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%
110.143277632470326723259332649326320.35
210.143253332623325780.20
单位质量响应值RSD%判断
3218.153212.820.12数据可信
供试品溶液-2025072421批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16312-631217.61215.5017.6717.6115.5117.67
26242-624217.41717.42
34213-421311.75511.76
44380-438012.22112.22
56052-605216.88716.89
66141-614117.13517.14
10min110561-1056129.46827.329.7229.5027.349.73
210375-1037528.94928.98
38415-841523.48023.50
48733-873324.36824.39
510290-1029028.71228.74
610363-1036328.91628.94
15min113363-1336337.28735.477.3637.3735.547.37
213014-1301436.31336.39
311405-1140531.82331.88
411724-1172432.71332.77
513749-1374938.36438.44
613021-1302136.33236.41
20min115292-1529242.66940.504.4542.8140.634.46
214844-1484441.41941.56
313553-1355337.81737.93
413934-1393438.88039.00
514652-1465240.88341.02
614808-1480841.31941.46
30min117477-1747748.76647.961.8648.9848.161.88
217342-1734248.38948.60
316694-1669446.58146.76
416888-1688847.12247.30
517317-1731748.31948.53
617407-1740748.57048.78
45min120046-2004655.93455.532.0956.2355.812.11
220071-2007156.00456.29
319230-1923053.65753.91
419626-1962654.76255.02
520428-2042857.00057.29
620001-2000155.80856.10
60min121895-2189561.09360.511.4261.4860.881.43
222001-2200161.38961.77
321207-2120759.17459.52
421533-2153360.08360.43
521552-2155260.13660.52
621921-2192161.16661.55
90min124033-2403367.05966.691.2667.5567.161.27
224084-2408467.20167.68
323337-2333765.11765.56
423949-2394966.82467.27
523834-2383466.50466.99
624169-2416967.43867.92
120min125332-2533270.68370.730.9671.2871.310.97
225688-2568871.67772.27
324934-2493469.57370.12
425398-2539870.86871.43
525356-2535670.75071.35
625375-2537570.80371.40
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126297-2629773.37672.980.8374.0973.680.84
226251-2625173.24873.96
325754-2575471.86172.53
426097-2609772.81873.50
526173-2617373.03073.74
626348-2634873.51874.23
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%
110.143275232728326153274532915327510.33
210.143313933107331230.07
单位质量响应值RSD%判断
3229.883266.570.80数据可信
供试品溶液-2025072421批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16400-640017.67816.725.1017.6816.725.11
25526-552615.26415.26
36160-616017.01517.02
45971-597116.49316.49
55985-598516.53216.53
66286-628617.36317.36
10min110442-1044228.84328.951.9028.8728.971.91
210169-1016928.08928.11
310614-1061429.31829.35
410488-1048828.97029.00
510407-1040728.74728.77
610757-1075729.71329.74
15min113081-1308136.13336.591.2436.2136.671.24
213151-1315136.32636.40
313289-1328936.70736.78
413176-1317636.39536.47
513242-1324236.57836.65
613548-1354837.42337.50
20min115193-1519341.96742.581.4542.1042.721.45
215656-1565643.24643.38
315673-1567343.29343.43
415305-1530542.27642.41
515179-1517941.92842.06
615485-1548542.77342.91
30min117734-1773448.98649.891.6449.1950.101.64
218120-1812050.05250.26
318263-1826350.44750.66
417984-1798449.67649.88
517770-1777049.08549.29
618501-1850151.10451.32
45min120559-2055956.78957.481.3457.0857.771.34
220876-2087657.66557.95
320797-2079757.44657.74
420715-2071557.22057.51
520589-2058956.87257.16
621321-2132158.89459.19
60min122284-2228461.55462.591.6461.9462.981.63
222970-2297063.44963.83
322724-2272462.76963.16
422371-2237161.79462.18
522408-2240861.89662.28
623204-2320464.09564.49
90min124395-2439567.38569.051.6067.8769.541.60
225373-2537370.08670.58
325109-2510969.35769.85
424732-2473268.31668.80
524932-2493268.86869.35
625451-2545170.30270.80
120min125789-2578971.23572.811.5171.8373.421.50
226827-2682774.10374.71
326188-2618872.33872.95
426230-2623072.45473.06
526320-2632072.70273.30
626797-2679774.02074.64
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126348-2634872.78074.161.0473.5074.891.04
226943-2694374.42375.15
326839-2683974.13674.87
426842-2684274.14474.87
526921-2692174.36275.08
627199-2719975.13075.87
