贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数2000
标示量(mg)10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%
110.969713409717929719359715519702109713660.08
210.959731939732299732110.01
单位质量响应值RSD%判断
88628.2888877.720.20数据可信
供试品溶液-2025112921批-依折麦布-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1431943-43194343.69251.6613.7343.6951.6613.73
2594780-59478060.16360.16
3436114-43611444.11444.11
4485982-48598249.15849.16
5576567-57656758.32158.32
6538688-53868854.48954.49
10min1903142-90314291.35491.032.4691.8491.602.49
2939347-93934795.01795.69
3895470-89547090.57891.07
4877104-87710488.72189.27
5902628-90262891.30291.95
6881798-88179889.19589.80
15min1926161-92616193.68393.671.0395.1895.251.04
2939073-93907394.98996.71
3934500-93450094.52696.02
4918629-91862992.92194.45
5923826-92382693.44795.11
6913754-91375492.42894.02
20min1941696-94169695.25493.901.0897.8096.531.08
2931978-93197894.27197.05
3924057-92405793.47096.02
4911583-91158392.20894.77
5930300-93030094.10196.80
6930318-93031894.10396.73
30min1936287-93628794.70793.860.7398.3197.530.75
2933541-93354194.42998.26
3922835-92283593.34696.93
4922289-92228993.29196.88
5931800-93180094.25398.00
6920905-92090593.15196.82
45min1915754-91575492.63092.681.4197.2897.391.41
2924611-92461193.52698.40
3917561-91756192.81397.44
4899490-89949090.98595.61
5934864-93486494.56399.36
6905040-90504091.54696.25
60min1929453-92945394.01691.682.0499.7097.421.95
2895416-89541690.57396.49
3887091-88709189.73195.38
4890214-89021490.04795.68
5926667-92666793.73499.58
6909095-90909591.95797.68
极限1925585-92558593.62592.671.01100.3599.431.03
2922228-92222893.285100.21
3912410-91241092.29298.94
4900684-90068491.10697.74
5922247-92224793.287100.17
6913662-91366292.41899.16
贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数100
标示量(mg)180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%
110.192599712574692557532566142566542572920.63
210.272588992591872590430.08
单位质量响应值RSD%判断
25249.4625223.270.08数据可信
供试品溶液-2025112921批-贝派度酸-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min144256-4425617.48821.4113.9317.4921.4113.92
262667-6266724.76224.76
346835-4683518.50718.51
452994-5299420.94020.94
561320-6132024.23024.23
656954-5695422.50522.51
10min1108206-10820642.75743.472.8342.9543.712.86
2116008-11600845.84046.12
3110562-11056243.68843.89
4109213-10921343.15543.39
5108478-10847842.86443.13
6107581-10758142.51042.76
15min1128817-12881750.90151.761.7451.5752.481.79
2135005-13500553.34654.13
3129345-12934551.11051.80
4130135-13013551.42252.13
5132175-13217552.22852.97
6130516-13051651.57352.30
20min1145990-14599057.68758.331.3058.9259.621.31
2149373-14937359.02460.40
3146725-14672557.97859.24
4147690-14769058.35959.64
5145539-14553957.50958.83
6150338-15033859.40560.70
30min1162630-16263064.26266.621.8366.1468.561.84
2171036-17103667.58469.62
3168710-16871066.66568.57
4170815-17081567.49769.43
5169420-16942066.94568.91
6168937-16893766.75468.71
45min1184866-18486673.04974.632.2075.6477.322.19
2192323-19232375.99578.78
3182793-18279372.23074.87
4193128-19312876.31379.00
5190422-19042275.24477.95
6189732-18973274.97177.67
60min1202253-20225379.91979.771.2583.3283.291.17
2197961-19796178.22381.85
3199755-19975578.93282.38
4204306-20430680.73084.26
5203248-20324880.31283.86
6203780-20378080.52284.05
极限1210151-21015183.04084.331.0687.3388.731.05
2212497-21249783.96788.46
3213580-21358084.39588.72
4217051-21705185.76690.19
5213010-21301084.17088.61
6214158-21415884.62389.05
贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数2000
