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%
1 14.125223552283523015226552304522780.06
214.105207452079520760.01
单位质量响应值RSD%判断
3702.413693.330.18数据可信
供试品溶液-F94945批-氢氯噻嗪-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min137098-3709872.01670.573.8472.0270.583.84
236016-3601669.91569.92
335743-3574369.38569.39
434300-3430066.58466.58
536513-3651370.88070.88
638461-3846174.66274.66
10min143219-4321983.89886.133.7284.3086.523.71
246716-4671690.68691.07
343974-4397485.36485.75
442359-4235982.22882.60
544010-4401085.43385.83
645939-4593989.17889.59
15min146218-4621889.72091.712.9190.5992.582.90
247136-4713691.50292.39
347092-4709291.41692.28
445879-4587989.06289.89
547350-4735091.91792.79
649780-4978096.63497.54
20min146385-4638590.04494.193.9791.4195.563.95
248582-4858294.30995.71
348524-4852494.19695.56
447449-4744992.10993.43
548094-4809493.36194.74
652078-52078101.095102.54
30min147313-4731391.84594.563.0793.7196.463.07
249139-4913995.39097.31
349109-4910995.33297.22
446860-4686090.96692.80
548792-4879294.71696.61
651042-5104299.084101.09
45min150741-5074198.50098.061.89100.87100.481.89
250093-5009397.24299.70
349413-4941395.92298.34
450100-5010097.25699.59
550519-5051998.069100.49
652217-52217101.365103.92
60min149816-4981696.70496.942.2199.6399.912.21
249695-4969596.46999.46
350527-5052798.084101.04
448651-4865194.44397.32
549155-4915595.42198.39
651772-51772100.501103.62
极限149796-4979696.66598.282.77100.12101.792.76
251421-5142199.820103.35
350029-5002997.118100.62
448687-4868794.51397.92
551191-5119199.373102.87
652634-52634102.175105.86
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%
111.201735561740811739621738291741321739120.14
2 11.121730841733191732020.10
单位质量响应值RSD%判断
15527.8615575.720.22数据可信
供试品溶液-F94945批-替米沙坦-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min114406-144068.3377.279.108.347.279.13
211292-112926.5356.53
311382-113826.5876.59
412850-128507.4367.44
512703-127037.3517.35
612704-127047.3527.35
10min133586-3358619.43718.841.9019.4818.881.91
232582-3258218.85618.89
332087-3208718.56918.61
431882-3188218.45118.49
532892-3289219.03519.08
632307-3230718.69618.74
15min140785-4078523.60323.481.5923.7623.621.58
239859-3985923.06723.21
340898-4089823.66823.81
439661-3966122.95223.10
541185-4118523.83423.98
641014-4101423.73523.88
20min140904-4090423.67224.693.1223.9624.973.08
241662-4166224.11024.38
343127-4312724.95825.23
442486-4248624.58724.86
543110-4311024.94825.23
644737-4473725.89026.17
30min141791-4179124.18524.921.7824.6025.331.76
242693-4269324.70725.11
343761-4376125.32525.73
442848-4284824.79725.20
543596-4359625.23025.65
643656-4365625.26425.68
45min144374-4437425.68025.651.7026.2326.201.68
243131-4313124.96025.50
343749-4374925.31825.87
445073-4507326.08426.63
544753-4475325.89926.46
644899-4489925.98426.54
60min144618-4461825.82125.241.7926.5125.941.75
242493-4249324.59125.27
344376-4437625.68126.37
443214-4321425.00925.70
543566-4356625.21225.91
643446-4344625.14325.85
极限143412-4341225.12325.651.5625.9626.491.52
244603-4460325.81226.63
344368-4436825.67626.51
443621-4362125.24426.07
545180-4518026.14626.99
644800-4480025.92626.77
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%
1 14.125274852815528775276452834528080.10
214.105239752514524560.16
单位质量响应值RSD%判断
3739.943720.280.38数据可信
供试品溶液-F57850批-氢氯噻嗪-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min136919-3691971.04969.363.1971.0569.363.19
235761-3576168.82168.82
334556-3455666.50266.50
434897-3489767.15867.16
537314-3731471.80971.81
636811-3681170.84170.84
10min144117-4411784.90184.152.3085.3084.542.29
244206-4420685.07385.45
342296-4229681.39781.77
444939-4493986.48386.86
544073-4407384.81785.22
642721-4272182.21582.61
15min148379-4837993.10388.453.6893.9789.313.66
245921-4592188.37389.23
343947-4394784.57485.40
444551-4455185.73786.59
547448-4744891.31292.18
645531-4553187.62388.47
20min147635-4763591.67290.622.6093.0691.962.60
247483-4748391.37992.73
345837-4583788.21189.50
445669-4566987.88889.22
548942-4894294.18795.56
646966-4696690.38491.72
30min148136-4813692.63692.212.1494.5394.062.12
248029-4802992.43094.28
348085-4808592.53894.32
446746-4674689.96191.78
549585-4958595.42497.32
646921-4692190.29892.14
45min148595-4859593.51993.132.5495.9395.492.52
248738-4873893.79496.16
347332-4733291.08893.38
447036-4703690.51992.84
550477-5047797.14199.57
648192-4819292.74495.08
60min148795-4879593.90493.481.6096.8396.361.59
248601-4860193.53196.42
348718-4871893.75696.56
447077-4707790.59893.42
549301-4930194.87897.85
648953-4895394.20897.06
极限150294-5029496.78995.693.00100.2499.082.95
248526-4852693.38696.79
350217-5021796.64199.96
447608-4760891.62094.94
551863-5186399.808103.31
649827-4982795.89099.27
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%
