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DJ333-221017对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.67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%
110.969449289450379447449443879442689446730.04
211.019428949420309424620.07
单位质量响应值RSD%判断
86192.7985600.540.49数据可信
供试品溶液-24052301SP批-依折麦布-pH6.6
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min139440-394404.1194.211.764.124.211.75
241163-411634.2994.30
339632-396324.1394.14
440032-400324.1814.18
540990-409904.2814.28
640439-404394.2234.22
10min158394-583946.0986.254.316.146.304.26
261145-611456.3866.43
361856-618566.4606.51
459683-596836.2336.28
562584-625846.5366.58
655627-556275.8095.86
15min162141-621416.4906.704.856.606.814.81
265117-651176.8006.92
366601-666016.9557.07
465421-654216.8326.95
566740-667406.9707.09
658760-587606.1366.25
20min164082-640826.6926.865.276.887.055.20
267350-673507.0347.23
367577-675777.0577.25
467344-673447.0337.22
568288-682887.1317.33
659257-592576.1886.37
30min164336-643366.7197.8327.456.988.0926.62
266827-668276.9797.25
3115788-11578812.09212.37
471091-710917.4247.69
572311-723117.5527.83
659267-592676.1896.44
45min1108022-10802211.2819.5127.0111.629.8626.28
270267-702677.3387.69
3126678-12667813.22913.64
496477-9647710.07510.43
584816-848168.8589.22
659998-599986.2666.58
60min1116996-11699612.21812.3437.2912.6812.8036.36
2102532-10253210.70811.14
3192146-19214620.06620.62
492476-924769.65810.12
5139996-13999614.62015.08
664776-647766.7657.15
极限1223439-22343923.33419.5229.9623.9320.1229.55
2154705-15470516.15616.71
3267118-26711827.89628.67
4155317-15531716.22016.79
5207939-20793921.71622.34
6113162-11316211.81812.28
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%
19.842539882517622516142514442513162520250.45
210.102548642547052547840.05
单位质量响应值RSD%判断
25612.3025226.141.08数据可信
供试品溶液-24052301SP批-贝派度酸-pH6.6
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min190750-9075035.60336.085.1335.6036.085.13
296137-9613737.71737.72
385381-8538133.49733.50
488408-8840834.68534.68
597844-9784438.38738.39
693210-9321036.56936.57
10min1159882-15988262.72661.945.0463.1262.345.03
2167943-16794365.88866.31
3158388-15838862.13962.51
4146661-14666157.53957.92
5163666-16366664.21064.64
6150727-15072759.13459.54
15min1188839-18883974.08673.262.8675.1874.342.87
2192316-19231675.45076.60
3190567-19056774.76475.83
4180153-18015370.67871.70
5188467-18846773.94075.08
6180004-18000470.62071.68
20min1206087-20608780.85378.982.5682.7780.882.55
2203575-20357579.86781.86
3206651-20665181.07482.97
4194188-19418876.18577.99
5200953-20095378.83980.80
6196355-19635577.03578.88
30min1222650-22265087.35185.462.6090.1788.242.57
2213938-21393883.93386.81
3223998-22399887.88090.67
4209150-20915082.05584.71
5220524-22052486.51789.35
6216727-21672785.02787.73
45min1225693-22569388.54589.091.7092.3392.821.70
2227325-22732589.18592.99
3233687-23368791.68195.45
4221723-22172386.98790.56
5227199-22719989.13692.93
6226842-22684288.99692.64
60min1224945-22494588.25189.852.3693.0294.572.31
2230185-23018590.30795.11
3237428-23742893.14997.94
4221851-22185187.03891.57
5228490-22849089.64294.43
6231208-23120890.70995.35
极限1235347-23534792.33291.622.6298.0897.342.55
2231991-23199191.01696.82
3243017-24301795.341101.17
4225058-22505888.29693.80
5229907-22990790.19895.98
6235935-23593592.56398.21
