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%
110.233440034585342423476233833343641.04
210.183445034942346961.01
单位质量响应值RSD%判断
3359.143408.251.03数据可信
供试品溶液-5122301批-非布司他-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min14449-444911.79718.5922.1311.8018.6022.13
27343-734319.47119.47
36881-688118.24618.25
48208-820821.76521.77
56325-632516.77216.77
68865-886523.50723.51
10min115201-1520140.30946.668.4940.3346.698.50
218241-1824148.37048.40
316840-1684044.65544.69
418766-1876649.76249.80
517223-1722345.67045.70
619303-1930351.18651.23
15min121771-2177157.73061.693.8757.8261.803.88
223380-2338061.99762.11
322987-2298760.95561.06
424169-2416964.08964.21
523081-2308161.20461.31
624193-2419364.15364.28
20min125023-2502366.35469.172.2366.5469.382.25
226523-2652370.33170.55
325934-2593468.76968.98
426283-2628369.69569.92
526102-2610269.21569.42
626636-2663670.63170.86
30min128377-2837775.24876.711.1875.5477.041.19
229305-2930577.70878.04
328974-2897476.83177.15
429103-2910377.17377.51
528692-2869276.08376.40
629126-2912677.23477.58
45min130344-3034480.46381.640.9780.8882.100.98
231250-3125082.86683.33
330857-3085781.82482.27
430860-3086081.83282.30
530791-3079181.64982.10
630634-3063481.23281.71
60min131732-3173284.14484.430.6584.7085.020.64
231845-3184584.44485.04
332112-3211285.15285.74
431745-3174584.17884.79
532047-3204784.97985.56
631566-3156683.70484.32
极限132310-3231085.67785.720.8186.3786.450.81
232757-3275786.86287.60
332280-3228085.59786.32
432399-3239985.91386.66
531947-3194784.71485.44
632257-3225785.53686.29
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C025-22401010对照品来源自制对照品使用方法直接使用
对照品含量(%)101.3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%
110.202505892492932478482491732461052486020.69
210.142506132530862518500.70
单位质量响应值RSD%判断
24372.7524837.281.34数据可信
供试品溶液-5122301批-多替诺雷-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min138247-3824714.17322.5522.3014.1722.5522.30
264256-6425623.81123.81
358566-5856621.70321.70
470546-7054626.14226.14
556065-5606520.77620.78
677456-7745628.70328.70
10min1121896-12189645.17151.657.6445.1951.687.65
2143738-14373853.26553.30
3134654-13465449.89849.93
4148338-14833854.96955.01
5136758-13675850.67850.71
6150858-15085855.90355.95
15min1166653-16665361.75665.673.4161.8665.803.43
2179612-17961266.55866.69
3175917-17591765.18965.31
4183413-18341367.96768.10
5175702-17570265.10965.23
6181992-18199267.44067.58
20min1189900-18990070.37172.711.6970.5772.941.71
2197763-19776373.28473.52
3196526-19652672.82673.05
4198960-19896073.72873.98
5195841-19584172.57272.80
6198320-19832073.49173.74
30min1213928-21392879.27580.010.7479.5980.370.76
2217798-21779880.70981.07
3216311-21631180.15880.51
4217519-21751980.60580.98
5214403-21440379.45179.80
6215536-21553679.87180.25
45min1229844-22984485.17385.940.7185.6286.430.72
2233915-23391586.68187.18
3232784-23278486.26286.75
4233312-23331286.45886.96
5230793-23079385.52486.01
6230825-23082585.53686.05
60min1239305-23930588.67989.351.0089.2789.981.00
2242900-24290090.01190.65
3245066-24506690.81391.44
4240558-24055889.14389.79
5240198-24019889.01089.63
6238723-23872388.46389.11
极限1245253-24525390.88391.100.5691.6291.880.56
2247654-24765491.77292.56
3246377-24637791.29992.08
4246518-24651891.35292.15
5243670-24367090.29691.07
6245513-24551390.97991.78
