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%
111.631023913102299910291721028306102671210262200.27
211.641020309101941510198620.07
单位质量响应值RSD%判断
88239.0487617.010.51数据可信
供试品溶液-24091101批-依折麦布-pH4.5sds
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1364421-36442137.20828.3724.7037.2128.3724.70
2266082-26608227.16727.17
3300773-30077330.70930.71
4256488-25648826.18826.19
5317258-31725832.39332.39
6162213-16221316.56216.56
10min1827227-82722784.46170.8215.8984.8771.1415.92
2659814-65981467.36867.67
3759972-75997277.59577.94
4653304-65330466.70466.99
5748647-74864776.43876.80
6513006-51300652.37952.56
15min1879421-87942189.79087.857.7591.1488.957.84
2851644-85164486.95488.00
3938190-93819095.79196.99
4827803-82780384.52085.55
5913486-91348693.26994.48
6751743-75174376.75477.52
20min1882159-88215990.07090.994.6292.4293.074.74
2913635-91363593.28495.30
3943449-94344996.32898.60
4885793-88579390.44192.41
5901686-90168692.06494.31
6820404-82040483.76585.38
30min1883220-88322090.17891.433.7893.5394.523.87
2932006-93200695.16098.21
3929819-92981994.93698.27
4892158-89215891.09194.07
5895413-89541391.42394.69
6840451-84045185.81288.36
45min1873532-87353289.18990.982.6393.5495.082.72
2918803-91880393.81197.92
3913484-91348493.26897.66
4896416-89641691.52695.51
5886266-88626690.48994.77
6857708-85770887.57491.08
60min1865945-86594588.41591.072.8093.7696.192.86
2908348-90834892.74497.90
3931489-93148995.107100.54
4886715-88671590.53595.54
5891233-89123390.99796.29
6868209-86820988.64693.12
极限1883839-88383990.24291.891.6496.5798.021.65
2921542-92154294.091100.27
3911537-91153793.07099.56
4903151-90315192.21398.22
5888360-88836090.70397.00
6891421-89142191.01696.48
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%
110.312593202583252596562593332584082590080.24
210.262565582595912580740.84
单位质量响应值RSD%判断
25122.0225153.410.09数据可信
供试品溶液-24091101批-贝派度酸-pH4.5sds
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min150495-5049520.03114.5227.7720.0314.5227.76
232209-3220912.77712.78
339063-3906315.49615.50
433323-3332313.21913.22
543422-4342217.22517.23
621093-210938.3678.37
10min1122544-12254448.61340.5017.1748.8440.6617.21
293059-9305936.91637.06
3111197-11119744.11144.28
497656-9765638.74038.89
5114089-11408945.25945.45
674014-7401429.36129.45
15min1153361-15336160.83857.089.3061.6057.699.40
2135292-13529253.67054.22
3154472-15447261.27861.94
4143589-14358956.96157.54
5154974-15497461.47762.17
6121611-12161148.24248.66
20min1168619-16861966.89065.485.0568.3366.725.20
2160426-16042663.64064.79
3171987-17198768.22669.57
4165655-16565565.71466.92
5172862-17286268.57369.95
6150822-15082259.83060.79
30min1187593-18759374.41773.713.3076.6075.683.45
2186426-18642673.95475.81
3188990-18899074.97177.07
4188608-18860874.82076.76
5189729-18972975.26577.40
6173551-17355168.84770.47
45min1200279-20027979.45080.012.5982.4682.802.70
2199436-19943679.11581.79
3204036-20403680.94083.87
4208482-20848282.70485.48
5204524-20452481.13484.11
6193389-19338976.71679.10
60min1210182-21018283.37884.902.4787.2788.582.53
2208408-20840882.67486.23
3218913-21891386.84290.68
4214042-21404284.90988.60
5221704-22170487.94991.83
6210895-21089583.66186.90
极限1220467-22046787.45888.320.7292.2892.940.63
2221151-22115187.72992.20
3223195-22319588.54093.34
4224315-22431588.98593.62
5222482-22248288.25793.11
6224208-22420888.94293.11
