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%
115.003387543391793390553384783387373388410.09
215.103391473385183388320.14
单位质量响应值RSD%判断
22589.4022439.210.48数据可信
供试品溶液-24093001-1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%
30min137501-375019.7389.563.049.749.563.02
235075-350759.1089.11
337107-371079.6369.64
438258-382589.9359.93
536759-367599.5459.55
636077-360779.3689.37
60min172000-7200018.69718.322.5618.7118.342.57
268622-6862217.82017.83
370910-7091018.41418.43
472831-7283118.91318.93
570677-7067718.35318.37
668293-6829317.73417.75
120min1126993-12699332.97732.102.6933.0232.142.69
2120373-12037331.25831.30
3125239-12523932.52232.57
4125723-12572332.64732.70
5124657-12465732.37132.42
6118637-11863730.80730.85
240min1201497-20149752.32450.603.6852.4350.703.68
2189277-18927749.15149.25
3197229-19722951.21651.32
4199645-19964551.84351.95
5198527-19852751.55351.65
6183065-18306547.53847.63
360min1252622-25262265.60062.214.9265.7962.394.91
2230438-23043859.84060.02
3243131-24313163.13663.32
4245917-24591763.85964.05
5244626-24462663.52463.71
6220586-22058657.28157.46
480min1274988-27498871.40868.884.9971.7169.174.99
2254667-25466766.13166.41
3272020-27202070.63870.93
4273651-27365171.06171.36
5273045-27304570.90471.20
6243091-24309163.12563.40
600min1290926-29092675.54773.164.9575.9673.564.95
2270937-27093770.35670.75
3288593-28859374.94175.35
4291675-29167575.74276.16
5290122-29012275.33875.75
6258182-25818267.04467.42
720min1304377-30437779.04076.475.0979.5877.005.08
2282904-28290473.46473.97
3300469-30046978.02578.56
4304216-30421678.99879.54
5305625-30562579.36479.90
6269311-26931169.93470.42
960min1320718-32071883.28380.504.5583.9681.154.55
2298954-29895477.63278.26
3316998-31699882.31782.98
4320326-32032683.18283.85
5316673-31667382.23382.90
6286388-28638874.36974.97
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1330986-33098685.95083.424.1486.7684.204.14
2309206-30920680.29481.05
3328266-32826685.24386.04
4331282-33128286.02786.84
5327698-32769885.09685.90
6299975-29997577.89778.63
1440min1337265-33726587.58085.223.5688.5486.153.57
2317550-31755082.46183.35
3334212-33421286.78787.73
4336366-33636687.34788.30
5334129-33412986.76687.71
6309573-30957380.38981.25
极限1337307-33730787.59185.233.5188.6986.303.52
2316939-31693982.30283.33
3333683-33368386.65087.74
4336175-33617587.29788.40
5334732-33473286.92288.01
6310423-31042380.61081.60
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%
115.003397683399853395453392003391193395230.11
215.103378413384453381430.13
单位质量响应值RSD%判断
22634.8722393.580.76数据可信
供试品溶液-24093001-2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%
30min138454-384549.9869.843.149.999.843.14
237360-373609.7029.70
336259-362599.4169.42
437064-370649.6259.62
538676-3867610.04410.04
639476-3947610.25110.25
60min172439-7243918.81119.033.3718.8319.053.35
272507-7250718.82918.85
370009-7000918.18018.20
475963-7596319.72619.74
572284-7228418.77118.79
676463-7646319.85619.87
120min1124647-12464732.36932.382.1532.4232.422.14
2125309-12530932.54132.59
3120032-12003231.17031.22
4127651-12765133.14933.20
5123730-12373032.13132.18
6126655-12665532.89032.94
240min1192053-19205349.87349.932.0049.9750.032.01
2191738-19173849.79149.89
3185709-18570948.22648.32
4197092-19709251.18251.29
5192025-19202549.86649.97
6194908-19490850.61450.72
360min1234408-23440860.87261.121.8861.0661.301.88
2234336-23433660.85361.04
3228025-22802559.21459.39
4240851-24085162.54562.73
5235863-23586361.25061.43
6238718-23871861.99162.18
480min1259485-25948567.38468.072.4867.6768.362.48
2259262-25926267.32667.61
3252238-25223865.50265.78
4270412-27041270.22170.52
