非布司他片项目信息
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101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.323927910392329739242183924793392606439252560.05
210.353975717397899339773550.06
单位质量响应值RSD%判断
380354.26384285.510.73数据可信
供试品溶液-2024011311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%
5min13335352-333535278.51875.0916.8378.5275.0916.83
23508621-350862182.59782.60
33236147-323614776.18376.18
43634863-363486385.56985.57
53285703-328570377.34977.35
62137293-213729350.31450.31
10min14191606-419160698.67598.213.6998.8198.343.71
24221511-422151199.37999.52
34227280-422728099.51599.64
44326659-4326659101.854102.00
54189458-418945898.62598.75
63874893-387489391.21991.30
15min14301777-4301777101.269101.490.71101.56101.780.73
24268670-4268670100.489100.79
34328351-4328351101.894102.19
44349605-4349605102.395102.71
54332095-4332095101.982102.28
64287290-4287290100.928101.16
20min14315373-4315373101.589102.010.98102.05102.470.96
24271127-4271127100.547101.02
34336938-4336938102.096102.56
44340780-4340780102.187102.67
54332752-4332752101.998102.46
64402126-4402126103.631104.04
30min14315696-4315696101.596102.001.04102.23102.631.01
24267911-4267911100.471101.11
34334740-4334740102.045102.68
44336922-4336922102.096102.75
54334974-4334974102.050102.68
64406682-4406682103.738104.32
45min14310463-4310463101.473101.801.10102.28102.601.07
24255917-4255917100.189100.99
34328207-4328207101.891102.69
44323950-4323950101.791102.61
54323757-4323757101.786102.59
64403889-4403889103.672104.42
60min14302611-4302611101.288101.581.07102.26102.551.05
24250757-4250757100.068101.04
34307928-4307928101.413102.39
44316098-4316098101.606102.60
54318873-4318873101.671102.64
64394290-4394290103.447104.37
极限14287138-4287138100.924101.360.89102.06102.490.89
24247029-424702999.980101.12
34326559-4326559101.852102.99
44351253-4351253102.433103.60
54332031-4332031101.981103.12
64289209-4289209100.973102.07
非布司他片项目信息
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101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.323971081397364539748643972386396553239715020.10
210.354015998401652840162630.01
单位质量响应值RSD%判断
384835.47388044.730.59数据可信
供试品溶液-2024011311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%
5min13377397-337739778.65968.6716.9078.6668.6716.90
22639838-263983861.48261.48
33511223-351122381.77681.78
43286223-328622376.53676.54
52366371-236637155.11355.11
62510152-251015258.46158.46
10min14278565-427856599.64795.634.5999.7895.754.60
23951796-395179692.03792.14
34276435-427643599.59899.73
44129234-412923496.16996.30
53810989-381098988.75888.85
64190333-419033397.59297.69
15min14301667-4301667100.18599.491.32100.4899.761.33
24258349-425834999.17799.43
34311802-4311802100.421100.72
44304365-4304365100.248100.54
54164075-416407596.98197.22
64290990-429099099.937100.20
20min14291739-429173999.95499.860.90100.42100.300.91
24315417-4315417100.506100.93
34299323-4299323100.131100.60
44315970-4315970100.519100.97
54212833-421283398.11798.52
64291163-429116399.941100.37
30min14285757-428575799.81599.960.77100.45100.560.78
24324790-4324790100.724101.31
34283595-428359599.765100.40
44334310-4334310100.946101.57
54244572-424457298.85699.42
64277844-427784499.631100.22
45min14271497-427149799.48399.940.71100.28100.720.71
24319166-4319166100.593101.35
34280303-428030399.688100.49
44338223-4338223101.037101.83
54263561-426356199.298100.03
64274977-427497799.564100.32
60min14266373-426637399.36399.740.60100.33100.680.60
24309476-4309476100.367101.29
34265718-426571899.348100.32
44321085-4321085100.638101.60
54269179-426917999.429100.32
64264498-426449899.320100.24
极限14248519-424851998.94899.430.57100.08100.540.57
24300826-4300826100.166101.26
34258688-425868899.184100.32
44298985-4298985100.123101.25
54262344-426234499.270100.33
