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%
19.662862189286042128584802860543285990028603070.05
29.602865017286333528641760.05
单位质量响应值RSD%判断
296098.03298351.670.54数据可信
中间条件18月-供试品溶液-2023010811批-pH12.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1578114-57811419.37319.202.3919.3719.202.38
2571000-57100019.13419.13
3580701-58070119.46019.46
4577076-57707619.33819.34
5546657-54665718.31918.32
6584408-58440819.58419.58
10min11257816-125781642.15041.462.3042.1941.502.30
21212792-121279240.64140.68
31247653-124765341.80941.85
41228989-122898941.18441.22
51199947-119994740.21140.25
61275436-127543642.74042.78
15min11790878-179087860.01359.431.7060.1459.551.71
21752657-175265758.73258.85
31790310-179031059.99460.12
41760352-176035258.99059.11
51732521-173252158.05858.17
61814401-181440160.80160.93
20min12199524-219952473.70773.631.3673.9573.871.36
22182772-218277273.14673.38
32220604-222060474.41374.66
42181437-218143773.10173.34
52158702-215870272.33972.57
62240956-224095675.09575.34
30min12742468-274246891.90191.880.8292.2992.270.82
22720495-272049591.16591.55
32761757-276175792.54892.94
42732947-273294791.58291.97
52719225-271922591.12291.50
62773976-277397692.95793.35
45min13016437-3016437101.082100.001.18101.66100.571.18
22937429-293742998.43599.00
33008649-3008649100.821101.40
42966466-296646699.40899.98
52956041-295604199.05899.62
63019330-3019330101.179101.76
60min13037367-3037367101.784100.571.21102.56101.341.21
22946167-294616798.72799.49
33026258-3026258101.411102.19
42984909-2984909100.026100.79
52980944-298094499.893100.65
63031120-3031120101.574102.36
极限13036052-3036052101.740100.491.21102.72101.461.20
22944366-294436698.66799.63
33025624-3025624101.390102.37
42977392-297739299.774100.74
52983679-298367999.984100.94
63025803-3025803101.396102.38
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%
19.662863240286374928627922864245286338228634820.02
29.602871360286701728691880.11
单位质量响应值RSD%判断
296426.71298873.750.59数据可信
中间条件18月-供试品溶液-2023010811批-pH12.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1544339-54433918.21518.614.5918.2218.614.61
2541327-54132718.11418.11
3558239-55823918.68018.68
4533758-53375817.86117.86
5553802-55380218.53218.53
6605004-60500420.24520.25
10min11198248-119824840.09740.633.4840.1340.673.49
21207033-120703340.39140.43
31209853-120985340.48540.52
41170317-117031739.16239.20
51204482-120448240.30540.34
61295325-129532543.34543.39
15min11725109-172510957.72758.453.1957.8458.573.19
21727931-172793157.82157.94
31741638-174163858.28058.40
41693684-169368456.67556.79
51736549-173654958.11058.23
61855019-185501962.07462.20
20min12146549-214654971.82972.513.0472.0672.743.04
22151876-215187672.00772.24
32168072-216807272.54972.78
42093013-209301370.03870.27
52151395-215139571.99172.23
62290272-229027276.63976.89
30min12682169-268216989.75390.021.5590.1390.401.56
22672112-267211289.41689.79
32688849-268884989.97690.36
42647203-264720388.58288.95
52680725-268072589.70490.08
62769372-276937292.67193.08
45min12933641-293364198.16798.640.7298.7299.200.73
22934915-293491598.21098.77
32953066-295306698.81799.38
42923080-292308097.81498.36
52963524-296352499.16799.72
62979249-297924999.694100.28
60min12949410-294941098.69599.180.6099.4599.930.61
22946903-294690398.61199.36
32972665-297266599.473100.23
42948010-294801098.64899.39
52979709-297970999.709100.46
62985939-298593999.917100.71
极限12941938-294193898.44599.040.4799.3999.990.48
22946562-294656298.60099.55
32970086-297008699.387100.34
42954242-295424298.85799.79
52969431-296943199.365100.32
62975162-297516299.557100.55
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