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%
110.062899631289965028998652895046289992628988240.08
29.922891670289539128935300.10
单位质量响应值RSD%判断
288153.48291686.490.87数据可信
中间36月--供试品溶液-2023011011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%
5min1595275-59527520.45119.812.7320.4519.812.73
2556553-55655319.12119.12
3569420-56942019.56319.56
4581823-58182319.98919.99
5564513-56451319.39419.39
6592767-59276720.36520.36
10min11279345-127934543.95342.132.6543.9842.162.66
21187164-118716440.78640.81
31236414-123641442.47842.51
41222837-122283742.01142.04
51198706-119870641.18241.21
61233968-123396842.39442.42
15min11784544-178454461.30959.321.9061.4159.411.90
21696307-169630758.27858.37
31725253-172525359.27259.37
41714794-171479458.91359.01
51698719-169871958.36058.45
61739444-173944459.76059.85
20min12175129-217512974.72873.121.6774.9273.301.67
22087197-208719771.70771.88
32127864-212786473.10473.29
42127079-212707973.07773.26
52091940-209194071.87072.05
62160905-216090574.23974.42
30min12662718-266271891.47989.711.7891.7890.011.78
22565852-256585288.15188.44
32562203-256220388.02688.32
42631545-263154590.40890.70
52584178-258417888.78189.07
62661524-266152491.43891.73
45min12843223-284322397.68197.470.8498.1297.890.84
22796814-279681496.08696.50
32822247-282224796.96097.38
42851902-285190297.97998.41
52845802-284580297.76998.19
62861776-286177698.31898.75
60min12847483-284748397.82797.820.6298.4198.390.62
22822541-282254196.97097.53
32829980-282998097.22697.79
42861207-286120798.29898.87
52856688-285668898.14398.71
62865299-286529998.43999.02
极限12842042-284204297.64097.710.5398.3798.440.53
22820212-282021296.89097.60
32834812-283481297.39298.11
42855594-285559498.10698.83
52853758-285375898.04398.76
62858850-285885098.21798.94
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%
110.062893540289652028961892894202289215528945210.07
29.922895372288722828913000.20
单位质量响应值RSD%判断
287725.75291461.690.92数据可信
中间36月--供试品溶液-2023011011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%
5min1563769-56376919.39119.253.3719.3919.243.38
2542054-54205418.64418.64
3593654-59365420.41820.42
4553318-55331819.03119.03
5543743-54374318.70218.70
6560940-56094019.29319.29
10min11210022-121002241.61840.851.1241.6540.881.13
21172388-117238840.32440.35
31180722-118072240.61040.64
41182058-118205840.65640.68
51185336-118533640.76940.80
61195789-119578941.12841.16
15min11685004-168500457.95557.940.5358.0558.030.54
21694118-169411858.26858.36
31688483-168848358.07458.17
41670487-167048757.45557.54
51691558-169155858.18058.27
61678010-167801057.71457.80
20min12072295-207229571.27571.920.6671.4572.100.66
22091554-209155471.93872.11
32078764-207876471.49871.68
42098260-209826072.16872.34
52110507-211050772.59072.77
62094483-209448372.03972.22
30min12581339-258133988.78489.361.0689.0789.641.06
22579886-257988688.73489.02
32565731-256573188.24788.53
42610131-261013189.77490.06
52640590-264059090.82291.11
62610313-261031389.78090.07
45min12823548-282354897.11497.930.9897.5398.350.98
22828356-282835697.28097.70
32815737-281573796.84697.26
42870650-287065098.73499.15
52864665-286466598.52998.95
62880451-288045199.07299.49
60min12823578-282357897.11598.251.0197.6898.811.01
22839340-283934097.65898.22
32829520-282952097.32097.88
42877599-287759998.97399.54
52880592-288059299.07699.65
62888365-288836599.34499.91
极限12809859-280985996.64497.901.0497.3598.611.03
22831941-283194197.40398.11
32819837-281983796.98797.70
42872474-287247498.79799.51
52866907-286690798.60699.32
62877547-287754798.97299.69
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%
