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%
113.843114231161311683117031215311710.09
213.953131631246312810.16
单位质量响应值RSD%判断
2252.242242.370.32数据可信
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%
5min122256-2225662.52957.519.3862.5357.519.39
222764-2276463.95663.96
320564-2056457.77557.77
417421-1742148.94548.94
519787-1978755.59255.59
620026-2002656.26356.26
10min132567-3256791.49789.033.3091.8489.353.31
232294-3229490.73091.09
332263-3226390.64390.96
429964-2996484.18484.46
530834-3083486.62986.94
632213-3221390.50390.82
15min133947-3394795.37593.682.8896.2394.502.89
234088-3408895.77196.63
334134-3413495.90096.72
432760-3276092.04092.78
531698-3169889.05689.85
633441-3344193.95394.77
20min135050-3505098.47395.641.9599.8696.981.95
234261-3426196.25797.65
334148-3414895.93997.30
434147-3414795.93697.19
533135-3313593.09394.38
633519-3351994.17295.51
30min135615-35615100.06197.312.25101.9999.172.27
235380-3538099.401101.33
334244-3424496.20998.10
434000-3400095.52397.31
533686-3368694.64196.44
634880-3488097.99699.86
45min135011-3501198.36496.732.04100.8599.142.03
234866-3486697.956100.43
333651-3365194.54396.97
433490-3349094.09196.41
534472-3447296.85099.18
635083-3508398.566100.97
60min135030-3503098.41796.571.96101.4599.511.97
235216-3521698.940101.96
334529-3452997.01099.96
434062-3406295.69898.53
533484-3348494.07496.94
633917-3391795.29098.24
90min133346-3334693.68695.022.8597.2798.502.80
234560-3456097.097100.67
334681-3468197.437100.93
432341-3234190.86294.23
533351-3335193.70097.09
634653-3465397.358100.84
120min133387-3338793.80193.952.2097.9097.962.14
232883-3288392.38596.50
333809-3380994.98799.02
432733-3273391.96495.84
533101-3310192.99896.91
634717-3471797.538101.56
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134696-3469697.47997.071.42102.10101.601.43
234723-3472397.555102.18
334861-3486197.942102.50
434535-3453597.027101.41
533585-3358594.35898.78
634900-3490098.052102.62
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%
114.982050750205350420540422052032205316520526990.07
215.102050833205119220510120.02
单位质量响应值RSD%判断
137029.31135828.610.63数据可信
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%
5min1631997-63199727.79524.759.8227.8024.759.82
2608000-60800026.74026.74
3558887-55888724.58024.58
4472940-47294020.80020.80
5545237-54523723.97923.98
6559271-55927124.59724.60
10min11118715-111871549.20147.843.1049.3647.983.11
21110633-111063348.84548.99
31108051-110805148.73248.87
41031796-103179645.37845.49
51063505-106350546.77346.91
61093801-109380148.10548.24
15min11386885-138688560.99560.042.1461.4260.442.15
21377744-137774460.59361.01
31402182-140218261.66862.07
41330813-133081358.52958.90
51333055-133305558.62759.02
61360434-136043459.83260.24
20min11588630-158863069.86868.691.2870.6369.431.30
21561997-156199768.69669.45
31583806-158380669.65570.41
41545673-154567367.97868.67
51545903-154590367.98868.71
61545320-154532067.96368.70
30min11817960-181796079.95378.930.9381.1180.050.94
21786443-178644378.56779.71
31813365-181336579.75180.89
41783163-178316378.42379.49
51786979-178697978.59179.69
61779923-177992378.28179.39
45min11939067-193906785.28085.710.9986.8887.270.97
21929885-192988584.87686.45
31965684-196568486.45088.03
41928434-192843484.81286.32
51974116-197411686.82188.35
61956157-195615786.03187.58
60min12042659-204265989.83689.620.6091.9191.650.61
22026511-202651189.12691.17
32055923-205592390.41992.48
42023092-202309288.97590.95
52043013-204301389.85191.87
62034637-203463789.48391.51
90min12078796-207879691.42593.542.5194.0096.072.45
22064656-206465690.80393.34
32201268-220126896.81199.37
42108713-210871392.74195.21
52134210-213421093.86296.38
62173075-217307595.57198.10
120min12096937-209693792.22393.591.9395.3096.641.89
22079762-207976291.46794.51
32185755-218575596.12999.23
42107841-210784192.70295.69
52134282-213428293.86596.90
62163737-216373795.16198.22
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12140780-214078094.15194.641.3297.7498.211.29
22110007-211000792.79896.35
32183604-218360496.03499.67
42157828-215782894.90198.40
52137685-213768594.01597.57
62181261-218126195.93199.51
