贝派度酸片项目信息
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对照品来源自制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50
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%
19.983019093021693025193024333025113023080.09
210.133035013034163034580.02
单位质量响应值RSD%判断
30291.3829956.370.79数据可信
供试品溶液-6050701批-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%
5min162978-6297841.69737.1111.1941.7037.1111.19
257466-5746638.04738.05
350115-5011533.18033.18
460183-6018339.84639.85
546753-4675330.95530.95
658821-5882138.94538.94
10min1190824-190824126.342117.824.80126.81118.244.81
2181124-181124119.920120.34
3166184-166184110.028110.40
4179195-179195118.643119.09
5171158-171158113.321113.67
6179245-179245118.676119.11
15min1248459-248459164.501162.381.17166.37164.101.22
2247581-247581163.920165.68
3241104-241104159.632161.22
4246428-246428163.157164.92
5242688-242688160.680162.28
6245299-245299162.409164.16
20min1273783-273783181.268180.880.64184.96184.410.68
2275503-275503182.407185.98
3272176-272176180.204183.57
4274184-274184181.534185.11
5270447-270447179.059182.45
6273118-273118180.828184.38
30min1292841-292841193.886195.931.03199.60201.470.97
2296977-296977196.625202.23
3301319-301319199.499204.87
4295991-295991195.972201.56
5293646-293646194.419199.80
6294794-294794195.179200.74
45min1300204-300204198.761201.740.76206.62209.460.72
2306852-306852203.163210.95
3305644-305644202.363209.95
4305646-305646202.364210.13
5304805-304805201.807209.35
6305091-305091201.997209.73
60min1303840-303840201.168204.040.81211.24213.990.76
2310656-310656205.681215.73
3310071-310071205.294215.13
4309188-309188204.709214.73
5307208-307208203.398213.18
6308068-308068203.968213.95
90min1306978-306978203.246206.610.96215.55218.840.91
2314996-314996208.555220.89
3314156-314156207.999220.11
4313922-313922207.844220.13
5310640-310640205.671217.71
6311698-311698206.371218.62
120min1-0.0000.00-14.5714.520.83
2-0.00014.65
3-0.00014.42
4-0.00014.60
5-0.00014.33
6-0.00014.54
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1-0.0000.00-14.5714.520.83
2-0.00014.65
3-0.00014.42
4-0.00014.60
5-0.00014.33
6-0.00014.54
贝派度酸片项目信息
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对照品来源自制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50
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%
19.983020073017433017423017643015673017650.06
210.133027873032593030230.12
单位质量响应值RSD%判断
30236.9729913.430.77数据可信
供试品溶液-6050702批-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%
5min171570-7157047.46242.2811.0147.4642.2811.00
267088-6708844.49044.49
366350-6635044.00044.00
465361-6536143.34543.34
560964-6096440.42940.43
651237-5123733.97833.98
10min1206036-206036136.634130.593.30137.16131.063.31
2197807-197807131.177131.67
3199688-199688132.424132.91
4187079-187079124.063124.54
5198457-198457131.608132.06
6192477-192477127.642128.02
15min1254340-254340168.667166.201.04170.71168.121.07
2251812-251812166.991168.94
3250261-250261165.962167.92
4246359-246359163.375165.23
5250721-250721166.267168.18
6250244-250244165.951167.75
20min1274948-274948182.334181.510.48186.25185.280.49
2274741-274741182.196186.00
3273321-273321181.255185.06
4271634-271634180.136183.81
5273031-273031181.062184.82
6274604-274604182.106185.75
30min1291905-291905193.579194.570.88199.52200.360.82
2293064-293064194.347200.18
3292288-292288193.833199.65
4297365-297365197.200202.88
5290323-290323192.530198.30
6295463-295463195.938201.60
45min1299891-299891198.875199.610.81206.97207.550.77
2302497-302497200.603208.59
3300139-300139199.039207.01
4298348-298348197.852205.72
5299974-299974198.930206.84
6305133-305133202.351210.19
60min1302767-302767200.782201.240.74211.09211.400.71
2305030-305030202.283212.50
3303745-303745201.431211.61
4301305-301305199.812209.88
5301019-301019199.623209.74
6306854-306854203.492213.58
90min1311061-311061206.282205.530.90218.82217.930.85
2309432-309432205.202217.67
3309781-309781205.433217.86
4311849-311849206.805219.09
5304824-304824202.146214.48
6312612-312612207.311219.66
120min1-0.0000.00-14.8314.680.68
2-0.00014.75
3-0.00014.70
4-0.00014.58
5-0.00014.58
6-0.00014.65
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1-0.0000.00-14.8314.680.68
2-0.00014.75
3-0.00014.70
4-0.00014.58
5-0.00014.58
6-0.00014.65
贝派度酸片项目信息
