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%
112.379683197000965609652396504966840.23
212.589676796555966610.16
单位质量响应值RSD%判断
7816.017683.701.21数据可信
供试品溶液-2023061421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%
5min148726-4872650.15239.4819.2350.1539.4819.23
239453-3945340.60740.61
339038-3903840.18040.18
429560-2956030.42530.42
530368-3036831.25631.26
642980-4298044.23744.24
10min182977-8297785.40582.623.1685.6682.823.19
282087-8208784.48884.69
380901-8090183.26883.47
477013-7701379.26679.42
577250-7725079.51079.67
681409-8140983.79184.01
15min187500-8750090.06089.563.4390.7490.173.44
291271-9127193.94194.57
387932-8793290.50491.12
486665-8666589.20089.75
582007-8200784.40684.96
686711-8671189.24889.89
20min189367-8936791.98191.741.6693.1192.801.68
291753-9175394.43795.53
389573-8957392.19493.26
487667-8766790.23291.23
588222-8822290.80391.78
688228-8822890.80991.90
30min193946-9394696.69495.624.4898.2897.144.40
293991-9399196.74198.31
390916-9091693.57695.11
4100173-100173103.104104.55
589430-8943092.04693.48
688973-8897391.57693.12
45min193849-9384996.59594.121.6198.6796.121.64
292256-9225694.95597.01
391229-9122993.89895.90
489970-8997092.60294.56
589973-8997392.60594.50
691396-9139694.07096.07
60min189780-8978092.40793.121.4294.9695.591.42
292249-9224994.94897.47
391630-9163094.31196.78
489396-8939692.01194.44
589062-8906291.66894.02
690740-9074093.39595.86
极限189883-8988392.51393.531.3995.5396.461.37
292295-9229594.99598.00
392071-9207194.76597.70
491610-9161094.29097.17
589553-8955392.17394.98
689798-8979892.42595.36
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%
114.812533012534032562572564132561372551020.63
214.932609672604292606980.15
单位质量响应值RSD%判断
17224.9817461.350.97数据可信
供试品溶液-2023061421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%
5min14556-45561.7511.6220.861.751.6220.82
23893-38931.4971.50
33856-38561.4821.48
43129-31291.2031.20
55734-57342.2042.20
64080-40801.5681.57
10min19253-92533.5573.566.413.573.566.35
210265-102653.9463.95
39204-92043.5383.55
49036-90363.4743.48
58429-84293.2403.25
69326-93263.5853.59
15min111504-115044.4224.383.404.454.413.38
211706-117064.5004.53
311457-114574.4044.43
411679-116794.4904.51
510649-106494.0944.12
611432-114324.3954.42
20min112727-127274.8924.901.674.944.951.66
212790-127904.9174.97
312337-123374.7434.79
412884-128844.9535.00
512883-128834.9525.00
612883-128834.9525.00
30min114612-146125.6175.733.275.695.803.20
215248-152485.8625.94
314527-145275.5845.66
415638-156386.0116.08
515040-150405.7825.85
614374-143745.5265.60
45min116020-160206.1586.192.476.266.292.41
215863-158636.0986.20
316044-160446.1686.27
416680-166806.4126.51
515549-155495.9776.08
616388-163886.3006.40
60min116634-166346.3946.461.676.536.591.67
216910-169106.5006.63
316923-169236.5056.64
417151-171516.5936.73
516338-163386.2816.41
616855-168556.4796.61
极限117319-173196.6586.661.956.826.821.93
217522-175226.7366.90
317339-173396.6656.83
417804-178046.8447.01
516800-168006.4586.62
617163-171636.5986.76
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%
112.379642696299964769648896448964270.08
212.589642496688965560.20
单位质量响应值RSD%判断
7795.237675.361.10数据可信
供试品溶液-2023061421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%
5min150173-5017351.73740.6919.8251.7440.6919.82
242003-4200343.31343.31
330031-3003130.96730.97
445786-4578647.21447.21
535782-3578236.89836.90
632978-3297834.00634.01
10min185484-8548488.14981.944.9588.4182.154.98
280067-8006782.56382.78
374742-7474277.07277.23
482189-8218984.75284.99
576885-7688579.28279.47
677436-7743679.85080.02
15min188803-8880391.57288.183.0692.2788.793.10
285889-8588988.56789.20
382064-8206484.62385.16
487846-8784690.58591.24
585381-8538188.04388.62
683106-8310685.69786.27
20min190963-9096393.79991.232.0294.9692.292.07
289252-8925292.03593.11
386066-8606688.75089.71
489332-8933292.11793.23
586873-8687389.58290.60
688357-8835791.11292.11
30min190119-9011992.92991.671.1294.5693.181.18
289337-8933792.12393.65
387525-8752590.25491.66
489541-8954192.33393.91
