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(%)99.70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%
1 11.664579904576464579664577654580214578780.04
2 11.714569164568054568600.02
单位质量响应值RSD%判断
39269.1339014.520.46数据可信
供试品溶液-506993批-氢氯噻嗪-含0.35%吐温20的磷酸盐缓冲液（pH6.5）
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1342728-34272862.85564.757.1162.8664.757.11
2337068-33706861.81761.82
3389032-38903271.34771.35
4362630-36263066.50566.51
5318803-31880358.46758.47
6368102-36810267.50967.51
10min1465240-46524085.32388.154.9085.4388.264.90
2464223-46422385.13785.24
3466186-46618685.49785.62
4489561-48956189.78489.89
5474161-47416186.96087.06
6524573-52457396.20596.32
15min1506220-50622092.83994.102.9793.0994.362.97
2497629-49762991.26391.51
3499089-49908991.53191.79
4523987-52398796.09796.36
5515134-51513494.47494.72
6536598-53659898.41098.68
20min1526288-52628896.51997.051.6496.9297.461.65
2519886-51988695.34595.74
3519729-51972995.31795.73
4540011-54001199.03699.46
5531853-53185397.54097.94
6537369-53736998.55298.99
30min1529728-52972897.15097.890.8097.7198.460.81
2529143-52914397.04397.60
3532890-53289097.73098.30
4540345-54034599.09799.68
5533709-53370997.88098.44
6536693-53669398.42899.03
45min1530059-53005997.21197.970.6597.9498.710.66
2532524-53252497.66398.38
3533097-53309797.76898.50
4539924-53992499.02099.77
5533233-53323397.79398.52
6536468-53646898.38699.15
60min1529076-52907697.03197.700.7297.9298.600.73
2529154-52915497.04597.93
3531808-53180897.53298.43
4538481-53848198.75699.67
5531619-53161997.49798.39
6536112-53611298.32199.25
极限1527913-52791396.81797.360.6497.8798.420.65
2527426-52742696.72897.77
3530045-53004597.20898.27
4535712-53571298.24899.33
5529855-52985597.17498.22
6534158-53415897.96399.06
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(%)99.80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%
1 15.873041233045753041773041143044953042970.08
2 15.863045243042013043620.08
单位质量响应值RSD%判断
19174.3519190.540.06数据可信
供试品溶液-506993批-坎地沙坦酯-含0.35%吐温20的磷酸盐缓冲液（pH6.5）
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min183772-8377224.51624.386.7624.5224.386.76
282853-8285324.24724.25
391008-9100826.63426.63
484079-8407924.60624.61
573503-7350321.51121.51
684712-8471224.79124.79
10min1171894-17189450.30552.044.3950.3552.084.39
2171335-17133550.14150.18
3177068-17706851.81951.86
4181907-18190753.23553.28
5173151-17315150.67350.71
6191514-19151456.04756.09
15min1230753-23075367.53069.614.1467.6569.744.14
2229887-22988767.27767.40
3231268-23126867.68167.81
4244793-24479371.63971.77
5236071-23607169.08669.21
6254452-25445274.46574.60
20min1274689-27468980.38881.242.5380.6381.482.54
2270646-27064679.20579.44
3270800-27080079.25079.49
4283551-28355182.98183.23
5277922-27792281.33481.57
6287980-28798084.27784.54
30min1312186-31218691.36192.731.7091.7393.111.70
2314025-31402591.90092.27
3311476-31147691.15491.53
4321170-32117093.99194.38
5317383-31738392.88293.25
6325006-32500695.11395.51
45min1331642-33164297.05598.090.9797.5898.620.98
2332943-33294397.43697.96
3332802-33280297.39597.92
4339024-33902499.21699.76
5335754-33575498.25998.78
6338935-33893599.18999.75
60min1335257-33525798.11399.080.7998.8099.780.79
2337142-33714298.66599.35
3337562-33756298.78899.48
4341132-34113299.832100.54
5337948-33794898.90199.59
6342303-342303100.175100.90
极限1334464-33446497.88198.920.7598.7399.780.76
2338089-33808998.94299.79
3336496-33649698.47699.33
4340902-34090299.765100.64
5337186-33718698.67899.53
6340858-34085899.752100.64
