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%
19.661438119143707714369981437040143573314369930.06
29.601431438143189814316680.03
单位质量响应值RSD%判断
148757.04149132.080.18数据可信
长期18月-供试品溶液-2023010511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%
5min1341857-34185722.86020.2913.6422.8620.3013.64
2307569-30756920.56720.57
3254748-25474817.03517.04
4330294-33029422.08722.09
5249751-24975116.70116.70
6336581-33658122.50722.51
10min1589029-58902939.38942.3210.1839.4342.3610.18
2679017-67901745.40645.45
3551883-55188336.90536.94
4679645-67964545.44845.49
5588065-58806539.32439.36
6709979-70997947.47747.52
15min1854484-85448457.14061.278.3457.2661.408.34
2952263-95226363.67863.81
3825988-82598855.23455.34
4980887-98088765.59365.73
5869931-86993158.17358.28
61014072-101407267.81267.95
20min11078905-107890572.14776.066.3172.3976.316.32
21178305-117830578.79479.05
31051733-105173370.33070.55
41194158-119415879.85480.12
51093938-109393873.15273.38
61227785-122778582.10382.38
30min11354960-135496090.60793.673.5390.9994.073.55
21428591-142859195.53195.95
31334819-133481989.26089.62
41437773-143777396.14596.57
51388669-138866992.86193.24
61459732-145973297.61398.05
45min11473384-147338498.52698.391.4599.0998.981.46
21471142-147114298.37698.98
31433875-143387595.88496.42
41470186-147018698.31298.93
51498786-1498786100.225100.79
61481136-148113699.04499.68
60min11478713-147871398.88298.092.2899.6498.872.27
21415640-141564094.66595.47
31442834-144283496.48397.21
41469538-146953898.26999.08
51511375-1511375101.067101.83
61482941-148294199.165100.00
极限11477327-147732798.79099.001.3699.7599.981.36
21478167-147816798.84699.84
31452096-145209697.10398.02
41474003-147400398.56899.58
51513752-1513752101.226102.19
61487586-148758699.476100.51
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%
19.661440551143815414379251438845143808814387130.08
29.601437388143798114376840.03
单位质量响应值RSD%判断
148935.09149758.750.39数据可信
长期18月-供试品溶液-2023010511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%
5min1264929-26492917.66818.1610.6317.6718.1610.63
2269622-26962217.98117.98
3328720-32872021.92321.92
4261101-26110117.41317.41
5265137-26513717.68217.68
6244602-24460216.31316.31
10min1618793-61879341.26840.587.6041.3040.627.60
2583094-58309438.88738.92
3691347-69134746.10746.15
4586104-58610439.08839.12
5613564-61356440.91940.95
6558207-55820737.22737.26
15min1920218-92021861.37059.595.5861.4959.715.58
2861946-86194657.48457.60
3978473-97847365.25565.39
4865007-86500757.68857.80
5893762-89376259.60659.72
6842038-84203856.15656.26
20min11152718-115271876.87674.504.6377.1274.734.63
21073189-107318971.57271.80
31195774-119577479.74780.01
41075944-107594471.75671.98
51132438-113243875.52375.76
61072178-107217871.50471.72
30min11428249-142824995.25192.802.4995.6593.192.50
21357172-135717290.51190.88
31430519-143051995.40395.83
41360785-136078590.75291.12
51407765-140776593.88594.27
61364665-136466591.01191.37
45min11477213-147721398.51798.130.6499.1098.700.62
21473750-147375098.28698.84
31459795-145979597.35597.97
41483309-148330998.92399.48
51460683-146068397.41497.99
61473838-147383898.29298.84
60min11475376-147537698.39498.330.8399.1899.100.80
21478593-147859398.60999.36
31457266-145726697.18698.00
41491554-149155499.473100.22
51464203-146420397.64998.42
61479672-147967298.68199.42
极限11469433-146943397.99898.621.1298.9899.581.09
21494224-149422499.651100.60
31456635-145663597.14498.15
41501588-1501588100.142101.09
51473794-147379498.28999.25
61476996-147699698.50299.44