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对照品来源自制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50
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%
19.983026253025623029873030193028993028180.07
210.133017773017583017680.01
单位质量响应值RSD%判断
30342.4829789.541.31数据可信
供试品溶液-6050703批-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%
5min1127917-12791784.86084.519.3984.8684.519.39
2138052-13805291.58391.58
3135947-13594790.18790.19
4126019-12601983.60183.60
5131556-13155687.27487.27
6104834-10483469.54769.55
10min1236357-236357156.798159.402.65157.74160.332.68
2242610-242610160.947161.96
3242011-242011160.549161.55
4243860-243860161.776162.70
5247285-247285164.048165.02
6229513-229513152.258153.03
15min1268181-268181177.910180.772.05180.60183.492.07
2273337-273337181.331184.14
3271716-271716180.255183.04
4277646-277646184.189186.92
5279402-279402185.354188.15
6264707-264707175.606178.07
20min1279593-279593185.481189.041.97190.14193.761.98
2285540-285540189.426194.25
3283114-283114187.817192.61
4290766-290766192.893197.67
5292049-292049193.744198.60
6278663-278663184.864189.28
30min1289295-289295191.917195.491.67198.64202.311.69
2295051-295051195.736202.66
3292217-292217193.856200.73
4300315-300315199.228206.14
5300688-300688199.475206.48
6290509-290509192.723199.19
45min1294173-294173195.153198.931.68204.01207.921.70
2299573-299573198.736207.84
3297379-297379197.280206.31
4305397-305397202.599211.73
5306477-306477203.316212.54
6296167-296167196.476205.09
60min1295541-295541196.061199.801.69207.08211.001.69
2300181-300181199.139210.45
3297427-297427197.312208.53
4306977-306977203.647215.03
5307840-307840204.220215.70
6299068-299068198.401209.19
90min1307713-307713204.136204.690.75217.34218.120.75
2306618-306618203.409216.93
3305623-305623202.749216.16
4310200-310200205.786219.43
5311596-311596206.712220.46
6309583-309583205.376218.37
120min1-0.0000.00-15.4715.701.83
2-0.00015.78
3-0.00015.67
4-0.00015.93
5-0.00016.05
6-0.00015.28
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1-0.0000.00-15.4715.701.83
2-0.00015.78
3-0.00015.67
4-0.00015.93
5-0.00016.05
6-0.00015.28
贝派度酸片项目信息
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对照品来源自制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50
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%
19.983023263021383027713021183023873023480.09
210.133017143018973018060.05
单位质量响应值RSD%判断
30295.3929793.291.19数据可信
供试品溶液-6050701批-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%
5min18887-88875.9006.9216.125.906.9216.13
210131-101316.7266.73
310481-104816.9586.96
413431-134318.9168.92
510736-107367.1277.13
68839-88395.8685.87
10min137874-3787425.14327.148.0425.2127.228.05
238579-3857925.61125.69
340040-4004026.58126.66
446139-4613930.63030.73
543650-4365028.97829.06
639004-3900425.89325.96
15min166171-6617143.92944.876.3344.2745.256.34
260577-6057740.21540.57
368882-6888245.72846.10
472697-7269748.26148.70
570894-7089447.06447.47
666351-6635144.04844.40
20min182926-8292655.05254.725.4255.8855.605.44
274345-7434549.35550.16
383002-8300255.10255.98
487112-8711257.83158.81
585741-8574156.92057.84
681465-8146554.08254.92
30min1102270-10227067.89366.414.2669.3467.904.28
292301-9230161.27562.63
399557-9955766.09267.59
4105033-10503369.72871.35
5100223-10022366.53568.09
6100846-10084666.94868.39
45min1113075-11307575.06776.213.0377.2778.443.09
2109190-10919072.48774.52
3117359-11735977.91180.14
4118491-11849178.66281.06
5116958-11695877.64479.94
6113746-11374675.51277.70
60min1122127-12212781.07681.451.5584.1184.521.65
2120275-12027579.84682.69
3124153-12415382.42185.51
4125198-12519883.11586.38
5123393-12339381.91685.07
6120988-12098880.32083.35
90min1131177-13117787.08487.711.8891.0291.691.92
2129462-12946285.94589.67
3135917-13591790.23194.24
4134142-13414289.05293.24
5131992-13199287.62591.69
6130066-13006686.34690.26
120min1130523-13052386.65088.321.9691.5593.281.98
2129880-12988086.22390.91
3136760-13676090.79095.80
4134804-13480489.49294.67
5132697-13269788.09393.14
6133608-13360888.69893.58
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1136439-13643990.57791.040.8496.4496.970.92
2136595-13659590.68196.32
3137431-13743191.23697.26
4139218-13921892.42298.60
5135974-13597490.26896.29
6137119-13711991.02996.89
贝派度酸片项目信息