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%
110.143268332734326773255232728326750.23
210.143248632543325140.13
单位质量响应值RSD%判断
3222.393206.510.35数据可信
供试品溶液-2025072521批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16211-621117.33616.5110.5717.3416.5110.59
25903-590316.47616.48
36173-617317.23017.23
45992-599216.72516.72
54713-471313.15513.15
66506-650618.16018.16
10min110482-1048229.25728.685.7729.2928.705.77
210338-1033828.85528.88
310563-1056329.48329.51
410399-1039929.02629.05
59102-910225.40525.43
610760-1076030.03330.06
15min113339-1333937.23236.273.5637.3136.353.57
213236-1323636.94437.02
312950-1295036.14636.22
413115-1311536.60736.68
512092-1209233.75133.82
613243-1324336.96437.04
20min115138-1513842.25342.032.3742.3942.172.38
215069-1506942.06142.20
315398-1539842.97943.12
414994-1499441.85141.99
514406-1440640.21040.33
615347-1534742.83642.98
30min117673-1767349.32949.701.4649.5449.911.47
217903-1790349.97150.18
317867-1786749.87050.08
418065-1806550.42350.63
517352-1735248.43348.62
617985-1798550.20050.41
45min120355-2035556.81557.051.0657.1157.341.07
220300-2030056.66156.95
320479-2047957.16157.45
420728-2072857.85658.15
520144-2014456.22656.49
620624-2062457.56657.86
60min121932-2193261.21762.282.4061.6062.662.39
221907-2190761.14761.53
323290-2329065.00765.40
422198-2219861.95962.35
522006-2200661.42361.79
622544-2254462.92563.32
90min124190-2419067.51967.851.1468.0168.341.15
224053-2405367.13767.62
324463-2446368.28168.78
424034-2403467.08467.57
524349-2434967.96368.43
624759-2475969.10769.61
120min125237-2523770.44171.561.2571.0472.161.25
225503-2550371.18471.78
325715-2571571.77672.39
425442-2544271.01471.62
525774-2577471.94072.52
626155-2615573.00473.62
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126648-2664874.38073.461.1075.1074.181.09
226132-2613272.94073.66
326476-2647673.90074.63
425874-2587472.21972.94
526257-2625773.28873.99
626524-2652474.03474.77
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%
110.143274732747325953275432736327160.21
210.143346633275333700.41
单位质量响应值RSD%判断
3226.433290.931.40数据可信
供试品溶液-2025072521批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16718-671818.49816.1712.2518.5016.1612.26
25967-596716.43116.43
35575-557515.35115.35
44617-461712.71312.71
56086-608616.75816.76
66261-626117.24017.24
10min110386-1038628.59927.905.7128.6327.925.72
210377-1037728.57428.60
39855-985527.13627.16
49087-908725.02225.04
510407-1040728.65628.68
610681-1068129.41129.44
15min113313-1331336.65835.682.4336.7435.752.44
213069-1306935.98636.06
312888-1288835.48835.56
412379-1237934.08634.15
513032-1303235.88435.96
613062-1306235.96736.04
20min115169-1516941.76941.171.8941.9141.301.89
215263-1526342.02842.16
314817-1481740.80040.93
414471-1447139.84739.97
514994-1499441.28741.42
614992-1499241.28141.42
30min117926-1792649.36048.840.9249.5749.040.93
217952-1795249.43249.64
317596-1759648.45248.65
417591-1759148.43848.62
517648-1764848.59548.80
617716-1771648.78248.99
45min120634-2063456.81755.881.1457.1156.161.14
220498-2049856.44356.73
320040-2004055.18155.46
420295-2029555.88456.15
520134-2013455.44055.73
620155-2015555.49855.79
60min122225-2222561.19861.341.8961.5861.721.88
222288-2228861.37161.75
321935-2193560.39960.77
422213-2221361.16561.52
523075-2307563.53863.92
621935-2193560.39960.78
90min124577-2457767.67467.271.2568.1667.741.24
224734-2473468.10768.59
324047-2404766.21566.69
424762-2476268.18468.65
524180-2418066.58167.06
624271-2427166.83267.31
120min126401-2640172.69771.241.5573.3071.831.55
226134-2613471.96272.56
325379-2537969.88370.46
426070-2607071.78572.36
525469-2546970.13170.73
625775-2577570.97371.57
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126421-2642172.75272.431.3373.4773.141.32
226601-2660173.24873.96
325784-2578470.99871.70
426726-2672673.59274.29
526070-2607071.78572.50
626231-2623172.22972.94
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