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%
111.471009125100942610104361008244101217410098810.15
211.421006191100835710072740.16
单位质量响应值RSD%判断
88045.4288202.630.13数据可信
供试品溶液-2024092721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%
5min1233595-23359523.79726.1024.0923.8026.1024.09
2248342-24834225.29925.30
3220046-22004622.41722.42
4247316-24731625.19525.19
5209802-20980221.37321.37
6378375-37837538.54638.55
10min1536958-53695854.70265.3716.8154.9765.6616.83
2652532-65253266.47666.76
3648608-64860866.07666.33
4613840-61384062.53462.81
5558228-55822856.86957.11
6839777-83977785.55185.98
15min1748068-74806876.20886.308.5777.0887.318.64
2839108-83910885.48386.50
3909465-90946592.65093.63
4877336-87733689.37790.35
5778246-77824679.28380.15
6930265-93026594.76996.15
20min1824928-82492884.03892.614.7085.7694.594.68
2935219-93521995.27497.24
3931261-93126194.87196.88
4919894-91989493.71395.68
5936244-93624495.37897.13
6907059-90705992.40594.84
30min1840276-84027685.60291.593.4888.2594.603.52
2933180-93318095.06698.09
3910896-91089692.79695.86
4908282-90828292.53095.54
5904954-90495492.19195.00
6896962-89696291.37794.84
45min1864118-86411888.03191.912.7891.6395.932.93
2923032-92303294.03398.12
3923907-92390794.12298.22
4904769-90476992.17296.21
5879222-87922289.56993.40
6918020-91802093.52298.00
60min1849505-84950586.54290.232.6991.1295.282.75
2920076-92007693.73198.86
3882178-88217889.87195.01
4901401-90140191.82996.89
5876373-87637389.27994.11
6884992-88499290.15795.67
极限1913084-91308493.01991.962.0598.5698.011.83
2916063-91606393.32399.49
3909773-90977392.68298.82
4918402-91840293.56199.64
5884739-88473990.13295.95
6874301-87430189.06895.58
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%
110.242563112563012567882551592570372563190.29
210.272567112590002578560.63
单位质量响应值RSD%判断
25031.1525107.690.22数据可信
供试品溶液-2024092721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%
5min130699-3069912.21113.7524.8112.2113.7524.82
234473-3447313.71313.71
329872-2987211.88211.88
432915-3291513.09313.09
528028-2802811.14911.15
651454-5145420.46720.47
10min179101-7910131.46537.9819.6831.6038.1319.70
2100436-10043639.95140.10
396533-9653338.39938.53
490421-9042135.96736.11
577408-7740830.79130.91
6128917-12891751.28051.51
15min1126041-12604150.13656.1710.5350.6256.7410.61
2138867-13886755.23855.83
3153512-15351261.06361.62
4141684-14168456.35956.90
5124798-12479849.64250.11
6162391-16239164.59565.39
20min1148233-14823358.96465.575.6760.0166.775.59
2170175-17017567.69268.90
3169631-16963167.47568.71
4173772-17377269.12270.29
5167283-16728366.54167.56
6159981-15998163.63765.15
30min1170008-17000867.62572.974.0069.3274.904.10
2190334-19033475.71077.67
3186991-18699174.38176.37
4184461-18446173.37475.31
5180922-18092271.96673.72
6188013-18801374.78777.01
45min1194973-19497377.55680.883.1380.0083.613.28
2206287-20628782.05684.86
3208539-20853982.95285.77
4204000-20400081.14683.90
5196125-19612578.01480.57
6209983-20998383.52686.58
60min1202969-20296980.73683.872.6484.0587.512.71
2218266-21826686.82190.54
3209189-20918983.21086.95
4215192-21519285.59889.25
5207217-20721782.42685.85
6212298-21229884.44788.43
极限1226162-22616289.96288.111.9594.1792.681.77
2223706-22370688.98593.66
3223252-22325288.80493.46
4223758-22375889.00693.61
