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5000
标示量(mg)2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%
110.313182131899317913186832275319310.62
210.253192832220320740.65
单位质量响应值RSD%判断
3097.093129.170.73数据可信
中间条件6月-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%
5min14478-447812.90614.8425.1712.9114.8425.18
24414-441412.72212.72
33540-354010.20310.20
45394-539415.54615.55
57212-721220.78620.79
65854-585416.87216.87
10min19924-992428.60232.5910.9328.6232.6110.93
211335-1133532.66932.69
310271-1027129.60229.62
411758-1175833.88833.91
513407-1340738.64038.67
611143-1114332.11532.14
15min114380-1438041.44543.103.9041.5143.183.92
214735-1473542.46842.54
314326-1432641.28941.36
415030-1503043.31843.40
515712-1571245.28345.38
615543-1554344.79644.88
20min117354-1735450.01649.642.1950.1549.792.21
216957-1695748.87249.02
316778-1677848.35648.49
417491-1749150.41150.57
517769-1776951.21251.39
616995-1699548.98149.14
30min120485-2048559.04058.170.9459.2658.400.93
220138-2013858.04058.27
320031-2003157.73157.95
420059-2005957.81258.05
520341-2034158.62558.88
620040-2004057.75758.00
45min123166-2316666.76765.461.3567.0965.791.33
222463-2246364.74165.07
322997-2299766.28066.59
422419-2241964.61464.95
522689-2268965.39265.75
622540-2254064.96265.30
60min125075-2507572.26970.931.5572.7071.371.53
224164-2416469.64370.08
324905-2490571.77972.20
424155-2415569.61770.06
524666-2466671.09071.56
624693-2469371.16871.61
90min126825-2682577.31275.921.4977.8676.471.47
226373-2637376.00976.56
326528-2652876.45677.00
425652-2565273.93274.49
526229-2622975.59476.18
626435-2643576.18876.75
120min128190-2819081.24679.161.7981.9379.841.77
226865-2686577.42778.10
327779-2777980.06280.73
427040-2704077.93278.61
527333-2733378.77679.49
627588-2758879.51180.20
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128629-2862982.51281.401.3583.3382.211.34
228344-2834481.69082.49
327895-2789580.39681.20
427717-2771779.88380.69
528220-2822081.33382.18
628646-2864682.56083.38
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5000
标示量(mg)2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%
110.313254031850322313222431993321680.82
210.253222632008321170.48
单位质量响应值RSD%判断
3120.083133.370.31数据可信
中间条件6月-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%
5min17228-722820.74120.1011.6220.7420.1011.62
26557-655718.81518.82
37217-721720.70920.71
48413-841324.14124.14
56462-646218.54318.54
66147-614717.63917.64
10min112911-1291137.04835.745.4637.0835.785.47
211926-1192634.22234.25
312600-1260036.15636.19
413527-1352738.81638.86
511923-1192334.21334.24
611850-1185034.00434.03
15min115904-1590445.63745.682.6045.7345.782.60
215425-1542544.26244.35
316504-1650447.35847.45
416311-1631146.80446.91
515745-1574545.18045.27
615630-1563044.85044.94
20min118282-1828252.46052.691.7552.6352.861.76
218163-1816352.11952.28
318582-1858253.32153.49
418907-1890754.25454.44
518154-1815452.09352.26
618081-1808151.88452.04
30min121290-2129061.09261.071.1861.3561.321.19
220807-2080759.70659.95
321399-2139961.40561.67
421373-2137361.33061.60
521542-2154261.81562.06
621279-2127961.06061.31
45min123985-2398568.82568.881.4769.1969.241.47
223314-2331466.90067.25
324143-2414369.27869.64
424252-2425269.59169.97
524239-2423969.55469.91
624082-2408269.10369.45
60min125478-2547873.10973.881.7873.5974.351.77
224986-2498671.69772.16
326205-2620575.19575.68
425735-2573573.84774.34
526124-2612474.96375.43
625942-2594274.44174.90
90min127024-2702477.54578.802.0678.1479.402.06
226519-2651976.09676.68
327838-2783879.88180.49
427871-2787179.97680.59
527877-2787779.99380.59
627648-2764879.33679.92
120min127971-2797180.26381.651.7080.9982.381.70
227812-2781279.80780.51
328661-2866182.24382.98
429032-2903283.30784.06
528822-2882282.70583.43
628430-2843081.58082.30
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129067-2906783.40883.291.2784.2784.151.27
228360-2836081.37982.22
328999-2899983.21384.09
429304-2930484.08884.97
529417-2941784.41285.28
629007-2900783.23684.09
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5000
