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%
112.474800134796374796644795864796554797110.04
212.534783014783834783420.02
单位质量响应值RSD%判断
38469.2138175.740.55数据可信
加速3月-供试品溶液-2024082721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%
5min1304875-30487557.10957.166.5457.1157.166.54
2301384-30138456.45556.45
3326157-32615761.09561.10
4268756-26875650.34350.34
5317798-31779859.52959.53
6312001-31200158.44458.44
10min1446441-44644183.62783.592.6783.7283.682.67
2439208-43920882.27282.37
3437582-43758281.96782.07
4433526-43352681.20781.29
5457083-45708385.62085.72
6463617-46361786.84486.94
15min1475702-47570289.10890.141.8689.3490.371.85
2472642-47264288.53588.77
3472721-47272188.54988.79
4483682-48368290.60390.82
5488477-48847791.50191.74
6493938-49393892.52492.77
20min1485932-48593291.02492.211.7191.4192.591.70
2484043-48404390.67091.05
3484674-48467490.78891.17
4497510-49751093.19393.56
5497976-49797693.28093.67
6503445-50344594.30594.70
30min1498678-49867893.41294.861.2193.9595.401.21
2502959-50295994.21394.74
3501687-50168793.97594.51
4513161-51316196.12596.65
5509512-50951295.44195.99
6512472-51247295.99596.55
45min1510848-51084895.69197.541.1396.3898.241.13
2520429-52042997.48698.17
3518205-51820597.06997.76
4527638-52763898.83699.52
5522388-52238897.85398.56
6524864-52486498.31799.03
60min1516911-51691196.82799.171.2997.68100.021.28
2531629-53162999.584100.43
3528635-52863599.02399.88
4537226-537226100.632101.48
5529975-52997599.274100.15
6531985-53198599.651100.53
极限1525492-52549298.434100.341.2699.45101.361.25
2542008-542008101.528102.54
3533862-533862100.002101.02
4543962-543962101.894102.91
5532319-53231999.713100.75
6536194-536194100.439101.48
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%
116.621518161519161516661516581517431517600.08
216.551510851511581511220.04
单位质量响应值RSD%判断
9131.179131.240.01数据可信
加速3月-供试品溶液-2024082721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%
5min161906-6190638.05937.356.5138.0637.356.52
260670-6067037.29937.30
364618-6461839.72639.73
453256-5325632.74132.74
563138-6313838.81638.82
660904-6090437.44337.44
10min1108565-10856566.74467.773.2766.8167.833.27
2112261-11226169.01769.08
3108648-10864866.79566.86
4104584-10458464.29764.35
5113819-11381969.97570.04
6113492-11349269.77369.84
15min1128075-12807578.73980.661.9778.9180.841.98
2131628-13162880.92381.10
3129012-12901279.31579.49
4130258-13025880.08180.24
5133483-13348382.06482.25
6134744-13474482.83983.02
20min1137478-13747884.52086.611.6384.8386.921.62
2140613-14061386.44786.76
3139157-13915785.55285.86
4141748-14174887.14587.44
5142673-14267387.71488.03
6143637-14363788.30688.62
30min1145599-14559989.51291.811.4789.9692.261.46
2149544-14954491.93892.39
3148002-14800290.99091.44
4151357-15135793.05293.49
5150579-15057992.57493.04
6150910-15091092.77893.24
45min1150106-15010692.28394.501.2692.8895.111.26
2155007-15500795.29695.91
3153343-15334394.27394.88
4155436-15543695.56096.16
5153814-15381494.56395.18
6154601-15460195.04795.67
60min1151563-15156393.17995.551.4093.9396.311.40
2156253-15625396.06296.83
3154966-15496695.27196.03
4158028-15802897.15497.91
5155287-15528795.46996.24
6156413-15641396.16196.94
极限1153897-15389794.61496.541.1895.5297.461.17
2158225-15822597.27598.20
3156586-15658696.26797.19
4159145-15914597.84098.76
5156457-15645796.18897.12
6157880-15788097.06398.00
