阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.302865982865922864342866022864052865260.04
210.332842712842022842360.02
单位质量响应值RSD%判断
27818.0627515.590.78数据可信
供试品溶液-20220124批-阿齐沙坦-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min14305-43051.3961.5220.131.401.5220.02
25872-58721.9041.90
33889-38891.2611.26
43475-34751.1271.13
55072-50721.6451.65
65484-54841.7791.78
10min118187-181875.8996.105.465.916.115.48
220526-205266.6576.67
318426-184265.9765.98
417551-175515.6925.70
518903-189036.1316.14
619245-192456.2426.25
15min129839-298399.6789.491.249.729.531.24
229529-295299.5779.62
329185-291859.4669.51
429002-290029.4069.44
528887-288879.3699.41
629078-290789.4319.48
20min135847-3584711.62611.241.8611.7211.331.84
234757-3475711.27311.37
334212-3421211.09611.19
434670-3467011.24511.33
534117-3411711.06511.16
634254-3425411.11011.21
30min142006-4200613.62413.231.9513.7813.391.93
240629-4062913.17713.34
340888-4088813.26113.42
441318-4131813.40113.55
540133-4013313.01613.17
639822-3982212.91613.07
45min147499-4749915.40614.682.4915.6414.912.47
244885-4488514.55814.79
344988-4498814.59114.82
445201-4520114.66014.89
544655-4465514.48314.71
644395-4439514.39914.63
60min150016-5001616.22215.562.2016.5415.872.17
247237-4723715.32115.64
347877-4787715.52815.84
447988-4798815.56415.87
547208-4720815.31115.62
647479-4747915.39915.71
极限155151-5515117.88717.122.2918.3017.522.27
251945-5194516.84717.25
352954-5295417.17517.57
452340-5234016.97617.37
552050-5205016.88217.28
652305-5230516.96417.36
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检院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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.937189671920719257211072044719790.13
214.987166071881717700.22
单位质量响应值RSD%判断
4821.104791.050.45数据可信
供试品溶液-20220124批-氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min155014-5501474.21578.0514.9574.2178.0414.95
263472-6347285.62585.62
355686-5568675.12175.12
466121-6612189.19889.20
563950-6395086.27086.27
642881-4288157.84757.85
10min170587-7058795.22395.381.0395.6495.811.07
270208-7020894.71295.19
370709-7070995.38895.80
471983-7198397.10697.60
570870-7087095.60596.08
669857-6985794.23894.56
15min170109-7010994.57895.011.4095.5295.971.36
269154-6915493.29094.29
370114-7011494.58595.53
471665-7166596.67797.71
569971-6997194.39295.40
671544-7154496.51497.36
20min169925-6992594.33095.001.5295.8096.501.50
268965-6896593.03594.56
370136-7013694.61596.09
472059-7205997.20998.78
570315-7031594.85696.39
671152-7115295.98597.37
30min168598-6859892.54093.971.0994.5395.991.09
269083-6908393.19495.23
370149-7014994.63296.63
470635-7063595.28897.40
569412-6941293.63895.70
670061-7006194.51396.43
45min169449-6944993.68893.151.1496.1995.691.13
268420-6842092.30094.85
368661-6866192.62595.15
470273-7027394.79997.44
568157-6815791.94594.53
669346-6934693.54995.99
60min167443-6744390.98292.731.4994.0195.791.45
267545-6754591.11994.19
369100-6910093.21796.26
469788-6978894.14597.31
568902-6890292.95096.04
669669-6966993.98596.94
极限167760-6776091.40992.281.2594.9495.851.19
267166-6716690.60894.18
368693-6869392.66896.22
468628-6862892.58096.27
568525-6852592.44196.05
669649-6964993.95897.44
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.302843012841512839342840112839222840640.06
210.332824632823142823880.04
单位质量响应值RSD%判断
27579.0327336.690.63数据可信
供试品溶液-20220124批-阿齐沙坦-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min14349-43491.4211.3931.151.421.3931.26
24024-40241.3151.32
36595-65952.1552.16
44538-45381.4831.48
52787-27870.9110.91
63246-32461.0611.06
10min117447-174475.7025.7612.735.715.7712.76
217199-171995.6215.63
321721-217217.0987.11
418084-180845.9105.92
515506-155065.0675.07
615764-157645.1525.16
15min129103-291039.5119.414.719.559.454.78
228559-285599.3339.37
331260-3126010.21610.27
428566-285669.3359.38
527389-273898.9518.98
627830-278309.0959.13
20min135052-3505211.45511.233.3111.5511.323.34
234363-3436311.23011.32
336273-3627311.85411.96
433499-3349910.94711.04
533249-3324910.86610.95
633788-3378811.04211.13
30min141181-4118113.45813.283.1113.6113.433.13
240310-4031013.17313.33
342799-4279913.98714.16
439329-3932912.85313.01
539562-3956212.92913.07
640559-4055913.25513.40
45min146104-4610415.06715.002.1815.3015.232.20
