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%
19.744150941584414454151141468415030.13
29.784138041522414510.25
单位质量响应值RSD%判断
4261.094238.340.38数据可信
长期18月-供试品溶液-2022081001批-培哚普利-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min145806-4580691.96492.391.3091.9692.391.30
246090-4609092.53492.53
345236-4523690.81990.82
447022-4702294.40594.41
545743-4574391.83791.84
646209-4620992.77392.77
10min147007-4700794.37595.711.1495.4096.741.13
247487-4748795.33996.37
348001-4800196.37197.38
448096-4809696.56197.61
547130-4713094.62295.64
648314-4831496.99998.03
15min146690-4669093.73895.060.9595.8197.150.94
247899-4789996.16698.25
347217-4721794.79796.88
447796-4779695.95998.08
547370-4737095.10497.18
647126-4712694.61496.72
20min146086-4608692.52694.141.4295.6497.281.40
248022-4802296.41399.57
346846-4684694.05297.18
447165-4716594.69297.88
546448-4644893.25396.38
646769-4676993.89797.06
30min147148-4714894.65892.941.2298.8097.131.16
246145-4614592.64496.87
345844-4584492.04096.22
446800-4680093.95998.20
546079-4607992.51296.68
645725-4572591.80196.00
45min145645-4564591.64091.311.0596.8396.541.00
244803-4480389.95095.21
345702-4570291.75596.96
446171-4617192.69797.98
545139-4513990.62595.82
645431-4543191.21196.43
极限144296-4429688.93290.562.2095.1496.802.08
246806-4680693.971100.23
345090-4509090.52696.75
445641-4564191.63297.95
544599-4459989.54095.74
644211-4421188.76195.00
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%
114.171680581681341679601682321681491681070.07
214.181689021692671690840.16
单位质量响应值RSD%判断
11863.5911924.120.36数据可信
长期18月-供试品溶液-2022081001批-氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1157138-15713885.64687.131.1285.6587.131.11
2160997-16099787.74987.75
3161463-16146388.00388.00
4160503-16050387.48087.48
5158138-15813886.19186.19
6160924-16092487.70987.71
10min1170417-17041792.88394.061.1293.8395.021.11
2171058-17105893.23294.21
3174451-17445195.08296.06
4174157-17415794.92195.89
5171045-17104593.22594.18
6174316-17431695.00895.98
15min1169482-16948292.37393.901.0094.3695.910.99
2173458-17345894.54096.55
3173365-17336594.49096.52
4173354-17335494.48496.51
5173249-17324994.42796.42
6170782-17078293.08295.11
20min1166827-16682790.92693.061.4893.9496.121.45
2174209-17420994.95098.01
3172025-17202593.75996.84
4171707-17170793.58696.66
5169534-16953492.40295.44
6170187-17018792.75895.82
30min1168779-16877991.99091.830.6796.0195.920.65
2168971-16897192.09596.21
3168444-16844491.80895.93
4169937-16993792.62196.74
5168252-16825291.70395.77
6166543-16654390.77294.87
45min1165368-16536890.13190.341.1695.1795.441.11
2162512-16251288.57593.71
3167972-16797291.55096.70
4167433-16743391.25796.40
5165613-16561390.26595.35
6165565-16556590.23995.34
极限1159413-15941386.88589.241.8192.9395.361.73
2166574-16657490.78896.91
3165944-16594490.44596.61
4165952-16595290.44996.61
5163448-16344889.08595.18
6161118-16111887.81593.92
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%
19.744154541589414304147441621415320.20
29.784156141553415570.02
单位质量响应值RSD%判断
4264.074249.180.25数据可信
长期18月-供试品溶液-2022081101批-培哚普利-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min145420-4542091.04094.153.5691.0494.153.56
247939-4793996.08996.09
346706-4670693.61893.62
448759-4875997.73397.73
548363-4836396.93996.94
644642-4464289.48189.48
10min148744-4874497.70397.461.8898.7198.511.88
247660-4766095.53096.60
349789-4978999.798100.84
449326-4932698.87099.96
548768-4876897.75198.83
647461-4746195.13196.13
15min149888-4988899.99697.111.94102.0999.241.90
248303-4830396.81998.95
349029-4902998.274100.42
448549-4854997.31299.50
547369-4736994.94797.11
647565-4756595.34097.39
