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%
19.402849839285053228506602850972285059528505200.02
29.332855639285706128563500.04
单位质量响应值RSD%判断
303246.81306146.840.68数据可信
供试品溶液-23003N1批-pH1.0(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%
5min1423478-42347813.84314.077.9813.8414.077.99
2398162-39816213.01613.02
3409470-40947013.38513.39
4429264-42926414.03214.03
5496380-49638016.22616.23
6425932-42593213.92313.92
10min1987969-98796932.29633.596.8332.3233.626.82
2991332-99133232.40632.43
3984807-98480732.19232.22
41040024-104002433.99734.03
51164359-116435938.06238.09
6996278-99627832.56732.60
15min11448216-144821647.34149.726.2847.4349.816.29
21486073-148607348.57848.67
31462356-146235647.80347.89
41515992-151599249.55649.65
51708864-170886455.86155.97
61503680-150368049.15449.25
20min11821417-182141759.54062.334.8959.7362.524.89
21879914-187991461.45261.64
31838915-183891560.11260.30
41907509-190750962.35562.55
52081954-208195468.05768.28
61910680-191068062.45862.65
30min12321265-232126575.88078.093.2576.1978.413.27
22354951-235495176.98177.29
32330944-233094476.19676.50
42395674-239567478.31278.63
52533570-253357082.82083.18
62396899-239689978.35278.67
45min12682373-268237387.68488.701.5088.1489.171.51
22691760-269176087.99188.46
32682578-268257887.69188.15
42724008-272400889.04589.52
52788790-278879091.16391.68
62710946-271094688.61889.09
60min12789540-278954091.18791.710.9591.8292.360.97
22790171-279017191.20891.85
32785482-278548291.05591.69
42811593-281159391.90892.56
52855901-285590193.35694.06
62800552-280055291.54792.20
极限12848200-284820093.10593.540.7693.9294.380.79
22849136-284913693.13593.96
32842955-284295592.93393.75
42868919-286891993.78294.62
52901781-290178194.85695.75
62858962-285896293.45794.29
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%
19.402839760283674728391522838291283820528384310.05
29.332843046284299328430200.01
单位质量响应值RSD%判断
301960.74304718.110.65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%
5min1391537-39153712.85612.563.3012.8612.563.31
2378431-37843112.42612.43
3359161-35916111.79311.79
4384189-38418912.61512.61
5390124-39012412.81012.81
6391956-39195612.87012.87
10min1984485-98448532.32631.563.5732.3531.583.57
2954039-95403931.32631.35
3917371-91737130.12230.15
41000455-100045532.85032.88
5984362-98436232.32232.35
6925474-92547430.38830.41
15min11484257-148425748.73647.833.2348.8347.923.23
21453293-145329347.71947.81
31397103-139710345.87445.96
41511399-151139949.62749.72
51488953-148895348.89048.98
61404966-140496646.13246.22
20min11899820-189982062.38161.022.7562.5761.212.75
21854950-185495060.90861.09
31787802-178780258.70358.88
41895675-189567562.24562.44
51906017-190601762.58462.77
61806560-180656059.31959.50
30min12352994-235299477.26178.532.0077.5778.832.00
22423909-242390979.58979.89
32331894-233189476.56876.86
42410064-241006479.13579.45
52458868-245886880.73781.05
62371752-237175277.87778.17
45min12675862-267586287.86290.561.8188.3391.021.80
22801101-280110191.97592.44
32745481-274548190.14890.59
42745513-274551390.14990.62
52816306-281630692.47492.95
62763210-276321090.73191.18
60min12867656-286765694.16094.490.9594.8095.130.94
22904571-290457195.37296.02
32879769-287976994.55895.18
42836385-283638593.13393.79
52910063-291006395.55296.21
62867026-286702694.13994.77
极限12914318-291431895.69296.280.6596.5297.110.65
22945514-294551496.71697.56
32939949-293994996.53497.35
42903520-290352095.33896.18
52951838-295183896.92497.77
62937480-293748096.45397.28
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%
19.402845306285142128472702847635284434028471940.10
29.332839741284189228408160.06
单位质量响应值RSD%判断
302892.98304481.890.37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%
5min1479276-47927615.71915.561.4815.7215.561.48
2465557-46555715.26915.27
3470926-47092615.44515.45
4484528-48452815.89115.89
5469643-46964315.40315.40
6477026-47702615.64515.65
10min11137577-113757737.30936.990.6337.3437.020.63
21118284-111828436.67636.71
31126200-112620036.93636.97
41134054-113405437.19437.23
51127098-112709836.96637.00
61123639-112363936.85236.88
15min11661369-166136954.48853.940.6354.5954.040.63
21645148-164514853.95654.06
31650890-165089054.14454.25
41639948-163994853.78653.89
51635810-163581053.65053.75
61633967-163396753.58953.69
20min12083568-208356868.33567.530.8268.5567.750.82
22064692-206469267.71667.93
32066091-206609167.76267.97
42040317-204031766.91667.13
52039687-203968766.89667.11
62060535-206053567.58067.79
30min12612728-261272885.69084.561.0486.0484.911.04
22596986-259698685.17485.52
32592492-259249285.02685.37
42544888-254488883.46583.81
52570611-257061184.30984.65
62552850-255285083.72684.07
45min12915355-291535595.61594.321.1196.1494.831.11
22896466-289646694.99695.51
32896466-289646694.99695.51
42866718-286671894.02094.53
52839683-283968393.13393.65
62840146-284014693.14993.66
60min12983656-298365697.85596.531.3698.5797.241.35
22950853-295085396.77997.49
32956201-295620196.95597.66
42979425-297942597.71798.42
52889749-288974994.77595.48
62899203-289920395.08595.79
极限13015548-301554898.90197.750.8399.8198.650.83
22990609-299060998.08398.98
32997292-299729298.30299.21
42967504-296750497.32698.22
52951844-295184496.81297.70
62959801-295980197.07397.96
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