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%
111.868610228614968610018606718604008609180.05
211.658587598619968603780.27
单位质量响应值RSD%判断
72590.0573852.191.22数据可信
供试品溶液-2024070321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%
5min130070-300703.6964.4018.223.704.4018.20
247416-474165.8295.83
336169-361694.4464.45
429356-293563.6093.61
534652-346524.2604.26
637258-372584.5804.58
10min187838-8783810.79712.1911.9010.8212.2211.90
2120793-12079314.84814.88
394957-9495711.67311.70
494595-9459511.62811.65
5104050-10405012.79012.81
693003-9300311.43211.46
15min1133699-13369916.43517.295.0916.5217.385.14
2153432-15343218.86118.98
3136769-13676916.81216.90
4137863-13786316.94717.03
5144337-14433717.74317.84
6137870-13787016.94817.04
20min1173264-17326421.29821.113.8121.4721.303.82
2178232-17823221.90922.13
3164454-16445420.21520.40
4170003-17000320.89821.08
5179806-17980622.10322.30
6164844-16484420.26320.45
30min1180353-18035322.17023.443.8722.4623.743.84
2187636-18763623.06523.41
3187095-18709522.99923.29
4195531-19553124.03624.33
5201569-20156924.77825.09
6191834-19183423.58123.88
45min1212508-21250826.12225.182.6926.5425.622.59
2197159-19715924.23624.71
3202195-20219524.85525.28
4209155-20915525.71026.14
5205970-20597025.31925.77
6202223-20222324.85825.28
60min1203048-20304824.96025.071.5725.5225.651.57
2205290-20529025.23525.84
3206542-20654225.38925.95
4202792-20279224.92825.50
5207373-20737325.49126.09
6198630-19863024.41624.98
极限1204351-20435125.12025.051.1525.8225.771.17
2205522-20552225.26426.01
3200113-20011324.59925.30
4205255-20525525.23125.94
5205762-20576225.29326.03
6201728-20172824.79725.50
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%
111.868609618615998607328625678583868608490.19
211.658298528269978284240.25
单位质量响应值RSD%判断
72584.2371109.361.46数据可信
供试品溶液-2024070421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%
5min1106757-10675713.37413.095.1813.3713.095.18
296887-9688712.13812.14
3101058-10105812.66112.66
4107271-10727113.43913.44
5102699-10269912.86612.87
6112287-11228714.06714.07
10min1123787-12378715.50816.102.5815.5816.172.58
2131905-13190516.52516.59
3127356-12735615.95516.03
4128271-12827116.07016.14
5126915-12691515.90015.97
6132647-13264716.61816.70
15min1155980-15598019.54120.252.8319.7020.412.83
2159411-15941119.97120.13
3159555-15955519.98920.15
4162871-16287120.40420.57
5162400-16240020.34520.51
6169422-16942221.22521.40
20min1176635-17663522.12922.522.3522.4022.802.32
2182077-18207722.81123.08
3181384-18138422.72422.99
4186383-18638323.35023.63
5176038-17603822.05422.33
6176134-17613422.06622.35
30min1166681-16668120.88223.034.6621.2723.424.60
2186445-18644523.35823.75
3189874-18987423.78724.18
4188025-18802523.55623.96
5186980-18698023.42523.82
6184780-18478023.14923.56
45min1203359-20335925.47725.022.2625.9825.552.19
2203015-20301525.43425.96
3202104-20210425.32025.85
4201571-20157125.25325.79
5195648-19564824.51125.04
6192551-19255124.12324.66
60min1193344-19334424.22223.991.0124.8724.660.95
2191302-19130223.96624.63
3190382-19038223.85124.52
4189629-18962923.75724.43
5194357-19435724.34925.01
6190008-19000823.80424.48
极限1193499-19349924.24224.200.7925.0325.000.76
2192537-19253724.12124.92
3190595-19059523.87824.68
4194783-19478324.40225.21
5194493-19449324.36625.16
6193297-19329724.21625.02
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%
111.868163968260878244378274078285038245660.59
211.658131178154498142830.21
单位质量响应值RSD%判断
69524.9669895.540.38数据可信
供试品溶液-2024070521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%
5min1103058-10305813.30514.166.4413.3114.166.44
2122675-12267515.83815.84
3105517-10551713.62313.62
4112393-11239314.51114.51
5106721-10672113.77813.78
6107885-10788513.92913.93
10min1116048-11604814.98315.957.8115.0616.037.80
2139087-13908717.95718.05
3113476-11347614.65114.73
4117757-11775715.20315.28
5128435-12843516.58216.66
6126394-12639416.31816.40
15min1150501-15050119.43119.623.4219.5919.793.45
2160630-16063020.73820.93
3144787-14478718.69318.85
4151176-15117619.51819.68
5150761-15076119.46419.63
6153902-15390219.87020.04
20min1177266-17726622.88622.692.6823.1522.962.67
2178581-17858123.05623.36
3167355-16735521.60721.87
4180146-18014623.25823.53
5177709-17770922.94323.22
6173253-17325322.36822.65
30min1186008-18600824.01524.201.7924.4124.601.77
2189289-18928924.43824.87
3187717-18771724.23624.62
4192800-19280024.89225.29
5185831-18583123.99224.40
6183068-18306823.63524.04
45min1194701-19470125.13725.161.5925.6625.701.52
2192856-19285624.89925.47
3197574-19757425.50826.02
4191075-19107524.66925.21
5193757-19375725.01525.55
6199450-19945025.75026.28
60min1194442-19444225.10424.820.6825.7725.500.65
2192329-19232924.83125.54
3192327-19232724.83125.49
4190410-19041024.58325.26
5191720-19172024.75225.43
6192169-19216924.81025.49
极限1192673-19267324.87524.721.8325.6825.541.73
2189445-18944524.45925.30
3195933-19593325.29626.09
4193593-19359324.99425.81
5191463-19146324.71925.53
6185904-18590424.00124.82
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