左氨氯地平贝那普利片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100546-202105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2000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.614237004233724234064234824233554234630.04
213.634234624233604234110.02
单位质量响应值RSD%判断
31114.1131064.640.12数据可信
供试品溶液-2024071721批-左氨氯地平-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%
5min1267882-26788260.44856.7833.1160.4556.7833.11
2368529-36852983.15983.16
3298875-29887567.44167.44
4128779-12877929.05929.06
5193060-19306043.56443.56
6252632-25263257.00757.01
10min1401217-40121790.53590.523.0390.7290.693.09
2413718-41371893.35693.61
3415480-41548093.75393.96
4384965-38496586.86886.95
5390540-39054088.12688.26
6400949-40094990.47490.65
15min1403452-40345291.03993.192.7891.4993.632.82
2422902-42290295.42895.96
3429051-42905196.81697.30
4401366-40136690.56890.92
5404992-40499291.38791.78
6416012-41601293.87394.32
20min1414210-41421093.46794.442.2994.1995.162.34
2426465-42646596.23297.05
3432071-43207197.49798.27
4407785-40778592.01792.64
5409984-40998492.51393.18
6420516-42051694.89095.61
30min1421362-42136295.08195.592.0796.0996.592.11
2426252-42625296.18497.29
3437995-43799598.83499.90
4413437-41343793.29294.19
5416380-41638093.95694.90
6426186-42618696.16997.18
45min1423896-42389695.65296.052.4496.9497.342.48
2433260-43326097.76599.16
3439745-43974599.229100.59
4411895-41189592.94494.12
5416802-41680294.05295.28
6428461-42846196.68297.98
60min1425298-42529895.96996.571.9297.5598.151.97
2433271-43327197.76899.45
3439960-43996099.277100.94
4418113-41811394.34795.80
5420695-42069594.93096.44
6430481-43048197.13898.73
极限1423856-42385695.64396.251.8897.5198.121.94
2434437-43443798.031100.01
3437527-43752798.728100.69
4417670-41767094.24795.98
5419321-41932194.62096.42
6426495-42649596.23998.12
左氨氯地平贝那普利片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100768-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数500
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.068447828453738448238449538450638449990.03
210.078450258443658446950.06
单位质量响应值RSD%判断
83995.9283882.320.10数据可信
供试品溶液-2024071721批-贝那普利-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%
5min1-0.00024.61115.250.0024.61115.24
2352349-35234941.64141.64
3284116-28411633.57733.58
4-0.0000.00
527744-277443.2793.28
6585224-58522469.16269.16
10min1827233-82723397.76397.101.5297.7697.181.58
2828514-82851497.91598.04
3828860-82886097.95598.06
4800446-80044694.59794.60
5812575-81257596.03196.04
6832178-83217898.34898.56
15min1848275-848275100.25098.611.14100.5498.971.16
2838994-83899499.15399.57
3837659-83765998.99599.39
4822164-82216497.16497.45
5825608-82560897.57197.87
6833512-83351298.50599.01
20min1845986-84598699.97998.331.17100.5798.991.19
2836418-83641898.84999.56
3834984-83498498.67999.37
4818458-81845896.72697.30
5824046-82404697.38797.98
6832388-83238898.37299.17
30min1844277-84427799.77798.041.14100.6798.991.15
2832576-83257698.39599.41
3831907-83190798.31699.30
4817437-81743796.60597.47
5821724-82172497.11297.99
6829406-82940698.02099.11
45min1839397-83939799.20197.601.13100.3998.851.15
2829631-82963198.04799.35
3828425-82842597.90499.19
4813217-81321796.10797.26
5817626-81762696.62897.80
6826963-82696397.73199.12
60min1835690-83569098.76397.301.03100.2598.851.05
2826858-82685897.71999.32
3826138-82613897.63499.21
4811244-81124495.87497.32
5817000-81700096.55498.02
6823145-82314597.28098.96