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对照品来源自制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50
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%
19.983019373024143014103019873019353019370.12
210.133030343027843029090.06
单位质量响应值RSD%判断
30254.2129902.170.83数据可信
供试品溶液-6050702批-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%
5min18310-83105.5108.0038.365.518.0038.35
213878-138789.2029.20
313445-134458.9158.92
410603-106037.0317.03
519533-1953312.95212.95
66603-66034.3784.38
10min145512-4551230.17932.598.1830.2432.688.25
250999-5099933.81733.92
354139-5413935.89936.00
448285-4828532.01832.10
552182-5218234.60234.75
643741-4374129.00429.05
15min169403-6940346.02147.654.6446.4248.104.72
274396-7439649.33249.81
373680-7368048.85749.35
472404-7240448.01148.44
574913-7491349.67450.20
666374-6637444.01244.38
20min180247-8024753.21154.022.1854.1255.002.25
282735-8273554.86155.89
383490-8349055.36256.40
482496-8249654.70355.67
581077-8107753.76254.84
678770-7877052.23253.09
30min195169-9516963.10664.751.9264.6166.331.99
299885-9988566.23367.87
397813-9781364.85966.52
498734-9873465.47067.05
598633-9863365.40367.08
695628-9562863.41064.85
45min1107779-10777971.46873.762.0773.6776.062.08
2112549-11254974.63177.00
3111675-11167574.05176.43
4114514-11451475.93478.24
5110957-11095773.57575.98
6109946-10994672.90575.05
60min1117597-11759777.97878.901.1180.9782.021.14
2120054-12005479.60782.81
3120536-12053679.92783.13
4119770-11977079.41982.57
5117445-11744577.87781.10
6118495-11849578.57381.53
90min1121840-12184080.79183.342.0484.6587.332.04
2126917-12691784.15888.24
3124808-12480882.76086.85
4129023-12902385.55489.58
5127235-12723584.36988.46
6124242-12424282.38486.21
120min1125288-12528883.07885.971.8687.8490.901.88
2131422-13142287.14592.17
3129694-12969485.99991.01
4131857-13185787.43492.41
5130798-13079886.73191.76
6128854-12885485.44290.19
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1132751-13275188.02689.931.1993.7195.811.18
2136794-13679490.70796.70
3134907-13490789.45695.42
4136022-13602290.19596.15
5136122-13612290.26296.25
6137178-13717890.96296.65
贝派度酸片项目信息
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对照品来源自制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50
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%
19.983025563027213021573026023023403024750.08
210.133019823019913019860.01
单位质量响应值RSD%判断
30308.1229811.061.17数据可信
供试品溶液-6050703批-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%
5min125489-2548916.91320.1912.7616.9120.1912.77
228517-2851718.92218.92
335591-3559123.61623.62
428248-2824818.74318.74
530337-3033720.12920.13
634405-3440522.82922.83
10min173476-7347648.75351.234.6148.9451.464.64
275185-7518549.88750.10
382917-8291755.01855.28
477650-7765051.52351.73
574537-7453749.45749.68
679511-7951152.75853.01
15min190894-9089460.31162.053.1061.0462.843.14
290423-9042359.99860.76
397540-9754064.72065.59
494376-9437662.62163.40
591902-9190260.98061.75
695961-9596163.67364.51
20min1100912-10091266.95868.453.2068.3669.933.23
299238-9923865.84767.28
3107679-10767971.44873.04
4103957-10395768.97870.45
5101080-10108067.06968.52
6106083-10608370.38971.94
30min1110998-11099873.65075.502.6375.7977.742.67
2111172-11117273.76675.93
3118795-11879578.82481.21
4113134-11313475.06877.31
5112881-11288174.90077.10
6115693-11569376.76579.09
45min1120692-12069280.08281.292.6183.0484.372.63
2117306-11730677.83680.82
3124302-12430282.47885.74
4123554-12355481.98185.06
5122640-12264081.37584.40
6126557-12655783.97487.16
60min1123935-12393582.23483.291.8186.0987.281.87
2122998-12299881.61385.46
3127228-12722884.41988.60
4125486-12548683.26387.25
5124449-12444982.57586.51
6129105-12910585.66589.78
90min1126494-12649483.93285.052.4988.7089.962.44
2124644-12464482.70587.46
3126395-12639583.86788.98
4130347-13034786.48991.40
5127766-12776684.77689.63
6133393-13339388.51093.58
120min1124656-12465682.71385.923.5088.4191.783.45
2123460-12346081.91987.59
3132682-13268288.03894.09
4131571-13157187.30193.18
5129738-12973886.08591.88
6134813-13481389.45295.50
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1134109-13410988.98589.581.8495.6096.381.88
2132041-13204187.61394.20
3136062-13606290.28197.31
4133327-13332788.46695.31
5135317-13531789.78796.53
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