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%
112.014730274727374723144727454723284726300.07
212.124687744688084687910.01
单位质量响应值RSD%判断
39353.0438679.131.23数据可信
供试品溶液-24062601批-氢氯噻嗪-pH6.8(内含0.35%吐温20)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1313044-31304457.60055.377.4657.6055.377.46
2270290-27029049.73349.73
3282000-28200051.88851.89
4298790-29879054.97754.98
5308771-30877156.81456.81
6332651-33265161.20861.21
10min1436609-43660980.33678.816.4880.4378.906.48
2378711-37871169.68369.77
3420079-42007977.29477.38
4442331-44233181.38981.48
5431392-43139279.37679.47
6460613-46061384.75384.85
15min1460156-46015684.66884.713.4284.9084.933.43
2433999-43399979.85680.05
3453317-45331783.41083.63
4474219-47421987.25687.48
5463157-46315785.22185.45
6477372-47737287.83688.08
20min1466394-46639485.81686.921.8686.1987.281.87
2460878-46087884.80185.13
3468112-46811286.13286.49
4480615-48061588.43388.81
5474781-47478187.35987.73
6483546-48354688.97289.36
30min1478568-47856888.05689.431.0588.5789.941.06
2480919-48091988.48988.96
3487628-48762889.72390.22
4488728-48872889.92690.45
5488690-48869089.91990.43
6491545-49154590.44490.98
45min1491930-49193090.51591.560.7191.1892.220.70
2496379-49637991.33391.95
3501113-50111392.20492.85
4496336-49633691.32692.00
5501002-50100292.18492.85
6498912-49891291.80092.49
60min1499618-49961891.92993.000.9792.7493.810.96
2505612-50561293.03293.81
3511348-51134894.08894.89
4502671-50267192.49193.31
5511159-51115994.05394.87
6502242-50224292.41293.25
极限1531632-53163297.82098.720.8698.7899.680.87
2531014-53101497.70698.63
3538097-53809799.01099.97
4540257-54025799.407100.38
5535737-53573798.57599.55
6542392-54239299.800100.80
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%
116.013031703033533033433034603034213033490.04
215.852962642960892961760.05
单位质量响应值RSD%判断
18947.4718686.180.99数据可信
供试品溶液-24062601批-坎地沙坦酯-pH6.8(内含0.35%吐温20)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1143052-14305242.68042.096.6742.6842.096.66
2128896-12889638.45638.46
3131814-13181439.32739.33
4142630-14263042.55442.55
5145601-14560143.44043.44
6154512-15451246.09946.10
10min1245556-24555673.26272.317.4473.3372.387.44
2210895-21089562.92162.98
3236916-23691670.68470.75
4249817-24981774.53374.60
5245673-24567373.29773.37
6265272-26527279.14479.22
15min1285826-28582685.27685.355.4585.4785.545.45
2258927-25892777.25177.42
3282698-28269884.34384.53
4298515-29851589.06289.26
5286774-28677485.55985.75
6303629-30362990.58890.80
20min1303825-30382590.64791.383.6890.9891.713.69
2287117-28711785.66285.96
3305802-30580291.23691.56
4316025-31602594.28694.63
5305798-30579891.23591.57
6319128-31912895.21295.57
30min1319736-31973695.39496.462.1095.8896.952.12
2312307-31230793.17793.62
3325439-32543997.09597.57
4329246-32924698.23198.73
5322409-32240996.19196.68
6330780-33078098.68999.21
45min1327953-32795397.84598.421.2898.4999.071.30
2323170-32317096.41897.01
3333356-33335699.457100.09
4333590-33359099.527100.19
5328112-32811297.89398.54
6333151-33315199.396100.08
60min1328950-32895098.14398.741.1798.9599.551.19
2324379-32437996.77997.54
3334508-33450899.801100.60
4334026-33402699.657100.49
5330532-33053298.61599.43
6333284-33328499.436100.28
极限1335451-335451100.082100.570.78101.05101.540.81
2333699-33369999.559100.48
3336390-336390100.362101.33
4338392-338392100.960101.96
5337259-337259100.622101.60
6341336-341336101.838102.85