极限1834977-83497798.67896.891.25100.4798.721.27
2825106-82510697.51299.41
3822947-82294797.25799.13
4806918-80691895.36297.09
5810532-81053295.78997.54
6818479-81847996.72998.70
左氨氯地平贝那普利片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100546-202105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2000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.614243104243294240004239584235364240270.08
213.634205444197014201220.15
单位质量响应值RSD%判断
31155.5530823.330.76数据可信
供试品溶液-2024071721批-左氨氯地平-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%
5min1234183-23418353.01545.8039.2753.0245.8039.27
2293076-29307666.34866.35
3126557-12655728.65128.65
4255413-25541357.82257.82
5218300-21830049.42049.42
686235-8623519.52219.52
10min1389214-38921488.11287.942.1988.2788.072.18
2385852-38585287.35187.55
3383954-38395486.92187.01
4378596-37859685.70885.88
5403781-40378191.41091.56
6389206-38920688.11088.17
15min1402215-40221591.05592.092.0791.4892.492.05
2399857-39985790.52190.98
3405658-40565891.83592.18
4403183-40318391.27491.71
5423182-42318295.80296.22
6406498-40649892.02592.35
20min1407674-40767492.29193.141.9392.9993.821.91
2405148-40514891.71992.45
3411160-41116093.08093.70
4405606-40560691.82392.53
5426377-42637796.52597.24
6412606-41260693.40894.01
30min1410917-41091793.02594.131.9394.0095.091.91
2407630-40763092.28193.29
3414779-41477993.90094.80
4411949-41194993.25994.24
5429949-42994997.33498.33
6419565-41956594.98395.86
45min1416202-41620294.22294.492.1995.4795.732.18
2412983-41298393.49394.78
3417608-41760894.54095.72
4407249-40724992.19593.45
5434445-43444598.35299.64
6415876-41587694.14895.31
60min1413910-41391093.70394.842.3895.2496.372.36
2414436-41443693.82295.39
3417004-41700494.40395.87
4409275-40927592.65494.19
5437509-43750999.045100.63
6421534-42153495.42996.88
极限1418416-41841694.72395.221.9596.5497.031.95
2416039-41603994.18596.03
3422339-42233995.61197.36
4416086-41608694.19596.01
5436312-43631298.774100.66
6414438-41443893.82295.56
左氨氯地平贝那普利片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100768-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数500
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.068469028468648458348458028445578459920.12
210.078387528385618386560.02
单位质量响应值RSD%判断
84094.6383282.620.69数据可信
供试品溶液-2024071721批-贝那普利-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%
5min1423421-42342150.19137.5793.0150.1937.5793.01
2566272-56627267.12467.12
3129379-12937915.33615.34
458301-583016.9116.91
5719155-71915585.24785.25
65257-52570.6230.62
10min1834307-83430798.89797.531.2499.0597.641.34
2829412-82941298.31698.52
3818284-81828496.99797.04
4811285-81128596.16896.19
5831332-83133298.54498.80
6812006-81200696.25396.25
15min1842358-84235899.85199.040.56100.3099.440.61
2838776-83877699.42699.92
3833088-83308898.75299.09
4829138-82913898.28498.59
5833580-83358098.81099.36
6835939-83593999.09099.38
20min1837380-83738099.26198.630.61100.0199.330.66
2837230-83723099.243100.04
3828530-82853098.21298.85
4824976-82497697.79198.39
5830039-83003998.39199.24
6834214-83421498.88699.47
30min1835483-83548399.03698.310.55100.0899.300.59
2832817-83281798.72099.81
3825093-82509397.80498.73
4824766-82476697.76698.66
5826216-82621697.93899.08
6831556-83155698.57099.46
45min1831251-83125198.53498.010.6099.8899.300.64
2833396-83339698.789100.18
3824025-82402597.67898.90
4820719-82071997.28698.48
5823520-82352097.61899.05
6827976-82797698.14699.33
