玛巴洛沙韦混悬剂项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)0
对照品批号DQTL-4125-250109对照品来源自制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)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.159841098458983699833298377983890.05
211.119824998211982300.03
单位质量响应值RSD%判断
8824.138841.580.14数据可信
加速6月-供试品溶液-2025062721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%
5min132082-3208232.61432.392.1932.6132.392.19
232671-3267133.21333.21
332581-3258133.12133.12
430939-3093931.45231.45
531529-3152932.05232.05
631363-3136331.88331.88
10min138121-3812138.75338.740.7738.9338.920.77
238361-3836138.99739.18
338129-3812938.76138.95
437893-3789338.52138.70
537678-3767838.30338.48
638461-3846139.09939.28
15min140985-4098541.66541.810.5942.0642.200.59
241542-4154242.23142.63
341017-4101741.69742.10
440858-4085841.53541.92
541109-4110941.79142.18
641242-4124241.92642.32
20min142000-4200042.69642.720.8343.3243.340.83
242323-4232343.02543.66
342350-4235043.05243.68
441762-4176242.45443.07
542218-4221842.91843.54
641474-4147442.16242.79
30min144952-4495245.69744.991.1546.5645.861.12
243694-4369444.41845.29
344459-4445945.19646.07
443982-4398244.71145.57
544657-4465745.39746.26
643810-4381044.53645.40
45min145629-4562946.38646.681.6847.5047.801.64
245505-4550546.25947.38
345855-4585546.61547.74
445712-4571246.47047.57
545376-4537646.12847.24
647457-4745748.24449.35
60min146267-4626747.03447.391.3448.4148.761.30
247572-4757248.36149.74
345761-4576146.52047.90
446834-4683447.61148.97
546371-4637147.14048.51
646874-4687447.65149.03
90min147482-4748248.26948.821.5049.9150.461.46
248566-4856649.37151.02
349232-4923250.04851.69
447823-4782348.61650.24
547537-4753748.32549.96
647528-4752848.31649.96
120min148555-4855549.36048.960.7551.2750.870.74
248484-4848449.28851.21
348350-4835049.15251.07
447754-4775448.54650.44
548106-4810648.90450.80
647739-4773948.53150.44
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148205-4820549.00449.272.1151.1851.452.03
250300-5030051.13453.33
347880-4788048.67450.86
448987-4898749.79951.97
547675-4767548.46550.64
647747-4774748.53950.72
玛巴洛沙韦混悬剂项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)0
对照品批号DQTL-4125-250109对照品来源自制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)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.159801897881979979809597711979400.16
211.119823397864980480.27
单位质量响应值RSD%判断
8783.868825.200.34数据可信
中间条件6月-供试品溶液-2025062621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%
5min133636-3363634.30433.182.3134.3033.172.31
232838-3283833.49033.49
332596-3259633.24333.24
432604-3260433.25133.25
532125-3212532.76332.76
631380-3138032.00332.00
10min139509-3950940.29339.602.2540.4839.782.25
240210-4021041.00841.19
337809-3780938.56038.74
438452-3845239.21539.40
538631-3863139.39839.58
638356-3835639.11839.30
15min142800-4280043.65043.140.9344.0643.550.93
242445-4244543.28843.70
342272-4227243.11143.51
442602-4260243.44843.85
541874-4187442.70543.11
641827-4182742.65843.05
20min144798-4479845.68745.251.3246.3445.891.32
245046-4504645.94046.59
344169-4416945.04645.68
444756-4475645.64546.29
543760-4376044.62945.27
643664-4366444.53145.16
30min147751-4775148.69947.661.6349.6148.561.62
247560-4756048.50449.41
346151-4615147.06747.96
446279-4627947.19848.10
546729-4672947.65748.54
645952-4595246.86447.74
45min148796-4879649.76549.370.9350.9550.530.92
248768-4876849.73650.92
348165-4816549.12150.27
447701-4770148.64849.81
548771-4877149.73950.89
648252-4825249.21050.35
60min149206-4920650.18349.960.5851.6451.400.58
249218-4921850.19551.65
348519-4851949.48250.91
449109-4910950.08451.51
549105-4910550.08051.51
648783-4878349.75251.16
90min150103-5010351.09850.401.0052.8352.110.98
249311-4931150.29052.02
348695-4869549.66251.36
449797-4979750.78652.49
549173-4917350.14951.85
649458-4945850.44052.13
120min149506-4950650.48950.691.2452.5152.681.20
250430-5043051.43153.44
350084-5008451.07853.05
450103-5010351.09853.09
548758-4875849.72651.71
649347-4934750.32752.30
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150342-5034251.34250.861.4453.6453.131.40
250309-5030951.30853.61
350625-5062551.63053.89
449953-4995350.94553.22
549048-4904850.02252.28
648932-4893249.90452.15