110.062892669289163428936892894871289389328933510.05
29.922892466288821028903380.11
单位质量响应值RSD%判断
287609.44291364.720.92数据可信
中间36月--供试品溶液-2023011111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%
5min1621456-62145621.38319.865.1521.3819.865.15
2543031-54303118.68418.68
3595834-59583420.50120.50
4587730-58773020.22220.22
5552521-55252119.01119.01
6562668-56266819.36019.36
10min11312778-131277845.16941.884.3845.2041.914.38
21163317-116331740.02640.05
31233910-123391042.45542.49
41193085-119308541.05141.08
51181551-118155140.65440.68
61218894-121889441.93941.97
15min11827565-182756562.88159.503.5862.9859.593.58
21650590-165059056.79256.88
31730705-173070559.54959.64
41716336-171633659.05459.15
51686078-168607858.01358.10
61764741-176474160.72060.81
20min12220973-222097376.41773.232.8676.6173.412.87
22051367-205136770.58270.75
32104854-210485472.42272.61
42128782-212878273.24573.43
52090468-209046871.92772.10
62173427-217342774.78174.96
30min12653226-265322691.29089.901.6091.6090.191.60
22554953-255495387.90988.19
32583771-258377188.90089.19
42618982-261898290.11290.40
52601529-260152989.51189.80
62664358-266435891.67391.97
45min12855199-285519998.23998.270.6898.6898.700.68
22831475-283147597.42397.83
32835136-283513697.54997.97
42871225-287122598.79199.22
52866820-286682098.63999.06
62877225-287722598.99799.43
60min12885105-288510599.26899.280.4799.8699.850.47
22876903-287690398.98699.54
32865855-286585598.60699.18
42886452-288645299.31599.89
52905396-290539699.966100.53
62892691-289269199.529100.11
极限12885066-288506699.26799.210.27100.0199.930.27
22884140-288414099.23599.94
32883485-288348599.21299.93
42878348-287834899.03699.76
52896032-289603299.644100.36
62872806-287280698.84599.58
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%
110.062894044290005628920402891735288713828930030.17
29.922882298288572228840100.09
单位质量响应值RSD%判断
287574.85290726.810.78数据可信
中间36月--供试品溶液-2023011111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%
5min1520151-52015117.91717.323.0917.9217.323.09
2506073-50607317.43317.43
3511347-51134717.61417.61
4511375-51137517.61517.62
5489979-48997916.87816.88
6478613-47861316.48716.49
10min11129296-112929638.90137.452.7638.9337.482.77
21091869-109186937.61137.64
31115606-111560638.42938.46
41060997-106099736.54836.57
51067827-106782736.78336.81
61058293-105829336.45536.48
15min11632565-163256556.23654.062.7756.3254.142.77
21614402-161440255.61155.69
31560565-156056553.75653.84
41542188-154218853.12353.20
51535499-153549952.89352.97
61531424-153142452.75352.83
20min11981374-198137468.25266.592.6668.4266.762.66
22009437-200943769.21969.38
31929617-192961766.46966.63
41901108-190110865.48765.65
51895736-189573665.30265.46
61882332-188233264.84065.00
30min12500137-250013786.12282.643.6786.3982.903.67
22374128-237412881.78182.05
32519831-251983186.80087.06
42341801-234180180.66780.93
52338312-233831280.54780.80
62319392-231939279.89580.15
45min12812941-281294196.89791.893.5497.3092.283.54
22637842-263784290.86591.26
32757976-275797695.00395.40
42607859-260785989.83290.21
52602940-260294089.66390.04
62586367-258636789.09289.47
60min12878733-287873399.16394.693.4399.7195.223.43
22710180-271018093.35793.89
32859557-285955798.50299.04
42688483-268848392.60993.12
52684846-268484692.48493.00
62671690-267169092.03192.54
极限12904583-2904583100.05395.433.12100.7596.103.12
22750303-275030394.73995.41
32850133-285013398.17898.86
42710879-271087993.38194.03
52705168-270516893.18493.84
62701524-270152493.05993.71
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