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%
110.959762797894978099790497833978130.12
211.009761097678976440.05
单位质量响应值RSD%判断
8932.698876.730.45数据可信
供试品溶液-2025051221批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min119468-1946819.63117.8113.3319.6317.8113.34
218645-1864518.80118.80
314285-1428514.40514.40
418756-1875618.91318.91
515096-1509615.22315.22
619738-1973819.90419.90
10min130858-3085831.11731.415.9731.3331.606.01
232391-3239132.66332.87
328449-2844928.68828.85
432704-3270432.97833.19
529517-2951729.76529.93
632955-3295533.23133.45
15min136012-3601236.31436.603.2536.8837.143.31
236560-3656036.86737.44
334355-3435534.64335.12
437005-3700537.31537.89
535969-3596936.27136.77
637843-3784338.16038.75
20min138820-3882039.14639.792.7240.1140.742.79
240086-4008640.42241.40
337990-3799038.30939.17
440398-4039840.73741.73
538800-3880039.12540.03
640662-4066241.00342.02
30min141645-4164541.99442.961.2443.4044.361.23
243071-4307143.43244.86
342824-4282443.18344.47
442953-4295343.31344.76
542391-4239142.74744.08
642754-4275443.11344.58
45min144172-4417244.54245.150.8746.4147.020.92
245285-4528545.66547.58
344512-4451244.88546.65
444863-4486345.23947.16
544856-4485645.23247.04
644977-4497745.35447.30
60min144226-4422644.59745.681.4346.9648.061.40
246091-4609146.47848.90
345576-4557645.95848.23
445080-4508045.45847.89
545138-4513845.51747.83
645702-4570246.08548.54
90min145702-4570246.08547.151.3548.9450.041.32
246386-4638646.77549.71
346920-4692047.31350.09
447437-4743747.83550.77
546897-4689747.29050.11
647228-4722847.62450.59
120min145900-4590046.28546.791.3449.6650.201.24
246019-4601946.40549.86
346136-4613646.52349.83
447155-4715547.55051.01
547242-4724247.63850.98
645978-4597846.36449.86
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146983-4698347.37747.121.1951.2651.051.12
246399-4639946.78850.76
346849-4684947.24251.06
446122-4612246.50950.50
546383-4638346.77250.65
647661-4766148.06152.07
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%
110.959814897710978319800097975979330.18
211.009814898483983160.25
单位质量响应值RSD%判断
8943.658937.820.05数据可信
供试品溶液-2025051321批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min117269-1726917.34320.499.7717.3420.499.78
219468-1946819.55219.55
320578-2057820.66720.67
420205-2020520.29220.29
523071-2307123.17123.17
621806-2180621.90021.90
10min130922-3092231.05532.713.7031.2532.943.74
231398-3139831.53331.75
333177-3317733.32033.55
432538-3253832.67832.90
534037-3403734.18434.44
633371-3337133.51533.76
15min135908-3590836.06337.263.0836.6037.863.11
236054-3605436.21036.78
338108-3810838.27238.87
436307-3630736.46437.05
537746-3774637.90938.55
638497-3849738.66339.28
20min138524-3852438.69040.002.1639.6341.012.21
239034-3903439.20240.17
340040-4004040.21341.24
440306-4030640.48041.47
540337-4033740.51141.57
640735-4073540.91141.96
30min141589-4158941.76842.561.6443.1444.011.68
242124-4212442.30643.71
343053-4305343.23944.71
441991-4199142.17243.62
542100-4210042.28243.79
643398-4339843.58545.09
45min144511-4451144.70344.721.7746.5446.651.62
245518-4551845.71447.59
344794-4479444.98746.94
445034-4503445.22847.14
543285-4328543.47245.45
644044-4404444.23446.22
60min145487-4548745.68345.790.9348.0148.210.92
245383-4538345.57947.96
345744-4574445.94148.39
445663-4566345.86048.27
545027-4502745.22147.68
646283-4628346.48348.96
90min145950-4595046.14846.240.8348.9849.170.78
246253-4625346.45349.34
346545-4654546.74649.71
446160-4616046.35949.28
545410-4541045.60648.57
645952-4595246.15049.14
120min146411-4641146.61147.070.9149.9650.520.94
246685-4668546.88650.29
347392-4739247.59651.08
446605-4660546.80650.25
546734-4673446.93650.41
647405-4740547.60951.11
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145856-4585646.05446.651.0349.9250.610.97
246752-4675246.95450.88
346009-4600946.20750.22
447149-4714947.35251.31
546500-4650046.70150.69
646407-4640746.60750.64
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%
110.959816898321980349849198204982440.18
211.009867198482985760.14
单位质量响应值RSD%判断
8972.058961.450.09数据可信
供试品溶液-2025051421批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min126023-2602326.05921.6116.2826.0621.6116.29
226040-2604026.07626.08
318873-1887318.89918.90
420292-2029220.32020.32
518392-1839218.41818.42
619865-1986519.89319.89
10min135625-3562535.67533.604.8635.9633.844.93
235442-3544235.49235.78
331874-3187431.91932.13
432495-3249532.54032.77
532340-3234032.38532.59
633519-3351933.56633.79
15min138265-3826538.31937.821.4739.0038.431.57
238416-3841638.47039.15
336851-3685136.90337.47
437646-3764637.69938.29
537759-3775937.81238.38
637642-3764237.69538.29
20min139924-3992439.98040.521.5941.0941.551.63
241627-4162741.68542.80
339950-3995040.00640.98
440199-4019940.25541.26
540335-4033540.39141.38
640724-4072440.78141.79
30min142547-4254742.60743.141.0344.1644.621.04
243597-4359743.65845.23
342575-4257542.63544.05
443491-4349143.55245.01
543162-4316243.22244.66
643098-4309843.15844.62
45min143785-4378543.84644.591.1545.8846.561.05
244476-4447644.53846.60
344156-4415644.21846.11
444971-4497145.03446.97
545163-4516345.22647.14
644623-4462344.68546.63
60min144395-4439544.45745.171.2646.9747.631.12
244977-4497745.04047.59
345108-4510845.17147.56
445197-4519745.26047.70
546104-4610446.16948.58
644856-4485644.91947.36
90min145917-4591745.98145.960.7548.9948.920.70
245850-4585045.91448.97
345968-4596846.03248.92
445281-4528145.34448.29
546304-4630446.36949.30
646079-4607946.14349.08
120min145000-4500045.06346.531.6648.5850.001.50
246776-4677646.84150.41
346802-4680246.86750.27
446948-4694847.01450.46
547012-4701247.07850.52
646240-4624046.30549.76
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145954-4595446.01846.521.3550.0450.501.15
245614-4561445.67849.76
347127-4712747.19351.11
446440-4644046.50550.47
547191-4719147.25751.22
646375-4637546.44050.41
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