厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100309-201404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7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%
112.379663396550966859655796685966220.07
212.589641596389964020.02
单位质量响应值RSD%判断
7810.997663.121.36数据可信
供试品溶液-AA482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%
5min122173-2217322.86025.4523.4122.8625.4523.41
220758-2075821.40121.40
320769-2076921.41221.41
435434-3543436.53236.53
527169-2716928.01128.01
621828-2182822.50422.50
10min180418-8041882.90981.833.7283.0281.963.73
277618-7761880.02280.13
380427-8042782.91883.03
481368-8136883.88984.07
582143-8214384.68884.83
674233-7423376.53376.65
15min191811-9181194.65592.021.6895.1892.561.66
288533-8853391.27691.78
390294-9029493.09193.61
488702-8870291.45092.05
588134-8813490.86491.43
688053-8805390.78191.28
20min191979-9197994.82894.271.6795.8395.261.63
292147-9214795.00195.96
393468-9346896.36397.35
489951-8995192.73793.80
589348-8934892.11693.13
691729-9172994.57195.52
30min192480-9248095.34595.091.5896.8296.561.54
293468-9346896.36397.80
394370-9437097.29398.76
491190-9119094.01595.54
590913-9091393.72995.21
690997-9099793.81695.24
45min192858-9285895.73494.381.3697.6996.321.34
292182-9218295.03896.96
392526-9252695.39297.35
490119-9011992.91194.90
591614-9161494.45296.40
689955-8995592.74294.63
60min191443-9144394.27693.061.2196.7195.481.17
291446-9144694.27996.67
390542-9054293.34795.78
488970-8897091.72694.18
589108-8910891.86894.29
690072-9007292.86295.22
极限190915-9091593.73194.080.8896.6396.960.87
291683-9168394.52397.39
392325-9232595.18598.08
490839-9083993.65396.57
591706-9170694.54797.43
690077-9007792.86795.69
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-201804对照品来源中检院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1000
标示量(mg)150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%
114.812565432563722565942568862566202566030.08
214.932563532562662563100.03
单位质量响应值RSD%判断
17326.3317167.450.66数据可信
供试品溶液-AA482批-厄贝沙坦-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%
5min12045-20450.7900.9128.060.790.9128.10
21848-18480.7140.71
31785-17850.6900.69
43522-35221.3611.36
52748-27481.0621.06
62250-22500.8700.87
10min18282-82823.2013.315.323.213.315.27
28093-80933.1283.13
38534-85343.2993.30
49150-91503.5373.54
59074-90743.5083.51
68211-82113.1743.18
15min111704-117044.5244.491.844.544.511.85
211277-112774.3594.38
311660-116604.5074.53
411829-118294.5734.60
511766-117664.5484.57
611429-114294.4184.44
20min113239-132395.1185.190.935.165.230.93
213360-133605.1645.21
313380-133805.1725.21
413532-135325.2315.28
513411-134115.1845.23
613581-135815.2505.29
30min115168-151685.8635.981.295.936.051.26
215479-154795.9836.05
315769-157696.0966.16
415404-154045.9546.03
515432-154325.9656.04
615566-155666.0176.09
45min116530-165306.3906.521.456.496.621.44
216608-166086.4206.52
317043-170436.5886.69
416938-169386.5476.65
517147-171476.6286.73
616932-169326.5456.64
60min117729-177296.8536.860.736.986.990.68
217766-177666.8677.00
317751-177516.8626.99
417659-176596.8266.96
517577-175776.7946.93
617961-179616.9437.07
极限118130-181307.0087.181.227.177.341.22
218514-185147.1577.32
318725-187257.2387.40
418668-186687.2167.39
518691-186917.2257.39
618656-186567.2127.38
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100309-201404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7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%
112.379642696546965649649896155964380.18
212.589631896189962540.10
单位质量响应值RSD%判断
7796.127651.351.33数据可信
供试品溶液-AA482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%
5min137356-3735638.57928.1319.7538.5828.1319.75
227327-2732728.22228.22
321552-2155222.25822.26
424673-2467325.48125.48
527084-2708427.97127.97
625426-2542626.25926.26
10min184199-8419986.95785.032.2987.1585.172.30
280199-8019982.82682.97
381677-8167784.35284.46
481021-8102183.67583.80
585034-8503487.81987.96
681886-8188684.56884.70
15min190980-9098093.96093.171.6194.5993.741.63
290647-9064793.61694.17
388289-8828991.18191.71
488540-8854091.44091.99
591830-9183094.83895.42
691003-9100393.98394.54
20min191351-9135194.34393.640.8795.4494.680.89
290877-9087793.85394.88
389932-8993292.87793.87
489474-8947492.40493.41
591088-9108894.07195.12
691330-9133094.32195.35
30min190372-9037293.33294.061.1294.9095.561.11
291426-9142694.42095.91
391197-9119794.18495.64
