替米沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.868181488175318169738164398164928171170.09
211.658162268151868157060.10
单位质量响应值RSD%判断
68896.8870017.681.15数据可信
供试品溶液-2023052121批-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%
5min138115-381154.9394.875.404.944.865.44
239827-398275.1615.16
334454-344544.4654.46
439518-395185.1215.12
537065-370654.8034.80
636375-363754.7144.71
10min198980-9898012.82612.686.6712.8512.706.68
2102272-10227213.25313.28
389970-8997011.65911.68
4105741-10574113.70213.73
5100146-10014612.97713.00
689964-8996411.65811.68
15min1145294-14529418.82817.755.9618.9317.855.96
2147356-14735619.09519.20
3130071-13007116.85516.94
4139373-13937318.06118.17
5129743-12974316.81316.91
6129947-12994716.83916.93
20min1171756-17175622.25721.634.4022.4621.824.41
2174668-17466822.63422.84
3159904-15990420.72120.90
4173397-17339722.47022.67
5164129-16412921.26921.46
6157629-15762920.42620.61
30min1182747-18274723.68123.681.5824.0124.001.60
2186505-18650524.16824.50
3182854-18285423.69523.99
4185053-18505323.98024.31
5181030-18103023.45923.77
6178404-17840423.11823.42
45min1192297-19229724.91924.951.0725.3825.401.06
2191866-19186624.86325.33
3193964-19396425.13525.56
4195001-19500125.26925.73
5192942-19294225.00225.44
6189069-18906924.50024.93
60min1192377-19237724.92924.930.5025.5325.520.50
2193054-19305425.01725.62
3192117-19211724.89525.46
4191338-19133824.79425.40
5193835-19383525.11825.70
6191522-19152224.81825.38
极限1195828-19582825.37625.270.7426.1126.000.69
2194924-19492425.25926.00
3194437-19443725.19625.90
4193014-19301425.01225.75
5194746-19474625.23625.96
6197282-19728225.56526.27
替米沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.868162048162588159188165208149868159770.08
211.658145358140848143100.04
单位质量响应值RSD%判断
68800.7669897.851.12数据可信
供试品溶液-2023052121批-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%
5min199397-9939712.90012.632.3212.9012.632.33
297327-9732712.63212.63
393324-9332412.11212.11
498830-9883012.82712.83
598669-9866912.80612.81
696369-9636912.50712.51
10min1115433-11543314.98215.063.5015.0515.133.50
2114064-11406414.80414.87
3111265-11126514.44114.51
4119475-11947515.50615.58
5113900-11390014.78314.85
6122296-12229615.87215.94
15min1145443-14544318.87619.033.9919.0319.183.99
2146744-14674419.04519.20
3140109-14010918.18418.33
4151542-15154219.66819.83
5140937-14093718.29218.44
6155030-15503020.12120.28
20min1172710-17271022.41522.261.7022.6822.521.72
2172927-17292722.44322.70
3168709-16870921.89622.14
4175039-17503922.71822.98
5167270-16727021.70921.96
6172373-17237322.37222.64
30min1178023-17802323.10523.901.9223.4924.281.91
2187191-18719124.29524.68
3183407-18340723.80424.17
4186585-18658524.21624.61
5182782-18278223.72324.10
6186786-18678624.24224.64
45min1192643-19264325.00224.870.4725.5225.390.45
2190331-19033124.70225.22
3192660-19266025.00525.51
4191629-19162924.87125.40
5191415-19141524.84325.35
6191226-19122624.81825.35
60min1188240-18824024.43124.552.0225.0825.211.94
2191048-19104824.79525.45
3190517-19051724.72625.37
4190710-19071024.75125.42
5192577-19257724.99425.64
6181930-18193023.61224.28
极限1190120-19012024.67524.561.1925.4625.351.18
2189261-18926124.56325.36
3186198-18619824.16624.94
4192838-19283825.02825.83
5189383-18938324.57925.36
6187812-18781224.37525.17
替米沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.868145088147568150438135708134138142580.09
211.658162118136248149180.23
单位质量响应值RSD%判断
68655.8269950.041.33数据可信
供试品溶液-F73103批-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%
5min199164-9916412.87914.2510.0812.8814.2510.09
294118-9411812.22412.22
3113643-11364314.75914.76
4111847-11184714.52614.53
5115871-11587115.04915.05
6123829-12382916.08216.08
10min1102653-10265313.33214.998.9913.4015.079.00
2106940-10694013.88913.96
3113811-11381114.78114.86
4114064-11406414.81414.89
5125836-12583616.34316.43
6129183-12918316.77816.87
15min1120910-12091015.70317.156.6415.8517.316.66
2126034-12603416.36916.51
3131801-13180117.11817.28
4129496-12949616.81816.98
5139127-13912718.06918.24
6144968-14496818.82819.01
20min1140818-14081818.28919.927.6518.5220.187.66
2145256-14525618.86519.10
3150347-15034719.52619.79
4148071-14807119.23119.49
5166961-16696121.68421.96
6168948-16894821.94222.23
30min1155178-15517820.15422.396.4320.4922.756.44
2162397-16239721.09121.43
3177658-17765823.07423.44
4175583-17558322.80423.17
5179855-17985523.35923.75
6183512-18351223.83424.24
45min1183938-18393823.88924.614.0624.3425.114.08
2186311-18631124.19724.66
3178887-17888723.23323.73
4193656-19365625.15125.64
5195196-19519625.35125.88
6199086-19908625.85626.40
60min1189931-18993124.66724.850.7725.2525.480.80
2190477-19047724.73825.33
3193077-19307725.07625.70
4191691-19169124.89625.53
5192934-19293425.05725.72
6189857-18985724.65825.34
极限1194807-19480725.30124.871.0326.0225.640.95
2189199-18919924.57225.30
3191175-19117524.82925.59
4192531-19253125.00525.77
5190848-19084824.78725.59
6190300-19030024.71525.54
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