依折麦布贝派度酸片项目信息
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%
110.889575119575859573539574469576409575070.02
210.849564469561499562980.03
单位质量响应值RSD%判断
88006.1688219.370.18数据可信
供试品溶液-1996049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%
5min159794-597946.0925.714.076.095.704.08
253429-534295.4445.44
354800-548005.5835.58
454694-546945.5735.57
557362-573625.8445.84
655980-559805.7045.70
10min167638-676386.8916.901.776.966.961.72
266737-667376.8006.86
369907-699077.1237.18
468135-681356.9427.00
566730-667306.7996.86
667261-672616.8536.92
15min169051-690517.0357.111.337.187.251.28
269769-697697.1097.24
371391-713917.2747.41
469859-698597.1187.26
568706-687067.0007.14
669749-697497.1067.25
20min171850-718507.3217.301.787.547.521.70
271740-717407.3097.52
371419-714197.2777.50
469697-696977.1017.32
573664-736647.5057.72
671356-713567.2707.49
30min173493-734937.4887.471.177.797.771.15
274595-745957.6007.90
373761-737617.5157.82
472792-727927.4177.71
572904-729047.4287.73
672159-721597.3527.65
45min173278-732787.4667.351.277.857.731.24
271977-719777.3337.71
372181-721817.3547.74
471521-715217.2877.67
573103-731037.4487.83
670893-708937.2237.60
60min173328-733287.4717.520.807.947.980.74
274802-748027.6218.08
373359-733597.4747.94
473766-737667.5167.98
574090-740907.5498.02
673339-733397.4727.93
极限173839-738397.5237.530.968.088.080.92
274355-743557.5768.12
374212-742127.5618.11
473239-732397.4628.01
574860-748607.6278.18
672999-729997.4387.98
依折麦布贝派度酸片项目信息
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%
19.642398372398272397602401022401512399350.08
29.722393002388032390520.15
单位质量响应值RSD%判断
24889.5224593.830.85数据可信
供试品溶液-1996049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%
5min176869-7686930.98331.746.2930.9831.746.29
272336-7233629.15629.16
376399-7639930.79330.79
478152-7815231.50031.50
586484-8648434.85834.86
682244-8224433.14933.15
10min1125243-12524350.48052.693.5550.8253.043.56
2125716-12571650.67150.99
3130403-13040352.56052.90
4132448-13244853.38453.73
5137175-13717555.29055.68
6133429-13342953.78054.15
15min1158363-15836363.83064.832.0764.7365.772.10
2157049-15704963.30064.19
3159679-15967964.36065.29
4162355-16235565.43966.38
5166390-16639067.06568.07
6161243-16124364.99065.96
20min1179851-17985172.49174.043.6074.1075.703.60
2178409-17840971.90973.50
3180851-18085172.89474.53
4182121-18212173.40675.08
5196518-19651879.20880.96
6184458-18445874.34776.04
30min1203821-20382182.15282.971.0884.5785.451.11
2205627-20562782.88085.27
3203542-20354282.03984.49
4208870-20887084.18786.67
5208153-20815383.89886.52
6205145-20514582.68685.20
45min1222934-22293489.85689.621.7693.1993.021.78
2218588-21858888.10491.41
3218949-21894988.24991.61
4224739-22473990.58394.00
5228644-22864492.15795.72
6220196-22019688.75292.18
60min1225881-22588191.04391.861.4895.3796.261.50
2225211-22521190.77395.06
3225958-22595891.07495.42
4232257-23225793.61398.04
5232206-23220693.59398.18
6225960-22596091.07595.49
极限1237283-23728395.63995.100.75100.98100.520.75
2236185-23618595.197100.49
3232530-23253093.72399.08
4237099-23709995.565101.03
5236703-23670395.405101.03
6235867-23586795.068100.50
依折麦布贝派度酸片项目信息
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%
110.889526009511579506569512799511429513670.08
