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%
111.127078470676706467075470674707070.09
211.157178871998718930.21
单位质量响应值RSD%判断
6358.546447.800.99数据可信
供试品溶液-1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%
5min120175-2017528.27123.0920.2728.2723.1020.27
219188-1918826.88726.89
318661-1866126.14926.15
415214-1521421.31921.32
511909-1190916.68816.69
613735-1373519.24619.25
10min139603-3960355.49452.906.3655.5452.946.36
239206-3920654.93854.98
339392-3939255.19955.24
437857-3785753.04853.08
533258-3325846.60346.63
637194-3719452.11952.15
15min148051-4805167.33266.453.2067.4766.583.21
248346-4834667.74667.88
348193-4819367.53167.67
447674-4767466.80466.93
544361-4436162.16162.27
647899-4789967.11967.24
20min152483-5248373.54373.512.1973.7973.752.20
253306-5330674.69674.95
352623-5262373.73973.99
452891-5289174.11474.35
550221-5022170.37370.58
653250-5325074.61774.85
30min157245-5724580.21580.751.5180.5981.111.52
258098-5809881.41181.78
357728-5772880.89281.26
458170-5817081.51281.87
556074-5607478.57478.90
658446-5844681.89882.25
45min160384-6038484.61485.471.2485.1285.961.24
261617-6161786.34286.85
361079-6107985.58886.09
461470-6147086.13686.63
559795-5979583.78984.25
661630-6163086.36086.85
60min162006-6200686.88787.711.1487.5488.351.14
262986-6298688.26088.91
362325-6232587.33487.98
462931-6293188.18388.82
561693-6169386.44887.05
663617-6361789.14489.78
极限162850-6285088.06989.431.1388.8690.211.13
264325-6432590.13690.94
363673-6367389.22390.02
464267-6426790.05590.84
563138-6313888.47389.21
664663-6466390.61091.39
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%
111.085424905427045414015428835428825424720.12
211.105525765535195530480.13
单位质量响应值RSD%判断
48959.5749824.141.24数据可信
供试品溶液-1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%
5min1183095-18309533.33227.4019.4933.3327.4019.49
2173187-17318731.52831.53
3171123-17112331.15331.15
4137387-13738725.01125.01
5110224-11022420.06620.07
6128042-12804223.31023.31
10min1315648-31564857.46355.265.0357.5255.315.04
2312107-31210756.81856.87
3313521-31352157.07657.13
4305470-30547055.61055.65
5274775-27477550.02250.06
6299871-29987154.59154.63
15min1367025-36702566.81666.222.4966.9766.362.50
2370107-37010767.37767.52
3368637-36863767.11067.26
4366181-36618166.66366.80
5345682-34568262.93163.05
6364819-36481966.41566.54
20min1391727-39172771.31371.471.4071.5871.721.41
2396711-39671172.22072.48
3395486-39548671.99772.26
4395569-39556972.01372.26
5381990-38199069.54169.76
6394166-39416671.75772.00
30min1422858-42285876.98077.351.0377.3677.721.04
2427127-42712777.75878.14
3426769-42676977.69278.07
4428064-42806477.92878.29
5416837-41683775.88476.22
6427657-42765777.85478.21
45min1446830-44683081.34582.070.8681.8582.560.87
2453147-45314782.49583.00
3452149-45214982.31382.82
4453959-45395982.64283.14
5445076-44507681.02581.49
6453701-45370182.59583.09
60min1462754-46275484.24384.970.7284.8985.600.72
2468599-46859985.30885.95
3466256-46625684.88185.53
4469084-46908485.39686.03
5462973-46297384.28384.88
6470870-47087085.72186.35
极限1472380-47238085.99686.940.7686.7887.720.76
2479842-47984287.35488.14
3477120-47712086.85987.65
4479975-47997587.37888.15
5474434-47443486.37087.11
6481767-48176787.70588.48
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%
111.123628836414365543654636491364590.31
211.153660536888367460.55
单位质量响应值RSD%判断
3278.693295.610.37数据可信
供试品溶液-1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%
5min111784-1178432.16433.477.2732.1633.467.27
212980-1298035.42835.43
310999-1099930.02130.02
411678-1167831.87531.87
513057-1305735.63935.64
613068-1306835.66935.67
10min121652-2165259.09858.701.8759.1558.761.87
221691-2169159.20559.26
320845-2084556.89656.95
421220-2122057.91957.97
521961-2196159.94260.00
621669-2166959.14559.20
15min125588-2558869.84269.241.9669.9969.391.96
225409-2540969.35369.51
325015-2501568.27868.42
424948-2494868.09568.24
526230-2623071.59471.75
625004-2500468.24868.41
20min127690-2769075.57974.361.3075.8574.631.30
227651-2765175.47375.75
327081-2708173.91774.18
426799-2679973.14773.41
527153-2715374.11374.39
627092-2709273.94774.22
30min129993-2999381.86580.371.7682.2680.771.75
229934-2993481.70482.10
329681-2968181.01381.40
428680-2868078.28178.67
529324-2932480.03980.44
629068-2906879.34079.74