20min148117-4811796.44695.802.4499.6599.002.40
249128-4912898.473101.68
348143-4814396.49899.74
447424-4742495.05798.32
548256-4825696.72599.94
645689-4568991.58094.69
30min147090-4709094.38893.112.0798.6797.382.04
245635-4563591.47195.77
346853-4685393.91398.23
447223-4722394.65498.98
547019-4701994.24598.54
644891-4489189.98094.11
45min146835-4683593.87793.061.3399.2198.361.34
246654-4665493.51498.83
346454-4645493.11398.47
446819-4681993.84599.22
546581-4658193.36798.71
645208-4520890.61595.74
极限146073-4607392.34991.982.8898.7298.322.78
245403-4540391.00697.36
347845-4784595.901102.29
445935-4593592.07398.49
546303-4630392.81099.19
643784-4378487.76193.90
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%
114.171688301689381692301690941690671690320.10
214.181693491693951693720.02
单位质量响应值RSD%判断
11928.8611944.430.10数据可信
长期18月-供试品溶液-2022081101批-氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1155867-15586784.64889.204.0084.6589.204.00
2169595-16959592.10392.10
3164170-16417089.15789.16
4172174-17217493.50493.50
5166438-16643890.38990.39
6157246-15724685.39785.40
10min1176265-17626595.72596.132.1696.6797.122.16
2175457-17545795.28796.31
3180603-18060398.08199.07
4182451-18245199.085100.12
5175092-17509295.08896.09
6172156-17215693.49494.44
15min1178428-17842896.90095.472.2698.9097.532.24
2177531-17753196.41398.50
3178840-17884097.12499.20
4178496-17849696.93799.08
5171241-17124192.99795.06
6170225-17022592.44594.43
20min1175291-17529195.19694.471.6798.2897.591.68
2174075-17407594.53697.69
3175553-17555395.33998.50
4176099-17609995.63598.85
5174472-17447294.75297.85
6168226-16822691.36094.37
30min1170524-17052492.60892.302.2096.7596.472.17
2166904-16690490.64294.85
3172869-17286993.88198.10
4174329-17432994.67498.95
5170734-17073492.72296.87
6164351-16435189.25593.29
45min1170116-17011692.38692.241.5997.5597.431.60
2170920-17092092.82398.03
3170142-17014292.40097.66
4173983-17398394.48699.82
5167639-16763991.04196.22
6166269-16626990.29795.32
极限1167438-16743890.93291.063.2297.1397.283.12
2166027-16602790.16596.41
3174940-17494095.006101.29
4171597-17159793.19099.57
5166924-16692490.65396.84
6159064-15906486.38492.41
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%
19.744150441434413304140141584414510.24
29.784146441323413940.25
单位质量响应值RSD%判断
4255.754232.520.39数据可信
长期18月-供试品溶液-2022081101批-培哚普利-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min143232-4323286.91091.283.8486.9191.283.84
247451-4745195.39295.39
344428-4442889.31489.31
446924-4692494.33294.33
546407-4640793.29393.29
643991-4399188.43688.44
10min147957-4795796.40996.130.4297.3797.150.40
247753-4775395.99997.06
347593-4759395.67796.67
447604-4760495.69996.75
547991-4799196.47797.51
648025-4802596.54697.53
15min148040-4804096.57695.980.4098.6198.060.38
247749-4774995.99198.12
347721-4772195.93497.99
447507-4750795.50497.62
547844-4784496.18298.29
647589-4758995.66997.72
20min146972-4697294.42994.461.6397.5497.611.60
248210-4821096.918100.11
345890-4589092.25495.37
446747-4674793.97697.15
546786-4678694.05597.23
647330-4733095.14898.27
30min147074-4707494.63492.661.4698.7996.861.41
246489-4648993.45897.73
345242-4524290.95195.10
445476-4547691.42195.64
546247-4624792.97197.19
646016-4601692.50796.68
45min145906-4590692.28691.531.1297.5096.761.08
245694-4569491.86097.17
344858-4485890.17995.34
444911-4491190.28595.52
545863-4586392.19997.45
645947-4594792.36897.57
极限145149-4514990.76490.361.3297.0096.611.27
244885-4488590.23396.56
343894-4389488.24194.40
444799-4479990.06096.30
545533-4553391.53697.82
645431-4543191.33197.56
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%
