玛巴洛沙韦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)0
对照品批号DQTL-4125-250109对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.77对照品水分(%)0对照品稀释倍数2500
标示量(mg)20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%
111.159866998244982429833098109983190.22
211.029835998458984080.08
单位质量响应值RSD%判断
8817.858929.950.90数据可信
加速6月-供试品溶液-2025051221批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min117620-1762017.83017.6624.7817.8317.6624.77
215968-1596816.15816.16
325861-2586126.16926.17
416075-1607516.26716.27
513524-1352413.68513.69
615664-1566415.85115.85
10min131773-3177332.15231.5610.3732.3531.7610.46
230930-3093031.29931.48
336852-3685237.29137.58
431332-3133231.70531.89
527405-2740527.73227.88
628845-2884529.18929.36
15min137517-3751737.96438.335.2938.5238.885.42
236959-3695937.39937.93
341591-4159142.08742.79
438501-3850138.96039.49
535990-3599036.41936.88
636736-3673637.17437.67
20min142155-4215542.65742.313.3843.6343.283.53
241719-4171942.21643.16
344164-4416444.69045.86
442114-4211442.61643.58
540461-4046140.94341.81
640262-4026240.74241.66
30min143264-4326443.78045.873.0445.2347.313.08
245452-4545245.99447.41
346714-4671447.27148.94
446542-4654247.09748.54
544106-4410644.63245.95
645883-4588346.43047.80
45min148814-4881449.39648.691.1351.3350.641.15
247419-4741947.98449.91
348350-4835048.92651.12
447976-4797648.54850.51
548531-4853149.10950.93
647610-4761048.17750.06
60min149536-4953650.12650.050.5052.6152.550.69
249187-4918749.77352.23
349814-4981450.40853.15
449642-4964250.23452.74
549359-4935949.94752.31
649236-4923649.82352.24
90min149299-4929949.88750.981.6352.9354.021.55
249762-4976250.35553.36
350269-5026950.86854.17
451676-5167652.29255.35
550560-5056051.16354.08
650688-5068851.29254.26
120min151650-5165052.26652.030.5855.8655.640.44
251350-5135051.96255.53
350957-5095751.56455.43
451476-5147652.09055.73
551257-5125751.86855.35
651785-5178552.40255.94
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限152416-5241653.04151.811.4657.2256.011.38
250945-5094551.55255.70
350850-5085051.45655.89
451390-5139052.00256.22
550191-5019150.78954.85
651423-5142352.03656.16
玛巴洛沙韦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)0
对照品批号DQTL-4125-250109对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.77对照品水分(%)0对照品稀释倍数2500
标示量(mg)20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%
111.159848998427986179827898199984020.17
211.029850598654985800.11
单位质量响应值RSD%判断
8825.298945.550.96数据可信
加速6月-供试品溶液-2025051221批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min116170-1617016.34217.5724.4916.3417.5724.50
215876-1587616.04416.04
315670-1567015.83615.84
417596-1759617.78317.78
525625-2562525.89725.90
613387-1338713.52913.53
10min131420-3142031.75331.559.5331.9331.759.62
230921-3092131.24931.43
329241-2924129.55129.73
431740-3174032.07732.27
536408-3640836.79437.08
627611-2761127.90428.05
15min138541-3854138.95038.265.1339.4838.815.26
237000-3700037.39337.92
336515-3651536.90237.41
437527-3752737.92538.48
541439-4143941.87942.58
636156-3615636.54037.00
20min142278-4227842.72742.302.9043.6943.273.06
241664-4166442.10643.05
340573-4057341.00441.92
442278-4227842.72743.70
543766-4376644.23045.39
640560-4056040.99041.86
30min146225-4622546.71645.563.2248.1647.003.24
245402-4540245.88447.29
346016-4601646.50447.87
443178-4317843.63645.09
546315-4631546.80648.46
643326-4332643.78645.11
45min148347-4834748.86048.641.0650.8250.591.11
247471-4747147.97549.89
347498-4749848.00249.89
448585-4858549.10151.04
548445-4844548.95951.13
648442-4844248.95650.76
60min149805-4980550.33450.110.4152.8452.600.56
249346-4934649.87052.32
349389-4938949.91352.33
449749-4974950.27752.76
549727-4972750.25552.97
649497-4949750.02252.37
90min151375-5137551.92050.831.5854.9853.881.47
249698-4969850.22553.23
350758-5075851.29754.27
449198-4919849.72052.76
550079-5007950.61053.89
650693-5069351.23154.14
120min151619-5161952.16752.000.5555.8155.600.43
251498-5149852.04455.61
351101-5110151.64355.19
451492-5149252.03855.63
551152-5115251.69555.53
651833-5183352.38355.86
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限152102-5210252.65551.661.0556.8755.840.99
250851-5085151.39155.53
350671-5067151.20955.33
450832-5083251.37155.54
550878-5087851.41855.83
651355-5135551.90055.96
