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500
标示量(mg)30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%
115.063473843471223469443461103466523468420.15
215.103477383466763472070.22
单位质量响应值RSD%判断
23030.6822993.840.12数据可信
供试品溶液-1261778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%
30min150936-5093613.21213.162.4913.2113.162.47
248637-4863712.61512.62
351556-5155613.37213.37
451392-5139213.33013.33
549893-4989312.94112.94
652024-5202413.49413.49
60min185290-8529022.12222.251.7122.1422.271.71
283142-8314221.56521.59
386047-8604722.31822.34
487172-8717222.61022.63
586041-8604122.31722.34
686997-8699722.56522.59
120min1146450-14645037.98536.352.8338.0436.402.82
2134168-13416834.80034.86
3139881-13988136.28236.34
4141421-14142136.68136.74
5139536-13953636.19236.25
6139351-13935136.14436.20
240min1213439-21343955.36155.531.4355.4855.651.43
2208455-20845554.06854.18
3216865-21686556.24956.37
4214664-21466455.67855.80
5214724-21472455.69455.81
6216518-21651856.15956.28
360min1267735-26773569.44469.301.1669.6669.511.16
2262362-26236268.05068.26
3267275-26727569.32469.54
4269538-26953869.91170.13
5265177-26517768.78068.99
6270954-27095470.27970.49
480min1314255-31425581.51081.291.5981.8481.621.59
2306102-30610279.39579.71
3312818-31281881.13781.47
4315420-31542081.81282.14
5310777-31077780.60880.93
6321039-32103983.26983.60
600min1334896-33489686.86486.191.3287.3386.661.32
2326488-32648884.68385.13
3331305-33130585.93286.40
4334678-33467886.80787.27
5328403-32840385.18085.64
6338097-33809787.69488.16
720min1345601-34560189.64089.201.2990.2589.811.29
2339361-33936188.02288.61
3342008-34200888.70889.32
4346729-34672989.93390.54
5339406-33940688.03388.64
6350425-35042590.89191.51
960min1358181-35818192.90392.321.4693.6693.071.46
2350498-35049890.91091.65
3352801-35280191.50892.26
4359229-35922993.17593.94
5351317-35131791.12391.87
6363526-36352694.29095.06
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1363731-36373194.34394.041.5595.2694.951.55
2356993-35699392.59593.49
3360232-36023293.43594.34
4366430-36643095.04395.96
5356885-35688592.56793.47
6371026-37102696.23597.16
1440min1367891-36789195.42295.041.4096.4996.111.40
2361081-36108193.65594.70
3365009-36500994.67495.74
4370230-37023096.02897.10
5360797-36079793.58294.64
6373622-37362296.90897.99
极限1366801-36680195.13994.841.4796.3796.071.47
2359567-35956793.26394.46
3364741-36474194.60595.83
4369733-36973395.89997.13
5360017-36001793.37994.59
6373142-37314296.78498.03
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500
标示量(mg)30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%
115.063453913451813463533461123455863457250.15
215.103467473457413462440.21
单位质量响应值RSD%判断
22956.5122930.070.09数据可信
供试品溶液-1261778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%
30min148427-4842712.59912.892.3812.6012.892.39
249513-4951312.88112.88
349837-4983712.96512.97
448481-4848112.61312.61
549416-4941612.85612.86
651658-5165813.43913.44
60min183344-8334421.68222.122.1621.7022.142.16
284709-8470922.03722.06
386171-8617122.41822.44
483224-8322421.65121.67
584743-8474322.04622.07
688060-8806022.90922.93
120min1135692-13569235.30135.701.8335.3635.761.83
2135967-13596735.37235.43
3138666-13866636.07536.13
4134308-13430834.94135.00
5137366-13736635.73635.79
6141339-14133936.77036.83
240min1213241-21324155.47655.611.3655.5955.721.36
2211473-21147355.01655.13
3217351-21735156.54556.66
4209970-20997054.62554.74
5213670-21367055.58755.70
6216817-21681756.40656.53
360min1267014-26701469.46569.450.9669.6769.660.96
2265116-26511668.97169.18
3268454-26845469.84070.05
4263218-26321868.47768.68
5267425-26742569.57269.78
6270472-27047270.36570.58
480min1312016-31201681.17281.321.1581.5081.651.15
2311554-31155481.05281.38
3314524-31452481.82582.15
4306265-30626579.67680.00
5314740-31474081.88182.21
6316362-31636282.30382.64
600min1332639-33263986.53885.910.9387.0086.370.93
2329974-32997485.84486.30
3330420-33042085.96086.43
4324826-32482684.50584.96
5329918-32991885.83086.29
6333597-33359786.78787.26
720min1344115-34411589.52388.871.1890.1389.471.18
2341107-34110788.74189.34
3341945-34194588.95989.57
4335312-33531287.23387.83
5339816-33981688.40589.01
6347227-34722790.33390.95
960min1354124-35412492.12791.961.0092.8892.721.00
2354385-35438592.19592.94
3353379-35337991.93392.69
4347430-34743090.38691.13
5353276-35327691.90692.66
6358363-35836393.23094.00
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1359573-35957393.54593.541.0994.4594.441.09
2358525-35852593.27294.18
3359674-35967493.57194.48
4353768-35376892.03492.92
5359768-35976893.59594.50
6365999-36599995.21696.14
1440min1363407-36340794.54294.581.0595.6095.651.05
2363000-36300094.43695.50
3364844-36484494.91695.98
4356835-35683592.83293.88
5365078-36507894.97796.04
6368270-36827095.80796.89
极限1362081-36208194.19794.491.1095.4295.711.10
2363623-36362394.59895.81
3363827-36382794.65195.88
4356835-35683592.83294.03
5363598-36359894.59295.81
6369205-36920596.05097.29
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