玛巴洛沙韦混悬剂项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)0
对照品批号DQTL-4125-250109对照品来源自制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)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.159782698142978989811497763979490.18
211.119762097922977710.22
单位质量响应值RSD%判断
8784.668800.270.13数据可信
中间条件6月-供试品溶液-2025062721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%
5min133576-3357634.28934.601.0434.2934.601.04
234227-3422734.95434.95
333797-3379734.51534.52
434244-3424434.97234.97
533395-3339534.10534.10
634033-3403334.75634.76
10min139497-3949740.33640.431.1640.5340.631.15
239463-3946340.30240.50
340343-4034341.20041.39
439164-3916439.99640.19
539908-3990840.75640.95
639170-3917040.00240.20
15min142418-4241843.31943.810.9643.7344.220.96
243116-4311644.03244.45
343526-4352644.45144.87
442864-4286443.77544.19
542957-4295743.87044.29
642488-4248843.39143.81
20min143883-4388344.81645.390.8745.4746.050.86
244421-4442145.36546.03
344839-4483945.79246.46
444126-4412645.06445.72
544820-4482045.77246.43
644589-4458945.53746.19
30min146212-4621247.19447.341.1348.1048.261.11
247083-4708348.08449.00
346271-4627147.25448.18
446220-4622047.20248.11
546779-4677947.77348.69
645578-4557846.54747.46
45min147385-4738548.39249.190.9449.5650.360.93
248041-4804149.06250.24
348691-4869149.72650.91
448346-4834649.37350.55
548427-4842749.45650.64
648092-4809249.11450.28
60min146096-4609647.07649.082.5848.5150.522.51
247230-4723048.23449.69
348959-4895949.99951.46
448458-4845849.48850.93
549515-4951550.56752.02
648065-4806549.08650.53
90min148860-4886049.89850.410.9351.6052.130.91
250089-5008951.15352.88
349277-4927750.32452.06
449554-4955450.60752.33
549476-4947650.52752.26
648920-4892049.96051.67
120min149873-4987350.93350.861.5852.9152.861.51
250065-5006551.12953.14
349954-4995451.01653.03
450057-5005751.12153.12
548282-4828249.30851.32
650587-5058751.66253.65
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149136-4913650.18050.420.9252.4452.710.89
249954-4995451.01653.31
349483-4948350.53552.84
448753-4875349.78952.08
549794-4979450.85253.14
649129-4912950.17352.45
玛巴洛沙韦混悬剂项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)0
对照品批号DQTL-4125-250109对照品来源自制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)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.159818998118983299810098309982090.11
211.119823398148981900.07
单位质量响应值RSD%判断
8807.988837.980.25数据可信
加速6月-供试品溶液-2025062621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%
5min130929-3092931.47731.481.4331.4831.481.43
231117-3111731.66831.67
330984-3098431.53331.53
431128-3112831.68031.68
530077-3007730.61030.61
631346-3134631.90131.90
10min138189-3818938.86638.660.9339.0438.830.92
237513-3751338.17838.35
338227-3822738.90439.08
437965-3796538.63838.81
538387-3838739.06739.24
637626-3762638.29338.47
15min141208-4120841.93841.790.9242.3342.180.91
240742-4074241.46441.85
341052-4105241.77942.17
441739-4173942.47942.87
540825-4082541.54841.94
640816-4081641.53941.93
20min142627-4262743.38243.591.3744.0144.211.35
243568-4356844.34044.96
341808-4180842.54943.17
443038-4303843.80144.43
542946-4294643.70744.32
643008-4300843.77044.39
30min143747-4374744.52245.291.0145.3946.160.99
244856-4485645.65146.52
344992-4499245.78946.65
444394-4439445.18146.05
544675-4467545.46746.33
644372-4437245.15846.02
45min147101-4710147.93647.400.9749.0548.520.95
246676-4667647.50348.62
346052-4605246.86847.98
446058-4605846.87448.00
547012-4701247.84548.96
646561-4656147.38648.50
60min148281-4828149.13748.640.8850.5150.020.86
247640-4764048.48449.87
347104-4710447.93949.31
448132-4813248.98550.37
547905-4790548.75450.13
647687-4768748.53249.91
90min148179-4817949.03349.221.1150.6850.861.07
247994-4799448.84450.50
347810-4781048.65750.30
448535-4853549.39551.05
548310-4831049.16650.82
649323-4932350.19751.84
120min148485-4848549.34449.501.0551.2751.421.00
248362-4836249.21951.14
348776-4877649.64051.55
447869-4786948.71750.65
549170-4917050.04151.96
649177-4917750.04851.97
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149969-4996950.85449.601.6253.0551.801.55
247494-4749448.33650.53
348786-4878649.65051.84
448584-4858449.44551.64
548847-4884749.71351.91
648736-4873649.60051.80
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