玛巴洛沙韦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)0
对照品批号DQTL-4125-250109对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.77对照品水分(%)0对照品稀释倍数2500
标示量(mg)20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%
111.159824398239981249814398151981800.06
211.029833798292983140.04
单位质量响应值RSD%判断
8805.388921.420.93数据可信
加速6月-供试品溶液-2025051321批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min125390-2539025.72318.6819.4025.7218.6819.41
216488-1648816.70416.70
317618-1761817.84917.85
416573-1657316.79016.79
515699-1569915.90515.90
618876-1887619.12419.12
10min136095-3609536.56931.958.6036.8532.168.66
231950-3195032.36932.55
330009-3000930.40330.60
429221-2922129.60429.79
529045-2904529.42629.60
632920-3292033.35233.56
15min139978-3997840.50338.373.1241.1938.943.24
238019-3801938.51839.06
337110-3711037.59738.13
437003-3700337.48838.00
536878-3687837.36237.87
638277-3827738.77939.36
20min143223-4322343.79042.223.0544.9343.213.11
241782-4178242.33043.30
342898-4289843.46144.41
440519-4051941.05141.98
540004-4000440.52941.45
641642-4164242.18843.20
30min144203-4420344.78345.322.0346.4146.782.01
245353-4535345.94847.39
344811-4481145.39946.84
444467-4446745.05046.44
543489-4348944.06045.43
646087-4608746.69248.17
45min147590-4759048.21448.260.8050.3450.220.77
247342-4734247.96349.92
348117-4811748.74850.69
448088-4808848.71950.61
547250-4725047.87049.73
647441-4744148.06350.06
60min149560-4956050.21050.050.8352.8752.540.87
249665-4966550.31752.80
349535-4953550.18552.67
449758-4975850.41152.84
548652-4865249.29051.68
649232-4923249.87852.41
90min148123-4812348.75450.231.8051.9753.291.57
248970-4897049.61252.66
350067-5006750.72453.76
450613-5061351.27754.27
549793-4979350.44653.38
649937-4993750.59253.68
120min151006-5100651.67551.360.8555.4454.970.82
250332-5033250.99254.59
351194-5119451.86655.47
450863-5086351.53055.09
550712-5071251.37754.88
650053-5005350.71054.36
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限150696-5069651.36151.470.6555.7055.660.54
250697-5069751.36255.53
350881-5088151.54955.73
450454-5045451.11655.25
551415-5141552.09056.16
650700-5070051.36555.58
玛巴洛沙韦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)0
对照品批号DQTL-4125-250109对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.77对照品水分(%)0对照品稀释倍数2500
标示量(mg)20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%
111.159844198691988509868598706986750.15
211.029860398853987280.18
单位质量响应值RSD%判断
8849.788958.980.87数据可信
加速6月-供试品溶液-2025051321批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min117716-1771617.86618.5120.7717.8718.5220.78
218720-1872018.87818.88
325758-2575825.97625.98
416450-1645016.58916.59
515477-1547715.60815.61
616027-1602716.16216.16
10min130250-3025030.50631.708.2130.7031.908.28
232613-3261332.88933.10
335930-3593036.23436.52
429252-2925229.49929.68
529088-2908829.33429.51
631444-3144431.71031.89
15min137216-3721637.53138.032.7838.0738.592.90
237885-3788538.20538.78
339323-3932339.65540.35
436929-3692937.24137.75
536493-3649336.80137.30
638427-3842738.75239.28
20min141900-4190042.25441.872.6643.2142.852.77
241816-4181642.16943.17
343216-4321643.58144.71
440578-4057840.92141.85
540085-4008540.42441.33
641511-4151141.86242.82
30min144811-4481145.19044.981.2246.6146.431.21
245474-4547445.85847.33
344195-4419544.56946.18
444596-4459644.97346.35
543898-4389844.26945.63
644667-4466745.04546.47
45min147602-4760248.00448.011.2049.9349.951.27
247454-4745447.85549.83
348442-4844248.85150.96
448040-4804048.44650.33
547250-4725047.64949.50
646841-4684147.23749.17
60min148459-4845948.86949.611.3651.3352.101.36
249205-4920549.62152.13
349494-4949449.91252.57
449786-4978650.20752.63
548341-4834148.75051.13
649907-4990750.32952.78
90min150806-5080651.23550.172.0554.2453.201.81
249953-4995350.37553.44
348250-4825048.65851.87
450750-5075051.17954.16
549842-4984250.26353.18
648888-4888849.30152.31
120min150950-5095051.38151.050.9154.9554.640.98
250448-5044850.87454.49
351345-5134551.77955.53
450545-5054550.97254.52
550417-5041750.84354.32
650040-5004050.46354.02
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限150862-5086251.29251.020.7255.4355.170.81
250418-5041850.84455.03
351204-5120451.63755.96
450298-5029850.72354.83
550438-5043850.86454.91
650334-5033450.75954.88
玛巴洛沙韦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)0
