替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100309-202205对照品来源中检所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10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.455018650279502195017850182502090.09
213.435042250355503880.10
单位质量响应值RSD%判断
3733.013751.900.36数据可信
供试品溶液-F94945批-氢氯噻嗪-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min133226-3322663.73168.334.3063.7368.334.30
237236-3723671.42371.42
336303-3630369.63369.63
436949-3694970.87270.87
534558-3455866.28666.29
635471-3547168.03768.04
10min143357-4335783.16486.354.3083.5286.724.28
245512-4551287.29787.69
344349-4434985.06685.45
444754-4475485.84386.24
543518-4351883.47283.84
648607-4860793.23493.61
15min147130-4713090.40193.953.0591.2294.813.05
251138-5113898.08898.97
349480-4948094.90895.77
449159-4915994.29295.16
547416-4741690.94991.78
649558-4955895.05895.95
20min147312-4731290.75096.053.1392.0797.433.12
251704-5170499.174100.60
349881-4988195.67797.06
449867-4986795.65097.04
550262-5026296.40897.75
651431-5143198.650100.07
30min150442-5044296.75398.791.8698.58100.711.87
251852-5185299.458101.44
351218-5121898.242100.16
451320-5132098.437100.36
550988-5098897.80199.67
653212-53212102.067104.04
45min148548-4854893.12097.262.9395.4899.722.92
251193-5119398.194100.72
351753-5175399.268101.73
450607-5060797.07099.54
549518-4951894.98197.40
652603-52603100.898103.44
60min149248-4924894.46399.112.8297.34102.122.77
251770-5177099.301102.38
352020-5202099.780102.80
451613-5161398.999102.01
553812-53812103.217106.16
651573-5157398.923102.02
90min149314-4931494.59097.771.6797.99101.321.70
251420-5142098.629102.26
351194-5119498.196101.77
451211-5121198.228101.79
550961-5096197.749101.27
651719-5171999.203102.85
120min148179-4817992.41397.432.7096.34101.532.67
250507-5050796.878101.05
351806-5180699.370103.49
451026-5102697.874101.98
551622-5162299.017103.08
651622-5162299.017103.22
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限149842-4984295.60397.252.05100.04101.882.04
251356-5135698.507103.22
351297-5129798.393103.06
449957-4995795.823100.47
549603-4960395.14499.75
652147-52147100.024104.77
替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检所对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.061789041790761793421788841794461791300.15
211.081801241806181803710.20
单位质量响应值RSD%判断
16196.2016278.970.37数据可信
供试品溶液-F94945批-替米沙坦-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min116690-166909.2518.1612.759.258.1612.76
213840-138407.6717.67
314439-144398.0038.00
415637-156378.6678.67
511569-115696.4126.41
616165-161658.9608.96
10min141108-4110822.78520.5314.4622.8420.5814.47
235039-3503919.42119.46
333476-3347618.55518.60
440386-4038622.38522.43
529149-2914916.15716.19
643102-4310223.89023.94
15min162481-6248134.63232.1412.7934.8132.3012.79
258330-5833032.33132.48
354491-5449130.20330.35
464160-6416035.56235.73
544861-4486124.86524.99
663632-6363235.27035.45
20min177157-7715742.76640.8411.7043.1441.1811.72
273438-7343840.70541.03
369485-6948538.51438.83
480856-8085644.81645.19
558937-5893732.66732.93
682223-8222345.57445.95
30min1109745-10974560.82955.2713.1561.4455.8413.14
297786-9778654.20054.76
391770-9177050.86651.39
4109730-10973060.82061.44
578215-7821543.35243.80
6111075-11107561.56662.20
45min1128892-12889271.44166.929.4472.3967.799.48
2122014-12201467.62968.49
3110044-11004460.99461.81
4128569-12856971.26272.22
5103593-10359357.41958.10
6131272-13127272.76173.73
60min1144560-14456080.12678.645.1881.4779.885.23
2147727-14772781.88183.11
3129583-12958371.82472.98
4147832-14783281.93983.29
5136358-13635875.58076.58
6145217-14521780.49081.87
90min1169644-16964494.02991.253.2395.8292.933.30
2166213-16621392.12793.82
3155066-15506685.94987.50
4166272-16627292.16093.97
5162280-16228089.94791.37
6168260-16826093.26295.09
120min1171432-17143295.02094.272.1397.3396.462.11
2166518-16651892.29694.50
3164915-16491591.40893.44
4170718-17071894.62496.94
5173988-17398896.43798.36
6172943-17294395.85898.20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1178712-17871299.05595.162.74101.8997.872.78
2173756-17375696.30899.02
3166158-16615892.09794.63
4168363-16836393.31996.16
5168820-16882093.57296.03