489418-8941892.34793.81
592003-9200395.01696.54
692032-9203295.04696.54
45min191037-9103794.01993.631.4696.0595.601.45
291437-9143794.43296.40
391268-9126894.25796.18
488009-8800990.89192.82
591380-9138094.37396.37
690852-9085293.82895.80
60min191941-9194194.95295.200.9397.4697.640.93
292571-9257195.60398.04
392637-9263795.67198.07
490541-9054193.50695.89
592746-9274695.78498.25
692644-9264495.67898.12
极限189927-8992792.87294.261.2295.8597.181.18
292137-9213795.15598.07
391389-9138994.38297.26
489999-8999992.94795.80
591561-9156194.56097.51
692632-9263295.66698.58
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-201804对照品来源中检院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1000
标示量(mg)150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%
114.812564692566692568222565382553902563780.23
214.932559532557692558610.06
单位质量响应值RSD%判断
17311.1417137.370.72数据可信
供试品溶液-AA482批-厄贝沙坦-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%
5min13852-38521.4911.0918.881.491.0918.87
22770-27701.0721.07
32347-23470.9080.91
42531-25310.9800.98
52616-26161.0131.01
62803-28031.0851.08
10min19339-93393.6153.492.923.623.502.91
28841-88413.4223.43
38694-86943.3653.37
48855-88553.4273.43
59254-92543.5823.59
69169-91693.5493.55
15min112407-124074.8024.662.464.834.692.48
212111-121114.6884.71
311590-115904.4864.51
411809-118094.5714.59
512197-121974.7214.74
612176-121764.7134.74
20min113232-132325.1225.182.215.175.222.18
213039-130395.0475.09
313181-131815.1025.15
413341-133415.1645.21
513783-137835.3355.38
613688-136885.2985.34
30min115496-154965.9985.941.396.076.021.37
215318-153185.9296.00
315164-151645.8695.94
415109-151095.8485.92
515382-153825.9546.03
615683-156836.0706.14
45min116890-168906.5376.511.166.646.621.14
216965-169656.5666.67
316982-169826.5736.67
416456-164566.3696.47
516802-168026.5036.61
616876-168766.5326.64
60min117498-174986.7736.901.246.917.031.22
217620-176206.8206.95
317964-179646.9537.08
417876-178766.9197.05
517853-178536.9107.05
618089-180897.0027.14
极限118256-182567.0667.130.907.247.300.89
218393-183937.1197.29
318406-184067.1247.29
418297-182977.0827.25
518405-184057.1247.29
618725-187257.2487.42
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100309-201404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7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%
112.379641796407964009633496304963720.06
212.589617095980960750.14
单位质量响应值RSD%判断
7790.787637.121.41数据可信
供试品溶液-9A612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%
5min134991-3499136.18330.0320.1836.1830.0420.18
229424-2942430.42730.43
322298-2229823.05823.06
421509-2150922.24222.24
531968-3196833.05733.06
634074-3407435.23535.24
10min175860-7586078.44573.864.0778.6374.014.10
270044-7004472.43172.58
367704-6770470.01170.13
469614-6961471.98672.10
572209-7220974.66974.83
673124-7312475.61675.79
15min184571-8457187.45384.582.6088.0385.102.64
281678-8167884.46184.98
379266-7926681.96782.43
479848-7984882.56983.04
581471-8147184.24784.79
683934-8393486.79487.35
20min187135-8713590.10487.492.1291.1188.432.15
284695-8469587.58188.52
381643-8164384.42585.30
484035-8403586.89887.78
584938-8493887.83288.79
685192-8519288.09589.08
30min188481-8848191.49690.011.9892.9691.392.00
288361-8836191.37292.75
384424-8442487.30188.60
486593-8659389.54390.86
585807-8580788.73190.13
688596-8859691.61593.04
45min189669-8966992.72490.371.8594.6492.201.87
287426-8742690.40592.24
385323-8532388.23089.96
487615-8761590.60092.37
585866-8586688.79290.63
688483-8848391.49893.38
60min187751-8775190.74190.210.9393.1292.490.95
288030-8803091.02993.31
386235-8623589.17391.35
487679-8767990.66692.89
586189-8618989.12691.41
687525-8752590.50792.85
极限187723-8772390.71291.640.9393.5594.380.90
288585-8858591.60394.34
387808-8780890.80093.42
489781-8978192.84095.51
588473-8847391.48894.22
689366-8936692.41195.21
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-201804对照品来源中检院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1000
标示量(mg)150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%
114.812565052564232563082562972561662563400.06
214.932553992552302553140.05
单位质量响应值RSD%判断
17308.5817100.740.86数据可信
供试品溶液-9A612批-厄贝沙坦-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%
5min14016-40161.5561.3418.061.561.3418.12
23563-35631.3811.38
32806-28061.0871.09
42641-26411.0231.02
53611-36111.3991.40
64181-41811.6201.62