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%
113.843112631214312243116231281312010.20
213.953132431198312610.29
单位质量响应值RSD%判断
2254.412240.930.43数据可信
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%
5min120649-2064958.00455.598.2358.0055.598.23
221064-2106459.17059.17
318269-1826951.31951.32
421897-2189761.51061.51
517965-1796550.46550.46
618897-1889753.08353.08
10min131688-3168889.01487.951.7889.3488.261.80
231744-3174489.17189.50
331043-3104387.20287.49
431824-3182489.39689.74
530379-3037985.33785.62
631183-3118387.59587.89
15min134022-3402295.57094.192.3196.3994.992.33
233868-3386895.13795.96
333264-3326493.44194.21
434563-3456397.09097.93
532391-3239190.98891.74
633082-3308292.93093.71
20min134987-3498798.28196.461.6399.6397.781.65
234673-3467397.39998.75
333914-3391495.26796.56
434587-3458797.15798.53
533457-3345793.98395.24
634409-3440996.65797.95
30min135686-35686100.24496.232.25102.1498.092.24
234074-3407495.71697.61
334043-3404395.62997.45
434164-3416495.96997.89
533352-3335293.68895.47
634231-3423196.15797.99
45min134961-3496198.20898.061.77100.66100.461.78
235489-3548999.691102.12
334895-3489598.022100.37
435335-3533599.258101.71
533739-3373994.77597.08
635042-3504298.435100.80
60min135641-35641100.11898.352.29103.11101.282.29
235884-35884100.801103.78
334531-3453197.00099.89
435096-3509698.587101.59
533683-3368394.61897.45
635233-3523398.972101.89
90min133310-3331093.57095.881.6397.1299.361.59
234646-3464697.323100.86
333873-3387395.15298.58
434820-3482097.812101.36
533918-3391895.27898.63
634231-3423196.15799.62
120min133560-3356094.27295.021.7798.3499.041.72
233759-3375994.83198.91
333137-3313793.08497.05
434142-3414295.907100.00
533518-3351894.15498.04
634846-3484697.885101.88
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135749-35749100.42198.481.86105.02103.021.86
235505-3550599.736104.34
334266-3426696.255100.73
435307-3530799.180103.81
534223-3422396.135100.54
635297-3529799.152103.70
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%
114.982051398205203620518582052413205204620519500.02
215.102050883204917420500280.06
单位质量响应值RSD%判断
136979.31135763.440.64数据可信
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%
5min1591915-59191526.04325.075.2126.0425.075.21
2586822-58682225.81925.82
3530747-53074723.35223.35
4607330-60733026.72226.72
5552303-55230324.30024.30
6550259-55025924.21124.21
10min11064926-106492646.85547.591.9747.0047.721.97
21088979-108897947.91348.06
31078333-107833347.44547.57
41118818-111881849.22649.37
51058889-105888946.58946.72
61079202-107920247.48347.62
15min11343164-134316459.09760.132.1459.5060.532.14
21372194-137219460.37460.78
31366850-136685060.13960.53
41421185-142118562.53062.95
51345801-134580159.21359.61
61350596-135059659.42459.82
20min11533825-153382567.48668.751.3668.2269.491.36
21577954-157795469.42770.17
31569003-156900369.03469.76
41591428-159142870.02070.79
51546263-154626368.03368.76
61557023-155702368.50669.23
30min11718204-171820475.59877.121.8676.7178.241.85
21746418-174641876.84077.97
31781709-178170978.39279.50
41800146-180014679.20480.36
51748740-174874076.94278.04
61721544-172154475.74576.85
45min11892259-189225983.25686.252.3184.7887.802.30
21989905-198990587.55389.11
31999499-199949987.97589.52
42005400-200540088.23489.83
51930114-193011484.92286.45
61944677-194467785.56387.09
60min12002829-200282988.12190.421.7490.1192.451.73
22102438-210243892.50494.55
32074264-207426491.26493.30
42075160-207516091.30493.39
52037646-203764689.65391.65
62038149-203814989.67591.68
90min12016096-201609688.70592.942.7891.1995.472.75
22154984-215498494.81697.37
32151403-215140394.65897.20
42171438-217143895.54098.14
52096320-209632092.23594.73
62083784-208378491.68394.19
120min12037329-203732989.63994.162.7192.6197.212.68
22163807-216380795.20498.29
32188415-218841596.28799.35
42195148-219514896.58399.71
52129892-212989293.71296.72
62126059-212605993.54396.56
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12115139-211513993.06395.701.8496.5399.271.84
22229554-222955498.097101.71
32165988-216598895.30098.90
42208845-220884597.186100.85
52167249-216724995.35598.89
62163782-216378295.20398.74
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%
