布瑞哌唑口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数25000
标示量(mg)2供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.948260682656825268287782811826950.18
210.928271482802827580.08
单位质量响应值RSD%判断
7558.967578.570.19数据可信
供试品溶液-25061901批-pH4.3
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
10min145521-4552153.85851.935.8953.8651.935.89
242467-4246750.24550.25
346789-4678955.35955.36
445178-4517853.45353.45
543811-4381151.83551.84
639571-3957146.81946.82
15min165802-6580277.85477.142.5878.1577.422.58
263801-6380175.48675.77
367205-6720579.51479.82
466522-6652278.70679.00
565086-6508677.00777.29
662763-6276374.25874.52
20min167697-6769780.09681.581.9680.8382.301.97
267990-6799080.44381.14
370073-7007382.90783.66
471071-7107184.08884.82
568852-6885281.46382.18
668019-6801980.47781.15
30min172262-7226285.49785.891.8986.6787.061.90
271206-7120684.24885.39
373745-7374587.25288.46
474573-7457388.23189.43
572633-7263385.93687.10
671154-7115484.18685.31
45min173619-7361987.10386.471.5588.7588.111.55
273174-7317486.57688.19
373878-7387887.40989.10
474312-7431287.92389.61
571331-7133184.39686.04
672172-7217285.39186.98
60min172504-7250485.78386.562.3187.9288.692.30
270379-7037983.26985.36
375138-7513888.90091.08
474580-7458088.24090.42
573473-7347386.93089.04
672912-7291286.26688.33
极限174915-7491588.63687.651.1491.2590.261.14
274072-7407287.63990.20
373269-7326986.68989.36
475146-7514688.90991.58
574041-7404187.60290.20
673049-7304986.42888.97
布瑞哌唑口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数25000
标示量(mg)2供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.948300082822828868290282797828810.10
210.928270682584826450.11
单位质量响应值RSD%判断
7575.967568.220.08数据可信
供试品溶液-25062301批-pH4.3
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
10min143767-4376751.76050.203.7851.7650.203.78
243935-4393551.95951.96
343700-4370051.68151.68
440479-4047947.87247.87
540606-4060648.02248.02
642182-4218249.88649.89
15min159317-5931770.15072.232.3570.4472.512.34
261323-6132372.52372.81
361139-6113972.30572.59
460123-6012371.10371.37
560989-6098972.12872.39
663554-6355475.16175.44
20min164421-6442176.18678.661.8276.8679.341.81
267123-6712379.38280.07
366719-6671978.90479.59
465965-6596578.01278.67
567920-6792080.32480.99
666954-6695479.18279.88
30min168241-6824180.70482.911.5281.8084.031.52
270879-7087983.82484.96
371076-7107684.05785.18
469514-6951482.21083.30
570403-7040383.26184.37
670541-7054183.42484.56
45min169282-6928281.93583.452.4383.4885.022.39
272196-7219685.38186.98
371439-7143984.48686.08
470778-7077883.70485.26
571884-7188485.01286.59
667775-6777580.15381.75
60min169356-6935682.02383.931.1784.0385.971.17
271175-7117584.17486.25
371601-7160184.67886.74
470876-7087683.82085.84
571458-7145884.50986.56
671332-7133284.36086.40
极限170276-7027683.11184.701.9585.5787.211.93
273113-7311386.46689.01
372563-7256385.81588.35
469650-6965082.37084.85
571561-7156184.63087.15
672567-7256785.82088.33
布瑞哌唑口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数25000
标示量(mg)2供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.948249482618825488275882631826100.13
210.928293382989829610.05
单位质量响应值RSD%判断
7551.197597.160.43数据可信
供试品溶液-25062302批-pH4.3
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
10min158662-5866269.35769.041.7169.3669.041.71
257730-5773068.25568.26
356955-5695567.33967.34
458223-5822368.83868.84
559011-5901169.77069.77
659787-5978770.68770.69
15min163067-6306774.56574.331.0674.9574.721.06
263323-6332374.86875.25
361691-6169172.93873.31
463596-6359675.19175.57
562859-6285974.31974.71
662695-6269574.12574.52
20min168660-6866081.17879.331.5881.9880.131.57
266228-6622878.30379.10
367019-6701979.23880.02
466359-6635978.45779.26
568117-6811780.53681.34
666189-6618978.25679.06
30min173039-7303986.35583.961.7887.6185.201.77
269925-6992582.67483.90
370185-7018582.98184.20
470633-7063383.51184.75
572102-7210285.24786.50
670192-7019282.98984.23
45min173510-7351086.91285.302.0788.6487.012.04
272339-7233985.52887.22
371490-7149084.52486.20
469544-6954482.22383.92
573498-7349886.89888.62
672517-7251785.73887.44
60min173983-7398387.47186.361.4989.6888.541.48
272793-7279386.06488.23
372563-7256385.79387.94
471251-7125184.24186.40
574214-7421487.74589.95
673443-7344386.83389.01
极限173300-7330086.66486.381.1989.3689.041.16
271489-7148984.52387.17
372749-7274986.01288.64
473372-7337286.74989.37
573963-7396387.44890.14
673487-7348786.88589.54
布瑞哌唑口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数25000
标示量(mg)2供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.948343783403830758309883194832410.21
210.928300383067830350.06
单位质量响应值RSD%判断
7608.877603.940.05数据可信
供试品溶液-2810778批-pH4.3
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
10min157536-5753667.73772.294.2467.7472.294.24
264978-6497876.49876.50
359419-5941969.95469.95
462369-6236973.42773.43
562508-6250873.59173.59
661600-6160072.52272.52
15min164059-6405975.41775.251.6475.7975.651.64
264651-6465176.11376.54
362251-6225173.28873.68
463749-6374975.05275.46
565296-6529676.87377.28
663505-6350574.76475.17
20min165484-6548477.09477.791.9577.8978.611.94
268019-6801980.07980.93
364521-6452175.96076.76
466922-6692278.78779.61
565134-6513476.68277.52
666360-6636078.12578.94
30min166894-6689478.75478.752.6879.9880.002.66
268987-6898781.21882.51
363772-6377275.07976.30
467921-6792179.96381.23
567495-6749579.46280.72
666250-6625077.99679.25
45min169033-6903381.27280.151.5182.9381.841.49
267644-6764479.63781.38
366834-6683478.68480.32
469520-6952081.84683.55
567353-6735379.29581.00
668118-6811880.19581.88
60min167614-6761479.60280.492.2981.7182.632.27
270131-7013182.56584.75
366423-6642378.20080.27
469417-6941781.72483.89
566971-6697178.84580.99
669674-6967482.02784.16
极限168900-6890081.11680.572.3383.6783.162.29
269869-6986982.25784.90
367272-6727279.19981.71
469557-6955781.88984.50
565775-6577577.43780.02
669264-6926481.54484.13
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