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%
110.043033498303984030402013042409303642530384750.12
210.143027527302631330269200.03
单位质量响应值RSD%判断
302636.95298512.820.98数据可信
供试品溶液-24081301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%
5min1696690-69669023.08722.422.1223.0922.422.12
2665612-66561222.05722.06
3679317-67931722.51122.51
4686161-68616122.73822.74
5675230-67523022.37622.38
6656618-65661821.75921.76
10min11337739-133773944.33043.551.3744.3843.591.37
21290458-129045842.76342.81
31319025-131902543.71043.75
41328618-132861844.02844.07
51310458-131045843.42643.47
61298392-129839243.02643.07
15min11810560-181056059.99859.410.8760.1359.540.88
21774832-177483258.81458.94
31801754-180175459.70759.84
41802611-180261159.73559.87
51793687-179368759.43959.57
61772973-177297358.75358.88
20min12131588-213158870.63770.560.6470.8970.820.64
22113248-211324870.02970.28
32125811-212581170.44570.70
42146329-214632971.12571.38
52142870-214287071.01171.26
62116536-211653670.13870.38
30min12462977-246297781.61882.440.8482.0182.830.84
22481318-248131882.22682.61
32470594-247059481.87182.26
42498182-249818282.78583.18
52520191-252019183.51483.91
62493733-249373382.63783.02
45min12628368-262836887.09988.361.2087.6688.921.19
22710153-271015389.80990.36
32635244-263524487.32787.88
42658137-265813788.08688.65
52690138-269013889.14689.71
62676110-267611088.68189.23
60min12689504-268950489.12590.100.8689.8690.840.85
22733753-273375390.59191.32
32694335-269433589.28590.02
42719999-271999990.13590.87
52749634-274963491.11891.86
62726863-272686390.36391.09
极限12704948-270494889.63790.960.9990.5591.870.98
22749150-274915091.10192.01
32725837-272583790.32991.24
42743370-274337090.91091.83
52781383-278138392.17093.09
62763880-276388091.59092.50
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%
110.043025050303067530311493023597302923930279420.12
210.143028630302854630285880.01
单位质量响应值RSD%判断
301587.85298677.320.69数据可信
供试品溶液-25020301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%
5min1384600-38460012.76313.058.6112.7613.058.60
2360708-36070811.97011.97
3377167-37716712.51712.52
4379366-37936612.59012.59
5457248-45724815.17415.17
6400290-40029013.28413.28
10min1694730-69473023.05524.497.4523.0824.517.44
2705779-70577923.42223.45
3734302-73430224.36924.39
4715007-71500723.72823.75
5845587-84558728.06228.09
6731584-73158424.27824.30
15min11034027-103402734.31536.205.2334.3936.275.22
21065177-106517735.34935.42
31105473-110547336.68636.76
41061671-106167135.23335.31
51196527-119652739.70839.79
61081326-108132635.88535.96
20min11331041-133104144.17246.324.2144.3146.464.21
21376285-137628545.67445.82
31399562-139956246.44646.59
41367189-136718945.37245.51
51504343-150434349.92350.09
61395828-139582846.32246.47
30min11758265-175826558.35060.882.9558.5861.122.95
21816146-181614660.27160.50
31835498-183549860.91361.15
41811503-181150360.11760.35
51916576-191657663.60463.87
61868138-186813861.99662.24
45min12134806-213480670.84672.341.6071.1972.711.62
22154167-215416771.48871.84
32191526-219152672.72873.09
42164700-216470071.83872.19
52227002-222700273.90674.30
62207643-220764373.26373.63
60min12353953-235395378.11978.200.7678.6178.700.77
22328677-232867777.28077.78
32368556-236855678.60379.11
42347159-234715977.89378.39
52380623-238062379.00479.54
62358743-235874378.27878.79
极限12485015-248501582.46882.390.3883.1183.050.40
22472005-247200582.03682.69
32479490-247949082.28582.95
42483663-248366382.42383.08
52498851-249885182.92783.63
62476282-247628282.17882.84
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