非布司他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241101对照品来源ZZ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%
111.143677536928369343692037050369210.27
211.393848538602385440.22
单位质量响应值RSD%判断
3314.273384.021.48数据可信
供试品溶液-6042701批-多替诺雷-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%
5min120429-2042954.73453.7114.1654.7353.7114.16
215858-1585842.48742.49
318273-1827348.95748.96
421142-2114256.64456.64
524312-2431265.13765.14
620273-2027354.31654.32
10min130935-3093582.88183.241.5082.9783.331.51
230265-3026581.08681.16
331027-3102783.12883.21
431624-3162484.72784.82
531204-3120483.60283.71
631365-3136584.03384.12
15min133254-3325489.09488.721.6189.3288.951.60
232979-3297988.35888.56
333632-3363290.10790.33
433564-3356489.92590.16
532165-3216586.17786.42
633090-3309088.65588.89
20min133988-3398891.06190.582.1891.4490.962.17
233595-3359590.00890.36
334395-3439592.15192.52
434518-3451892.48192.87
532474-3247487.00587.40
633880-3388090.77291.15
30min134469-3446992.35091.562.0192.8892.082.00
234375-3437592.09892.60
334755-3475593.11693.64
434466-3446692.34292.88
532833-3283387.96788.50
634136-3413691.45891.99
45min134931-3493193.58893.011.0894.2793.691.07
234612-3461292.73393.39
335200-3520094.30894.99
434849-3484993.36894.06
534107-3410791.38092.06
634591-3459192.67793.36
60min135111-3511194.07093.342.0294.9194.172.00
235059-3505993.93094.74
335381-3538194.79395.63
435098-3509894.03594.88
533433-3343389.57490.41
634942-3494293.61794.45
极限135202-3520294.31493.692.0595.3194.682.03
235165-3516594.21495.18
335558-3555895.26796.26
435233-3523394.39795.40
533549-3354989.88590.87
635110-3511094.06795.06
非布司他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101278-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
111.112672832667662674642672702674652672500.11
211.312774452776322775380.05
单位质量响应值RSD%判断
24054.9124539.171.41数据可信
供试品溶液-6042701批-非布司他-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%
5min1168537-16853762.37261.7114.2062.3761.7014.20
2130338-13033848.23648.24
3153807-15380756.92156.92
4175022-17502264.77264.77
5201626-20162674.61874.62
6171080-17108063.31463.31
10min1242866-24286689.88090.171.5889.9890.271.59
2237808-23780888.00888.09
3246575-24657591.25391.35
4245812-24581290.97191.08
5240862-24086289.13989.26
6247918-24791891.75091.86
15min1257311-25731195.22694.512.0995.4894.762.08
2252454-25245493.42993.66
3261434-26143496.75297.00
4256788-25678895.03395.29
5246215-24621591.12091.39
6258003-25800395.48295.74
20min1261859-26185996.90995.872.5897.3296.282.57
2256059-25605994.76395.15
3263679-26367997.58397.99
4263423-26342397.48897.91
5246702-24670291.30091.72
6262578-26257897.17597.59
30min1264339-26433997.82796.452.6898.4097.022.66
2257870-25787095.43395.97
3265560-26556098.27998.85
4260992-26099296.58897.17
5248081-24808191.81092.39
6266891-26689198.77299.35
45min1267090-26709098.84597.302.9099.5898.032.89
2260419-26041996.37697.08
3267871-26787199.13499.87
4262373-26237397.09997.84
5249289-24928992.25792.99
6270384-270384100.064100.81
60min1267217-26721798.89297.543.1599.7998.433.13
2260920-26092096.56297.42
3268957-26895799.536100.44
4262776-26277697.24998.15
5248976-24897692.14293.03
6272522-272522100.855101.77
极限1267408-26740898.96397.523.20100.0398.573.17
2261063-26106396.61597.64
3269181-26918199.619100.68
4263022-26302297.34098.41
5248377-24837791.92092.96
6271926-271926100.635101.71
