厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105对照品来源中检院对照品使用方法左氨氯地平需分装,厄贝沙坦105℃烘干2小时
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.573175031548315843149631374315500.44
213.593157631565315700.03
单位质量响应值RSD%判断
2324.982323.030.06数据可信
长期6月-供试品溶液-24032001批-左氨氯地平-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%
5min119948-1994854.19457.997.3054.1957.997.30
220310-2031055.17855.18
321252-2125257.73757.74
421587-2158758.64758.65
524280-2428065.96365.96
620694-2069456.22156.22
10min130154-3015481.92286.302.6882.2286.622.69
231630-3163085.93286.24
331889-3188986.63586.96
432032-3203287.02487.35
532416-3241688.06788.43
632470-3247088.21488.53
15min134300-3430093.18593.870.5393.9494.670.54
234480-3448093.67494.46
334660-3466094.16394.97
434759-3475994.43295.24
534413-3441393.49294.35
634703-3470394.28095.08
20min134111-3411192.67295.771.9593.9597.091.94
235388-3538896.14197.45
335211-3521195.66096.99
435354-3535496.04997.38
535176-3517695.56596.94
636262-3626298.51699.84
30min134203-3420392.92294.981.6894.7196.841.67
234306-3430693.20295.04
335631-3563196.80198.66
435082-3508295.31097.18
535110-3511095.38697.29
635430-3543096.25598.13
45min135455-3545596.32397.601.3298.6399.991.31
235697-3569796.98199.34
336553-3655399.306101.70
436033-3603397.893100.29
535442-3544296.28898.72
636381-3638198.839101.25
60min135838-3583897.36497.731.15100.20100.661.13
235538-3553896.54999.44
336489-3648999.132102.08
435866-3586697.440100.38
535639-3563996.82399.79
636471-3647199.083102.04
90min135669-3566996.90597.331.91100.29100.801.85
235921-3592197.589101.02
335302-3530295.90899.40
435980-3598097.749101.23
535062-3506295.25598.76
637016-37016100.564104.07
120min136494-3649499.146100.130.92103.07104.140.91
236817-36817100.023104.00
336988-36988100.488104.52
437217-37217101.110105.14
536439-3643998.996103.03
637187-37187101.029105.10
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限137476-37476101.814102.401.46106.28106.961.41
237721-37721102.479107.01
338607-38607104.886109.47
437125-37125100.860105.45
537234-37234101.156105.74
637991-37991103.213107.84
厄贝沙坦左氨氯地平片项目信息
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对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数200
标示量(mg)150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%
115.152066883205563220578092056223205101220575120.29
215.202056986205179720543920.18
单位质量响应值RSD%判断
135809.37135157.370.35数据可信
长期6月-供试品溶液-24032001批-厄贝沙坦-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%
5min1495450-49545021.94222.595.4821.9422.595.48
2505996-50599622.40922.41
3524120-52412023.21123.21
4525042-52504223.25223.25
5545159-54515924.14324.14
6465189-46518920.60120.60
10min1992651-99265143.96146.413.0044.0846.533.00
21056243-105624346.77746.90
31072178-107217847.48347.61
41064533-106453347.14447.27
51072416-107241647.49347.63
61029539-102953945.59445.71
15min11315229-131522958.24659.281.5958.6159.661.60
21350474-135047459.80760.19
31355844-135584460.04560.44
41352033-135203359.87660.27
51349878-134987859.78160.18
61307701-130770157.91358.28
20min11458767-145876764.60367.251.9865.2967.961.99
21530724-153072467.79068.51
31529767-152976767.74768.47
41534212-153421267.94468.67
51539010-153901068.15768.89
61518290-151829067.23967.93
30min11699656-169965675.27177.511.5876.3278.601.58
21761857-176185778.02679.12
31770660-177066078.41679.52
41774047-177404778.56679.67
51754323-175432377.69278.80
61740850-174085077.09678.16
45min11898928-189892884.09685.551.1385.5687.061.15
21954741-195474186.56888.09
31943625-194362586.07687.61
41946882-194688286.22087.76
