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%
111.231005979100638610058741005978100613510060700.02
211.291008064100812610080950.01
单位质量响应值RSD%判断
89587.7189290.970.24数据可信
供试品溶液-2024092721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%
5min165544-655446.5796.556.596.586.556.57
268548-685486.8816.88
368906-689066.9166.92
467253-672536.7516.75
557335-573355.7555.76
664028-640286.4276.43
10min178082-780827.8387.922.467.917.992.44
278078-780787.8377.91
376926-769267.7217.80
481425-814258.1738.25
577587-775877.7887.85
681217-812178.1528.22
15min178709-787097.9007.783.838.067.943.77
278627-786277.8928.06
378018-780187.8317.99
480749-807498.1058.27
576938-769387.7237.87
672015-720157.2297.39
20min1104779-10477910.5179.569.1110.779.818.88
280290-802908.0598.31
391620-916209.1969.45
499985-9998510.03610.29
594386-943869.4749.71
6100254-10025410.06310.31
30min1117780-11778011.82210.8618.9012.1911.2218.39
276614-766147.6908.03
3110245-11024511.06611.42
4120156-12015612.06112.43
592011-920119.2369.58
6132528-13252813.30313.66
45min1143482-14348214.40214.4719.1814.9014.9418.77
295402-954029.57610.00
3154529-15452915.51115.99
4175798-17579817.64618.15
5135460-13546013.59714.04
6160296-16029616.09016.59
60min1206004-20600420.67819.2415.2921.3319.8715.04
2134441-13444113.49514.03
3203193-20319320.39621.04
4215949-21594921.67622.37
5200784-20078420.15420.75
6189562-18956219.02719.71
极限1293307-29330729.44127.618.6330.3328.468.65
2244545-24454524.54625.23
3262700-26270026.36927.24
4303899-30389930.50431.44
5256219-25621925.71826.54
6289565-28956529.06529.96
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%
19.922513152508052515782509762510912511530.12
29.932525462525292525380.01
单位质量响应值RSD%判断
25317.8425431.820.32数据可信
供试品溶液-2024092721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%
5min1115185-11518545.26742.0816.0045.2742.0816.00
2125669-12566949.38749.39
3118815-11881546.69346.69
4108244-10824442.53942.54
579165-7916531.11131.11
695399-9539937.49137.49
10min1196605-19660577.26476.264.3377.7776.734.38
2201358-20135879.13279.68
3193922-19392276.20976.73
4198385-19838577.96378.44
5177693-17769369.83270.18
6196387-19638777.17877.59
15min1221597-22159787.08584.825.0888.4586.145.09
2224226-22422688.11989.55
3219926-21992686.42987.79
4225024-22502488.43289.77
5205314-20531480.68681.81
6198984-19898478.19979.47
20min1229209-22920990.07789.941.4492.4192.201.52
2230137-23013790.44192.85
3227637-22763789.45991.78
4233791-23379191.87794.20
5223765-22376587.93789.96
6228636-22863689.85291.99
30min1237931-23793193.50491.923.2796.8395.173.11
2219302-21930286.18389.60
3233973-23397391.94995.27
4239457-23945794.10497.45
5233234-23323491.65994.65
6239449-23944994.10197.24
45min1243292-24329295.61195.641.4199.9899.921.43
2242062-24206295.12899.50
3240888-24088894.66799.01
4249874-24987498.198102.59
5240504-24050494.51698.53
6243626-24362695.74399.93
60min1240286-24028694.43091.663.4499.8697.003.24
2236404-23640492.90498.33
3232638-23263891.42496.82
4219843-21984386.39691.88
5228959-22895989.97995.04
6241234-24123494.803100.05
极限1238696-23869693.80592.305.17100.2998.664.97
2232897-23289791.52697.98
3241643-24164394.963101.37
4244345-24434596.025102.46
5211338-21133883.05489.12
6240283-24028394.429100.73
