西格列汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101546-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5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0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.171750061742381747361747771746631746840.17
213.241744741746521745630.08
单位质量响应值RSD%判断
13263.7813184.520.43数据可信
供试品溶液-2012030601批-50mg规格-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1187970-18797099.51498.280.7899.5198.280.78
2184811-18481197.84197.84
3185251-18525198.07498.07
4183885-18388597.35197.35
5186583-18658398.78098.78
6185305-18530598.10398.10
10min1189645-189645100.40199.020.77100.5799.180.77
2186076-18607698.51198.67
3186545-18654598.75998.92
4186087-18608798.51798.68
5187775-18777599.41199.58
6186096-18609698.52298.69
15min1189353-189353100.24698.980.71100.5899.310.71
2186727-18672798.85699.18
3186592-18659298.78499.11
4185315-18531598.10898.43
5187083-18708399.04499.37
6186748-18674898.86799.19
20min1189052-189052100.08798.660.78100.5999.160.78
2186175-18617598.56499.06
3185798-18579898.36498.86
4184879-18487997.87798.37
5186616-18661698.79799.29
6185625-18562598.27298.76
30min1188836-18883699.97298.450.86100.6499.110.86
2184941-18494197.91098.57
3186035-18603598.48999.15
4184531-18453197.69398.35
5186449-18644998.70999.37
6184971-18497197.92698.58
45min1187714-18771499.37898.120.74100.2198.940.74
2184589-18458997.72498.54
3185441-18544198.17599.00
4184080-18408097.45498.27
5185907-18590798.42299.25
6184256-18425697.54898.37
极限1187040-18704099.02197.870.70100.0298.850.70
2184079-18407997.45498.44
3185028-18502897.95698.94
4183330-18333097.05798.04
5185303-18530398.10299.09
6184357-18435797.60198.58
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