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%
19.816132460803610426108760554609620.49
29.916158061507615440.09
单位质量响应值RSD%判断
6214.276210.290.05数据可信
加速6月-供试品溶液-2025072121批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min111279-1127916.29019.2121.3816.2919.2121.39
210490-1049015.15015.15
310431-1043115.06515.06
415447-1544722.30922.31
515839-1583922.87622.88
616329-1632923.58323.58
10min124051-2405134.73635.3514.7634.7635.3814.77
221209-2120930.63130.66
320292-2029229.30729.33
424744-2474435.73735.77
526284-2628437.96138.00
630265-3026543.71043.75
15min131011-3101144.78844.8214.2544.8744.9114.25
227241-2724139.34339.42
326392-2639238.11738.19
430286-3028643.74143.84
532573-3257347.04447.15
638707-3870755.90356.01
20min136459-3645952.65651.8512.9852.8252.0212.99
232218-3221846.53146.67
330820-3082044.51244.65
434758-3475850.19950.37
537117-3711753.60653.79
644026-4402663.58563.79
30min143485-4348562.80360.5911.5863.0560.8411.58
238821-3882156.06756.29
336295-3629552.41952.63
440156-4015657.99558.25
542641-4264161.58461.85
650317-5031772.67072.98
45min149197-4919771.05367.999.7571.4068.349.77
244224-4422463.87164.18
341409-4140959.80560.10
445154-4515465.21465.56
547915-4791569.20169.57
654570-5457078.81379.25
60min152421-5242175.70971.958.8176.1872.428.83
247194-4719468.16068.58
344315-4431564.00264.40
447569-4756968.70269.16
550783-5078373.34373.83
656622-5662281.77682.34
90min155450-5545080.08476.727.5380.6877.317.56
251024-5102473.69274.22
348082-4808269.44369.95
450846-5084673.43474.01
553994-5399477.98178.59
659348-5934885.71386.41
120min157266-5726682.70779.216.3783.4479.936.40
253582-5358277.38678.04
350501-5050172.93673.56
452329-5232975.57676.27
555251-5525179.79680.54
660150-6015086.87287.71
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158600-5860084.63381.346.4485.5082.196.47
254913-5491379.30880.09
351621-5162174.55475.30
454095-5409578.12778.95
556779-5677982.00382.88
661910-6191089.41490.40
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%
19.816076761109610496107860985609980.23
29.916174861459616040.34
单位质量响应值RSD%判断
6217.946216.350.02数据可信
加速6月-供试品溶液-2025072221批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min120001-2000128.86423.1719.8428.8623.1719.84
212927-1292718.65518.66
312003-1200317.32217.32
417725-1772525.57925.58
515265-1526522.02922.03
618405-1840526.56126.56
10min134057-3405749.14840.5115.3249.2040.5615.32
225018-2501836.10436.14
322480-2248032.44132.47
428635-2863541.32441.37
526537-2653738.29638.33
631720-3172045.77645.82
15min141209-4120959.47050.9012.0259.6051.0112.03
232701-3270147.19247.28
329919-2991943.17743.26
435317-3531750.96751.08
533288-3328848.03948.14
639191-3919156.55756.68
20min145399-4539965.51657.559.5265.7557.749.54
237807-3780754.56054.73
335532-3553251.27751.43
439237-3923756.62456.82
537761-3776154.49454.67
643547-4354762.84463.06
30min151127-5112773.78365.948.0074.1266.228.02
243686-4368663.04463.31
341765-4176560.27260.51
444723-4472364.54164.83
543611-4361162.93663.21
649230-4923071.04571.36
45min155295-5529579.79772.776.6180.2673.176.64
248431-4843169.89270.26
346593-4659367.23967.58
449829-4982971.90972.31
548814-4881470.44570.82
653605-5360577.35977.80
60min157833-5783383.46076.465.8684.0576.975.89
251659-5165974.55075.03
349536-4953671.48771.94
452046-5204675.10975.63
551195-5119573.88174.37
655608-5560880.24980.82
90min160467-6046787.26180.555.3187.9981.205.34
254681-5468178.91179.52
352467-5246775.71676.29
454597-5459778.79079.43
554401-5440178.50779.12
658304-5830484.14084.84
120min161385-6138588.58682.374.9689.4683.154.99
255482-5548280.06780.81
353701-5370177.49778.20
456660-5666081.76782.54
555793-5579380.51681.26
659442-5944285.78286.62
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161151-6115188.24884.063.4689.2784.973.51
257024-5702482.29383.16
356489-5648981.52182.35
457179-5717982.51683.43
557158-5715882.48683.37
660474-6047487.27188.26