10min19089-90893.5223.314.863.533.324.86
28680-86803.3643.37
37950-79503.0813.09
48175-81753.1683.17
58663-86633.3573.36
68757-87573.3933.40
15min111339-113394.3944.302.804.424.322.87
211142-111424.3184.34
310662-106624.1324.15
410763-107634.1714.19
511169-111694.3284.35
611438-114384.4324.46
20min112751-127514.9414.852.204.994.902.20
212554-125544.8654.91
312047-120474.6684.71
412346-123464.7844.83
512747-127474.9404.98
612645-126454.9004.95
30min114044-140445.4425.551.705.515.621.72
214308-143085.5445.61
314083-140835.4575.52
414371-143715.5695.63
514420-144205.5885.66
614708-147085.6995.77
45min116064-160646.2256.170.646.326.270.68
215980-159806.1926.29
315769-157696.1116.20
415863-158636.1476.24
515924-159246.1716.27
615965-159656.1876.29
60min116575-165756.4236.470.386.556.590.39
216703-167036.4736.60
316699-166996.4716.59
416687-166876.4666.59
516769-167696.4986.63
616671-166716.4606.59
极限117402-174026.7436.740.806.916.900.80
217413-174136.7486.91
317141-171416.6426.80
417555-175556.8036.96
517436-174366.7576.92
617458-174586.7656.93
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100309-201404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7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%
112.379617496174961739615496039961430.07
212.589613196118961240.01
单位质量响应值RSD%判断
7772.277641.021.21数据可信
供试品溶液-9A612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%
5min127212-2721228.16528.7717.7828.1728.7717.78
229658-2965830.69730.70
319172-1917219.84419.84
427532-2753228.49628.50
534322-3432235.52435.52
628892-2889229.90429.90
10min172932-7293275.48774.432.6875.6374.572.70
272552-7255275.09375.25
369557-6955771.99372.09
470935-7093573.42073.56
574878-7487877.50177.68
670605-7060573.07873.23
15min183106-8310686.01785.141.5386.5485.661.55
282822-8282285.72386.25
381389-8138984.24084.70
482305-8230585.18885.70
583699-8369986.63187.20
680260-8026083.07183.59
20min185632-8563288.63189.141.0989.5890.081.12
286182-8618289.20190.16
385204-8520488.18889.07
486490-8649089.51990.45
587767-8776790.84191.84
685457-8545788.45089.38
30min190998-9099894.18592.001.6495.5893.381.65
288910-8891092.02493.43
387460-8746090.52391.84
488825-8882591.93693.32
589951-8995193.10294.55
687159-8715990.21291.58
45min187230-8723090.28590.741.7292.1592.581.72
286909-8690989.95391.82
387137-8713790.18991.96
488347-8834791.44193.28
590340-9034093.50495.42
686040-8604089.05490.88
60min188052-8805291.13691.051.4393.4593.351.45
289499-8949992.63494.95
386556-8655689.58891.81
487467-8746790.53192.83
589398-8939892.52994.91
686861-8686189.90392.17
极限190568-9056893.74092.751.5496.5195.501.55
289287-8928792.41495.19
388580-8858091.68394.36
489027-8902792.14594.90
591899-9189995.11897.97
688285-8828591.37794.10
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-201804对照品来源中检院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1000
标示量(mg)150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%
114.812559892559562559012558842558802559220.02
214.932556952557852557400.03
单位质量响应值RSD%判断
17280.3517129.270.63数据可信
供试品溶液-9A612批-厄贝沙坦-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%
5min13260-32601.2631.2713.101.261.2713.18
23458-34581.3401.34
32503-25030.9700.97
43220-32201.2481.25
53784-37841.4661.47
63454-34541.3381.34
10min18650-86503.3523.314.643.363.324.67
28682-86823.3643.37
37833-78333.0353.04
48435-84353.2693.27
59010-90103.4913.50
68684-86843.3653.37
15min111135-111354.3154.262.414.344.292.43
211292-112924.3764.40
310585-105854.1024.12
410878-108784.2154.24
511226-112264.3504.37
610905-109054.2264.25
20min112518-125184.8514.892.434.904.942.39
212789-127894.9565.00
312065-120654.6754.72
412630-126304.8944.94
512922-129225.0075.05
612788-127884.9555.00
30min114757-147575.7185.641.905.795.711.91
214730-147305.7085.78
314049-140495.4445.51
414454-144545.6015.67
514758-147585.7195.79
614542-145425.6355.70
45min115112-151125.8566.072.535.956.162.54
215583-155836.0386.14
315459-154595.9906.08
415804-158046.1246.22
516304-163046.3186.42
615666-156666.0716.17
60min116451-164516.3756.441.786.506.571.76
217124-171246.6356.76
316256-162566.2996.42
416657-166576.4556.58
516711-167116.4756.61
616515-165156.3996.53
极限117756-177566.8806.761.137.046.921.13
217363-173636.7286.89
317149-171496.6456.80
417495-174956.7796.94
517442-174426.7596.92
617457-174576.7656.92
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