多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D241101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(%)99.69对照品水分(%)0对照品稀释倍数10000
标示量(mg)1供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.143285032569327013267232871327330.39
210.143303032743328860.62
单位质量响应值RSD%判断
3228.113243.200.33数据可信
供试品溶液-2025072421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%
5min18655-865523.99924.549.0924.0024.549.10
29527-952726.41726.42
39130-913025.31725.32
49559-955926.50626.51
58837-883724.50424.50
67383-738320.47220.47
10min114608-1460840.50740.313.2240.5540.353.23
215036-1503641.69341.74
314790-1479041.01141.05
414686-1468640.72340.77
514416-1441639.97440.02
613677-1367737.92537.96
15min117907-1790749.65449.281.8649.7649.391.87
218168-1816850.37850.49
317801-1780149.36049.47
417848-1784849.49149.60
517738-1773849.18649.29
617171-1717147.61447.71
20min120076-2007655.66955.551.6955.8655.741.69
220309-2030956.31556.51
320343-2034356.40956.60
420225-2022556.08256.28
519733-1973354.71854.91
619514-1951454.11054.29
30min123171-2317164.25163.571.3664.5363.861.37
222866-2286663.40563.70
323022-2302263.83864.12
423272-2327264.53164.82
522841-2284163.33663.62
622391-2239162.08862.35
45min125524-2552470.77670.221.2971.1770.611.30
225242-2524269.99470.39
325551-2555170.85071.24
425704-2570471.27571.67
525077-2507769.53669.92
624846-2484668.89669.27
60min127174-2717475.35174.571.0475.8675.071.05
226806-2680674.33074.84
326925-2692574.66075.17
427234-2723475.51776.03
526712-2671274.07074.57
626501-2650173.48573.97
90min128709-2870979.60779.361.0880.2479.991.09
228535-2853579.12579.76
328609-2860979.33079.97
429169-2916980.88381.52
528424-2842478.81779.44
628271-2827178.39379.00
120min129865-2986582.81382.200.8283.5882.960.82
229598-2959882.07282.84
329715-2971582.39783.16
429931-2993182.99683.77
529435-2943581.62082.38
629316-2931681.29082.03
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130614-3061484.89084.000.8385.7984.900.83
230226-3022683.81484.72
330247-3024783.87284.78
430563-3056384.74885.66
530131-3013183.55084.44
629974-2997483.11583.99
多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D241101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(%)99.69对照品水分(%)0对照品稀释倍数10000
标示量(mg)1供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.143275932970329073280732971328830.30
210.143347433530335020.12
单位质量响应值RSD%判断
3242.903303.941.32数据可信
供试品溶液-2025072421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%
5min18753-875323.99322.6713.2623.9922.6713.27
26360-636017.43417.43
39126-912625.01625.02
48947-894724.52524.52
57533-753320.64920.65
68896-889624.38524.39
10min114462-1446239.64238.956.7739.6838.996.78
212612-1261234.57134.60
314912-1491240.87640.92
414753-1475340.44040.48
513481-1348136.95336.99
615040-1504041.22741.27
15min117833-1783348.88348.903.7248.9949.003.74
216700-1670045.77745.86
318154-1815449.76249.87
418374-1837450.36650.47
517503-1750347.97848.07
618473-1847350.63750.75
20min120051-2005154.96255.243.5355.1555.423.54
219247-1924752.75952.92
320561-2056156.36056.55
420710-2071056.76956.96
519396-1939653.16753.34
620954-2095457.43857.63
30min122819-2281962.55063.322.2962.8363.602.30
222600-2260061.95062.20
323502-2350264.42264.71
423549-2354964.55164.84
522477-2247761.61261.88
623657-2365764.84765.14
45min125499-2549969.89670.972.5970.2871.352.60
225350-2535069.48869.84
326586-2658672.87673.27
426264-2626471.99372.39
525056-2505668.68269.05
626580-2658072.85973.26
60min127101-2710174.28775.152.4874.7975.652.49
226746-2674673.31473.78
327909-2790976.50277.02
428014-2801476.79077.30
526605-2660572.92873.41
628121-2812177.08377.60
90min128784-2878478.90180.222.3779.5280.852.38
228823-2882379.00879.60
329490-2949080.83681.48
430113-3011382.54483.19
528425-2842577.91778.52
629963-2996382.13382.78
120min129830-2983081.76882.822.2282.5283.582.23
229750-2975081.54982.27
330606-3060683.89584.67
430741-3074184.26585.05
529326-2932680.38681.12
631029-3102985.05585.84
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130298-3029883.05184.411.2683.9485.301.28
230341-3034183.16984.03
331086-3108685.21186.13
431014-3101485.01385.93
530818-3081884.47685.34
631202-3120285.52986.45
