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%
19.763969139865397123977339627397340.23
29.693961139541395760.13
单位质量响应值RSD%判断
4071.114084.210.23数据可信
长期24月-供试品溶液-2022081001批-培哚普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min142943-4294389.85391.581.9789.8591.581.97
245083-4508394.33194.33
342747-4274789.44389.44
444172-4417292.42592.42
544045-4404592.15992.16
643622-4362291.27491.27
10min146800-4680097.92498.611.0998.9299.621.10
247520-4752099.430100.48
346296-4629696.86997.86
447400-4740099.179100.21
547656-4765699.715100.74
647087-4708798.52499.54
15min146981-4698198.30298.221.02100.39100.331.02
246992-4699298.325100.48
346111-4611196.48298.55
446901-4690198.135100.26
547587-4758799.570101.70
647082-4708298.514100.62
20min146730-4673097.77797.170.68100.96100.380.68
246209-4620996.68799.93
345967-4596796.18199.32
446545-4654597.390100.61
546786-4678697.894101.13
646415-4641597.118100.32
30min146267-4626796.80896.490.69101.07100.770.68
245686-4568695.59399.91
345783-4578395.796100.01
446407-4640797.101101.40
546435-4643597.160101.49
646103-4610396.465100.75
45min145370-4537094.93195.121.12100.27100.471.09
245068-4506894.30099.68
344761-4476193.65798.93
445729-4572995.683101.06
545622-4562295.459100.86
646199-4619996.666102.02
极限144828-4482893.79793.950.47100.19100.360.44
244589-4458993.29799.73
344900-4490093.948100.26
444986-4498694.128100.57
544879-4487993.904100.37
645223-4522394.624101.05
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%
114.041654891654341650941652911649681652550.14
214.041650671651361651020.03
单位质量响应值RSD%判断
11770.3011759.400.07数据可信
长期24月-供试品溶液-2022081001批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1159546-15954687.91190.522.3487.9190.522.34
2170013-17001393.67893.68
3162037-16203789.28389.28
4163240-16324089.94689.95
5163265-16326589.96089.96
6167619-16761992.35992.36
10min1174191-17419195.98096.401.3296.9697.411.32
2177376-17737697.73598.78
3172078-17207894.81695.81
4174320-17432096.05297.05
5178070-17807098.11899.12
6173707-17370795.71496.74
15min1175370-17537096.63096.051.5398.6798.131.51
2175732-17573296.83098.96
3170440-17044093.91495.96
4173275-17327595.47697.54
5178092-17809298.130100.22
6173006-17300695.32797.42
20min1173643-17364395.67894.770.9498.8097.920.93
2171503-17150394.49997.70
3170332-17033293.85496.94
4171356-17135694.41897.55
5174326-17432696.05599.23
6170822-17082294.12497.27
30min1172466-17246695.03094.190.9699.2198.390.94
2170542-17054293.97098.22
3168390-16839092.78496.92
4171854-17185494.69398.87
5172498-17249895.04899.29
6169897-16989793.61497.81
45min1169285-16928593.27792.511.0198.5197.750.99
2167284-16728492.17597.47
3164804-16480490.80895.97
4168115-16811592.63397.86
5169318-16931893.29598.60
6168527-16852792.86098.09
极限1166382-16638291.67891.380.6397.9597.650.63
2165111-16511190.97797.30
3164955-16495590.89197.06
4164852-16485290.83597.09
5167453-16745392.26898.61
6166314-16631491.64097.91
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%
19.763979839799397863963539879397790.23
29.693966839878397730.38
单位质量响应值RSD%判断
4075.724104.540.50数据可信
长期24月-供试品溶液-2022081101批-培哚普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min144141-4414192.07995.623.2692.0895.623.26
244715-4471593.27793.28
347019-4701998.08398.08
447069-4706998.18798.19
547460-4746099.00399.00
644630-4463093.09993.10
10min147454-4745498.99098.030.96100.0199.090.94
247517-4751799.122100.16
346912-4691297.86098.95
446933-4693397.90398.99
546845-4684597.72098.82
646302-4630296.58797.62
15min147191-4719198.44297.460.99100.5699.620.97
246989-4698998.020100.16
346933-4693397.903100.08
446262-4626296.50498.68
546922-4692297.880100.07
646034-4603496.02898.14
20min147063-4706398.17596.761.56101.3999.991.52
247142-4714298.339101.57
346433-4643396.860100.13
445667-4566795.26298.51
546615-4661597.240100.51
645385-4538594.67497.85
