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D241101对照品来源工作对照品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%
110.206633066172663966622866115662480.18
210.356807267863679680.22
单位质量响应值RSD%判断
6494.906566.960.79数据可信
供试品溶液-2025042722-1批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min132898-3289845.19650.687.1145.2050.687.11
234379-3437947.23147.23
337906-3790652.07652.08
439482-3948254.24154.24
538047-3804752.27052.27
638639-3863953.08353.08
10min139172-3917253.81667.8010.3953.8967.8810.39
249585-4958568.12168.20
350794-5079469.78269.87
453106-5310672.95973.05
551348-5134870.54370.63
652095-5209571.57071.66
15min141500-4150057.01474.0311.4357.1874.2211.42
254985-5498575.54075.73
355519-5551976.27476.48
457143-5714378.50578.72
556263-5626377.29677.50
657887-5788779.52779.73
20min142817-4281758.82377.4911.9259.0877.8111.92
258469-5846980.32680.64
357688-5768879.25379.58
459749-5974982.08582.43
559354-5935481.54281.88
660347-6034782.90683.25
30min144672-4467261.37280.5211.7161.7380.9711.70
261088-6108883.92484.38
360299-6029982.84083.30
462088-6208885.29885.78
561527-6152784.52885.00
661996-6199685.17285.65
45min147234-4723464.89182.8610.6665.3583.4410.66
262550-6255085.93386.52
362108-6210885.32685.93
463425-6342587.13587.76
562982-6298286.52687.14
663559-6355987.31987.94
60min149221-4922167.62184.309.7368.1985.029.74
263615-6361587.39688.13
362966-6296686.50487.25
464170-6417088.15988.93
563740-6374087.56888.32
664462-6446288.56089.33
90min151203-5120370.34485.798.8871.0386.668.90
264345-6434588.39989.28
363772-6377287.61288.50
465013-6501389.31790.23
564727-6472788.92489.82
665630-6563090.16491.08
120min153076-5307672.91787.458.2473.7288.468.26
265058-6505889.37890.41
364816-6481689.04690.08
466481-6648191.33392.40
565686-6568690.24191.29
666826-6682691.80792.87
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限153281-5328173.19988.078.3074.1289.228.32
265615-6561590.14491.32
366017-6601790.69691.88
466624-6662491.53092.74
566337-6633791.13692.33
666760-6676091.71792.93
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D241101对照品来源工作对照品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%
110.206698766771662776688866526666900.44
210.356922768898690620.34
单位质量响应值RSD%判断
6538.246672.661.44数据可信
供试品溶液-2025042722-2批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min134455-3445546.80546.9711.5246.8046.9711.53
235296-3529647.94747.95
337707-3770751.22251.22
436164-3616449.12649.13
537043-3704350.32050.32
626806-2680636.41436.41
10min152126-5212670.80968.216.2770.8968.286.27
251148-5114869.48169.56
352117-5211770.79770.88
451029-5102969.31969.40
550954-5095469.21769.30
643886-4388659.61659.68
15min157722-5772278.41176.594.0378.6176.794.04
257334-5733477.88478.08
358290-5829079.18379.39
456550-5655076.81977.02
556419-5641976.64176.84
651986-5198670.61970.78
20min161484-6148483.52281.052.7383.8581.372.74
260240-6024081.83282.16
361130-6113083.04183.38
458764-5876479.82780.15
559230-5923080.46080.79
657134-5713477.61277.89
30min162730-6273085.21484.281.7885.6884.731.80
262369-6236984.72485.19
363649-6364986.46386.94
461553-6155383.61584.07
561389-6138983.39383.85
660542-6054282.24282.65
45min164295-6429587.34086.831.5787.9587.421.58
264438-6443887.53488.14
365405-6540588.84889.47
462967-6296785.53686.13
563663-6366386.48287.08
662735-6273585.22185.77
60min165199-6519988.56887.891.3089.3288.631.31
264896-6489688.15788.91
366002-6600289.65990.42
463819-6381986.69487.43
564410-6441087.49688.24
663890-6389086.79087.48
90min166232-6623289.97189.211.6890.8790.101.68
266102-6610289.79590.69
367392-6739291.54792.46
464491-6449187.60688.49
564982-6498288.27389.16
664843-6484388.08588.92
120min166521-6652190.36490.401.8991.4291.441.90
267370-6737091.51792.56
368636-6863693.23794.31
465355-6535588.78089.81
565697-6569789.24590.28
665699-6569989.24790.23
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限166846-6684690.80691.301.1792.0192.481.19
267351-6735191.49292.69
368679-6867993.29694.52
466839-6683990.79691.97
567124-6712491.18392.37
666418-6641890.22491.35