210.849500729503269501990.02
单位质量响应值RSD%判断
87441.8287656.730.18数据可信
供试品溶液-1996049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%
5min1574666-57466658.92848.5416.8458.9348.5416.85
2534777-53477754.83754.84
3446288-44628845.76345.76
4466322-46632247.81847.82
5474835-47483548.69148.69
6343211-34321135.19435.19
10min1849744-84974487.13585.482.0787.7986.022.14
2836124-83612485.73886.35
3835134-83513485.63786.15
4850895-85089587.25387.78
5824851-82485184.58285.12
6804719-80471982.51882.91
15min1875256-87525689.75189.303.2091.3790.793.16
2864916-86491688.69190.25
3862832-86283288.47789.94
4920591-92059194.40095.90
5835493-83549385.67387.15
6866344-86634488.83790.14
20min1882110-88211090.45489.991.3493.0792.471.37
2880455-88045590.28492.83
3867431-86743188.94891.39
4896849-89684991.96594.51
5864587-86458788.65791.09
6874176-87417689.64091.94
30min1871230-87123089.33889.860.6992.9693.340.65
2874753-87475389.69993.25
3870332-87033289.24692.68
4885159-88515990.76694.34
5874131-87413189.63593.05
6882183-88218390.46193.75
45min1873599-87359989.58190.141.5794.2094.621.52
2884997-88499790.75095.30
3854055-85405587.57792.00
4893091-89309191.58096.16
5885948-88594890.84795.26
6882787-88278790.52394.82
60min1841923-84192386.33388.882.2791.9594.362.14
2870289-87028989.24294.80
3868051-86805189.01294.41
4896777-89677791.95897.56
5848733-84873387.03192.45
6874725-87472589.69695.00
极限1879480-87948090.18490.851.0696.7697.321.06
2893201-89320191.59198.14
3875254-87525489.75196.14
4899974-89997492.28598.90
5880311-88031190.26996.66
6887906-88790691.04897.35
依折麦布贝派度酸片项目信息
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%
19.642396682403292399822402812400952400710.12
29.722399632407262403440.23
单位质量响应值RSD%判断
24903.6324726.750.51数据可信
供试品溶液-1996049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%
5min137910-3791015.23413.1815.6615.2313.1815.66
238728-3872815.56315.56
331826-3182612.78912.79
431809-3180912.78312.78
531904-3190412.82112.82
624570-245709.8749.87
10min186356-8635634.70333.255.2434.8733.405.28
286226-8622634.65034.82
385144-8514434.21634.36
482332-8233233.08633.23
581478-8147832.74232.88
674920-7492030.10730.22
15min1117112-11711247.06246.073.3147.6246.583.31
2115017-11501746.22046.78
3113420-11342045.57846.10
4120502-12050248.42448.93
5109973-10997344.19344.70
6111815-11181544.93445.38
20min1141028-14102856.67355.791.4857.7556.821.48
2137865-13786555.40256.47
3136222-13622254.74255.77
4141164-14116456.72857.78
5137218-13721855.14256.14
6139483-13948356.05257.00
30min1166483-16648366.90268.352.2468.6170.002.13
2167273-16727367.22068.91
3168375-16837567.66269.30
4171603-17160368.96070.64
5169904-16990468.27769.89
6176891-17689171.08572.65
45min1192775-19277577.46879.023.5779.9281.433.44
2191253-19125376.85679.29
3188652-18865275.81178.20
4200563-20056380.59783.04
5199149-19914980.02982.40
6207435-20743583.35985.72
60min1242138-24213897.30587.866.14100.6291.145.95
2220705-22070588.69291.98
3206757-20675783.08686.32
4216030-21603086.81390.15
5204909-20490982.34485.60
6221252-22125288.91192.19
极限1229678-22967892.29793.543.3496.6997.803.21
2223779-22377989.92794.20
3228721-22872191.91396.07
4235859-23585994.78199.09
5232124-23212493.28097.45
6246386-24638699.012103.28
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