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101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0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%
19.961472361147071614723801470525146658814705140.17
210.081492622149340914930160.04
单位质量响应值RSD%判断
147641.97148116.670.23数据可信
供试品溶液-3780C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%
5min11133292-113329268.97363.0618.2868.9763.0618.27
21045930-104593063.65663.66
31162042-116204270.72370.72
4658896-65889640.10140.10
51085383-108538366.05766.06
61131310-113131068.85268.85
10min11489206-148920690.63486.815.8690.7986.955.87
21423321-142332186.62486.77
31458467-145846788.76388.92
41265475-126547577.01877.11
51432824-143282487.20387.35
61488893-148889390.61590.77
15min11565462-156546295.27593.842.3395.6394.172.37
21548907-154890794.26794.60
31562169-156216995.07595.43
41471737-147173789.57189.83
51538512-153851293.63593.98
61564349-156434995.20795.56
20min11623684-162368498.81897.291.3299.3897.831.31
21592052-159205296.89397.44
31614998-161499898.29098.86
41605973-160597397.74098.20
51565032-156503295.24995.80
61589414-158941496.73397.30
30min11612529-161252998.13997.871.2498.9398.631.23
21616993-161699398.41199.17
31634951-163495199.504100.29
41609424-160942497.95198.63
51575515-157551595.88796.65
61599397-159939797.34098.12
45min11616895-161689598.40598.141.2299.4199.111.21
21613225-161322598.18299.16
31634919-163491999.502100.51
41626523-162652398.99199.89
51578704-157870496.08197.05
61604640-160464097.65998.66
60min11615756-161575698.33698.061.3099.5699.261.29
21614387-161438798.25399.45
31634661-163466199.486100.71
41626689-162668999.001100.12
51575827-157582795.90697.09
61600504-160050497.40898.62
极限11616502-161650298.38198.001.3699.8299.411.34
21614520-161452098.26199.67
31631136-163113699.272100.72
41629409-162940999.167100.50
51573936-157393695.79197.19
61595995-159599597.13398.56
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101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0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%
19.961496574149769514981791499263149887714981180.08
210.081484505148552614850160.05
单位质量响应值RSD%判断
150413.45147323.021.47数据可信
供试品溶液-3780C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%
5min11102346-110234666.65155.0026.5866.6555.0026.58
21035645-103564562.61862.62
3510468-51046830.86430.86
41027274-102727462.11262.11
5710589-71058942.96442.96
61071783-107178364.80364.80
10min11436073-143607386.82982.996.8986.9883.126.92
21442331-144233187.20787.35
31198172-119817272.44572.51
41401674-140167484.74984.89
51331785-133178580.52380.62
61425571-142557186.19486.34
15min11551720-155172093.82193.081.6894.1693.391.72
21547610-154761093.57393.91
31488848-148884890.02090.25
41557405-155740594.16594.49
51537538-153753892.96493.24
61554012-155401293.96094.30
20min11595124-159512496.44596.071.7197.0096.581.74
21596928-159692896.55597.10
31538040-153804092.99493.42
41618190-161819097.84098.38
51599028-159902896.68197.16
61586114-158611495.90196.45
30min11605028-160502897.04497.420.9897.8198.140.97
21601619-160161996.83897.59
31596844-159684496.54997.19
41606166-160616697.11397.87
51640006-164000699.15999.85
61617484-161748497.79798.55
45min11606445-160644597.13097.510.7998.1198.460.74
21603882-160388296.97597.95
31635840-163584098.90799.76
41601358-160135896.82297.79
51611911-161191197.46098.38
61616950-161695097.76598.74
60min11601988-160198896.86097.280.5198.0698.440.49
21596576-159657696.53397.72
31611155-161115597.41598.49
41611092-161109297.41198.59
51618377-161837797.85198.98
61614656-161465697.62698.82
极限11599152-159915296.68996.940.3998.1098.320.39
21598237-159823796.63498.03
31600842-160084296.79198.08
41599216-159921696.69398.09
51611718-161171897.44998.80
61610699-161069997.38798.80
