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%
111.377509975140749577495574977750260.12
211.247452774440744840.09
单位质量响应值RSD%判断
6598.596626.690.31数据可信
供试品溶液-6041601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%
5min121276-2127628.86824.9211.9628.8724.9211.96
219157-1915725.99325.99
319572-1957226.55626.56
418621-1862125.26525.27
515632-1563221.21021.21
615918-1591821.59821.60
10min138462-3846252.18650.402.4652.2350.442.46
237161-3716150.42150.46
337725-3772551.18651.23
436669-3666949.75349.80
537093-3709350.32850.36
635785-3578548.55448.59
15min145916-4591662.30061.011.7462.4361.131.75
245408-4540861.61061.74
344971-4497161.01761.15
444241-4424160.02760.15
545391-4539161.58761.71
643845-4384559.49059.61
20min150227-5022768.14967.041.5468.3967.271.54
249901-4990167.70667.94
349647-4964767.36267.59
448535-4853565.85366.08
549764-4976467.52167.74
648400-4840065.67065.89
30min154954-5495474.56273.761.1874.9174.101.17
254946-5494674.55274.89
354173-5417373.50373.85
453310-5331072.33272.67
554696-5469674.21274.55
654075-5407573.37073.70
45min158350-5835079.17078.551.3779.6579.011.37
258665-5866579.59880.06
357552-5755278.08778.55
456663-5666376.88177.34
558614-5861479.52879.99
657498-5749878.01478.46
60min160491-6049182.07581.361.4982.6881.951.48
260707-6070782.36882.97
359416-5941680.61781.21
458622-5862279.53980.12
560912-6091282.64683.24
659623-5962380.89781.48
极限161700-6170083.71683.271.2984.4684.001.29
261972-6197284.08584.82
360923-6092382.66183.39
460057-6005781.48682.20
562216-6221684.41685.14
661365-6136583.26183.97
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%
111.395557065553955560235548855564315556880.11
211.345550615561245555920.14
单位质量响应值RSD%判断
48787.3648994.000.30数据可信
供试品溶液-6041601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%
5min1189345-18934534.82130.2511.0934.8230.2511.10
2170476-17047631.35131.35
3173647-17364731.93431.93
4167188-16718830.74630.75
5141567-14156726.03426.03
6144664-14466426.60426.60
10min1307902-30790256.62354.912.0256.6854.962.03
2295934-29593454.42354.47
3301356-30135655.42055.47
4298749-29874954.94054.99
5298058-29805854.81354.86
6289640-28964053.26553.31
15min1354827-35482765.25364.151.4565.4164.301.46
2349832-34983264.33464.48
3350197-35019764.40264.55
4346633-34663363.74663.89
5351505-35150564.64264.78
6340127-34012762.55062.68
20min1382942-38294270.42369.471.3070.6869.721.30
2379373-37937369.76770.02
3378838-37883869.66969.92
4374012-37401268.78169.03
5381408-38140870.14170.38
6369938-36993868.03268.27
30min1414893-41489376.29975.661.0176.6876.021.01
2414101-41410176.15476.52
3411514-41151475.67876.05
4406246-40624674.70975.07
5415201-41520176.35676.72
6406458-40645874.74875.10
45min1444037-44403781.65981.051.0182.1681.541.01
2444075-44407581.66682.16
3440412-44041280.99281.49
4434951-43495179.98880.48
5445001-44500181.83682.32
6435846-43584680.15280.63
60min1459425-45942584.48984.171.0285.1384.791.02
2461918-46191884.94785.58
3457842-45784284.19884.83
4450359-45035982.82183.44
5462256-46225685.00985.63
6454266-45426683.54084.15
极限1473839-47383987.13986.610.9987.9287.380.99
2473828-47382887.13787.91
3471220-47122086.65887.43
4462450-46245085.04585.80
5474995-47499587.35288.12
6469496-46949686.34187.09
