267945-126794598.33598.82
51289910-1289910100.038100.53
61272827-127282798.71499.19
极限11255592-125559297.37798.481.1098.0199.121.10
21283844-128384499.568100.22
31255897-125589797.40198.04
41264883-126488398.09798.74
51288749-128874999.948100.60
61269611-126961198.46499.11
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%
113.761162823116232511629841163818116366811631240.06
213.741163839116287111633550.06
单位质量响应值RSD%判断
84529.3684669.210.12数据可信
供试品溶液-2025020721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%
5min11284273-128427399.62397.591.9499.6297.591.95
21288816-128881699.97699.98
31255501-125550197.39197.39
41253046-125304697.20197.20
51226783-122678395.16495.16
61239792-123979296.17396.17
10min11330623-1330623103.219100.702.03103.38100.862.03
21323223-1323223102.645102.81
31287494-128749499.873100.04
41306383-1306383101.338101.50
51264518-126451898.09198.25
61276825-127682599.04599.21
15min11337248-1337248103.733101.301.92104.07101.631.92
21327865-1327865103.005103.34
31295155-1295155100.467100.80
41316492-1316492102.122102.45
51276405-127640599.01399.33
61282194-128219499.46299.79
30min11338371-1338371103.820101.382.00104.33101.882.00
21329188-1329188103.107103.62
31294434-1294434100.411100.91
41321155-1321155102.484102.99
51274854-127485498.89399.38
61283831-128383199.589100.08
极限11334293-1334293103.503101.122.07104.19101.792.07
21325826-1325826102.846103.53
31292093-1292093100.230100.89
41321076-1321076102.478103.15
51271776-127177698.65499.31
61276343-127634399.00899.67
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%
113.761163497116357011645491163944116503111641180.06
213.741163181116322911632050.01
单位质量响应值RSD%判断
84601.6084658.300.05数据可信
供试品溶液-2025020721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%
5min11269051-126905198.40798.431.1798.4198.431.17
21294063-1294063100.346100.35
31252407-125240797.11697.12
41277287-127728799.04599.05
51259873-125987397.69597.69
61263468-126346897.97497.97
10min11295865-1295865100.486101.041.05100.65101.211.05
21288334-128833499.902100.07
31321292-1321292102.458102.62
41318272-1318272102.223102.39
51293679-1293679100.316100.48
61300813-1300813100.870101.03
15min11302678-1302678101.014101.571.14101.35101.911.14
21294858-1294858100.408100.74
31330510-1330510103.172103.50
41326270-1326270102.844103.18
51298814-1298814100.715101.04
61306317-1306317101.296101.63
30min11302370-1302370100.990101.411.12101.49101.921.12
21293097-1293097100.271100.77
31330402-1330402103.164103.67
41320542-1320542102.399102.91
51296046-1296046100.500101.00
61304367-1304367101.145101.65
极限11298668-1298668100.703101.211.09101.37101.881.09
21289141-128914199.964100.63
31326212-1326212102.839103.52
41318011-1318011102.203102.88
51295915-1295915100.490101.16
61303018-1303018101.041101.71
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