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%
111.631032969103286110337991033775103448210335770.07
211.641032587103257010325780.01
单位质量响应值RSD%判断
88871.6388709.450.13数据可信
供试品溶液-24091101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%
5min122866-228662.3123.7630.532.313.7630.57
243239-432394.3724.37
334234-342343.4613.46
444304-443044.4804.48
526337-263372.6632.66
652214-522145.2795.28
10min157397-573975.8036.577.985.836.618.11
269649-696497.0427.09
363226-632266.3936.43
469474-694747.0247.07
561070-610706.1756.20
669058-690586.9827.04
15min166190-661906.6927.003.586.787.113.73
272863-728637.3677.49
369884-698847.0667.18
470393-703937.1177.25
566710-667106.7456.84
669280-692807.0057.14
20min172610-726107.3427.472.397.517.672.51
276183-761837.7037.91
375166-751667.6007.79
474099-740997.4927.70
571258-712587.2057.38
674136-741367.4967.71
30min172794-727947.3607.250.987.617.520.77
271319-713197.2117.51
372150-721507.2957.57
470855-708557.1647.45
571617-716177.2417.49
671302-713027.2097.51
45min173761-737617.4587.340.977.797.700.77
272875-728757.3687.74
372245-722457.3057.66
471827-718277.2627.63
572917-729177.3737.71
672169-721697.2977.67
60min173513-735137.4337.440.697.847.880.68
274432-744327.5267.98
373632-736327.4457.88
473144-731447.3967.85
573797-737977.4627.88
673029-730297.3847.84
极限170994-709947.1787.230.697.677.750.83
272063-720637.2867.83
371907-719077.2707.79
471901-719017.2707.80
571207-712077.2007.70
671039-710397.1837.72
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%
110.312588222591512592452591172560472584760.53
210.262592692593562593120.03
单位质量响应值RSD%判断
25070.4225274.070.58数据可信
供试品溶液-24091101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%
5min137262-3726214.76226.9240.3214.7626.9240.32
274117-7411729.36229.36
357991-5799122.97422.97
483711-8371133.16333.16
543817-4381717.35817.36
6110888-11088843.92943.93
10min1106589-10658942.22660.6923.4642.3960.9923.53
2169519-16951967.15667.48
3149370-14937059.17459.43
4183714-18371472.78073.15
5115888-11588845.91046.10
6194155-19415576.91677.40
15min1156795-15679562.11576.4814.6762.7577.4514.82
2209475-20947582.98584.06
3201461-20146179.81080.72
4216178-21617885.64086.82
5157625-15762562.44463.15
6216772-21677285.87687.22
20min1191639-19163975.91984.639.3677.2486.469.60
2225345-22534589.27291.27
3220864-22086487.49789.30
4229313-22931390.84492.97
5184969-18496973.27774.67
6229685-22968590.99193.29
30min1214538-21453884.99189.414.7787.1692.175.14
2231544-23154491.72894.71
3226600-22660089.76992.54
4235680-23568093.36696.50
5210551-21055183.41185.62
6235199-23519993.17696.48
45min1228726-22872690.61192.092.2593.7295.842.66
2231891-23189191.86595.87
3231568-23156891.73795.51
4239284-23928494.79498.97
5225586-22558689.36792.51
6237627-23762794.13898.48
60min1234399-23439992.85993.291.3296.9898.071.68
2233336-23333692.43897.46
3233611-23361192.54797.34
4240337-24033795.211100.44
5232872-23287292.25496.38
6238320-23832094.41299.80
极限1233697-23369792.58193.251.2197.7399.071.35
2231249-23124991.61197.66
3233971-23397192.68998.51
4238384-23838494.438100.72
5237654-23765494.14899.30
6237380-23738094.040100.48
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%
111.63100718799926810034879929159905309986770.70
211.641013272101377510135240.04
单位质量响应值RSD%判断
85870.7787072.510.99数据可信
供试品溶液-24091201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%
5min147527-475274.9344.3422.384.934.3422.34
257020-570205.9205.92
339266-392664.0774.08
434931-349313.6273.63
530898-308983.2083.21
641123-411234.2704.27
10min166548-665486.9096.812.556.966.852.65
266678-666786.9236.99
366777-667776.9336.98
462746-627466.5156.55
564240-642406.6706.71
666338-663386.8886.93
15min166070-660706.8607.092.046.997.221.92
267489-674897.0077.15
369441-694417.2107.33
468109-681097.0717.18
569135-691357.1787.29
669720-697207.2397.36
20min171488-714887.4227.391.457.637.591.41
271863-718637.4617.68
370707-707077.3417.54
471042-710427.3767.57
572319-723197.5097.70
669382-693827.2047.41
30min169631-696317.2297.241.207.527.521.16
269455-694557.2117.51
370641-706417.3347.62
470818-708187.3537.63
569258-692587.1917.46
668642-686427.1277.41
45min171006-710067.3727.421.227.747.781.05
271007-710077.3727.76
371412-714127.4147.78
