培哚普利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
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.214144541367417834133341437414730.44
210.164117741557413670.65
单位质量响应值RSD%判断
4062.004071.560.17数据可信
供试品溶液-2022081302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%
5min145949-4594996.40097.601.0896.4097.601.08
246297-4629797.13097.13
347074-4707498.76098.76
446038-4603896.58796.59
546721-4672198.02098.02
647058-4705898.72798.73
10min146817-4681798.22198.211.2499.2999.291.23
246365-4636597.27398.35
346913-4691398.42299.52
446097-4609796.71197.78
546898-4689898.39199.48
647779-47779100.239101.34
15min145905-4590596.30897.340.9598.4799.520.94
246774-4677498.131100.29
346588-4658897.74199.93
446280-4628097.09499.24
545907-4590796.31298.49
646930-4693098.458100.67
20min145304-4530495.04796.301.3598.2899.561.33
245442-4544295.33698.59
346508-4650897.573100.85
445666-4566695.80699.03
545668-4566895.81199.06
646822-4682298.232101.54
30min145108-4510894.63694.881.5798.9299.211.54
244749-4474993.88298.19
346042-4604296.595100.96
444634-4463493.64197.93
544642-4464293.65897.98
646178-4617896.880101.28
45min144316-4431692.97493.381.5798.3198.761.54
243969-4396992.24697.60
344580-4458093.52898.96
444008-4400892.32897.66
544335-4433593.01498.37
645854-4585496.201101.67
极限143643-4364391.56292.761.6197.9499.181.58
243860-4386092.01798.40
344489-4448993.33799.81
443582-4358291.43497.79
544245-4424592.82599.22
645475-4547595.406101.95
培哚普利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(%)99.9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0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.128338783550832198323583062832910.23
214.128332483176832500.13
单位质量响应值RSD%判断
5898.805895.890.04数据可信
供试品溶液-2022081302批-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%
5min146410-4641051.01553.013.7951.0253.003.79
250255-5025555.24255.24
349155-4915554.03254.03
447372-4737252.07352.07
546118-4611850.69450.69
650016-5001654.97954.98
10min162945-6294569.19169.924.2369.7670.514.22
264143-6414370.50871.12
366739-6673973.36173.96
461234-6123467.31067.89
560155-6015566.12466.69
666447-6644773.04073.65
15min170355-7035577.33677.943.3878.6779.313.38
271669-7166978.78080.18
373357-7335780.63682.05
469576-6957676.48077.81
567151-6715173.81475.11
673322-7332280.59782.02
20min171857-7185778.98780.073.1781.1882.303.18
271941-7194179.07981.35
375830-7583083.35485.67
471939-7193979.07781.25
570004-7000476.95079.07
675496-7549682.98785.31
30min174842-7484282.26881.393.5185.3484.513.50
273137-7313780.39483.55
376937-7693784.57187.81
472089-7208979.24282.30
570487-7048777.48180.45
676771-7677184.38987.63
45min176059-7605983.60681.922.9687.5985.942.95
273459-7345980.74884.79
375550-7555083.04687.22
472746-7274679.96483.90
571797-7179778.92182.76
677532-7753285.22589.40
极限179056-7905686.90087.572.0191.8292.512.07
280091-8009188.03892.98
380905-8090588.93394.03
478373-7837386.15090.97
577669-7766985.37690.09
681907-8190790.03495.16
培哚普利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
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.214134541271413464134241380413370.10
210.164143741438414380.01
单位质量响应值RSD%判断
4048.684078.540.52数据可信
供试品溶液-2022081401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%
5min147298-4729899.30997.670.9499.3197.670.94
246585-4658597.81297.81
346413-4641397.45197.45
445975-4597596.53196.53
546488-4648897.60897.61
646338-4633897.29397.29
10min147494-4749499.72098.440.82100.8299.520.82
246994-4699498.67099.76
346496-4649697.62598.71
446560-4656097.75998.83
547086-4708698.86499.95
646667-4666797.98499.06
15min147098-4709898.88997.461.18101.1099.641.16
246584-4658497.81099.99
346120-4612096.83599.00
445682-4568295.91698.07
546108-4610896.81098.99