245350-4535014.82015.05
347311-4731115.46115.71
446337-4633715.14315.37
544340-4434014.49014.71
645981-4598115.02715.25
60min149029-4902916.02315.802.3116.3416.112.34
248489-4848915.84616.15
350046-5004616.35516.69
447153-4715315.41015.72
547161-4716115.41215.71
648228-4822815.76116.06
极限153282-5328217.41217.171.3717.8217.571.39
252898-5289817.28717.68
353048-5304817.33617.76
451723-5172316.90317.30
551579-5157916.85617.24
652740-5274017.23517.63
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检院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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.937195171630718797189171725718150.19
214.987143671451714440.02
单位质量响应值RSD%判断
4810.114769.290.61数据可信
供试品溶液-20220124批-氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min146316-4631662.69572.0113.4462.7072.0113.44
255734-5573475.44475.44
365132-6513288.16588.17
452068-5206870.48170.48
554275-5427573.46973.47
645664-4566461.81361.81
10min169081-6908193.51193.721.8393.8694.121.84
270811-7081195.85396.27
368735-6873593.04293.53
467728-6772891.67992.07
570709-7070995.71496.12
668329-6832992.49392.84
15min169058-6905893.48093.841.9694.3594.761.96
271282-7128296.49097.44
368765-6876593.08394.09
467404-6740491.24192.14
570409-7040995.30896.25
669023-6902393.43294.29
20min168513-6851392.74293.402.6694.1394.842.65
271365-7136596.60298.09
368335-6833592.50194.02
466237-6623789.66191.07
570687-7068795.68597.15
668839-6883993.18394.56
30min167697-6769791.63792.982.4993.5494.942.48
270118-7011894.91496.94
368547-6854792.78894.83
466413-6641389.89991.81
571149-7114996.31098.31
668206-6820692.32694.22
45min167667-6766791.59792.941.8194.0195.421.81
269669-6966994.30796.86
367730-6773091.68294.24
468006-6800692.05694.46
570697-7069795.69898.23
668178-6817892.28894.70
60min167679-6767991.61392.262.1894.5395.262.18
269739-6973994.40197.48
367534-6753491.41794.48
466415-6641589.90292.82
570217-7021795.04898.12
667356-6735691.17694.10
极限166850-6685090.49191.042.0793.9294.542.05
269125-6912593.57097.17
366361-6636189.82993.40
465299-6529988.39191.81
568370-6837092.54896.14
667520-6752091.39894.82
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.302811062812272807862808162810742810020.07
210.332792292793642792960.04
单位质量响应值RSD%判断
27281.7527037.370.64数据可信
供试品溶液-20220126批-阿齐沙坦-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15965-59651.9712.2915.701.972.2915.75
27892-78922.6072.61
37259-72592.3982.40
47872-78722.6012.60
57418-74182.4512.45
65243-52431.7321.73
10min119002-190026.2786.828.806.296.848.80
221358-213587.0567.07
320532-205326.7846.80
422316-223167.3737.39
522605-226057.4687.48
618066-180665.9695.98
15min128969-289699.5719.943.489.629.993.49
230391-3039110.04110.09
330621-3062110.11710.17
430823-3082310.18410.24
531107-3110710.27710.33
628585-285859.4449.49
20min134042-3404211.24711.613.5311.3511.713.55
235288-3528811.65911.77
336341-3634112.00712.11
435912-3591211.86511.98
535970-3597011.88412.00
633218-3321810.97511.07
30min139825-3982513.15813.432.3513.3213.602.39
240831-4083113.49013.66
341453-4145313.69613.87
441351-4135113.66213.84
541325-4132513.65313.83
639147-3914712.93413.09
45min143994-4399414.53514.852.2114.7715.102.23
244714-4471414.77315.02
346436-4643615.34215.59
445606-4560615.06815.32
545176-4517614.92615.18
643840-4384014.48414.71
60min146578-4657815.38915.622.5415.7015.952.54
246444-4644415.34515.68
349110-4911016.22516.56
448135-4813515.90316.24
547479-4747915.68616.02
645918-4591815.17115.48
极限151679-5167917.07417.161.0417.4717.571.08
251798-5179817.11317.53
352864-5286417.46617.89
451807-5180717.11617.54
552199-5219917.24617.67
651303-5130316.95017.34
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检院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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.937126871603714337155571512714740.19
214.987135771448714020.10
单位质量响应值RSD%判断
4787.274766.490.31数据可信
供试品溶液-20220126批-氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min151669-5166970.12869.0511.0170.1369.0511.01
254476-5447673.93873.94
350053-5005367.93567.93
444399-4439960.26160.26
559264-5926480.43680.44
645392-4539261.60861.61
10min165961-6596189.52691.231.8989.9291.621.86
266056-6605689.65590.07
368690-6869093.23093.61
468774-6877493.34493.68
567312-6731291.35991.81
