氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
112.566124560988610826072860154608390.71
212.555973659542596390.24
单位质量响应值RSD%判断
4843.874752.111.36数据可信
供试品溶液-2025020311批-氨氯地平-pH4.5(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%
5min135207-3520747.57946.5325.7047.5846.5325.70
235931-3593148.55748.56
340807-4080755.14755.15
434970-3497047.25847.26
517478-1747823.62023.62
642196-4219657.02457.02
10min157984-5798478.36082.8011.6978.8983.3211.77
264326-6432686.93087.47
365344-6534488.30688.92
464049-6404986.55687.08
548211-4821165.15265.41
667696-6769691.48492.12
15min162918-6291885.02792.164.8086.4393.604.88
268030-6803091.93693.44
370626-7062695.44497.04
470559-7055995.35396.84
565892-6589289.04690.03
671154-7115496.15797.81
20min165133-6513388.02193.113.4090.3695.573.50
268097-6809792.02694.55
371277-7127796.32498.98
470796-7079695.67498.22
567765-6776591.57893.55
670325-7032595.03797.76
30min166303-6630389.60294.113.5792.9297.613.61
268253-6825392.23795.79
372905-7290598.524102.25
472151-7215197.505101.11
568789-6878992.96195.95
669448-6944893.85297.63
45min165596-6559688.64693.314.6392.9697.854.61
267430-6743091.12595.70
374239-74239100.327105.15
471512-7151296.641101.33
567703-6770391.49495.52
667807-6780791.63496.45
60min165485-6548588.49693.374.0593.8098.944.10
267461-6746191.16796.75
372508-7250897.987103.92
471923-7192397.197102.96
567333-6733390.99496.04
669821-6982194.356100.19
极限166131-6613189.36993.603.2495.66100.223.29
267809-6780991.63798.24
370800-7080095.679102.70
472492-7249297.966104.81
568733-6873392.88698.94
669619-6961994.083100.97
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
19.011366940136696113666551366472137111213676280.15
29.051368586136109713648420.39
单位质量响应值RSD%判断
151790.01150811.270.46数据可信
供试品溶液-2025020311批-厄贝沙坦-pH4.5(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%
5min1364902-36490221.70619.8529.0921.7119.8529.09
2358294-35829421.31321.31
3379754-37975422.59022.59
4312753-31275318.60418.60
5152291-1522919.0599.06
6433857-43385725.80825.81
10min1810078-81007848.18748.2714.9748.4348.4915.03
2895485-89548553.26853.50
3863231-86323151.34951.60
4809238-80923848.13748.34
5579095-57909534.44734.55
6911532-91153254.22254.51
15min11037029-103702961.68863.635.3262.4664.395.46
21099239-109923965.38866.22
31100019-110001965.43466.26
41067460-106746063.49864.24
5976818-97681858.10658.59
61137848-113784867.68568.57
20min11173470-117347069.80471.322.3371.2772.792.51
21219682-121968272.55374.11
31215912-121591272.32873.88
41199843-119984371.37272.82
51157623-115762368.86169.99
61227517-122751773.01974.66
30min11326669-132666978.91780.341.5381.1582.591.65
21361457-136145780.98683.35
31376824-137682481.90084.25
41361875-136187581.01183.25
51325665-132566578.85780.75
61350617-135061780.34182.79
45min11417593-141759384.32585.771.8287.4488.921.77
21439611-143961185.63588.90
31485624-148562488.37291.63
41453476-145347686.46089.60
51440970-144097085.71688.49
61414179-141417984.12287.47
60min11465207-146520787.15889.011.6291.2193.121.57
21487507-148750788.48492.70
31512009-151200989.94294.19
41534445-153444591.27695.38
51496534-149653489.02192.74
61482624-148262488.19492.47
极限11513316-151331690.01990.881.3295.0495.981.17
21520797-152079790.46495.66
31520867-152086790.46995.71
41560867-156086792.84897.96
51543022-154302291.78696.50
61508216-150821689.71694.98
