氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.566198461884617296169261294617170.43
212.556171161734617220.03
单位质量响应值RSD%判断
4913.774918.090.07数据可信
供试品溶液-2025020311批-氨氯地平-shui(内含0.4%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min137238-3723849.11240.5423.5949.1140.5423.59
236014-3601447.49747.50
322114-2211429.16529.17
437217-3721749.08449.08
522050-2205029.08129.08
629781-2978139.27739.28
10min165906-6590686.92183.325.0387.1983.545.08
265544-6554486.44386.71
359194-5919478.06878.23
466212-6621287.32487.60
559742-5974278.79178.95
662454-6245482.36882.59
15min174209-7420997.87193.903.2998.6394.593.33
271995-7199594.95195.70
370305-7030592.72293.32
471945-7194594.88595.64
567180-6718088.60189.20
671573-7157394.39595.07
20min174295-7429597.98597.601.5199.2898.811.53
274177-7417797.82999.10
374011-7401197.61098.72
475544-7554499.632100.92
573903-7390397.46898.56
672086-7208695.07196.27
30min171786-7178694.67596.721.4096.5298.471.29
273155-7315596.48198.30
374767-7476798.607100.26
472752-7275295.95097.79
573676-7367697.16898.80
673863-7386397.41599.14
45min174574-7457498.35296.642.34100.7298.932.32
272151-7215195.15797.51
374205-7420597.866100.07
473555-7355597.00999.38
570376-7037692.81694.99
674811-7481198.665100.93
60min172598-7259895.74698.602.4198.66101.432.33
275881-75881100.076102.96
374821-7482198.678101.42
476753-76753101.226104.14
575955-75955100.174102.86
672563-7256395.70098.52
极限174128-7412897.76499.021.41101.21102.401.32
275430-7543099.481102.92
376427-76427100.796104.09
474702-7470298.521101.99
576034-76034100.278103.52
673780-7378097.305100.65
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.011354790135453913553361355849135301013547050.08
29.051352654135250513525800.01
单位质量响应值RSD%判断
150355.72149456.350.43数据可信
供试品溶液-2025020311批-厄贝沙坦-shui(内含0.4%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1452162-45216227.14723.3424.3627.1523.3424.36
2469654-46965428.19728.20
3257719-25771915.47315.47
4476489-47648928.60828.61
5291972-29197217.52917.53
6384745-38474523.09923.10
10min1991697-99169759.54059.555.9459.6959.685.98
21019869-101986961.23161.39
3893556-89355653.64753.73
41066936-106693664.05764.22
5964749-96474957.92258.02
61014457-101445760.90661.03
15min11260821-126082175.69775.532.4276.1875.992.47
21277263-127726376.68577.18
31208383-120838372.54972.93
41287416-128741677.29477.81
51236007-123600774.20874.63
61278416-127841676.75477.22
20min11369207-136920782.20582.721.5383.1183.601.56
21382565-138256583.00783.93
31341478-134147880.54081.33
41403827-140382784.28385.23
51385711-138571183.19684.03
61384111-138411183.09983.99
30min11447589-144758986.91188.741.2988.2790.071.26
21465576-146557687.99089.37
31481877-148187788.96990.20
41487557-148755789.31090.72
51483188-148318889.04890.34
61502119-150211990.18491.54
45min11540656-154065692.49892.973.8094.3494.803.75
21534550-153455092.13294.00
31548530-154853092.97194.70
41554982-155498293.35895.27
51464069-146406987.90089.69
61647894-164789498.937100.79
60min11570726-157072694.30395.111.1696.6697.461.19
21594784-159478495.74898.13
31564533-156453393.93296.18
41612216-161221696.79499.22
51571940-157194094.37696.65
61591071-159107195.52597.93
极限11586948-158694895.27796.710.9898.1699.580.94
21621107-162110797.328100.24
31621212-162121297.335100.10
41597362-159736295.90398.87
51610679-161067996.70299.50
61627090-162709097.687100.62