587947-8794790.68992.16
688903-8890391.67593.13
45min187651-8765190.38491.781.7092.4793.751.70
289571-8957192.36494.36
387392-8739290.11791.98
491579-9157994.43496.47
588994-8899491.76993.69
688827-8882791.59793.51
60min190820-9082093.65293.421.4696.1995.841.50
290883-9088393.71796.17
389183-8918391.96494.27
492906-9290695.80398.31
589587-8958792.38094.76
690170-9017092.98195.35
极限189614-8961492.40893.762.1095.4296.662.07
292535-9253595.42098.34
389834-8983492.63595.40
493324-9332496.23499.22
588460-8846091.21894.06
691810-9181094.67397.51
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%
114.812606512610532608712609692608762608840.06
214.932606962608602607780.05
单位质量响应值RSD%判断
17615.4017466.710.60数据可信
供试品溶液-2023061421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%
5min14897-48971.8611.5918.701.861.5918.77
24090-40901.5541.55
32849-28491.0831.08
44914-49141.8681.87
54505-45051.7121.71
63837-38371.4581.46
10min110030-100303.8123.527.073.823.527.06
29321-93213.5433.55
38331-83313.1663.17
49792-97923.7223.73
59409-94093.5763.58
68651-86513.2883.30
15min112258-122584.6594.404.614.694.424.61
211561-115614.3944.42
310751-107514.0864.11
411963-119634.5474.57
511242-112424.2734.30
611673-116734.4374.46
20min113121-131214.9874.912.335.044.962.38
212901-129014.9034.95
312464-124644.7374.78
413361-133615.0785.13
512817-128174.8714.92
612915-129154.9094.95
30min115155-151555.7605.502.985.845.573.03
214423-144235.4825.55
314024-140245.3305.40
414785-147855.6195.70
514151-141515.3785.45
614232-142325.4095.48
45min116092-160926.1166.071.856.226.171.81
215793-157936.0026.10
316193-161936.1546.25
416366-163666.2206.32
515762-157625.9916.09
615601-156015.9296.03
60min116729-167296.3586.555.226.496.685.16
216767-167676.3736.50
316735-167356.3606.48
417573-175736.6796.81
516690-166906.3436.47
618940-189407.1987.33
极限117821-178216.7736.772.346.946.942.36
217628-176286.7006.86
317231-172316.5496.70
418077-180776.8707.04
518461-184617.0167.18
617727-177276.7376.90
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%
112.379659996719965779654596664966210.08
212.589650696543965240.03
单位质量响应值RSD%判断
7810.917672.811.27数据可信
供试品溶液-2023061521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%
5min138789-3878939.96538.7313.1939.9738.7313.19
236914-3691438.03338.03
334904-3490435.96235.96
429734-2973430.63630.64
541679-4167942.94342.94
643533-4353344.85344.85
10min181828-8182884.30983.252.9984.5183.443.01
282215-8221584.70884.90
378466-7846680.84581.03
477596-7759679.94980.10
580671-8067183.11783.33
684008-8400886.55686.78
15min188489-8848991.17289.302.5691.7989.912.55
288199-8819990.87491.49
385921-8592188.52789.11
485711-8571188.31088.86
583033-8303385.55186.18
688692-8869291.38292.04
20min188018-8801890.68791.071.7791.7692.131.75
287992-8799290.66091.73
385966-8596688.57389.60
490683-9068393.43394.43
588407-8840791.08892.15
689273-8927391.98093.09
30min189600-8960092.31792.100.4593.8593.620.44
288730-8873091.42192.94
389546-8954692.26193.73
489766-8976692.48893.95
589088-8908891.79093.30
689628-8962892.34693.92
45min189336-8933692.04592.900.9894.0494.880.96
290727-9072793.47895.46
389543-8954392.25894.19
491480-9148094.25496.18
589371-8937192.08194.05
690544-9054493.29095.33
60min190592-9059293.33992.701.1295.7995.141.09
290751-9075193.50395.95
389592-8959292.30994.70
490860-9086093.61596.01
588217-8821790.89293.33
689802-8980292.52595.03
极限182796-8279685.30790.973.4088.2393.873.28
291187-9118793.95296.87
388909-8890991.60594.46
490498-9049893.24296.11
587479-8747990.13293.02
688893-8889391.58994.55
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%
114.812614742615872609972609152613652612680.12
214.932618232616642617440.05
单位质量响应值RSD%判断
17641.3217531.410.45数据可信
供试品溶液-2023061521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%
5min13638-36381.3791.4012.601.381.4012.64
23321-33211.2591.26
33382-33821.2821.28
43235-32351.2261.23
54264-42641.6161.62
64241-42411.6081.61
10min18605-86053.2623.254.213.273.264.24
28639-86393.2753.28
38277-82773.1383.14