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
112.566010759557599965987359631598330.40
212.555930759648594780.41
单位质量响应值RSD%判断
4763.774739.280.37数据可信
供试品溶液-2025020311批-氨氯地平-pH4.5(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%
5min134618-3461847.23647.8315.8347.2447.8315.83
238662-3866252.75452.75
343305-4330559.09059.09
429645-2964540.45140.45
528491-2849138.87638.88
635595-3559548.56948.57
10min164142-6414287.52284.238.8488.0584.768.88
262591-6259185.40585.99
369207-6920794.43395.09
458282-5828279.52679.98
553189-5318972.57673.01
662978-6297885.93386.47
15min169560-6956094.91594.503.4096.4195.973.47
267347-6734791.89593.43
373792-73792100.689102.39
468203-6820393.06394.40
567823-6782392.54493.78
668829-6882993.91795.41
20min170554-7055496.27195.292.3798.8297.802.47
271210-7121097.16699.72
372042-7204298.301101.13
468255-6825593.13495.50
568645-6864593.66695.93
668285-6828593.17595.71
30min170489-7048996.18296.242.9299.8099.812.94
269805-6980595.24998.88
373867-73867100.791104.71
467922-6792292.67996.08
571708-7170897.845101.15
669391-6939194.68498.26
45min171155-7115597.09195.192.85101.7899.842.91
269465-6946594.78599.48
372959-7295999.552104.59
468219-6821993.08597.52
569211-6921194.43898.83
667568-6756892.19696.82
60min170867-7086796.69894.512.63102.47100.212.68
270068-7006895.608101.35
371400-7140097.425103.57
467879-6787992.62198.09
568655-6865593.68099.12
666717-6671791.03596.68
极限169053-6905394.22393.042.13101.0799.802.23
268286-6828693.17699.99
370517-7051796.220103.45
467056-6705691.49897.99
567684-6768492.35598.84
666530-6653090.78097.44
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
19.011371039134861113627381360781136000613606350.59
29.051367917136869913683080.05
单位质量响应值RSD%判断
151013.87151194.250.09数据可信
供试品溶液-2025020311批-厄贝沙坦-pH4.5(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%
5min1321554-32155419.15220.3515.2819.1520.3515.29
2379959-37995922.63122.63
3412664-41266424.57924.58
4301200-30120017.94017.94
5273202-27320216.27216.27
6361403-36140321.52621.53
10min1834201-83420149.68648.7610.3349.9048.9910.35
2853796-85379650.85351.10
3914326-91432654.45954.73
4768199-76819945.75545.95
5675992-67599240.26340.44
6865739-86573951.56551.80
15min11068984-106898463.67064.243.0064.4465.023.09
21073851-107385163.96064.78
31124534-112453466.97967.86
41053827-105382762.76863.48
51040940-104094062.00062.63
61109488-110948866.08366.90
20min11208112-120811271.95771.962.1973.4373.442.29
21215738-121573872.41173.94
31238129-123812973.74575.37
41189197-118919770.83172.24
51167248-116724869.52370.84
61230051-123005173.26474.81
30min11357979-135797980.88381.391.6783.1683.671.69
21361133-136113381.07183.40
31393266-139326682.98585.43
41328378-132837879.12081.31
51380025-138002582.19784.29
61378088-137808882.08184.44
45min11481005-148100588.21186.861.1291.3890.051.15
21449970-144997086.36389.60
31472812-147281287.72391.09
41435883-143588385.52488.59
51457423-145742386.80689.81
61452833-145283386.53389.81
60min11527482-152748290.97989.301.4095.1393.441.32
21522756-152275690.69894.89
31480844-148084488.20192.54
41492597-149259788.90192.92
51492122-149212288.87392.84
61479445-147944588.11892.35
极限11511572-151157290.03289.900.3695.1995.040.34
21512892-151289290.11095.31
31506675-150667589.74095.06
41501948-150194889.45894.47
51516723-151672390.33895.29
61506153-150615389.70994.92