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.566134760791606886073560553608230.51
212.556029760371603340.09
单位质量响应值RSD%判断
4842.604807.490.52数据可信
供试品溶液-2025020311批-氨氯地平-shui(内含0.4%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min129486-2948639.62140.8023.1739.6240.8023.17
239779-3977953.45253.45
322470-2247030.19330.19
423296-2329631.30331.30
530039-3003940.36440.36
637109-3710949.86449.86
10min162135-6213583.49285.735.1883.7185.965.22
268335-6833591.82392.12
359220-5922079.57579.74
462143-6214383.50383.68
564588-6458886.78887.01
666396-6639689.21789.49
15min168399-6839991.90997.534.0292.5998.234.04
276435-76435102.707103.51
372738-7273897.73998.35
470052-7005294.13094.77
573786-7378699.14899.85
674085-7408599.549100.32
20min171071-7107195.49998.933.1596.69100.173.19
276490-76490102.781104.16
370794-7079495.12796.28
473319-7331998.52099.68
574979-74979100.751102.01
675086-75086100.894102.22
30min171749-7174996.410101.172.5898.14102.962.58
277453-77453104.075106.02
376448-76448102.725104.41
475608-75608101.596103.30
574940-74940100.698102.52
675539-75539101.503103.39
45min171666-7166696.299100.822.3298.56103.182.32
276459-76459102.739105.27
376080-76080102.230104.48
475396-75396101.311103.58
575745-75745101.780104.16
674852-74852100.580103.03
60min172168-7216896.973101.122.4599.77104.042.44
277247-77247103.798106.90
376939-76939103.384106.20
475032-75032100.822103.66
575538-75538101.502104.44
674614-74614100.260103.27
极限173295-7329598.488100.871.68101.82104.341.71
276533-76533102.839106.51
376301-76301102.527105.92
474019-7401999.461102.86
575157-75157100.990104.50
675081-75081100.888104.45
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.011355396135504413562081355816135516813555260.04
29.051354801135476313547820.01
单位质量响应值RSD%判断
150446.84149699.670.36数据可信
供试品溶液-2025020311批-厄贝沙坦-shui(内含0.4%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1376223-37622322.56322.1223.6222.5622.1123.63
2465950-46595027.94427.94
3252696-25269615.15415.15
4293875-29387517.62417.62
5358994-35899421.52921.53
6464943-46494327.88327.88
10min11005825-100582560.32058.495.3460.4558.625.37
21015031-101503160.87361.03
3874857-87485752.46652.55
4977147-97714758.60158.70
5973454-97345458.37958.50
61005681-100568160.31260.47
15min11228236-122823673.65974.032.4274.1274.482.46
21278395-127839576.66777.16
31193911-119391171.60071.98
41212704-121270472.72773.15
51240354-124035474.38574.83
61252644-125264475.12275.61
20min11335960-133596080.11980.203.2880.9981.063.31
21382399-138239982.90483.82
31255793-125579375.31176.08
41335311-133531180.08080.91
51348452-134845280.86881.73
61365458-136545881.88882.80
30min11463979-146397987.79688.410.7089.1189.710.72
21486053-148605389.12090.50
31465690-146569087.89989.09
41487784-148778489.22490.50
51470062-147006288.16189.47
61471401-147140188.24289.60
45min11530909-153090991.81092.680.8893.6194.480.87
21548431-154843192.86194.74
31537458-153745892.20393.88
41567710-156771094.01795.79
51551921-155192193.07094.87
61536233-153623392.13093.98
60min11589078-158907895.29995.020.9297.6197.330.86
21583582-158358294.96997.36
31609042-160904296.49698.69
41565340-156534093.87596.17
51577366-157736694.59696.91
61582252-158225294.88997.25
极限11617911-161791197.02896.480.5699.8799.320.55
21618330-161833097.05399.97
31612704-161270496.71699.44
41602662-160266296.11398.93
51596074-159607495.71898.56