5216491-21649186.11590.45
6215729-21572985.81290.73
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%
111.471007097101159710085261010951100905210094450.19
211.421029487102798210287340.11
单位质量响应值RSD%判断
88007.4190081.791.65数据可信
供试品溶液-2024092721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%
5min1235101-23510123.70629.4628.0323.7129.4628.03
2203925-20392520.56320.56
3245491-24549124.75424.75
4311483-31148331.40831.41
5328666-32866633.14133.14
6428546-42854643.21243.21
10min1605007-60500761.00570.7717.5061.2771.1017.54
2567266-56726657.20057.43
3618776-61877662.39462.67
4773332-77333277.97878.33
5767022-76702277.34277.71
6879587-87958788.69289.17
15min1868765-86876587.60188.764.3388.5489.874.47
2837185-83718584.41785.28
3839686-83968684.66985.64
4931690-93169093.94695.16
5901594-90159490.91192.14
6902664-90266491.01992.48
20min1894925-89492590.23992.162.0992.1594.262.03
2920049-92004992.77294.57
3917511-91751192.51694.43
4940319-94031994.81697.08
5922314-92231493.00195.24
6888556-88855689.59792.07
30min1910090-91009091.76892.411.3294.6995.541.27
2922099-92209992.97995.81
3920277-92027792.79595.73
4935098-93509894.29097.60
5900246-90024690.77594.05
6911105-91110591.87095.34
45min1890438-89043889.78691.421.9693.7295.571.90
2912198-91219891.98195.85
3921024-92102492.87096.84
4927437-92743793.51797.88
5881455-88145588.88193.16
6907049-90704991.46195.95
60min1891672-89167289.91192.042.6094.8597.202.45
2917402-91740292.50597.39
3933063-93306394.08499.08
4945498-94549895.338100.74
5904072-90407291.16196.43
6884798-88479889.21894.73
极限1912022-91202291.96392.132.3097.9098.322.09
2918361-91836192.60298.52
3943055-94305595.092101.14
4922926-92292693.06299.52
5879538-87953888.68794.97
6906352-90635291.39197.89
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%
110.242554532585102595752586642591662582740.64
210.272640122610322625220.81
单位质量响应值RSD%判断
25222.0725562.030.95数据可信
供试品溶液-2024092721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%
5min133289-3328913.07416.0527.7013.0716.0527.70
229372-2937211.53611.54
332631-3263112.81512.82
444062-4406217.30517.30
546449-4644918.24218.24
659346-5934623.30723.31
10min197076-9707638.12643.5017.9638.2743.6818.00
291168-9116835.80535.93
392932-9293236.49836.64
4121753-12175347.81748.01
5121704-12170447.79848.00
6139887-13988754.93955.20
15min1151992-15199259.69359.847.7060.2660.507.82
2138573-13857354.42354.95
3138417-13841754.36254.91
4161143-16114363.28764.01
5157532-15753261.86962.60
6166481-16648165.38466.25
20min1167869-16786965.92966.983.2467.1668.313.40
2164499-16449964.60565.74
3165091-16509164.83865.99
4175975-17597569.11270.54
5177279-17727969.62471.05
6172586-17258667.78169.38
30min1192888-19288875.75575.252.7877.7277.322.94
2187266-18726673.54775.40
3184611-18461172.50474.38
4194417-19441776.35578.55
5190812-19081274.93977.13
6199584-19958478.38480.73
45min1206576-20657681.13081.031.9583.9483.942.10
2204477-20447780.30682.97
3201216-20121679.02581.70
4209680-20968082.35085.39
5203824-20382480.05083.08
6212115-21211583.30686.53
60min1218404-21840485.77685.871.5089.4889.681.53
2217055-21705585.24688.80
3216216-21621684.91688.47
4224767-22476788.27592.23
5219381-21938186.15990.08
6216047-21604784.85089.00
极限1233259-23325991.61090.181.5796.2794.941.49
2229074-22907489.96694.47
3230443-23044390.50495.00
