培哚普利左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10 供试品稀释倍数2系数1.000
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.413915339459391913929739645393490.52
29.573934539304393240.08
单位质量响应值RSD%判断
4181.624109.091.24数据可信
供试品溶液-24050602批-培哚普利-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min147074-4707496.89697.700.6696.9097.700.65
247862-4786298.51898.52
347394-4739497.55497.55
447525-4752597.82497.82
547751-4775198.28998.29
647191-4719197.13697.14
10min147221-4722197.19897.710.6898.2798.800.68
247771-4777198.33099.42
347434-4743497.63798.72
447188-4718897.13098.22
547957-4795798.71399.81
647249-4724997.25698.34
15min146659-4665996.04197.150.9998.2099.320.97
247466-4746697.70299.89
347379-4737997.52399.69
447557-4755797.890100.06
547573-4757397.923100.11
646561-4656195.84098.00
20min146468-4646895.64895.920.7998.8799.170.79
247037-4703796.819100.09
346647-4664796.01799.27
446788-4678896.30799.56
546701-4670196.12899.40
645953-4595394.58897.81
30min145585-4558593.83195.010.8398.1299.330.81
246588-4658895.895100.24
346427-4642795.56499.88
446399-4639995.50699.83
546038-4603894.76399.11
645910-4591094.50098.78
45min144707-4470792.02393.921.0997.3599.291.06
245788-4578894.24899.66
346062-4606294.812100.19
445916-4591694.51299.90
545855-4585594.38699.78
645436-4543693.52498.85
极限144690-4469091.98893.150.8498.3499.560.80
244917-4491792.45698.92
345337-4533793.32099.75
445491-4549193.637100.07
545692-4569294.051100.50
645397-4539793.44499.81
培哚普利左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5 供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.254091940942413884077940737409530.64
214.164094340976409600.06
单位质量响应值RSD%判断
2873.892892.660.47数据可信
供试品溶液-24050602批-左氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min124843-2484354.40250.535.6154.4050.535.61
223896-2389652.32852.33
323538-2353851.54451.54
422967-2296750.29450.29
521651-2165147.41247.41
621554-2155447.19947.20
10min140084-4008487.77783.572.6488.3884.142.65
237923-3792383.04583.63
338402-3840284.09484.67
437645-3764582.43682.99
537516-3751682.15382.68
637416-3741681.93482.46
15min140644-4064489.00386.781.9290.5888.271.93
239253-3925385.95787.46
339795-3979587.14488.65
440303-4030388.25689.73
538630-3863084.59386.03
639152-3915285.73687.17
20min141318-4131890.47987.352.1893.0589.812.19
239765-3976587.07889.54
339728-3972886.99789.47
440176-4017687.97890.43
538635-3863584.60486.98
639719-3971986.97889.37
30min141114-4111490.03287.762.1893.6191.182.18
239970-3997087.52790.95
340120-4012087.85691.30
440615-4061588.94092.37
538517-3851784.34587.67
640116-4011687.84791.20
45min140391-4039188.44988.051.8093.0292.451.76
239781-3978187.11391.51
340210-4021088.05392.47
440938-4093889.64794.07
539040-3904085.49189.75
640903-4090389.57093.90
极限143229-4322994.66493.071.45100.2298.451.43
243339-4333994.905100.27
341998-4199891.96897.36
442138-4213892.27597.69
542254-4225492.52997.74
642050-4205092.08297.41
培哚普利左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10 供试品稀释倍数2系数1.000
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.413933839373393483936339358393560.04
29.573924539170392080.14
单位质量响应值RSD%判断
4182.364096.971.46数据可信
供试品溶液-24050602批-培哚普利-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min149387-49387101.799101.710.85101.80101.710.85
249130-49130101.270101.27
350037-50037103.139103.14
449561-49561102.158102.16
548912-48912100.820100.82
649022-49022101.047101.05
10min148994-48994100.989101.161.09102.12102.291.08
248571-48571100.117101.24
349512-49512102.057103.20
449844-49844102.741103.88
548474-4847499.917101.04
649056-49056101.117102.24
15min148814-48814100.618100.521.49102.87102.781.47
247994-4799498.928101.17
349624-49624102.288104.57
449469-49469101.968104.24
547881-4788198.695100.93
648815-48815100.620102.87
20min148054-4805499.05299.110.89102.42102.490.89
247671-4767198.262101.60
348525-48525100.022103.44
448658-48658100.297103.71
547943-4794398.823102.15
647657-4765798.233101.60
30min147872-4787298.67697.951.10103.15102.421.09
246834-4683496.537100.97
347624-4762498.165102.69
448014-4801498.969103.49
546897-4689796.667101.09
647870-4787098.672103.13
45min146572-4657295.99796.450.94101.56102.010.94
246234-4623495.300100.80
347315-4731597.528103.15
447240-4724097.374103.00
546470-4647095.787101.29
646913-4691396.700102.25
极限145741-4574194.28495.721.24100.92102.351.19
246705-4670596.271102.83
347144-4714497.176103.88
446794-4679496.454103.16
545763-4576394.329100.89
646473-4647395.793102.42