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
112.565944059605593215923759187593580.29
212.555881158592587020.27
单位质量响应值RSD%判断
4725.964677.450.73数据可信
供试品溶液-2025020411批-氨氯地平-pH4.5(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%
5min112392-1239217.08840.8236.2217.0940.8236.22
221637-2163729.83729.84
336514-3651450.35250.35
429960-2996041.31441.31
540396-4039655.70655.71
636702-3670250.61250.61
10min140434-4043455.75877.6414.7855.9578.1014.82
262683-6268386.43986.77
355935-5593577.13477.69
462172-6217285.73486.19
560625-6062583.60184.22
655981-5598177.19777.76
15min157164-5716478.82887.717.4779.6489.027.52
268353-6835394.25895.55
364936-6493689.54690.96
468189-6818994.03295.44
564384-6438488.78590.33
658589-5858980.79382.21
20min158793-5879381.07590.187.4282.7692.477.48
268629-6862994.63896.98
368597-6859794.59497.01
469818-6981896.27898.73
566787-6678792.09894.63
659762-5976282.41184.73
30min159693-5969382.31690.626.6584.9093.916.72
270250-7025096.874100.26
368511-6851194.47697.94
469160-6916095.37198.90
565299-6529990.04693.60
661385-6138584.64987.88
45min161196-6119684.38892.705.2787.8997.005.44
270588-7058897.340101.81
368847-6884794.93999.45
469779-6977996.224100.81
567998-6799893.76898.33
664939-6493989.55093.72
60min161328-6132884.57092.044.6389.0197.374.83
269895-6989596.384101.93
368032-6803293.81599.38
468959-6895995.093100.75
566857-6685792.19597.79
665411-6541190.20195.37
极限160727-6072783.74292.225.5289.1298.575.63
271931-7193199.192105.81
367647-6764793.28499.89
468443-6844394.382101.09
566909-6690992.26798.89
665581-6558190.43596.61
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
19.011358036136106313570451360534136084213595040.14
29.051361075135604113585580.27
单位质量响应值RSD%判断
150888.35150116.910.37数据可信
供试品溶液-2025020411批-厄贝沙坦-pH4.5(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%
5min1100568-1005686.01416.1441.456.0116.1441.46
2191115-19111511.42911.43
3325736-32573619.47919.48
4250901-25090115.00415.00
5406458-40645824.30624.31
6344211-34421120.58420.58
10min1476702-47670228.50742.2517.3928.5742.4317.44
2790809-79080947.29047.42
3703926-70392642.09542.31
4726081-72608143.42043.59
5829240-82924049.58949.86
6712473-71247342.60642.83
15min1890448-89044853.24957.986.3153.6358.636.41
21020257-102025761.01161.66
3985319-98531958.92259.61
4983677-98367758.82459.47
51037551-103755162.04662.87
6900331-90033153.84054.54
20min11067391-106739163.83066.675.3764.8167.965.41
21164256-116425669.62370.95
31147990-114799068.65069.99
41129958-112995867.57268.87
51162589-116258969.52371.03
61016773-101677360.80362.10
30min11263337-126333775.54876.024.2977.2378.064.27
21310173-131017378.34880.45
31303697-130369777.96180.06
41302541-130254177.89279.95
51282042-128204276.66678.95
61165731-116573169.71171.69
45min11446853-144685386.52284.482.7489.0587.362.65
21419232-141923284.87087.84
31429311-142931185.47388.44
41438777-143877786.03988.96
51401822-140182283.82986.96
61340663-134066380.17282.92
60min11507274-150727490.13587.572.2393.6291.392.11
21477387-147738788.34892.27
31451945-145194586.82690.74
41482964-148296488.68192.56
51454114-145411486.95691.02
61412482-141248284.46688.11
极限11535446-153544691.82089.252.6396.3194.042.51
21537602-153760291.94996.85
31474864-147486488.19793.08
41488528-148852889.01493.87
51483826-148382688.73393.77
61434076-143407685.75890.34
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