对照品批号DQTL-4125-250109对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.77对照品水分(%)0对照品稀释倍数2500
标示量(mg)20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%
111.159731797393970709717997496972910.18
211.029753197281974060.19
单位质量响应值RSD%判断
8725.658839.020.92数据可信
加速6月-供试品溶液-2025051421批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min118671-1867119.09118.6511.4519.0918.6511.45
216337-1633716.70416.70
315748-1574816.10216.10
419292-1929219.72519.73
521490-2149021.97321.97
617927-1792718.33018.33
10min131202-3120231.90331.135.6832.1231.345.70
228050-2805028.68028.87
328516-2851629.15729.34
431657-3165732.36832.59
532181-3218132.90433.15
631072-3107231.77031.97
15min137951-3795138.80437.573.2539.3738.123.31
235649-3564936.45036.95
335203-3520335.99436.50
437235-3723538.07238.65
538058-3805838.91339.52
636383-3638337.20137.76
20min141345-4134542.27441.783.0043.2742.763.01
239280-3928040.16341.07
339887-3988740.78341.69
440561-4056141.47242.47
541426-4142642.35743.40
642700-4270043.65944.63
30min144522-4452245.52245.942.1046.9947.372.13
244243-4424345.23746.59
343745-4374544.72846.08
445542-4554246.56548.03
545188-4518846.20347.72
646326-4632647.36748.82
45min146966-4696648.02148.450.5749.9950.400.50
247402-4740248.46750.33
347676-4767648.74750.60
447570-4757048.63950.62
547191-4719148.25150.28
647528-4752848.59650.58
60min147825-4782548.90049.811.2651.4152.301.21
248391-4839149.47851.88
349155-4915550.26052.65
449432-4943250.54353.06
549111-4911150.21552.78
648384-4838449.47151.99
90min148043-4804349.12350.331.4752.1753.361.40
249416-4941650.52653.47
349096-4909650.19953.15
450148-5014851.27554.36
548934-4893450.03453.15
649685-4968550.80153.87
120min149239-4923950.34551.151.3153.9454.751.22
250599-5059951.73655.24
349770-4977050.88854.40
449560-4956050.67454.33
550022-5002251.14654.82
650980-5098052.12655.76
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限149683-4968350.79951.541.0454.9555.701.05
250340-5034051.47155.55
350016-5001651.14055.22
450771-5077151.91256.13
551137-5113752.28656.53
650477-5047751.61155.83
玛巴洛沙韦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)0
对照品批号DQTL-4125-250109对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.77对照品水分(%)0对照品稀释倍数2500
标示量(mg)20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%
111.159688397020973009718797592971960.29
211.029745697066972610.29
单位质量响应值RSD%判断
8717.138825.860.88数据可信
加速6月-供试品溶液-2025051421批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min115345-1534515.70918.4011.3115.7118.4011.31
220241-2024120.72120.72
315694-1569416.06616.07
418183-1818318.61418.61
518704-1870419.14819.15
619650-1965020.11620.12
10min128037-2803728.70230.985.5528.8831.195.59
231650-3165032.40132.63
328224-2822428.89429.07
431318-3131832.06132.27
530845-3084531.57731.79
631527-3152732.27532.50
15min135720-3572036.56837.822.6137.0638.372.67
237976-3797638.87739.47
335993-3599336.84737.35
436649-3664937.51938.08
537820-3782038.71739.28
637498-3749838.38838.97
20min140598-4059841.56141.582.4242.4642.552.39
240046-4004640.99642.02
339337-3933740.27041.18
442290-4229043.29444.27
540678-4067841.64342.64
640762-4076241.72942.74
30min141706-4170642.69645.563.6244.0646.993.59
244673-4467345.73347.21
344286-4428645.33746.69
446391-4639147.49248.95
544256-4425645.30646.76
645690-4569046.77448.25
45min147062-4706248.17948.100.6250.0150.040.61
247338-4733848.46150.45
346903-4690348.01649.88
447103-4710348.22150.21
547052-4705248.16950.13
646479-4647947.58249.57
60min146669-4666947.77648.231.5150.1550.701.54
247445-4744548.57151.10
346125-4612547.22049.61
447821-4782148.95651.48
547885-4788549.02151.52
646729-4672947.83850.36
90min149800-4980050.98250.903.5753.8853.913.38
248886-4888650.04653.11
349613-4961350.79053.71
449392-4939250.56453.63
547650-4765048.78151.82
652983-5298354.24057.29
120min149215-4921550.38349.687.1653.8553.256.78
249893-4989351.07754.70
341572-4157242.55946.04
449320-4932050.49054.12
550102-5010251.29154.87
651067-5106752.27955.93
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限149414-4941450.58751.621.2854.6255.751.35
250872-5087252.07956.27
349873-4987351.05655.01
450656-5065651.85856.05
551097-5109752.31056.46
650632-5063251.83456.07
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