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%
111.471014055101356410140061013885101410810139240.03
211.421017319101742610173720.01
单位质量响应值RSD%判断
88397.9189086.870.55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%
5min153340-533405.3964.7511.005.404.7511.03
250200-502005.0785.08
342573-425734.3074.31
444299-442994.4824.48
550637-506375.1235.12
640470-404704.0944.09
10min171464-714647.2307.322.617.297.382.61
272938-729387.3797.44
371657-716577.2497.30
471383-713837.2217.27
575978-759787.6867.74
670899-708997.1737.22
15min172610-726107.3467.572.327.497.712.26
274478-744787.5357.67
373194-731947.4057.53
476954-769547.7857.92
575709-757097.6597.80
676275-762757.7167.84
20min1118322-11832211.9708.6621.2312.198.8820.74
274215-742157.5087.73
374095-740957.4967.71
474809-748097.5687.78
596080-960809.7209.95
676068-760687.6957.91
30min198008-980089.9159.2416.8210.279.5516.42
273883-738837.4747.78
372303-723037.3157.61
494163-941639.5269.83
5111814-11181411.31211.65
697591-975919.87310.17
45min1113857-11385711.51810.9414.3311.9811.3614.00
2102257-10225710.34510.73
379560-795608.0498.42
4117355-11735511.87212.28
5113511-11351111.48311.94
6122357-12235712.37812.78
60min1159471-15947116.13316.5215.3216.7317.0615.05
2164529-16452916.64517.15
3127886-12788612.93813.40
4160147-16014716.20116.74
5206237-20623720.86421.45
6161319-16131916.32016.86
极限1238828-23882824.16124.799.4324.9325.529.41
2251367-25136725.43026.12
3208547-20854721.09821.71
4241038-24103824.38525.10
5279790-27979028.30529.13
6250966-25096625.38926.11
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%
110.242563722567962567232566332569072566860.08
210.272581022578462579740.08
单位质量响应值RSD%判断
25066.9925119.180.15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%
5min192354-9235436.70227.4826.7136.7027.4926.70
280112-8011231.83731.84
358321-5832123.17723.18
452908-5290821.02621.03
583546-8354633.20133.20
647727-4772718.96718.97
10min1179429-17942971.30565.3512.7871.7165.6512.84
2181407-18140772.09172.45
3159350-15935063.32663.58
4148740-14874059.10959.34
5184902-18490273.48073.85
6132792-13279252.77252.98
15min1206732-20673282.15581.193.8683.3682.223.99
2212355-21235584.39085.54
3202874-20287480.62281.58
4203667-20366780.93781.83
5210139-21013983.50984.69
6190049-19004975.52676.32
20min1220123-22012387.47788.362.4189.5990.302.53
2228965-22896590.99193.08
3222973-22297388.61090.47
4221805-22180588.14589.94
5226582-22658290.04492.16
6213655-21365584.90786.54
30min1226756-22675690.11391.681.3793.2094.591.36
2233543-23354392.81095.91
3229477-22947791.19494.04
4235071-23507193.41796.19
5230957-23095791.78294.90
6228344-22834490.74493.32
45min1228362-22836290.75193.741.7594.8497.681.66
2237183-23718394.25798.39
3238728-23872894.87198.73
4239582-23958295.21099.02
5237314-23731494.30998.44
6234198-23419893.07096.66
60min1228139-22813990.66394.142.0595.7699.111.95
2239598-23959895.216100.40
3239892-23989295.333100.24
4241329-24132995.904100.77
5237588-23758894.41899.60
6234734-23473493.28397.91
极限1230537-23053791.61693.891.7897.7299.911.64
2233971-23397192.98099.22
3240302-24030295.496101.46
4241730-24173096.064101.99
5236685-23668594.059100.29
6234377-23437793.14298.80
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%
111.471016808101655610166921016536101624310165670.03
211.421025407102592810256680.04
单位质量响应值RSD%判断
88628.3389813.310.94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%
5min161083-610836.1474.8125.266.154.8125.28
262499-624996.2896.29
350330-503305.0645.06
436335-363353.6563.66
541470-414704.1734.17
635210-352103.5433.54
10min181851-818518.2367.954.728.308.004.84
282878-828788.3408.41
380751-807518.1268.18
477286-772867.7777.82
578564-785647.9067.95
672684-726847.3147.35
15min186596-865968.7148.422.508.878.572.56
282935-829358.3458.51
384009-840098.4538.60
483782-837828.4318.56
584736-847368.5278.66
680292-802928.0798.20
20min1103409-10340910.4068.818.8910.669.058.78
283655-836558.4188.67
384982-849828.5518.79
484103-841038.4638.68
585492-854928.6038.83
683879-838798.4408.65
30min1112853-11285311.3569.4512.3611.739.7912.17
295772-957729.6379.99
386512-865128.7059.04
487969-879698.8529.17
5100101-10010110.07310.40
680400-804008.0908.39
45min1147776-14777614.87011.7623.4715.3712.2022.90
