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%
111.854770394771374772294771744774274772010.04
211.834754284759584756930.08
单位质量响应值RSD%判断
40270.1340210.740.11数据可信
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%
5min1342047-34204761.01756.8812.8861.0256.8812.88
2327908-32790858.49558.49
3272599-27259948.62848.63
4300398-30039853.58753.59
5286001-28600151.01951.02
6384032-38403268.50768.51
10min1467820-46782083.45381.125.9883.5681.225.99
2444816-44481679.35079.45
3414771-41477173.99074.07
4458340-45834081.76281.85
5446267-44626779.60979.69
6496423-49642388.55688.67
15min1501661-50166189.49087.873.2489.7388.103.25
2479756-47975685.58385.81
3476960-47696085.08485.29
4484755-48475586.47486.70
5493032-49303287.95188.17
6519331-51933192.64292.90
20min1512412-51241291.40890.212.3191.8090.592.33
2496231-49623188.52288.89
3496802-49680288.62388.97
4497017-49701788.66289.03
5506238-50623890.30790.67
6525490-52549093.74194.16
30min1527128-52712894.03392.752.1194.5893.282.13
2510899-51089991.13891.66
3515404-51540491.94292.44
4508227-50822790.66291.18
5520279-52027992.81193.33
6537555-53755595.89396.47
45min1542530-54253096.78195.461.8797.4896.141.88
2527081-52708194.02594.70
3532908-53290895.06495.71
4523641-52364193.41194.08
5533962-53396295.25295.92
6550634-55063498.22698.96
60min1550103-55010398.13296.691.7498.9997.521.75
2535820-53582095.58496.41
3541223-54122396.54897.35
4529381-52938194.43595.26
5540289-54028996.38197.21
6555188-55518899.03999.93
极限1552828-55282898.61897.061.4499.6498.061.45
2541170-54117096.53897.53
3543891-54389197.02497.99
4532457-53245794.98495.97
5541416-54141696.58297.57
6552903-55290398.63199.69
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%
116.171522331522721523511524611526051523840.10
216.121526571527261526920.04
单位质量响应值RSD%判断
9423.879472.210.37数据可信
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%
5min169969-6996941.57438.1112.4441.5738.1112.44
267144-6714439.89539.90
354835-5483532.58232.58
461907-6190736.78436.78
556005-5600533.27733.28
674959-7495944.53944.54
10min1113649-11364967.52765.197.0067.6065.257.00
2110030-11003065.37765.44
398978-9897858.81058.86
4110692-11069265.77065.83
5103894-10389461.73161.79
6121045-12104571.92272.00
15min1131314-13131478.02376.513.7278.2176.693.73
2126544-12654475.18975.36
3123833-12383373.57873.73
4126811-12681175.34875.52
5126914-12691475.40975.57
6137220-13722081.53381.73
20min1139312-13931282.77681.622.3983.0981.922.40
2136691-13669181.21881.52
3133641-13364179.40679.68
4135023-13502380.22780.52
5136772-13677281.26681.55
6142798-14279884.84785.18
30min1147432-14743287.60086.481.9188.0586.911.93
2143431-14343185.22385.66
3144027-14402785.57785.98
4142980-14298084.95585.39
5145188-14518886.26786.69
6150185-15018589.23689.71
45min1152621-15262190.68489.491.6091.2890.071.61
2148713-14871388.36288.94
3149312-14931288.71789.27
4148344-14834488.14288.71
5150308-15030889.30989.87
6154379-15437991.72892.35
60min1154554-15455491.83290.611.5692.5891.341.57
2150944-15094489.68790.41
3151844-15184490.22290.92
4149506-14950688.83389.55
5152167-15216790.41491.13
6155965-15596592.67093.44
极限1156733-15673393.12791.711.3194.0392.591.33
2153204-15320491.03091.90
3153481-15348191.19592.04
4152073-15207390.35891.22
5153628-15362891.28292.14
6156987-15698793.27894.21
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%
