达格列净片项目信息
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101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
112.572051772054262048132048672050362050640.13
212.522049052045682047360.12
单位质量响应值RSD%判断
16313.7616352.720.17数据可信
加速2月-供试品溶液-2025041711批-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%
5min1109758-10975854.02859.049.0954.0359.049.09
2125041-12504161.55161.55
3102980-10298050.69250.69
4125151-12515161.60561.61
5126415-12641562.22862.23
6130327-13032764.15364.15
10min1137627-13762767.74770.787.3167.8370.877.32
2147976-14797672.84172.93
3125500-12550061.77761.85
4149925-14992573.80073.89
5147421-14742172.56872.66
6154335-15433575.97176.07
15min1148399-14839973.04976.006.3273.2376.206.32
2157927-15792777.73977.94
3137578-13757867.72367.89
4159654-15965478.58978.79
5158456-15845678.00078.20
6164365-16436580.90881.12
20min1154697-15469776.14979.175.1776.4479.485.18
2163150-16315080.31080.63
3147196-14719672.45772.73
4165935-16593581.68182.00
5164394-16439480.92381.24
6169649-16964983.50983.84
30min1160975-16097579.24082.714.6379.6583.144.64
2168315-16831582.85383.29
3156602-15660277.08777.47
4172618-17261884.97185.41
5172765-17276585.04385.48
6176865-17686587.06287.52
45min1167664-16766482.53285.724.4383.0686.274.44
2172764-17276485.04385.61
3162967-16296780.22080.71
4179026-17902688.12588.70
5179617-17961788.41688.98
6182781-18278189.97490.56
60min1172788-17278885.05587.534.1085.7088.214.12
2176044-17604486.65787.35
3166748-16674882.08182.70
4182220-18222089.69890.40
5183132-18313290.14690.85
6185997-18599791.55792.28
极限1195902-19590296.43297.011.1997.2197.821.20
2197182-19718297.06397.88
3194815-19481595.89796.64
4201410-20141099.14499.98
5195733-19573396.34997.19
6197368-19736897.15498.01
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