30min146047-4604796.05595.271.23100.3699.581.20
246410-4641096.812101.13
345936-4593695.824100.16
445280-4528094.45598.76
545476-4547694.86499.22
644888-4488893.63797.86
45min145883-4588395.71394.241.05101.0999.611.02
245512-4551294.939100.33
345148-4514894.18099.59
444763-4476393.37798.74
545162-4516294.20999.62
644601-4460193.03998.31
极限145221-4522194.33293.250.97100.7799.670.95
245072-4507294.021100.47
344956-4495693.779100.23
444282-4428292.37398.77
544469-4446992.76399.22
644218-4421892.24098.54
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%
114.041655251653011654221654931654821654450.06
214.041655961655371655660.03
单位质量响应值RSD%判断
11783.8311792.450.06数据可信
长期24月-供试品溶液-2022081101批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1160578-16057888.30592.504.0088.3092.504.00
2165704-16570491.12491.12
3171426-17142694.27094.27
4176005-17600596.78896.79
5174446-17444695.93195.93
6161071-16107188.57688.58
10min1173709-17370995.52695.491.4496.5196.521.45
2175829-17582996.69297.70
3172479-17247994.84995.90
4176286-17628696.94398.02
5174151-17415195.76996.83
6169436-16943693.17694.16
15min1173312-17331295.30795.111.1297.3597.201.13
2173804-17380495.57897.66
3173190-17319095.24097.34
4173992-17399295.68197.83
5174282-17428295.84197.97
6169111-16911192.99795.02
20min1173014-17301495.14494.161.6898.2597.311.65
2174121-17412195.75298.90
3170500-17050093.76196.92
4170872-17087293.96697.18
5172794-17279495.02398.22
6166102-16610291.34294.40
30min1170015-17001593.49492.921.4697.6597.111.44
2171792-17179294.47298.68
3168735-16873592.79096.99
4169920-16992093.44297.70
5168862-16886292.86097.11
6164495-16449590.45994.53
45min1168940-16894092.90391.781.3198.1097.001.30
2168986-16898692.92898.19
3165662-16566291.10196.33
4167619-16761992.17797.47
5166915-16691591.79097.07
6163276-16327689.78894.86
极限1165804-16580491.17990.751.1497.4197.001.14
2167013-16701391.84398.14
3165024-16502490.75096.99
4166323-16632391.46497.79
5164208-16420890.30196.60
6161785-16178588.96895.04
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%
19.763976739872398393967939968398250.28
29.693979539703397490.17
单位质量响应值RSD%判断
4080.434102.060.38数据可信
长期24月-供试品溶液-2022081201批-培哚普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min147430-4743098.91397.051.5698.9197.051.56
247047-4704798.11498.11
345763-4576395.43695.44
446981-4698197.97697.98
546327-4632796.61296.61
645680-4568095.26395.26
10min147871-4787199.83298.711.31100.9399.791.31
246772-4677297.54098.63
346763-4676397.52298.58
448282-48282100.689101.78
547050-4705098.12099.19
647258-4725898.55499.61
15min147359-4735998.76497.891.54100.97100.061.52
246188-4618896.32298.50
346429-4642996.82598.97
448162-48162100.439102.65
546678-4667897.34499.51
646813-4681397.62699.78
20min147025-4702598.06896.541.74101.3799.801.72
245691-4569195.28698.53
345679-4567995.26198.48
447488-4748899.033102.36
546282-4628296.51899.76
645576-4557695.04698.28
30min145881-4588195.68294.651.74100.0898.991.72
244829-4482993.48897.79
344836-4483693.50397.78
446565-4656597.109101.53
545700-4570095.30599.62
644518-4451892.84097.13
45min145266-4526694.40093.811.4599.8699.201.44
244339-4433992.46697.81
344695-4469593.20998.53
446148-4614896.239101.74
544587-4458792.98498.36
644872-4487293.57898.90
极限146389-4638996.74293.472.12103.2599.902.06
244086-4408691.93998.31
344227-4422792.23398.59
445604-4560495.105101.68
544277-4427792.33798.75
644325-4432592.43798.80
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%
114.041654761653971656171658741653231655370.14
214.041661721662681662200.05
单位质量响应值RSD%判断
11790.3811839.030.30数据可信
长期24月-供试品溶液-2022081201批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1168284-16828492.33593.621.8992.3393.621.89
2176287-17628796.72696.73
3167128-16712891.70091.70
4170028-17002893.29293.29
5171830-17183094.28094.28
6170239-17023993.40793.41
