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%
111.169832098209982509787697864981040.23
211.179814498381982620.18
单位质量响应值RSD%判断
8790.688796.960.06数据可信
供试品溶液-01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%
5min13586-35863.6625.8153.603.665.8153.60
211208-1120811.44411.44
34596-45964.6934.69
47033-70337.1817.18
54823-48234.9254.92
62887-28872.9482.95
10min119478-1947819.88924.7213.3519.9324.7813.44
228529-2852929.13129.26
326192-2619226.74426.80
425176-2517625.70725.79
524175-2417524.68524.74
621697-2169722.15522.19
15min131862-3186232.53436.147.2232.8036.487.31
239288-3928840.11740.57
336495-3649537.26537.61
434149-3414934.86935.23
536334-3633437.10037.43
634240-3424034.96235.24
20min140929-4092941.79242.353.0342.4243.093.15
243726-4372644.64845.54
341823-4182342.70543.47
440263-4026341.11241.87
541586-4158642.46343.20
640526-4052641.38142.05
30min147089-4708948.08248.182.6449.1749.392.75
248903-4890349.93451.33
347425-4742548.42549.66
446996-4699647.98749.20
547636-4763648.64149.85
645066-4506646.01747.14
45min148269-4826949.28749.661.9350.9151.412.02
250344-5034451.40653.35
347842-4784248.85150.63
448963-4896349.99651.74
547888-4788848.89850.65
648518-4851849.54151.18
60min150747-5074751.81752.350.7453.9954.650.80
251204-5120452.28454.80
351876-5187652.97055.29
451063-5106352.14054.44
551443-5144352.52854.82
651279-5127952.36154.55
90min150532-5053251.59852.631.8754.3455.511.92
252227-5222753.32956.43
351079-5107952.15655.06
452986-5298654.10456.98
551758-5175852.85055.73
650657-5065751.72554.50
极限152456-5245653.56253.640.7856.8857.110.66
251823-5182352.91656.61
352935-5293554.05257.54
452819-5281953.93357.41
552774-5277453.88757.35
652407-5240753.51256.86
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%
111.169826798646983139835398350983860.16
211.179859398156983740.32
单位质量响应值RSD%判断
8815.958806.980.08数据可信
供试品溶液-01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%
5min118057-1805718.40115.0716.6718.4015.0616.67
214174-1417414.44414.44
311647-1164711.86911.87
414024-1402414.29114.29
513389-1338913.64413.64
617410-1741017.74217.74
10min133392-3339234.02831.067.8134.2331.227.85
229619-2961930.18330.34
328968-2896829.52029.65
429321-2932129.87930.04
528013-2801328.54728.70
633535-3353534.17434.37
15min136295-3629536.98638.092.9737.5738.602.98
236913-3691337.61638.11
336352-3635237.04437.50
437673-3767338.39138.88
537788-3778838.50838.98
639236-3923639.98340.56
20min140975-4097541.75542.962.8342.7543.902.84
241864-4186442.66143.58
341797-4179742.59343.46
442651-4265143.46344.38
541352-4135242.14043.04
644304-4430445.14846.17
30min148520-4852049.44448.022.0150.9049.432.02
247777-4777748.68750.07
346051-4605146.92848.27
447252-4725248.15249.55
546179-4617947.05948.42
646944-4694447.83849.36
45min150070-5007051.02451.330.8753.0353.270.92
250788-5078851.75553.68
349925-4992550.87652.74
450442-5044251.40353.34
550020-5002050.97352.86
650962-5096251.93353.99
60min150544-5054451.50751.621.1954.0854.131.09
251611-5161152.59455.10
350333-5033351.29253.72
450855-5085551.82454.33
550772-5077251.73954.19
649799-4979950.74853.38
90min151240-5124052.21652.181.2955.3655.261.18
250159-5015951.11454.20
351519-5151952.50055.50
452068-5206853.06056.14
551431-5143152.41155.44
650788-5078851.75554.95
极限151553-5155352.53552.141.6956.2655.811.55
250721-5072151.68755.34
352121-5212153.11456.70
452070-5207053.06256.73
550210-5021051.16654.78
650320-5032051.27855.05
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%
111.169810698362981809801898123981580.14
211.179838298202982920.13
单位质量响应值RSD%判断
8795.528799.640.04数据可信
供试品溶液-01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%
5min110499-1049910.71615.7333.8710.7215.7333.86
211385-1138511.62011.62
310198-1019810.40910.41
419110-1911019.50519.50
521065-2106521.50021.50
620208-2020820.62520.63
10min126670-2667027.22131.4013.8427.3431.5713.94
225790-2579026.32326.45
328540-2854029.13029.25
434288-3428834.99635.21
535536-3553636.27036.51
633749-3374934.44634.68
15min136018-3601836.76238.417.8637.1838.948.01
234019-3401934.72235.14
335377-3537736.10836.55
441148-4114841.99842.60
540787-4078741.62942.27
638468-3846839.26339.87
20min141411-4141142.26642.383.0143.1043.343.22
240522-4052241.35942.17
339619-3961940.43741.28
442753-4275343.63644.71
542407-4240743.28344.39
642452-4245243.32944.38
30min145690-4569046.63446.503.5347.9347.923.63
242426-4242643.30244.57
346105-4610547.05748.35
446933-4693347.90249.46
546465-4646547.42549.01
645749-4574946.69448.22
45min150148-5014851.18449.873.8253.0051.813.65
249583-4958350.60752.36
347891-4789148.88050.69
450173-5017351.20953.30
549890-4989050.92153.03
645479-4547946.41848.47
60min148541-4854149.54450.762.1451.9353.252.17
248525-4852549.52751.84
351059-5105952.11454.47
449663-4966350.68953.35
550708-5070851.75554.43
649876-4987650.90653.47
90min152211-5221153.28952.261.3656.2355.321.18
250809-5080951.85854.72
351376-5137652.43755.37
450672-5067251.71954.94
550406-5040651.44754.70
651752-5175252.82155.95
极限150866-5086651.91752.301.3155.4555.941.51
250393-5039351.43454.87
350770-5077051.81955.34
451528-5152852.59256.39
552153-5215353.23057.06
651748-5174852.81756.53
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