112.565963259386592195966659092593990.43
212.555840058482584410.10
单位质量响应值RSD%判断
4729.224656.651.10数据可信
供试品溶液-2025020411批-氨氯地平-pH4.5(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%
5min136143-3614349.93540.9126.5449.9440.9126.54
231650-3165043.72843.73
317407-1740724.05024.05
438685-3868553.44753.45
524090-2409033.28333.28
629674-2967440.99841.00
10min156558-5655878.14177.639.6778.7078.089.71
261279-6127984.66485.15
351527-5152771.19071.46
457735-5773579.76780.36
548135-4813566.50466.87
661887-6188785.50485.96
15min165870-6587091.00789.255.9792.4390.576.00
268449-6844994.57096.00
362278-6227886.04487.10
461732-6173285.28986.77
559935-5993582.80783.92
669339-6933995.79997.20
20min168415-6841594.52390.955.7696.9693.265.81
268856-6885695.13297.61
363136-6313687.22989.24
463279-6327987.42789.85
561059-6105984.36086.39
670247-7024797.05499.52
30min169509-6950996.03492.415.2599.5295.735.29
269715-6971596.31999.85
365398-6539890.35493.34
463674-6367487.97291.37
562398-6239886.21089.18
670620-7062097.569101.12
45min169823-6982396.46893.534.24101.0297.884.36
270778-7077897.787102.39
365623-6562390.66594.65
466281-6628191.57495.95
563736-6373688.05891.98
669947-6994796.639101.27
60min169954-6995496.64994.023.26102.2799.403.41
269080-6908095.441101.13
364660-6466089.33594.33
467462-6746293.20698.60
566646-6664692.07996.98
670507-7050797.413103.12
极限167143-6714392.76591.252.8799.4697.683.06
267230-6723092.88599.64
363000-6300087.04193.03
466325-6632591.63598.06
564577-6457789.22095.15
667991-6799193.937100.73
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
19.011371124136101513611731362779136098713634160.33
29.051365376135518313602800.53
单位质量响应值RSD%判断
151322.53150307.180.48数据可信
供试品溶液-2025020411批-厄贝沙坦-pH4.5(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%
5min1321945-32194519.21316.0831.0619.2116.0831.05
2302286-30228618.03918.04
3150814-1508149.0009.00
4383611-38361122.89322.89
5208593-20859312.44812.45
6249957-24995714.91714.92
10min1706927-70692742.18741.9712.2742.4042.1412.32
2803194-80319447.93248.13
3639491-63949138.16338.26
4773834-77383446.18046.43
5570335-57033534.03634.17
6725627-72562743.30343.47
15min1996957-99695759.49558.784.7960.1859.434.87
21055794-105579463.00663.74
3970391-97039157.91058.43
4986828-98682858.89059.66
5909553-90955354.27954.80
6990683-99068359.12059.77
20min11135823-113582367.78266.873.6469.1368.173.69
21167484-116748469.67171.10
31119270-111927066.79467.96
41091718-109171865.15066.57
51057058-105705863.08264.20
61152312-115231268.76670.07
30min11295229-129522977.29576.452.7079.3978.492.70
21313602-131360278.39180.60
31292275-129227577.11879.03
41235716-123571673.74375.89
51239985-123998573.99875.82
61309523-130952378.14880.22
45min11429406-142940685.30284.451.9188.2687.341.90
21433512-143351285.54788.63
31445432-144543286.25889.02
41379482-137948282.32385.29
51385418-138541882.67785.32
61417343-141734384.58287.52
60min11503772-150377289.74088.481.5393.6492.321.41
21455459-145545986.85790.89
31492746-149274689.08292.81
41453796-145379686.75790.64
51487643-148764388.77792.34
61502949-150294989.69193.57
极限11471132-147113287.79287.560.8492.6992.370.73
21446907-144690786.34691.34
31475538-147553888.05592.77
41458180-145818087.01991.86
51471922-147192287.83992.39
61479684-147968488.30293.17
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