多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D241101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(%)99.69对照品水分(%)0对照品稀释倍数10000
标示量(mg)1供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.143293632966327553294332992329180.29
210.143285932660327600.43
单位质量响应值RSD%判断
3246.353230.770.35数据可信
供试品溶液-2025072521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%
5min17662-766221.22724.917.4321.2324.917.43
29265-926525.66825.67
39165-916525.39125.39
49080-908025.15525.16
59245-924525.61225.61
69524-952426.38526.39
10min113528-1352837.47840.283.6537.5140.323.66
214451-1445140.03540.08
314619-1461940.50140.54
414757-1475740.88340.92
514905-1490541.29341.34
614970-1497041.47341.52
15min117381-1738148.15349.551.4648.2549.661.46
217995-1799549.85449.96
317996-1799649.85649.97
417986-1798649.82949.94
518102-1810250.15050.26
617852-1785249.45749.57
20min119627-1962754.37555.881.4154.5556.071.42
220207-2020755.98256.17
320237-2023756.06556.26
420233-2023356.05456.25
520474-2047456.72156.92
620243-2024356.08156.28
30min122710-2271062.91663.750.9463.1864.040.95
222991-2299163.69563.98
322880-2288063.38763.67
423073-2307363.92264.21
523355-2335564.70364.99
623065-2306563.90064.19
45min125439-2543970.47770.830.9970.8571.220.99
225649-2564971.05871.45
325378-2537870.30870.70
425603-2560370.93171.32
526010-2601072.05872.46
625316-2531670.13670.53
60min127002-2700274.80775.250.8275.3075.760.83
227352-2735275.77676.29
326941-2694174.63875.15
427160-2716075.24475.76
527504-2750476.19776.72
627021-2702174.85975.37
90min128886-2888680.02680.541.3180.6481.181.31
229086-2908680.58081.22
328842-2884279.90480.54
429214-2921480.93581.57
529741-2974182.39583.04
628670-2867079.42880.06
120min129947-2994782.96683.200.6983.7183.960.69
230034-3003483.20783.98
329811-2981182.58983.36
430010-3001083.14083.91
530420-3042084.27685.06
629958-2995882.99683.77
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130394-3039484.20484.450.4485.0985.360.44
230461-3046184.39085.30
330454-3045484.37085.27
430682-3068285.00285.91
530586-3058684.73685.66
630316-3031683.98884.90
多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D241101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(%)99.69对照品水分(%)0对照品稀释倍数10000
标示量(mg)1供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.143318233246330063307433233331480.32
210.143278632950328680.36
单位质量响应值RSD%判断
3269.033241.420.60数据可信
供试品溶液-2025072521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%
5min18889-888924.50024.221.5324.5024.221.52
28863-886324.42924.43
38740-874024.09024.09
48688-868823.94623.95
58947-894724.66024.66
68598-859823.69823.70
10min114654-1465440.39040.601.4540.4340.641.45
214934-1493441.16241.20
315008-1500841.36641.41
414429-1442939.77039.81
514728-1472840.59440.64
614628-1462840.31940.36
15min117792-1779249.03950.403.0549.1550.513.05
219370-1937053.38953.50
318052-1805249.75649.87
418018-1801849.66249.77
518290-1829050.41250.52
618200-1820050.16450.27
20min119947-1994754.97956.021.0555.1756.221.05
220595-2059556.76556.96
320324-2032456.01856.21
420306-2030655.96956.16
520416-2041656.27256.46
620370-2037056.14556.34
30min123099-2309963.66764.400.6863.9564.680.68
223495-2349564.75865.05
323307-2330764.24064.53
423347-2334764.35064.63
523389-2338964.46664.75
623550-2355064.91065.19
45min125765-2576571.01571.720.6771.4072.110.67
226246-2624672.34172.74
325954-2595471.53671.93
425922-2592271.44871.84
526108-2610871.96172.35
626124-2612472.00572.40
60min127505-2750575.81176.320.8176.3276.830.81
228090-2809077.42377.94
327523-2752375.86176.37
427600-2760076.07376.58
527804-2780476.63577.15
627607-2760776.09276.60
90min129280-2928080.70381.450.6181.3482.090.61
229752-2975282.00482.65
329499-2949981.30781.95
429495-2949581.29681.93
529747-2974781.99182.63
629527-2952781.38482.02
120min130454-3045483.93984.160.2684.7184.940.26
230631-3063184.42785.21
330533-3053384.15784.93
430443-3044383.90984.68
530608-3060884.36485.14
630541-3054184.17984.95
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130839-3083985.00085.070.4285.9185.980.42
230888-3088885.13586.06
330703-3070384.62685.54
430845-3084585.01785.93
531091-3109185.69586.61
630811-3081184.92385.84
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