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%
110.283055038305813330574993056964305644030568150.04
210.253057267305636430568160.03
单位质量响应值RSD%判断
297355.54298225.950.21数据可信
供试品溶液-25110901批-pH2.0(内含1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1547368-54736818.30716.1819.6218.3116.1819.63
2501366-50136616.76916.77
3455061-45506115.22015.22
4370995-37099512.40812.41
5401649-40164913.43413.43
6626629-62662920.95820.96
10min11873897-187389762.67557.8115.5062.7157.8415.49
21776775-177677559.42759.46
31805894-180589460.40160.43
41192374-119237439.88139.91
51804094-180409460.34060.37
61917863-191786364.14664.19
15min12394176-239417680.07775.858.6080.2476.008.61
22331386-233138677.97678.13
32362977-236297779.03379.18
41875948-187594862.74462.85
52348683-234868378.55578.70
62294421-229442176.74076.91
20min12625446-262544687.81281.807.4988.1382.107.50
22530823-253082384.64784.96
32490131-249013183.28683.60
42094839-209483970.06570.29
52497261-249726183.52483.83
62434840-243484081.43781.76
30min12862165-286216595.72989.883.9796.2390.344.00
22712963-271296390.73991.22
32674575-267457589.45589.93
42530078-253007884.62284.99
52683339-268333989.74890.22
62659866-265986688.96389.45
45min13025437-3025437101.19097.132.35101.8897.772.37
22903877-290387797.12497.78
32854556-285455695.47596.13
42860842-286084295.68596.22
52846269-284626995.19795.85
62933607-293360798.11998.78
60min13044232-3044232101.819101.213.86102.71102.053.85
22974203-297420399.476100.33
32949264-294926498.64299.49
42933021-293302198.09998.83
53249879-3249879108.697109.54
63006479-3006479100.556101.42
极限13044121-3044121101.815100.971.12102.91102.011.13
23023495-3023495101.125102.18
33038464-3038464101.626102.67
43007986-3007986100.606101.53
52955847-295584798.86299.92
63042636-3042636101.765102.83
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%
110.283051793305391630532203054079305208530530190.04
210.253056014305623430561240.01
单位质量响应值RSD%判断
296986.28298158.440.28数据可信
供试品溶液-25110902批-pH2.0(内含1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1580727-58072719.43815.6138.0519.4415.6138.06
2512598-51259817.15717.16
3417636-41763613.97913.98
4159856-1598565.3515.35
5679714-67971422.75122.75
6447377-44737714.97414.97
10min11752226-175222658.64953.2412.5058.6953.2712.50
21575344-157534452.72852.76
31294479-129447943.32743.36
41472931-147293149.30049.31
51854142-185414262.06062.11
61594579-159457953.37253.40
15min12416809-241680980.89371.979.0281.0572.109.03
22199198-219919873.60973.75
31896834-189683463.48963.60
42025955-202595567.81167.92
52308962-230896277.28377.45
62053013-205301368.71668.85
20min12583824-258382486.48379.695.9386.8079.975.95
22397356-239735680.24280.53
32244283-224428375.11875.36
42322728-232272877.74477.99
52501953-250195383.74384.07
62234330-223433074.78575.06
30min12719503-271950391.02487.874.3491.5288.314.35
22608702-260870287.31687.76
32476147-247614782.87983.27
42724600-272460091.19591.60
52719068-271906891.01091.50
62503787-250378783.80484.23
45min12833880-283388094.85393.192.1495.5393.812.17
22757490-275749092.29692.92
32685585-268558589.88990.45
42829997-282999794.72395.31
52832880-283288094.81995.49
62765407-276540792.56193.15
60min12876481-287648196.27995.611.0497.1496.411.07
22849126-284912695.36396.17
32805806-280580693.91394.65
42853163-285316395.49896.27
52892085-289208596.80197.66
62862690-286269095.81796.59
极限12870403-287040396.07597.011.1997.1398.011.19
22881122-288112296.43497.43
32888045-288804596.66697.59
42867572-286757295.98096.94
52940769-294076998.43099.49
62942891-294289198.50199.47
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%