64247157-424715798.916100.01
非布司他片项目信息
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101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.323996682400079040025223998589400769540012560.11
210.354047713405225840499860.08
单位质量响应值RSD%判断
387718.60391303.000.66数据可信
供试品溶液-2024011411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%
5min13100679-310067971.64675.984.3471.6575.984.34
23225745-322574574.53574.54
33377702-337770278.04778.05
43265079-326507975.44475.44
53244056-324405674.95874.96
63516711-351671181.25981.26
10min14227890-422789097.69196.840.7997.8196.960.80
24177795-417779596.53496.66
34176149-417614996.49696.63
44164176-416417696.21996.34
54161990-416199096.16996.29
64237374-423737497.91098.05
15min14315887-431588799.72599.130.75100.0199.420.74
24260359-426035998.44298.73
34320954-432095499.842100.13
44282751-428275198.95999.25
54314475-431447599.69299.98
64246303-424630398.11798.42
20min14313672-431367299.67399.130.62100.1299.580.62
24263408-426340898.51298.96
34318589-431858999.787100.24
44280421-428042198.90599.36
54307535-430753599.53299.98
64257646-425764698.37998.84
30min14325982-432598299.95899.250.71100.5799.870.71
24260204-426020498.43899.05
34328935-4328935100.026100.65
44286962-428696299.05699.67
54308787-430878799.561100.18
64262369-426236998.48899.11
45min14321315-432131599.85099.070.73100.6399.850.73
24256169-425616998.34599.12
34317181-431718199.754100.54
44275766-427576698.79899.58
54304267-430426799.456100.24
64249579-424957998.19298.98
60min14303592-430359299.44098.800.67100.3999.750.67
24246154-424615498.11399.05
34305815-430581599.492100.45
44265183-426518398.55399.50
54292792-429279299.191100.14
64242045-424204598.01898.97
极限14297379-429737999.29798.520.67100.4199.630.66
24232579-423257997.80098.90
34286468-428646899.045100.17
44249600-424960098.19399.30
54280892-428089298.916100.03
64234450-423445097.84398.96
非布司他片项目信息
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101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.324046506404950740521754051583404506340489670.08
210.354006388400504240057150.03
单位质量响应值RSD%判断
392341.76387025.600.97数据可信
供试品溶液-2024011411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%
5min13091089-309108971.39475.686.5771.3975.686.57
23307152-330715276.38476.38
33021875-302187569.79569.80
43197248-319724873.84673.85
53572353-357235382.51082.51
63470039-347003980.14780.15
10min14268690-426869098.59398.300.4498.7198.430.44
24239852-423985297.92798.05
34234565-423456597.80597.92
44282301-428230198.90799.03
54263532-426353298.47498.61
64248351-424835198.12398.26
15min14326985-432698599.93999.410.62100.2299.690.62
24261862-426186298.43598.73
34289899-428989999.08399.36
44330783-4330783100.027100.31
54294993-429499399.20099.50
64318682-431868299.747100.04
20min14317499-431749999.72099.330.70100.1799.780.70
24266196-426619698.53598.99
34272845-427284598.68999.13
44327357-432735799.948100.40
54283255-428325598.92999.40
64335566-4335566100.137100.60
30min14325217-432521799.89899.430.76100.51100.050.76
24257178-425717898.32798.95
34283579-428357998.93799.55
44333798-4333798100.097100.72
54290903-429090399.10699.74
64338858-4338858100.213100.84
45min14310269-431026999.55399.190.73100.3499.980.73
24250166-425016698.16598.95
34268742-426874298.59499.37
44321671-432167199.816100.60
54287370-428737099.02499.82
64329053-432905399.987100.78
60min14295443-429544399.21198.840.72100.1699.790.72
24234992-423499297.81498.76
34255145-425514598.28099.22
44305161-430516199.435100.39
54271835-427183598.66599.63
64312581-431258199.607100.57
极限14290766-429076699.10398.630.76100.2299.750.76
24222765-422276597.53298.64
34245504-424550498.05799.16
44293305-429330599.161100.28
54263121-426312198.46499.59
64306341-430634199.462100.59
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