非布司他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241101对照品来源ZZ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%
111.143742137517374833764437537375200.22
211.393822638101381640.24
单位质量响应值RSD%判断
3368.043350.660.37数据可信
供试品溶液-6042702批-多替诺雷-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%
5min120238-2023854.05260.527.4554.0560.527.45
223980-2398064.04664.05
323636-2363663.12763.13
424216-2421664.67664.68
520892-2089255.79855.80
622992-2299261.40761.41
10min130406-3040681.20884.942.6081.3085.052.60
232679-3267987.27987.39
331841-3184185.04185.15
432299-3229986.26486.37
531333-3133383.68483.78
632270-3227086.18786.29
15min132992-3299288.11589.711.2588.3489.961.25
233374-3337489.13589.39
333506-3350689.48889.73
434099-3409991.07291.32
533538-3353889.57389.81
634036-3403690.90391.15
20min133617-3361789.78491.271.3290.1691.671.32
233768-3376890.18890.59
334071-3407190.99791.39
434756-3475692.82693.23
534242-3424291.45491.84
634592-3459292.38892.79
30min134156-3415691.22492.471.3091.7593.011.30
234173-3417391.26991.82
334387-3438791.84192.39
435165-3516593.91994.48
534757-3475792.82993.36
635087-3508793.71094.26
45min134586-3458692.37293.531.1893.0594.231.18
234645-3464592.53093.23
334773-3477392.87293.57
435569-3556994.99895.71
535157-3515793.89794.59
635396-3539694.53695.24
60min134924-3492493.27594.031.0594.1094.881.06
234838-3483893.04593.90
334946-3494693.33494.19
435771-3577195.53796.41
535271-3527194.20295.05
635480-3548094.76095.63
极限134904-3490493.22294.391.2694.2195.401.26
235002-3500293.48394.50
335054-3505493.62294.63
435947-3594796.00797.04
535329-3532994.35795.36
635817-3581795.66096.68
非布司他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101278-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
111.112740582743952736652736712732422738060.16
211.312773472766232769850.19
单位质量响应值RSD%判断
24645.0024490.270.45数据可信
供试品溶液-6042702批-非布司他-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%
5min1170217-17021762.29569.727.3962.2969.727.39
2201129-20112973.60873.61
3197388-19738872.23972.24
4205522-20552275.21575.22
5176758-17675864.68964.69
6192052-19205270.28670.29
10min1240381-24038187.97391.472.0788.0891.582.07
2249997-24999791.49291.61
3250976-25097691.85091.97
4254567-25456793.16593.29
5249357-24935791.25891.37
6254322-25432293.07593.19
15min1256201-25620193.76395.591.4794.0195.861.48
2258786-25878694.70994.98
3259219-25921994.86795.14
4266816-26681697.64797.93
5263116-26311696.29396.55
6263063-26306396.27496.55
20min1259788-25978895.07596.471.4395.4896.901.43
2260227-26022795.23695.67
3261991-26199195.88296.31
4269672-26967298.69399.14
5265806-26580697.27897.70
6264052-26405296.63697.07
30min1263521-26352196.44297.251.5297.0197.841.52
2261574-26157495.72996.32
3262826-26282696.18796.78
4272066-27206699.569100.18
5268927-26892798.42099.00
6265492-26549297.16397.76
45min1265509-26550997.16997.561.6897.9098.311.67
2262058-26205895.90696.66
3262989-26298996.24797.00
4273405-273405100.059100.83
5270556-27055699.01699.76
6264891-26489196.94397.70
60min1267547-26754797.91597.651.7998.8098.561.78
2262268-26226895.98396.89
3262216-26221695.96496.88
4273312-273312100.025100.97
5271428-27142899.335100.25
6264171-26417196.67997.60
极限1265379-26537997.12297.461.7798.1798.531.76
2261535-26153595.71596.79
3261608-26160895.74196.81
4272404-27240499.692100.80
5271481-27148199.355100.43
6265369-26536997.11898.20