2149879-14987915.08215.54
3114879-11487911.56011.99
498459-984599.90710.32
5109631-10963111.03211.47
680556-805568.1068.50
60min1222580-22258022.39717.6133.4923.0618.1832.77
2238931-23893124.04324.67
3208271-20827120.95721.52
4114186-11418611.49012.01
5167921-16792116.89717.46
697871-978719.84810.33
极限1285648-28564828.74325.8321.0229.6626.6020.77
2279492-27949228.12429.01
3300612-30061230.24931.04
4164991-16499116.60217.25
5292516-29251629.43530.18
6217011-21701121.83722.43
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%
110.242576952578942579472578092576152577920.06
210.272600002601582600790.05
单位质量响应值RSD%判断
25175.0025324.150.42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%
5min1112039-11203944.24930.0441.7744.2530.0441.77
2117142-11714246.26446.26
376100-7610030.05530.05
446416-4641618.33218.33
557644-5764422.76622.77
646988-4698818.55718.56
10min1191074-19107475.46363.9719.1775.9564.3119.28
2197005-19700577.80578.32
3178442-17844270.47470.81
4131485-13148551.92952.13
5149028-14902858.85759.11
6124857-12485749.31149.52
15min1215099-21509984.95178.729.2386.2879.779.43
2217144-21714485.75987.14
3210062-21006282.96284.08
4175559-17555969.33570.12
5199842-19984278.92679.83
6178297-17829770.41771.17
20min1226160-22616089.32085.625.7291.5987.545.96
2226119-22611989.30491.64
3226822-22682289.58191.62
4196772-19677277.71379.26
5217582-21758285.93287.72
6207230-20723081.84483.38
30min1234438-23443892.58990.813.9395.8693.684.20
2238016-23801694.00297.33
3236818-23681893.52996.56
4215120-21512084.96087.37
5232308-23230891.74894.49
6222850-22285088.01390.46
45min1238237-23823794.09092.872.0698.3896.752.30
2237942-23794293.97398.34
3236643-23664393.46097.53
4225472-22547289.04892.41
5235598-23559893.04796.81
6236980-23698093.59397.02
60min1235260-23526092.91493.070.8998.2597.981.15
2238070-23807094.02499.44
3235814-23581493.13398.24
4232037-23203791.64195.99
5235588-23558893.04397.84
6237205-23720593.68298.15
极限1235316-23531692.93693.421.4599.3199.361.53
2239532-23953294.601101.06
3238936-23893694.366100.51
4235037-23503792.82698.19
5230940-23094091.20897.03
6239415-23941594.555100.06
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%
111.471021422102133410201491019958101966010205050.09
211.421024305102418310242440.01
单位质量响应值RSD%判断
88971.6789688.620.57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%
5min154509-545095.4784.0622.435.484.0622.45
231731-317313.1893.19
347301-473014.7544.75
435991-359913.6173.62
540835-408354.1044.10
632079-320793.2243.22
10min174822-748227.5207.257.297.587.307.33
269707-697077.0067.04
377592-775927.7987.85
474743-747437.5127.55
573365-733657.3737.42
662814-628146.3136.35
15min177994-779947.8387.784.917.987.904.92
276460-764607.6847.80
376845-768457.7237.86
482948-829488.3368.46
578949-789497.9348.06
671289-712897.1657.27
20min177916-779167.8317.862.308.068.072.39
278071-780717.8468.04
378605-786057.9008.13
481187-811878.1598.38
577961-779617.8358.05
675576-755767.5957.78
30min179198-791987.9597.946.688.288.246.59
276365-763657.6757.96
377862-778627.8258.14
488843-888438.9299.24
578741-787417.9138.22
673172-731727.3547.62
45min197355-973559.7849.7812.6110.1910.1612.27
296601-966019.70810.08
391047-910479.1509.55
4106051-10605110.65811.06
5114098-11409811.46711.86
678522-785227.8918.24
60min1145521-14552114.62515.4524.5915.1415.9523.94
2152483-15248315.32415.80
3151629-15162915.23915.74
4147838-14783814.85815.38
5221258-22125822.23622.75
6103943-10394310.44610.89
极限1225797-22579722.69324.0916.4223.3724.7616.20
2240981-24098124.21824.87
3215497-21549721.65722.33
4243135-24313524.43525.12
5313015-31301531.45832.22
6200034-20003420.10320.66
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%
110.242589762590632585572586442585062587490.10
210.272598192598572598380.02
单位质量响应值RSD%判断
25268.4625300.680.10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%
5min1105714-10571441.69326.4834.7841.6926.4834.77
245583-4558317.97817.98
382381-8238132.49032.49
454510-5451021.49821.50
566946-6694626.40326.40
647645-4764518.79118.79
10min1191400-19140075.48661.9417.8075.9562.2317.86
2135014-13501453.24853.45
3182552-18255271.99772.36
4147882-14788258.32358.56
5166100-16610065.50865.80
6119344-11934447.06847.28
15min1217807-21780785.90178.609.8287.2079.589.93
