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)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%
111.169760097926976459787497826977740.15
211.179751297385974480.10
单位质量响应值RSD%判断
8761.118724.080.30数据可信
供试品溶液-01批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19990-999010.2618.6523.6510.268.6523.65
25769-57695.9255.93
310511-1051110.79610.80
49891-989110.15910.16
57819-78198.0318.03
66565-65656.7436.74
10min130031-3003130.84428.939.5930.9629.029.62
224260-2426024.91724.98
329636-2963630.43930.56
431304-3130432.15232.26
525789-2578926.48726.58
627973-2797328.73028.81
15min139130-3913040.19039.244.3440.6539.664.41
235865-3586536.83637.18
339699-3969940.77441.23
439529-3952940.59941.07
536406-3640637.39237.78
638580-3858039.62540.02
20min143636-4363644.81844.272.7745.7245.132.84
242511-4251143.66244.41
344443-4444345.64646.56
443893-4389345.08246.00
541095-4109542.20843.01
643064-4306444.23045.06
30min146304-4630447.55847.872.2048.9649.222.20
247519-4751948.80650.04
347199-4719948.47749.90
447256-4725648.53649.96
544721-4472145.93247.20
646642-4664247.90549.23
45min148670-4867049.98849.691.2051.9251.571.24
248778-4877850.09951.88
348303-4830349.61151.57
449024-4902450.35252.31
547435-4743548.72050.50
648060-4806049.36151.22
60min148560-4856049.87551.451.7452.3653.881.68
250573-5057351.94254.28
350416-5041651.78154.29
451062-5106252.44554.97
549716-4971651.06253.38
650221-5022151.58153.99
90min150703-5070352.07651.920.8655.1254.930.88
250458-5045851.82454.74
350095-5009551.45254.54
451320-5132052.71055.81
550509-5050951.87754.76
650245-5024551.60654.59
极限151884-5188453.28952.831.0656.9156.401.10
251267-5126752.65556.14
352272-5227253.68757.34
451270-5127052.65856.35
550797-5079752.17355.64
651113-5111352.49756.05
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)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%
111.169816297907983119806497996980880.16
211.179773697588976620.11
单位质量响应值RSD%判断
8789.258743.240.38数据可信
供试品溶液-01批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110768-1076811.03014.1019.8611.0314.1119.85
214163-1416314.50714.51
313439-1343913.76613.77
418289-1828918.73418.73
514776-1477615.13515.14
611186-1118611.45811.46
10min127225-2722527.88729.159.1328.0129.319.13
232535-3253533.32633.49
328938-2893829.64229.79
430133-3013330.86631.07
526094-2609426.72826.90
625826-2582626.45426.58
15min136843-3684337.73938.174.2438.1738.654.25
236583-3658337.47238.00
338885-3888539.83040.31
439222-3922240.17640.73
534954-3495435.80436.27
637107-3710738.00938.43
20min143044-4304444.09042.343.5144.9443.243.42
240597-4059741.58442.53
343223-4322344.27445.20
440628-4062841.61642.61
539702-3970240.66741.53
640804-4080441.79642.64
30min147045-4704548.18947.752.2549.5349.132.26
247837-4783749.00050.41
347232-4723248.38049.80
446475-4647547.60549.06
546338-4633847.46548.78
644792-4479245.88147.19
45min149411-4941150.61248.357.2452.4950.256.93
248264-4826449.43751.39
340337-4033741.31843.27
448867-4886750.05552.04
547601-4760148.75850.60
648708-4870849.89251.71
60min151016-5101652.25651.840.7554.7054.280.78
250923-5092352.16154.66
350804-5080452.03954.45
450540-5054051.76954.31
550322-5032251.54553.93
650050-5005051.26753.64
90min149537-4953750.74150.652.5953.7653.672.42
246976-4697648.11851.20
350220-5022051.44154.43
450594-5059451.82454.94
549784-4978450.99453.95
649578-4957850.78353.73
极限150755-5075551.98951.504.0755.5755.083.79
246236-4623647.36050.98
350717-5071751.95055.51
451755-5175553.01356.71
551651-5165152.90756.43
650553-5055351.78255.29
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)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%
111.169788697492978459776497901977780.18
211.179747197268973700.15
单位质量响应值RSD%判断
8761.478717.100.36数据可信
供试品溶液-01批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min117476-1747617.95614.2528.7617.9614.2528.75
218386-1838618.89118.89
316348-1634816.79716.80
411211-1121111.51911.52
59109-91099.3599.36
610676-1067610.96910.97
10min133001-3300133.90830.589.6934.1130.749.78
231196-3119632.05332.26
332478-3247833.37033.56
428329-2832929.10729.24
525852-2585226.56226.67
627692-2769228.45328.57
15min138159-3815939.20738.262.6639.7838.752.73
238215-3821539.26539.83
336266-3626637.26237.82
437682-3768238.71739.17
535844-3584436.82937.23
637230-3723038.25338.69
20min143542-4354244.73842.805.2445.7543.725.29
244221-4422145.43646.44
340823-4082341.94442.92
442005-4200543.15944.04
538105-3810539.15239.96
641226-4122642.35943.22
30min145777-4577747.03547.161.4648.5448.561.56
246701-4670147.98449.49
346381-4638147.65549.09
446208-4620847.47748.84
545481-4548146.73047.97
644862-4486246.09447.43
45min149891-4989151.26250.231.4553.2952.151.54
249540-4954050.90152.94
348123-4812349.44551.41
448949-4894950.29452.18
548557-4855749.89151.65
648281-4828149.60751.45
60min151328-5132852.73851.561.9455.3454.041.89
250361-5036151.74454.35
348883-4888350.22652.74
450431-5043151.81654.26
550922-5092252.32154.64
649144-4914450.49452.89
90min153156-5315654.61652.002.8857.8055.062.76
248946-4894650.29153.47
349703-4970351.06854.14
450685-5068552.07755.10
550099-5009951.47554.37
651092-5109252.49655.45
极限152203-5220353.63752.741.2857.4356.361.30
251111-5111152.51556.25
350778-5077852.17355.81
452003-5200353.43257.03
551293-5129352.70256.17
650571-5057151.96055.50
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