472218-722187.4987.85
572686-726867.5477.90
670351-703517.3047.67
60min172592-725927.5377.481.107.997.921.09
272720-727207.5508.02
371905-719057.4667.91
471554-715547.4297.87
572590-725907.5377.97
670701-707017.3417.79
极限184047-840478.7267.647.639.268.177.21
275872-758727.8778.43
369865-698657.2547.78
469822-698227.2497.77
570942-709427.3667.89
670811-708117.3527.88
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%
110.312520312501012518332493632487702504200.59
210.262535712536222535960.02
单位质量响应值RSD%判断
24289.0424716.961.24数据可信
供试品溶液-24091201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%
5min193219-9321937.94030.6530.6637.9430.6530.66
2111214-11121445.26445.26
366323-6632326.99426.99
455627-5562722.64022.64
551108-5110820.80120.80
674376-7437630.27130.27
10min1180271-18027173.37167.817.8273.7968.157.89
2175106-17510671.26871.77
3168114-16811468.42368.72
4143493-14349358.40258.65
5161298-16129865.64965.88
6171420-17142069.76870.10
15min1210692-21069285.75282.843.9086.9983.933.92
2199643-19964381.25582.55
3207228-20722884.34285.40
4189167-18916776.99177.89
5207258-20725884.35485.31
6207177-20717784.32185.43
20min1225932-22593291.95589.522.6294.1491.532.62
2213541-21354186.91289.11
3221486-22148690.14592.14
4212342-21234286.42488.18
5225148-22514891.63693.53
6221194-22119490.02692.07
30min1238663-23866397.13693.993.15100.3597.003.08
2218794-21879489.05092.21
3229280-22928093.31796.32
4227633-22763392.64795.36
5235160-23516095.71198.63
6236032-23603296.06599.11
45min1243948-24394899.28797.653.42103.58101.713.25
2223786-22378691.08195.23
3239181-23918197.347101.38
4243627-24362799.157102.90
5245713-245713100.006103.99
6243349-24334999.043103.16
60min1245873-245873100.07197.713.51105.46102.843.35
2223340-22334090.90096.06
3241864-24186498.439103.56
4241288-24128898.205103.05
5245499-24549999.918105.01
6242504-24250498.700103.92
极限1244680-24468099.58597.263.85106.09103.483.66
2220900-22090089.90796.08
3239012-23901297.278103.49
4241621-24162198.340104.28
5245972-245972100.111106.31
6241600-24160098.332104.64
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%
111.631031027103224610330441033618103287510325620.10
211.641032821102734310300820.38
单位质量响应值RSD%判断
88784.3588495.020.24数据可信
供试品溶液-24091202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%
5min148566-485664.9194.1016.464.924.1016.47
247601-476014.8214.82
340576-405764.1104.11
436555-365553.7023.70
538398-383983.8893.89
631211-312113.1613.16
10min168100-681006.8976.742.796.956.782.89
268637-686376.9527.01
366811-668116.7676.81
464835-648356.5676.61
566809-668096.7666.81
663854-638546.4676.50
15min171434-714347.2357.091.447.377.211.56
270407-704077.1317.26
369738-697387.0637.18
468920-689206.9807.09
570484-704847.1397.26
668847-688476.9737.08
20min174590-745907.5557.461.257.777.661.26
273370-733707.4317.64
374141-741417.5097.71
472364-723647.3297.52
573016-730167.3957.59
674634-746347.5597.74
30min172061-720617.2987.292.017.597.571.86
271362-713627.2287.52
369954-699547.0857.37
471479-714797.2397.51
572843-728437.3787.66
674203-742037.5157.78
45min171407-714077.2327.292.197.617.652.16
275084-750847.6057.98
371262-712627.2177.58
470834-708347.1747.53
571873-718737.2797.64
671227-712277.2147.57
60min172323-723237.3257.350.787.787.790.78
273524-735247.4477.90
372035-720357.2967.74
472035-720357.2967.73
572550-725507.3487.79
672731-727317.3667.80
极限172714-727147.3657.171.837.907.701.75
270307-703077.1217.66
372168-721687.3097.83
470213-702137.1117.63
569542-695427.0437.57
670003-700037.0907.60
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%
110.312592332598342598862604652601092599050.18
210.262604562588262596410.45
单位质量响应值RSD%判断
25209.0225306.140.28数据可信
供试品溶液-24091202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%
5min194833-9483337.44128.7023.2337.4428.7023.23
290249-9024935.63235.63
373428-7342828.99028.99
464092-6409225.30425.30
561624-6162424.33024.33
651961-5196120.51520.51
10min1181818-18181871.78464.6211.2472.2064.9411.29
2181120-18112071.50971.90
3174402-17440268.85669.18
4157478-15747862.17462.46
5150548-15054859.43859.71
6136621-13662153.94054.17
15min1212880-21288084.04879.515.7085.2680.555.81
2210593-21059383.14584.34
3209643-20964382.77083.86
4199272-19927278.67579.65
5190197-19019775.09276.02
