阿齐沙坦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68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
111.042940822959532957142958492956072954410.27
211.202952042948832950440.08
单位质量响应值RSD%判断
26760.9626343.211.12数据可信
供试品溶液-20220124批-pH5.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min18039-80392.7172.3667.462.722.3667.48
2-0.0000.00
313399-133994.5284.53
47727-77272.6112.61
53316-33161.1211.12
69450-94503.1943.19
10min165926-6592622.28021.5614.6922.3021.5814.72
253394-5339418.04518.05
373829-7382924.95124.98
470967-7096723.98424.00
551136-5113617.28217.29
667531-6753122.82322.84
15min1150614-15061450.90251.583.1051.0451.713.04
2161127-16112754.45554.55
3148339-14833950.13350.30
4153151-15315151.75951.91
5153736-15373651.95752.06
6148738-14873850.26850.41
20min1180760-18076061.09061.282.7661.5161.702.72
2190073-19007364.23764.64
3176823-17682359.75960.20
4181244-18124461.25361.69
5182732-18273261.75662.15
6176276-17627659.57460.00
30min1202609-20260968.47468.432.8269.2369.192.79
2212530-21253071.82772.59
3198126-19812666.95967.73
4202675-20267568.49669.27
5202922-20292268.58069.31
6196021-19602166.24767.00
45min1215446-21544672.81272.424.3973.9573.564.33
2209464-20946470.79171.95
3228464-22846477.21278.36
4217478-21747873.49974.66
5214824-21482472.60273.72
6199984-19998467.58768.71
60min1219511-21951174.18672.282.9475.7373.822.88
2222666-22266675.25276.80
3212115-21211571.68673.26
4208973-20897370.62572.19
5206083-20608369.64871.17
6213829-21382972.26673.76
阿齐沙坦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68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
111.042948192952542950342956322949302951340.11
211.202955332965302960320.24
单位质量响应值RSD%判断
26733.1526431.430.81数据可信
供试品溶液-20220126批-pH5.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min113627-136274.6004.0213.954.604.0213.99
211879-118794.0104.01
313355-133554.5084.51
410740-107403.6253.63
59287-92873.1353.13
612639-126394.2674.27
10min166476-6647622.44022.276.7222.4722.296.73
266505-6650522.45022.47
371157-7115724.02024.05
460098-6009820.28720.31
561516-6151620.76620.78
670026-7002623.63823.66
15min1152958-15295851.63350.932.1151.7851.082.12
2148973-14897350.28850.44
3149946-14994650.61750.78
4146433-14643349.43149.56
5151390-15139051.10451.24
6155545-15554552.50752.66
20min1180957-18095761.08560.332.3261.5260.762.32
2176318-17631859.51959.95
3177258-17725859.83660.28
4172755-17275558.31658.72
5180443-18044360.91261.33
6184579-18457962.30862.75
30min1204868-20486869.15767.462.5269.9368.222.51
2195457-19545765.98066.74
3196813-19681366.43767.21
4194436-19443665.63566.37
5201208-20120867.92168.68
6206264-20626469.62870.42
45min1219739-21973974.17770.933.3775.3472.073.35
2202362-20236268.31169.43
3205066-20506669.22370.36
4205401-20540169.33670.43
5211087-21108771.25672.39
6217124-21712473.29474.47
60min1201956-20195668.17472.864.9469.7574.404.82
2207776-20777670.13871.64
3227316-22731676.73478.26
4227539-22753976.81078.29
5210729-21072971.13572.66
6219762-21976274.18475.77
阿齐沙坦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68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
111.042945102947082947182947032951602947600.09
211.202949832950492950160.02
单位质量响应值RSD%判断
26699.2826340.710.96数据可信
供试品溶液-20220127批-pH5.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min13862-38621.3073.7265.011.313.7264.96
29258-92583.1333.13
35612-56121.8991.90
416726-167265.6595.66
58087-80872.7362.74
622467-224677.6027.60
10min156273-5627319.04122.2717.7519.0522.2917.79
262102-6210221.01321.03
353838-5383818.21718.23
473808-7380824.97425.01
563859-6385921.60821.62
684944-8494428.74228.78
15min1152758-15275851.68852.703.7451.8052.853.79
2154975-15497552.43852.57
3147483-14748349.90350.01
4157039-15703953.13653.31
5157170-15717053.18153.32
6165114-16511455.86956.07
20min1187016-18701663.27962.932.7063.6863.362.74
2185652-18565262.81863.24
3177129-17712959.93460.32
4184965-18496562.58563.05
5189185-18918564.01364.44
6191910-19191064.93565.45
30min1210245-21024571.13970.392.9371.8971.182.93
2208848-20884870.66771.44
3198405-19840567.13367.86
4203392-20339268.82169.63
5214811-21481172.68473.47
6212444-21244471.88372.76
45min1221823-22182375.05773.902.3276.2075.082.33
2219574-21957474.29675.46
3210617-21061771.26572.36
4213713-21371372.31373.51
5222088-22208875.14776.34
6222658-22265875.33976.61
60min1214384-21438472.54069.403.4874.1070.983.39
2197956-19795666.98168.56
3200148-20014867.72369.21
4208613-20861370.58772.18
5211044-21104471.41073.02
6198442-19844267.14668.84
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