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%
111.231006566100625410059361006135100575910061300.04
211.291005672100587310057720.02
单位质量响应值RSD%判断
89593.0589085.210.41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%
5min1476677-47667747.90133.3427.5347.9033.3427.54
2412496-41249641.45141.45
3252981-25298125.42225.42
4300668-30066830.21430.21
5261617-26161726.29026.29
6286019-28601928.74228.74
10min1925914-92591493.04483.1412.9793.5883.5113.00
2909242-90924291.36991.83
3691779-69177969.51669.80
4829903-82990383.39683.73
5699736-69973670.31670.61
6907481-90748191.19291.51
15min1952943-95294395.76095.544.3197.3396.844.20
2877770-87777088.20689.68
3940562-94056294.51695.57
4986315-98631599.114100.38
5955730-95573096.04097.11
6991182-99118299.603100.94
20min1972674-97267497.74395.933.07100.3798.282.98
2899775-89977590.41792.87
3969196-96919697.39399.50
4947646-94764695.22897.59
5958046-95804696.27398.41
6980519-98051998.531100.97
30min1889578-88957889.39395.413.7693.1198.843.49
2923374-92337492.78996.25
3959840-95984096.45399.64
4979872-97987298.466101.89
5975583-97558398.035101.25
6968641-96864197.337100.87
45min1949119-94911995.37695.771.28100.09100.251.30
2938678-93867894.32798.82
3944747-94474794.93699.20
4964852-96485296.957101.47
5950402-95040295.50599.80
6970360-97036097.510102.13
60min1939682-93968294.42794.570.88100.20100.120.76
2940406-94040694.500100.04
3938851-93885194.34499.66
4948198-94819895.283100.88
5951469-95146995.612100.97
6927926-92792693.24698.95
极限1922493-92249392.70092.572.9399.5299.162.82
2895103-89510389.94896.54
3883385-88338588.77095.13
4930684-93068493.523100.17
5944043-94404394.866101.29
6951298-95129895.595102.33
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%
19.922516112515722517242514532507342514190.16
29.932515292514862515080.02
单位质量响应值RSD%判断
25344.6625328.100.05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%
5min162549-6254924.61817.2529.0324.6217.2529.03
257092-5709222.47122.47
332563-3256312.81612.82
438884-3888415.30415.30
534099-3409913.42113.42
637771-3777114.86614.87
10min1140032-14003255.11448.7214.5455.3948.9214.59
2141534-14153455.70655.96
3100840-10084039.68939.83
4122508-12250848.21748.39
5103674-10367440.80440.95
6134183-13418352.81252.98
15min1164335-16433564.68063.033.0765.5763.763.13
2155911-15591161.36462.23
3154062-15406260.63661.22
4164129-16412964.59965.30
5157364-15736461.93662.54
6165098-16509864.98065.73
20min1182116-18211671.67869.401.8573.2870.841.93
2174003-17400368.48570.04
3175644-17564469.13170.39
4173863-17386368.43069.85
5174245-17424568.58069.87
6178140-17814070.11371.59
30min1185798-18579873.12777.002.6675.5379.202.47
2197654-19765477.79480.10
3195894-19589477.10179.13
4200297-20029778.83481.02
5199061-19906178.34780.40
6195065-19506576.77579.03
45min1211920-21192083.40883.881.3786.6286.941.41
2218538-21853886.01389.19
3211276-21127683.15586.04
4214360-21436084.36987.43
5211011-21101183.05185.97
6211642-21164283.29986.41
60min1220135-22013586.64286.842.3690.7890.842.28
2228055-22805589.75993.89
3220551-22055186.80590.61
4220841-22084186.92090.92
5222407-22240787.53691.38
6211888-21188883.39687.43
极限1224092-22409288.19988.692.3993.3093.652.25
2225215-22521588.64193.77
3219540-21954086.40891.18
4224115-22411588.20893.17
5235582-23558292.72197.54
