乌帕替尼缓释片项目信息
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D240501对照品来源自制对照品使用方法直接使用
对照品含量(%)97.44对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
115.023426143433503430423425683427423428630.10
215.073426953431943429440.11
单位质量响应值RSD%判断
22827.1022756.740.22数据可信
供试品溶液-24091801-1批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
30min154039-5403913.86213.872.7513.8613.862.74
254090-5409013.87513.87
354081-5408113.87213.87
456741-5674114.55514.55
552502-5250213.46713.47
652876-5287613.56313.56
60min192025-9202523.60623.391.2923.6323.411.29
291718-9171823.52723.55
392708-9270823.78123.80
489782-8978223.03023.05
589987-8998723.08323.11
690803-9080323.29223.31
120min1147074-14707437.72637.081.4837.7937.141.47
2145680-14568037.36937.43
3146077-14607737.47137.53
4141584-14158436.31836.38
5142603-14260336.57936.64
6144387-14438737.03737.10
240min1218155-21815555.96055.501.3256.0855.631.31
2218167-21816755.96356.09
3219134-21913456.21156.34
4211654-21165454.29254.42
5214428-21442855.00355.13
6216715-21671555.59055.71
360min1265796-26579668.18067.760.9968.4067.980.99
2267242-26724268.55168.77
3265554-26555468.11868.34
4259917-25991766.67266.89
5262811-26281167.41467.63
6263692-26369267.64067.86
480min1293747-29374775.35075.411.0975.6875.741.09
2295881-29588175.89776.23
3296977-29697776.17876.51
4287927-28792773.85774.18
5295297-29529775.74776.07
6293997-29399775.41475.74
600min1311965-31196580.02379.830.8980.4880.280.89
2312481-31248180.15580.61
3312221-31222180.08980.55
4305778-30577878.43678.88
5313551-31355180.43080.88
6311212-31121279.83080.28
720min1322549-32254982.73882.440.9383.3383.030.93
2322524-32252482.73183.32
3322279-32227982.66983.26
4315706-31570680.98381.56
5324330-32433083.19583.78
6321001-32100182.34182.93
960min1332587-33258785.31385.350.9586.0486.070.95
2331966-33196685.15385.88
3334742-33474285.86686.60
4327375-32737583.97684.69
5336744-33674486.37987.10
6332932-33293285.40186.13
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1345284-34528488.57087.441.1489.4488.311.13
2336736-33673686.37787.25
3342494-34249487.85488.73
4336499-33649986.31687.17
5344706-34470688.42189.29
6339640-33964087.12287.99
1440min1339532-33953287.09488.851.4188.1189.861.40
2345772-34577288.69589.71
3347979-34797989.26190.28
4342487-34248787.85288.85
5353114-35311490.57891.59
6349317-34931789.60490.62
乌帕替尼缓释片项目信息
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D240501对照品来源自制对照品使用方法直接使用
对照品含量(%)97.44对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
115.023428753428243423573420813424993425270.10
215.073420233417883419060.05
单位质量响应值RSD%判断
22804.7322687.860.37数据可信
供试品溶液-24091801-2批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
30min151172-5117213.15312.873.7613.1512.873.76
247708-4770812.26212.26
347901-4790112.31212.31
452402-5240213.46913.47
550822-5082213.06313.06
650438-5043812.96412.96
60min189518-8951823.00922.822.6923.0322.842.68
290684-9068423.30823.33
384561-8456121.73521.76
487737-8773722.55122.57
591092-9109223.41323.43
689149-8914922.91422.94
120min1144750-14475037.20536.922.0637.2736.982.07
2143516-14351636.88836.95
3137866-13786635.43535.49
4144778-14477837.21237.27
5146275-14627537.59737.66
6144573-14457337.15937.22
240min1218874-21887456.25755.861.5156.3855.991.51
2215917-21591755.49755.62
3211999-21199954.49054.61
4216469-21646955.63955.76
5221155-22115556.84356.97
6219657-21965756.45856.58
360min1269206-26920669.19468.520.9869.4168.730.98
2264937-26493768.09668.31
3262941-26294167.58367.79
4265102-26510268.13968.35
5269141-26914169.17769.40
