美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号D211-4R701-2402002对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.12208153
208153+0
208136
208136+0
208146
208146+0
208051
208051+0
207974
207974+0
2080920.04
218.11206428
206428+0
206307
206307+0
2063680.05
单位质量响应值RSD%判断
11484.1111395.250.55数据可信
供试品溶液-pH7.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
24041601批1183482.4
171108+15468*0.8
183382.4
170992+15488*0.8
183432.489.7589.191.9587.37%~91.00%
2186686
174058+15785*0.8
187283.8
174667+15771*0.8
186984.991.48
3180932.4
168854+15098*0.8
181250
169150+15125*0.8
181091.288.60
4179938.8
167950+14986*0.8
179963
167975+14985*0.8
179950.988.04
5184886.2
172779+15134*0.8
185107
173003+15130*0.8
184996.690.51
6177281.6
165968+14142*0.8
177302
166018+14105*0.8
177291.886.74
24041701批1179098.6
166773+15407*0.8
177388.8
165232+15196*0.8
178243.787.2187.082.3484.95%~89.22%
2173991
161967+15030*0.8
174292.4
162258+15043*0.8
174141.785.20
3179957.8
167801+15196*0.8
180184.8
167996+15236*0.8
180071.388.10
4171499.6
159890+14512*0.8
172250
160558+14615*0.8
171874.884.09
5182106.8
169926+15226*0.8
182104.6
169923+15227*0.8
182105.789.10
6181600.8
169644+14946*0.8
181457.6
169536+14902*0.8
181529.288.81
24040701批1178465.8
166621+14806*0.8
178672.8
166828+14806*0.8
178569.387.3788.001.9586.21%~89.80%
2176511.2
164616+14869*0.8
178000.4
165982+15023*0.8
177255.886.72
3183554.6
171205+15437*0.8
183773
171413+15450*0.8
183663.889.86
4184719
172419+15375*0.8
185200
172864+15420*0.8
18496090.49
5177305.8
165601+14631*0.8
176638.2
164987+14564*0.8
176972.086.59
6177736.6
166375+14202*0.8
177885.2
166490+14244*0.8
177810.987.00
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