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%
111.377665376866766587666876812767310.14
211.247651276367764400.14
单位质量响应值RSD%判断
6748.556800.710.55数据可信
供试品溶液-6042201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%
5min122180-2218029.37528.916.4729.3728.916.46
222310-2231029.54729.55
323576-2357631.22431.22
419623-1962325.98825.99
522549-2254929.86429.86
620750-2075027.48127.48
10min140091-4009153.09652.222.9253.1452.272.92
239888-3988852.82752.88
340357-4035753.44853.50
437970-3797050.28750.33
540314-4031453.39153.44
637952-3795250.26350.31
15min147845-4784563.36562.062.0963.5062.192.09
247192-4719262.50062.64
346925-4692562.14762.29
445818-4581860.68160.81
547813-4781363.32363.46
645555-4555560.33260.46
20min151597-5159768.33467.951.8368.5868.191.83
251954-5195468.80769.05
351287-5128767.92468.17
450254-5025466.55666.78
552544-5254469.58969.83
650203-5020366.48866.72
30min155805-5580573.90773.861.1074.2674.221.11
256101-5610174.29974.66
356205-5620574.43774.80
455053-5505372.91173.25
556458-5645874.77275.13
655004-5500472.84773.19
45min158764-5876477.82678.280.9378.3178.750.94
259373-5937378.63379.11
359281-5928178.51178.99
458335-5833577.25877.72
559923-5992379.36179.85
658950-5895078.07378.53
60min160919-6091980.68080.751.0481.2981.361.04
260924-6092480.68781.30
361110-6111080.93381.55
459832-5983279.24179.83
561675-6167581.68282.30
661383-6138381.29581.89
极限161986-6198682.09382.700.8182.8483.440.80
262523-6252382.80583.55
362521-6252182.80283.55
461753-6175381.78582.51
563094-6309483.56184.31
662802-6280283.17483.90
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%
111.395767475769025771685769045760095767460.08
211.345725055724365724700.01
单位质量响应值RSD%判断
50636.1750482.360.22数据可信
供试品溶液-6042201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%
5min1189450-18945033.69033.065.8733.6933.065.87
2189987-18998733.78633.79
3199054-19905435.39835.40
4170680-17068030.35230.35
5191602-19160234.07334.07
6174613-17461331.05231.05
10min1308048-30804854.78153.863.0454.8453.913.04
2304902-30490254.22154.28
3309250-30925054.99455.05
4296774-29677452.77652.83
5310989-31098955.30455.36
6287134-28713451.06151.11
15min1351257-35125762.46461.661.9062.6161.801.91
2346831-34683161.67761.82
3350389-35038962.31062.46
4344428-34442861.25061.39
5352720-35272062.72562.87
6334815-33481559.54159.68
20min1374614-37461466.61866.291.5066.8766.541.51
2374013-37401366.51166.76
3376481-37648166.95067.20
4370323-37032365.85566.10
5378385-37838567.28967.54
6362780-36278064.51464.75
30min1405290-40529072.07371.770.9372.4472.130.93
2402609-40260971.59671.96
3407179-40717972.40972.78
4400499-40049971.22171.57
5407568-40756872.47872.84
6398399-39839970.84871.19
45min1430895-43089576.62776.710.8277.1177.190.83
2431030-43103076.65177.13
3434668-43466877.29877.78
4427696-42769676.05876.53
5436195-43619577.56978.06
6427628-42762876.04676.51
60min1449074-44907479.85979.930.7080.4780.530.71
2449279-44927979.89680.50
3452405-45240580.45281.07
4444621-44462179.06879.66
5453298-45329880.61181.23
6448038-44803879.67580.26
极限1461978-46197882.15482.170.6382.9082.910.64
2461505-46150582.07082.81
3464495-46449582.60283.35
4457313-45731381.32582.05
5465623-46562382.80283.55
6461479-46147982.06582.79