51934456-193445685.67087.21
61911796-191179684.66686.16
60min12011042-201104289.06189.611.0191.0091.601.01
22061566-206156691.29993.31
32016331-201633189.29691.31
42007319-200731988.89690.91
52031203-203120389.95491.97
62013215-201321589.15891.12
90min12120188-212018893.89596.001.2296.3298.491.22
22194114-219411497.16999.68
32158534-215853495.59398.11
42182777-218277796.66799.18
52182191-218219196.64199.16
62167998-216799896.01298.47
120min12170005-217000596.10197.410.9099.05100.430.92
22207825-220782597.776100.83
32192459-219245997.096100.14
42223220-222322098.458101.51
52215763-221576398.128101.18
62187745-218774596.88799.88
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限12216790-221679098.17398.961.40101.66102.531.37
22294990-2294990101.636105.23
32241683-224168399.275102.86
42217452-221745298.202101.80
52222590-222259098.430102.03
62214370-221437098.066101.59
厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105对照品来源中检院对照品使用方法左氨氯地平需分装,厄贝沙坦105℃烘干2小时
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.573181631442316843162231517316160.47
213.593153631433314840.24
单位质量响应值RSD%判断
2329.852316.700.41数据可信
长期6月-供试品溶液-24032501批-左氨氯地平-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%
5min115950-1595043.34755.8512.2843.3555.8512.28
222403-2240360.88460.88
320077-2007754.56254.56
420702-2070256.26156.26
523147-2314762.90562.91
621026-2102657.14157.14
10min129785-2978580.94583.752.0681.1984.072.10
231449-3144985.46785.81
330816-3081683.74784.05
430647-3064783.28883.60
531522-3152285.66686.02
630694-3069483.41683.73
15min133013-3301389.71891.521.7290.4192.301.74
233539-3353991.14791.96
333193-3319390.20790.98
433589-3358991.28392.06
534438-3443893.59094.42
634292-3429293.19493.97
20min134821-3482194.63194.692.0995.8295.982.09
234427-3442793.56194.88
333978-3397892.34093.61
434408-3440893.50994.79
535831-3583197.37698.72
635592-3559296.72798.03
30min136283-3628398.60596.811.38100.3298.621.34
235849-3584997.42599.26
334789-3478994.54496.33
435624-3562496.81498.62
535695-3569597.00798.89
635501-3550196.47998.32
45min134504-3450493.77095.942.0996.0398.282.08
234770-3477094.49396.87
334791-3479194.55096.86
435453-3545396.34998.69
535943-3594397.681100.11
636348-3634898.781101.15
60min136151-3615198.24697.623.19101.03100.503.11
234525-3452593.82796.73
335439-3543996.31199.14
435797-3579797.284100.16
535641-3564196.86099.83
637977-37977103.208106.13
90min136787-3678799.97497.323.15103.30100.743.03
236537-3653799.295102.72
334887-3488794.81198.18
435633-3563396.838100.25
536882-36882100.232103.74
634128-3412892.74896.24
120min135397-3539796.19794.131.54100.0898.101.45
234444-3444493.60797.59
334341-3434193.32797.22
434432-3443293.57497.53
534028-3402892.47696.54
635187-3518795.62699.64
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限134659-3465994.19195.441.1598.6199.921.13
235722-3572297.080101.58
334945-3494594.96899.38
434905-3490594.86099.33
534983-3498395.07299.65
635494-3549496.460101.00
厄贝沙坦左氨氯地平片项目信息
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对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数200
标示量(mg)150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%
115.152052407204364020461632034821204616720446400.32
215.202058821204945120541360.33
单位质量响应值RSD%判断
134959.74135140.530.10数据可信
长期6月-供试品溶液-24032501批-厄贝沙坦-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%
5min1364203-36420316.18122.6615.1916.1822.6615.19
2549479-54947924.41224.41
3510036-51003622.66022.66
4505719-50571922.46822.47
5588391-58839126.14126.14
6541792-54179224.07124.07
