玛巴洛沙韦干混悬剂项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DQTL-4125-250109对照品来源自制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%
111.189854698831982839901398406986160.31
211.239954199860997000.23
单位质量响应值RSD%判断
8820.758878.010.46数据可信
供试品溶液-2025062721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%
5min133199-3319933.68735.494.0433.6935.494.03
235165-3516535.68235.68
335541-3554136.06336.06
436789-3678937.33037.33
533390-3339033.88133.88
635768-3576836.29436.29
10min139411-3941139.99041.181.8040.1841.381.80
240296-4029640.88841.09
340510-4051041.10541.31
441617-4161742.22842.44
540826-4082641.42641.61
640840-4084041.44041.64
15min142524-4252443.14944.061.2643.5644.491.26
243380-4338044.01744.44
343369-4336944.00644.43
443471-4347144.11044.55
543585-4358544.22544.64
644222-4422244.87245.30
20min144446-4444645.09945.320.9745.7545.990.96
245129-4512945.79246.46
345048-4504845.71046.38
444415-4441545.06845.75
544032-4403244.67945.34
644899-4489945.55946.24
30min144822-4482245.48146.191.3346.3847.121.32
244904-4490445.56446.49
345711-4571146.38347.31
446464-4646447.14748.08
545646-4564646.31747.23
645602-4560246.27247.21
45min146160-4616046.83847.931.6347.9949.111.61
247602-4760248.30149.48
348410-4841049.12150.31
447081-4708147.77348.97
547395-4739548.09149.26
646765-4676547.45248.64
60min147580-4758048.27948.670.8549.6950.120.84
247580-4758048.27949.72
348150-4815048.85750.32
448117-4811748.82450.29
548615-4861549.32950.77
647759-4775948.46149.92
90min148692-4869249.40749.791.7351.0951.511.68
250589-5058951.33253.05
349080-4908049.80151.53
448714-4871449.43051.17
548086-4808648.79250.50
649249-4924949.97351.70
120min146907-4690747.59648.962.1649.5550.962.10
247054-4705447.74549.74
348816-4881649.53351.54
448826-4882649.54351.55
549477-4947750.20452.19
648443-4844349.15551.16
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147980-4798048.68549.571.8350.9051.831.76
249109-4910949.83152.09
347900-4790048.60450.88
449295-4929550.01952.31
550254-5025450.99253.25
648561-4856149.27451.55
玛巴洛沙韦干混悬剂项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DQTL-4125-250109对照品来源自制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%
111.189888498581984889838498603985880.19
211.239876198267985140.36
单位质量响应值RSD%判断
8818.258772.400.37数据可信
供试品溶液-2025062821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%
5min133631-3363134.33535.602.2634.3335.602.27
234218-3421834.93434.93
335491-3549136.23436.23
434942-3494235.67335.67
535380-3538036.12036.12
635565-3556536.30936.31
10min139539-3953940.36642.042.6340.5642.242.62
242130-4213043.01243.21
340664-4066441.51541.72
440610-4061041.46041.66
541856-4185642.73242.93
642272-4227243.15743.36
15min143342-4334244.24944.821.2544.6645.251.26
243743-4374344.65845.09
343501-4350144.41144.84
443824-4382444.74145.17
544159-4415945.08345.52
644861-4486145.80046.24
20min144338-4433845.26646.444.4445.9347.124.39
245117-4511746.06146.74
344289-4428945.21645.89
444620-4462045.55446.23
545033-4503345.97546.66
649545-4954550.58251.28
30min145855-4585546.81547.551.9847.7348.481.98
246599-4659947.57448.51
346169-4616947.13548.06
446247-4624747.21548.14
546172-4617247.13848.08
648385-4838549.39750.37
45min145987-4598746.94948.832.5348.1250.042.52
247745-4774548.74449.95
347937-4793748.94050.13
447566-4756648.56149.75
547990-4799048.99450.20
649768-4976850.80952.06
60min146414-4641447.38548.963.3248.8250.443.28
247468-4746848.46149.93
347053-4705348.03849.50
448817-4881749.83851.30
547234-4723448.22249.70
650771-5077151.83353.37
90min146548-4654847.52249.162.8349.2250.912.81
247497-4749748.49150.23
348215-4821549.22450.95
448027-4802749.03250.77
548005-4800549.00950.76
650643-5064351.70353.52
120min147948-4794848.95149.622.7750.9151.642.75
247348-4734848.33950.35
348910-4891049.93351.94
448720-4872049.73951.75
547620-4762048.61650.63
651049-5104952.11754.23
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147723-4772348.72250.634.1350.9552.924.05
248883-4888349.90652.19
348909-4890949.93252.21
449165-4916550.19452.48
549257-4925750.28852.58
653614-5361454.73657.13
玛巴洛沙韦干混悬剂项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DQTL-4125-250109对照品来源自制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%
111.189967099202997059978099672996060.24
211.239913198459987950.49
单位质量响应值RSD%判断
8909.308797.420.90数据可信
供试品溶液-2025062821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%
5min133885-3388534.36834.901.2534.3734.901.25
234510-3451035.00235.00
334092-3409234.57834.58
434836-3483635.33335.33
534184-3418434.67234.67
634958-3495835.45735.46
10min140883-4088341.46641.081.3441.6641.281.34
240432-4043241.00941.20
340481-4048141.05841.25
440684-4068441.26441.46
539504-3950440.06840.26
641039-4103941.62441.82
15min143901-4390144.52743.861.1944.9544.281.18
243697-4369744.32044.74
342526-4252643.13343.55
443166-4316643.78244.21
543311-4331143.92944.34
642847-4284743.45843.89
20min144017-4401744.64545.170.8345.3145.840.83
244556-4455645.19245.86
344374-4437445.00745.67
444975-4497545.61746.29
544370-4437045.00345.66
644939-4493945.58046.25
30min145835-4583546.48946.830.7747.4147.750.76
246408-4640847.07047.99
346540-4654047.20448.11
445990-4599046.64647.57
545750-4575046.40347.31
646500-4650047.16348.09
45min148232-4823248.92048.611.4750.1049.781.44
247789-4778948.47149.65
348136-4813648.82349.99
448961-4896149.65950.84
546892-4689247.56148.73
647521-4752148.19949.38
60min146241-4624146.90148.191.4048.3549.641.36
247448-4744848.12549.58
347605-4760548.28449.73
448105-4810548.79150.25
547804-4780448.48649.92
647884-4788448.56750.02
90min148114-4811448.80048.920.7550.5150.630.73
248807-4880749.50351.22
348082-4808248.76850.48
448516-4851649.20850.94
548028-4802848.71350.41
647837-4783748.51950.24
120min147642-4764248.32249.631.5950.3051.621.52
248698-4869849.39351.39
349741-4974150.45152.43
448620-4862049.31451.32
549408-4940850.11352.08
649481-4948150.18752.18
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147538-4753848.21649.661.8450.4651.921.77
248941-4894149.63951.91
348939-4893949.63751.90
449060-4906049.76052.04
548919-4891949.61751.87
650374-5037451.09353.36
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