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101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0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%
19.961460477145943914590951459717145892914595310.05
210.081507939150885915083990.05
单位质量响应值RSD%判断
146539.26149642.761.49数据可信
供试品溶液-3785B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%
5min11118816-111881668.00258.8316.1668.0058.8316.16
2746601-74660145.37845.38
3939752-93975257.11857.12
41124753-112475368.36368.36
5830360-83036050.46950.47
61046881-104688163.63063.63
10min11498383-149838391.07288.463.6891.2288.593.70
21423867-142386786.54386.64
31460848-146084888.79188.92
41483835-148383590.18890.34
51363292-136329282.86182.97
61501984-150198491.29191.43
15min11580299-158029996.05195.861.9596.4096.191.95
21599794-159979497.23697.53
31587232-158723296.47296.80
41578541-157854195.94496.30
51517427-151742792.22992.53
61599492-159949297.21797.56
20min11590110-159011096.64798.211.5297.2198.751.51
21643265-164326599.878100.39
31627303-162730398.90899.45
41617470-161747098.31098.88
51582391-158239196.17896.68
61633989-163398999.31499.87
30min11599772-159977297.23499.381.6498.02100.141.63
21654390-1654390100.554101.29
31663865-1663865101.130101.89
41624021-162402198.70899.49
51611708-161170897.96098.67
61656442-1656442100.679101.46
45min11598197-159819797.13998.801.1598.1499.781.13
21653313-1653313100.489101.44
31623420-162342098.67299.65
41622371-162237198.60899.61
51618641-161864198.38199.31
61637666-163766699.538100.54
60min11588266-158826696.53598.541.3797.7599.741.35
21648303-1648303100.184101.36
31616818-161681898.27099.47
41618448-161844898.36999.59
51611866-161186697.96999.12
61643706-164370699.905101.13
极限11594758-159475896.93098.171.0098.3699.580.99
21629024-162902499.012100.41
31607806-160780697.72399.14
41609243-160924397.81099.25
51610810-161081097.90599.27
61639081-163908199.624101.07
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101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0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%
19.961497626149672014966271496934149645914968730.04
210.081530983153058415307840.02
单位质量响应值RSD%判断
150288.45151863.490.74数据可信
供试品溶液-3785B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%
5min1803274-80327447.85459.3411.2147.8559.3411.22
21001208-100120859.64659.65
31095984-109598465.29265.29
4934450-93445055.66955.67
51079477-107947764.30964.31
61062437-106243763.29463.29
10min11399724-139972483.38886.282.6283.4986.422.63
21440619-144061985.82485.96
31472466-147246687.72187.87
41409086-140908683.94584.07
51489233-148923388.72088.86
61478868-147886888.10388.24
15min11539745-153974591.72992.671.0192.0293.001.02
21533192-153319291.33991.66
31573519-157351993.74194.08
41564405-156440593.19893.51
51563956-156395693.17293.51
61558844-155884492.86793.20
20min11579893-157989394.12194.960.9094.6295.490.90
21610634-161063495.95296.48
31604280-160428095.57496.12
41602487-160248795.46795.98
51591642-159164294.82195.37
61574791-157479193.81794.36
30min11594690-159469095.00395.190.7795.7195.930.76
21589717-158971794.70695.45
31609917-160991795.91096.67
41614426-161442696.17896.91
51596340-159634095.10195.86
61582019-158201994.24895.00
45min11596920-159692095.13595.060.8496.0596.010.83
21590107-159010794.73095.68
31605685-160568595.65896.63
41614889-161488996.20697.15
51588733-158873394.64895.62
61577219-157721993.96294.92
60min11593957-159395794.95994.970.8396.0996.130.82
21587789-158778994.59195.75
31605680-160568095.65796.84
41612862-161286296.08597.24
51587202-158720294.55695.74
61577210-157721093.96195.13
极限11592701-159270194.88494.720.7596.2296.090.74
21581496-158149694.21795.59
31597134-159713495.14896.55
41605737-160573795.66197.03
51590322-159032294.74296.13
61572220-157222093.66495.04
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