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D241101对照品来源工作对照品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%
110.206772967816676576748267765676900.20
210.356926368944691040.33
单位质量响应值RSD%判断
6636.276676.710.43数据可信
供试品溶液-25052901-1批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min141950-4195056.54449.966.7456.5449.966.74
237019-3701949.89749.90
336031-3603148.56648.57
436645-3664549.39349.39
535795-3579548.24848.25
634954-3495447.11447.11
10min153596-5359672.24169.751.7972.3469.831.80
251593-5159369.54169.62
351367-5136769.23769.32
451510-5151069.43069.51
551373-5137369.24569.33
651040-5104068.79668.87
15min159354-5935480.00278.261.6080.2278.461.61
256752-5675276.49576.69
357999-5799978.17678.37
457367-5736777.32477.52
558694-5869479.11379.31
658212-5821278.46378.66
20min162586-6258684.35982.692.2184.7183.022.20
259813-5981380.62180.95
360743-6074381.87582.20
459926-5992680.77381.10
562751-6275184.58184.91
662284-6228483.95284.28
30min165616-6561688.44386.911.6188.9387.381.61
263003-6300384.92185.38
364742-6474287.26587.73
463411-6341185.47185.93
564959-6495987.55788.03
665151-6515187.81688.28
45min167862-6786291.47089.691.8692.1190.311.86
265145-6514587.80888.41
367409-6740990.86091.47
465024-6502487.64588.25
567475-6747590.94891.56
666352-6635289.43590.05
60min168470-6847092.29090.621.7693.0891.381.76
266398-6639889.49790.25
368030-6803091.69792.46
465340-6534088.07188.82
567971-6797191.61792.38
667164-6716490.52991.29
90min169250-6925093.34191.382.0494.2892.292.03
266820-6682090.06690.96
368471-6847192.29193.20
465757-6575788.63389.53
569082-6908293.11594.03
667401-6740190.84991.76
120min169494-6949493.67091.641.6794.7792.701.67
266983-6698390.28591.33
368510-6851092.34493.41
466424-6642489.53290.58
568640-6864092.51993.59
667858-6785891.46592.53
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限169772-6977294.04592.301.2595.3093.521.26
267624-6762491.14992.35
368470-6847092.29093.51
467495-6749590.97592.17
568986-6898692.98594.21
668511-6851192.34593.56
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D241101对照品来源工作对照品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%
110.206841268127674096711667374676880.82
210.356713667527673320.42
单位质量响应值RSD%判断
6636.086505.511.41数据可信
供试品溶液-25052901-2批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min132985-3298545.04441.8810.7045.0441.8810.69
232405-3240544.25244.25
329751-2975140.62840.63
432957-3295745.00645.01
524449-2444933.38733.39
631462-3146242.96442.96
10min149126-4912667.08664.725.4667.1664.795.46
248331-4833166.00066.07
347345-4734564.65464.72
448932-4893266.82166.90
542275-4227557.73057.79
648355-4835566.03366.10
15min156581-5658177.26675.583.0877.4575.763.09
255531-5553175.83276.02
356087-5608776.59276.77
455568-5556875.88376.07
551975-5197570.97671.13
656335-5633576.93077.11
20min161110-6111083.45181.891.8483.7782.201.85
259643-5964381.44881.76
360789-6078983.01383.32
459958-5995881.87882.19
558003-5800379.20879.48
660310-6031082.35982.67
30min165073-6507388.86387.891.0389.3288.331.04
264314-6431487.82688.27
365056-6505688.84089.28
463839-6383987.17887.63
563404-6340486.58486.99
664462-6446288.02888.48
45min167038-6703891.54691.060.5992.1591.640.60
266666-6666691.03891.63
367099-6709991.62992.22
466207-6620790.41191.01
566219-6621990.42890.97
666855-6685591.29691.89
60min168744-6874493.87692.550.7694.6393.290.76
267675-6767592.41693.16
367863-6786392.67393.42
467380-6738092.01392.76
567376-6737692.00892.70
667606-6760692.32293.07
90min168784-6878493.93093.340.6294.8494.230.63
268186-6818693.11494.01
368782-6878293.92894.82
467947-6794792.78893.69
567831-6783192.62993.48
668560-6856093.62594.52
120min168727-6872793.85393.800.4294.9294.850.43
268727-6872793.85394.91
369059-6905994.30695.36
468384-6838493.38494.44
568331-6833193.31294.32
668890-6889094.07595.13
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限169398-6939894.76994.100.5295.9995.300.53
268663-6866393.76594.97
368959-6895994.16995.38
468684-6868493.79495.00
568508-6850893.55494.71
669245-6924594.56095.77
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