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)10
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%
111.049709096849969679710097015970040.11
211.049660196639966200.03
单位质量响应值RSD%判断
8786.598751.810.29数据可信
供试品溶液-2025051521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%
5min120452-2045220.94228.3514.1420.9428.3514.14
228209-2820928.88528.88
330913-3091331.65431.65
427898-2789828.56728.57
527329-2732927.98427.98
631342-3134232.09332.09
10min142031-4203143.03847.185.7443.2747.495.78
248147-4814749.30149.62
346054-4605447.15847.51
445169-4516946.25146.57
545369-4536946.45646.77
649673-4967350.86351.22
15min151953-5195353.19856.183.1953.9157.023.25
256331-5633157.68158.55
353991-5399155.28556.16
455478-5547856.80757.64
554727-5472756.03856.87
656731-5673158.09059.01
20min157831-5783159.21761.692.4760.5263.162.55
261695-6169563.17364.68
359790-5979061.22362.71
460451-6045161.90063.36
559834-5983461.26862.72
661891-6189163.37464.94
30min166388-6638867.97969.151.1569.9471.301.24
268065-6806569.69671.91
366800-6680068.40170.57
467577-6757769.19671.35
568037-6803769.66771.80
668307-6830769.94472.22
45min171626-7162673.34274.181.1876.0677.101.20
273728-7372875.49578.48
371699-7169973.41776.35
473218-7321874.97277.89
572174-7217473.90376.81
672214-7221473.94476.99
60min171740-7174073.45976.163.2476.9979.903.19
273754-7375475.52179.35
372665-7266574.40678.15
473580-7358075.34379.10
576475-7647578.30882.03
678073-7807379.94483.81
90min178949-7894980.84180.411.5385.1985.001.49
277947-7794779.81584.48
378428-7842880.30784.88
478394-7839480.27384.86
576934-7693478.77883.37
680544-8054482.47487.23
120min181579-8157983.53482.411.1388.7887.890.98
278947-7894780.83986.39
380205-8020582.12787.59
480406-8040682.33387.81
581163-8116383.10888.58
680564-8056482.49588.17
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180202-8020282.12469.5149.0288.3075.9144.77
281234-8123483.18189.63
383607-8360785.61091.99
481430-8143083.38189.78
580818-8081882.75589.15
6-0.0006.59
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)10
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%
111.049722697358970909724597186972210.10
211.049838398348983660.03
单位质量响应值RSD%判断
8806.258909.960.83数据可信
供试品溶液-2025051621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%
5min131378-3137831.80829.0712.5831.8129.0712.58
221717-2171722.01522.01
329010-2901029.40829.41
428436-2843628.82628.83
530256-3025630.67130.67
631245-3124531.67431.67
10min148848-4884849.51847.857.6549.8748.177.68
240255-4025540.80741.05
347031-4703147.67648.00
447758-4775848.41348.73
548708-4870849.37649.72
650599-5059951.29351.64
15min157184-5718457.96856.664.9658.8757.515.02
250501-5050151.19451.89
355474-5547456.23557.09
457036-5703657.81858.68
557099-5709957.88258.77
658049-5804958.84559.77
20min161242-6124262.08261.993.6763.6363.483.75
256992-5699257.77459.04
361938-6193862.78864.27
461360-6136062.20263.70
561598-6159862.44363.98
663789-6378964.66466.24
30min167616-6761668.54368.661.6970.7870.831.81
265785-6578566.68768.60
367760-6776068.68970.87
467810-6781068.74070.93
568088-6808869.02271.25
669324-6932470.27572.57
45min173829-7382974.84274.871.3077.8477.811.37
272876-7287673.87676.53
373455-7345574.46377.40
475024-7502476.05379.01
572986-7298673.98776.98
674998-7499876.02779.10
60min175626-7562676.66377.321.0480.4981.091.12
275413-7541376.44779.92
376633-7663377.68481.45
476579-7657977.62981.43
575871-7587176.91280.73
677522-7752278.58582.51
90min178818-7881879.89980.631.0184.5885.261.11
278368-7836879.44383.76
379823-7982380.91885.55
480049-8004981.14785.81
579675-7967580.76885.44
680524-8052481.62886.42
120min180517-8051781.62182.130.9087.1987.651.02
279826-7982680.92186.12
381148-8114882.26187.79
481428-8142882.54588.11
581325-8132582.44088.01
681848-8184882.97188.67
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181115-8111582.22882.230.9288.7088.660.98
280676-8067681.78387.88
380876-8087681.98588.43
481240-8124082.35488.84
580303-8030381.40487.89
682475-8247583.60690.23
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)10
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%
111.049657196469964489674596662965790.14
211.049693897116970270.13
单位质量响应值RSD%判断
8748.108788.680.33数据可信
供试品溶液-2025051622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%
5min128448-2844829.13227.5916.1529.1327.5916.15
228268-2826828.94828.95
329050-2905029.74929.75
432225-3222533.00033.00
523552-2355224.11924.12
620109-2010920.59320.59
10min147851-4785149.00246.536.6949.3346.846.75
246094-4609447.20347.52
346706-4670647.83048.16
448263-4826349.42449.79
543414-4341444.45944.73
640318-4031841.28841.52
15min155535-5553556.87156.053.7057.7456.883.78
255672-5567257.01157.86
354638-5463855.95356.81
457543-5754358.92759.84
553263-5326354.54455.31
651756-5175653.00153.69
20min161210-6121062.68361.022.7664.1862.472.85
260532-6053261.98863.47
359449-5944960.87962.36
460717-6071762.17863.75
558897-5889760.31461.68
656725-5672558.09059.37
30min166849-6684968.45768.681.0370.6570.801.14
267323-6732368.94371.11
367588-6758869.21471.37
467598-6759869.22471.49
567239-6723968.85770.89
665779-6577967.36269.28
45min172198-7219873.93574.801.5776.8977.691.61
272821-7282174.57377.51
372623-7262374.37077.30
475284-7528477.09580.13
573073-7307374.83177.63
672264-7226474.00376.67
60min175501-7550177.31778.401.3681.1082.121.31
276595-7659578.43882.20
375296-7529677.10880.86
477754-7775479.62583.51
577662-7766279.53083.17
676560-7656078.40281.89
90min178891-7889180.78981.641.0385.4386.230.91
279838-7983881.75986.39
379028-7902880.92985.54
479415-7941581.32686.10
581117-8111783.06987.59
680045-8004581.97186.33
120min180518-8051882.45583.410.6787.9988.900.66
281223-8122383.17788.72
381678-8167883.64389.15
482092-8209284.06789.74
581698-8169883.66489.10
681496-8149683.45788.73
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180134-8013482.06284.622.3888.5191.042.25
284749-8474986.78893.26
380570-8057082.50888.95
483915-8391585.93492.54
584206-8420686.23292.60
682198-8219884.17690.38
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