塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100
标示量(mg)100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%
19.711442615143463014534851453520145085014470200.57
29.761447810145482614513180.35
单位质量响应值RSD%判断
149023.69148700.610.16数据可信
供试品溶液-23040N1批-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1143505-1435059.60210.8513.379.6010.8513.36
2132239-1322398.8488.85
3167877-16787711.23211.23
4176480-17648011.80811.81
5161540-16154010.80810.81
6191640-19164012.82212.82
10min1372874-37287424.94827.8711.5224.9727.8911.52
2351250-35125023.50123.52
3424348-42434828.39228.41
4457655-45765530.62130.64
5416484-41648427.86627.89
6476355-47635531.87231.90
15min1596465-59646539.90843.849.3839.9843.929.39
2565556-56555637.84037.90
3665935-66593544.55644.64
4701376-70137646.92747.01
5679344-67934445.45345.53
6722772-72277248.35948.45
20min1790230-79023052.87258.117.9553.0258.287.96
2776202-77620251.93452.07
3875772-87577258.59658.76
4932630-93263062.40062.58
5912044-91204461.02361.19
6924438-92443861.85262.04
30min11108944-110894474.19779.245.4374.4579.525.45
21105408-110540873.96074.20
31182177-118217779.09779.38
41228729-122872982.21182.51
51256518-125651884.07184.36
61223938-122393881.89182.20
45min11384692-138469292.64693.491.9893.0593.932.00
21360628-136062891.03691.43
31398341-139834193.56094.00
41427190-142719095.49095.96
51431526-143152695.78096.24
61381481-138148192.43292.91
60min11440547-144054796.38495.521.4796.9796.151.47
21406976-140697694.13794.71
31428474-142847495.57696.21
41440287-144028796.36697.03
51451509-145150997.11797.77
61398025-139802593.53994.20
极限11477247-147724798.83997.600.8899.6298.420.86
21457162-145716297.49598.26
31456282-145628297.43698.26
41462714-146271497.86798.72
51461656-146165697.79698.64
61437624-143762496.18897.03
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100
标示量(mg)100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%
19.712912395291520429222182918585291957229175950.14
29.762901930288368928928100.45
单位质量响应值RSD%判断
300473.22296394.470.97数据可信
供试品溶液-23003N1批-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1382553-38255312.76812.485.8612.7712.485.86
2369201-36920112.32212.32
3384417-38441712.83012.83
4348709-34870911.63811.64
5351537-35153711.73311.73
6406327-40632713.56113.56
10min1880682-88068229.39330.404.3829.4230.434.39
2907293-90729330.28230.31
3947112-94711231.61131.64
4882968-88296829.47029.49
5875583-87558329.22329.25
6971634-97163432.42932.46
15min11348627-134862745.01145.773.0845.1045.853.09
21365186-136518645.56445.65
31417165-141716547.29947.39
41343189-134318944.83044.91
51324604-132460444.21044.29
61428635-142863547.68247.77
20min11725515-172551557.59058.452.6957.7658.622.69
21749724-174972458.39858.57
31789881-178988159.73959.92
41725568-172556857.59257.76
51694849-169484956.56756.74
61822133-182213360.81561.00
30min12286014-228601476.29876.272.1576.5976.562.15
22258409-225840975.37675.67
32337581-233758178.01978.32
42279036-227903676.06576.35
52210640-221064073.78274.07
62339492-233949278.08278.39
45min12684943-268494389.61289.471.0890.0589.911.09
22666564-266656488.99989.44
32706344-270634490.32690.79
42658919-265891988.74489.18
52646047-264604788.31488.74
62720586-272058690.80291.27
60min12799345-279934593.43093.850.9494.0594.480.95
22787673-278767393.04193.66
32855012-285501295.28895.93
42804872-280487293.61594.23
52792807-279280793.21293.82
62832563-283256394.53995.19
极限12893653-289365396.57896.130.9597.3996.940.96
22888374-288837496.40297.21
32906375-290637597.00397.83
42877500-287750096.03996.84
52828123-282812394.39195.18
62887679-288767996.37997.21
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100