6223537-22353787.98192.94
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%
111.231009899100996410099261009937101038610100220.03
211.291009089100950610092980.03
单位质量响应值RSD%判断
89939.6389397.520.43数据可信
供试品溶液-2024092721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%
5min154451-544515.4525.358.755.455.368.74
256809-568095.6885.69
357214-572145.7285.73
456715-567155.6785.68
545722-457224.5784.58
649909-499094.9975.00
10min169797-697976.9887.433.277.057.493.26
274101-741017.4197.48
376762-767627.6857.75
475735-757357.5837.65
575054-750547.5147.57
673667-736677.3767.43
15min175548-755487.5647.622.267.707.762.16
278257-782577.8357.98
374192-741927.4287.58
474319-743197.4417.59
577778-777787.7877.92
676525-765257.6627.80
20min172410-724107.2507.313.107.477.542.96
274921-749217.5017.73
369165-691656.9257.16
472372-723727.2467.48
575393-753937.5487.77
673858-738587.3957.62
30min171475-714757.1567.909.917.468.219.60
292988-929889.3109.63
379496-794967.9598.27
473990-739907.4087.72
581415-814158.1518.46
674286-742867.4377.74
45min177448-774487.7548.7014.788.149.1014.28
2110726-11072611.08611.51
380278-802788.0378.43
481173-811738.1278.52
592529-925299.2649.66
679212-792127.9318.32
60min1112324-11232411.24611.7616.2511.7112.2515.75
2133912-13391213.40713.95
391776-917769.1899.67
4120073-12007312.02212.50
5143097-14309714.32714.83
6103341-10334110.34610.82
极限1180793-18079318.10118.6020.2418.6919.2219.73
2194649-19464919.48820.18
3133638-13363813.38013.97
4193636-19363619.38720.00
5247016-24701624.73125.39
6165030-16503016.52317.11
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%
19.922528682527832526482528372524902527250.07
29.932524062532012528040.23
单位质量响应值RSD%判断
25476.3125458.610.05数据可信
供试品溶液-2024092721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%
5min192301-9230136.14133.0513.7936.1433.0413.79
283853-8385332.83332.83
387809-8780934.38234.38
498231-9823138.46338.46
564741-6474125.35025.35
679458-7945831.11231.11
10min1174196-17419668.20869.973.8068.6170.343.80
2169286-16928666.28566.65
3181058-18105870.89571.28
4188684-18868473.88174.31
5176825-17682569.23769.52
6182130-18213071.31571.66
15min1212319-21231983.13582.550.9684.2983.700.96
2208517-20851781.64782.75
3207994-20799481.44282.61
4212306-21230683.13084.38
5212144-21214483.06784.12
6211675-21167582.88384.02
20min1223239-22323987.41185.704.0689.4987.763.95
2222865-22286587.26589.27
3201299-20129978.82080.89
4220078-22007886.17388.35
5220131-22013186.19488.17
6225658-22565888.35890.42
30min1230695-23069590.33191.592.2793.3894.602.21
2225673-22567388.36491.34
3236230-23623092.49895.45
4239749-23974993.87697.01
5238506-23850693.38996.32
6232613-23261391.08294.12
45min1239034-23903493.59692.253.4897.6596.283.39
2237391-23739192.95296.91
3231664-23166490.71094.69
4243246-24324695.24599.42
5220975-22097586.52590.49
6241278-24127894.47498.53
60min1239244-23924493.67893.041.7398.7898.101.74
2236395-23639592.56297.56
3233717-23371791.51496.50
4245024-24502495.941101.17
5234762-23476291.92396.85
6236535-23653592.61797.72
极限1231824-23182490.77391.552.3096.9197.642.15
2230023-23002390.06796.09
3229054-22905489.68895.69
4230913-23091390.41696.71
5238935-23893593.55799.51
6242085-24208594.790100.92
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