10min1178372-17837297.87096.391.2098.9097.421.20
2176086-17608696.61697.69
3171867-17186794.30195.32
4176125-17612596.63797.67
5175754-17575496.43397.48
6175797-17579796.45797.49
15min1177266-17726697.26395.811.1799.3897.931.16
2174376-17437695.67797.83
3171953-17195394.34896.41
4176752-17675296.98199.09
5174038-17403895.49297.61
6173372-17337295.12697.24
20min1174976-17497696.00694.501.3499.2097.681.33
2172765-17276594.79398.00
3168940-16894092.69595.81
4174182-17418295.57198.76
5172326-17232694.55297.73
6170210-17021093.39196.56
30min1171161-17116193.91392.681.4998.1796.901.47
2169180-16918092.82697.09
3165455-16545590.78294.93
4170920-17092093.78198.03
5170576-17057693.59297.82
6166142-16614291.15995.36
45min1168627-16862792.52391.700.9797.8396.960.96
2166785-16678591.51296.81
3164781-16478190.41395.57
4169140-16914092.80498.10
5166115-16611591.14596.42
6167299-16729991.79497.01
极限1170414-17041493.50390.831.6299.8497.111.57
2163837-16383789.89596.21
3162860-16286089.35995.52
4166390-16639091.29597.62
5165435-16543590.77197.05
6164359-16435990.18196.42
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%
19.763985039537398283975939590397130.36
29.693974839974398610.41
单位质量响应值RSD%判断
4068.954113.620.78数据可信
长期24月-供试品溶液-2022081302批-培哚普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min146474-4647496.92096.041.4296.9296.041.42
246117-4611796.17696.18
346806-4680697.61297.61
446249-4624996.45196.45
545709-4570995.32595.32
644951-4495193.74493.74
10min147669-4766999.41298.670.91100.4999.740.91
247074-4707498.17199.24
347773-4777399.629100.71
447633-4763399.337100.41
546934-4693497.87998.94
646798-4679897.59698.64
15min147068-4706898.15997.181.12100.3499.341.11
246865-4686597.73599.89
347017-4701798.052100.24
446710-4671097.41299.59
546115-4611596.17198.32
645807-4580795.52997.66
20min146819-4681997.64096.101.07100.9199.341.06
245888-4588895.69898.94
346132-4613296.20799.49
446409-4640996.785100.04
545836-4583695.59098.80
645413-4541394.70797.89
30min145847-4584795.61295.941.2399.97100.261.16
245563-4556395.02099.33
346258-4625896.470100.82
446174-4617496.294100.63
545307-4530794.48698.76
646886-4688697.779102.02
45min144884-4488493.60494.301.1099.0299.681.06
245332-4533294.53899.90
345551-4555194.995100.42
445963-4596395.854101.26
544603-4460393.01898.35
644988-4498893.82199.15
极限144932-4493293.70493.210.76100.1699.640.76
244805-4480593.43999.85
344958-4495893.759100.24
444936-4493693.713100.18
544185-4418592.14698.51
644360-4436092.51198.88
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%
114.048264282642824298250882636825710.12
214.048252182565825430.04
单位质量响应值RSD%判断
5881.135879.130.03数据可信
长期24月-供试品溶液-2022081302批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min183203-8320391.72791.141.8891.7391.141.88
283647-8364792.21692.22
383872-8387292.46492.46
483511-8351192.06692.07
582005-8200590.40690.41
679808-7980887.98487.98
10min187644-8764496.62397.151.0197.6498.161.02
288717-8871797.80698.83
389387-8938798.54499.57
488465-8846597.52898.55
587501-8750196.46597.47
686993-8699395.90596.88
15min186221-8622195.05495.580.7497.1597.670.75
287433-8743396.39098.50
387396-8739696.34998.47
486940-8694095.84697.95
586069-8606994.88696.96
686131-8613194.95597.00
20min185959-8595994.76594.410.7197.9197.560.72
286165-8616594.99298.17
385857-8585794.65397.85
486025-8602594.83898.01
585205-8520593.93497.06
684609-8460993.27796.37
30min184610-8461093.27893.640.7997.4897.840.78
285170-8517093.89598.13
386153-8615394.97999.22
484644-8464493.31597.54
584225-8422592.85397.03
684838-8483893.52997.66
45min182544-8254491.00092.461.1296.2497.701.09
284050-8405092.66097.94
384547-8454793.20898.51
485149-8514993.87299.13
583167-8316791.68796.89
683741-8374192.32097.49
极限181766-8176690.14291.250.8896.3997.520.87
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