2188196-18819674.22375.01
3209559-20955982.64883.81
4204316-20431680.58081.47
5210976-21097683.20784.23
6164966-16496665.06165.79
20min1229490-22949090.50985.636.1892.7787.496.37
2208274-20827482.14183.76
3225150-22515088.79790.88
4218966-21896686.35888.14
5226373-22637389.27991.23
6194458-19445876.69278.15
30min1234430-23443092.45789.623.4595.7292.433.71
2221837-22183787.49090.02
3231223-23122391.19294.26
4228004-22800489.92392.66
5233681-23368192.16295.10
6214271-21427184.50786.81
45min1235568-23556892.90693.061.6997.2096.861.91
2230666-23066690.97394.47
3239069-23906994.28798.37
4237785-23778593.78097.52
5240656-24065694.91398.87
6232015-23201591.50594.75
60min1234915-23491592.64893.831.5897.9798.671.62
2232761-23276191.79996.31
3241671-24167195.313100.44
4236778-23677893.38398.17
5242029-24202995.454100.47
6239373-23937394.40798.67
极限1237621-23762193.71693.561.23100.0799.451.12
2233280-23328092.00497.54
3235249-23524992.78098.97
4237147-23714793.52999.35
5238265-23826593.970100.05
6241862-24186295.388100.70
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%
111.471030777103030710292501028487102700510291650.15
211.421034483103222210333520.16
单位质量响应值RSD%判断
89726.6890486.160.60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%
5min137255-372553.7125.4318.153.715.4318.17
253678-536785.3485.35
361451-614516.1236.12
459778-597785.9565.96
564315-643156.4086.41
650291-502915.0115.01
10min174025-740257.3758.034.257.428.094.34
281808-818088.1518.21
382673-826738.2378.31
483243-832438.2948.36
581882-818828.1588.23
679659-796597.9377.99
15min182721-827218.2428.301.388.378.451.31
283097-830978.2798.43
383072-830728.2778.44
483661-836618.3358.49
582047-820478.1758.34
685408-854088.5108.65
20min184080-840808.3778.241.158.598.481.03
281532-815328.1238.37
382865-828658.2568.51
482865-828658.2568.51
583024-830248.2728.52
681676-816768.1388.38
30min193568-935689.3238.425.709.638.755.37
281670-816708.1378.47
385075-850758.4768.82
480499-804998.0208.36
584587-845878.4288.77
681517-815178.1228.45
45min194494-944949.4159.9610.969.8310.3910.58
299204-992049.88410.31
3117525-11752511.70912.15
487576-875768.7269.16
5107887-10788710.74911.19
693232-932329.2899.71
60min1140748-14074814.02317.2613.6014.5417.8013.27
2175586-17558617.49418.03
3205082-20508220.43321.00
4151218-15121815.06615.60
5180992-18099218.03318.59
6185541-18554118.48619.01
极限1262192-26219226.12326.735.2926.8027.465.26
2278593-27859327.75728.48
3282535-28253528.15028.94
4250891-25089124.99725.69
5281029-28102928.00028.76
6254380-25438025.34526.07
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%
110.242616722607182606762608062602302608200.21
210.272620972620202620580.03
单位质量响应值RSD%判断
25470.7025516.850.13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%
5min149451-4945119.34335.2629.2919.3435.2629.29
279408-7940831.06131.06
3107675-10767542.11842.12
496424-9642437.71737.72
5126123-12612349.33449.33
681751-8175131.97731.98
10min1129722-12972250.74170.4614.4050.9670.8614.46
2180395-18039570.56270.91
3196678-19667876.93277.40
4194262-19426275.98676.41
5198727-19872777.73378.28
6181068-18106870.82671.18
15min1185623-18562372.60782.796.4973.3983.976.65
2213267-21326783.42084.55
3221789-22178986.75488.08
4221301-22130186.56387.83
5219265-21926585.76787.18
6208746-20874681.65282.79
20min1208916-20891681.71888.414.4783.3090.514.66
2223638-22363887.47789.53
3233467-23346791.32293.61
4236564-23656492.53394.76
5231471-23147190.54192.91
6222157-22215786.89888.95
30min1228263-22826389.28692.102.6291.7895.182.80
2232464-23246490.92993.96
3241968-24196894.64797.95
4243304-24330495.16998.42
5236127-23612792.36295.73
6230578-23057890.19293.21
45min1235581-23558192.14993.781.7095.6397.881.85
2238505-23850593.29297.33
3244625-24462595.686100.04
4244788-24478895.750100.06
5236048-23604892.33196.73
6239032-23903293.49897.52
60min1237885-23788593.05094.292.5997.5699.432.59
2241011-24101194.27399.35
3247627-24762796.860102.28
4248762-24876297.304102.68
5232352-23235290.88696.31
6238632-23863293.34298.40
极限1237533-23753392.91294.132.8198.46100.322.85
2238248-23824893.19299.31
3247744-24774496.906103.40
4250440-25044097.961104.42
5235756-23575692.21798.65
6234096-23409691.56897.66
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