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%
112.014703064710844706564703024704034705500.08
212.124679414680754680080.03
单位质量响应值RSD%判断
39179.8538614.521.03数据可信
供试品溶液-24062602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%
5min1310242-31024257.25852.2419.3257.2652.2419.31
2279805-27980551.64051.64
3303859-30385956.08056.08
4244526-24452645.12945.13
5358286-35828666.12466.12
6201730-20173037.23137.23
10min1468995-46899586.55782.199.0486.6582.279.05
2457785-45778584.48884.57
3455803-45580384.12284.22
4402025-40202574.19774.27
5495513-49551391.45191.56
6391741-39174172.29972.36
15min1485900-48590089.67789.204.2789.9289.424.29
2499555-49955592.19792.42
3491205-49120590.65690.89
4458306-45830684.58484.78
5506648-50664893.50693.77
6458335-45833584.58984.77
20min1490166-49016690.46491.362.8990.8591.732.91
2511746-51174694.44794.83
3501354-50135492.52992.91
4474548-47454887.58287.92
5507459-50745993.65694.07
6484849-48484989.48389.81
30min1496831-49683191.69493.082.2592.2393.602.27
2517958-51795895.59396.13
3510445-51044594.20794.75
4486281-48628189.74790.23
5510530-51053094.22294.80
6503923-50392393.00393.48
45min1502567-50256792.75394.351.9993.4595.031.99
2524110-52411096.72997.43
3516376-51637695.30196.00
4496057-49605791.55192.19
5513008-51300894.68095.41
6515121-51512195.07095.70
60min1505598-50559893.31294.911.8894.1695.751.87
2526232-52623297.12097.98
3518541-51854195.70196.56
4500546-50054692.38093.17
5514217-51421794.90395.79
6520405-52040596.04596.83
极限1540878-54087899.823101.301.30100.83102.301.31
2554955-554955102.421103.44
3557968-557968102.977103.99
4546164-546164100.799101.74
5551691-551691101.819102.87
6541669-54166999.969100.92
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%
116.013035453032883033873032993031223033280.06
215.852958912959912959410.03
单位质量响应值RSD%判断
18946.1618671.361.04数据可信
供试品溶液-24062602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%
5min1135602-13560240.47536.9117.1540.4736.9117.14
2122435-12243536.54436.54
3129257-12925738.58138.58
4110793-11079333.07033.07
5152799-15279945.60845.61
691153-9115327.20727.21
10min1251184-25118474.97469.9110.2475.0469.9710.24
2234051-23405169.86069.92
3239252-23925271.41271.48
4214746-21474664.09864.15
5266029-26602979.40579.48
6200054-20005459.71259.76
15min1291148-29114886.90285.285.0287.0985.465.03
2288131-28813186.00286.18
3288128-28812886.00186.18
4274590-27459081.96082.12
5306852-30685291.58991.80
6265384-26538479.21279.36
20min1308034-30803491.94292.083.2992.2892.403.31
2312428-31242893.25493.57
3309650-30965092.42592.75
4301892-30189290.10990.41
5324500-32450096.85797.22
6294434-29443487.88388.16
30min1321145-32114595.85696.451.5796.3596.931.59
2328575-32857598.07398.55
3324468-32446896.84797.33
4318328-31832895.01595.46
5329079-32907998.22498.75
6317308-31730894.71095.13
45min1323759-32375996.63697.701.4197.2998.331.42
2334097-33409799.721100.36
3328486-32848698.04798.69
4322708-32270896.32296.93
5330891-33089198.76599.45
6323918-32391896.68397.26
60min1323787-32378796.64497.761.3297.4698.561.33
2334023-33402399.699100.51
3328087-32808797.92898.73
4322866-32286696.36997.14
5330772-33077298.72999.58
6325577-32557797.17897.92
极限1332114-33211499.130100.371.14100.10101.331.15
2341517-341517101.936102.91
3339510-339510101.337102.31
4334860-33486099.949100.88
5337097-337097100.617101.63
6332430-33243099.224100.13