61605339-160533996.27499.17
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.566089460600605656029960380605480.39
212.556043860563605000.15
单位质量响应值RSD%判断
4820.704820.720.01数据可信
供试品溶液-2025020411批-氨氯地平-shui(内含0.4%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min116875-1687522.69534.2433.9022.7034.2533.90
217910-1791024.08724.09
332963-3296344.33244.33
418595-1859525.00925.01
530209-3020940.62840.63
636223-3622348.71748.72
10min150689-5068968.17275.637.5668.3075.827.62
252396-5239670.46870.60
358743-5874379.00479.25
455915-5591575.20175.34
557306-5730677.07177.30
662343-6234383.84684.12
15min162972-6297284.69285.031.2885.2085.641.27
263425-6342585.30185.83
362914-6291484.61485.30
464275-6427586.44487.00
561945-6194583.31083.96
663797-6379785.80186.54
20min165351-6535187.89186.312.6188.8787.392.54
265091-6509187.54188.54
362870-6287084.55485.71
465076-6507687.52188.56
561358-6135882.52183.64
665301-6530187.82489.04
30min165199-6519987.68786.633.4889.1588.203.35
267602-6760290.91892.40
362399-6239983.92185.55
465853-6585388.56690.09
561636-6163682.89584.47
663805-6380585.81287.51
45min166945-6694590.03584.883.8891.9986.923.76
260662-6066281.58583.58
361726-6172683.01685.11
465114-6511487.57289.59
561301-6130182.44484.48
662911-6291184.61086.79
60min165321-6532187.85184.563.6390.3087.083.45
265111-6511187.56890.01
360425-6042581.26683.82
464267-6426786.43388.93
561561-6156182.79485.29
660567-6056781.45784.10
极限164359-6435986.55784.184.8589.5087.174.66
267115-6711590.26493.19
360133-6013380.87383.88
463552-6355285.47288.45
558785-5878579.06082.01
661625-6162582.88085.98
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.011353209135368513530061352001135265313529110.05
29.051354383135527913548310.05
单位质量响应值RSD%判断
150156.60149705.080.22数据可信
供试品溶液-2025020411批-厄贝沙坦-shui(内含0.4%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1179053-17905310.74818.8642.2510.7518.8642.24
2203961-20396112.24312.24
3433947-43394726.04926.05
4212486-21248612.75512.76
5368193-36819322.10222.10
6487562-48756229.26729.27
10min1699856-69985642.01152.5113.7742.0752.6213.82
2777680-77768046.68246.75
3967440-96744058.07358.22
4862831-86283151.79451.86
5918451-91845155.13355.26
61022447-102244761.37561.54
15min11042471-104247162.57768.025.0162.8768.415.08
21089697-108969765.41265.74
31181677-118167770.93371.40
41163487-116348769.84270.20
51136254-113625468.20768.64
61184956-118495671.13071.63
20min11207652-120765272.49375.652.6673.1376.422.76
21243027-124302774.61675.31
31275332-127533276.55577.42
41259170-125917075.58576.33
51268374-126837476.13876.95
61307775-130777578.50379.40
30min11353081-135308181.22282.151.2382.2783.351.32
21371433-137143382.32483.43
31372542-137254282.39183.68
41350844-135084481.08882.25
51366403-136640382.02283.25
61397202-139720283.87185.21
45min11470547-147054788.27486.561.4489.7788.211.41
21439316-143931686.39987.96
31434984-143498486.13987.88
41417533-141753385.09186.71
51426645-142664585.63887.33
61463142-146314287.82989.63
60min11492858-149285889.61387.292.0791.6089.421.96
21466948-146694888.05890.10
31446204-144620486.81289.04
41411462-141146284.72786.82
51475790-147579088.58890.75
61431597-143159785.93688.22
极限11508799-150879990.57088.751.3593.0591.361.26
21489735-148973589.42691.96
31484947-148494789.13891.84
41453416-145341687.24589.81
51467212-146721288.07490.73
61466631-146663188.03990.80
