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%
114.205194452043521385202652190520680.19
214.185226052153522060.15
单位质量响应值RSD%判断
3666.763681.660.29数据可信
供试品溶液-23K2033批-氢氯噻嗪-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min133875-3387566.18369.102.7166.1869.102.72
234595-3459567.58967.59
336328-3632870.97570.98
435827-3582769.99670.00
535435-3543569.23169.23
636162-3616270.65170.65
10min146073-4607390.01485.754.0690.3886.144.04
241960-4196081.97982.35
341827-4182781.71982.11
443508-4350885.00385.39
545516-4551688.92689.31
644473-4447386.88887.28
15min147804-4780493.39691.712.1594.2692.572.15
245134-4513488.18089.01
347912-4791293.60794.46
447027-4702791.87892.74
547132-4713292.08392.96
646633-4663391.10891.98
20min148692-4869295.13194.921.7596.5296.291.74
247347-4734792.50393.82
348613-4861394.97796.35
448705-4870595.15796.53
549950-4995097.58998.98
648196-4819694.16295.54
30min147606-4760693.00997.462.4894.9299.362.44
249753-4975397.20499.04
350146-5014697.97299.87
450319-5031998.310100.21
551335-51335100.295102.23
650136-5013697.95299.86
45min148360-4836094.48397.911.8696.91100.341.84
249957-4995797.60399.98
350591-5059198.841101.28
450231-5023198.138100.58
551034-5103499.707102.20
650506-5050698.675101.12
60min149915-4991597.52198.951.36100.48101.931.33
250390-5039098.449101.37
351540-51540100.695103.68
451055-5105599.748102.74
551091-5109199.818102.86
649886-4988697.464100.46
极限150305-5030598.283100.021.58101.78103.551.57
250269-5026998.212101.68
351417-51417100.455104.00
451081-5108199.799103.34
552283-52283102.147105.75
651801-51801101.205104.74
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%
111.108686386948870528688987124869750.13
211.168720986981870950.19
单位质量响应值RSD%判断
7835.597804.210.29数据可信
供试品溶液-23K2033批-替米沙坦-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min128579-2857932.89231.1114.2532.8931.1114.25
233023-3302338.00738.01
326042-2604229.97229.97
428125-2812532.36932.37
521744-2174425.02525.03
624654-2465428.37528.37
10min165978-6597875.93567.059.8576.1267.229.85
261019-6101970.22870.44
352943-5294360.93361.10
462842-6284272.32672.51
553832-5383261.95662.10
652933-5293360.92161.08
15min176892-7689288.49685.645.5289.1086.195.53
275373-7537386.74887.35
373230-7323084.28184.79
479840-7984091.88992.47
573472-7347284.56085.04
667674-6767477.88778.38
20min182214-8221494.62194.163.0295.7295.183.03
281091-8109193.32994.41
381894-8189494.25395.23
484682-8468297.46298.55
583516-8351696.12097.07
677505-7750589.20290.13
30min178449-7844990.28895.472.9191.9197.022.84
283213-8321395.77197.37
383288-8328895.85797.35
484970-8497097.79399.43
585071-8507197.90999.40
682743-8274395.23096.65
45min178143-7814389.93694.552.5092.0696.632.45
282840-8284095.34297.48
383132-8313295.67897.71
483872-8387296.53098.71
582917-8291795.43097.46
682027-8202794.40696.36
60min180044-8004492.12494.901.9694.7597.501.94
282313-8231394.73597.40
383662-8366296.28898.85
484501-8450197.25399.97
582904-8290495.41597.98
681302-8130293.57296.05
极限180987-8098793.20995.531.4796.3498.661.43
282246-8224694.65897.85
383848-8384896.50299.60
484367-8436797.099100.35
583270-8327095.83798.93
683316-8331695.89098.89
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%
114.205193252182519455211951949520250.23
214.185208152207521440.18
单位质量响应值RSD%判断
3663.733677.290.27数据可信
供试品溶液-23H1439批-氢氯噻嗪-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min130637-3063759.91766.705.6359.9266.705.63
234881-3488168.21768.22
333250-3325065.02765.03
435171-3517168.78468.78
534720-3472067.90267.90
635984-3598470.37470.37
10min143236-4323684.55784.972.0284.8985.352.02
243130-4313084.34984.73
342125-4212582.38482.75
444221-4422186.48386.87
544602-4460287.22887.61
643384-4338484.84685.24
15min144119-4411986.28490.442.6187.0991.282.60
246106-4610690.17091.02
347353-4735392.60893.43
447285-4728592.47593.34
546747-4674791.42392.28
645851-4585189.67190.53
20min148871-4887195.57794.840.8796.8696.190.86
248320-4832094.49995.85
347930-4793093.73795.07
449055-4905595.93797.31
548567-4856794.98396.35
648234-4823494.33195.69
30min150229-5022998.23397.811.32100.0599.681.28
249530-4953096.86698.74
350789-5078999.328101.18
450402-5040298.571100.48
550161-5016198.100100.00
648968-4896895.76797.65
45min150175-5017598.12798.471.11100.49100.881.08
249797-4979797.38899.80
351243-51243100.216102.62
449774-4977497.34399.80
550486-5048698.736101.18
650614-5061498.986101.40
60min149844-4984497.48099.692.36100.38102.652.30
250332-5033298.434101.39
352932-52932103.519106.48
451900-51900101.501104.50
550119-5011998.018101.01
650707-5070799.168102.13
极限150653-5065399.06299.492.06102.51103.012.01
250195-5019598.166101.67
352182-52182102.052105.59
451837-51837101.378104.94
549352-4935296.518100.05
651021-5102199.782103.30