6268084-26808468.90569.12
480min1300988-30098877.36276.330.9877.6976.660.98
2293182-29318275.35675.68
3295379-29537975.92176.24
4295287-29528775.89776.23
5297827-29782776.55076.88
6299226-29922676.91077.24
600min1318854-31885481.95480.910.9882.4181.370.97
2310180-31018079.72580.18
3315538-31553881.10281.55
4312749-31274980.38580.84
5314645-31464580.87381.33
6316847-31684781.43981.90
720min1329143-32914384.59983.341.0185.2083.931.01
2319412-31941282.09882.68
3323727-32372783.20783.79
4322785-32278582.96583.55
5324431-32443183.38883.98
6325964-32596483.78284.38
960min1340725-34072587.57686.161.1388.3186.891.13
2329279-32927984.63485.36
3335130-33513086.13886.86
4334163-33416385.88986.62
5334575-33457585.99586.73
6337342-33734286.70687.44
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1348731-34873189.63488.251.1490.5289.121.14
2337277-33727786.69087.55
3342399-34239988.00688.87
4342756-34275688.09888.97
5342596-34259688.05788.94
6346275-34627589.00289.88
1440min1352713-35271390.65788.382.7991.6989.402.76
2333912-33391285.82586.83
3348376-34837689.54290.55
4329816-32981684.77285.79
5347485-34748589.31390.34
6350938-35093890.20191.23
乌帕替尼缓释片项目信息
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D240501对照品来源自制对照品使用方法直接使用
对照品含量(%)97.44对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
115.023427903430623427433426403421863426840.10
215.073422013421423421720.02
单位质量响应值RSD%判断
22815.1822705.510.35数据可信
供试品溶液-24091801-3批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
30min149153-4915312.62612.185.7212.6312.185.72
244251-4425111.36711.37
346741-4674112.00612.01
448001-4800112.33012.33
544820-4482011.51311.51
651437-5143713.21313.21
60min187526-8752622.48321.632.9422.5021.652.94
282419-8241921.17121.19
383429-8342921.43021.45
486501-8650122.21922.24
580972-8097220.79920.82
684311-8431121.65721.68
120min1141371-14137136.31435.921.5036.3735.971.50
2139299-13929935.78235.84
3136484-13648435.05935.11
4142622-14262236.63536.69
5139929-13992935.94336.00
6139277-13927735.77635.83
240min1214595-21459555.12355.321.6655.2455.431.66
2217217-21721755.79655.91
3209811-20981153.89454.01
4217871-21787155.96456.08
5213071-21307154.73154.85
6219503-21950356.38456.50
360min1264226-26422667.87268.581.6068.0868.781.60
2269189-26918969.14669.35
3260822-26082266.99767.20
4269526-26952669.23369.44
5265458-26545868.18868.39
6272566-27256670.01470.23
480min1297502-29750276.41977.111.2876.7477.431.28
2303295-30329577.90778.23
3295506-29550675.90676.22
4302173-30217377.61977.95
5297541-29754176.42976.75
6305038-30503878.35578.68
600min1318693-31869381.86282.051.2782.3182.501.27
2324095-32409583.25083.70
3314681-31468180.83281.27
4320306-32030682.27782.73
5315161-31516180.95581.40
6323672-32367283.14183.60
720min1329234-32923484.57084.850.9985.1685.440.99
2333854-33385485.75786.35
3327364-32736484.09084.67
4330730-33073084.95485.55
5326530-32653083.87684.46
6334310-33431085.87486.47
960min1340447-34044787.45087.590.8688.1888.320.86
2344062-34406288.37989.11
3338716-33871687.00687.72
4341399-34139987.69588.43
5336987-33698786.56287.28
6344295-34429588.43989.18
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1354777-35477791.13190.890.8792.0191.770.87
2356302-35630291.52392.40
3351404-35140490.26591.13
4355026-35502691.19592.08
5348877-34887789.61690.48
6356726-35672691.63292.52
1440min1356777-35677791.64591.030.9892.6792.060.97
2357267-35726791.77192.80
3351943-35194390.40391.42
4355196-35519691.23992.27
5348554-34855489.53390.55
6356569-35656991.59292.63
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