6174342-17434296.63399.51
替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100309-202205对照品来源中检所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10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.455038350373501475010849995502010.35
213.435057950328504540.36
单位质量响应值RSD%判断
3732.423756.810.47数据可信
供试品溶液-23H1439批-氢氯噻嗪-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min135129-3512967.34364.894.9667.3464.894.96
234576-3457666.28366.28
332287-3228761.89561.89
431532-3153260.44760.45
533701-3370164.60564.61
635861-3586168.74668.75
10min144945-4494586.16082.294.0486.5382.654.04
243651-4365183.68084.05
341709-4170979.95780.30
441410-4141079.38479.72
541108-4110878.80579.16
644745-4474585.77786.16
15min145555-4555587.33088.802.7988.1889.622.79
247620-4762091.28892.12
345570-4557087.35888.15
445378-4537886.99087.77
545519-4551987.26188.06
648306-4830692.60393.46
20min147398-4739890.86392.532.1492.2093.842.13
247500-4750091.05892.40
348807-4880793.56494.84
448204-4820492.40893.67
547618-4761891.28492.57
650071-5007195.98797.36
30min148819-4881993.58795.562.5195.4397.382.50
249175-4917594.26996.12
350168-5016896.17397.97
449972-4997295.79797.57
548831-4883193.61095.40
652117-5211799.909101.82
45min150698-5069897.18997.472.2399.5599.822.22
250447-5044796.70899.08
351361-5136198.460100.79
451246-5124698.239100.54
548962-4896293.86196.17
652346-52346100.348102.81
60min150378-5037896.57599.504.1499.48102.404.08
251305-5130598.352101.26
351719-5171999.146102.02
451523-5152398.770101.62
550381-5038196.58199.41
656128-56128107.598110.62
90min149559-4955995.00599.773.9598.44103.223.80
250064-5006495.97399.43
354728-54728104.914108.34
453969-53969103.459106.86
552083-5208399.844103.21
651871-5187199.437103.05
120min150849-5084997.47896.802.52101.45100.802.43
250416-5041696.648100.63
348045-4804592.10396.11
450747-5074797.283101.26
551368-5136898.473102.39
651534-5153498.791102.96
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限149800-4980095.46796.921.5599.98101.461.55
250205-5020596.244100.77
351055-5105597.873102.39
450179-5017996.194100.71
550199-5019996.232100.70
651911-5191199.514104.23
替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检所对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.069058390459905889037190291904580.15
211.089073290902908170.14
单位质量响应值RSD%判断
8178.848196.480.16数据可信
供试品溶液-23H1439批-替米沙坦-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15716-57166.2839.9946.096.289.9946.11
25594-55946.1496.15
313933-1393315.31515.32
414536-1453615.97815.98
55778-57786.3516.35
68966-89669.8569.86
10min116567-1656718.21123.7828.0318.2523.8328.06
217765-1776519.52819.56
327271-2727129.97730.06
428121-2812130.91131.00
514371-1437115.79715.83
625699-2569928.24928.30
15min125554-2555428.08935.5521.4628.2335.7421.52
228149-2814930.94231.08
338268-3826842.06542.32
439293-3929343.19243.45
524613-2461327.05527.18
638174-3817441.96142.17
20min131982-3198235.15544.9020.6335.4545.2820.68
235690-3569039.23139.55
348791-4879153.63254.12
448326-4832653.12153.62
532094-3209435.27835.55
648198-4819852.98053.42
30min140420-4042044.43055.6419.4544.9256.2819.49
244791-4479149.23549.77
357758-5775863.48964.27
456731-5673162.36063.16
540737-4073744.77945.25
663292-6329269.57270.31
45min148028-4802852.79365.1120.3353.5366.0520.33
251289-5128956.37857.18
373928-7392881.26382.40
461609-6160967.72268.86
547773-4777352.51353.23
672756-7275679.97581.10
60min151930-5193057.08271.9219.9058.1173.2219.89
257947-5794763.69664.82
381237-8123789.29790.88
463781-6378170.10971.63
555922-5592261.47062.48
681733-8173389.84291.41
90min158306-5830664.09180.0015.1865.4481.7015.22
265503-6550372.00273.48
390428-9042899.400101.48
472259-7225979.42881.34
571513-7151378.60879.96
678647-7864786.45088.52
120min167616-6761674.32582.626.9276.0384.777.12
272935-7293580.17182.04
378984-7898486.82089.46
473121-7312180.37682.72
575794-7579483.31485.10
682516-8251690.70393.25
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限178035-7803585.77790.103.9487.8992.704.21
279872-7987287.79790.12
385884-8588494.40597.52
479901-7990187.82890.62
582634-8263490.83393.08
685457-8545793.93696.99