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%
111.108710087556870328742387129872480.27
211.168709687300871980.17
单位质量响应值RSD%判断
7860.187813.440.43数据可信
供试品溶液-23H1439批-替米沙坦-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min127032-2703231.04538.3316.7531.0438.3316.76
234140-3414039.20839.21
342814-4281449.16949.17
428899-2889933.18933.19
531940-3194036.68136.68
635443-3544340.70440.70
10min159142-5914267.92171.805.9168.0972.025.93
265028-6502874.68174.90
365259-6525974.94675.22
456684-5668465.09865.28
565190-6519074.86775.07
663825-6382573.29973.53
15min169979-6997980.36687.075.4280.9287.685.43
278984-7898490.70891.34
378279-7827989.89890.59
471194-7119481.76282.31
578932-7893290.64891.27
677510-7751089.01589.65
20min181549-8154993.65493.962.9494.6595.052.95
283503-8350395.89897.03
381048-8104893.07894.27
477510-7751089.01590.02
583954-8395496.41697.54
683307-8330795.67396.80
30min182574-8257494.83196.641.6496.3598.251.66
284324-8432496.84198.51
383745-8374596.17697.88
483346-8334695.71897.21
586614-8661499.471101.13
684272-8427296.78198.44
45min181642-8164293.76195.722.1595.8097.882.19
283688-8368896.11098.32
383589-8358995.99798.24
480849-8084992.85094.88
585080-8508097.70999.92
685265-8526597.921100.12
60min179285-7928591.05495.142.2493.6297.832.24
282409-8240994.64297.38
384279-8427996.78999.56
483626-8362696.03998.58
583687-8368796.10998.86
683789-8378996.22698.97
极限180616-8061692.58295.251.8495.6598.471.83
282524-8252494.77498.04
382793-8279395.08398.39
483683-8368396.10599.18
582755-8275595.03998.33
685274-8527497.932101.21
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%
114.205239052275523975236852278523420.12
214.185183951809518240.05
单位质量响应值RSD%判断
3686.063654.720.61数据可信
供试品溶液-23H1439批-氢氯噻嗪-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min133863-3386366.22966.992.7866.2366.992.78
234125-3412566.74166.74
333348-3334865.22265.22
435177-3517768.79968.80
535629-3562969.68369.68
633374-3337465.27365.27
10min141877-4187781.90382.403.0082.2782.773.00
243356-4335684.79585.17
341604-4160481.36981.73
443618-4361885.30885.69
542169-4216982.47482.86
640152-4015278.52978.89
15min144087-4408786.22590.042.3687.0590.872.34
245976-4597689.92090.76
346278-4627890.51091.32
447386-4738692.67793.53
546046-4604690.05790.90
646449-4644990.84591.64
20min146848-4684891.62594.331.7592.9395.661.74
247704-4770493.29994.64
348901-4890195.64096.96
448998-4899895.83097.20
548131-4813194.13495.48
648793-4879395.42996.73
30min147008-4700891.93896.122.6393.7597.972.60
248442-4844294.74396.60
350619-5061999.000100.85
450132-5013298.04899.95
549245-4924596.31398.18
649417-4941796.65098.48
45min145543-4554389.07398.004.9291.39100.394.84
249473-4947396.75999.15
352688-52688103.047105.45
451275-51275100.283102.73
550760-5076099.276101.68
650908-5090899.566101.94
60min147274-4727492.45898.343.2795.27101.273.23
249845-4984597.487100.41
351299-51299100.330103.30
451125-5112599.990103.00
550270-5027098.318101.27
651862-51862101.431104.36
极限148678-4867895.20499.702.4298.53103.182.41
250774-5077499.304102.77
352313-52313102.313105.84
451432-51432100.590104.15
551379-51379100.487103.99
651288-51288100.309103.80
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%
111.108790287766879248788187535878020.19
211.168702986820869240.18
单位质量响应值RSD%判断
7910.097788.891.10数据可信
供试品溶液-23H1439批-替米沙坦-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min130897-3089735.42838.209.0935.4338.209.09
233845-3384538.80838.81
333026-3302637.86937.87
438565-3856544.22044.22
533696-3369638.63738.64
629870-2987034.25034.25
10min163570-6357072.89273.639.5273.0973.849.51
266503-6650376.25576.47
367407-6740777.29277.50
468886-6888678.98779.23
566650-6665076.42476.64
652260-5226059.92360.11
15min174984-7498485.98090.413.6186.5891.033.63
280738-8073892.57793.22
381493-8149393.44394.08
480450-8045092.24792.93
579925-7992591.64592.28
675516-7551686.59087.11
20min183526-8352695.77496.031.4696.8597.151.48
285273-8527397.77798.93
385007-8500797.47298.63
483816-8381696.10797.30
582280-8228094.34695.49
682600-8260094.71295.72
30min182183-8218394.23496.121.7095.8597.781.68
283528-8352895.77797.47
385680-8568098.24499.94
484497-8449796.88898.62
582262-8226294.32596.00
684834-8483497.27498.80
45min179137-7913790.74296.123.3392.8898.313.29
284614-8461497.02299.25
387519-87519100.353102.60
484386-8438696.76099.03
582579-8257994.68896.88
684704-8470497.12599.20
60min180314-8031492.09195.202.2294.7397.922.16
284143-8414396.48299.25
383398-8339895.62798.43
483000-8300095.17197.98
581718-8171893.70196.42
685569-8556998.117100.73
极限182287-8228794.35496.311.5297.5099.561.51
285102-8510297.581100.89
385398-8539897.921101.26
483179-8317995.37698.71
583175-8317595.37298.61
684825-8482597.264100.42
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