6185785-18578573.35074.18
20min1222560-22256087.87086.453.0790.0288.373.21
2225006-22500688.83590.95
3226094-22609489.26591.27
4217674-21767485.94187.79
5212418-21241883.86685.63
6210010-21001082.91584.56
30min1232973-23297391.98190.521.1895.1093.401.34
2230042-23004290.82493.93
3228358-22835890.15993.16
4231342-23134291.33794.14
5227362-22736289.76692.46
6225601-22560189.07091.63
45min1235652-23565293.03993.751.1297.1897.641.17
2240949-24094995.13099.24
3239256-23925694.46298.46
4236407-23640793.33797.15
5233734-23373492.28195.98
6238717-23871794.24997.80
60min1234524-23452492.59393.771.0697.7798.700.95
2239932-23993294.72899.90
3235871-23587193.12598.18
4238562-23856294.18899.04
5235581-23558193.01197.73
6240525-24052594.96399.56
极限1234693-23469392.66093.641.2998.8799.611.22
2238695-23869594.240100.46
3237236-23723693.66499.75
4239812-23981294.681100.58
5232432-23243291.76797.52
6240129-24012994.806100.46
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%
111.631042718104307210435971042927104331610431260.04
211.641043779104298610433820.06
单位质量响应值RSD%判断
89692.6989637.630.05数据可信
供试品溶液-2024092721批-依折麦布-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%
5min139333-393333.9384.5420.253.944.5520.25
252492-524925.2565.26
330067-300673.0103.01
446407-464074.6464.65
554370-543705.4445.44
649691-496914.9754.98
10min172057-720577.2157.524.207.267.574.27
275842-758427.5937.65
371551-715517.1647.20
477202-772027.7307.78
579782-797827.9888.05
674186-741867.4287.48
15min176438-764387.6537.781.997.787.912.00
278066-780667.8167.96
378637-786377.8737.99
478024-780247.8127.95
579608-796087.9718.12
675348-753487.5447.68
20min181765-817658.1878.182.148.408.401.97
281700-817008.1808.41
384673-846738.4788.68
482094-820948.2198.44
580118-801188.0228.26
679787-797877.9888.21
30min177929-779297.8027.921.538.108.231.56
278967-789677.9068.23
379231-792317.9338.23
480060-800608.0168.33
580762-807628.0868.41
677635-776357.7738.08
45min176915-769157.7017.861.438.098.261.39
280027-800278.0138.42
379476-794767.9578.34
478757-787577.8858.29
578044-780447.8148.23
678046-780467.8148.21
60min180923-809238.1028.022.018.578.511.92
282854-828548.2968.79
378600-786007.8708.34
480137-801378.0248.52
579241-792417.9348.44
678844-788447.8948.38
极限177756-777567.7857.721.328.358.301.19
277319-773197.7418.33
378063-780637.8168.37
477220-772207.7318.31
577185-771857.7288.32
675166-751667.5268.10
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%
110.312636952642272639042638572635512638470.10
210.262642172638732640450.10
单位质量响应值RSD%判断
25591.3725735.380.40数据可信
供试品溶液-2024092721批-贝派度酸-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%
5min178340-7834030.44138.1528.9330.4438.1528.93
2120294-12029446.74346.74
353624-5362420.83720.84
492890-9289036.09436.09
5123144-12314447.85047.85
6120846-12084646.95746.96
10min1191433-19143374.38677.369.6274.7277.789.72
2211831-21183182.31282.83
3163524-16352463.54163.77
4204256-20425679.36879.77
5212171-21217182.44482.98
6211286-21128682.10082.62
15min1233311-23331190.65889.373.0491.8290.663.18
2234365-23436591.06892.50
3216211-21621184.01484.95
4232514-23251490.34991.63
5229458-22945889.16190.61
6234145-23414590.98292.42
20min1243685-24368594.68994.240.5196.8696.510.60
2241852-24185293.97796.42
3240883-24088393.60095.47
4244167-24416794.87797.16
5242122-24212294.08296.52
6242442-24244294.20696.65
30min1245297-24529795.31695.061.0898.5498.381.14
2242950-24295094.40497.89
3241541-24154193.85696.77
4248781-24878196.669100.01
5243088-24308894.45797.94
6246157-24615795.65099.14
45min1242949-24294994.40394.810.7498.6999.190.83
2245416-24541695.36299.90
3243221-24322194.50998.46
4243959-24395994.79699.21
5241731-24173193.93098.46
6246693-24669395.858100.41
60min1255904-25590499.43796.012.41104.77101.442.32
2251931-25193197.893103.49
3242254-24225494.13399.14
4245379-24537995.348100.82
5240102-24010293.29798.87
6246936-24693695.953101.57
极限1244515-24451595.01294.011.26101.45100.511.02
2239202-23920292.94799.63
3245742-24574295.489101.54
4240961-24096193.631100.16
5238066-23806692.50699.12
6243096-24309694.460101.15
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原始图谱下载图谱(谢鑫慧 于 2024-11-04 16:01:13 完成)
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