4230250-23025090.42895.37
5222889-22288987.53792.41
6231778-23177891.02896.12
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%
111.471004881100666410070921008808100648410067860.14
211.421011470101200010117350.04
单位质量响应值RSD%判断
87775.5988593.260.66数据可信
供试品溶液-2024092721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%
5min1419322-41932242.68924.7439.6742.6924.7439.67
2237971-23797124.22724.23
3188271-18827119.16719.17
4247669-24766925.21425.21
5132424-13242413.48213.48
6232541-23254123.67423.67
10min1863200-86320087.87967.5421.6788.3567.8221.73
2649095-64909566.08266.35
3562886-56288657.30557.52
4676495-67649568.87169.15
5459264-45926446.75646.91
6769539-76953978.34478.61
15min1881367-88136789.72887.219.6991.1888.239.80
2891457-89145790.75691.76
3781768-78176879.58980.44
4895950-89595091.21392.26
5732324-73232474.55575.22
6956703-95670397.39898.53
20min1886323-88632390.23392.234.2592.6894.224.36
2922061-92206193.87195.88
3910218-91021892.66694.40
4932512-93251294.93596.99
5839174-83917485.43386.93
6945474-94547496.25598.47
30min1881599-88159989.75293.172.6393.2096.192.60
2914097-91409793.06096.12
3931451-93145194.82797.59
4928774-92877494.55597.67
5892247-89224790.83693.28
6943031-94303196.00699.29
45min1903608-90360891.99393.691.5296.4497.741.53
2915267-91526793.18097.27
3936613-93661395.35399.17
4922691-92269193.93598.10
5907781-90778192.41795.87
6935617-93561795.25199.60
60min1869145-86914588.48492.802.7393.9597.902.54
2907006-90700692.33997.46
3909298-90929892.57297.45
4918336-91833693.49298.70
5920290-92029093.69198.17
6945283-94528396.235101.65
极限1897338-89733891.35493.381.3597.8199.511.13
2917846-91784693.44299.59
3909336-90933692.57698.48
4925760-92576094.248100.49
5932050-93205094.888100.41
6921142-92114293.778100.26
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%
110.242556532575162567512572452572812568890.30
210.272570702573402572050.08
单位质量响应值RSD%判断
25086.8225044.300.12数据可信
供试品溶液-2024092721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%
5min170016-7001627.85516.3637.4627.8516.3637.45
238659-3865915.38015.38
331992-3199212.72812.73
440584-4058416.14616.15
524972-249729.9359.93
640495-4049516.11016.11
10min1151348-15134860.21245.2721.6260.5245.4521.68
2113684-11368445.22845.40
397280-9728038.70238.84
4113239-11323945.05145.23
579775-7977531.73731.85
6127399-12739950.68450.86
15min1171668-17166868.29664.5210.6969.2765.2010.78
2168018-16801866.84467.52
3147015-14701558.48859.06
4166418-16641866.20766.89
5136304-13630454.22754.69
6183642-18364273.06073.80
20min1194524-19452477.38974.965.8979.1376.366.04
2192958-19295876.76678.18
3188989-18898975.18776.41
4189939-18993975.56576.98
5166673-16667366.30967.37
6197495-19749578.57180.12
30min1205935-20593581.92983.582.4084.5385.812.49
2213470-21347084.92687.20
3211561-21156184.16786.22
4212008-21200884.34586.60
5202089-20208980.39882.20
6215399-21539985.69488.12
45min1232756-23275692.59993.142.5496.1196.312.63
2243281-24328196.786100.00
3234698-23469893.37296.36
4232668-23266892.56495.76
5224981-22498189.50692.20
6236366-23636694.03597.41
60min1223019-22301988.72595.624.1493.2699.823.94
2245593-24559397.706101.99
3236150-23615093.94997.98
4247145-24714598.323102.54
5239775-23977595.39199.08
6250460-25046099.642104.07
极限1233364-23336492.84197.342.9598.36102.602.82