646927-4692798.530100.70
20min146583-4658397.80795.881.48101.1299.141.46
245590-4559095.72398.99
344725-4472593.90697.15
445110-4511094.71597.94
545928-4592896.43299.69
646061-4606196.71199.98
30min145519-4551995.57394.581.0299.9798.911.01
245039-4503994.56698.90
344432-4443293.29197.58
444713-4471393.88198.16
544958-4495894.39698.73
645612-4561295.769100.11
45min145615-4561595.77593.531.33101.2398.911.30
243966-4396692.31397.70
344079-4407992.55097.87
444406-4440693.23798.56
544515-4451593.46598.84
644696-4469693.84599.25
极限144880-4488094.23291.902.06100.7598.321.96
242345-4234588.90995.32
343373-4337391.06897.42
443668-4366891.68798.04
544553-4455393.54599.96
643807-4380791.97998.42
培哚普利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(%)99.9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0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.128320383157830278292183179830970.15
214.128279282704827480.08
单位质量响应值RSD%判断
5885.065860.340.30数据可信
供试品溶液-2022081401批-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%
5min148501-4850153.53851.193.8953.5451.193.89
246392-4639251.21051.21
346442-4644251.26551.26
447456-4745652.38452.38
546307-4630751.11651.12
643134-4313447.61347.61
10min167302-6730274.29172.803.4174.8973.373.40
267922-6792274.97575.54
367079-6707974.04574.61
467189-6718974.16674.75
563670-6367070.28270.85
662563-6256369.06069.59
15min177138-7713885.14885.141.6686.5786.521.67
277679-7767985.74587.15
376941-7694184.93186.32
479141-7914187.35988.77
575232-7523283.04484.39
676675-7667584.63785.93
20min180252-8025288.58688.011.4990.9590.331.50
280097-8009788.41590.77
378902-7890287.09589.43
481619-8161990.09592.47
578274-7827486.40288.67
679232-7923287.46089.70
30min179917-7991788.21688.960.5191.5792.260.46
280861-8086189.25892.60
380720-8072089.10292.41
480434-8043488.78792.16
580490-8049088.84892.08
681103-8110389.52592.73
45min180191-8019188.51888.900.3992.8593.190.38
280227-8022788.55892.89
380759-8075989.14593.44
480907-8090789.30993.67
580754-8075489.14093.36
680366-8036688.71192.91
极限181169-8116989.59888.301.7994.9193.581.68
277523-7752385.57390.89
379033-7903387.24092.52
480915-8091589.31794.67
580796-8079689.18694.40
680508-8050888.86894.06
培哚普利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
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.214140241462413414136041513414160.18
210.164137641640415080.45
单位质量响应值RSD%判断
4056.424085.430.51数据可信
供试品溶液-2022081501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%
5min145915-4591596.23297.481.8396.2397.481.84
246619-4661997.70797.71
347979-47979100.558100.56
446896-4689698.28898.29
545824-4582496.04196.04
645820-4582096.03396.03
10min146011-4601196.43397.662.1397.5098.752.13
246302-4630297.04398.13
348396-48396101.431102.55
447067-4706798.64699.74
546074-4607496.56597.63
645737-4573795.85996.93
15min145900-4590096.20096.482.3698.3498.642.35
245554-4555495.47597.64
347848-47848100.283102.53
446682-4668297.839100.03
545410-4541095.17397.31
644799-4479993.89396.02
20min144417-4441793.09294.972.6396.3098.212.61
245304-4530494.95198.18
347221-4722198.969102.33
446215-4621596.860100.14
544348-4434892.94796.14
644374-4437493.00296.18
30min144288-4428892.82293.331.6997.0797.631.71
244214-4421492.66796.95
345622-4562295.618100.08
445112-4511294.54998.90
544482-4448293.22897.46
643464-4346491.09595.30
45min143882-4388291.97193.072.5597.2598.402.52
243964-4396492.14397.45
346379-4637997.204102.72
445092-4509294.50799.91
543808-4380891.81697.08
643314-4331490.78096.00
极限142875-4287589.86091.642.2996.1698.012.28
243455-4345591.07697.41
345397-4539795.146101.75
444467-4446793.19799.65
543054-4305490.23596.52
643106-4310690.34496.57