非布司他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241101对照品来源ZZ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%
111.143824138269382393831038446383010.23
211.393885639001389280.27
单位质量响应值RSD%判断
3438.153417.730.43数据可信
供试品溶液-6042703批-多替诺雷-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%
5min119779-1977951.76946.6120.5351.7746.6120.52
220074-2007452.54152.54
317990-1799047.08647.09
410555-1055527.62627.63
518489-1848948.39248.39
619968-1996852.26452.26
10min131324-3132481.98678.934.5582.0779.004.57
230714-3071480.39080.48
329780-2978077.94578.02
427676-2767672.43872.48
530084-3008478.74178.82
631349-3134982.05282.14
15min133628-3362888.01785.672.1688.2485.882.18
232810-3281085.87686.10
332784-3278485.80886.02
431569-3156982.62882.79
532403-3240384.81085.02
633190-3319086.87087.09
20min134364-3436489.94387.811.5090.3188.161.51
233413-3341387.45487.82
333736-3373688.29988.65
433071-3307186.55986.86
533011-3301186.40286.76
633705-3370588.21888.59
30min134977-3497791.54889.291.5392.0789.791.53
233846-3384688.58789.10
334300-3430089.77690.27
434142-3414289.36289.81
533406-3340687.43687.93
634025-3402589.05689.57
45min135249-3524992.26090.341.4192.9390.981.41
234384-3438489.99590.65
334737-3473790.91991.57
434604-3460490.57191.17
533789-3378988.43889.08
634325-3432589.84190.51
60min135502-3550292.92290.881.3893.7591.681.37
234418-3441890.08490.89
334791-3479191.06191.86
434903-3490391.35492.10
534105-3410589.26590.06
634612-3461290.59291.41
极限135635-3563593.27091.191.4594.2592.141.44
234513-3451390.33391.29
335034-3503491.69792.65
434909-3490991.37092.27
534148-3414889.37890.32
634799-3479991.08292.05
非布司他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101278-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
111.112821742817642810742808172808072813270.22
211.312828132830862829500.07
单位质量响应值RSD%判断
25321.9625017.680.86数据可信
供试品溶液-6042703批-非布司他-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%
5min1164851-16485158.88953.1620.1958.8953.1620.19
2166931-16693159.63259.63
3152058-15205854.31954.32
488905-8890531.75931.76
5154084-15408455.04355.04
6166123-16612359.34459.34
10min1246436-24643688.03385.353.7288.1385.443.73
2242836-24283686.74786.85
3237387-23738784.80184.89
4223233-22323379.74579.80
5236515-23651584.48984.58
6247165-24716588.29488.39
15min1260326-26032692.99590.771.7093.2491.001.71
2253887-25388790.69590.94
3256448-25644891.61091.84
4248264-24826488.68688.87
5250509-25050989.48889.72
6255097-25509791.12791.37
20min1264063-26406394.33092.351.5994.7392.731.59
2256429-25642991.60392.00
3262390-26239093.73394.12
4257924-25792492.13792.47
5252800-25280090.30790.69
6257502-25750291.98792.38
30min1274511-27451198.06393.892.6298.6294.432.61
2259629-25962992.74693.29
3265700-26570094.91595.46
4263846-26384694.25394.74
5255038-25503891.10691.64
6258339-25833992.28692.84
45min1268323-26832395.85294.022.0296.5794.712.00
2261427-26142793.38994.09
3268262-26826295.83096.53
4266483-26648395.19595.84
5255690-25569091.33992.02
6258943-25894392.50193.21
60min1268721-26872195.99494.242.0596.8795.082.03
2262563-26256393.79494.65
3268579-26857995.94496.80
4267846-26784695.68296.48
5256340-25634091.57192.41
6258777-25877792.44293.30
极限1268843-26884396.03894.091.9697.0895.101.95
2262694-26269493.84194.86
3267303-26730395.48896.51
4266797-26679795.30796.27
5256000-25600091.45092.44
6258784-25878492.44593.46
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