666522-6652290.28790.63
15min167556-6755691.69191.841.3992.5892.731.37
266351-6635190.05590.96
369162-6916293.87094.77
468151-6815192.49893.35
567244-6724491.26792.22
667528-6752891.65392.50
20min166296-6629689.98191.192.0291.3892.591.99
266066-6606689.66891.08
369637-6963794.51595.93
467821-6782192.05093.42
566834-6683490.71192.17
666449-6644990.18891.54
30min167204-6720491.21391.131.5393.1193.031.50
265712-6571289.18891.10
368688-6868893.22795.17
467794-6779492.01493.89
566749-6674990.59592.56
666689-6668990.51492.37
45min165916-6591689.46590.591.9791.8793.011.93
265252-6525288.56490.97
368919-6891993.54196.00
467354-6735491.41693.81
566008-6600889.59092.06
667033-6703390.98193.34
60min166063-6606389.66490.202.2392.5693.122.19
264532-6453287.58690.48
368807-6880793.38996.37
467471-6747191.57594.47
565835-6583589.35592.32
666050-6605089.64792.51
极限166242-6624289.90790.331.7193.3193.751.69
264872-6487288.04891.43
368408-6840892.84796.35
466759-6675990.60994.02
566618-6661890.41893.88
666410-6641090.13593.50
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.302790242789422790932789172788192789590.04
210.332777842779412778620.04
单位质量响应值RSD%判断
27083.4026898.550.49数据可信
供试品溶液-20220126批-阿齐沙坦-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17369-73692.4502.179.412.452.179.40
26562-65622.1822.18
36245-62452.0762.08
47099-70992.3602.36
55879-58791.9541.95
65945-59451.9761.98
10min120842-208426.9296.783.836.946.793.83
221244-212447.0637.07
320542-205426.8296.84
420506-205066.8176.83
520230-202306.7256.74
618960-189606.3036.31
15min130020-300209.9809.941.7810.039.991.80
230564-3056410.16110.21
330308-3030810.07610.13
429759-297599.8939.94
529704-297049.8759.92
629049-290499.6579.70
20min134992-3499211.63311.591.3711.7411.691.37
234925-3492511.61111.72
335689-3568911.86511.97
434401-3440111.43711.54
534427-3442711.44511.55
634695-3469511.53411.63
30min140790-4079013.56113.472.5713.7313.642.56
240160-4016013.35113.52
342486-4248614.12414.30
439773-3977313.22213.39
539706-3970613.20013.37
640214-4021413.36913.53
45min145327-4532715.06915.012.8715.3215.262.85
244997-4499714.95915.21
347622-4762215.83216.08
444383-4438314.75515.00
544509-4450914.79715.04
644053-4405314.64514.88
60min147733-4773315.86915.783.2016.2016.113.17
246613-4661315.49615.83
350425-5042516.76417.10
446437-4643715.43815.76
546781-4678115.55215.87
646802-4680215.55915.88
极限151682-5168217.18217.191.4917.6017.601.50
251850-5185017.23717.65
353058-5305817.63918.07
451317-5131717.06017.47
550753-5075316.87317.28
651505-5150517.12317.53
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检院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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.937148471129712177113571131712190.22
214.987119371058711260.14
单位质量响应值RSD%判断
4770.194748.060.33数据可信
供试品溶液-20220126批-氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min155299-5529975.33573.188.8975.3373.188.89
257620-5762078.49778.50
355016-5501674.94974.95
455211-5521175.21575.21
554971-5497174.88874.89
644198-4419860.21260.21
10min167307-6730791.69491.881.2392.1192.291.22
266409-6640990.47090.91
368845-6884593.78994.21
466906-6690691.14791.57
567746-6774692.29292.71
667471-6747191.91792.25
15min167392-6739291.80992.390.3792.7493.300.37
267976-6797692.60593.54
368056-6805692.71493.65
467990-6799092.62493.55
567734-6773492.27593.20
667749-6774992.29693.14
20min166580-6658090.70391.801.0192.1493.230.98
267433-6743391.86593.32
368073-6807392.73794.19
466616-6661690.75292.19
567447-6744791.88493.33
668151-6815192.84394.20
30min167064-6706491.36291.611.2393.3093.561.21
266435-6643590.50692.47
368714-6871493.61095.58
467382-6738291.79693.74
566513-6651390.61292.56
667387-6738791.80293.68
45min167041-6704191.33191.561.1093.7894.001.10
266704-6670490.87293.34
368445-6844593.24495.73
467434-6743491.86794.32
567311-6731191.69994.15
666297-6629790.31892.70
60min166353-6635390.39490.621.6093.3593.581.55
264621-6462188.03491.01
367806-6780692.37395.38
466752-6675290.93793.90
566535-6653590.64293.61
667031-6703191.31894.20
极限166247-6624790.24990.560.9393.7194.020.90
265947-6594789.84193.30
367209-6720991.56095.08
466903-6690391.14394.61
565666-6566689.45892.93
666890-6689091.12594.52
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