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%
19.992938835294043529400932939293293925529395820.03
210.072943964294383829439010.01
单位质量响应值RSD%判断
294252.45292343.690.47数据可信
供试品溶液-6030301批-pH1.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1479083-47908316.26915.692.8016.2715.692.79
2466310-46631015.83515.84
3446285-44628515.15515.16
4473065-47306516.06516.06
5450625-45062515.30315.30
6457080-45708015.52215.52
10min11079700-107970036.66635.812.1436.6935.832.14
21067523-106752336.25236.28
31026144-102614434.84734.87
41070672-107067236.35936.38
51028736-102873634.93534.96
61054158-105415835.79835.82
15min11575677-157567753.50852.481.3853.5952.561.39
21556505-155650552.85752.94
31517075-151707551.51851.59
41548186-154818652.57552.65
51525518-152551851.80551.88
61549432-154943252.61752.69
20min11966829-196682966.79265.781.0666.9565.941.06
21951065-195106566.25666.41
31909861-190986164.85765.01
41940188-194018865.88766.04
51921524-192152465.25365.41
61932717-193271765.63365.79
30min12464401-246440183.68983.260.5983.9583.520.59
22456105-245610583.40783.66
32426703-242670382.40882.66
42465221-246522183.71683.97
52445832-244583283.05883.31
62452703-245270383.29183.55
45min12758286-275828693.66993.380.4694.0593.760.46
22747594-274759493.30693.69
32732575-273257592.79593.17
42769154-276915494.03894.42
52747481-274748193.30293.68
62744420-274442093.19893.58
60min12851803-285180396.84496.590.4797.3797.110.47
22839465-283946596.42596.95
32826987-282698796.00296.51
42865689-286568997.31697.84
52844712-284471296.60497.12
62837545-283754596.36096.88
极限12900730-290073098.50698.130.5599.1898.800.55
22888062-288806298.07698.74
32867089-286708997.36398.02
42912582-291258298.90899.58
52888327-288832798.08598.75
62880915-288091597.83398.50
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%
19.992935683293817429304422937874293574529355840.11
210.072940125294132429407240.03
单位质量响应值RSD%判断
293852.25292028.200.45数据可信
供试品溶液-6030302批-pH1.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1533159-53315918.12818.642.4118.1318.642.40
2550419-55041918.71418.71
3533100-53310018.12618.13
4547103-54710318.60218.60
5562918-56291819.13919.14
6562066-56206619.11019.11
10min11160178-116017839.44739.682.4139.4739.702.42
21155974-115597439.30439.33
31138707-113870738.71738.74
41150670-115067039.12339.15
51217877-121787741.40841.44
61178168-117816840.05840.09
15min11664346-166434656.58856.541.8456.6756.631.84
21646137-164613755.96956.06
31637336-163733655.67055.76
41640838-164083855.78955.88
51719448-171944858.46258.55
61669295-166929556.75756.85
20min12056377-205637769.91869.761.4170.0969.941.41
22034230-203423069.16569.34
32026802-202680268.91269.08
42031674-203167469.07869.25
52104126-210412671.54171.72
62057958-205795869.97170.15
30min12562659-256265987.13286.720.6887.4187.000.68
22530605-253060586.04286.32
32538096-253809686.29686.57
42540955-254095586.39486.67
52576398-257639887.59987.88
62554680-255468086.86087.14
45min12836159-283615996.43196.290.2796.8496.700.27
22823458-282345895.99996.40
32831930-283193096.28796.69
42828903-282890396.18496.59
52826989-282698996.11996.54
62844624-284462496.71897.13
60min12895198-289519898.43898.380.4098.9998.930.40
22887378-288737898.17298.72
32899354-289935498.57999.13
42882707-288270798.01398.56
52883847-288384798.05298.61
62912632-291263299.03199.58
极限12929324-292932499.59899.420.40100.30100.120.40
22914327-291432799.08899.78
32927426-292742699.534100.23
42916101-291610199.14999.84
52913920-291392099.07599.78
62942957-2942957100.062100.76
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