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%
111.331004431006621005211006611006031005780.10
211.341004561003771004160.06
单位质量响应值RSD%判断
8877.148855.030.18数据可信
供试品溶液-2025051521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%
5min122342-2234222.62723.117.1522.6323.117.16
223213-2321323.50923.51
322426-2242622.71222.71
424565-2456524.87924.88
524300-2430024.61024.61
620078-2007820.33420.33
10min136464-3646436.93035.923.7537.1836.173.76
236005-3600536.46536.73
333895-3389534.32834.58
436227-3622736.69036.97
536543-3654337.01037.28
633644-3364434.07434.30
15min141346-4134641.87441.132.0142.5441.782.03
240852-4085241.37442.04
339480-3948039.98440.62
441538-4153842.06842.75
540564-4056441.08241.77
639861-3986140.37040.97
20min145205-4520545.78243.923.1146.9145.043.10
243434-4343443.98945.11
342279-4227942.81943.90
443690-4369044.24845.40
544182-4418244.74645.89
641437-4143741.96643.02
30min146552-4655247.14747.101.3248.7848.701.34
246698-4669847.29448.91
345491-4549146.07247.63
446517-4651747.11148.75
547393-4739347.99849.64
646380-4638046.97248.49
45min147461-4746148.06748.831.7950.2350.951.71
248263-4826348.87951.02
347861-4786148.47250.54
449649-4964950.28352.45
547355-4735547.96050.13
648685-4868549.30751.35
60min148419-4841949.03750.151.7051.7352.811.65
250049-5004950.68853.37
349657-4965750.29152.90
450797-5079751.44654.17
549144-4914449.77252.48
649013-4901349.63952.23
90min150558-5055851.20451.431.2754.4454.651.10
250363-5036351.00654.25
351760-5176052.42155.58
449928-4992850.56653.86
550921-5092151.57154.83
651139-5113951.79254.93
120min149903-4990350.54051.381.1054.3555.171.01
250398-5039851.04254.86
351518-5151852.17655.92
451095-5109551.74855.61
550701-5070151.34955.18
650748-5074851.39655.11
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151395-5139552.05152.220.6056.4256.580.53
251223-5122351.87756.26
352127-5212752.79357.12
451519-5151952.17756.61
551600-5160052.25956.66
651493-5149352.15156.44
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%
111.331004281002041004311004341002941003580.11
211.341005581006151005860.05
单位质量响应值RSD%判断
8857.728870.020.10数据可信
供试品溶液-2025051621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%
5min122453-2245322.74524.076.5222.7524.076.51
225566-2556625.89925.90
325713-2571326.04826.05
422249-2224922.53922.54
522815-2281523.11223.11
623754-2375424.06324.06
10min135857-3585736.32436.602.3536.5836.862.37
237242-3724237.72738.01
336603-3660337.08037.37
435509-3550935.97136.22
534932-3493235.38735.64
636618-3661837.09537.36
15min141206-4120641.74341.981.9442.4042.651.95
242744-4274443.30144.01
341589-4158942.13142.83
441801-4180142.34543.00
540517-4051741.04541.69
640771-4077141.30241.98
20min144354-4435444.93244.541.1546.0545.681.12
243641-4364144.20945.40
344633-4463345.21446.38
444223-4422344.79945.92
543563-4356344.13045.24
643387-4338743.95245.09
30min147254-4725447.86947.301.6649.4948.941.64
247628-4762848.24849.93
346723-4672347.33149.00
445363-4536345.95447.57
546552-4655247.15848.75
646631-4663147.23848.87
45min147349-4734947.96649.161.8050.1251.321.75
248494-4849449.12651.34
349760-4976050.40852.61
447883-4788348.50750.64
548502-4850249.13451.25
649199-4919949.84051.99
60min150196-5019650.85050.401.2553.5353.111.12
248773-4877349.40852.17
349390-4939050.03352.79
449614-4961450.26052.93
550434-5043451.09153.76
650118-5011850.77153.48
90min149355-4935549.99851.141.3753.2554.401.30
250031-5003150.68353.99
351274-5127451.94255.26
450536-5053651.19454.42
550872-5087251.53554.77
650806-5080651.46854.74
120min151663-5166352.33652.311.0056.1456.150.95
252057-5205752.73556.61
352042-5204252.72056.61
451519-5151952.19055.99
551866-5186652.54156.35
650684-5068451.34455.19
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151617-5161752.28952.521.4356.6856.941.34
252726-5272653.41357.87
351741-5174152.41556.89
451341-5134152.01056.38
552736-5273653.42357.81
650932-5093251.59556.01
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%
111.331009091006331004321003271005691005740.23
211.341010151005841008000.31
单位质量响应值RSD%判断
8876.798888.890.10数据可信
供试品溶液-2025051622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%
5min122130-2213022.37024.009.1622.3724.009.16
220960-2096021.18821.19
326999-2699927.29227.29
424740-2474025.00925.01
524715-2471524.98324.98
622880-2288023.12823.13
10min134727-3472735.10435.142.8135.3535.402.79
233694-3369434.06034.30
333514-3351433.87834.18
435694-3569436.08236.36
535781-3578136.17036.45
635136-3513635.51835.77
15min141631-4163142.08340.463.2742.7241.113.23
238435-3843538.85239.47
338809-3880939.23039.91
441075-4107541.52142.20
540729-4072941.17141.85
639448-3944839.87640.53
20min142628-4262843.09143.191.3644.2044.291.36
242419-4241942.88043.93
341857-4185742.31243.43
443501-4350143.97345.11
543193-4319343.66244.80
642729-4272943.19344.29
30min145466-4546645.96046.421.1547.5448.011.17
245586-4558646.08147.60
345973-4597346.47248.06
446704-4670447.21148.84
546377-4637746.88148.50
645441-4544145.93447.51
45min147427-4742747.94248.812.5350.0450.912.48
247026-4702647.53749.57
348513-4851349.04051.14
447775-4777548.29450.45
550472-5047251.02053.16
648483-4848349.01051.09
60min150525-5052551.07450.620.8453.7053.270.72
250371-5037150.91853.48
350094-5009450.63853.28
449624-4962450.16352.85
549527-4952750.06552.77
650340-5034050.88753.52
90min150653-5065351.20351.922.5854.4055.132.49
249397-4939749.93353.06
353097-5309753.67456.88
451262-5126251.81955.07
552509-5250953.07956.35
651247-5124751.80455.00
120min152288-5228852.85652.231.5056.6256.011.44
251183-5118351.73955.42
350600-5060051.15054.96
451586-5158652.14655.97
552769-5276953.34257.20
651569-5156952.12955.90
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151193-5119351.74952.352.3256.1056.722.11
251681-5168152.24256.50
351328-5132851.88556.26
451537-5153752.09756.50
550825-5082551.37755.83
654163-5416354.75159.10
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