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DJ333-221017对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.67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%
110.969424249431929430929424039420079426240.06
211.019367489371709369590.04
单位质量响应值RSD%判断
86005.8485100.730.75数据可信
供试品溶液-24052301SP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%
5min1500462-50046252.47547.3414.5352.4847.3414.53
2348087-34808736.49836.50
3533314-53331455.92055.92
4449918-44991847.17547.18
5412237-41223743.22443.22
6464790-46479048.73548.73
10min1728593-72859376.39574.288.8876.9874.808.85
2620595-62059565.07165.48
3669568-66956870.20670.83
4807768-80776884.69785.22
5700922-70092273.49473.97
6722991-72299175.80876.35
15min1756172-75617279.28784.008.3180.7285.358.23
2770207-77020780.75981.89
3743986-74398678.00979.41
4927079-92707997.20798.67
5803009-80300984.19885.50
6806358-80635884.54985.93
20min1903557-90355794.74190.645.6297.0592.935.60
2829489-82948986.97589.00
3796116-79611683.47585.74
4928781-92878197.38699.93
5874526-87452691.69793.93
6854411-85441189.58891.91
30min1902983-90298394.68192.773.2798.0596.063.34
2862765-86276590.46493.46
3854425-85442589.58992.79
4929432-92943297.454101.08
5893147-89314793.64996.90
6865624-86562490.76494.08
45min1883026-88302692.58892.122.2697.0196.452.39
2855308-85530889.68293.68
3874307-87430791.67495.87
4914300-91430095.867100.58
5875838-87583891.83596.13
6868787-86878791.09595.42
60min1890868-89086893.41191.961.5598.8697.301.68
2863624-86362490.55495.55
3878851-87885192.15097.36
4895087-89508793.85399.63
5867333-86733390.94396.25
6866193-86619390.82396.16
极限1893879-89387993.72693.531.62100.2199.901.61
2887447-88744793.05299.05
3905677-90567794.963101.20
4901363-90136394.511101.33
5898290-89829094.189100.51
6865438-86543890.74497.09
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%
19.842524732513722511542509082509902513790.26
210.102547202534412540800.36
单位质量响应值RSD%判断
25546.6525156.441.09数据可信
供试品溶液-24052301SP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%
5min143048-4304816.93417.978.9316.9317.978.92
242067-4206716.54816.55
348507-4850719.08119.08
446382-4638218.24518.25
541981-4198116.51416.51
652075-5207520.48520.48
10min191214-9121435.88136.118.3836.0736.318.35
284003-8400333.04433.23
385207-8520733.51833.73
4104808-10480841.22941.43
589573-8957335.23635.42
695918-9591837.73137.96
15min1113562-11356244.67247.067.3445.2647.667.33
2116435-11643545.80246.35
3111084-11108443.69744.28
4135736-13573653.39554.06
5118996-11899646.81047.38
6121960-12196047.97648.62
20min1142816-14281656.18055.124.6957.2656.244.70
2136017-13601753.50554.57
3130312-13031251.26152.33
4149799-14979958.92760.18
5141093-14109355.50256.60
6140693-14069355.34556.52
30min1162728-16272864.01363.352.6165.7265.082.65
2159318-15931862.67164.33
3156211-15621161.44963.09
4168023-16802366.09668.00
5161964-16196463.71265.42
6157996-15799662.15163.95
45min1176379-17637969.38369.921.5271.8072.361.57
2178429-17842970.18972.54
3177542-17754269.84072.16
4182740-18274071.88574.53
5175357-17535768.98171.40
6176012-17601269.23871.72
60min1190964-19096475.12074.350.9178.3177.560.87
2189565-18956574.57077.70
3190099-19009974.78077.88
4189565-18956574.57078.01
5186679-18667973.43476.62
6187130-18713073.61276.87
极限1201244-20124479.16479.191.6883.1983.241.51
2204177-20417780.31884.28
3205423-20542380.80884.74
4199659-19965978.54082.81
5201446-20144679.24383.25
6195943-19594377.07981.15
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