塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
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50
标示量(mg)200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%
110.042989596298726229864532991946298971229889940.08
210.142987332298472229860270.07
单位质量响应值RSD%判断
297708.57294479.980.78数据可信
供试品溶液-23004N1批-pH4.5(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1286193-2861939.62710.747.169.6310.747.17
2352730-35273011.86511.87
3316628-31662810.65110.65
4305401-30540110.27310.27
5321117-32111710.80210.80
6333244-33324411.21011.21
10min1776076-77607626.10627.426.6926.1227.446.68
2870213-87021329.27329.29
3837190-83719028.16228.18
4749426-74942625.21025.23
5778956-77895626.20326.22
6879661-87966129.59129.61
15min11279269-127926943.03342.895.3943.0942.945.38
21340954-134095445.10845.17
31312586-131258644.15444.21
41179407-117940739.67439.73
51203088-120308840.47140.53
61333918-133391844.87244.93
20min11661072-166107255.87755.744.7755.9955.864.77
21732969-173296958.29558.42
31706320-170632057.39957.52
41554176-155417652.28152.39
51566307-156630752.68952.81
61721688-172168857.91658.04
30min12212457-221245774.42574.133.1474.6374.343.14
22263438-226343876.14076.36
32263589-226358976.14576.36
42119132-211913271.28571.48
52116904-211690471.21071.41
62246949-224694975.58575.80
45min12638405-263840588.75388.971.7689.0789.281.77
22686532-268653290.37290.70
32685905-268590590.35190.68
42612671-261267187.88788.19
52570847-257084786.48186.78
62674044-267404489.95290.28
60min12783212-278321293.62493.931.2294.0794.381.23
22839077-283907795.50495.97
32791680-279168093.90994.37
42771424-277142493.22893.66
52745841-274584192.36792.80
62822036-282203694.93095.39
极限12838409-283840995.48196.130.9996.0796.721.00
22900580-290058097.57298.18
32845391-284539195.71696.32
42858092-285809296.14396.71
52824467-282446795.01295.58
62880061-288006196.88297.49
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
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50
标示量(mg)200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%
110.042989636299376929946482995418300014929947240.13
210.142990831299164229912360.02
单位质量响应值RSD%判断
298279.28294993.690.79数据可信
供试品溶液-23004N1批-pH4.5(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1300434-30043410.08810.062.8110.0910.062.79
2309986-30998610.40910.41
3303259-30325910.18310.18
4293806-2938069.8659.87
5286113-2861139.6079.61
6303459-30345910.18910.19
10min1750025-75002525.18425.612.7025.2025.632.70
2791214-79121426.56726.58
3781511-78151126.24126.26
4764310-76431025.66425.68
5736363-73636324.72524.74
6753239-75323925.29225.31
15min11178620-117862039.57540.182.4639.6340.242.46
21245548-124554841.82241.88
31208534-120853440.58040.63
41206391-120639140.50840.56
51170609-117060939.30639.36
61170395-117039539.29939.35
20min11545594-154559451.89752.882.5452.0153.002.54
21641147-164114755.10655.22
31579525-157952553.03653.15
41598953-159895353.68953.80
51544371-154437151.85651.97
61540272-154027251.71851.83
30min12086457-208645770.05871.622.2370.2571.812.23
22193832-219383273.66373.86
32151970-215197072.25872.45
42177206-217720673.10573.30
52093531-209353170.29570.48
62094110-209411070.31570.50
45min12541741-254174185.34587.311.5985.6487.611.59
22646273-264627388.85589.17
32611056-261105687.67387.98
42641772-264177288.70489.01
52567723-256772386.21886.51
62593249-259324987.07587.37
60min12719454-271945491.31293.271.2091.7493.701.20
22803523-280352394.13594.58
32792497-279249793.76594.20
42808705-280870594.30994.75
52762896-276289692.77193.19
62779922-277992293.34393.77
极限12796832-279683293.91195.530.8694.4796.100.86
22862376-286237696.11196.70
32855240-285524095.87296.45
42859136-285913696.00396.58
52847442-284744295.61096.17
62849948-284994895.69496.26