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%
112.014659634658654657144658874659014658660.02
212.124641114640124640620.02
单位质量响应值RSD%判断
38789.8438288.940.92数据可信
供试品溶液-24062603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%
5min1343857-34385764.05059.3616.4864.0559.3616.48
2297010-29701055.32455.32
3403469-40346975.15475.15
4280200-28020052.19352.19
5256581-25658147.79347.79
6331070-33107061.66861.67
10min1416008-41600877.48976.517.6777.6076.617.68
2390148-39014872.67372.76
3464873-46487386.59286.72
4395824-39582473.73073.82
5375751-37575169.99170.07
6421772-42177278.56378.67
15min1463055-46305586.25385.413.8486.4985.643.86
2442227-44222782.37382.59
3490301-49030191.32891.60
4452425-45242584.27384.48
5444030-44403082.70982.91
6459091-45909185.51585.75
20min1486104-48610490.54689.542.4890.9389.912.50
2467646-46764687.10887.46
3501253-50125393.36893.79
4472061-47206187.93088.28
5478320-47832089.09689.43
6478861-47886189.19789.57
30min1501962-50196293.50092.851.7394.0393.361.75
2489254-48925491.13391.63
3513388-51338895.62896.21
4491975-49197591.64092.14
5495926-49592692.37692.86
6498174-49817492.79493.32
45min1516688-51668896.24396.001.3496.9396.671.36
2508078-50807894.63995.29
3527850-52785098.32299.06
4511340-51134095.24795.90
5512536-51253695.47096.11
6515696-51569696.05896.74
60min1527671-52767198.28998.301.0299.1499.141.05
2521696-52169697.17697.98
3537439-537439100.108101.01
4525312-52531297.84998.66
5525516-52551697.88798.68
6528821-52882198.50399.34
极限1544171-544171101.362101.800.48102.37102.790.46
2548977-548977102.258103.22
3546895-546895101.870102.94
4546132-546132101.728102.70
5549741-549741102.400103.36
6543100-543100101.163102.17
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%
116.013021533022953021703021613022223022000.02
215.852963202962492962840.02
单位质量响应值RSD%判断
18875.7018693.000.69数据可信
供试品溶液-24062603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%
5min1134027-13402740.05536.9314.1140.0636.9414.12
2116968-11696834.95734.96
3151662-15166245.32645.33
4110255-11025532.95132.95
5103606-10360630.96430.96
6124988-12498837.35437.35
10min1209533-20953362.62160.917.8962.6960.977.90
2194086-19408658.00458.06
3229115-22911568.47368.55
4196161-19616158.62558.68
5183312-18331254.78554.84
6210581-21058162.93463.00
15min1254559-25455976.07775.614.0776.2575.774.08
2244779-24477973.15573.31
3269928-26992880.67180.86
4251028-25102875.02275.17
5240630-24063071.91572.06
6256961-25696176.79576.96
20min1282447-28244784.41284.332.2184.7184.622.23
2275089-27508982.21382.49
3293225-29322587.63387.96
4280374-28037483.79284.07
5278196-27819683.14283.40
6283803-28380384.81785.11
30min1306648-30664891.64592.161.1192.0892.591.12
2303926-30392690.83191.25
3313736-31373693.76394.23
4306762-30676291.67992.10
5308946-30894692.33192.73
6310236-31023692.71793.15
45min1318745-31874595.26095.640.5895.8596.220.59
2317906-31790695.00995.57
3322740-32274096.45497.08
4319018-31901895.34295.91
5321494-32149496.08296.64
6320109-32010995.66896.26
60min1321509-32150996.08696.320.4496.8497.070.44
2320733-32073395.85496.58
3324066-32406696.85097.64
4321143-32114395.97796.71
5323711-32371196.74497.46
6322653-32265396.42897.18
极限1324589-32458997.00796.860.5197.9297.760.51
2324544-32454496.99397.88
3325187-32518797.18598.13
4322334-32233496.33397.22
5326001-32600197.42998.31
6321860-32186096.19197.10
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