2253814-253814100.977106.35
3242042-24204296.293101.37
4250594-25059499.696105.01
5242528-24252896.487101.24
6245746-24574697.767103.30
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%
111.471019732101914610167801013231100855510154890.46
211.421029517102753810285280.14
单位质量响应值RSD%判断
88534.3590063.751.22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%
5min149724-497244.9995.0724.705.005.0724.69
243340-433404.3574.36
358502-585025.8825.88
429345-293452.9502.95
561027-610276.1366.14
660510-605106.0846.08
10min178090-780907.8517.596.027.917.646.17
273648-736487.4057.45
377788-777887.8217.89
467048-670486.7416.77
577043-770437.7467.81
679222-792227.9658.03
15min178120-781207.8547.821.908.007.962.07
278678-786787.9108.04
377802-778027.8227.97
474821-748217.5237.63
578237-782377.8668.02
678789-787897.9218.08
20min181545-815458.1998.191.098.438.420.97
281060-810608.1508.37
382266-822668.2718.51
482314-823148.2768.47
579918-799188.0358.28
681567-815678.2018.44
30min182313-823138.2768.062.878.608.382.65
280160-801608.0598.37
381269-812698.1718.50
482330-823308.2778.56
576902-769027.7328.06
677868-778687.8298.16
45min178952-789527.9388.092.708.358.502.52
282536-825368.2988.70
383335-833358.3798.80
480939-809398.1388.51
578588-785887.9018.32
678254-782547.8688.29
60min176387-763877.6808.152.968.188.652.77
282156-821568.2608.75
381117-811178.1568.67
482083-820838.2538.72
581703-817038.2148.72
683091-830918.3548.86
极限179937-799378.0378.182.288.628.772.03
283507-835078.3968.98
379425-794257.9858.59
482515-825158.2968.85
583138-831388.3598.95
679853-798538.0288.63
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%
110.242602692616772606502601262597702604980.29
210.272648892637182643040.32
单位质量响应值RSD%判断
25439.2625735.540.82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%
5min196838-9683837.74139.7233.4937.7439.7233.49
279919-7991931.14731.15
3125304-12530448.83548.84
447224-4722418.40518.40
5137013-13701353.39953.40
6125188-12518848.79048.79
10min1199973-19997377.93775.6117.3978.3676.0617.47
2190603-19060374.28574.63
3215853-21585384.12684.67
4128360-12836050.02750.23
5216005-21600584.18584.78
6213257-21325783.11483.66
15min1223099-22309986.95086.469.3788.2487.749.53
2230995-23099590.02791.20
3233485-23348590.99892.47
4180131-18013170.20470.96
5232680-23268090.68492.21
6230675-23067589.90291.37
20min1233050-23305090.82890.805.2993.0893.045.54
2237127-23712792.41794.59
3240768-24076893.83696.32
4208489-20848981.25682.80
5238120-23812092.80495.34
6240238-24023893.62996.09
30min1237947-23794792.73793.292.7796.0096.543.01
2247945-24794596.63399.83
3240420-24042093.70097.23
4227704-22770488.74491.19
5240545-24054593.74997.32
6241695-24169594.19797.70
45min1234786-23478691.50594.031.7895.8098.321.71
2246372-24637296.020100.29
3245142-24514295.541100.11
4242373-24237394.46297.89
5238773-23877393.05897.67
6240197-24019793.61398.16
60min1230120-23012089.68693.402.4094.9998.732.14
2245953-24595395.857101.20
3237366-23736692.51098.14
4245082-24508295.517100.00
5239667-23966793.40799.05
6239700-23970093.42099.01
极限1233786-23378691.11594.372.8097.42100.742.34
2240738-24073893.824100.23
3242404-24240494.474101.14
4254326-25432699.120104.66
5242438-24243894.487101.17
6239179-23917993.21799.85
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