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101278-202003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%
19.651813991181265818116351812470181231418126140.05
29.711816724181722418169740.02
单位质量响应值RSD%判断
187835.65187124.000.27数据可信
供试品溶液-2024112422批-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1427728-42772820.53319.4912.9820.5319.4912.97
2432065-43206520.74120.74
3459768-45976822.07122.07
4381191-38119118.29918.30
5423242-42324220.31820.32
6311584-31158414.95814.96
10min1681650-68165032.72332.174.1932.7732.224.20
2665086-66508631.92831.97
3691932-69193233.21633.27
4667177-66717732.02832.07
5696152-69615233.41933.46
6619039-61903929.71729.75
15min1786117-78611737.73837.533.1137.8637.643.12
2774442-77444237.17737.29
3792604-79260438.04938.17
4784492-78449237.66037.77
5813097-81309739.03339.15
6739805-73980535.51535.61
20min1838753-83875340.26540.452.8640.4740.642.86
2830705-83070539.87840.08
3846036-84603640.61440.82
4857402-85740241.16041.36
5876446-87644642.07442.28
6805835-80583538.68438.86
30min1911463-91146343.75543.942.7844.0544.232.79
2896501-89650143.03743.33
3923339-92333944.32544.62
4930584-93058444.67344.96
5950768-95076845.64245.94
6879074-87907442.20042.46
45min1954240-95424045.80946.282.5446.2046.672.54
2949593-94959345.58645.97
3971234-97123446.62447.02
4985670-98567047.31747.70
5994592-99459247.74648.15
6929110-92911044.60244.96
60min1975852-97585246.84647.502.8647.3447.992.87
2973986-97398646.75747.24
3997820-99782047.90148.40
41004311-100431148.21248.70
51033131-103313149.59650.10
6952319-95231945.71646.17
极限1995165-99516547.77348.312.6148.3748.902.61
2994903-99490347.76148.35
31008855-100885548.43049.04
41019892-101989248.96049.56
51048145-104814550.31750.93
6971137-97113746.62047.18
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101278-202003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%
19.651830299183043218287641828914182644018289700.09
29.711846369184575918460640.03
单位质量响应值RSD%判断
189530.57190119.880.22数据可信
供试品溶液-b批-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1434148-43414820.58419.079.3720.5819.079.37
2424699-42469920.13620.14
3378504-37850417.94617.95
4434913-43491320.62020.62
5401660-40166019.04419.04
6339408-33940816.09216.09
10min1677025-67702532.09931.433.1132.1431.483.12
2666415-66641531.59631.64
3638447-63844730.27030.31
4680622-68062232.27032.32
5679456-67945632.21432.26
6636085-63608530.15830.19
15min1818945-81894538.82837.162.8238.9537.272.83
2787034-78703437.31537.43
3763213-76321336.18636.29
4778265-77826536.89937.02
5795716-79571637.72737.84
6759465-75946536.00836.11
20min1835420-83542039.60939.871.8539.8140.061.85
2857855-85785540.67340.87
3830248-83024839.36439.55
4839767-83976739.81540.01
5860758-86075840.81041.01
6821635-82163538.95539.14
30min1903216-90321642.82343.261.6243.1143.541.63
2927355-92735543.96844.26
3901247-90124742.73043.01
4911014-91101443.19343.48
5933667-93366744.26744.56
6898052-89805242.57942.85
45min1951701-95170145.12245.611.6145.5145.991.61
2981927-98192746.55546.94
3951496-95149645.11245.48
4957195-95719545.38345.77
5981483-98148346.53446.92
6948702-94870244.98045.34
60min1971090-97109046.04146.791.8746.5347.271.87
21007388-100738847.76248.25
3986149-98614946.75547.23
4981887-98188746.55347.04
51009811-100981147.87748.37
6965134-96513445.75946.22
极限1996582-99658247.25047.631.4347.8448.221.44
21021668-102166848.43949.04
3999638-99963847.39547.97
4990780-99078046.97547.56
51023784-102378448.54049.14
6995160-99516047.18347.75
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101278-202003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%