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%
111.377418074532742527422274345743060.19
211.247424674328742870.08
单位质量响应值RSD%判断
6535.276609.160.80数据可信
供试品溶液-6042401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%
5min121710-2171029.63822.0031.8129.6422.0031.82
219235-1923526.26026.26
315269-1526920.84520.85
419911-1991127.18227.18
512126-1212616.55416.55
68419-841911.49411.49
10min139102-3910253.38248.8910.2753.4348.9210.29
238893-3889353.09753.14
335051-3505147.85247.89
438350-3835052.35552.40
533587-3358745.85345.88
629873-2987340.78340.80
15min146486-4648663.46360.994.5263.6061.114.54
246764-4676463.84263.97
343966-4396660.02260.14
445717-4571762.41362.55
543604-4360459.52859.63
641518-4151856.68056.77
20min150457-5045768.88467.332.4269.1367.552.45
250346-5034668.73268.97
348738-4873866.53766.75
450006-5000668.26868.50
548999-4899966.89367.10
647360-4736064.65664.84
30min155270-5527075.45574.291.2675.8174.621.29
254825-5482574.84775.20
353692-5369273.30073.63
454861-5486174.89675.25
554249-5424974.06174.38
653586-5358673.15673.44
45min158508-5850879.87579.100.8780.3679.560.89
258421-5842179.75680.23
357183-5718378.06678.51
457897-5789779.04179.52
558019-5801979.20779.65
657609-5760978.64879.06
60min160075-6007582.01481.650.6582.6382.240.66
259928-5992881.81482.42
359298-5929880.95481.53
460047-6004781.97682.58
560153-6015382.12182.69
659345-5934581.01881.56
极限162045-6204584.70483.940.8385.4684.660.83
261855-6185584.44485.19
360705-6070582.87483.59
461099-6109983.41284.16
561741-6174184.28985.00
661457-6145783.90184.58
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%
111.395556715557815547095545825541715549830.13
211.345541515549125545320.10
单位质量响应值RSD%判断
48725.4648900.530.26数据可信
供试品溶液-6042401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%
5min1186842-18684234.41525.8730.5634.4225.8730.57
2166078-16607830.59030.59
3135280-13528024.91824.92
4172301-17230131.73731.74
5106686-10668619.65119.65
675485-7548513.90413.90
10min1305113-30511356.20051.908.7956.2651.958.80
2301355-30135555.50855.56
3280115-28011551.59551.64
4297222-29722254.74654.80
5265465-26546548.89748.93
6241454-24145444.47444.50
15min1348930-34893064.27162.153.6964.4262.283.71
2348179-34817964.13264.28
3335686-33568661.83161.96
4344104-34410463.38263.53
5330946-33094660.95861.07
6316574-31657458.31158.41
20min1374862-37486269.04767.652.0269.3167.882.04
2374211-37421168.92769.18
3364232-36423267.08967.32
4370982-37098268.33268.58
5363333-36333366.92467.14
6355949-35594965.56365.76
30min1405207-40520774.63674.010.8775.0174.350.90
2405286-40528674.65175.02
3398777-39877773.45273.79
4403892-40389274.39474.76
5400359-40035973.74374.07
6397177-39717773.15773.46
45min1432905-43290579.73879.270.5480.2479.750.56
2432786-43278679.71680.21
3427435-42743578.73179.20
4430692-43069279.33179.82
5430466-43046679.28979.74
6428026-42802678.84079.27
60min1449012-44901282.70582.460.4483.3483.060.45
2449722-44972282.83683.46
3444629-44462981.89882.49
4447627-44762782.45083.07
5448755-44875582.65883.24
6446205-44620582.18882.75
极限1463292-46329285.33585.170.4486.1085.910.43
2464302-46430285.52186.28
3459022-45902284.54985.28
4460984-46098484.91085.67
5463298-46329885.33686.06
6463525-46352585.37886.07
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%
