坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.011712231706651706231702351697281704950.33
215.941690381692811691600.11
单位质量响应值RSD%判断
10649.2810612.300.25数据可信
供试品溶液-24092401批-pH6.5(内含0.35%吐温20)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min180152-8015242.32646.5110.5642.3346.5110.56
288249-8824946.60146.60
385793-8579345.30445.30
482633-8263343.63643.64
5106186-10618656.07356.07
685446-8544645.12145.12
10min1134180-13418070.85672.102.8971.3372.622.94
2137774-13777472.75473.27
3134668-13466871.11471.62
4133132-13313270.30370.79
5143909-14390975.99476.62
6135593-13559371.60272.10
15min1157337-15733783.08482.511.4784.3483.831.50
2154695-15469581.68983.02
3156981-15698182.89684.19
4155572-15557282.15283.42
5159726-15972684.34685.81
6153177-15317780.88882.18
20min1163231-16323186.19785.911.0588.3888.141.09
2163260-16326086.21288.45
3160097-16009784.54286.76
4163056-16305686.10488.28
5165022-16502287.14389.55
6161414-16141485.23787.43
30min1173395-17339591.56489.631.7294.7092.821.72
2170517-17051790.04493.24
3166909-16690988.13991.29
4167195-16719588.29091.43
5172807-17280791.25494.63
6167604-16760488.50691.65
45min1172035-17203590.84690.600.7495.0094.790.81
2170517-17051790.04494.24
3170871-17087190.23194.36
4171196-17119690.40394.52
5173935-17393591.84996.24
6170888-17088890.24094.37
60min1170684-17068490.13389.841.0595.3095.031.08
2169442-16944289.47794.67
3171622-17162290.62895.76
4167560-16756088.48393.60
5172403-17240391.04096.45
6169072-16907289.28194.41
极限1170774-17077490.18089.631.2196.3595.821.21
2166845-16684588.10594.29
3168179-16817988.81094.95
4170914-17091490.25496.36
5172482-17248291.08297.50
6169207-16920789.35395.47
坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.011682581682341685221683101682461683140.08
215.941691981690221691100.08
单位质量响应值RSD%判断
10513.0510609.160.65数据可信
供试品溶液-2批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min198121-9812152.15745.8416.8952.1645.8416.89
2106892-10689256.82056.82
376047-7604740.42440.42
468278-6827836.29436.29
578749-7874941.86041.86
689337-8933747.48847.49
10min1128813-12881368.47267.743.5869.0568.243.67
2134313-13431371.39572.03
3125751-12575166.84467.29
4121514-12151464.59265.00
5124217-12421766.02966.49
6129957-12995769.08069.61
15min1146271-14627177.75278.551.7779.0979.821.83
2152705-15270581.17282.60
3148707-14870779.04780.24
4146143-14614377.68478.80
5146199-14619977.71478.91
6146644-14664477.95079.25
20min1155208-15520882.50283.271.4284.7185.411.48
2160819-16081985.48587.81
3156191-15619183.02585.10
4156736-15673683.31585.30
5154430-15443082.08984.15
6156560-15656083.22185.38
30min1166805-16680588.66789.161.3691.7992.221.41
2171119-17111990.96094.24
3164749-16474987.57490.57
4168204-16820489.41192.32
5166296-16629688.39691.37
6169195-16919589.93793.02
45min1171152-17115290.97892.741.3595.0896.791.35
2177439-17743994.32098.61
3174199-17419992.59796.56
4175897-17589793.50097.40
5172458-17245891.67295.63
6175702-17570293.39697.48
60min1172781-17278191.84492.711.3896.9697.791.43
2177734-17773494.47699.81
3174106-17410692.54897.54
4172911-17291191.91396.85
5171925-17192591.38996.36
6177004-17700494.08899.21
极限1173251-17325192.09393.551.8198.2399.661.73
2178689-17868994.984101.37
3172248-17224891.56097.58
4176166-17616693.64399.61
5180529-18052995.962101.95
6175012-17501293.02999.20
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