非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.552030115202968920311062030012203062020303080.03
210.702037685203720420374440.02
单位质量响应值RSD%判断
192446.26190415.330.76数据可信
供试品溶液-250601批-pH6.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1760744-76074435.73148.7915.0135.7348.7915.01
21050069-105006949.32049.32
31172442-117244255.06855.07
41197695-119769556.25456.25
51008438-100843847.36547.37
61043517-104351749.01349.01
10min11506209-150620970.74579.326.4970.8279.436.50
21665661-166566178.23478.34
31791355-179135584.13884.26
41812209-181220985.11785.24
51670547-167054778.46378.57
61687158-168715879.24479.35
15min11884171-188417188.49791.782.3988.7392.072.42
21936695-193669590.96491.25
32002852-200285294.07194.38
42007740-200774094.30194.62
51959182-195918292.02092.30
61933855-193385590.83191.12
20min12008476-200847694.33595.831.2894.7796.321.31
22024175-202417595.07395.56
32063276-206327696.90997.43
42077822-207782297.59398.12
52041585-204158595.89196.37
62026806-202680695.19695.68
30min12071487-207148797.29598.190.7397.9498.900.76
22084936-208493697.92798.62
32103788-210378898.81299.55
42113100-211310099.25099.99
52086696-208669698.00998.71
62083785-208378597.87398.57
45min12102515-210251598.75299.530.8599.61100.450.87
22109511-210951199.081100.00
32136839-2136839100.365101.32
42146312-2146312100.809101.77
52111424-211142499.171100.09
62107821-210782199.00299.92
60min12105458-210545898.89199.640.5899.97100.780.61
22115764-211576499.375100.51
32135963-2135963100.323101.50
42136280-2136280100.338101.52
52116155-211615599.393100.53
62118579-211857999.507100.64
极限12115970-211597099.38499.850.55100.68101.220.57
22123358-212335899.731101.09
32138730-2138730100.453101.85
42138265-2138265100.432101.84
52110379-211037999.122100.48
62128980-212898099.995101.35
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.552050574205067020513472050635205159820509650.03
210.702081823208186120818420.01
单位质量响应值RSD%判断
194404.27194564.670.06数据可信
供试品溶液-250601批-pH6.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1712097-71209732.92046.5220.3132.9246.5220.31
2975343-97534345.09045.09
3828388-82838838.29638.30
41181248-118124854.60954.61
51119430-111943051.75151.75
61221008-122100856.44756.45
10min11512632-151263269.92978.528.7770.0078.628.78
21637053-163705375.68175.78
31554461-155446171.86371.95
41822449-182244984.25284.37
51813360-181336083.83183.95
61850489-185048985.54885.67
15min11923730-192373088.93491.032.7689.1691.312.79
21947483-194748390.03290.30
31895677-189567787.63787.88
42007811-200781192.82193.13
52027771-202777193.74494.04
62012380-201238093.03293.35
20min12023353-202335393.53994.811.4193.9795.291.44
22042826-204282694.44094.91
32019254-201925493.35093.79
42051349-205134994.83495.35
52091188-209118896.67597.19
62076982-207698296.01996.54
30min12080314-208031496.17397.160.9096.8197.850.92
22102404-210240497.19497.87
32089270-208927096.58797.23
42093854-209385496.79997.52
52133432-213343298.62899.35
62110389-211038997.56398.30
45min12111920-211192097.63498.430.9698.4899.340.98
22133547-213354798.63499.53
32115827-211582797.81598.68
42123550-212355098.17299.11
52167824-2167824100.218101.16
62122287-212228798.11399.07
60min12114537-211453797.75598.500.7698.8299.630.78
22127878-212787898.37299.49
32122398-212239898.11899.20
42129245-212924598.43599.59
52161348-216134899.919101.09
62128389-212838998.39599.57
极限12117893-211789397.91098.690.6399.19100.030.65
22135843-213584398.740100.07
32137129-213712998.799100.10
42126868-212686898.32599.70
52158107-215810799.769101.16
62132397-213239798.58199.97
