维格列汀片项目信息
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101002-200701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200
标示量(mg)50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%
110.012585282586432584362591932593342588270.16
210.052587292588042587660.03
单位质量响应值RSD%判断
25856.8425747.860.30数据可信
稳定性考察-中间条件36月-供试品溶液-S210101批-50mg-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1232281-23228189.66390.992.9789.6690.992.97
2247241-24724195.43895.44
3234985-23498590.70790.71
4232052-23205289.57589.58
5240201-24020192.72192.72
6227581-22758187.84987.85
10min1243961-24396194.17295.593.0794.3195.733.06
2253484-25348497.84897.99
3241903-24190393.37893.51
4242925-24292593.77293.91
5260438-260438100.532100.67
6243093-24309393.83793.97
15min1246332-24633295.08796.773.2095.3697.053.20
2255009-25500998.43798.73
3244974-24497494.56394.84
4245361-24536194.71394.99
5265222-265222102.379102.67
6247251-24725195.44295.71
20min1247404-24740495.50197.292.9895.9297.712.98
2254993-25499398.43198.87
3246228-24622895.04795.47
4248206-24820695.81196.23
5266008-266008102.683103.13
6249318-24931896.24096.66
30min1248034-24803495.74497.912.8696.3198.492.86
2257485-25748599.39399.98
3248734-24873496.01596.58
4250314-25031496.62497.19
5266735-266735102.963103.56
6250636-25063696.74997.31
45min1250762-25076296.79798.512.4397.5099.222.43
2257933-25793399.566100.30
3251009-25100996.89397.60
4252232-25223297.36598.07
5266644-266644102.928103.68
6252553-25255397.48998.19
维格列汀片项目信息
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101002-200701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200
标示量(mg)50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%
110.012549602549172548182545312547552547960.07
210.052552552554202553380.05
单位质量响应值RSD%判断
25454.1525406.770.14数据可信
稳定性考察-中间条件36月-供试品溶液-S210102批-50mg-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1231959-23195990.84894.893.3990.8594.893.39
2250848-25084898.24698.25
3237289-23728992.93692.94
4252945-25294599.06899.07
5238121-23812193.26293.26
6242506-24250694.97994.98
10min1244028-24402895.57598.322.2895.7198.472.28
2255086-25508699.906100.05
3248053-24805397.15297.29
4260144-260144101.887102.04
5249122-24912297.57097.71
6249857-24985797.85898.00
15min1246442-24644296.52198.921.8796.8099.201.87
2254757-25475799.777100.07
3249473-24947397.70897.99
4260118-260118101.877102.18
5253287-25328799.20299.49
6251265-25126598.41098.70
20min1248282-24828297.24199.341.5597.6799.781.55
2256493-256493100.457100.90
3252079-25207998.72899.16
4259572-259572101.663102.12
5253312-25331299.21199.65
6252185-25218598.77099.21
30min1249153-24915397.58299.351.4398.1599.941.43
2254910-25491099.837100.43
3251822-25182298.62899.21
4259227-259227101.528102.13
5255627-255627100.118100.70
6251333-25133398.43699.02
45min1252081-25208198.72999.251.1199.4599.991.12
2255448-255448100.048100.80
3251438-25143898.47799.21
4257951-257951101.028101.79
5253074-25307499.11899.85
6250451-25045198.09198.82
维格列汀片项目信息
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101002-200701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200
标示量(mg)50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%
110.012630562636422641072640882643102638410.20
210.052639292641722640500.07
单位质量响应值RSD%判断
26357.7426273.630.23数据可信
稳定性考察-中间条件36月-供试品溶液-S210103批-50mg-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1239033-23903390.47091.382.5590.4791.382.56
2246977-24697793.47693.48
3234921-23492188.91388.91
4241101-24110191.25291.25
5236139-23613989.37489.37
6250488-25048894.80594.81
10min1245918-24591893.07695.462.5693.2195.602.56
2252680-25268095.63595.78
3259031-25903198.03998.17
4247722-24772293.75893.90
5247074-24707493.51393.65
6260901-26090198.74698.89
15min1250256-25025694.71896.322.4294.9996.602.41
2252153-25215395.43595.72
3259937-25993798.38298.66
4248760-24876094.15194.43
5251680-25168095.25695.53
6264211-26421199.999100.29
20min1249826-24982694.55596.582.3194.9797.002.31
2252556-25255695.58896.01
3259409-25940998.18298.61
4251009-25100995.00295.42
5253164-25316495.81896.24
6265093-265093100.333100.77
30min1251441-25144195.16696.812.3595.7397.382.35
2253797-25379796.05896.63
3259717-25971798.29898.87
4250310-25031094.73895.30
5253425-25342595.91796.48
6266083-266083100.708101.30
45min1252068-25206895.40396.832.0296.1197.552.02
2253186-25318695.82696.54
3258335-25833597.77598.50
4251157-25115795.05995.76
5255354-25535496.64797.35
6264948-264948100.278101.02
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