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%
111.631022446102051710210711021929102373910219400.13
211.641016845101721510170300.03
单位质量响应值RSD%判断
87871.0287373.710.41数据可信
供试品溶液-24091201批-依折麦布-pH4.5sds
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1254170-25417026.04238.7722.0826.0438.7722.08
2374750-37475038.39638.40
3324986-32498633.29733.30
4415440-41544042.56542.56
5499613-49961351.18951.19
6401504-40150441.13741.14
10min1712380-71238072.98984.006.9273.2884.436.98
2837801-83780185.83986.27
3808398-80839882.82683.20
4835033-83503385.55586.03
5852973-85297387.39487.96
6872294-87229489.37389.83
15min1901097-90109792.32491.871.7293.4293.231.70
2910530-91053093.29194.67
3879171-87917190.07891.37
4885902-88590290.76792.19
5885715-88571590.74892.29
6917526-91752694.00795.46
20min1888616-88861691.04591.631.5593.1794.011.55
2921204-92120494.38496.80
3887926-88792690.97593.27
4886296-88629690.80893.24
5896785-89678591.88294.43
6885007-88500790.67693.17
30min1879121-87912190.07391.402.3793.2194.802.37
2917482-91748294.00397.47
3872858-87285889.43192.73
4877177-87717789.87393.31
5885669-88566990.74394.31
6920088-92008894.27097.77
45min1906693-90669392.89890.891.8397.0495.311.70
2894278-89427891.62696.14
3876663-87666389.82194.12
4867562-86756288.88893.33
5874782-87478289.62894.21
6902416-90241692.45997.01
60min1874575-87457589.60791.132.4394.7896.562.39
2920096-92009694.27199.80
3877955-87795589.95395.25
4878933-87893390.05395.48
5871312-87131289.27294.85
6913847-91384793.63199.21
极限1890490-89049091.23791.452.7797.4097.892.67
2907434-90743492.97399.55
3883969-88396990.56996.86
4868907-86890789.02695.45
5870517-87051789.19195.76
6933898-93389895.685102.30
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%
110.312574022590472583272614722585692589630.59
210.262592192584472588330.22
单位质量响应值RSD%判断
25117.6525227.390.31数据可信
供试品溶液-24091201批-贝派度酸-pH4.5sds
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min127536-2753610.90817.1922.9010.9117.1922.90
240998-4099816.24116.24
340090-4009015.88215.88
449395-4939519.56819.57
557019-5701922.58822.59
645295-4529517.94417.94
10min187999-8799934.86142.6810.2034.9842.8710.25
2103006-10300640.80640.99
3110837-11083743.90844.08
4113481-11348144.95545.17
5119191-11919147.21747.47
6111870-11187044.31744.52
15min1129107-12910751.14554.794.3051.6555.454.41
2135669-13566953.74554.38
3139234-13923455.15755.82
4142849-14284956.58957.31
5146118-14611857.88458.66
6136810-13681054.19754.89
20min1147430-14743058.40462.094.1759.4863.364.26
2153192-15319260.68761.92
3159036-15903663.00264.28
4160748-16074863.68065.03
5165988-16598865.75667.17
6154034-15403461.02062.31
30min1171176-17117667.81171.363.1069.5473.333.21
2178176-17817670.58472.49
3183263-18326372.59974.58
4183602-18360272.73474.79
5186814-18681474.00676.16
6177844-17784470.45372.42
45min1206130-20613081.65879.762.6084.1482.512.53
2194701-19470177.13079.82
3204543-20454381.02983.81
4201110-20111079.66982.53
5206166-20616681.67284.64
6195324-19532477.37780.13
60min1208715-20871582.68284.651.6686.0788.301.76
2213978-21397884.76788.31
3215968-21596885.55589.24
4214608-21460885.01788.76
5218350-21835086.49990.38
6210538-21053883.40487.02
极限1225571-22557189.36089.261.1193.6693.841.08
2227160-22716089.98994.48
3227441-22744190.10094.74
4221819-22181987.87392.56
5227204-22720490.00694.85
6222657-22265788.20592.75
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%
