坎地沙坦酯氢氯噻嗪片项目信息
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(%)99.7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%
1 12.014544974543494543824542674541224543230.04
2 12.094488674490214489440.03
单位质量响应值RSD%判断
37828.7337133.501.32数据可信
中间条件18月-供试品溶液-2024082721批-氢氯噻嗪-含0.35%吐温20的磷酸盐缓冲液（pH6.8）
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1353116-35311667.63559.5310.4967.6359.5310.49
2278705-27870553.38253.38
3280952-28095253.81353.81
4286306-28630654.83854.84
5335807-33580764.31964.32
6330057-33005763.21863.22
10min1457278-45727887.58683.115.5887.7083.215.59
2406646-40664677.88877.98
3429994-42999482.36082.45
4407657-40765778.08178.17
5437471-43747183.79283.90
6464306-46430688.93289.04
15min1483102-48310292.53291.382.2692.7991.622.28
2465506-46550689.16289.38
3480107-48010791.95892.19
4464001-46400188.87389.09
5477535-47753591.46691.71
6492259-49225994.28694.54
20min1492478-49247894.32893.881.6794.7494.271.68
2481766-48176692.27692.64
3493426-49342694.50994.89
4479034-47903491.75392.12
5493342-49334294.49394.89
6500726-50072695.90896.32
30min1506392-50639296.99396.391.3797.5696.931.39
2496308-49630895.06195.58
3507543-50754397.21397.75
4492952-49295294.41994.94
5506095-50609596.93697.49
6510080-51008097.69998.27
45min1518171-51817199.24999.090.8499.9899.800.85
2513988-51398898.44899.13
3521100-52110099.810100.51
4510294-51029497.74098.42
5520689-52068999.731100.45
6519951-51995199.590100.32
60min1523963-523963100.358100.570.63101.26101.440.64
2524223-524223100.408101.25
3529282-529282101.377102.24
4519881-51988199.576100.42
5527824-527824101.098101.98
6525239-525239100.603101.50
极限1526266-526266100.799101.010.58101.86102.050.57
2528075-528075101.146102.16
3531414-531414101.785102.82
4522913-522913100.157101.17
5529610-529610101.440102.49
6525868-525868100.723101.79
坎地沙坦酯氢氯噻嗪片项目信息
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%
116.071528451529501530321530661528991529580.06
216.131517391518031517710.03
单位质量响应值RSD%判断
9518.239409.240.82数据可信
中间条件18月-供试品溶液-2024082721批-坎地沙坦酯-含0.35%吐温20的磷酸盐缓冲液（pH6.8）
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min169589-6958941.28136.399.5441.2836.399.54
255822-5582233.11433.11
355068-5506832.66732.67
458169-5816934.50634.51
565299-6529938.73638.74
664083-6408338.01438.01
10min1112355-11235566.65063.234.7466.7263.304.74
299762-9976259.17959.23
3103305-10330561.28161.34
4104991-10499162.28162.34
5106762-10676263.33263.40
6112414-11241466.68566.75
15min1130600-13060077.47376.202.1777.6576.362.17
2124470-12447073.83673.99
3127388-12738875.56775.72
4127626-12762675.70875.87
5128161-12816176.02676.20
6132482-13248278.58978.76
20min1138705-13870582.28182.171.2982.5982.461.30
2135860-13586080.59380.87
3138183-13818381.97182.25
4137904-13790481.80582.09
5139134-13913482.53582.83
6141323-14132383.83484.14
30min1147300-14730087.37987.350.7687.8387.780.76
2145827-14582786.50586.92
3147216-14721687.32987.75
4146283-14628386.77687.20
5147959-14795987.77088.20
6148881-14888188.31788.76
45min1152886-15288690.69390.380.5291.2890.950.53
2151272-15127289.73590.29
3152554-15255490.49691.06
4151476-15147689.85690.42
5153022-15302290.77391.35
6152921-15292190.71491.31
60min1154535-15453591.67191.490.3792.4192.220.38
2153530-15353091.07591.78
3154348-15434891.56092.28
4153518-15351891.06891.79
5154878-15487891.87492.61
6154549-15454991.67992.42
极限1155960-15596092.51692.400.3693.4193.280.36
2155480-15548092.23293.09
3156364-15636492.75693.62
4155354-15535492.15793.03
5156383-15638392.76793.65
6155046-15504691.97492.87
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