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%
110.977149571606713707131171369714300.17
211.017176071801717800.05
单位质量响应值RSD%判断
6511.396519.530.09数据可信
供试品溶液-6042001-1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%
5min113963-1396319.22827.9416.7419.2327.9416.74
222452-2245230.91730.92
322446-2244630.90930.91
422538-2253831.03631.04
521433-2143329.51429.51
618896-1889626.02126.02
10min136890-3689050.79954.654.2550.8354.694.26
239498-3949854.39154.44
341530-4153057.18957.24
441147-4114756.66156.71
540144-4014455.28055.33
638903-3890353.57153.61
15min147256-4725665.07465.701.6765.1965.841.68
246944-4694464.64464.79
349018-4901867.50067.65
447841-4784165.87966.03
548174-4817466.33866.48
647048-4704864.78764.92
20min152349-5234972.08771.491.4972.3171.741.49
251043-5104370.28970.54
353130-5313073.16373.42
452160-5216071.82772.08
551463-5146370.86771.12
651368-5136870.73670.98
30min157548-5754879.24677.921.5279.5978.291.52
255903-5590376.98177.35
357457-5745779.12179.50
456970-5697078.45078.83
556131-5613177.29577.67
655495-5549576.41976.78
45min161159-6115984.21982.951.0484.7083.441.03
259690-5969082.19682.69
360717-6071783.61084.12
460379-6037983.14583.65
559836-5983682.39782.90
659632-5963282.11682.60
60min162759-6275986.42285.220.9487.0485.860.93
261245-6124584.33784.97
362288-6228885.77486.43
462030-6203085.41886.06
561579-6157984.79785.43
661422-6142284.58185.20
极限164036-6403688.18187.000.9188.9487.780.90
262774-6277486.44387.22
363726-6372687.75488.55
463085-6308586.87187.66
562686-6268686.32287.10
662767-6276786.43387.20
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%
111.035306345319665334015322645320955320720.19
211.115355645346875351260.12
单位质量响应值RSD%判断
48238.6248166.160.11数据可信
供试品溶液-6042001-1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%
5min1121155-12115522.59932.8416.7622.6032.8416.76
2195363-19536336.44036.44
3191546-19154635.72835.73
4198017-19801736.93536.94
5186131-18613134.71834.72
6164151-16415130.61830.62
10min1285419-28541953.23856.773.6453.2856.823.64
2304472-30447256.79256.85
3314534-31453458.66958.73
4314719-31471958.70358.76
5307974-30797457.44557.50
6299019-29901955.77555.83
15min1349107-34910765.11865.991.2965.2466.141.29
2350838-35083865.44065.60
3357702-35770266.72166.88
4357081-35708166.60566.76
5358714-35871466.91067.06
6349133-34913365.12265.27
20min1376835-37683570.29070.450.7570.5270.710.75
2375849-37584970.10670.37
3381206-38120671.10571.37
4380508-38050870.97571.25
5377979-37797970.50370.77
6373852-37385269.73369.99
30min1406849-40684975.88875.770.8476.2476.140.84
2405710-40571075.67676.06
3409078-40907876.30476.69
4409197-40919776.32676.71
5406440-40644075.81276.19
6399888-39988874.59074.96
45min1434070-43407080.96580.540.4381.4481.040.43
2430848-43084880.36480.87
3433421-43342180.84481.36
4432720-43272080.71481.23
5429912-42991280.19080.70
6429796-42979680.16880.66
60min1449207-44920783.78983.330.4484.4083.970.44
2446784-44678483.33783.98
3448147-44814783.59184.24
4447506-44750683.47284.12
5444425-44442582.89783.54
6444479-44447982.90783.53
极限1458271-45827185.48085.180.3386.2385.960.32
2456017-45601785.05985.84
3458102-45810285.44886.24
4456973-45697385.23786.03
5454291-45429184.73785.52
6456322-45632285.11685.88
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%
110.977268372587725777241872664725860.15
211.017264372447725450.20
单位质量响应值RSD%判断
6616.776589.010.30数据可信
供试品溶液-6042001-2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%
5min117999-1799924.45727.119.9324.4627.119.93
221644-2164429.41029.41
317600-1760023.91523.92
421354-2135429.01629.02
519027-1902725.85425.85
622091-2209130.01830.02
10min136891-3689150.12852.953.5150.1753.003.52
240211-4021154.64054.69
338544-3854452.37452.41
439259-3925953.34653.39
538281-3828152.01752.06
640627-4062755.20555.25
15min145857-4585762.31164.051.6862.4464.181.68
247390-4739064.39464.53
347317-4731764.29564.42
446794-4679463.58563.72
547211-4721164.15164.28
648251-4825165.56465.71
20min151036-5103669.34970.220.9269.5870.460.92
251437-5143769.89470.14
351928-5192870.56170.80
451358-5135869.78670.03
552058-5205870.73770.97
652256-5225671.00671.26
30min156177-5617776.33476.431.6276.6876.791.62
255910-5591075.97276.34
356517-5651776.79677.15
454725-5472574.36174.72
556701-5670177.04677.40
657445-5744578.05778.43
45min159748-5974881.18781.340.9881.6681.820.98
259150-5915080.37480.86
360129-6012981.70482.18
459283-5928380.55581.04
560153-6015381.73782.22
660702-6070282.48382.98
60min161961-6196184.19484.111.1384.8084.721.13
260952-6095282.82383.45
361909-6190984.12384.74
461601-6160183.70584.32
561859-6185984.05584.67
663095-6309585.73586.37
极限163269-6326985.97185.851.0986.7286.611.09
262237-6223784.56985.33
363098-6309885.73986.50
462674-6267485.16385.92
563607-6360786.43087.19
664180-6418087.20987.99
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%