110.283054177305168130525503052690305207330526340.04
210.253048227306797930581030.46
单位质量响应值RSD%判断
296948.83298351.510.34数据可信
供试品溶液-25110901批-pH6.8(内含1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1631088-63108821.11824.7819.2221.1224.7819.21
2718630-71863024.04724.05
3986567-98656733.01333.01
4593287-59328719.85319.85
5701860-70186023.48623.49
6811587-81158727.15827.16
10min11729992-172999257.88962.879.1757.9362.929.17
21766804-176680459.12159.17
31883361-188336163.02263.09
41771815-177181559.28959.33
51926508-192650864.46564.51
62194859-219485973.44573.50
15min12562784-256278485.75782.977.5385.9183.147.52
22440530-244053081.66681.83
32185177-218517773.12173.31
42387308-238730879.88580.04
52572573-257257386.08486.26
62727992-272799291.28591.49
20min12803055-280305593.79789.795.5794.1390.145.56
22685191-268519189.85390.18
32453425-245342582.09782.44
42582888-258288886.42986.75
52709737-270973790.67491.02
62866113-286611395.90796.29
30min12869544-286954496.02296.362.4496.5496.882.45
22852027-285202795.43595.94
32805356-280535693.87494.38
42820465-282046594.37994.87
52972221-297222199.45799.99
62957761-295776198.97399.55
45min12886473-288647396.58897.511.3697.3098.221.37
22900351-290035197.05297.75
32925653-292565397.89998.59
42869722-286972296.02796.71
52918898-291889897.67398.40
62982400-298240099.798100.57
60min12891487-289148796.75697.641.2397.6698.551.25
22904743-290474397.19998.09
32941383-294138398.42599.31
42873803-287380396.16497.04
52924115-292411597.84898.77
62972581-297258199.469100.44
极限12899587-289958797.02798.542.3098.1299.642.28
23063290-3063290102.505103.59
32931996-293199698.11199.19
42873320-287332096.14897.21
52924030-292403097.84598.96
62976874-297687499.613100.79
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%
110.283052823305154930508333050513305009930511630.04
210.253054735305181930532770.07
单位质量响应值RSD%判断
296805.74297880.680.26数据可信
供试品溶液-25110902批-pH6.8(内含1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11164164-116416438.99637.199.8439.0037.199.85
21095327-109532736.69036.69
31015197-101519734.00634.01
41254697-125469742.02842.03
5959332-95933232.13532.13
61172483-117248339.27439.27
10min12155478-215547872.20269.632.7272.2869.702.72
22073973-207397369.47169.54
32078892-207889269.63669.70
42052081-205208168.73868.82
52120303-212030371.02371.09
61991441-199144166.70766.79
15min12756585-275658592.33790.433.2992.5690.653.28
22722767-272276791.20491.42
32816603-281660394.34794.55
42626985-262698587.99588.22
52704564-270456490.59490.80
62570991-257099186.12086.33
20min12934438-293443898.29496.991.7898.7097.391.77
22898069-289806997.07697.47
32967904-296790499.41599.81
42839074-283907495.10095.50
52895439-289543996.98897.38
62838930-283893095.09595.48
30min13011305-3011305100.86999.800.70101.47100.390.70
22970549-297054999.504100.09
32970971-297097199.518100.11
42950398-295039898.82999.42
52989873-2989873100.151100.73
62983231-298323199.929100.50
45min13044196-3044196101.971100.120.91102.78100.910.92
22979186-297918699.793100.58
32975192-297519299.659100.45
42975070-297507099.655100.44
52983596-298359699.941100.72
62977182-297718299.726100.50
60min13007681-3007681100.74899.710.57101.76100.700.58
22972246-297224699.561100.55
32980564-298056499.839100.83
42969257-296925799.460100.45
52958051-295805199.085100.07
62971786-297178699.545100.52
极限12998752-2998752100.44899.910.44101.66101.100.44
22982209-298220999.894101.08
32996014-2996014100.357101.55
42969905-296990599.482100.67
52967200-296720099.392100.57
62982388-298238899.900101.07
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