48062-80623.0563.06
58817-88173.3423.35
69058-90583.4343.44
15min111097-110974.2074.152.914.234.182.95
211020-110204.1784.20
310619-106194.0264.05
410607-106074.0214.04
510937-109374.1464.17
611453-114534.3424.37
20min112213-122134.6304.661.974.674.712.05
212135-121354.6004.64
311952-119524.5314.57
412421-124214.7094.75
512508-125084.7424.79
612581-125814.7694.82
30min114270-142705.4105.381.295.485.451.33
214055-140555.3285.39
314057-140575.3295.39
414028-140285.3185.38
514494-144945.4945.56
614270-142705.4105.48
45min115036-150365.7005.912.035.796.002.03
215507-155075.8785.97
315458-154585.8605.95
415833-158336.0026.09
515778-157785.9816.08
615861-158616.0136.11
60min116573-165736.2836.290.956.416.420.92
216633-166336.3056.43
316475-164756.2456.37
416794-167946.3666.49
516361-163616.2026.33
616709-167096.3346.46
极限115671-156715.9416.8818.296.097.0417.93
217298-172986.5576.71
316918-169186.4136.57
417317-173176.5656.72
524822-248229.4109.57
616918-169186.4136.57
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%
112.379678196821967929692296593967820.13
212.589657196581965760.01
单位质量响应值RSD%判断
7823.937676.951.35数据可信
供试品溶液-2023061521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%
5min139354-3935440.50336.4122.4740.5036.4122.46
245036-4503646.35146.35
341839-4183943.06143.06
424774-2477425.49725.50
532598-3259833.55033.55
628679-2867929.51629.52
10min180614-8061482.96882.313.5083.1782.493.53
283288-8328885.72085.95
383129-8312985.55685.77
478124-7812480.40580.53
576834-7683479.07779.24
677875-7787580.14980.30
15min187449-8744990.00289.702.9090.6290.292.93
290175-9017592.80893.47
389722-8972292.34192.98
485802-8580288.30788.84
583493-8349385.93186.49
686288-8628888.80789.36
20min186826-8682689.36191.502.3190.4392.542.32
291112-9111293.77294.90
390221-9022192.85593.96
488982-8898291.58092.55
586034-8603488.54689.54
690265-9026592.90093.89
30min189237-8923791.84292.991.9793.3694.501.99
292996-9299695.71197.30
391577-9157794.25195.82
490962-9096293.61895.05
588555-8855591.14092.58
688813-8881391.40692.86
45min190423-9042393.06393.712.0295.0495.681.96
289949-8994992.57594.65
391350-9135094.01796.06
494162-9416296.91198.81
588801-8880191.39493.28
691634-9163494.30996.22
60min189491-8949192.10493.481.7494.5495.921.67
290579-9057993.22495.76
389905-8990592.53095.04
493342-9334296.06798.45
589532-8953292.14694.49
692134-9213494.82497.21
极限189766-8976692.38793.831.2195.2996.731.17
290449-9044993.09096.09
392156-9215694.84797.82
492723-9272395.43098.29
590739-9073993.38896.20
691153-9115393.81496.67
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%
114.812582362582642585492581732576252581690.14
214.932611792610392611090.04
单位质量响应值RSD%判断
17432.0717488.880.24数据可信
供试品溶液-2023061521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%
5min13653-36531.3951.2819.251.391.2819.42
23754-37541.4331.43
34074-40741.5561.56
42446-24460.9340.93
53569-35691.3631.36
62678-26781.0231.02
10min18656-86563.3053.185.333.313.195.36
28731-87313.3343.34
38808-88083.3633.37
47851-78512.9983.00
58091-80913.0893.10
67881-78813.0093.01
15min111126-111264.2484.133.874.274.153.89
211213-112134.2814.31
311219-112194.2844.31
410452-104523.9914.01
510409-104093.9744.00
610417-104173.9774.00
20min112379-123794.7264.692.704.774.732.66
212490-124904.7694.81
312716-127164.8554.90
412208-122084.6614.70
511768-117684.4934.54
612091-120914.6174.66
30min114180-141805.4145.401.985.485.462.03
214438-144385.5135.58
314454-144545.5195.59
414132-141325.3965.46
513879-138795.2995.36
613778-137785.2615.32
45min115683-156835.9885.971.876.086.061.86
215335-153355.8555.95
315790-157906.0296.13
415995-159956.1076.20
515222-152225.8125.90
615728-157286.0056.09
60min116559-165596.3226.361.696.456.491.68
216471-164716.2896.41
316921-169216.4616.59
416840-168406.4306.55
516261-162616.2096.33
616962-169626.4766.60
极限116798-167986.4146.531.736.576.681.69
216864-168646.4396.60
317419-174196.6516.81
417506-175066.6846.84
516967-169676.4786.63
617055-170556.5126.66
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