19.651828257182779918301711829051182728518285130.07
29.711875297187427018747840.04
单位质量响应值RSD%判断
189483.21193077.651.33数据可信
供试品溶液-2024112422批-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1698071-69807132.84834.8120.9932.8534.8120.99
2744260-74426035.02235.02
3973551-97355145.81145.81
4514537-51453724.21224.21
5834350-83435039.26139.26
6673536-67353631.69431.69
10min11379745-137974564.92563.189.2265.0063.269.23
21415045-141504566.58666.66
31475988-147598869.45369.56
41184593-118459355.74255.80
51408529-140852966.27966.37
61191492-119149256.06656.14
15min11610334-161033475.77575.003.7875.9975.223.80
21645038-164503877.40877.63
31652396-165239677.75478.01
41555856-155585673.21273.39
51606777-160677775.60875.84
61492998-149299870.25470.45
20min11724551-172455181.15080.992.7081.5481.372.71
21773294-177329483.44383.84
31752624-175262482.47182.90
41716929-171692980.79181.13
51721952-172195281.02781.43
61637444-163744477.05177.40
30min11842797-184279786.71487.342.1187.2887.912.11
21906150-190615089.69590.28
31867477-186747787.87588.49
41884173-188417388.66189.18
51841979-184197986.67587.26
61794390-179439084.43684.96
45min11944879-194487991.51791.691.9292.2892.451.91
21991928-199192893.73194.51
31937636-193763691.17691.98
41993300-199330093.79694.51
51924006-192400690.53591.31
61899863-189986389.39990.11
60min11971013-197101392.74793.532.1893.7194.502.17
22033355-203335595.68196.67
31979663-197966393.15494.16
42044277-204427796.19497.12
51968447-196844792.62693.60
61929754-192975490.80691.71
极限11987538-198753893.52591.848.0394.6993.017.95
22033352-203335295.68096.88
31995282-199528293.88995.11
42067543-206754397.28998.43
51988557-198855793.57394.75
61638637-163863777.10778.22
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101278-202003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%
19.651838949183906718364881834570183399418366140.13
29.711859058185833618586970.03
单位质量响应值RSD%判断
190322.69191420.910.41数据可信
供试品溶液-b批-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1713421-71342133.64036.036.1833.6436.046.18
2831265-83126539.19639.20
3813696-81369638.36838.37
4731411-73141134.48834.49
5748363-74836335.28735.29
6747087-74708735.22735.23
10min11352083-135208363.75461.832.8863.8361.912.87
21298017-129801761.20561.29
31268623-126862359.81959.90
41359795-135979564.11864.19
51311127-131112761.82361.90
61278239-127823960.27260.35
15min11617592-161759276.27374.352.1276.4974.572.12
21563319-156331973.71473.94
31563701-156370173.73273.95
41616244-161624476.21076.43
51566732-156673273.87574.09
61533099-153309972.28972.50
20min11717774-171777480.99779.751.9881.3880.131.97
21691615-169161579.76480.15
31649768-164976877.79178.17
41735541-173554181.83582.22
51695460-169546079.94580.33
61657343-165734378.14878.52
30min11816824-181682485.66886.181.9586.2386.741.95
21853385-185338587.39287.96
31774412-177441283.66884.22
41827878-182787886.18986.76
51878391-187839188.57189.13
61815408-181540885.60186.15
45min11945463-194546391.73390.531.3092.4991.281.30
21931566-193156691.07891.84
31888819-188881989.06289.80
41919652-191965290.51691.28
51942383-194238391.58892.34
61891322-189132289.18089.92
60min11944004-194400491.66592.291.7692.6293.241.75
21985771-198577193.63494.59
31913410-191341090.22291.16
41971436-197143692.95893.92
52000985-200098594.35195.31
61927955-192795590.90891.84
极限11977670-197767093.25290.925.0794.4292.085.03
21981436-198143693.43094.60
31805315-180531585.12586.26
41998360-199836094.22895.40
52005996-200599694.58895.76
61800297-180029784.88886.03
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