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.552036871203806220345172034351203238420352370.12
210.702096732209435120955420.09
单位质量响应值RSD%判断
192913.46195845.051.07数据可信
供试品溶液-250602批-pH6.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11101656-110165650.96047.897.7350.9647.897.73
2966478-96647844.70744.71
3929652-92965243.00343.00
41000983-100098346.30346.30
51119329-111932951.77751.78
61093801-109380150.59750.60
10min11766997-176699781.73779.003.5481.8579.103.54
21660135-166013576.79476.89
31611934-161193474.56474.66
41717973-171797379.46979.57
51758608-175860881.34981.46
61731015-173101580.07380.18
15min11988985-198898592.00690.411.7792.3090.691.78
21933358-193335889.43289.70
31895220-189522087.66887.93
41964580-196458090.87791.16
51978723-197872391.53191.83
61965614-196561490.92591.21
20min12065289-206528995.53594.471.0896.0394.951.09
22032147-203214794.00294.47
32004143-200414392.70793.16
42056375-205637595.12395.60
52052487-205248794.94395.44
62042949-204294994.50294.99
30min12109944-210994497.60197.180.8398.3197.880.83
22095723-209572396.94397.62
32072400-207240095.86496.53
42114973-211497397.83498.53
52118598-211859898.00198.71
62093723-209372396.85197.55
45min12133832-213383298.70698.350.5799.6399.260.59
22120830-212083098.10499.00
32104850-210485097.36598.24
42135989-213598998.80699.72
52135563-213556398.78699.71
62126375-212637598.36199.28
60min12140311-214031199.00698.350.61100.1599.470.62
22127075-212707598.39399.50
32106907-210690797.46098.55
42133898-213389898.70999.84
52133480-213348098.69099.84
62114776-211477697.82498.96
极限12141299-214129999.05198.190.58100.4299.540.58
22123414-212341498.22499.55
32107661-210766197.49598.80
42129572-212957298.50999.86
52111688-211168897.68299.05
62122619-212261998.18799.54
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.552070780207019820707482069767206874320700470.05
210.702104435210454421044900.01
单位质量响应值RSD%判断
196212.99196681.310.17数据可信
供试品溶液-250602批-pH6.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11177506-117750653.89245.4011.6253.8945.4011.61
2945744-94574443.28543.28
31046023-104602347.87447.87
4832373-83237338.09638.10
5954845-95484543.70143.70
6994794-99479445.53045.53
10min11795726-179572682.18778.705.7382.3178.815.74
21638365-163836574.98575.08
31818770-181877083.24283.35
41568053-156805371.76771.85
51720215-172021578.73178.83
61776651-177665181.31481.42
15min11988837-198883791.02589.662.9991.3389.943.00
21908792-190879287.36287.62
32024908-202490892.67692.97
41869568-186956885.56785.81
51968272-196827290.08490.36
61994183-199418391.27091.55
20min12053830-205383094.00093.861.9594.5094.331.97
22018202-201820292.36992.83
32105288-210528896.35596.85
41995713-199571391.34091.77
52050394-205039493.84394.31
62081035-208103595.24595.73
30min12095521-209552195.90896.691.6196.6297.381.62
22096862-209686295.96996.63
32150731-215073198.43599.15
42068028-206802894.65095.29
52109655-210965596.55597.24
62154866-215486698.62499.32
45min12115060-211506096.80297.611.4497.7398.511.45
22114527-211452796.77897.65
32178453-217845399.704100.63
42095820-209582095.92296.77
52135677-213567797.74698.64
62156800-215680098.71399.63
60min12123875-212387597.20697.641.4498.3598.761.45
22122011-212201197.12098.21
32176713-217671399.624100.78
42090427-209042795.67596.74
52128021-212802197.39598.51
62159635-215963598.84299.98
极限12119463-211946397.00497.681.4698.3699.011.47
22120236-212023697.03998.35
32182371-218237199.883101.26
42098420-209842096.04197.31
52124214-212421497.22198.55
62160737-216073798.893100.25
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