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D5124-1-24101对照品来源自制对照品使用方法直接使用
对照品含量(%)99.48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%
114.701679221691541697461698141692011691670.45
214.781705591707861706720.10
单位质量响应值RSD%判断
11507.9611547.500.25数据可信
供试品溶液-2025081321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%
30min128480-2848014.74614.213.6414.7514.213.64
227092-2709214.02814.03
328490-2849014.75214.75
425953-2595313.43813.44
527773-2777314.38014.38
626852-2685213.90313.90
60min150282-5028226.03525.675.0926.0625.695.09
253885-5388527.90127.92
349893-4989325.83425.86
446445-4644524.04824.07
548909-4890925.32425.35
648032-4803224.87024.89
120min180366-8036641.61240.842.0841.6840.902.08
278672-7867240.73540.80
379951-7995141.39741.46
475809-7580939.25239.31
579624-7962441.22841.29
678792-7879240.79740.86
240min1122059-12205963.20062.161.8263.3462.301.82
2119908-11990862.08662.22
3121008-12100862.65562.79
4115939-11593960.03160.16
5119980-11998062.12362.26
6121444-12144462.88163.01
360min1146874-14687476.04875.561.0276.2975.791.02
2146341-14634175.77276.01
3145864-14586475.52575.77
4143337-14333774.21774.44
5145463-14546375.31875.56
6147657-14765776.45476.69
480min1163706-16370684.76484.171.4585.1384.541.45
2165435-16543585.65986.03
3161353-16135383.54583.91
4159176-15917682.41882.77
5161310-16131083.52383.89
6164405-16440585.12585.49
600min1172849-17284989.49889.151.1290.0189.651.12
2172452-17245289.29289.80
3172631-17263189.38589.89
4169477-16947787.75288.24
5170654-17065488.36188.86
6174999-17499990.61191.12
720min1178864-17886492.61292.381.1193.2793.031.11
2179194-17919492.78393.44
3177555-17755591.93492.59
4175637-17563790.94191.58
5177675-17767591.99692.65
6181534-18153493.99594.65
960min1185818-18581896.21396.070.8397.0396.880.82
2184774-18477495.67296.49
3184502-18450295.53196.34
4186452-18645296.54197.33
5183715-18371595.12495.93
6187951-18795197.31798.13
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1189207-18920797.96797.811.1698.9498.781.15
2190544-19054498.66099.63
3187488-18748897.07798.04
4186678-18667896.65897.61
5187251-18725196.95597.92
6192249-19224999.543100.52
1440min1191162-19116298.98098.191.18100.1299.321.18
2189071-18907197.89799.03
3186735-18673596.68797.82
4188462-18846297.58298.69
5189193-18919397.96099.08
6193150-193150100.009101.15
极限1190167-19016798.46598.501.1199.7799.801.10
2190667-19066798.723100.02
3188610-18861097.65898.95
4188990-18899097.85599.13
5188825-18882597.77099.06
6194182-194182100.543101.85
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D5124-1-24101对照品来源自制对照品使用方法直接使用
对照品含量(%)99.48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%
114.701706851709681716971714991719081713510.30
214.781705651710231707940.19
单位质量响应值RSD%判断
11656.5311555.750.62数据可信
供试品溶液-2025081321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%
30min128042-2804214.42214.253.3414.4214.253.34
227978-2797814.38914.39
329124-2912414.97814.98
427217-2721713.99714.00
527491-2749114.13814.14
626374-2637413.56413.56
60min149771-4977125.59725.252.7525.6225.282.74
249279-4927925.34425.37
351134-5113426.29826.32
448444-4844424.91424.94
548884-4888425.14125.16
647100-4710024.22324.25
120min181369-8136941.84740.902.4041.9140.972.40
280464-8046441.38241.45
381681-8168142.00842.08
478769-7876940.51040.57
577235-7723539.72139.79
677688-7768839.95440.02
240min1120220-12022061.82862.081.7661.9662.221.76
2121435-12143562.45362.59
3124453-12445364.00564.14
4120138-12013861.78661.92
5118087-11808760.73160.86
6119967-11996761.69861.83
360min1145389-14538974.77275.261.4575.0175.501.45
2146015-14601575.09475.33
3150317-15031777.30677.55
4145334-14533474.74474.98
5144273-14427374.19874.43
6146707-14670775.45075.68
480min1162517-16251783.58183.861.3583.9484.221.34
2161976-16197683.30383.67
3162144-16214483.38983.76
4167108-16710885.94286.30
5160886-16088682.74283.10
6163767-16376784.22484.58
600min1171773-17177388.34188.901.4588.8489.401.45
2171143-17114388.01788.52
3177454-17745491.26391.78
4172168-17216888.54489.05
5170730-17073087.80588.30
6173898-17389889.43489.93
720min1177773-17777391.42792.041.5792.0892.701.57
2177281-17728191.17491.82
3184231-18423194.74895.41
4177953-17795391.51992.17
5176642-17664290.84591.49
6179968-17996892.55693.20
960min1184921-18492195.10395.541.5795.9196.341.56
2183487-18348794.36595.17
3191136-19113698.29999.12
4185134-18513495.21296.02
5183287-18328794.26395.05
6186643-18664395.98896.79
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1186980-18698096.16297.401.4497.1298.361.44
2188565-18856596.97797.94
3194439-19443999.998100.99
4188535-18853596.96297.92
5187561-18756196.46197.41
6190252-19025297.84598.81
1440min1190001-19000197.71598.211.6198.8499.341.61
2189256-18925697.33298.45
3197167-197167101.401102.55
4189761-18976197.59298.72
5189175-18917597.29198.40
6190472-19047297.95899.08
极限1189187-18918797.29797.791.2798.5899.081.27
2188251-18825196.81598.10
3194674-194674100.119101.44
4189239-18923997.32498.61
5188568-18856896.97898.25
6190967-19096798.21299.50
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