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100
标示量(mg)100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%
110.321528312152757615287581529342153008615288150.07
210.401529201153018615296940.05
单位质量响应值RSD%判断
148140.99147085.960.51数据可信
供试品溶液-23040N1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%
5min1174363-17436311.76515.3226.8811.7715.3226.88
2265643-26564317.92417.92
3145293-1452939.8049.80
4204250-20425013.78213.78
5294128-29412819.84619.85
6278521-27852118.79318.79
10min1402836-40283627.18134.8823.5627.2034.9123.56
2598289-59828940.36940.41
3344162-34416223.22223.24
4503551-50355133.97734.00
5641915-64191543.31343.35
6610809-61080941.21441.25
15min1617163-61716341.64352.0021.1941.7252.1021.20
2916264-91626461.82461.94
3539913-53991336.43036.50
4751372-75137250.69850.79
5928657-92865762.66162.79
6870250-87025058.72058.84
20min1840682-84068256.72467.3017.1656.8967.5017.17
21157380-115738078.09378.33
3754418-75441850.90451.04
4974941-97494165.78465.98
51162274-116227478.42478.68
61094534-109453473.85374.09
30min11147305-114730577.41484.579.2177.6984.909.25
21345381-134538190.77991.18
31080368-108036872.89773.14
41256046-125604684.75185.08
51344989-134498990.75291.16
61345681-134568190.79991.18
45min11370075-137007592.44595.652.2792.8796.162.34
21438618-143861897.07097.65
31382923-138292393.31293.70
41436663-143666396.93897.44
51441099-144109997.23797.83
61436167-143616796.90497.47
60min11396826-139682694.25096.931.6194.8697.621.67
21450712-145071297.88698.66
31420739-142073995.86396.44
41453928-145392898.10398.79
51453251-145325198.05798.84
61443569-144356997.40498.16
极限11439035-143903597.09898.711.2097.9099.601.26
21465289-146528998.86999.84
31447573-144757397.67498.44
41480334-148033499.885100.77
51483268-1483268100.083101.06
61462254-146225498.66599.62
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100
标示量(mg)100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%
110.321529399152936115269631529866152819715287570.08
210.401528445152982215291340.07
单位质量响应值RSD%判断
148135.37147032.120.53数据可信
供试品溶液-23040N1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%
5min1209046-20904614.10813.1617.6914.1113.1617.70
2157974-15797410.66110.66
3150598-15059810.16410.16
4207714-20771414.01814.02
5241744-24174416.31516.31
6202785-20278513.68613.69
10min1483432-48343232.62631.1518.1432.6531.1818.15
2353894-35389423.88423.90
3378437-37843725.54025.56
4510563-51056334.45734.48
5578403-57840339.03539.07
6465053-46505331.38631.41
15min1731170-73117049.34547.3815.5249.4447.4715.52
2556933-55693337.58637.66
3595347-59534740.17940.25
4767570-76757051.80251.90
5849186-84918657.31057.42
6712306-71230648.07248.16
20min1948567-94856764.01761.4613.1864.2161.6513.19
2752445-75244550.78150.93
3788456-78845653.21153.36
4984093-98409366.41566.62
51068882-106888272.13772.36
6921876-92187662.21662.40
30min11260852-126085285.09281.4010.2385.4181.7110.25
21036461-103646169.94970.19
31077539-107753972.72172.98
41286043-128604386.79387.13
51350851-135085191.16691.54
61225150-122515082.68382.99
45min11373783-137378392.71492.464.6193.2092.934.65
21275650-127565086.09186.48
31312363-131236388.56988.97
41421064-142106495.90596.41
51431312-143131296.59697.15
61406383-140638394.91495.39
60min11389887-138988793.80194.383.3394.4895.043.38
21332478-133247889.92690.48
31356943-135694391.57792.16
41442557-144255797.35598.05
51442223-144222397.33398.08
61426776-142677696.29096.96
极限11452194-145219498.00698.271.1098.8799.121.15
21434602-143460296.81897.56
31445042-144504297.52398.29
41461928-146192898.66399.56
51462363-146236398.69299.63
61480541-148054199.919100.78
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100
标示量(mg)100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%
110.321522047152177315229251522276152196215221970.03
210.401525404152643715259200.05
单位质量响应值RSD%判断
147499.71146723.080.38数据可信
供试品溶液-23040N1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%
5min1233025-23302515.77717.329.3815.7817.329.38
2290035-29003519.63719.64
3261511-26151117.70517.71
4227684-22768415.41515.42
5273685-27368518.53018.53
6249138-24913816.86816.87
10min1545536-54553636.93538.998.4536.9739.028.44
2636872-63687243.11943.16
3619682-61968241.95541.99
4511998-51199834.66434.70
5594244-59424440.23340.27
6546897-54689737.02737.06
15min1812123-81212354.98457.597.7355.0957.717.73
2938359-93835963.53163.66
3911204-91120461.69261.81
4768085-76808552.00352.10
5864934-86493458.56058.68
6809318-80931854.79454.90
20min11033793-103379369.99273.047.1370.2173.277.13
21190547-119054780.60580.86
31150361-115036177.88478.13
4993935-99393567.29467.50
51077328-107732872.94073.17
61027042-102704269.53569.75
30min11298822-129882287.93691.534.2488.2991.904.25
21425249-142524996.49596.91
31418385-141838596.03196.43
41307840-130784088.54688.89
51351380-135138091.49491.87
61309435-130943588.65489.01
45min11365737-136573792.46696.362.5093.0096.922.51
21456035-145603598.58099.19
31464307-146430799.14099.73
41426495-142649596.58097.10
51417934-141793496.00096.56
61408913-140891395.38995.92
60min11386430-138643093.86797.512.2494.5898.262.25
21472461-147246199.692100.50
31472451-147245199.691100.48
41444627-144462797.80798.52
51437502-143750297.32598.08
61427523-142752396.64997.37
极限11467933-146793399.38599.861.04100.29100.801.07
21501268-1501268101.642102.65
31480244-1480244100.219101.21
41461721-146172198.96599.87
51477906-1477906100.061101.01
61460354-146035498.87299.79
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