标示量(mg)100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%
19.711460572143728914496201448724144648114485370.58
29.761452886145379114533380.05
单位质量响应值RSD%判断
149179.92148907.580.13数据可信
供试品溶液-23040N1批-pH6.8(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1173606-17360611.60115.2318.9611.6015.2318.97
2276031-27603118.44618.45
3232907-23290715.56415.56
4274742-27474218.36018.36
5185020-18502012.36412.36
6225187-22518715.04815.05
10min1446855-44685529.86237.3917.0029.8837.4217.01
2677781-67778145.29345.33
3581585-58158538.86538.90
4647498-64749843.27043.31
5459185-45918530.68630.71
6544088-54408836.35936.39
15min1714845-71484547.77056.3613.1847.8556.4613.19
2990015-99001566.15966.29
3851281-85128156.88857.00
4949787-94978763.47163.59
5735215-73521549.13249.22
6818798-81879854.71754.82
20min1951764-95176463.60372.6810.0863.7872.9010.10
21235865-123586582.58882.85
31102233-110223373.65873.88
41174465-117446578.48578.74
5978950-97895065.41965.60
61082211-108221172.32072.53
30min11257007-125700784.00190.074.0184.3190.434.03
21364900-136490091.21191.64
31367760-136776091.40291.77
41416800-141680094.67995.09
51321099-132109988.28488.60
61359271-135927190.83591.19
45min11421404-142140494.98795.491.5195.4696.031.50
21411200-141120094.30594.91
31398880-139888093.48294.03
41450563-145056396.93597.53
51445576-144557696.60297.09
61446140-144614096.64097.18
60min11436807-143680796.01696.261.5996.6896.991.58
21419629-141962994.86895.66
31407870-140787094.08294.82
41462090-146209097.70698.50
51455303-145530397.25297.94
61460971-146097197.63198.36
极限11438136-143813696.10597.531.5596.9698.451.53
21436069-143606995.96796.95
31444166-144416696.50897.44
41471681-147168198.34799.33
51487102-148710299.377100.26
61479215-147921598.85099.78
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100
标示量(mg)100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%
19.712883264288612728934492891832289502828899400.18
29.762877756289666928872120.47
单位质量响应值RSD%判断
297625.13295820.900.43数据可信
供试品溶液-23003N1批-pH6.8(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1449793-44979315.09816.3813.9515.1016.3813.95
2445883-44588314.96714.97
3447881-44788115.03415.03
4611908-61190820.54020.54
5447996-44799615.03815.04
6525195-52519517.62917.63
10min11073091-107309136.02038.599.4436.0538.629.45
21086613-108661336.47436.50
31083049-108304936.35536.38
41351208-135120845.35645.40
51108326-110832637.20337.23
61196400-119640040.16040.19
15min11566990-156699052.59956.517.8352.7056.627.83
21621689-162168954.43554.54
31594856-159485653.53453.64
41897938-189793863.70863.84
51625817-162581754.57454.68
61793717-179371760.21060.33
20min11970659-197065966.14970.206.0366.3670.426.03
22068227-206822769.42469.64
31976808-197680866.35566.57
42298842-229884277.16577.42
52058501-205850169.09869.31
62175125-217512573.01273.25
30min12477566-247756683.16486.762.7983.5087.122.80
22600225-260022587.28287.63
32527653-252765384.84685.19
42678498-267849889.90990.32
52594236-259423687.08187.43
62629313-262931388.25888.64
45min12798013-279801393.92195.561.2194.4396.101.22
22876947-287694796.57097.10
32826281-282628194.87095.38
42874937-287493796.50397.10
52877810-287781096.59997.13
62827408-282740894.90895.47
60min12933174-293317498.45898.020.7099.1598.740.70
22937601-293760198.60699.32
32880794-288079496.70097.40
42924327-292432798.16198.95
52923648-292364898.13898.86
62920855-292085598.04498.79
极限12944876-294487698.85198.560.6899.7499.480.68
22922396-292239698.09699.01
32946435-294643598.90399.80
42959078-295907899.327100.31
52940699-294069998.71099.63
62903609-290360997.46598.41
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