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%
111.697630476136763157615076262762330.12
211.847729177428773600.13
单位质量响应值RSD%判断
6521.216533.780.14数据可信
供试品溶液-25032601-1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%
5min120946-2094628.79034.7313.1328.7934.7313.13
226626-2662636.59836.60
329207-2920740.14540.15
428342-2834238.95638.96
522443-2244330.84830.85
624044-2404433.04933.05
10min135928-3592849.38354.226.0649.4354.276.07
239859-3985954.78754.85
342307-4230758.15158.22
440945-4094556.27956.34
537269-3726951.22751.28
640351-4035155.46355.52
15min143766-4376660.15763.103.3460.2963.253.36
245847-4584763.01763.17
347918-4791865.86466.03
446575-4657564.01864.18
544538-4453861.21861.35
646795-4679564.32064.47
20min148309-4830966.40168.732.3366.6368.982.35
249559-4955968.11968.38
351449-5144970.71770.99
450902-5090269.96570.23
549262-4926267.71167.95
650521-5052169.44269.70
30min153116-5311673.00874.351.1673.3574.711.18
253728-5372873.85074.22
354969-5496975.55575.95
454186-5418674.47974.86
554121-5412174.39074.74
654414-5441474.79375.16
45min156284-5628477.36378.331.0977.8378.821.11
256602-5660277.80078.29
357933-5793379.62980.15
457231-5723178.66579.17
556543-5654377.71978.19
657334-5733478.80679.30
60min157676-5767679.27680.491.8479.8781.111.85
258042-5804279.77980.40
359656-5965681.99882.65
458464-5846480.35981.00
557437-5743778.94879.55
660067-6006782.56383.19
90min159316-5931681.53082.911.4482.2583.671.45
259135-5913581.28282.04
361049-6104983.91284.70
460631-6063183.33884.11
560750-6075083.50184.24
661056-6105683.92284.69
120min159297-5929781.50484.162.3682.3685.062.35
259571-5957181.88182.77
362250-6225085.56386.49
461888-6188885.06685.98
562731-6273186.22487.10
661647-6164784.73485.64
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161497-6149784.52885.381.3985.5286.421.39
260846-6084683.63384.66
362660-6266086.12787.20
461840-6184085.00086.05
562951-6295186.52787.55
662912-6291286.47387.52
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%
111.697630276011758957618376271761320.23
211.847766677842777540.17
单位质量响应值RSD%判断
6512.576567.060.59数据可信
供试品溶液-25032601-2批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min128418-2841838.98835.4214.0638.9935.4214.07
218538-1853825.43325.43
327274-2727437.41837.42
426907-2690736.91536.91
526359-2635936.16336.16
627389-2738937.57637.58
10min141398-4139856.79654.317.4856.8654.377.48
233648-3364846.16346.21
341350-4135056.73056.79
440614-4061455.72055.78
540026-4002654.91354.97
640502-4050255.56655.63
15min147789-4778965.56463.774.1365.7263.924.14
242676-4267658.54958.67
347732-4773265.48665.64
446766-4676664.16064.31
547171-4717164.71664.87
646751-4675164.14064.29
20min151217-5121770.26768.892.7470.5469.152.76
247573-4757365.26765.48
351146-5114670.16970.44
450600-5060069.42069.68
550827-5082769.73269.99
649924-4992468.49368.76
30min155306-5530675.87774.631.8376.2675.001.84
252627-5262772.20172.53
354916-5491675.34275.72
454875-5487575.28575.66
554795-5479575.17675.55
653848-5384873.87674.25
45min157981-5798179.54778.471.4780.0678.961.49
255815-5581576.57577.02
357618-5761879.04979.56
457501-5750178.88879.39
557727-5772779.19879.70
656522-5652277.54578.04
60min159021-5902180.97380.481.4781.6281.101.47
257563-5756378.97379.55
358708-5870880.54481.18
459006-5900680.95381.59
559863-5986382.12982.76
657785-5778579.27879.91
90min161870-6187084.88282.712.1485.6683.482.14
259738-5973881.95782.66
360341-6034182.78483.56
460810-6081083.42884.20
560896-6089683.54684.32
658087-5808779.69280.45
120min163007-6300786.44284.411.5287.3685.311.52
260626-6062683.17584.02
360924-6092483.58484.50
461636-6163684.56185.47
562174-6217485.29986.21
660791-6079183.40284.30
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163133-6313386.61585.081.7987.6886.121.77
262576-6257685.85186.83
360805-6080583.42184.47
462400-6240085.60986.66
562724-6272486.05487.11
660448-6044882.93183.96