111.035423875415885415545409455405465414040.13
211.115439895446295443090.09
单位质量响应值RSD%判断
49084.6848992.710.14数据可信
供试品溶液-6042001-2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%
5min1167800-16780030.76533.2010.8430.7733.2010.84
2189311-18931134.70934.71
3159001-15900129.15229.15
4187151-18715134.31334.31
5170116-17011631.19031.19
6213267-21326739.10139.10
10min1293375-29337553.78956.253.1353.8456.313.14
2315346-31534657.81757.88
3302226-30222655.41255.46
4307702-30770256.41656.47
5302479-30247955.45855.51
6319715-31971558.61858.68
15min1349597-34959764.09765.251.3964.2465.401.40
2359478-35947865.90966.06
3355548-35554865.18865.33
4353505-35350564.81364.96
5353588-35358864.82964.97
6363536-36353666.65366.82
20min1379695-37969569.61570.070.8069.8670.330.81
2384313-38431370.46270.73
3381601-38160169.96570.21
4379905-37990569.65469.91
5380382-38038269.74169.99
6387297-38729771.00971.28
30min1411156-41115675.38375.570.5875.7575.950.58
2414563-41456376.00876.39
3412713-41271375.66976.04
4408866-40886674.96475.34
5410761-41076175.31175.68
6415020-41502076.09276.48
45min1437596-43759680.23180.300.4780.7280.800.48
2437797-43779780.26880.78
3438439-43843980.38680.88
4436416-43641680.01580.52
5435877-43587779.91680.41
6441693-44169380.98281.50
60min1453933-45393383.22683.220.3483.8583.860.35
2453931-45393183.22683.87
3455258-45525883.46984.10
4453011-45301183.05783.69
5451567-45156782.79383.42
6455804-45580483.56984.22
极限1467459-46745985.70685.440.3386.4786.220.33
2464088-46408885.08885.87
3465686-46568685.38186.15
4465443-46544385.33786.11
5465241-46524185.30086.07
6468245-46824585.85086.64
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%
110.977136171456715847155271360714630.15
211.017144771229713380.22
单位质量响应值RSD%判断
6514.406479.380.39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%
5min118581-1858125.66025.1414.1225.6625.1414.12
216255-1625522.44822.45
319791-1979127.33127.33
419965-1996527.57227.57
520616-2061628.47128.47
614008-1400819.34519.34
10min139306-3930654.28152.915.2754.3252.955.28
237115-3711551.25651.29
339306-3930654.28154.33
439624-3962454.72054.77
539807-3980754.97355.02
634712-3471247.93747.97
15min148109-4810966.43865.032.3666.5765.162.37
246025-4602563.56063.68
347755-4775565.94966.09
447703-4770365.87866.01
547563-4756365.68465.82
645381-4538162.67162.78
20min153044-5304473.25371.741.4073.5071.981.41
251174-5117470.67170.90
352167-5216772.04272.29
452333-5233372.27272.52
551806-5180671.54471.79
651175-5117570.67270.89
30min158094-5809480.22778.701.0380.5979.061.02
256576-5657678.13178.48
356665-5666578.25478.62
457033-5703378.76279.13
556547-5654778.09178.46
656998-5699878.71479.05
45min161537-6153784.98283.531.1585.4884.021.14
260052-6005282.93183.41
360115-6011583.01883.51
460881-6088184.07684.57
559617-5961782.33182.83
660703-6070383.83084.30
60min163523-6352387.72586.081.4388.3786.701.42
261750-6175085.27685.89
361599-6159985.06885.70
462332-6233286.08086.72
561478-6147884.90185.54
663288-6328887.40088.01
极限164914-6491489.64687.971.3990.4388.741.37
263223-6322387.31188.07
362806-6280686.73587.51
463498-6349887.69088.47
563094-6309487.13287.91
664688-6468889.33490.08
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%
111.035356635355235362165358455364095359310.07
211.115338095338565338320.01
单位质量响应值RSD%判断
48588.4948049.680.79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%
5min1153728-15372828.60628.9713.5428.6128.9713.54
2140791-14079126.19926.20
3170141-17014131.66031.66
4171903-17190331.98831.99
5175421-17542132.64332.64
6122034-12203422.70822.71
10min1292814-29281454.48753.934.8254.5353.984.83
2282957-28295752.65352.70
3297631-29763155.38455.44
4301551-30155156.11356.17
5299163-29916355.66955.72
6264704-26470449.25649.29
15min1342793-34279363.78763.761.4663.9363.901.48
2338028-33802862.90163.03
3346152-34615264.41264.56
4348951-34895164.93365.08
5344387-34438764.08464.23
6335668-33566862.46262.58
20min1372097-37209769.24068.910.7169.4969.150.73
2369020-36902068.66868.90
3371117-37111769.05869.31
4373633-37363369.52669.78
5369930-36993068.83769.09
6366122-36612268.12868.35
30min1404475-40447575.26574.890.5675.6375.250.56
2401495-40149574.71175.06
3402224-40222474.84675.21
4405773-40577375.50775.88
5400088-40008874.44974.82
6400704-40070474.56474.90
45min1432480-43248080.47679.860.7280.9680.350.72
2428242-42824279.68880.16
3428160-42816079.67380.16
4433064-43306480.58581.08
5424827-42482779.05279.55
6428335-42833579.70580.17
60min1450618-45061883.85283.100.6984.4783.710.68
2444610-44461082.73483.34
3444743-44474382.75883.38
4448042-44804283.37284.00
5442604-44260482.36082.98
6448769-44876983.50884.10
极限1463420-46342086.23485.460.7986.9986.220.78
2457127-45712785.06385.81
3455602-45560284.77985.54
4459510-45951085.50686.28
5456210-45621084.89285.65
6463800-46380086.30587.04
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