60min1830425-83042598.43697.710.63100.0799.300.68
2830593-83059398.456100.14
3820619-82061997.27498.79
4818402-81840297.01198.49
5821680-82168097.40099.13
6824001-82400197.67599.15
极限1827052-82705298.03797.260.6099.9799.150.66
2826572-82657297.98099.96
3818055-81805596.97098.78
4817496-81749696.90498.68
5817712-81771296.92998.95
6816367-81636796.77098.54
左氨氯地平贝那普利片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100546-202105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2000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.614211994215524219914219494218044216990.08
213.634222744218394220560.08
单位质量响应值RSD%判断
30984.5030965.220.05数据可信
供试品溶液-2024071921批-左氨氯地平-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%
5min1253399-25339957.39161.4111.1457.3961.4111.14
2250534-25053456.74256.74
3321996-32199672.92772.93
4252994-25299457.29957.30
5295095-29509566.83466.83
6252959-25295957.29157.29
10min1411017-41101793.08993.361.1793.2693.541.16
2413192-41319293.58293.75
3408913-40891392.61392.83
4421066-42106695.36595.54
5411584-41158493.21793.42
6407491-40749192.29092.46
15min1421615-42161595.48996.181.4895.9496.651.47
2427699-42769996.86797.32
3418987-41898794.89495.39
4434682-43468298.44998.91
5426830-42683096.67097.15
6418231-41823194.72395.17
20min1426728-42672896.64797.061.4197.3997.811.40
2432863-43286398.03798.78
3425936-42593696.46897.25
4438662-43866299.350100.10
5423284-42328495.86796.64
6423742-42374295.97196.70
30min1426628-42662896.62597.671.1097.6598.721.09
2435871-43587198.71899.75
3430589-43058997.52298.59
4438163-43816399.237100.29
5428754-42875497.10698.16
6427524-42752496.82897.85
45min1430011-43001197.39198.611.1898.7199.951.18
2437631-43763199.117100.45
3435700-43570098.679100.04
4444232-444232100.612101.96
5433211-43321198.11699.46
6431648-43164897.76299.07
60min1428061-42806196.94998.541.5298.56100.171.51
2439735-43973599.593101.22
3433211-43321198.11699.77
4446011-446011101.015102.67
5431450-43145097.71799.36
6431929-43192997.82599.43
极限1431909-43190997.82198.731.6699.72100.651.64
2439738-43973899.594101.52
3434332-43433298.370100.32
4448750-448750101.635103.59
5429605-42960597.29999.24
6431075-43107597.63299.53
左氨氯地平贝那普利片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100768-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数500
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.068403358412608414238415668395928408350.11
210.078432748407858420300.21
单位质量响应值RSD%判断
83582.0183617.680.04数据可信
供试品溶液-2024071921批-贝那普利-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%
5min198325-9832511.66743.5541.7611.6743.5641.75
2332636-33263639.47139.47
3360747-36074742.80642.81
4459922-45992254.57554.57
5552529-55252965.56365.56
6398165-39816547.24647.25
10min1802018-80201895.16896.181.2995.2096.311.31
2809602-80960296.06896.19
3808039-80803995.88296.01
4830634-83063498.56398.73
5802900-80290095.27395.47
6809944-80994496.10896.25
15min1814955-81495596.70397.011.1497.0297.431.14
2817427-81742796.99697.40
3813997-81399796.58997.01
4835170-83517099.10299.56
5807699-80769995.84296.32
6816229-81622996.85497.28
20min1814390-81439096.63696.621.3197.2597.331.30
2814492-81449296.64897.35
3811939-81193996.34597.05
4830958-83095898.60299.36
5797650-79765094.65095.42
6815933-81593396.81997.54
30min1809251-80925196.02696.271.2696.9397.271.26
2811176-81117696.25597.24
3808856-80885695.97996.97
4829540-82954098.43499.49
5798114-79811494.70595.76
6810691-81069196.19797.21