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.566054460384605036014360027603200.38
212.556031160176602440.16
单位质量响应值RSD%判断
4802.554800.320.04数据可信
供试品溶液-2025020411批-氨氯地平-shui(内含0.4%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min124851-2485133.55635.4725.8433.5635.4725.84
219168-1916825.88325.88
332543-3254343.94343.94
434073-3407346.00946.01
517913-1791324.18824.19
629062-2906239.24339.24
10min154674-5467473.82777.137.0174.0177.327.04
257847-5784778.11178.26
359449-5944980.27480.52
461971-6197183.68083.94
550540-5054068.24568.38
658226-5822678.62378.84
15min161829-6182983.48886.913.5984.0887.543.57
265351-6535188.24488.82
362034-6203483.76584.46
464520-6452087.12287.84
564389-6438986.94587.46
668077-6807791.92592.58
20min162758-6275884.74387.052.0185.8088.161.98
266228-6622889.42890.50
363786-6378686.13187.29
463713-6371386.03287.24
564713-6471387.38288.38
665586-6558688.56189.73
30min164828-6482887.53887.782.7389.0789.382.63
266027-6602789.15790.72
362915-6291584.95586.59
462895-6289584.92886.61
566876-6687690.30391.79
666511-6651189.81091.47
45min162672-6267284.62686.022.8386.6488.092.71
265186-6518688.02190.08
361939-6193983.63785.74
462131-6213183.89686.05
566398-6639889.65891.64
663879-6387986.25688.41
60min163645-6364585.94085.642.7488.4388.202.61
265236-6523688.08990.64
361567-6156783.13485.70
461584-6158483.15785.78
565571-6557188.54191.02
662940-6294084.98887.62
极限165501-6550188.44685.383.6291.4188.413.48
263769-6376986.10889.15
360329-6032981.46384.50
460574-6057481.79484.88
563751-6375186.08389.06
665448-6544888.37591.48
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.011350566134941413507311349374134952113499210.05
29.051353038135387413534560.05
单位质量响应值RSD%判断
149824.75149553.150.13数据可信
供试品溶液-2025020411批-厄贝沙坦-shui(内含0.4%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1318811-31881119.16819.3131.3719.1719.3131.36
2214905-21490512.92112.92
3403732-40373224.27424.27
4435453-43545326.18126.18
5188597-18859711.33911.34
6365936-36593622.00222.00
10min1866980-86698052.12753.3211.5552.2353.4311.58
2874211-87421152.56252.63
3953029-95302957.30157.44
4999809-99980960.11360.26
5704111-70411142.33442.40
6923249-92324955.51055.63
15min11136853-113685368.35369.123.9168.7569.533.96
21159516-115951669.71670.08
31150328-115032869.16369.62
41178866-117886670.87971.36
51070621-107062164.37164.67
61201766-120176672.25672.69
20min11251094-125109475.22275.792.8776.0076.572.94
21261044-126104475.82076.57
31277301-127730176.79777.63
41280002-128000276.96077.83
51194737-119473771.83372.49
61298781-129878178.08978.92
30min11370753-137075382.41682.560.5483.6183.770.54
21367589-136758982.22683.40
31378683-137868382.89384.16
41380573-138057383.00784.31
51378660-137866082.89283.95
61362391-136239181.91383.18
45min11427528-142752885.83086.440.9787.4888.110.90
21425280-142528085.69587.32
31441619-144161986.67788.40
41433412-143341286.18487.95
51463608-146360887.99989.51
61434979-143497986.27888.00
60min11476671-147667188.78488.131.3390.9190.281.26
21437101-143710186.40588.51
31469523-146952388.35590.56
41461823-146182387.89290.13
51494244-149424489.84191.85
61455189-145518987.49389.69
极限11474738-147473888.66889.142.6991.2991.782.64
21429021-142902185.91988.50
31478878-147887888.91791.61
41473980-147398088.62391.35
51487050-148705089.40891.91
61552272-155227293.33096.02
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