10min1956839-95683942.51046.564.7242.6046.694.75
21075581-107558147.78647.92
31050305-105030546.66346.79
41038667-103866746.14646.27
51100124-110012448.87649.02
61066603-106660347.38747.52
15min11280516-128051656.89159.662.4757.2260.042.50
21355661-135566160.22960.63
31337519-133751959.42359.81
41345641-134564159.78460.17
51373146-137314661.00661.42
61364408-136440860.61861.01
20min11501151-150115166.69368.532.2467.3469.242.26
21534062-153406268.15568.89
31531211-153121168.02968.74
41520095-152009567.53568.25
51590822-159082270.67771.43
61577348-157734870.07870.81
30min11776599-177659978.93179.180.5479.9480.280.56
21783756-178375679.24980.36
31772329-177232978.74179.83
41786526-178652679.37280.46
51798293-179829379.89581.04
61775894-177589478.89980.02
45min11913084-191308484.99487.511.7986.4589.051.80
21953084-195308486.77288.33
31973985-197398587.70089.23
41970069-197006987.52689.06
51990541-199054188.43690.03
62017234-201723489.62291.18
60min12078003-207800392.32192.160.7094.2494.180.68
22060608-206060891.54993.59
32057055-205705591.39193.41
42096753-209675393.15495.17
52080551-208055192.43594.52
62072822-207282292.09194.15
90min12161043-216104396.01195.842.0898.4598.372.02
22191317-219131797.35699.90
32159200-215920095.92998.45
42179923-217992396.85099.38
52182132-218213296.94899.54
62069482-206948291.94394.51
120min12146220-214622095.35295.200.3898.3298.270.37
22135664-213566494.88397.97
32132549-213254994.74597.80
42149094-214909495.48098.55
52140351-214035195.09198.23
62153466-215346695.67498.76
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限12142451-214245195.18596.200.6398.6899.800.64
22172129-217212996.503100.12
32170398-217039896.426100.01
42171822-217182296.490100.09
52156264-215626495.79899.46
62178915-217891596.805100.42
厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105对照品来源中检院对照品使用方法左氨氯地平需分装,厄贝沙坦105℃烘干2小时
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.573149731242314373127431237313370.39
213.593147131301313860.39
单位质量响应值RSD%判断
2309.292309.490.01数据可信
长期6月-供试品溶液-24032502批-左氨氯地平-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%
5min122606-2260661.80463.434.5761.8063.434.58
223342-2334263.81663.82
323697-2369764.78764.79
424634-2463467.34967.35
521499-2149958.77858.78
623426-2342664.04664.05
10min130747-3074784.06187.772.6984.4088.122.69
232038-3203887.59187.95
331983-3198387.44187.80
433402-3340291.32091.69
532491-3249188.82989.16
631952-3195287.35687.71
15min133406-3340691.33193.092.1492.1493.932.14
233038-3303890.32591.17
334629-3462994.67595.52
434978-3497895.62996.51
534159-3415993.39094.21
634078-3407893.16894.01
20min134780-3478095.08795.792.0496.4197.152.03
235423-3542396.84598.19
335057-3505795.84597.22
436171-3617198.890100.30
534735-3473594.96496.30
634064-3406493.13094.49
30min134119-3411993.28096.423.4795.1398.303.43
234813-3481395.17897.06
334126-3412693.29995.20
437365-37365102.155104.12
535696-3569697.59299.46
635475-3547596.98898.86
45min134366-3436693.95698.853.6896.32101.283.64
236126-3612698.767101.18
335509-3550997.08199.50
438371-38371104.905107.43
536664-36664100.238102.65
635912-3591298.182100.60
60min135139-3513996.06997.951.3298.96100.931.33
236299-3629999.240102.20
335503-3550397.064100.03
436375-3637599.448102.56
535854-3585498.024100.99
635793-3579397.857100.82
90min135853-3585398.02198.851.84101.44102.361.84
235855-3585598.026101.54
335465-3546596.960100.46
437305-37305101.991105.66
536549-3654999.924103.43
635900-3590098.149101.65
120min132831-3283189.75994.203.2593.7298.273.19
234335-3433593.87197.93
333728-3372892.21196.25
436034-3603498.516102.75