111.854754634754254750644753694750374752720.05
211.834734204734754734480.01
单位质量响应值RSD%判断
40107.3440020.960.16数据可信
供试品溶液-2024082521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%
5min1290911-29091152.12356.4814.3852.1256.4814.38
2343099-34309961.47461.47
3384279-38427968.85268.85
4293878-29387852.65552.65
5323987-32398758.05058.05
6255212-25521245.72745.73
10min1412709-41270973.94679.717.1174.0379.807.12
2467249-46724983.71883.82
3485147-48514786.92587.04
4448895-44889580.43080.52
5452381-45238181.05481.15
6402816-40281672.17472.25
15min1467940-46794083.84287.374.3184.0587.604.32
2502025-50202589.94990.19
3508684-50868491.14291.40
4488466-48846687.52087.74
5502015-50201589.94790.18
6456661-45666181.82182.02
20min1487945-48794587.42690.483.1087.7890.863.12
2519308-51930893.04693.44
3516035-51603592.45992.87
4507895-50789591.00191.37
5515730-51573092.40592.79
6483018-48301886.54486.88
30min1513852-51385292.06893.662.1392.5694.182.15
2535249-53524995.90296.45
3525982-52598294.24294.81
4525765-52576594.20394.72
5530223-53022395.00295.54
6505255-50525590.52891.01
45min1530646-53064695.07796.401.5595.7397.081.57
2548014-54801498.18998.90
3534966-53496695.85196.57
4542193-54219397.14697.82
5545137-54513797.67498.37
6527318-52731894.48195.11
60min1538621-53862196.50697.451.2997.3198.291.29
2552339-55233998.96499.83
3536840-53684096.18797.07
4548572-54857298.28999.13
5549489-54948998.45499.31
6537492-53749296.30497.09
极限1541675-54167597.05397.911.2598.0298.911.25
2553240-55324099.126100.16
3537393-53739396.28697.33
4552976-55297699.078100.08
5551125-55112598.74799.77
6542320-54232097.16998.11
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%
116.171527081527611526431526551525681526670.05
216.121521581521521521550.01
单位质量响应值RSD%判断
9441.379438.900.02数据可信
供试品溶液-2024082521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%
5min157616-5761634.26236.5212.0334.2636.5212.03
266641-6664139.62939.63
372376-7237643.04043.04
456695-5669533.71533.71
563018-6301837.47537.47
652149-5214931.01131.01
10min196921-9692157.63661.725.4757.6961.785.48
2107706-10770664.04964.12
3111098-11109866.06666.14
4103642-10364261.63361.69
5105885-10588562.96663.03
697436-9743657.94257.99
15min1118657-11865770.56273.653.2770.7173.813.28
2125604-12560474.69374.87
3127095-12709575.57975.76
4125450-12545074.60174.76
5127473-12747375.80475.97
6118810-11881070.65370.80
20min1129589-12958977.06279.862.6577.3380.152.66
2136580-13658081.22081.52
3135003-13500380.28280.59
4136677-13667781.27881.56
5137803-13780381.94782.24
6130144-13014477.39377.66
30min1141323-14132384.04086.251.9784.4486.671.98
2147089-14708987.46987.90
3144514-14451485.93886.38
4147676-14767687.81888.24
5147590-14759087.76788.20
6142062-14206284.48084.87
45min1148803-14880388.48890.061.5089.0390.631.51
2153538-15353891.30491.88
3149788-14978889.07489.66
4153628-15362891.35891.92
5153331-15333191.18191.76
6149612-14961288.97089.51
60min1151672-15167290.19591.151.3090.8891.861.30
2155603-15560392.53293.26
3151098-15109889.85390.59
4154698-15469891.99492.71
5154856-15485692.08892.82
6151702-15170290.21290.90
极限1153968-15396891.56092.381.1192.4093.251.11
2156806-15680693.24894.13
3153801-15380191.46192.34
4157203-15720393.48494.35
5156710-15671093.19094.07
6153638-15363891.36492.20
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