培哚普利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(%)99.9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0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.128342682890829798326882957831040.28
214.128366483662836630.01
单位质量响应值RSD%判断
5885.555925.140.48数据可信
供试品溶液-2022081501批-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%
5min150034-5003454.92554.174.1354.9254.174.13
251803-5180356.86756.87
350991-5099155.97555.98
446152-4615250.66350.66
548618-4861853.37053.37
648472-4847253.21053.21
10min166121-6612172.58472.582.3873.1973.172.39
266364-6636472.85173.48
369035-6903575.78376.40
464561-6456170.87271.43
565372-6537271.76272.35
665225-6522571.60172.19
15min177028-7702884.55783.152.3885.9784.562.36
274576-7457681.86683.31
378714-7871486.40887.87
475358-7535882.72484.07
574962-7496282.28983.68
673863-7386381.08382.47
20min176707-7670784.20585.322.3886.5687.662.36
277028-7702884.55786.91
381196-8119689.13391.56
478283-7828385.93588.20
576051-7605183.48585.79
677088-7708884.62386.91
30min179751-7975187.54786.011.2190.8489.291.18
277317-7731784.87588.17
378493-7849386.16689.58
478687-7868786.37989.60
578590-7859086.27289.50
677254-7725484.80588.03
45min180375-8037588.23287.542.5592.5091.782.51
277546-7754685.12689.36
383432-8343291.58795.96
479540-7954087.31591.50
578736-7873686.43290.62
678857-7885786.56590.74
极限180321-8032188.17287.671.7693.4292.881.76
278492-7849286.16491.34
382439-8243990.49795.89
478957-7895786.67591.83
579397-7939787.15892.31
679594-7959487.37492.51
培哚普利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
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.214134141383413184128041497413640.21
210.164174241735417380.02
单位质量响应值RSD%判断
4051.324108.070.99数据可信
供试品溶液-322765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%
5min146486-4648697.22297.721.9097.2297.721.90
247332-4733298.99298.99
345898-4589895.99395.99
446104-4610496.42396.42
546299-4629996.83196.83
648219-48219100.847100.85
10min146964-4696498.22298.852.4099.3099.942.39
246758-4675897.79198.89
346617-4661797.49698.56
448036-48036100.464101.54
546056-4605696.32397.40
649161-49161102.817103.94
15min146556-4655697.36997.502.3399.5499.682.32
246331-4633196.89899.08
346074-4607496.36198.51
447262-4726298.845101.03
545152-4515294.43296.58
648329-48329101.077103.34
20min145530-4553095.22396.492.0698.4899.762.06
246151-4615196.52299.78
345772-4577295.72998.95
446259-4625996.748100.03
545211-4521194.55697.75
647901-47901100.182103.57
30min145734-4573495.65095.671.8599.96100.011.85
246010-4601096.227100.56
344739-4473993.56997.85
446379-4637996.999101.36
544778-4477893.65097.90
646818-4681897.917102.42
45min144784-4478493.66394.372.1299.0499.782.10
244593-4459393.26398.67
345343-4534394.832100.16
445062-4506294.24499.68
544088-4408892.20797.49
646870-4687098.025103.61
极限144941-4494193.99194.012.18100.41100.462.16
244827-4482793.753100.19
344107-4410792.24798.62
445325-4532594.794101.28
543889-4388991.79198.10
646616-4661697.494104.17
培哚普利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(%)99.9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0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.128276482953828888269282641827880.16
214.128367283927838000.22
单位质量响应值RSD%判断
5863.175934.840.86数据可信
供试品溶液-322765批-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%
5min161816-6181667.93369.673.5767.9369.663.57
264063-6406370.40270.40
360833-6083366.85366.85
461876-6187667.99968.00
565065-6506571.50471.50
666709-6670973.31073.31
10min176492-7649284.06184.672.2384.8285.442.23
276279-7627983.82784.61
375861-7586183.36884.11
477842-7784285.54586.30
575634-7563483.11883.91
680170-8017088.10388.92
15min179901-7990187.80888.252.4889.5089.962.47
279732-7973287.62289.34
380637-8063788.61790.29
480263-8026388.20589.91
577561-7756185.23686.95
