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%
111.049710196606967549665396800967830.21
211.049664596765967050.09
单位质量响应值RSD%判断
8766.588759.510.06数据可信
供试品溶液-2025051521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%
5min135999-3599936.88731.9211.7236.8931.9211.71
234688-3468835.54435.54
327507-2750728.18628.19
431422-3142232.19732.20
527117-2711727.78627.79
630183-3018330.92830.93
10min151257-5125752.52250.215.6052.9350.565.63
252760-5276054.06254.46
345520-4552046.64346.96
448480-4848049.67650.03
546599-4659947.74948.06
649370-4937050.58850.93
15min158851-5885160.30357.134.6161.3058.044.66
258461-5846159.90460.90
352089-5208953.37454.21
455279-5527956.64357.55
554202-5420255.54056.38
655620-5562056.99357.90
20min161684-6168463.20661.982.7764.8763.522.85
262953-6295364.50766.17
358059-5805959.49260.92
460043-6004361.52563.06
560303-6030361.79163.25
659864-5986461.34162.88
30min168238-6823869.92267.922.1472.2970.162.22
267490-6749069.15671.53
364332-6433265.92068.01
465375-6537566.98869.21
566229-6622967.86370.01
666034-6603467.66469.88
45min168929-6892970.63071.621.2773.7774.611.29
271018-7101872.77175.92
368945-6894570.64673.46
470762-7076272.50875.48
570043-7004371.77274.67
669666-6966671.38574.36
60min171745-7174573.51674.200.9977.4477.991.00
273717-7371775.53679.49
372695-7269574.48978.09
472198-7219873.98077.75
571915-7191573.69077.38
672224-7222474.00677.77
90min176479-7647978.36678.011.4883.1182.621.52
278073-7807380.00084.79
375957-7595777.83182.26
475857-7585777.72982.32
574673-7467376.51681.03
675729-7572977.59882.19
120min175770-7577077.64078.931.2483.2584.401.15
277836-7783679.75785.44
377993-7799379.91885.21
477766-7776679.68585.14
576255-7625578.13783.50
676548-7654878.43783.89
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178428-7842880.36380.010.3686.8486.360.35
277888-7788879.81086.38
378405-7840580.34086.52
477816-7781679.73686.08
577868-7786879.79086.02
678068-7806879.99586.32
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%
111.049620896013959719605296098960680.10
211.049647996165963220.24
单位质量响应值RSD%判断
8701.818724.820.19数据可信
供试品溶液-2025051621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%
5min126855-2685527.67526.849.9527.6726.849.95
227356-2735628.19128.19
327926-2792628.77928.78
428024-2802428.88028.88
521350-2135022.00222.00
624752-2475225.50825.51
10min148575-4857550.05846.917.7750.3747.217.76
240476-4047641.71242.02
347924-4792449.38749.71
447864-4786449.32549.65
541630-4163042.90143.15
646664-4666448.08948.37
15min157248-5724858.99655.434.3159.8656.254.32
250958-5095852.51453.29
353304-5330454.93155.80
454904-5490456.58057.45
551654-5165453.23153.95
654649-5464956.31757.14
20min161223-6122363.09261.303.0764.6162.733.12
256818-5681858.55359.91
360137-6013761.97363.45
460631-6063162.48263.98
557557-5755759.31460.63
660514-6051462.36163.80
30min166053-6605368.06967.651.7770.2969.761.82
263677-6367765.62167.63
365318-6531867.31269.48
467042-6704269.08971.28
565377-6537767.37369.34
666391-6639168.41870.55
45min170341-7034172.48872.692.1475.4675.552.13
268249-6824970.33373.07
370520-7052072.67375.59
472847-7284775.07178.03
571224-7122473.39876.12
670018-7001872.15675.05
60min174518-7451876.79375.251.7580.5778.931.80
270896-7089673.06076.58
373029-7302975.25878.98
474062-7406276.32380.12
572545-7254574.76078.30
673102-7310275.33479.03
90min176227-7622778.55478.361.0383.1982.871.05
275057-7505777.34881.68
376064-7606478.38682.95
477021-7702179.37284.01
576645-7664578.98583.35
675214-7521477.51082.05
120min177476-7747679.84179.361.6185.3584.751.54
275779-7577978.09283.28
375406-7540677.70883.14
477891-7789180.26985.79
578598-7859880.99786.24
676934-7693479.28384.68
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178937-7893781.34781.280.4587.7487.540.56
278512-7851280.90986.97
378874-7887481.28287.58
479519-7951981.94788.36
578656-7865681.05787.20
678726-7872681.12987.41
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%
111.049699296863968799674596579968120.17
211.049725297026971390.17
单位质量响应值RSD%判断
8769.208798.820.24数据可信
供试品溶液-2025051622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%
5min124511-2451125.05632.1714.5225.0632.1814.51
233990-3399034.74634.75
332135-3213532.85032.85
435661-3566136.45436.45
527308-2730827.91527.92
635244-3524436.02836.03
10min145696-4569646.71250.716.0646.9951.066.12
250852-5085251.98352.37
349939-4993951.04951.41
452187-5218753.34753.75
546203-4620347.23047.54
652758-5275853.93154.33
15min155571-5557156.80758.362.9557.6059.283.03
256581-5658157.83958.80
358086-5808659.37860.31
458447-5844759.74760.74
554850-5485056.07056.90
659013-5901360.32561.32
20min159617-5961760.94362.952.9262.3764.512.99
261422-6142262.78864.39
363711-6371165.12866.72
462764-6276464.16065.82
559307-5930760.62662.08
662637-6263764.03065.70
30min166826-6682668.31268.311.2170.4270.581.27
265934-6593467.40069.70
367769-6776969.27671.59
467181-6718168.67571.05
565802-6580267.26569.40
667455-6745568.95571.34
45min170133-7013371.69272.031.3174.5675.061.34
269554-6955471.10174.15
372080-7208073.68376.77
470695-7069572.26775.40
569708-6970871.25874.14
670627-7062772.19775.34
60min172951-7295174.57374.671.1778.2378.491.19
271966-7196673.56677.41
374426-7442676.08179.98
473459-7345975.09279.03
572438-7243874.04977.72
673007-7300774.63078.58
90min176133-7613377.82678.310.9782.3282.970.96
275761-7576177.44682.11
377609-7760979.33584.08
477212-7721278.92983.70
576893-7689378.60383.10
676032-7603277.72382.50
120min176170-7617077.86478.420.8483.2283.940.93
276534-7653478.23683.76
377166-7716678.88284.51
477670-7767079.39785.05
575951-7595177.64083.01
676769-7676978.47684.12
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178189-7818979.92879.491.6386.1585.891.55
275968-7596877.65784.05
378777-7877780.52987.04
479302-7930281.06587.60
577613-7761379.33985.57
676693-7669378.39884.91
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