113.843148831417313383137331115313460.45
213.953151331161313370.80
单位质量响应值RSD%判断
2264.882246.380.58数据可信
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%
5min125061-2506170.15067.084.7070.1567.084.70
224365-2436568.20268.20
325284-2528470.77470.77
422529-2252963.06363.06
523610-2361066.08866.09
622946-2294664.23064.23
10min132165-3216590.03587.452.3590.4387.822.36
230810-3081086.24386.62
331149-3114987.19187.58
430277-3027784.75185.10
532051-3205189.71690.08
630992-3099286.75287.11
15min133816-3381694.65792.222.2695.5593.082.25
232173-3217390.05890.92
333590-3359094.02494.90
433060-3306092.54193.36
533058-3305892.53593.40
631967-3196789.48190.32
20min133795-3379594.59894.290.6596.0195.660.67
233435-3343593.59094.95
334061-3406195.34396.74
433581-3358193.99995.33
533575-3357593.98295.36
633666-3366694.23795.57
30min135822-35822100.27296.553.30102.2198.443.25
234330-3433096.09697.97
333289-3328993.18295.11
433647-3364794.18496.04
535959-35959100.655102.56
633897-3389794.88496.74
45min135518-3551899.42196.252.11101.9298.682.09
234068-3406895.36297.77
335010-3501097.999100.45
434194-3419495.71598.10
533848-3384894.74697.21
633668-3366894.24396.63
60min134954-3495497.84295.291.92100.8998.251.89
234476-3447696.50499.45
334339-3433996.12199.11
433746-3374694.46197.37
533334-3333493.30896.29
633394-3339493.47696.39
90min133527-3352793.84894.172.0997.4497.672.02
232325-3232590.48393.96
334037-3403795.27598.80
434092-3409295.42998.87
534233-3423395.82499.33
633641-3364194.16797.60
120min134097-3409795.44394.081.1899.5698.091.17
233337-3333793.31697.30
333936-3393694.99399.05
433379-3337993.43497.40
533087-3308792.61696.65
633813-3381394.64898.60
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134305-3430596.02696.321.58100.67100.861.53
234360-3436096.180100.68
335401-3540199.094103.68
434524-3452496.639101.13
533989-3398995.14199.69
633885-3388594.85099.33
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%
114.982052448205176220526632051820204952920516440.07
215.102051766205286020523130.04
单位质量响应值RSD%判断
136958.88135914.770.55数据可信
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%
5min1639150-63915028.10826.207.9628.1126.207.96
2619381-61938127.23927.24
3645963-64596328.40828.41
4564310-56431024.81724.82
5580404-58040425.52425.52
6524838-52483823.08123.08
10min11095303-109530348.16847.623.5748.3247.773.58
21085256-108525647.72647.88
31129316-112931649.66449.82
41039549-103954945.71645.85
51113557-111355748.97149.11
61034744-103474445.50545.63
15min11373010-137301060.38159.761.9560.8060.161.96
21347929-134792959.27859.69
31398284-139828461.49261.93
41358485-135848559.74260.13
51356281-135628159.64560.06
61318802-131880257.99758.38
20min11520078-152007866.84968.142.0867.6168.882.08
21543778-154377867.89168.64
31606044-160604470.62971.40
41549562-154956268.14568.87
51559028-155902868.56169.31
61517898-151789866.75367.46
30min11730216-173021676.09077.801.7977.2278.921.79
21779615-177961578.26279.39
31809008-180900879.55580.72
41757463-175746377.28878.39
51797774-179777479.06180.19
61740968-174096876.56377.64
45min11951542-195154285.82385.831.0787.3887.381.09
21940893-194089385.35586.91
31984795-198479587.28588.90
41958002-195800286.10787.64
51953040-195304085.88987.45
61921911-192191184.52086.02
60min12011152-201115288.44588.871.3190.4790.901.32
22040977-204097789.75691.79
32063359-206335990.74092.84
42013678-201367888.55690.57
52002632-200263288.07090.11
61992565-199256587.62789.60
90min12000445-200044587.97490.972.9390.5093.502.86
21993995-199399587.69090.22
32104604-210460492.55495.15
42109162-210916292.75595.26
52140143-214014394.11796.65
62063659-206365990.75493.21
120min12073212-207321291.17492.651.4894.1895.681.47
22078673-207867391.41494.43
32143908-214390894.28397.40
42132969-213296993.80296.82
52126162-212616293.50296.56
62085586-208558691.71894.68
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12092441-209244192.01993.882.0095.5497.421.97
22126610-212661093.52297.05
32187831-218783196.21499.85
42173477-217347795.58399.12
52146102-214610294.37997.95
62082238-208223891.57195.04
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