坎地沙坦酯氨氯地平片项目信息
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2000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.217641876659766377713376736767170.35
216.337665876447765520.20
单位质量响应值RSD%判断
4732.704687.810.68数据可信
坎地沙坦酯--供试品溶液-6041401批-pH4.0(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12079-20792.4782.3813.732.482.3813.69
22177-21772.5952.59
32017-20172.4042.40
41466-14661.7471.75
52228-22282.6552.66
62008-20082.3932.39
10min13653-36534.3544.259.214.364.259.24
23855-38554.5954.60
33741-37414.4594.46
42928-29283.4903.49
53654-36544.3554.36
63539-35394.2184.22
15min15270-52706.2815.984.666.295.994.65
25094-50946.0716.08
34826-48265.7525.76
44648-46485.5405.55
55117-51176.0996.11
65161-51616.1516.16
20min16743-67438.0377.584.568.067.604.56
26327-63277.5417.56
36389-63897.6157.64
45848-58486.9706.99
56392-63927.6187.64
66445-64457.6817.70
30min18358-83589.9619.931.6410.009.971.64
28343-83439.9449.98
38164-81649.7309.76
48187-81879.7589.79
58498-849810.12810.16
68455-845510.07710.11
45min110631-1063112.67012.491.5112.7212.541.52
210701-1070112.75412.81
310432-1043212.43312.48
410320-1032012.30012.35
510476-1047612.48612.54
610320-1032012.30012.35
60min112505-1250514.90414.661.2614.9814.731.28
212234-1223414.58114.65
312273-1227314.62714.70
412089-1208914.40814.47
512233-1223314.58014.65
612451-1245114.84014.91
极限113478-1347816.06416.000.9516.1616.090.97
213337-1333715.89615.99
313602-1360216.21116.31
413318-1331815.87315.96
513288-1328815.83715.93
613518-1351816.11116.21
坎地沙坦酯氨氯地平片项目信息
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2000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.217707576884767247658776627767790.27
216.337703876413767260.58
单位质量响应值RSD%判断
4736.524698.470.58数据可信
坎地沙坦酯--供试品溶液-6041501批-pH4.0(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11729-17292.0581.949.222.061.949.26
21662-16621.9781.98
31465-14651.7431.74
41717-17172.0432.04
51785-17852.1242.12
61423-14231.6931.69
10min13399-33994.0454.203.234.054.213.23
23535-35354.2074.21
33475-34754.1354.14
43454-34544.1104.11
53675-36754.3734.38
63664-36644.3604.36
15min14863-48635.7875.963.205.805.983.20
25207-52076.1966.21
34847-48475.7685.78
44938-49385.8765.89
55201-52016.1896.20
65008-50085.9605.97
20min16098-60987.2577.434.107.287.454.10
26523-65237.7627.78
36124-61247.2887.31
45867-58676.9827.00
56469-64697.6987.72
66391-63917.6057.63
30min17930-79309.4379.711.789.479.741.77
28251-82519.8199.85
38091-80919.6289.66
48094-80949.6329.66
58317-83179.8979.93
68260-82609.8299.86
45min19958-995811.85012.262.5011.9012.312.49
210557-1055712.56312.61
310392-1039212.36712.41
410131-1013112.05612.10
510182-1018212.11712.17
610610-1061012.62612.68
60min111984-1198414.26114.481.8814.3314.551.89
212551-1255114.93615.01
312108-1210814.40914.48
411962-1196214.23514.30
512070-1207014.36314.43
612324-1232414.66614.74
极限113087-1308715.57415.881.1815.6615.971.19
213443-1344315.99716.09
313375-1337515.91616.01
413341-1334115.87615.97
513259-1325915.77815.87
613544-1354416.11716.21
坎地沙坦酯氨氯地平片项目信息
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2000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.217651876698767757668577254767860.37
216.337624577403768241.07
单位质量响应值RSD%判断
4736.954704.470.49数据可信
坎地沙坦酯--供试品溶液-6041502批-pH4.0(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11478-14781.7581.6422.331.761.6422.33
21137-11371.3521.35
31797-17972.1372.14
4922-9221.0961.10
51520-15201.8081.81
61424-14241.6931.69
10min13497-34974.1593.967.474.163.967.42
23142-31423.7363.74
33650-36504.3414.34
42957-29573.5163.52
53384-33844.0244.03
63346-33463.9793.98
15min15288-52886.2885.786.496.305.786.49
24867-48675.7885.80
35148-51486.1226.13
44459-44595.3035.31
54760-47605.6615.67
64617-46175.4905.50
20min16459-64597.6817.126.237.707.146.20
26077-60777.2277.24
36376-63767.5827.60
45602-56026.6626.68
55699-56996.7776.80
65704-57046.7836.80
30min18370-83709.9549.373.599.999.403.59
27781-77819.2539.28
38006-80069.5219.55
47642-76429.0889.12
57847-78479.3329.36
67607-76079.0469.08
45min110306-1030612.25611.912.2812.3111.952.29
210104-1010412.01612.06
310046-1004611.94712.00
49786-978611.63711.68
510127-1012712.04312.09
69697-969711.53211.58
60min112042-1204214.32013.991.5414.3914.051.54
211715-1171513.93114.00
311900-1190014.15114.22
411649-1164913.85313.92
511717-1171713.93414.00
611539-1153913.72213.79
极限113248-1324815.75415.401.7115.8515.491.72
212758-1275815.17215.26
313211-1321115.71015.80
412773-1277315.19015.27
512823-1282315.24915.34
612894-1289415.33315.42
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