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(%)99.70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%
1 11.664557384562874562294558904563864561060.07
2 11.714541324546024543670.08
单位质量响应值RSD%判断
39117.1538801.620.58数据可信
供试品溶液-506993批-氢氯噻嗪
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1346970-34697063.93157.1917.5963.9357.1917.59
2318316-31831658.65258.65
3395878-39587872.94372.94
4247678-24767845.63645.64
5277900-27790051.20551.20
6275690-27569050.79850.80
10min1488884-48888490.08086.875.9990.1986.966.00
2467662-46766286.17086.27
3496860-49686091.55091.67
4417979-41797977.01577.09
5484116-48411689.20189.29
6473217-47321787.19387.28
15min1524841-52484196.70593.754.1696.9693.994.16
2521999-52199996.18296.42
3514252-51425294.75495.03
4467025-46702586.05286.26
5511918-51191894.32494.56
6512825-51282594.49194.72
20min1536449-53644998.84495.583.0899.2695.983.09
2527307-52730797.16097.56
3520650-52065095.93396.37
4489107-48910790.12190.47
5520609-52060995.92696.32
6518208-51820895.48395.87
30min1539619-53961999.42896.971.88100.0197.531.89
2527938-52793897.27697.84
3527565-52756597.20797.80
4509091-50909193.80394.30
5528496-52849697.37997.93
6524989-52498996.73397.28
45min1540602-54060299.60997.421.53100.3698.131.55
2528277-52827797.33898.06
3529963-52996397.64998.40
4515330-51533094.95395.61
5530519-53051997.75298.46
6527468-52746897.18997.90
60min1540539-54053999.59897.381.42100.5198.261.44
2526145-52614596.94697.83
3528623-52862397.40298.32
4517350-51735095.32596.14
5530597-53059797.76698.64
6527786-52778697.24898.12
极限1538611-53861199.24397.411.03100.3298.451.04
2524725-52472596.68497.73
3528640-52864097.40598.48
4525180-52518096.76897.74
5530256-53025697.70398.74
6524631-52463196.66797.70
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(%)99.80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%
1 15.873037613040243041753040993043573040830.08
2 15.863025983037033031500.26
单位质量响应值RSD%判断
19160.8719114.120.18数据可信
供试品溶液-506993批-坎地沙坦酯
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min185589-8558925.10723.2215.0425.1123.2215.04
276388-7638822.40822.41
399399-9939929.15829.16
467403-6740319.77219.77
577275-7727522.66822.67
668783-6878320.17720.18
10min1180514-18051452.95252.347.5752.9952.387.57
2169667-16966749.77049.81
3198094-19809458.10958.16
4158960-15896046.62946.66
5186252-18625254.63554.67
6177078-17707851.94451.98
15min1243814-24381471.52070.975.0771.6571.105.07
2234542-23454268.80068.92
3254445-25444574.63874.78
4221172-22117264.87864.99
5251031-25103173.63773.77
6246691-24669172.36472.48
20min1284343-28434383.40981.952.8983.6682.202.91
2274846-27484680.62380.86
3287450-28745084.32084.59
4265276-26527677.81678.03
5282648-28264882.91183.16
6281712-28171282.63782.88
30min1326714-32671495.83893.352.2996.2393.732.30
2313281-31328191.89792.27
3320084-32008493.89394.30
4306360-30636089.86790.22
5322647-32264794.64595.03
6320274-32027493.94994.33
45min1346566-346566101.66198.732.16102.2199.262.16
2332602-33260297.56598.09
3335191-33519198.32498.89
4325788-32578895.56696.06
5341811-341811100.266100.81
6337415-33741598.97799.51
60min1348013-348013102.08599.091.90102.8099.801.91
2335390-33539098.38399.07
3337097-33709798.88399.61
4328628-32862896.39997.06
5340939-340939100.010100.73
6336834-33683498.80699.51
极限1344268-344268100.98798.841.21101.8799.701.21
2333698-33369897.88698.74
3335666-33566698.46499.36
4333391-33339197.79698.61
5338612-33861299.328100.21
6335983-33598398.55799.42
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