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%
111.697694177074766497696676792768840.22
211.847827877991781340.26
单位质量响应值RSD%判断
6576.906599.160.24数据可信
供试品溶液-25032601-3批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min124234-2423433.00434.184.3133.0034.184.31
224999-2499934.04634.05
326670-2667036.32136.32
426181-2618135.65535.66
524149-2414932.88832.89
624369-2436933.18833.19
10min137755-3775551.41852.201.8051.4752.251.81
238606-3860652.57752.63
339264-3926453.47353.53
438859-3885952.92152.98
537490-3749051.05751.11
637994-3799451.74351.80
15min144728-4472860.91461.461.5861.0661.611.58
245860-4586062.45662.60
345838-4583862.42662.58
445197-4519761.55361.70
543985-4398559.90260.04
645177-4517761.52661.67
20min149070-4907066.82867.161.1067.0767.411.10
249908-4990867.96968.22
349600-4960067.54967.80
449224-4922467.03767.29
548409-4840965.92766.17
649694-4969467.67767.92
30min154021-5402173.57073.271.1973.9273.631.19
254236-5423673.86374.22
353778-5377873.23973.61
453911-5391173.42073.78
552559-5255971.57971.93
654302-5430273.95374.31
45min157602-5760278.44778.001.4678.9278.481.45
257748-5774878.64679.13
356815-5681577.37577.86
457088-5708877.74778.23
555989-5598976.25076.72
658392-5839279.52380.00
60min159802-5980281.44380.761.5482.0581.371.53
259480-5948081.00581.62
358131-5813179.16879.78
459943-5994381.63582.25
558199-5819979.26079.86
660231-6023182.02882.64
90min161544-6154483.81683.271.8684.5684.021.85
262042-6204284.49485.24
359618-5961881.19381.94
461118-6111883.23683.99
560026-6002681.74882.48
662529-6252985.15785.91
120min162792-6279285.51584.841.9486.4085.721.93
263438-6343886.39587.29
360893-6089382.92983.81
462351-6235184.91585.80
560794-6079482.79483.66
663512-6351286.49687.39
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162892-6289285.65285.261.8386.6886.281.82
263521-6352186.50887.54
361404-6140483.62584.65
462209-6220984.72185.75
561384-6138483.59884.60
664199-6419987.43288.47
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%
111.697657076361769887649276654766130.31
211.847896278753788580.19
单位质量响应值RSD%判断
6553.726660.301.15数据可信
供试品溶液-25032801批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min120322-2032227.59830.9415.8027.6030.9415.80
226208-2620835.59235.59
325771-2577134.99835.00
416808-1680822.82622.83
524174-2417432.83032.83
623431-2343131.82131.82
10min135060-3506047.61350.187.0847.6650.237.08
238495-3849552.27852.34
339133-3913353.14553.20
432517-3251744.16044.20
538693-3869352.54752.60
637808-3780851.34551.40
15min144207-4420760.03661.453.9060.1661.583.91
246170-4617062.70162.85
347016-4701663.85064.00
442262-4226257.39457.51
546491-4649163.13763.28
645335-4533561.56761.71
20min149028-4902866.58368.102.4666.8168.332.47
250274-5027468.27568.53
351449-5144969.87170.12
448307-4830765.60465.81
551119-5111969.42269.67
650675-5067568.81969.06
30min155010-5501074.70775.991.6175.0476.341.63
255712-5571275.66076.02
357015-5701577.42977.80
454907-5490774.56774.88
556856-5685677.21477.58
656225-5622576.35776.71
45min159381-5938180.64382.001.3081.1082.471.31
259588-5958880.92481.41
361137-6113783.02783.53
460154-6015481.69282.13
560876-6087682.67383.16
661135-6113583.02583.51
60min161943-6194384.12285.121.2184.7285.731.22
261790-6179083.91484.54
363313-6331385.98386.62
462269-6226984.56585.14
563443-6344386.15986.79
663294-6329485.95786.58
90min164625-6462587.76488.651.2588.5089.411.26
264399-6439987.45788.22
365754-6575489.29890.08
464882-6488288.11388.83
566586-6658690.42791.20
665420-6542088.84489.61
120min165797-6579789.35690.661.4890.2491.561.48
266300-6630090.03990.95
366745-6674590.64391.57
466167-6616789.85890.72
566936-6693690.90391.83
668592-6859293.15294.06
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166184-6618489.88190.441.1790.9191.491.17
265453-6545388.88989.95
366760-6676090.66491.74
466354-6635490.11291.13
567691-6769191.92893.00
667111-6711191.14092.21
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