534619-3461994.64798.71
635192-3519296.214100.26
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限134773-3477395.06898.912.3499.53103.502.30
236345-3634599.366103.94
335588-3558897.296101.85
436616-36616100.107104.89
536750-36750100.473105.06
637005-37005101.171105.75
厄贝沙坦左氨氯地平片项目信息
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对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数200
标示量(mg)150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%
115.152051143204584720513302046941204402420478570.16
215.202047605204700820473060.03
单位质量响应值RSD%判断
135172.08134691.180.26数据可信
长期6月-供试品溶液-24032502批-厄贝沙坦-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%
5min1578377-57837725.71925.644.6025.7225.644.60
2610325-61032527.13927.14
3563516-56351625.05825.06
4603588-60358826.84026.84
5540550-54055024.03724.04
6563293-56329325.04825.05
10min11064739-106473947.34648.291.5247.4948.441.52
21100158-110015848.92149.07
31090009-109000948.47048.61
41104671-110467149.12249.27
51088722-108872248.41248.55
61067802-106780247.48247.62
15min11355466-135546660.27460.521.0860.6860.931.09
21377191-137719161.24061.66
31371541-137154160.98861.40
41372276-137227661.02161.44
51347601-134760159.92460.33
61341813-134181359.66760.07
20min11570812-157081269.84968.651.6270.5969.401.62
21564848-156484869.58470.35
31546041-154604168.74869.50
41554637-155463769.13069.89
51515738-151573867.40068.14
61511603-151160367.21767.95
30min11781708-178170879.22779.241.4980.3680.371.48
21776931-177693179.01580.16
31754232-175423278.00679.13
41832520-183252081.48782.63
51774221-177422178.89480.00
61773023-177302378.84179.95
45min11965561-196556187.40387.970.5588.9789.540.54
21990743-199074388.52390.11
31973047-197304787.73689.30
41971701-197170187.67689.27
51992409-199240988.59790.14
61976287-197628787.88089.43
60min12078752-207875292.43691.630.7994.4993.680.78
22076374-207637492.33094.41
32068784-206878491.99394.04
42047243-204724391.03593.12
52040246-204024690.72492.76
62051875-205187591.24193.28
90min12188948-218894897.33695.951.3599.9098.511.31
22113028-211302893.96096.55
32182969-218296997.07099.63
42172903-217290396.62399.21
52143633-214363395.32197.87
62144767-214476795.37297.91
120min12145991-214599195.42694.650.8698.5397.750.84
22111499-211149993.89297.01
32108579-210857993.76296.86
42144737-214473795.37098.50
52116336-211633694.10797.18
62144399-214439995.35598.43
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限12214645-221464598.47998.821.48102.12102.441.42
22201638-220163897.900101.54
32253853-2253853100.222103.84
42183176-218317697.080100.74
52210496-221049698.294101.89
62269675-2269675100.926104.53
厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105对照品来源中检院对照品使用方法左氨氯地平需分装,厄贝沙坦105℃烘干2小时
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.573157231382313853136431229313860.39
213.593134431254312990.21
单位质量响应值RSD%判断
2312.902303.090.31数据可信
长期6月-供试品溶液-2024042411批-左氨氯地平-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%
5min116821-1682146.01647.693.9146.0247.703.91
218505-1850550.62350.62
318002-1800249.24749.25
416855-1685546.10946.11
517348-1734847.45847.46
617076-1707646.71446.71
10min131065-3106584.98286.901.3585.2487.161.35
231765-3176586.89787.18
331989-3198987.51087.78
432256-3225688.24188.50
532011-3201187.57087.83
631501-3150186.17586.43
15min134699-3469994.92494.382.0295.6595.132.01
234911-3491195.50496.27
334343-3434393.95094.71
433486-3348691.60592.35
535488-3548897.08297.83
634079-3407993.22893.97
20min134869-3486995.38997.521.8696.6498.801.84
236387-3638799.542100.84
334934-3493495.56796.85