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
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50
标示量(mg)200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%
110.042985164299401529889082989870298735029890610.12
210.142985900299107629884880.13
单位质量响应值RSD%判断
297715.24294722.680.72数据可信
供试品溶液-24123101批-pH4.5(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1237623-2376237.9906.9014.727.996.9014.73
2221034-2210347.4327.43
3198412-1984126.6726.67
4151203-1512035.0845.08
5201259-2012596.7676.77
6221982-2219827.4647.46
10min1667399-66739922.44119.687.6122.4519.697.61
2593062-59306219.94119.95
3536795-53679518.05018.06
4581857-58185719.56519.57
5562169-56216918.90318.91
6570822-57082219.19419.20
15min11066316-106631635.85431.967.0435.9032.007.04
2906519-90651930.48130.52
3868388-86838829.19929.24
4962571-96257132.36632.40
5942282-94228231.68431.72
6956978-95697832.17832.22
20min11419873-141987347.74342.726.7847.8442.816.78
21191172-119117240.05340.14
31179696-117969639.66739.75
41284614-128461443.19543.28
51274169-127416942.84342.93
61273988-127398842.83742.93
30min11944228-194422865.37458.677.0565.5458.827.04
21677147-167714756.39356.54
31642704-164270455.23555.38
41751134-175113458.88159.03
51827255-182725561.44161.59
61626621-162662154.69554.85
45min12352039-235203979.08674.884.2879.3675.124.28
22162536-216253672.71472.95
32151645-215164572.34872.57
42221641-222164174.70274.94
52335645-233564578.53578.78
62137736-213773671.88172.12
60min12571270-257127086.45883.522.6186.8583.882.61
22447157-244715782.28582.63
32467933-246793382.98383.32
42472497-247249783.13783.49
52547518-254751885.65986.02
62397476-239747680.61480.96
极限12723736-272373691.58590.171.1892.1090.651.19
22692098-269209890.52190.98
32682319-268231990.19290.65
42681499-268149990.16490.64
52685145-268514590.28790.78
62625907-262590788.29588.76
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
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50
标示量(mg)200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%
110.042980100298190929816162981085298219329813810.03
210.142985957299339229896740.18
单位质量响应值RSD%判断
296950.30294839.640.51数据可信
供试品溶液-24123102批-pH4.5(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1296034-2960349.9658.9311.439.968.9311.41
2286711-2867119.6519.65
3252797-2527978.5098.51
4292701-2927019.8539.85
5238899-2388998.0428.04
6225428-2254287.5887.59
10min1718728-71872824.19323.745.4924.2123.755.50
2739326-73932624.88624.90
3713531-71353124.01824.03
4722240-72224024.31124.33
5708173-70817323.83823.85
6629254-62925421.18121.19
15min11134431-113443138.18637.525.0938.2437.575.09
21154762-115476238.87038.92
31164133-116413339.18639.23
41146177-114617738.58138.63
51025131-102513134.50734.55
61063363-106336335.79435.84
20min11516628-151662851.05150.755.1951.1650.865.19
21552977-155297752.27552.38
31580885-158088553.21453.32
41573488-157348852.96553.07
51402272-140227247.20247.30
61420108-142010847.80247.90
30min12168354-216835472.98971.124.5173.1771.314.51
22135276-213527671.87672.06
32212900-221290074.48874.68
42172472-217247273.12873.32
52003096-200309667.42667.60
61985630-198563066.83867.01
45min12611404-261140487.90387.032.2788.2087.322.28
22575214-257521486.68486.98
32656794-265679489.43089.73
42630591-263059188.54888.85
52538046-253804685.43385.70
62501621-250162184.20784.48
60min12752182-275218292.64192.441.5693.0792.861.57
22731481-273148191.94492.37
32800014-280001494.25194.68
42789473-278947393.89794.33
52712760-271276091.31491.71
62691226-269122690.58990.98
极限12837029-283702995.49795.451.8296.0696.001.83
22808906-280890694.55195.11
32921261-292126198.33398.91
42866293-286629396.48297.05
52798437-279843794.19894.73
62781776-278177693.63794.17
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