标示量(mg)10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%
110.969718809720669715879714309716319717190.03
210.959716399711999714190.04
单位质量响应值RSD%判断
88660.4988714.060.05数据可信
供试品溶液-2025112921批-依折麦布-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1491387-49138749.74143.0227.7149.7443.0227.71
2370122-37012237.46637.47
3363771-36377136.82336.82
4527210-52721053.36853.37
5550821-55082155.75855.76
6246468-24646824.94924.95
10min1882687-88268789.35184.709.5589.9085.189.65
2820201-82020183.02683.44
3828600-82860083.87684.29
4867368-86736887.80188.39
5927499-92749993.88794.51
6694255-69425570.27770.55
15min1904936-90493691.60393.784.3893.1595.204.47
2924883-92488393.62394.96
3964238-96423897.60698.95
4941238-94123895.27896.85
5964955-96495597.67999.34
6858551-85855186.90887.97
20min1887959-88795989.88593.594.2192.4596.054.29
2922112-92211293.34295.72
3948511-94851196.01498.44
4933599-93359994.50597.13
5980293-98029399.232101.98
6875034-87503488.57790.60
30min1906760-90676091.78894.473.5895.3597.973.67
2921748-92174893.30596.72
3959150-95915097.091100.58
4928984-92898494.03897.72
5985635-98563599.772103.62
6897188-89718890.81993.83
45min1898261-89826190.92894.704.4395.5199.254.44
2922949-92294993.42797.88
3971236-97123698.315102.89
4917696-91769692.89597.62
51000993-1000993101.327106.29
6901792-90179291.28595.30
60min1887916-88791689.88193.484.1495.4799.084.15
2913963-91396392.51798.01
3924632-92463293.59799.26
4908511-90851191.96597.72
5997492-997492100.973107.06
6908266-90826691.94196.97
极限1888013-88801389.89094.675.1696.48101.315.08
2917171-91717192.84299.36
3944500-94450095.608102.31
4913475-91347592.46899.24
51026380-1026380103.897111.10
6921651-92165193.29599.35
贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数100
标示量(mg)180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%
110.192609932568892567882582202572972580370.68
210.272573182584212578700.31
单位质量响应值RSD%判断
25322.5725109.060.60数据可信
供试品溶液-2025112921批-贝派度酸-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min153218-5321821.04618.3026.3021.0518.3026.31
241769-4176916.51916.52
338655-3865515.28715.29
457489-5748922.73522.74
558563-5856323.16023.16
627924-2792411.04311.04
10min1112051-11205144.31340.659.5144.5540.869.58
2102346-10234640.47540.66
397830-9783038.68938.86
4103419-10341940.89941.15
5113893-11389345.04245.30
687193-8719334.48234.61
15min1133568-13356852.82352.314.8253.5552.964.91
2133327-13332752.72753.36
3133539-13353952.81153.41
4136838-13683854.11654.82
5136673-13667354.05154.81
6119693-11969347.33547.84
20min1144359-14435957.09058.244.4358.4059.474.51
2146089-14608957.77458.99
3145937-14593757.71458.90
4150764-15076459.62360.93
5157855-15785562.42763.79
6138522-13852254.78255.81
30min1171665-17166567.88968.142.2969.8470.022.41
2172642-17264268.27570.14
3172813-17281368.34370.17
4171474-17147467.81369.78
5178741-17874170.68772.74
6166417-16641765.81367.45
45min1191294-19129475.65277.302.7478.3579.942.76
2195403-19540377.27779.90
3197353-19735378.04880.63
4191967-19196775.91878.64
5205209-20520981.15583.99
6191594-19159475.77078.14
60min1204593-20459380.91182.574.3484.4586.084.30
2208783-20878382.56886.05
3202932-20293280.25483.71
4204537-20453780.88984.46
5226860-22686089.71793.46
6205092-20509281.10884.32
极限1214397-21439784.78887.234.1289.2391.654.08
2219679-21967986.87791.27
3215185-21518585.10089.45
4217176-21717685.88790.35
5238671-23867194.38899.12
6218326-21832686.34290.46
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