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%
19.661432425143325714333481431830143259514326910.05
29.601435586143431014349480.07
单位质量响应值RSD%判断
148311.70149473.750.56数据可信
长期18月-供试品溶液-2023010611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%
5min1257761-25776117.24319.1212.4817.2419.1212.48
2319604-31960421.38021.38
3340963-34096322.80922.81
4268879-26887917.98717.99
5255428-25542817.08717.09
6272473-27247318.22718.23
10min1594182-59418239.74842.188.9539.7842.228.96
2677890-67789045.34745.39
3712505-71250547.66347.71
4640941-64094142.87642.91
5569638-56963838.10638.14
6587926-58792639.32939.37
15min1861400-86140057.62360.797.0357.7460.917.03
2956608-95660863.99264.13
3982668-98266865.73565.88
4959037-95903764.15564.28
5848984-84898456.79356.90
6843511-84351156.42756.54
20min11084214-108421472.52874.895.7072.7675.145.71
21155569-115556977.30277.56
31195867-119586779.99780.27
41174760-117476078.58578.84
51063300-106330071.12971.35
61043829-104382969.82770.05
30min11382404-138240492.47691.143.0392.8591.533.04
21381804-138180492.43692.85
31396721-139672193.43393.87
41388703-138870392.89793.30
51332480-133248089.13689.50
61292181-129218186.44086.81
45min11482001-148200199.13894.482.5799.7095.062.55
21395022-139502293.32093.92
31414657-141465794.63395.25
41409716-140971694.30394.90
51389533-138953392.95393.50
61383113-138311392.52393.06
60min11484767-148476799.32394.722.46100.0895.492.45
21399630-139963093.62894.42
31416545-141654594.76095.57
41406959-140695994.11894.90
51396514-139651493.42094.15
61391642-139164293.09493.82
极限11483797-148379799.25897.061.38100.2198.011.38
21445377-144537796.68897.66
31457022-145702297.46798.47
41457026-145702697.46798.44
51428952-142895295.58996.51
61433338-143333895.88396.79
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%
19.661439249144073414414041440903144131814407220.07
29.601443663144031714419900.17
单位质量响应值RSD%判断
149143.06150207.290.51数据可信
长期18月-供试品溶液-2023010611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%
5min1239871-23987115.96217.725.5015.9617.725.51
2276597-27659718.40618.41
3276515-27651518.40118.40
4269750-26975017.95017.95
5276161-27616118.37718.38
6259043-25904317.23817.24
10min1558750-55875037.18239.364.4737.2139.394.48
2627370-62737041.74841.79
3600371-60037139.95239.99
4594264-59426439.54539.58
5605453-60545340.29040.33
6562333-56233337.42037.45
15min1797562-79756253.07456.914.2753.1857.024.27
2901582-90158259.99660.12
3851856-85185656.68756.80
4857442-85744257.05857.17
5884547-88454758.86258.98
6838233-83823355.78055.89
20min11006170-100617066.95670.443.4067.1770.673.41
21080751-108075171.91972.16
31047532-104753269.70869.94
41063386-106338670.76370.99
51111584-111158473.97074.21
61041983-104198369.33969.56
30min11298506-129850686.40988.512.2986.7688.882.29
21356518-135651890.26990.65
31314366-131436687.46487.83
41314013-131401387.44187.81
51378012-137801291.70092.08
61319414-131941487.80088.16
45min11450112-145011296.49894.681.4897.0295.231.47
21446012-144601296.22596.79
31405831-140583193.55194.10
41399771-139977193.14893.69
51422570-142257094.66595.23
61412724-141272494.01094.54
60min11476812-147681298.27495.411.7998.9996.141.77
21451281-145128196.57597.33
31425636-142563694.86995.60
41407756-140775693.67994.41
51422913-142291394.68895.44
61418038-141803894.36395.09
极限11475597-147559798.19497.110.9199.1098.040.91
21464943-146494397.48598.43
31466612-146661297.59698.52
41451550-145155096.59397.51
51459464-145946497.12098.07
61437651-143765195.66896.58
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