111.631020841102037610214701023509102316010218710.14
211.641023783102248210231320.09
单位质量响应值RSD%判断
87865.0987897.940.03数据可信
供试品溶液-24091202批-依折麦布-pH4.5sds
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1195069-19506919.92733.1827.2219.9333.1827.22
2323993-32399333.09733.10
3271633-27163327.74927.75
4455119-45511946.49246.49
5329053-32905333.61433.61
6374081-37408138.21438.21
10min1555319-55531956.72878.2615.0756.9578.6215.12
2781373-78137379.82180.19
3749034-74903476.51776.83
4900045-90004591.94492.46
5823043-82304384.07884.45
6787453-78745380.44280.87
15min1738320-73832075.42390.228.4076.2791.468.50
2908971-90897192.85694.11
3923015-92301594.29095.45
4934606-93460695.47497.01
5921926-92192694.17995.49
6872331-87233189.11390.43
20min1790526-79052680.75691.776.5982.4594.016.70
2914420-91442093.41295.70
3925502-92550294.54496.75
4931835-93183595.19197.79
5954148-95414897.47199.82
6873510-87351089.23391.54
30min1825863-82586384.36692.604.8886.9595.865.07
2920135-92013593.99697.32
3915189-91518993.49196.75
4940987-94098796.12699.78
5945894-94589496.627100.06
6890499-89049990.96994.27
45min1857593-85759387.60793.133.5091.1397.423.72
2919516-91951693.93398.30
3939094-93909495.933100.23
4941829-94182996.212100.94
5919398-91939893.92198.43
6892558-89255891.17995.49
60min1865353-86535388.40093.063.0092.9098.383.26
2910796-91079693.04298.45
3927861-92786194.785100.15
4946008-94600896.639102.43
5915260-91526093.49899.05
6900331-90033191.97397.30
极限1885074-88507490.41493.542.2595.8999.892.49
2918129-91812993.791100.24
3941023-94102396.130102.54
4930665-93066595.072101.94
5920226-92022694.005100.60
6898684-89868491.80598.15
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%
110.312588912587552571992603512588612588110.44
210.262618772606002612380.35
单位质量响应值RSD%判断
25102.9125461.791.01数据可信
供试品溶液-24091202批-贝派度酸-pH4.5sds
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min118429-184297.26913.3729.717.2713.3729.70
233092-3309213.05313.05
329885-2988511.78811.79
449263-4926319.43219.43
535215-3521513.89013.89
637494-3749414.78914.79
10min169607-6960727.45638.5116.4127.5438.6616.45
299715-9971539.33239.48
395256-9525637.57337.70
4118803-11880346.86147.08
5103759-10375940.92741.08
698664-9866438.91839.08
15min1112635-11263544.42852.688.0744.8153.258.18
2136473-13647353.83154.41
3136142-13614253.70154.25
4143593-14359356.64057.38
5138647-13864754.68955.30
6133778-13377852.76853.36
20min1134491-13449153.04960.126.5953.9361.286.70
2154118-15411860.79161.97
3151913-15191359.92161.07
4159197-15919762.79464.16
5163864-16386464.63565.85
6150866-15086659.50860.69
30min1161813-16181363.82670.095.1465.3071.925.27
2178742-17874270.50472.36
3174397-17439768.79070.60
4184397-18439772.73574.80
5187975-18797574.14676.08
6178851-17885170.54772.39
45min1188507-18850774.35678.632.8976.5381.243.09
2201775-20177579.58982.23
3198998-19899878.49481.07
4204538-20453880.67983.55
5203227-20322780.16282.92
6199085-19908578.52881.16
60min1207913-20791382.01084.231.8585.0187.712.05
2213598-21359884.25387.78
3210068-21006882.86086.31
4218643-21864386.24390.01
5215372-21537284.95288.60
6215607-21560785.04588.55
极限1220487-22048786.97088.251.3290.8992.671.43
2225977-22597789.13693.60
3220490-22049086.97191.34
4223708-22370888.24192.97
5223877-22387788.30792.90
6227839-22783989.87094.32
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