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%
110.011965692196948919786231963925195197919659420.50
210.221975565197505019753080.02
单位质量响应值RSD%判断
196397.80193278.671.14数据可信
供试品溶液-3780C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%
5min1692487-69248731.99030.389.8431.9930.389.84
2550496-55049625.43025.43
3739140-73914034.14534.14
4646251-64625129.85429.85
5631952-63195229.19329.19
6685766-68576631.67931.68
10min11289671-128967159.57758.093.4159.6558.163.42
21204205-120420555.62855.68
31314484-131448460.72360.80
41265840-126584058.47658.54
51213019-121301956.03656.10
61258099-125809958.11858.19
15min11484188-148418868.56268.761.1868.7768.961.19
21467082-146708267.77267.95
31506564-150656469.59669.81
41508871-150887169.70269.90
51471081-147108167.95768.15
61492937-149293768.96669.17
20min11606800-160680074.22674.960.6574.5875.300.64
21632203-163220375.40075.73
31621088-162108874.88675.25
41634621-163462175.51275.86
51615294-161529474.61974.96
61625656-162565675.09775.45
30min11741352-174135280.44281.721.7080.9682.241.69
21760046-176004681.30681.80
31765131-176513181.54082.07
41759839-175983981.29681.81
51760357-176035781.32081.83
61827827-182782784.43784.96
45min11847356-184735685.33986.540.7086.0487.230.69
21877560-187756086.73487.41
31872902-187290286.51987.23
41879430-187943086.82187.52
51882799-188279986.97687.66
61879436-187943686.82187.53
60min11938573-193857389.55389.820.2390.4490.710.23
21941197-194119789.67490.55
31947170-194717089.95090.86
41945425-194542589.86990.76
51950885-195088590.12191.00
61943247-194324789.76990.67
极限12000728-200072892.42493.320.8193.5194.400.80
22010681-201068192.88493.95
32012416-201241692.96494.07
42047232-204723294.57295.66
52027602-202760293.66594.75
62021645-202164593.39094.49
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%
110.011971036197176719720171972592197461719724060.07
210.222039869204097820404240.04
单位质量响应值RSD%判断
197043.56199650.100.93数据可信
供试品溶液-3780C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%
5min1728171-72817133.04229.3722.2733.0429.3722.27
2690493-69049331.33331.33
3663192-66319230.09430.09
4673897-67389730.57930.58
5363188-36318816.48016.48
6764553-76455334.69334.69
10min11283452-128345258.23956.476.2058.3156.536.22
21282117-128211758.17958.25
31250355-125035556.73756.80
41266584-126658457.47457.54
51090035-109003549.46349.50
61293779-129377958.70858.78
15min11505033-150503368.29467.762.1368.5067.952.15
21513043-151304368.65768.86
31480888-148088867.19867.39
41509504-150950468.49768.69
51434068-143406865.07465.22
61517044-151704468.83969.05
20min11627183-162718373.83773.581.4074.1973.921.43
21636615-163661574.26574.62
31613841-161384173.23173.57
41629766-162976673.95474.30
51579751-157975171.68471.98
61642436-164243674.52974.89
30min11776537-177653780.61480.360.6481.1380.870.65
21775653-177565380.57481.09
31761893-176189379.94980.45
41758287-175828779.78680.30
51765556-176555680.11680.57
61788298-178829881.14881.67
45min11894990-189499085.98985.720.4786.6986.400.48
21882528-188252885.42486.12
31879811-187981185.30085.98
41884221-188422185.50086.19
51889070-188907085.72086.35
61903420-190342086.37287.08
60min11963985-196398589.12088.730.4590.0189.600.45
21953130-195313088.62789.51
31942403-194240388.14089.01
41950342-195034288.50189.38
51957699-195769988.83589.65
61965064-196506489.16990.07
极限12025477-202547791.91091.880.5293.0092.950.53
22024631-202463191.87292.95
32015379-201537991.45292.52
42016167-201616791.48892.56
52023295-202329591.81192.83
62044294-204429492.76493.86
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%
110.012015883201652620162122014057201033220146020.13
210.222014607201450820145580.01
单位质量响应值RSD%判断
201258.94197119.181.47数据可信
供试品溶液-3785B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%
5min1665124-66512430.05631.793.2930.0631.793.29
2720149-72014932.54232.54
3710972-71097232.12732.13
4702078-70207831.72631.73
5730696-73069633.01933.02
6692265-69226531.28231.28
10min11279287-127928757.80958.911.3257.8858.981.32
21300528-130052858.76858.84
31304720-130472058.95859.03
41292586-129258658.40958.48
51326335-132633559.93560.01
61318666-131866659.58859.66
15min11491549-149154967.40068.080.6267.6068.280.62
21506662-150666268.08368.29
31506903-150690368.09468.30
41513097-151309768.37468.57
51502367-150236767.88968.10
61518585-151858568.62268.82
20min11606228-160622872.58273.060.9272.9373.410.92
21626992-162699273.52173.87
31615563-161556373.00473.36
41604356-160435672.49872.85
51606009-160600972.57272.93
61641421-164142174.17374.53
30min11746970-174697078.94279.150.6579.4579.670.65
21757815-175781579.43279.95
31748424-174842479.00879.52
41752258-175225879.18179.69
51735254-173525478.41378.93
61769114-176911479.94380.46
45min11840538-184053883.17083.960.6683.8584.650.66
21873189-187318984.64685.34
31856705-185670583.90184.59
41858632-185863283.98884.68
51849614-184961483.58184.27
61869180-186918084.46585.16
60min11914675-191467586.52086.980.6887.3987.860.68
21943927-194392787.84288.72
31915214-191521486.54587.42
41927384-192738487.09587.97
51912104-191210486.40487.28
61936048-193604887.48688.37
极限11981598-198159889.54590.110.5390.6091.180.53
22011905-201190590.91491.99
31995756-199575690.18491.25
41995903-199590390.19191.26
51985987-198598789.74390.81
61993611-199361190.08791.17
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