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%
110.833564735636356203566235778356690.18
211.083591935979359490.12
单位质量响应值RSD%判断
3293.543244.491.07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%
5min111257-1125730.89830.0617.6230.9030.0617.62
211175-1117530.67230.67
312142-1214233.32733.33
412713-1271334.89434.89
511208-1120830.76330.76
67226-722619.83419.83
10min119839-1983954.45353.655.9754.5053.705.97
219923-1992354.68354.73
320096-2009655.15855.21
420480-2048056.21256.27
519705-1970554.08554.14
617231-1723147.29547.33
15min123741-2374165.16364.012.6865.3164.152.70
223583-2358364.72964.87
323555-2355564.65264.80
423593-2359364.75764.91
523388-2338864.19464.34
622068-2206860.57160.68
20min126618-2661873.06069.972.8373.3170.222.84
225702-2570270.54570.80
325057-2505768.77569.03
425746-2574670.66670.93
525342-2534269.55769.81
624489-2448967.21667.43
30min127684-2768475.98575.760.9676.3676.120.97
227892-2789276.55676.92
327476-2747675.41575.78
427655-2765575.90676.28
527760-2776076.19476.56
627144-2714474.50374.83
45min129739-2973981.62680.650.9082.1381.140.90
229602-2960281.25081.75
328989-2898979.56780.06
429286-2928680.38380.89
529332-2933280.50981.00
629345-2934580.54480.99
60min131321-3132185.96883.261.8286.6083.881.81
230588-3058883.95684.59
329924-2992482.13482.76
429837-2983781.89582.53
530144-3014482.73883.36
630200-3020082.89183.47
极限131311-3131185.94184.861.0986.7285.621.09
231313-3131385.94686.72
330595-3059583.97584.74
430635-3063584.08584.86
530977-3097785.02485.79
630674-3067484.19284.91
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%
110.842666872659332658182658012651162658710.22
211.102739622740522740070.03
单位质量响应值RSD%判断
24526.8524685.320.46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%
5min199631-9963136.40535.8217.5536.4135.8217.56
2102502-10250237.45437.45
3108049-10804939.48139.48
4113591-11359141.50641.51
599781-9978136.46036.46
664681-6468123.63523.63
10min1160142-16014258.51658.244.8058.5858.304.82
2161044-16104458.84658.91
3163764-16376459.84059.91
4166224-16622460.73860.81
5160573-16057358.67458.73
6144491-14449152.79752.84
15min1184847-18484767.54367.362.0067.7067.522.01
2186968-18696868.31868.48
3184888-18488867.55867.72
4187595-18759568.54768.72
5184453-18445367.39967.56
6177320-17732064.79364.92
20min1200282-20028273.18372.811.0173.4573.081.02
2201857-20185773.75974.03
3197680-19768072.23372.51
4200666-20066673.32473.61
5198476-19847672.52372.79
6196589-19658971.83472.07
30min1216149-21614978.98178.910.6079.3779.300.59
2218097-21809779.69380.09
3214469-21446978.36778.77
4215153-21515378.61779.02
5215339-21533978.68579.08
6216518-21651879.11679.47
45min1228090-22809083.34484.001.4683.8784.521.45
2230963-23096384.39484.92
3226829-22682982.88483.41
4226818-22681882.88083.42
5235501-23550186.05286.58
6231087-23108784.43984.93
60min1234833-23483385.80886.191.2186.4786.851.19
2238553-23855387.16887.84
3232978-23297885.13085.80
4232885-23288585.09685.77
5236339-23633986.35987.02
6239703-23970387.58888.22
极限1238589-23858987.18188.091.1887.9988.891.16
2242741-24274188.69889.51
3242437-24243788.58789.40
4236774-23677486.51887.34
5241497-24149788.24389.05
6244350-24435089.28690.06
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%
110.833669736644366113662136600366350.11
211.083677936870368240.18
单位质量响应值RSD%判断
3382.733323.471.25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%
5min111624-1162431.10624.5325.7031.1124.5425.71
28518-851822.79422.79
38739-873923.38523.39
49468-946825.33625.34
511464-1146430.67730.68
65198-519813.91013.91
10min120180-2018054.00150.996.5054.0551.036.51
219069-1906951.02851.07
318944-1894450.69450.73
419590-1959052.42252.46
519827-1982753.05753.11
616712-1671244.72144.74
15min123579-2357963.09762.352.5463.2462.482.56
223416-2341662.66162.78
323103-2310361.82361.95
424025-2402564.29064.42
523415-2341562.65862.80
622261-2226159.57059.67
20min125703-2570368.78168.061.1169.0368.291.13
225538-2553868.33968.57
325203-2520367.44367.67
425746-2574668.89669.13
525383-2538367.92468.17
625035-2503566.99367.19
30min127918-2791874.70874.930.9375.0775.280.92
228163-2816375.36375.70
327657-2765774.00974.35
428399-2839975.99576.35
527854-2785474.53774.89
628023-2802374.98975.30
45min129384-2938478.63180.091.6979.1280.561.66
229983-2998380.23480.70
329490-2949078.91479.38
430423-3042381.41181.89
529686-2968679.43979.92
630617-3061781.93082.36
60min130600-3060081.88582.631.4282.5083.231.41
231022-3102283.01483.61
330502-3050281.62382.22
431602-3160284.56685.18
530476-3047681.55382.17
631065-3106583.12983.70
极限131076-3107683.15983.941.4283.9184.681.40
231505-3150584.30785.05
330974-3097482.88683.62
432037-3203785.73086.48
530941-3094182.79783.55
631671-3167184.75185.46
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%