114.171690271691671687321691711690721690340.11
214.181686991680141683560.29
单位质量响应值RSD%判断
11929.0011872.780.34数据可信
长期18月-供试品溶液-2022081101批-氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1149986-14998681.69985.763.7581.7085.763.75
2164063-16406389.36789.37
3151728-15172882.64882.65
4162977-16297788.77588.78
5160220-16022087.27487.27
6155698-15569884.81084.81
10min1176561-17656196.17594.671.0997.0895.621.06
2173380-17338094.44295.43
3171612-17161293.47994.40
4171997-17199793.68994.68
5174103-17410394.83695.81
6175101-17510195.37996.32
15min1177558-17755896.71894.581.2798.6996.591.24
2173555-17355594.53796.58
3171118-17111893.21095.17
4172139-17213993.76695.79
5174003-17400394.78196.80
6173458-17345894.48496.49
20min1175141-17514195.40193.331.7998.4596.391.75
2173208-17320894.34897.44
3166595-16659590.74693.74
4169823-16982392.50495.57
5170274-17027492.75095.83
6173002-17300294.23697.29
30min1173418-17341894.46391.522.2098.5795.612.12
2169209-16920992.17096.31
3165146-16514689.95793.96
4162752-16275288.65392.75
5168946-16894692.02796.13
6168581-16858191.82895.93
45min1169671-16967192.42290.591.4997.5895.701.46
2166477-16647790.68295.85
3163432-16343289.02394.02
4163716-16371689.17894.26
5166274-16627490.57195.70
6168317-16831791.68496.80
极限1167819-16781991.41389.481.8297.6095.601.77
2163614-16361489.12295.30
3159718-15971887.00092.99
4162299-16229988.40694.48
5165712-16571290.26596.40
6166437-16643790.66096.80
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%
19.744144641492416004152241690415500.24
29.784150441409414560.17
单位质量响应值RSD%判断
4265.914238.850.45数据可信
长期18月-供试品溶液-2022081201批-培哚普利-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min148435-4843597.18194.522.4297.1894.522.42
247559-4755995.42495.42
346545-4654593.38993.39
447902-4790296.11296.11
545224-4522490.73990.74
646988-4698894.27894.28
10min149695-4969599.70998.031.79100.7999.081.78
248184-4818496.67897.74
350111-50111100.544101.58
448918-4891898.15099.22
548170-4817096.64997.66
648080-4808096.46997.52
15min148817-4881797.94898.002.31100.14100.142.27
250215-50215100.753102.89
350081-50081100.484102.64
448194-4819496.69898.86
548452-4845297.21599.30
647309-4730994.92297.04
20min147362-4736295.02895.230.5798.3098.460.58
247351-4735195.00698.26
347853-4785396.01399.28
447706-4770695.71898.95
547113-4711394.52997.69
647405-4740595.11598.29
30min147081-4708194.46493.821.8398.8098.111.80
246802-4680293.90598.21
348237-4823796.784101.12
446434-4643493.16697.46
545757-4575791.80896.02
646262-4626292.82197.05
45min146982-4698294.26694.041.1499.6599.371.13
247558-4755895.422100.77
347022-4702294.34699.76
447158-4715894.61999.95
546374-4637493.04698.28
646116-4611692.52897.79
极限145030-4503090.34992.031.2796.7898.411.19
245460-4546091.21297.63
346724-4672493.748100.21
445896-4589692.08798.47
545953-4595392.20198.47
646154-4615492.60498.89
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%
114.171678251680021686441683061685211682600.21
214.181694291686101690200.35
单位质量响应值RSD%判断
11874.3811919.610.27数据可信
长期18月-供试品溶液-2022081201批-氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1168796-16879691.97590.002.9791.9790.002.97
2165274-16527490.05690.06
3163450-16345089.06289.06
4171485-17148593.44093.44
5157168-15716885.63985.64
6164802-16480289.79989.80
10min1179477-17947797.79596.781.7598.8297.781.75
2174192-17419294.91595.92
3180880-18088098.55999.55
4180772-18077298.50199.54
5175191-17519195.46096.41
6175118-17511895.42096.42
15min1176375-17637596.10597.231.9898.2199.311.94
2181693-18169399.002101.06
3182152-18215299.253101.34
4179917-17991798.035100.17
5177573-17757396.75798.77
6172931-17293194.22896.29