5264375-26437568.65468.94
6266973-26697369.32869.62
600min1277139-27713971.96872.462.5472.3772.862.54
2275722-27572271.60072.00
3267532-26753269.47469.86
4286888-28688874.50074.91
5282441-28244173.34573.75
6284561-28456173.89674.30
720min1288436-28843674.90275.672.5375.4276.192.53
2288174-28817474.83475.35
3279803-27980372.66073.16
4299698-29969877.82778.36
5295011-29501176.60977.13
6297266-29726677.19577.73
960min1304947-30494779.19079.992.4979.8380.642.49
2304178-30417878.99079.63
3296200-29620076.91877.54
4316471-31647182.18282.85
5312110-31211081.05081.70
6314376-31437681.63882.30
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1316877-31687782.28883.032.1283.0683.812.12
2315853-31585382.02282.80
3309430-30943080.35481.11
4326067-32606784.67485.48
5324168-32416884.18184.97
6326005-32600584.65885.45
1440min1324678-32467884.31384.871.8985.2385.791.89
2323239-32323983.94084.85
3317155-31715582.36083.25
4332149-33214986.25487.20
5331718-33171886.14287.07
6331998-33199886.21487.15
极限1324864-32486484.36285.062.0785.4286.122.07
2323538-32353884.01785.07
3317315-31731582.40183.42
4333882-33388286.70487.79
5331662-33166286.12787.20
6334124-33412486.76687.85
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%
115.003389693394373391243388953391633391180.07
215.103387083390823388950.08
单位质量响应值RSD%判断
22607.8722443.380.52数据可信
供试品溶液-24093001-3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%
30min137812-378129.81410.273.349.8110.273.36
240677-4067710.55810.56
338330-383309.9489.95
441022-4102210.64710.65
540350-4035010.47310.47
639197-3919710.17310.17
60min169918-6991818.14719.072.9418.1619.082.95
274702-7470219.38919.41
371709-7170918.61218.63
475342-7534219.55519.57
574852-7485219.42819.45
674211-7421119.26119.28
120min1123938-12393832.16832.531.4032.2132.581.40
2125969-12596932.69532.74
3122506-12250631.79631.84
4127091-12709132.98633.04
5126504-12650432.83432.88
6125966-12596632.69432.74
240min1186587-18658748.42850.392.1048.5350.492.10
2194908-19490850.58850.69
3192652-19265250.00250.10
4196838-19683851.08951.19
5197080-19708051.15251.26
6196819-19681951.08451.19
360min1231413-23141360.06362.172.0360.2462.362.03
2236919-23691961.49261.68
3238829-23882961.98862.17
4242696-24269662.99163.18
5243705-24370563.25363.44
6243666-24366663.24363.43
480min1260291-26029167.55869.752.1467.8470.042.13
2264017-26401768.52568.82
3267799-26779969.50769.79
4273856-27385671.07971.37
5274325-27432571.20071.50
6272193-27219370.64770.94
600min1279305-27930572.49374.642.1172.8975.042.11
2281831-28183173.14973.55
3286049-28604974.24374.65
4292723-29272375.97676.39
5292988-29298876.04476.46
6292463-29246375.90876.32
720min1290044-29004475.28077.622.2575.7978.152.24
2292181-29218175.83576.36
3298398-29839877.44977.98
4305492-30549279.29079.83
5305430-30543079.27479.81
6302778-30277878.58579.12
960min1306503-30650379.55281.722.0580.1982.382.05
2308189-30818979.99080.64
3313362-31336281.33281.99
4320642-32064283.22283.89
5319927-31992783.03683.71
6320408-32040883.16183.83
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1316804-31680482.22684.211.9383.0085.011.93
2317096-31709682.30283.09
3323728-32372884.02384.81
4329289-32928985.46686.28
5329936-32993685.63486.45
6329866-32986685.61686.42
1440min1323216-32321683.89085.541.7384.8086.481.74
2322365-32236583.66984.59
3328803-32880385.34086.27
4334979-33497986.94387.90
5334518-33451886.82387.78
6333537-33353786.56987.52
极限1324549-32454984.23685.541.6085.2986.621.60
2322194-32219483.62584.69
3329280-32928085.46486.54
4332713-33271386.35587.45
5335391-33539187.05088.15
6333298-33329886.50787.60
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