683718-8371892.00293.80
20min179631-7963187.51188.392.0190.1891.092.00
280687-8068788.67191.36
380915-8091588.92291.58
480068-8006887.99190.68
578204-7820485.94388.61
683070-8307091.29094.11
30min180350-8035088.30188.282.3091.9491.952.26
280642-8064288.62292.29
380116-8011688.04491.69
481902-8190290.00793.67
576932-7693284.54588.16
682026-8202690.14393.97
45min178810-7881086.60987.502.0791.2392.162.03
278415-7841586.17590.83
381453-8145389.51394.13
479513-7951387.38192.05
577777-7777785.47390.03
681761-8176189.85294.68
极限180190-8019088.12588.211.4193.7193.841.43
279689-7968987.57593.19
379852-7985287.75493.37
481053-8105389.07494.71
578806-7880686.60492.11
682031-8203190.14895.98
培哚普利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
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.214151041364416124148041479414890.22
210.164138341575414790.33
单位质量响应值RSD%判断
4063.574082.580.34数据可信
供试品溶液-2021561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%
5min147973-47973100.49198.402.99100.4998.402.99
246578-4657897.56997.57
349093-49093102.837102.84
445278-4527894.84694.85
547081-4708198.62398.62
645840-4584096.02396.02
10min148271-48271101.115101.073.68102.23102.163.66
251160-51160107.167108.25
348759-48759102.138103.28
445874-4587496.09497.15
548354-48354101.289102.39
647079-4707998.61899.69
15min148329-48329101.237100.843.66103.48103.063.64
250747-50747106.302108.58
349282-49282103.233105.51
445886-4588696.11998.24
547957-47957100.458102.68
646642-4664297.70399.87
20min147708-4770899.93699.323.39103.30102.663.37
250086-50086104.917108.37
347875-47875100.286103.71
445278-4527894.84698.04
546948-4694898.344101.68
646590-4659097.594100.84
30min146116-4611696.60196.353.34101.08100.793.33
248155-48155100.872105.49
347242-4724298.960103.50
444169-4416992.52396.77
545775-4577595.887100.32
644522-4452293.26297.59
45min146218-4621896.81596.273.40102.36101.783.38
248265-48265101.103106.85
347147-4714798.761104.40
444165-4416592.51497.79
545303-4530394.898100.39
644655-4465593.54198.91
极限145270-4527094.82994.762.99101.45101.343.00
247224-4722498.922105.79
346166-4616696.706103.44
443574-4357491.27697.58
545197-4519794.676101.23
643997-4399792.16298.57
培哚普利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(%)99.9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0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.128321483215829068322483422831960.23
214.128297982654828160.28
单位质量响应值RSD%判断
5892.075865.160.33数据可信
供试品溶液-2021561批-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%
5min168356-6835675.37871.025.9375.3871.025.93
257286-5728663.17163.17
366448-6644873.27473.27
463788-6378870.34170.34
565699-6569972.44972.45
664834-6483471.49571.49
10min180816-8081689.11987.852.0689.9688.642.08
277754-7775485.74286.44
380025-8002588.24689.06
477511-7751185.47486.26
580529-8052988.80289.61
681354-8135489.71290.51
15min184554-8455493.24192.732.8795.0794.492.85
282341-8234190.80092.45
383082-8308291.61793.41
481771-8177190.17291.90
584325-8432592.98894.78
688474-8847497.56399.35
20min183911-8391192.53291.631.1295.4094.421.15
282458-8245890.92993.59
381948-8194890.36793.18
482447-8244790.91793.65
583570-8357092.15594.98
684204-8420492.85595.73
30min181007-8100789.32990.844.2993.2294.654.16
280009-8000988.22991.90
381795-8179590.19894.01
479842-7984288.04491.79
589314-8931498.490102.34
682284-8228490.73794.64
45min181901-8190190.31590.571.3895.2095.401.32
280647-8064788.93293.59
381928-8192890.34595.16
484038-8403892.67297.39
581660-8166090.04994.99
682636-8263691.12696.04
极限181035-8103589.36089.691.1895.2595.521.21
279773-7977387.96893.61
381926-8192690.34396.17
480997-8099789.31895.07
581732-8173290.12996.07
682530-8253091.00996.94
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