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%
110.233478934603348603500334880348270.43
210.183483434689347620.30
单位质量响应值RSD%判断
3404.403414.730.22数据可信
供试品溶液-5122302批-非布司他-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15271-527113.87015.5420.2913.8715.5420.29
26725-672517.69717.70
37178-717818.88918.89
43932-393210.34710.35
56635-663517.46017.46
65680-568014.94714.95
10min115819-1581941.62743.608.2341.6543.638.24
217651-1765146.44846.48
317948-1794847.22947.26
414260-1426037.52537.54
517131-1713145.07945.11
616609-1660943.70643.73
15min121597-2159756.83257.752.3656.9257.842.37
222385-2238558.90559.01
322221-2222158.47458.58
421053-2105355.40055.48
522284-2228458.63958.74
622134-2213458.24558.34
20min124855-2485565.40565.131.4165.5965.321.43
224908-2490865.54465.75
324840-2484065.36565.57
424069-2406963.33663.51
525067-2506765.96366.16
624767-2476765.17365.37
30min127959-2795973.57372.930.6573.8773.230.65
227752-2775273.02873.34
327660-2766072.78673.10
427491-2749172.34172.62
527858-2785873.30773.62
627564-2756472.53372.84
45min130235-3023579.56279.320.7979.9879.740.77
229811-2981178.44678.88
329963-2996378.84679.28
430487-3048780.22580.62
530123-3012379.26779.70
630242-3024279.58080.00
60min131624-3162483.21782.300.8383.7782.860.82
230896-3089681.30181.87
331083-3108381.79482.36
431455-3145582.77283.30
531276-3127682.30182.87
631318-3131882.41282.97
极限132601-3260185.78884.240.9686.4884.930.96
231928-3192884.01784.72
332061-3206184.36785.07
431891-3189183.92084.59
531849-3184983.80984.51
631742-3174283.52884.22
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C025-22401010对照品来源自制对照品使用方法直接使用
对照品含量(%)101.3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%
110.202544492548882549492538202538442543900.22
210.142549762546532548140.09
单位质量响应值RSD%判断
24940.2025129.590.54数据可信
供试品溶液-5122302批-多替诺雷-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min143578-4357815.87017.6519.0615.8717.6419.06
254214-5421419.74319.74
357694-5769421.01121.01
432990-3299012.01412.01
555020-5502020.03720.04
647239-4723917.20317.20
10min1117073-11707342.63544.526.9542.6644.546.96
2130090-13009047.37647.41
3130417-13041747.49547.53
4108284-10828439.43539.45
5125440-12544045.68245.72
6122108-12210844.46944.50
15min1155540-15554056.64457.182.5256.7457.282.54
2160763-16076358.54658.66
3161162-16116258.69158.81
4150352-15035254.75554.84
5157576-15757657.38657.50
6156687-15668757.06257.16
20min1176590-17659064.31063.931.6864.5064.131.69
2177650-17765064.69664.91
3177837-17783764.76464.98
4169915-16991561.87962.06
5176151-17615164.15064.36
6175107-17510763.77063.97
30min1199831-19983172.77472.351.0973.0772.661.10
2200377-20037772.97373.29
3200156-20015672.89273.21
4194683-19468370.89971.18
5199111-19911172.51272.82
6197882-19788272.06472.37
45min1220699-22069980.37380.010.4880.7980.440.48
2218990-21899079.75180.19
3219772-21977280.03680.48
4219361-21936179.88680.28
5218306-21830679.50279.93
6221088-22108880.51580.94
60min1232668-23266884.73284.300.5085.2984.860.51
2230933-23093384.10084.67
3232170-23217084.55185.13
4230184-23018483.82884.36
5230294-23029483.86884.43
6232663-23266384.73185.29
极限1242291-24229188.23787.450.6788.9388.150.67
2240582-24058287.61488.33
3240267-24026787.50088.22
4237755-23775586.58587.26
5238877-23887786.99387.70
6241022-24102287.77588.47
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