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%
111.834440854439234438274439624440364439670.03
211.944427684422534425100.09
单位质量响应值RSD%判断
37528.9137061.140.89数据可信
供试品溶液-2024082721批-氢氯噻嗪-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1401776-40177677.33571.225.9377.3471.225.93
2354112-35411268.16168.16
3361097-36109769.50569.51
4345986-34598666.59766.60
5365543-36554370.36170.36
6391551-39155175.36775.37
10min1512443-51244398.63795.602.0498.7795.722.04
2496388-49638895.54795.66
3490735-49073594.45894.57
4485035-48503593.36193.47
5491195-49119594.54794.66
6504350-50435097.07997.20
15min1526636-526636101.369100.170.74101.66100.450.74
2521455-521455100.372100.64
3515919-51591999.30699.58
4519770-519770100.047100.31
5517132-51713299.53999.81
6521685-521685100.416100.70
20min1531070-531070102.222100.960.75102.68101.410.75
2522095-522095100.495100.93
3523960-523960100.854101.29
4526400-526400101.323101.76
5519671-519671100.028100.47
6524033-524033100.868101.32
30min1534545-534545102.891101.670.87103.52102.280.87
2522244-522244100.523101.13
3530216-530216102.058102.66
4531194-531194102.246102.85
5525122-525122101.077101.68
6525829-525829101.213101.84
45min1536294-536294103.228101.911.11104.03102.691.10
2521572-521572100.394101.17
3533440-533440102.678103.46
4533718-533718102.732103.50
5526727-526727101.386102.16
6524961-524961101.046101.84
60min1535507-535507103.076101.931.14104.05102.891.13
2521448-521448100.370101.31
3534753-534753102.931103.88
4534186-534186102.822103.77
5526483-526483101.339102.28
6525076-525076101.069102.03
极限1539916-539916103.925103.970.71105.07105.090.71
2537198-537198103.402104.51
3537499-537499103.460104.58
4547475-547475105.380106.50
5538200-538200103.595104.71
6540621-540621104.061105.19
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%
116.171516341521121517461517181517701517960.13
216.221516701516171516440.03
单位质量响应值RSD%判断
9387.519349.200.29数据可信
供试品溶液-2024082721批-坎地沙坦酯-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
极限1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
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%
111.834428124425634428624425414429334427420.05
211.944434244434524434380.01
单位质量响应值RSD%判断
37425.3637138.860.55数据可信
供试品溶液-2024082721批-氢氯噻嗪-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1360885-36088569.48768.1611.2469.4968.1611.24
2292530-29253056.32556.33
3372892-37289271.79971.80
4369593-36959371.16471.16
5323469-32346962.28362.28
6404530-40453077.89077.89
10min1475735-47573591.60192.595.4091.7292.705.41
2441333-44133384.97785.07
3495255-49525595.35995.48
4495417-49541795.39095.51
5463866-46386689.31589.42
6513538-51353898.87999.01
15min1515540-51554099.265100.091.7599.53100.361.76
2507639-50763997.74497.98
3528253-528253101.713101.99
4527094-527094101.490101.77
5512455-51245598.67198.92
6527912-527912101.647101.94
20min1529999-529999102.049102.350.85102.48102.780.86
2529131-529131101.882102.28
3538757-538757103.735104.18
4533280-533280102.681103.13
5525509-525509101.184101.60
6532637-532637102.557103.02
30min1537326-537326103.460103.600.56104.06104.210.55
2538516-538516103.689104.26
3543557-543557104.660105.28
4537734-537734103.538104.16
5536244-536244103.251103.84
6534961-534961103.004103.64
45min1538581-538581103.701103.990.65104.48104.770.64
2540041-540041103.983104.72
3546765-546765105.277106.07
4539638-539638103.905104.70
5538750-538750103.734104.49
6536718-536718103.343104.15
60min1537491-537491103.492103.900.62104.44104.850.62
2539584-539584103.895104.81
3545888-545888105.108106.08
4539947-539947103.964104.93
5536938-536938103.385104.32
6537672-537672103.526104.51
极限1537275-537275103.450103.920.66104.57105.040.65
2541035-541035104.174105.26
3546262-546262105.180106.33
4538491-538491103.684104.82
5537842-537842103.559104.66
6537263-537263103.448104.60
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%
116.171516881518171518471517691518301517900.05
216.221522771523311523040.03
单位质量响应值RSD%判断
9387.149389.890.03数据可信
供试品溶液-2024082721批-坎地沙坦酯-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
极限1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
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