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%
112.474805334803734803814804394803154804080.02
212.534762804766214764500.06
单位质量响应值RSD%判断
38525.1038024.740.93数据可信
加速3月-供试品溶液-2024082721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%
5min1260652-26065248.88757.748.6948.8957.748.69
2296834-29683455.67355.67
3311449-31144958.41458.41
4319364-31936459.89959.90
5338244-33824463.44063.44
6320437-32043760.10060.10
10min1421177-42117778.99479.031.0779.0879.131.08
2418577-41857778.50778.60
3422816-42281679.30279.40
4416149-41614978.05178.15
5429261-42926180.51180.62
6420199-42019978.81178.91
15min1472796-47279688.67686.081.6788.8986.301.66
2458425-45842585.98186.20
3456803-45680385.67685.91
4452405-45240584.85185.08
5461180-46118086.49786.74
6452026-45202684.78085.01
20min1493756-49375692.60788.852.2192.9789.222.19
2471875-47187588.50388.87
3473215-47321588.75589.13
4466157-46615787.43187.80
5472478-47247888.61689.00
6464771-46477187.17187.54
30min1509616-50961695.58292.092.1496.1092.602.13
2485127-48512790.98991.50
3496355-49635593.09593.61
4484951-48495190.95691.47
5488665-48866591.65292.18
6481135-48113590.24090.76
45min1529331-52933199.27995.672.0999.9596.342.08
2502360-50236094.22194.89
3514262-51426296.45397.13
4507848-50784895.25095.92
5506934-50693495.07995.76
6499810-49981093.74394.41
60min1540418-540418101.35997.812.15102.2098.642.13
2512970-51297096.21197.03
3529644-52964499.338100.17
4516980-51698096.96397.79
5516576-51657696.88797.73
6512452-51245296.11496.94
极限1551905-551905103.51399.972.20104.52100.962.19
2523196-52319698.12999.11
3539314-539314101.152102.15
4534220-534220100.196101.19
5529921-52992199.390100.39
6519558-51955897.44698.43
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%
116.621522831524991524371524681523961524170.06
216.551508691507561508120.06
单位质量响应值RSD%判断
9170.709112.510.46数据可信
加速3月-供试品溶液-2024082721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%
5min152006-5200631.93738.359.0731.9438.359.06
260459-6045937.12837.13
364993-6499339.91239.91
464817-6481739.80439.80
568038-6803841.78241.78
664392-6439239.54339.54
10min1102589-10258962.99966.183.1963.0566.243.20
2105443-10544364.75264.81
3110320-11032067.74767.81
4109215-10921567.06867.13
5111965-11196568.75768.83
6107037-10703765.73165.80
15min1127876-12787678.52878.851.6278.6979.031.62
2125780-12578077.24177.41
3130197-13019779.95380.13
4129048-12904879.24879.43
5131042-13104280.47280.66
6126485-12648577.67477.85
20min1141164-14116486.68885.221.4686.9885.531.45
2137224-13722484.26884.57
3140049-14004986.00386.32
4138403-13840384.99385.30
5140025-14002585.98986.31
6135797-13579783.39283.70
30min1151886-15188693.27291.002.3993.7191.452.38
2144981-14498189.03289.47
3152857-15285793.86994.32
4147140-14714090.35890.81
5148075-14807590.93291.39
6144217-14421788.56389.01
45min1157918-15791896.97794.022.1197.5794.622.10
2150142-15014292.20192.79
3153958-15395894.54595.16
4155147-15514795.27595.88
5152097-15209793.40294.02
6149359-14935991.72192.31
60min1159413-15941397.89594.761.9098.6595.521.89
2152057-15205793.37794.12
3155939-15593995.76196.53
4153150-15315094.04994.81
5153619-15361994.33795.11
6151652-15165293.12993.87
极限1161443-16144399.14195.791.99100.0696.711.98
2153486-15348694.25595.15
3157384-15738496.64997.58
4155394-15539495.42796.34
5155333-15533395.38996.32
6152921-15292193.90894.81
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