111.201748921750701751281748761749651749860.07
2 11.121739721744411742060.20
单位质量响应值RSD%判断
15623.7515666.010.20数据可信
供试品溶液-F57850批-替米沙坦-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min114853-148538.5448.5012.048.548.5012.06
213756-137567.9137.91
317883-1788310.28810.29
413998-139988.0538.05
512758-127587.3397.34
615449-154498.8878.89
10min131423-3142318.07718.014.7418.1218.054.76
230714-3071417.66917.71
333677-3367719.37319.43
431162-3116217.92717.97
529113-2911316.74816.79
631712-3171218.24318.29
15min140897-4089723.52722.353.3623.6722.493.35
238448-3844822.11822.26
339773-3977322.88023.04
437291-3729121.45221.60
537927-3792721.81821.95
638725-3872522.27722.43
20min143468-4346825.00624.501.6225.2824.771.64
242355-4235524.36624.63
343366-4336624.94725.24
441717-4171723.99924.26
542347-4234724.36124.62
642235-4223524.29624.57
30min143281-4328124.89825.012.2725.3225.422.26
243753-4375325.17025.57
345124-4512425.95826.39
442710-4271024.57024.97
543662-4366225.11725.51
642297-4229724.33224.74
45min142544-4254424.47424.961.7325.0325.511.68
243523-4352325.03725.58
343224-4322424.86525.44
442637-4263724.52825.06
544444-4444425.56726.10
644001-4400125.31225.86
60min143438-4343824.98925.021.4625.6825.711.48
243313-4331324.91725.60
344525-4452525.61426.33
442902-4290224.68025.35
542874-4287424.66425.34
643896-4389625.25225.94
极限143926-4392625.26925.582.1926.1026.402.16
243330-4333024.92625.74
345754-4575426.32127.18
443654-4365425.11325.92
545261-4526126.03726.85
644878-4487825.81726.64
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%
1 14.125195551996519175203651985519780.09
214.105209552242521680.20
单位质量响应值RSD%判断
3681.163699.860.36数据可信
供试品溶液-23K2033批-氢氯噻嗪-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min137533-3753373.00670.184.2873.0170.184.28
233164-3316464.50864.51
336103-3610370.22470.22
437007-3700771.98371.98
536724-3672471.43271.43
635953-3595369.93369.93
10min143982-4398285.55085.011.9785.9685.401.98
242539-4253982.74383.10
343965-4396585.51785.91
444634-4463486.81887.22
544360-4436086.28586.68
642757-4275783.16783.56
15min145528-4552888.55792.834.2289.4493.694.18
246115-4611589.69990.52
347233-4723391.87392.74
447102-4710291.61992.50
550315-5031597.86898.74
650057-5005797.36698.22
20min147677-4767792.73793.142.0994.1194.522.07
247440-4744092.27693.59
348625-4862594.58195.96
448507-4850794.35195.74
548854-4885495.02696.45
646194-4619489.85291.24
30min148474-4847494.28796.783.0996.1898.683.06
248815-4881594.95196.78
350737-5073798.689100.59
449754-4975496.77798.69
552316-52316101.760103.71
648440-4844094.22196.11
45min149133-4913395.56998.472.1897.98100.902.16
250117-5011797.48399.84
352239-52239101.611104.06
450911-5091199.027101.48
551337-5133799.856102.37
650015-5001597.28599.70
60min150400-5040098.034101.814.57100.98104.794.45
250442-5044298.115101.01
355131-55131107.236110.25
451395-5139599.969102.97
551053-5105399.304102.37
655632-55632108.210111.16
极限150565-5056598.354100.261.97101.84103.801.96
250787-5078798.786102.23
353195-53195103.470107.08
450915-5091599.035102.59
552237-52237101.607105.23
651554-51554100.278103.83
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%
111.208716287181870838715587220871600.06
2 11.128738487538874610.13
单位质量响应值RSD%判断
7782.147865.200.76数据可信
供试品溶液-23K2033批-替米沙坦-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min114816-1481617.04423.1217.0917.0423.1217.10
221444-2144424.66924.67
316759-1675919.27919.28
423032-2303226.49626.50
522375-2237525.74025.74
622176-2217625.51125.51
10min123669-2366927.22928.404.5727.3228.534.57
226646-2664630.65330.79
324815-2481528.54728.65
424608-2460828.30928.46
523499-2349927.03327.18
624891-2489128.63428.78
15min130255-3025534.80536.335.7135.0536.625.69
232282-3228237.13737.44
330732-3073235.35435.62
429730-2973034.20134.51
531785-3178536.56536.86
634708-3470839.92840.23
20min133229-3322938.22638.971.3238.6739.461.37
234371-3437139.54040.05
333762-3376238.83939.30
433690-3369038.75739.25
533810-3381038.89539.39
634404-3440439.57840.10
30min136660-3666042.17342.532.0742.8243.242.08
236482-3648241.96842.70
336137-3613741.57242.25
436741-3674142.26642.98
538106-3810643.83744.55
637708-3770843.37944.12
45min136983-3698342.54544.272.3443.4345.202.36
238402-3840244.17745.14
338118-3811843.85044.76
438917-3891744.77045.71
538812-3881244.64945.60
639644-3964445.60646.59
60min139997-3999746.01246.012.1647.1347.202.12
239173-3917345.06446.28
340299-4029946.35947.51
440211-4021146.25847.45
538961-3896144.82046.02
641346-4134647.56448.80
极限140068-4006846.09446.651.2947.4748.091.32
240604-4060446.71048.17
339898-3989845.89847.31
440520-4052046.61448.06
541311-4131147.52448.98
640885-4088547.03448.53
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