45min131397-3139785.69784.511.1786.2385.041.16
231144-3114485.00785.54
331020-3102084.66885.18
431003-3100384.62285.14
530903-3090384.34984.88
630314-3031482.74183.27
60min132080-3208087.56186.181.2588.2486.841.24
231963-3196387.24287.92
331562-3156286.14786.81
431275-3127585.36486.02
531492-3149285.95686.63
631061-3106184.78085.45
极限132692-3269289.23287.491.5090.0588.301.50
232482-3248288.65989.48
332091-3209187.59188.39
431644-3164486.37187.17
531993-3199387.32488.14
631429-3142985.78486.59
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%
111.082774902784142778562780762783352780340.14
211.102814132824382819260.26
单位质量响应值RSD%判断
25093.3225398.740.86数据可信
供试品溶液-1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%
5min1111655-11165539.76641.217.0639.7741.217.06
2119532-11953242.57142.57
3104215-10421537.11637.12
4110544-11054439.37039.37
5124008-12400844.16544.17
6124339-12433944.28344.28
10min1183305-18330565.28464.451.5465.3564.521.55
2181499-18149964.64164.71
3176864-17686462.99063.05
4178882-17888263.70963.77
5184405-18440565.67665.75
6180869-18086964.41664.49
15min1206170-20617073.42773.071.4873.6073.241.49
2206130-20613073.41373.59
3202644-20264472.17172.34
4202443-20244372.10072.27
5210324-21032474.90775.09
6203237-20323772.38272.56
20min1219556-21955678.19477.280.9378.4977.580.93
2218484-21848477.81378.11
3216433-21643377.08277.37
4214635-21463576.44276.73
5217967-21796777.62977.94
6214867-21486776.52576.83
30min1234488-23448883.51282.881.2583.9483.311.25
2234168-23416883.39983.83
3236256-23625684.14284.56
4228530-22853081.39181.81
5232745-23274582.89283.33
6230112-23011281.95482.38
45min1246269-24626987.70887.040.7788.2887.600.77
2246249-24624987.70188.27
3244659-24465987.13587.69
4242608-24260886.40486.96
5244819-24481987.19287.77
6241732-24173286.09286.66
60min1252029-25202989.76089.150.8290.4789.860.81
2251848-25184889.69590.41
3251789-25178989.67490.38
4249007-24900788.68389.38
5250327-25032789.15489.87
6246928-24692887.94388.65
极限1256412-25641291.32190.440.8692.1891.300.86
2255609-25560991.03591.90
3254931-25493190.79391.64
4252139-25213989.79990.65
5253833-25383390.40291.27
6250684-25068489.28190.14
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%
111.123650036696366523675836753366720.29
211.153591136114360120.40
单位质量响应值RSD%判断
3297.843229.781.48数据可信
供试品溶液-2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%
5min19562-956226.28826.267.1626.2926.267.16
210287-1028728.28228.28
39051-905124.88424.88
48543-854323.48723.49
59590-959026.36526.37
610278-1027828.25728.26
10min120263-2026355.70856.163.7555.7556.213.76
221405-2140558.84858.90
319537-1953753.71253.75
419583-1958353.83953.88
520827-2082757.25957.30
620956-2095657.61457.66
15min124777-2477768.11968.552.3668.2668.692.36
225634-2563470.47570.62
324262-2426266.70366.83
424454-2445467.23167.36
525650-2565070.51970.66
624825-2482568.25168.39
20min126935-2693574.05174.661.4674.3074.921.46
227897-2789776.69676.96
326768-2676873.59273.83
426991-2699174.20574.45
527192-2719274.75875.01
627164-2716474.68174.94
30min129438-2943880.93380.981.4681.3181.351.46
230205-3020583.04283.43
328933-2893379.54479.91
429517-2951781.15081.51
529466-2946681.01081.39
629169-2916980.19380.57
45min131104-3110485.51385.431.3386.0285.941.33
231853-3185387.57288.10
330656-3065684.28184.78
430964-3096485.12885.63
531000-3100085.22785.74
630863-3086384.85185.37
60min131728-3172887.22987.371.1587.8888.021.15
232414-3241489.11589.79
331469-3146986.51787.15
431870-3187087.61988.26
531811-3181187.45788.12
631388-3138886.29486.95
极限132266-3226688.70888.761.0689.5089.561.06
232908-3290890.47391.30
331876-3187687.63688.42
432159-3215988.41489.20
532217-3221788.57389.38
632286-3228688.76389.56
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%
111.082817852811242816732814842807162813560.16
211.102781842776892779360.13
单位质量响应值RSD%判断
25393.1425039.281.00数据可信
供试品溶液-2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%
5min189048-8904831.75231.467.2131.7531.467.21
295340-9534033.99634.00
383418-8341829.74529.74
478576-7857628.01828.02
588856-8885631.68431.68
694050-9405033.53633.54
10min1168413-16841360.05260.513.1660.1060.563.16
2175493-17549362.57662.63
3162687-16268758.01058.06
4164382-16438258.61458.66
5173412-17341261.83461.89
6173806-17380661.97562.03
15min1197768-19776870.51970.981.9370.6771.141.93