替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100309-202205对照品来源中检所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10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.455014450301503435021450264502530.16
213.435007950182501300.15
单位质量响应值RSD%判断
3736.283732.690.07数据可信
供试品溶液-23K2033批-氢氯噻嗪-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min133172-3317263.76364.224.6963.7664.224.69
232241-3224161.97361.97
336342-3634269.85669.86
432735-3273562.92362.92
533821-3382165.01065.01
632146-3214661.79161.79
10min143566-4356683.74282.871.3284.1083.231.31
243378-4337883.38183.73
343105-4310582.85683.24
443753-4375384.10284.45
542441-4244181.58081.94
642432-4243281.56281.91
15min146263-4626388.92690.971.5489.7591.791.54
247584-4758491.46692.27
348332-4833292.90393.75
447760-4776091.80492.62
546847-4684790.04990.86
647184-4718490.69791.49
20min148365-4836592.96794.511.8394.2895.831.83
248596-4859693.41194.73
350830-5083097.70599.07
449150-4915094.47695.80
548667-4866793.54794.86
649398-4939894.95296.25
30min153338-53338102.52699.122.62104.36100.972.57
251923-5192399.806101.64
351226-5122698.466100.37
452703-52703101.305103.16
550304-5030496.69498.53
649896-4989695.91097.74
45min150207-5020796.50897.951.0598.91100.351.04
251344-5134498.693101.08
351371-5137198.745101.20
451315-5131598.637101.05
550347-5034796.77799.15
651157-5115798.334100.69
60min150420-5042096.91797.511.7099.85100.451.65
250854-5085497.751100.69
350724-5072497.501100.50
450689-5068997.434100.40
549501-4950195.15098.06
652169-52169100.279103.19
90min151045-5104598.11898.421.55101.59101.901.50
251602-5160299.189102.67
350322-5032296.729100.27
452571-52571101.052104.56
550920-5092097.878101.32
650754-5075497.559101.02
120min148376-4837692.98895.991.7797.01100.021.71
250602-5060297.267101.30
349928-4992895.971100.05
450704-5070497.463101.53
549563-4956395.27099.25
650464-5046497.002101.01
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限150819-5081997.68498.211.00102.22102.770.99
251030-5103098.090102.66
351571-5157199.129103.74
451258-5125898.528103.13
550257-5025796.604101.11
651609-5160999.202103.75
替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检所对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.069021889919900829023590311901530.18
211.089021990073901460.12
单位质量响应值RSD%判断
8151.278135.920.14数据可信
供试品溶液-23K2033批-替米沙坦-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15037-50375.5677.6018.205.577.6018.18
26150-61506.7976.80
38188-81889.0499.05
47953-79538.7898.79
57685-76858.4938.49
66255-62556.9136.91
10min114200-1420015.69320.9515.8615.7220.9915.87
218613-1861320.57020.61
321010-2101023.22023.27
421950-2195024.25824.31
521120-2112023.34123.39
616830-1683018.60018.64
15min123831-2383126.33734.0415.6626.4634.2015.65
230943-3094334.19734.35
334309-3430937.91738.10
433722-3372237.26837.45
535844-3584439.61439.79
626181-2618128.93429.08
20min128999-2899932.04943.0616.7632.3143.4016.75
237720-3772041.68742.03
345439-4543950.21850.61
442538-4253847.01147.40
544868-4486849.58749.98
634197-3419737.79338.10
30min139541-3954143.69956.0716.0444.1456.6616.03
249087-4908754.24954.82
353255-5325558.85659.52
459005-5900565.21065.86
559703-5970365.98266.65
643817-4381748.42548.94
45min141660-4166046.04165.5919.3746.7366.4919.30
260295-6029566.63667.51
357708-5770863.77764.77
469544-6954476.85877.87
573601-7360181.34182.38
653293-5329358.89859.68
60min146222-4622251.08373.1317.4652.0274.4017.43
269067-6906776.33077.58
363299-6329969.95671.31
476073-7607384.07385.51
578411-7841186.65788.15
663962-6396270.68971.80
90min157657-5765763.72081.3713.6164.9583.0413.64
276496-7649684.54186.21
368982-6898276.23677.98
483996-8399692.82994.74
583720-8372092.52494.50
670922-7092278.38079.88
120min163703-6370370.40282.949.3271.9885.069.46
276849-7684984.93187.07
372106-7210679.68981.85
481915-8191590.53092.95
582362-8236291.02493.51
673360-7336081.07583.01
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限174434-7443482.26289.494.4184.2392.074.68
280813-8081389.31291.92
382163-8216390.80493.41
483459-8345992.23695.16
584551-8455193.44396.43
680432-8043288.89191.28
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