培哚普利左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5 供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.254092040909409844093340962409420.08
214.164096040903409320.10
单位质量响应值RSD%判断
2873.122890.680.44数据可信
供试品溶液-24050602批-左氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min122582-2258249.47446.944.5549.4746.944.54
221527-2152747.16347.16
320056-2005643.94043.94
422354-2235448.97548.97
521407-2140746.90046.90
620620-2062045.17645.18
10min134556-3455675.70876.601.5776.2677.121.56
234350-3435075.25675.78
334714-3471476.05476.54
435821-3582178.47979.02
535351-3535177.44977.97
634988-3498876.65477.16
15min135913-3591378.68179.401.7580.0780.781.75
235451-3545177.66879.03
335871-3587178.58979.92
436855-3685580.74482.16
537115-3711581.31482.70
636254-3625479.42880.78
20min135897-3589778.64579.442.1580.9181.692.13
235880-3588078.60880.83
335603-3560378.00180.21
436970-3697080.99683.31
537488-3748882.13184.42
635710-3571078.23680.47
30min136393-3639379.73279.591.8982.8782.731.88
235803-3580378.44081.54
335269-3526977.27080.34
436988-3698881.03684.25
537011-3701181.08684.28
636514-3651479.99783.10
45min135640-3564078.08278.831.6982.1182.851.68
235360-3536077.46981.44
335383-3538377.51981.45
436626-3662680.24384.36
536701-3670180.40784.51
636167-3616779.23783.23
极限137740-3774082.68384.431.2687.5889.331.17
239031-3903185.51290.34
338852-3885285.11989.91
438877-3887785.17490.18
538300-3830083.91088.90
638419-3841984.17189.05
培哚普利左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10 供试品稀释倍数2系数1.000
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.413934239315393663935039348393440.05
29.573934839287393180.11
单位质量响应值RSD%判断
4181.084108.461.24数据可信
供试品溶液-24050602批-培哚普利-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min149205-49205101.296101.501.41101.30101.501.41
249115-49115101.111101.11
349386-49386101.669101.67
450222-50222103.390103.39
549735-49735102.387102.39
648158-4815899.14199.14
10min149463-49463101.827102.081.09102.95103.201.10
249293-49293101.477102.60
349574-49574102.056103.19
450251-50251103.449104.60
550124-50124103.188104.33
648798-48798100.458101.56
15min149085-49085101.049101.030.86103.31103.300.85
248811-48811100.485102.74
348895-48895100.658102.92
449890-49890102.706105.00
548729-48729100.316102.60
649058-49058100.993103.21
20min148867-48867100.600100.520.54103.98103.910.54
248657-48657100.168103.54
349178-49178101.240104.62
448772-48772100.405103.84
549045-49045100.967104.37
648458-4845899.758103.10
30min148114-4811499.05098.630.96103.55103.130.95
247597-4759797.986102.47
347970-4797098.754103.26
448412-4841299.664104.22
548200-4820099.227103.75
647156-4715697.078101.53
45min146536-4653695.80297.241.11101.40102.841.08
247142-4714297.049102.62
347458-4745897.700103.30
447775-4777598.352104.01
547765-4776598.332103.95
646737-4673796.215101.74
极限146909-4690996.56996.540.26103.23103.210.27
246893-4689396.536103.18
346986-4698696.728103.42
447049-4704996.858103.61
546720-4672096.180102.90
646798-4679896.341102.94
培哚普利左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5 供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.254096340966409274097940924409520.07
214.164089740881408890.03
单位质量响应值RSD%判断
2873.822887.640.34数据可信
供试品溶液-24050602批-左氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min134881-3488176.45076.123.1576.4576.123.15
234999-3499976.70976.71
335284-3528477.33477.33
436060-3606079.03479.03
534330-3433075.24375.24
632819-3281971.93171.93
10min138095-3809583.49583.211.9084.3484.061.91
237787-3778782.81983.67
338267-3826783.87284.73
438973-3897385.41986.30
537911-3791183.09183.93
636770-3677080.59081.39
15min138381-3838184.12183.332.1685.9085.102.16
238220-3822083.76985.54
337937-3793783.14884.94
439292-3929286.11887.95
537273-3727381.69383.45
637021-3702181.14182.84
20min138119-3811983.54783.441.4286.2686.141.43
238431-3843184.23186.93
338656-3865684.72487.44
438383-3838384.12686.91
537545-3754582.28984.96
637295-3729581.74184.34
30min138196-3819683.71682.291.7387.3685.911.73
236925-3692580.93084.57
337851-3785182.96086.62
438187-3818783.69687.42
537436-3743682.05085.63
636669-3666980.36983.87
45min136363-3636379.69881.211.9084.2785.751.88
237166-3716681.45886.00
337321-3732181.79886.38
438229-3822983.78888.44
536892-3689280.85885.35
636349-3634979.66884.07
极限139756-3975687.13586.971.1292.5992.421.12
239789-3978987.20792.65
340103-4010387.89693.38
440031-4003187.73893.32
538880-3888085.21590.61
639538-3953886.65791.94
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