110.842746972747182753352748152743282747790.14
211.102794182789442791810.13
单位质量响应值RSD%判断
25348.6225151.440.56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%
5min1103627-10362736.90029.2924.6036.9029.2924.59
276675-7667527.30327.30
378678-7867828.01628.02
485229-8522930.34930.35
5101331-10133136.08236.08
648012-4801217.09617.10
10min1168485-16848559.99555.976.2160.0656.016.22
2155316-15531655.30655.35
3157483-15748356.07756.12
4161146-16114657.38257.43
5161087-16108757.36157.42
6139504-13950449.67549.70
15min1186310-18631066.34265.492.2866.5065.632.30
2183457-18345765.32665.46
3183173-18317365.22565.37
4189658-18965867.53467.68
5183962-18396265.50665.66
6176977-17697763.01963.13
20min1199369-19936970.99270.821.0871.2671.071.08
2199164-19916470.91971.17
3197915-19791570.47470.72
4202685-20268572.17372.43
5197631-19763170.37370.64
6196564-19656469.99370.21
30min1214222-21422276.28176.951.2476.6777.321.23
2217362-21736277.39977.76
3213924-21392476.17576.54
4220714-22071478.59378.97
5214021-21402176.21076.59
6216402-21640277.05777.39
45min1227019-22701980.83882.121.7181.3682.621.69
2231034-23103482.26882.76
3227046-22704680.84881.34
4234228-23422883.40583.91
5228072-22807281.21381.72
6236299-23629984.14284.60
60min1233024-23302482.97684.371.4983.6385.011.48
2238325-23832584.86485.49
3233990-23399083.32083.95
4242155-24215586.22886.88
5234983-23498383.67484.32
6239205-23920585.17785.78
极限1237845-23784584.69386.282.3085.4887.052.27
2241943-24194386.15286.92
3237617-23761784.61285.38
4246370-24637087.72888.52
5238580-23858084.95585.74
6251392-25139289.51790.26
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%
110.833579735579356263566735780356900.27
211.083730537248372760.11
单位质量响应值RSD%判断
3295.483364.261.47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%
5min19984-998426.90427.688.9026.9027.688.90
28651-865123.31223.31
310934-1093429.46429.46
410141-1014127.32727.33
511126-1112629.98129.98
610797-1079729.09529.09
10min119249-1924951.87152.221.5251.9252.271.52
219204-1920451.74951.79
319714-1971453.12453.17
418963-1896351.10051.15
519680-1968053.03253.08
619461-1946152.44252.49
15min123418-2341863.10563.400.6963.2463.530.68
223757-2375764.01864.14
323363-2336362.95763.09
423548-2354863.45563.59
523669-2366963.78163.92
623401-2340163.05963.20
20min125676-2567669.19069.101.4669.4369.341.46
226212-2621270.63470.87
325410-2541068.47368.72
425715-2571569.29569.53
525757-2575769.40869.65
625095-2509567.62467.86
30min128189-2818975.96175.652.4676.3176.012.44
229298-2929878.95079.30
327614-2761474.41274.77
428161-2816175.88676.24
527892-2789275.16175.52
627291-2729173.54273.90
45min129541-2954179.60579.851.0780.0880.331.07
230183-3018381.33581.82
329431-2943179.30879.79
429719-2971980.08480.56
529664-2966479.93680.42
629258-2925878.84279.32
60min130700-3070082.72882.461.1883.3483.071.18
231247-3124784.20284.82
330407-3040781.93882.55
430579-3057982.40283.01
530476-3047682.12482.74
630190-3019081.35481.96
极限130733-3073382.81783.501.5383.5784.261.52
231924-3192486.02686.78
330771-3077182.91983.67
430958-3095883.42384.17
530900-3090083.26784.02
630644-3064482.57783.32
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%
110.842687842678782676602680132678392680350.17
211.102802362798832800600.09
单位质量响应值RSD%判断
24726.4825230.631.43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%
5min186669-8666931.20032.928.5631.2032.928.56
278886-7888628.39828.40
398273-9827335.37735.38
489935-8993532.37532.38
599032-9903235.65035.65
695835-9583534.49934.50
10min1155552-15555255.99657.031.3356.0557.081.33
2159135-15913557.28657.33
3160604-16060457.81557.87
4156397-15639756.30156.35
5160517-16051757.78457.84
6158293-15829356.98357.04
15min1182161-18216165.57566.641.2865.7266.781.28
2189215-18921568.11568.26
3185109-18510966.63766.79
4185469-18546966.76666.91
5185102-18510266.63466.79
6183573-18357366.08466.24
20min1196823-19682370.85372.122.1271.1172.382.11
2208283-20828374.97975.24
3199562-19956271.83972.11
4201077-20107772.38572.64
5199359-19935971.76672.03
6196892-19689270.87871.14
30min1213165-21316576.73677.791.8077.1178.181.79
2223017-22301780.28380.66
3215565-21556577.60077.99
4217897-21789778.44078.82
5214422-21442277.18977.58
6212523-21252376.50576.89
45min1225351-22535181.12382.461.7381.6282.971.73
2235936-23593684.93485.45
3228612-22861282.29782.81
4231199-23119983.22883.74
5227402-22740281.86182.38
6225918-22591881.32781.84
60min1231712-23171283.41385.231.9384.0585.881.92
2244036-24403687.84988.51
3235073-23507384.62385.28
4237854-23785485.62486.27
5232767-23276783.79384.44
6239143-23914386.08886.73
极限1235218-23521884.67586.231.9785.4587.021.96
2248171-24817189.33890.14
3238389-23838985.81786.61
4241349-24134986.88287.67
5236659-23665985.19485.98
6237386-23738685.45686.24
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