2203601-20360172.59972.76
3194405-19440569.32069.47
4196158-19615869.94570.09
5203602-20360272.59972.76
6198827-19882770.89771.06
20min1212713-21271375.84876.241.1976.1276.511.19
2218332-21833277.85178.13
3210844-21084475.18175.44
4212736-21273675.85676.12
5214051-21405176.32576.60
6214244-21424476.39476.67
30min1229403-22940381.79981.991.1882.2082.391.18
2234890-23489083.75684.17
3227052-22705280.96181.35
4229664-22966481.89282.28
5230338-23033882.13382.54
6228261-22826181.39281.80
45min1241716-24171686.19086.751.0186.7287.281.02
2248052-24805288.44989.00
3241273-24127386.03286.55
4243026-24302686.65787.18
5243246-24324686.73587.28
6242365-24236586.42186.96
60min1248238-24823888.51589.361.1489.1990.041.13
2254605-25460590.78691.48
3247693-24769388.32188.99
4253054-25305490.23290.90
5251271-25127189.59790.28
6248706-24870688.68289.37
极限1253015-25301590.21990.500.9191.0491.330.91
2257985-25798591.99192.84
3251482-25148289.67290.48
4253127-25312790.25891.08
5254711-25471190.82391.66
6252560-25256090.05690.89
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%
111.123694536927369833700036997369700.09
211.153718637278372320.18
单位质量响应值RSD%判断
3324.643339.190.31数据可信
供试品溶液-3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%
5min17245-724519.50916.5930.0719.5116.5930.06
28564-856423.06123.06
33234-32348.7088.71
46812-681218.34318.34
56032-603216.24316.24
65072-507213.65813.66
10min118004-1800448.48146.0310.0448.5146.0610.05
219105-1910551.44651.48
314892-1489240.10140.12
418544-1854449.93549.97
516515-1651544.47144.50
615496-1549641.72741.75
15min123928-2392864.43363.904.0664.5564.004.08
224954-2495467.19667.32
322765-2276561.30161.38
424594-2459466.22666.34
523584-2358463.50763.61
622547-2254760.71460.81
20min126544-2654471.47771.872.1471.7072.082.16
227469-2746973.96874.20
326321-2632170.87771.06
427289-2728973.48373.71
526502-2650271.36471.57
626008-2600870.03470.23
30min129322-2932278.95880.402.7879.3080.742.78
230332-3033281.67882.04
330371-3037181.78382.08
430997-3099783.46883.81
529308-2930878.92079.25
628825-2882577.62077.93
45min131014-3101483.51484.071.2283.9984.531.24
231672-3167285.28685.78
331094-3109483.73084.17
431682-3168285.31385.80
531117-3111783.79184.25
630735-3073582.76383.20
60min132082-3208286.39086.390.9287.0086.990.93
232332-3233287.06387.70
332219-3221986.75987.34
432214-3221486.74587.37
532126-3212686.50887.11
631509-3150984.84785.42
极限132379-3237987.19087.620.6287.9488.370.64
232693-3269388.03588.82
332523-3252387.57888.30
432772-3277288.24889.02
532632-3263287.87188.61
632242-3224286.82187.54
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%
111.082860772861352854242857752854902857800.12
211.102888702890702889700.05
单位质量响应值RSD%判断
25792.4226033.330.66数据可信
供试品溶液-3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%
5min164256-6425622.29519.1627.0922.3019.1627.09
273210-7321025.40225.40
330327-3032710.52310.52
461398-6139821.30421.30
554375-5437518.86718.87
647813-4781316.59016.59
10min1151596-15159652.60050.288.3952.6450.318.41
2158784-15878455.09555.14
3128415-12841544.55744.57
4155181-15518153.84453.88
5141021-14102148.93148.96
6134478-13447846.66146.69
15min1191064-19106466.29566.042.8566.4266.162.87
2196845-19684568.30168.44
3184362-18436263.97064.06
4195835-19583567.95068.08
5189618-18961865.79365.91
6184224-18422463.92264.03
20min1208659-20865972.40072.381.5972.6472.611.61
2212208-21220873.63173.88
3205657-20565771.35871.56
4212853-21285373.85574.09
5207367-20736771.95272.17
6204901-20490171.09671.31
30min1227694-22769479.00579.392.4279.3679.742.42
2227501-22750178.93879.31
3228213-22821379.18579.50
4239397-23939783.06583.43
5227132-22713278.81079.15
6222936-22293677.35477.68
45min1240716-24071683.52384.020.8484.0184.500.84
2242361-24236184.09484.60
3243077-24307784.34284.79
4245611-24561185.22285.72
5240308-24030883.38283.86
6240747-24074783.53483.99
60min1248966-24896686.38686.510.8187.0187.130.82
2249539-24953986.58587.23
3250015-25001586.75087.34
4252723-25272387.68988.33
5247519-24751985.88486.50
6247135-24713585.75086.35
极限1251452-25145287.24887.810.7088.0288.570.71
2253223-25322387.86388.65
3253434-25343487.93688.67
4256268-25626888.91989.71
5251721-25172187.34288.10
6252267-25226787.53188.27
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