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%
19.816116860899613046128361074611460.28
29.916215962208621840.06
单位质量响应值RSD%判断
6233.036274.870.48数据可信
加速6月-供试品溶液-2025072321批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min121856-2185631.35628.3312.7731.3628.3312.77
215918-1591822.83722.84
322988-2298832.98032.98
418477-1847726.50826.51
519107-1910727.41227.41
620143-2014328.89828.90
10min135277-3527750.61047.506.9250.6647.556.93
229923-2992342.92942.97
336205-3620551.94152.00
432668-3266846.86746.91
532679-3267946.88346.93
631914-3191445.78545.83
15min142315-4231560.70758.494.4060.8458.624.41
238533-3853355.28155.39
343397-4339762.25962.40
440353-4035357.89258.01
540500-4050058.10358.23
639528-3952856.70956.83
20min146475-4647566.67564.783.4366.9165.003.44
243104-4310461.83962.04
347320-4732067.88768.13
445159-4515964.78765.01
544798-4479864.26964.49
644053-4405363.20063.42
30min152171-5217174.84772.832.5575.2073.162.57
250171-5017171.97872.28
352521-5252175.34975.71
450434-5043472.35572.68
550072-5007271.83672.16
649230-4923070.62870.95
45min155816-5581680.07678.501.8180.5578.951.83
254583-5458378.30778.73
355929-5592980.23880.72
454630-5463078.37578.82
553813-5381377.20377.65
653540-5354076.81177.25
60min158125-5812583.38981.061.9284.0081.641.92
256477-5647781.02481.58
357316-5731682.22882.85
456310-5631080.78581.36
555316-5531679.35979.94
655459-5545979.56480.13
90min159283-5928385.05083.461.4285.8084.181.44
257502-5750282.49583.19
359042-5904284.70485.46
458023-5802383.24283.96
557238-5723882.11682.82
657949-5794983.13683.84
120min159813-5981385.81084.311.2486.7085.171.26
257884-5788483.04383.87
359392-5939285.20686.10
458596-5859684.06484.92
558171-5817183.45584.30
658756-5875684.29485.14
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161839-6183988.71787.341.2989.7588.341.30
260660-6066087.02687.99
361539-6153988.28789.32
461239-6123987.85688.85
560000-6000086.07987.06
660011-6001186.09487.08
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%
19.816094261213608946100561302610710.30
29.916232862003621660.37
单位质量响应值RSD%判断
6225.386273.060.54数据可信
加速6月-供试品溶液-J049F批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min121520-2152030.89730.791.4130.9030.791.41
220976-2097630.11630.12
321641-2164131.07131.07
421302-2130230.58430.58
521373-2137330.68630.69
621847-2184731.36731.37
10min135734-3573451.30551.221.4351.3651.271.43
235597-3559751.10851.16
335294-3529450.67350.72
435007-3500750.26150.31
536449-3644952.33152.38
635965-3596551.63651.69
15min143891-4389163.01663.081.6263.1563.211.62
243530-4353062.49862.63
343840-4384062.94363.08
442937-4293761.64661.78
544414-4441463.76763.91
644992-4499264.59764.73
20min148574-4857469.73969.822.1269.9870.062.12
248512-4851269.65069.89
347864-4786468.72068.96
447283-4728367.88668.12
549447-4944770.99371.24
650111-5011171.94672.19
30min153995-5399577.52377.941.7977.8878.291.79
254521-5452178.27878.63
353496-5349676.80677.16
453025-5302576.13076.48
555619-5561979.85480.22
655043-5504379.02779.39
45min158935-5893584.61584.391.4085.1084.871.40
259007-5900784.71885.20
357964-5796483.22183.70
457658-5765882.78283.26
559860-5986085.94386.44
659227-5922785.03485.53
60min160985-6098587.55887.361.1788.1987.991.17
261418-6141888.18088.81
360039-6003986.20086.82
460017-6001786.16986.78
561755-6175588.66489.30
660884-6088487.41388.05
90min162681-6268189.99390.211.3990.7790.981.38
263069-6306990.55091.32
362520-6252089.76290.53
461951-6195188.94589.70
564439-6443992.51793.30
662343-6234389.50890.29
120min163277-6327790.84990.910.7991.7791.840.79
263702-6370291.45992.38
363522-6352291.20192.12
462618-6261889.90390.81
563926-6392691.78192.72
662876-6287690.27391.21
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164760-6476092.97893.340.7494.0594.420.74
265604-6560494.19095.27
365161-6516193.55494.62
464699-6469992.89193.95
565481-6548194.01395.11
664380-6438092.43393.52
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