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%
19.651826997182760818272381826780182808418273410.03
29.711802733181132918070310.34
单位质量响应值RSD%判断
189361.76186100.001.23数据可信
供试品溶液-2024112521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%
5min11406701-140670167.44459.5110.2367.4459.5010.23
21039091-103909149.81949.82
31217482-121748258.37258.37
41341418-134141864.31464.31
51199475-119947557.50857.51
61242774-124277459.58459.58
10min11838728-183872888.15787.884.3088.3188.014.30
21800591-180059186.32986.44
31772674-177267484.99085.12
41987651-198765195.29795.44
51793974-179397486.01186.14
61803714-180371486.47886.61
15min11948280-194828093.40994.111.9993.7694.431.99
21935643-193564392.80493.11
31998636-199863695.82496.14
42023941-202394197.03797.39
51928089-192808992.44192.76
61942247-194224793.12093.44
20min11977298-197729894.80195.142.8295.3595.672.82
21962127-196212794.07394.58
31953263-195326393.64894.18
42096350-2096350100.509101.08
51948389-194838993.41593.94
61968281-196828194.36894.90
30min12000872-200087295.93196.782.7496.7097.532.75
21993151-199315195.56196.28
31988981-198898195.36196.10
42131043-2131043102.172102.97
51999645-199964595.87296.60
61997756-199775695.78296.52
45min11999600-199960095.87097.404.0596.8598.364.04
22009976-200997696.36797.30
31992624-199262495.53696.49
42198432-2198432105.403106.42
52002105-200210595.99096.94
61986161-198616195.22696.18
60min11996408-199640895.71797.032.8796.9198.202.87
22003320-200332096.04897.19
31998164-199816495.80196.96
42141620-2141620102.679103.93
51996281-199628195.71196.87
62006664-200666496.20997.37
极限12000347-200034795.90696.962.8497.3198.352.84
22004695-200469596.11497.47
31999619-199961995.87197.25
42139054-2139054102.556104.04
51993114-199311495.55996.93
61996798-199679895.73697.12
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%
19.651815338182080018228621821873182345518208660.18
29.711836425183588718361560.03
单位质量响应值RSD%判断
188690.78189099.490.16数据可信
供试品溶液-b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%
5min11027258-102725848.94452.0220.0548.9452.0220.05
21334064-133406463.56263.56
3776195-77619536.98236.98
41297879-129787961.83861.84
5930902-93090244.35344.35
61184699-118469956.44656.45
10min11800001-180000185.76285.604.1485.8785.724.15
21906989-190698990.86091.00
31773745-177374584.51184.59
41803220-180322085.91586.05
51677074-167707479.90580.00
61818781-181878186.65786.78
15min11976573-197657394.17594.053.6394.4794.353.62
22057284-205728498.02098.36
32019582-201958296.22496.49
41913584-191358491.17491.50
51866515-186651588.93189.21
62010173-201017395.77696.09
20min12023342-202334296.40396.533.4496.9197.043.44
22104227-2104227100.257100.82
32092538-209253899.700100.18
41963296-196329693.54294.07
51928796-192879691.89992.37
62043557-204355797.36697.90
30min12062182-206218298.25498.683.5598.9899.403.54
22147104-2147104102.300103.08
32152284-2152284102.547103.25
42002435-200243595.40796.15
51974041-197404194.05494.73
62088145-208814599.491100.24
45min12072362-207236298.73999.013.9199.6899.963.89
22159905-2159905102.910103.92
32165318-2165318103.168104.10
41982612-198261294.46395.41
51984453-198445394.55095.44
62103253-2103253100.211101.18
60min12078505-207850599.03199.583.64100.19100.753.63
22156647-2156647102.755103.99
32183605-2183605104.039105.20
42012994-201299495.91097.07
51994788-199478895.04396.14
62113899-2113899100.718101.91
极限12073680-207368098.80299.293.58100.18100.683.57
22161499-2161499102.986104.45
32162613-2162613103.039104.43
41989699-198969994.80096.17
52007126-200712695.63196.94
62109383-2109383100.503101.92
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%
19.651831016183589818373521836107183760418355950.15
29.711869342187086718701040.06
单位质量响应值RSD%判断
190217.10192595.670.88数据可信
供试品溶液-2024112621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%
5min11121684-112168452.74451.139.0652.7451.139.06
21171990-117199055.11055.11
3983976-98397646.26946.27
41144761-114476153.82953.83
51159168-115916854.50754.51
6942419-94241944.31544.31
10min11750705-175070582.32283.051.8682.4483.161.87
21793777-179377784.34784.47
31725902-172590281.15681.26
41766790-176679083.07883.20
51814507-181450785.32285.44
61745439-174543982.07482.17
15min11897390-189739089.21991.171.6589.5291.471.64
21963265-196326592.31792.63
31945223-194522391.46991.75
41900605-190060589.37189.67
51960809-196080992.20292.51
61966426-196642692.46692.75
20min11962026-196202692.25994.291.8292.7694.801.82
22038949-203894995.87696.39
32013820-201382094.69495.18
41957009-195700992.02392.53
52033711-203371195.63096.15
62026074-202607495.27095.76
30min11972489-197248992.75196.142.3893.4596.852.37
22075793-207579397.60898.34
32078273-207827397.72598.42
41993230-199323093.72694.43
52080819-208081997.84598.57
62067122-206712297.20197.90
45min12012582-201258294.63697.001.6995.5597.921.68
22088842-208884298.22299.17
32089921-208992198.27399.19
42024468-202446895.19596.11
52083367-208336797.96498.91
62077684-207768497.69798.61
60min12004750-200475094.26897.062.0695.3998.202.05
22087639-208763998.16599.33
32093559-209355998.44499.58
42016217-201621794.80795.93
52102965-210296598.886100.05
62080047-208004797.80898.94
极限12007929-200792994.41797.101.9795.7598.461.96
22090414-209041498.29699.68
32090508-209050898.30099.65
42018012-201801294.89196.23
52096022-209602298.56099.94
62087351-208735198.15299.50
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