坎地氢噻片项目信息
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100309-202205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)12.5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%
111.804538414548404552804551394552164548630.14
211.824538554534964536760.06
单位质量响应值RSD%判断
38547.7138382.060.31数据可信
加速1月-供试品溶液-24032701批-氢氯噻嗪-0.35tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1416195-41619577.67263.9516.7177.6763.9516.71
2321067-32106759.91859.92
3330298-33029861.64161.64
4392035-39203573.16373.16
5342932-34293263.99964.00
6253619-25361947.33147.33
10min1488404-48840491.14785.655.8991.2885.765.90
2463075-46307586.42086.52
3448156-44815683.63683.74
4485055-48505590.52290.64
5454109-45410984.74784.85
6414902-41490277.43077.51
15min1496014-49601492.56889.583.2092.8589.833.22
2482927-48292790.12590.37
3473858-47385888.43388.67
4493869-49386992.16792.44
5479559-47955989.49789.74
6453849-45384984.69984.91
20min1498547-49854793.04090.752.6293.4891.152.65
2489045-48904591.26791.66
3484346-48434690.39090.78
4495942-49594292.55492.98
5486964-48696490.87991.28
6462706-46270686.35286.70
30min1502319-50231993.74492.142.2294.3392.702.24
2497098-49709892.77093.32
3496389-49638992.63893.18
4499648-49964893.24693.83
5494907-49490792.36192.91
6472115-47211588.10888.60
45min1505340-50534094.30893.521.6595.0694.221.68
2506958-50695894.61095.31
3504196-50419694.09594.79
4503523-50352393.96994.71
5502060-50206093.69694.40
6484577-48457790.43391.07
60min1506093-50609394.44994.131.6495.3594.991.66
2513267-51326795.78796.65
3507489-50748994.70995.56
4505740-50574094.38395.28
5505047-50504794.25395.11
6488652-48865291.19491.98
极限1531007-53100799.09898.860.81100.1699.880.80
2523164-52316497.63498.65
3526252-52625298.21199.22
4532227-53222799.326100.38
5534732-53473299.793100.81
6531130-53113099.121100.06
坎地氢噻片项目信息
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(%)99.80对照品水分(%)0对照品稀释倍数1000
标示量(mg)16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%
116.163063683051103046313045113044693050180.27
216.163049693047033048360.07
单位质量响应值RSD%判断
18874.8818863.610.05数据可信
加速1月-供试品溶液-24032701批-坎地沙坦酯-0.35tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1146789-14678943.67135.2317.7643.6735.2317.76
2107741-10774132.05432.05
3118453-11845335.24135.24
4133661-13366139.76539.77
5117925-11792535.08435.08
685885-8588525.55125.55
10min1234251-23425169.69263.727.5269.7663.787.53
2210296-21029662.56562.62
3210207-21020762.53862.60
4229700-22970068.33868.40
5211283-21128362.85862.92
6189415-18941556.35256.40
15min1274230-27423081.58677.953.8781.7778.123.89
2260021-26002177.35877.52
3256528-25652876.31976.48
4273023-27302381.22781.41
5260656-26065677.54777.71
6247640-24764073.67573.81
20min1296633-29663388.25185.992.4188.5886.282.43
2287875-28787585.64585.93
3285073-28507384.81185.10
4297177-29717788.41388.73
5288382-28838285.79686.09
6279068-27906883.02583.28
30min1319500-31950095.05493.851.2495.5394.291.26
2315080-31508093.73994.17
3312633-31263393.01193.44
4320502-32050295.35295.81
5314611-31461193.59994.03
6310474-31047492.36892.77
45min1330093-33009398.20597.430.9598.8498.020.97
2328655-32865597.77798.36
3326070-32607097.00897.59
4330716-33071698.39199.01
5327034-32703497.29597.89
6322283-32228395.88296.43
60min1332253-33225398.84898.150.8299.6498.900.84
2331305-33130598.56699.31
3328442-32844297.71498.46
4332448-33244898.90699.69
5329508-32950898.03198.78
6325416-32541696.81497.53
极限1335429-33542999.79399.600.79100.75100.520.79
2331877-33187798.73699.65
3332108-33210898.80599.72
4335973-33597399.955100.91
5338863-338863100.814101.73
6334398-33439899.486100.36
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