标示量(mg)2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%
110.313194932165319383210531552319420.75
210.253225731912320840.77
单位质量响应值RSD%判断
3098.163130.150.73数据可信
中间条件6月-供试品溶液-2025072522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%
5min15730-573016.50918.2313.3516.5118.2313.35
26850-685019.73619.74
37373-737321.24321.24
45921-592117.05917.06
56910-691019.90919.91
65172-517214.90114.90
10min111214-1121432.30934.317.3632.3434.347.36
212683-1268336.54236.57
313013-1301337.49237.53
411287-1128732.52032.55
512325-1232535.51035.54
610921-1092131.46531.49
15min115497-1549744.64945.115.1644.7345.205.17
216301-1630146.96647.06
316716-1671648.16148.26
415317-1531744.13144.21
515715-1571545.27745.37
614403-1440341.49741.57
20min118078-1807852.08552.243.6852.2452.403.69
218997-1899754.73354.91
318760-1876054.05054.23
417836-1783651.38851.54
517962-1796251.75151.92
617153-1715349.42049.57
30min121396-2139661.64561.792.5061.8962.042.51
222014-2201463.42663.69
322151-2215163.82064.09
421271-2127161.28561.53
520818-2081859.98060.23
621018-2101860.55660.78
45min124582-2458270.82470.451.9371.1770.801.94
225038-2503872.13872.51
324900-2490071.74172.12
424254-2425469.87970.22
524107-2410769.45669.81
623830-2383068.65868.99
60min126353-2635375.92775.161.6076.3975.631.60
226257-2625775.65076.14
326475-2647576.27876.77
426047-2604775.04575.51
525304-2530472.90573.37
626090-2609075.16975.61
90min128569-2856982.31280.812.1082.9081.402.11
228401-2840181.82882.44
328655-2865582.55983.18
427947-2794780.51981.10
527290-2729078.62779.22
627428-2742879.02479.59
120min129712-2971285.60583.951.3686.3384.681.37
229169-2916984.04084.79
329501-2950184.99785.76
428864-2886483.16183.88
528836-2883683.08183.80
628743-2874382.81383.51
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129733-2973385.66584.921.7086.5385.791.70
229715-2971585.61386.51
329927-2992786.22487.12
429795-2979585.84486.70
528824-2882483.04683.91
628851-2885183.12483.96
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5000
标示量(mg)2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%
110.313187331905320213203532194320060.40
210.253249732271323840.50
单位质量响应值RSD%判断
3104.363159.411.25数据可信
加速6月-供试品溶液-2025072522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%
5min16720-672019.25314.1218.8819.2514.1218.88
25069-506914.52314.52
34581-458113.12413.12
44155-415511.90411.90
54675-467513.39413.39
64369-436912.51712.52
10min111479-1147932.88730.2110.5532.9230.2310.55
210346-1034629.64129.67
39465-946527.11727.14
410401-1040129.79929.82
512193-1219334.93334.95
69376-937626.86226.88
15min114723-1472342.18139.924.8942.2739.994.90
213914-1391439.86339.94
313046-1304637.37637.44
414175-1417540.61140.68
514514-1451441.58241.66
613221-1322137.87837.94
20min116865-1686548.31847.472.9248.4847.612.93
216516-1651647.31847.46
316535-1653547.37247.50
416786-1678648.09248.23
517045-1704548.83448.98
615674-1567444.90645.03
30min119966-1996657.20256.162.1557.4456.382.16
219649-1964956.29456.51
319223-1922355.07355.28
420144-2014457.71257.93
519578-1957856.09156.32
619047-1904754.56954.77
45min122723-2272365.10163.992.5465.4364.302.54
222042-2204263.15063.46
322200-2220063.60263.90
423126-2312666.25566.57
522431-2243164.26464.59
621492-2149261.57461.87
60min124282-2428269.56768.932.0670.0169.352.07
224218-2421869.38469.80
323608-2360867.63668.04
424770-2477070.96571.39
524092-2409269.02369.45
623396-2339667.02967.43
90min126507-2650775.94274.531.7176.5075.061.71
226224-2622475.13175.66
325498-2549873.05173.57
426472-2647275.84276.38
525733-2573373.72474.27
625643-2564373.46773.98
120min126936-2693677.17177.681.6277.8678.341.62
227221-2722177.98878.65
326805-2680576.79677.44
427940-2794080.04780.72
527031-2703177.44378.11
626745-2674576.62477.26
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128533-2853381.74679.721.3882.5680.511.39
227791-2779179.62180.41
327624-2762479.14279.91
427956-2795680.09380.90
527510-2751078.81679.61
627550-2755078.93079.69
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