20min1172751-17275194.13094.611.2197.3197.761.20
2171333-17133393.35796.51
3174884-17488495.29298.48
4176991-17699196.44099.66
5173876-17387694.74397.83
6171944-17194493.69096.80
30min1171781-17178193.60193.131.3297.8297.331.31
2168602-16860291.86996.06
3174178-17417894.90899.15
4172373-17237393.92498.22
5168592-16859291.86496.00
6169954-16995492.60696.75
45min1169739-16973992.48993.081.0597.7598.321.05
2171165-17116593.26698.48
3171165-17116593.26698.57
4173872-17387294.741100.08
5170401-17040192.85098.01
6168569-16856991.85197.03
极限1164281-16428189.51591.471.6595.8097.741.58
2164757-16475789.77496.02
3170924-17092493.13599.47
4170185-17018592.73299.12
5168715-16871591.93198.12
6168368-16836891.74297.94
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%
19.744151341543415794151741589415480.09
29.784202541973419990.09
单位质量响应值RSD%判断
4265.714294.380.48数据可信
长期18月-供试品溶液-2022081201批-培哚普利-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min146902-4690293.49792.572.3393.5092.572.33
247496-4749694.68194.68
345494-4549490.69090.69
444767-4476789.24189.24
547319-4731994.32994.33
646637-4663792.96992.97
10min147317-4731794.32595.622.0795.3696.652.07
249770-4977099.215100.27
348095-4809595.87596.88
446871-4687193.43594.43
547942-4794295.57096.62
647803-4780395.29396.33
15min147020-4702093.73394.190.4095.8296.280.40
247445-4744594.58096.73
347506-4750694.70196.77
447187-4718794.06596.10
547128-4712893.94896.06
647206-4720694.10396.20
20min145955-4595591.60992.670.8194.7495.810.80
246840-4684093.37496.58
346712-4671293.11996.24
446553-4655392.80295.88
546780-4678093.25496.41
646091-4609191.88195.02
30min145502-4550290.70691.921.4994.8596.091.44
247223-4722394.13798.38
346048-4604891.79595.95
446616-4661692.92797.03
545509-4550990.72094.91
645775-4577591.25195.41
45min145492-4549290.68790.751.1495.8495.941.07
245631-4563190.96496.25
345223-4522390.15095.33
445712-4571291.12596.26
544771-4477189.24994.45
646315-4631592.32797.50
极限144457-4445788.62389.650.9394.7995.840.87
245011-4501189.72896.03
344961-4496189.62895.81
445162-4516290.02996.18
545622-4562290.94697.14
644606-4460688.92095.12
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%
114.171689051685621689321688731692281689000.14
214.181709181705241707210.17
单位质量响应值RSD%判断
11919.5512039.560.71数据可信
长期18月-供试品溶液-2022081201批-氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1165167-16516789.37988.611.5889.3888.611.58
2166508-16650890.10590.10
3160834-16083487.03487.03
4160482-16048286.84486.84
5165878-16587889.76489.76
6163659-16365988.56388.56
10min1171769-17176992.95294.511.5893.9495.501.56
2175932-17593295.20596.21
3179372-17937297.06698.03
4172728-17272893.47194.44
5174820-17482094.60395.60
6173284-17328493.77294.76
15min1172280-17228093.22893.901.4995.2595.941.46
2174051-17405194.18796.25
3178312-17831296.49398.54
4173516-17351693.89795.90
5171382-17138292.74294.79
6171580-17158092.85094.88
20min1168269-16826991.05892.291.4694.1295.371.43
2169166-16916691.54394.65
3174718-17471894.54897.67
4171794-17179492.96596.01
5170921-17092192.49395.57
6168380-16838091.11894.18
30min1165928-16592889.79191.691.9593.8695.791.89
2172185-17218593.17797.30
3172990-17299093.61397.78
4171950-17195093.05097.13
5165973-16597389.81593.92
6167586-16758690.68894.76
45min1165482-16548289.55090.551.3794.6295.671.32
2168029-16802990.92896.09
3168928-16892891.41596.62
4169208-16920891.56696.68
5163570-16357088.51593.62
6168741-16874191.31396.39
极限1162756-16275688.07589.561.5994.1495.691.54
2165961-16596189.80995.98
3169180-16918091.55197.77
4166925-16692590.33196.46
5166019-16601989.84095.93
6162210-16221087.77993.87
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