435456-3545696.99598.25
536002-3600298.48899.78
636246-3624699.156100.41
30min136093-3609398.73798.821.91100.52100.631.90
236641-36641100.236102.08
335582-3558297.33999.15
435652-3565297.53199.32
537237-37237101.867103.70
635530-3553097.19799.00
45min134573-3457394.57995.342.2896.9197.702.23
234739-3473995.03397.44
333455-3345591.52193.87
435281-3528196.51698.85
535543-3554397.23399.64
635510-3551097.14299.49
60min135619-3561997.44198.151.03100.30101.041.03
236161-3616198.923101.86
335451-3545196.98199.84
435634-3563497.482100.35
536398-3639899.572102.51
636000-3600098.483101.37
90min135273-3527396.49498.111.3299.89101.551.31
236094-3609498.740102.22
335574-3557497.317100.72
435624-3562497.454100.87
536594-36594100.108103.60
636028-3602898.559101.99
120min134349-3434993.96696.762.1897.90100.742.13
235379-3537996.784100.81
334859-3485995.36199.30
435130-3513096.103100.06
536335-3633599.399103.45
636179-3617998.973102.95
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限135879-3587998.15298.091.04102.61102.611.04
236192-3619299.008103.58
335348-3534896.699101.17
435463-3546397.014101.50
536208-3620899.052103.66
636051-3605198.622103.15
厄贝沙坦左氨氯地平片项目信息
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对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数200
标示量(mg)150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%
115.152052965204633620483672047916204960720490380.13
215.202055955205088120534180.18
单位质量响应值RSD%判断
135250.03135093.290.09数据可信
长期6月-供试品溶液-2024042411批-厄贝沙坦-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%
5min1395864-39586417.57218.266.0317.5718.266.03
2438862-43886219.48019.48
3443880-44388019.70319.70
4412304-41230418.30118.30
5386699-38669917.16517.16
6391074-39107417.35917.36
10min1986927-98692743.80845.292.6243.9145.392.62
21028422-102842245.65045.76
31053132-105313246.74646.86
41046809-104680946.46646.57
51003327-100332744.53644.63
61002721-100272144.50944.61
15min11315151-131515158.37759.111.7558.7259.461.75
21329461-132946159.01259.37
31357266-135726660.24660.62
41363235-136323560.51160.87
51314417-131441758.34458.69
61310253-131025358.16058.50
20min11483798-148379865.86367.891.8066.5368.571.80
21530247-153024767.92568.61
31551388-155138868.86369.57
41551494-155149468.86869.56
51510942-151094267.06867.73
61549307-154930768.77169.44
30min11741709-174170977.31178.651.7778.3479.711.77
21765323-176532378.35979.43
31803443-180344380.05181.14
41815429-181542980.58381.66
51765147-176514778.35179.39
61740525-174052577.25878.31
45min11861879-186187982.64585.052.1184.1186.542.09
21884606-188460683.65485.16
31946388-194638886.39687.93
41962149-196214987.09688.62
51896838-189683884.19785.67
61944109-194410986.29587.77
60min11985712-198571288.14290.221.6490.0692.191.64
22019724-201972489.65291.62
32058057-205805791.35393.36
42068963-206896391.83793.85
52007276-200727689.09991.04
62055674-205567491.24793.20
90min12073085-207308592.02094.031.8394.4396.501.82
22076926-207692692.19194.66
32172287-217228796.42498.94
42141867-214186795.07397.59
52113168-211316893.79996.24
62132672-213267294.66597.13
120min12083688-208368892.49196.022.3995.4199.012.37
22135053-213505394.77197.75
32222062-222206298.633101.69
42196944-219694497.518100.57
52143223-214322395.13398.09
62198095-219809597.569100.56
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限12141443-214144395.05496.161.6898.4999.681.68
22135887-213588794.80898.31
32217773-221777398.443102.04
42186056-218605697.035100.62
52127344-212734494.42997.92
62188923-218892397.162100.69
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