111.377819378192782147853978608783490.27
211.247678177147769640.34
单位质量响应值RSD%判断
6890.856847.330.45数据可信
供试品溶液-6042401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%
5min114380-1438018.78318.3333.4218.7818.3433.42
214954-1495419.53219.53
318435-1843524.07924.08
47806-780610.19610.20
59286-928612.12912.13
619360-1936025.28725.29
10min136019-3601947.04745.5712.1447.0845.6012.16
236453-3645347.61447.65
338443-3844350.21350.25
428003-2800336.57736.59
531628-3162841.31141.33
638793-3879350.67050.71
15min144794-4479458.50957.696.3358.6257.806.35
245620-4562059.58759.70
346229-4622960.38360.51
439572-3957251.68851.77
542049-4204954.92355.01
646758-4675861.07461.20
20min149830-4983065.08664.343.9065.2964.543.93
250357-5035765.77565.99
350601-5060166.09366.32
445951-4595160.02060.18
547980-4798062.67062.85
650826-5082666.38766.62
30min154678-5467871.41971.482.1671.7371.792.19
255223-5522372.13172.45
355253-5525372.17072.50
452420-5242068.46968.73
555072-5507271.93372.22
655718-5571872.77773.12
45min158321-5832176.17776.571.7076.6177.001.72
258916-5891676.95477.40
359187-5918777.30877.76
456756-5675674.13374.51
559066-5906677.15077.56
659484-5948477.69678.16
60min160113-6011378.51879.081.1679.0879.641.18
260885-6088579.52680.10
360819-6081979.44080.02
459319-5931977.48177.98
561183-6118379.91580.45
660943-6094379.60280.19
极限161637-6163780.50880.871.2181.2081.561.22
261954-6195480.92281.62
361724-6172480.62281.34
460745-6074579.34379.97
562661-6266181.84682.51
662770-6277081.98882.71
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%
111.395968225979615986055990335987305982300.15
211.345869785876115872940.08
单位质量响应值RSD%判断
52522.3951789.591.00数据可信
供试品溶液-6042401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%
5min1127562-12756221.99121.3832.2321.9921.3832.23
2132038-13203822.76322.76
3162516-16251628.01728.02
471408-7140812.31012.31
582538-8253814.22914.23
6168068-16806828.97428.97
10min1282859-28285948.76447.4410.3048.8047.4710.31
2287459-28745949.55749.59
3299665-29966551.66151.71
4230560-23056039.74739.77
5250594-25059443.20143.22
6299813-29981351.68651.73
15min1335464-33546457.83257.404.7557.9557.524.78
2343224-34322459.17059.29
3346741-34674159.77659.91
4310146-31014653.46853.55
5316648-31664854.58954.68
6345638-34563859.58659.72
20min1365564-36556463.02162.952.4663.2463.172.49
2371476-37147664.04164.26
3372785-37278564.26664.50
4352267-35226760.72960.91
5356181-35618161.40461.59
6372794-37279464.26864.50
30min1400459-40045969.03769.200.9769.3669.510.99
2404983-40498369.81770.14
3403538-40353869.56869.91
4394839-39483968.06868.35
5399818-39981868.92769.22
6404630-40463069.75670.10
45min1427635-42763573.72274.250.6074.1674.680.60
2433726-43372674.77275.21
3429761-42976174.08974.54
4428113-42811373.80574.20
5432415-43241574.54674.95
6432581-43258174.57575.03
60min1445827-44582776.85877.270.4477.4277.830.44
2450902-45090277.73378.30
3447285-44728577.11077.69
4446938-44693877.05077.56
5450057-45005777.58878.12
6448343-44834377.29277.87
极限1459548-45954879.22479.590.6679.9180.280.65
2464841-46484180.13680.83
3457521-45752178.87479.58
4460527-46052779.39380.03
5465026-46502680.16880.83
6462688-46268879.76580.48
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