45min1805988-80598895.63996.001.0596.8397.291.06
2808480-80848095.93597.21
3805930-80593095.63296.91
4824294-82429497.81199.16
5798776-79877694.78396.12
6810698-81069896.19897.50
60min1800910-80091095.03695.711.1896.5197.291.19
2806074-80607495.64997.21
3804318-80431895.44197.01
4823409-82340997.70699.35
5795666-79566694.41496.04
6809232-80923296.02497.61
极限1802165-80216595.18595.501.1296.9597.361.12
2805262-80526295.55397.40
3800055-80005594.93596.79
4820389-82038997.34899.28
5793574-79357494.16696.07
6807265-80726595.79097.67
左氨氯地平贝那普利片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100546-202105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2000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.614219884224534221934223714204164218840.20
213.634215784223354219560.13
单位质量响应值RSD%判断
30998.0930957.890.10数据可信
供试品溶液-2024071921批-左氨氯地平-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%
5min1275927-27592762.48765.947.5662.4965.947.57
2313368-31336870.96670.97
3272248-27224861.65461.65
4268459-26845960.79660.80
5319025-31902572.24772.25
6298072-29807267.50267.50
10min1415244-41524494.03794.622.3794.2294.822.38
2427983-42798396.92297.13
3421183-42118395.38295.57
4409766-40976692.79692.98
5428649-42864997.07397.29
6404178-40417891.53191.73
15min1432326-43232697.90597.871.4998.3798.351.50
2438320-43832099.26399.77
3432612-43261297.97098.44
4430916-43091697.58698.05
5438142-43814299.22299.73
6420684-42068495.26995.75
20min1434733-43473398.45098.821.3499.2199.601.34
2442726-442726100.261101.06
3439440-43944099.516100.28
4434403-43440398.37699.13
5440392-44039299.732100.54
6426539-42653996.59597.36
30min1438851-43885199.38399.681.51100.44100.751.51
2447822-447822101.415102.52
3439920-43992099.625100.69
4438467-43846799.296100.34
5446506-446506101.117102.22
6429422-42942297.24898.30
45min1437756-43775699.135100.251.73100.49101.621.73
2450432-450432102.006103.41
3446199-446199101.047102.41
4441447-44144799.971101.32
5449662-449662101.831103.24
6430643-43064397.52498.87
60min1442039-442039100.105100.091.50101.76101.761.50
2452384-452384102.448104.16
3444806-444806100.732102.40
4437308-43730899.034100.68
5442369-442369100.180101.89
6432958-43295898.04899.69
极限1434411-43441198.378100.041.84100.33102.011.84
2453537-453537102.709104.73
3445146-445146100.809102.78
4435167-43516798.549100.49
5447428-447428101.325103.34
6434717-43471798.447100.38
左氨氯地平贝那普利片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100768-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数500
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.068431128425058417258411658416998420410.10
210.078421588419028420300.03
单位质量响应值RSD%判断
83701.8983617.680.08数据可信
供试品溶液-2024071921批-贝那普利-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%
5min1639968-63996875.88546.1062.8175.8846.1062.81
28522-85221.0111.01
3347742-34774241.23441.23
4672824-67282479.78079.78
5303750-30375036.01736.02
6359950-35995042.68142.68
10min1801190-80119095.00296.061.2095.2396.201.20
2810085-81008596.05696.06
3826167-82616797.96398.09
4816568-81656896.82597.06
5804511-80451195.39595.50
6802425-80242595.14895.28
15min1804878-80487895.43997.111.5095.9597.541.45
2832799-83279998.75099.04
3834257-83425798.92299.34
4819886-81988697.21897.75
5811207-81120796.18996.58
6810759-81075996.13696.55
20min1799941-79994194.85396.851.6295.6597.571.56
2831255-83125598.56699.15
3832954-83295498.76899.48
4817974-81797496.99297.81
5810293-81029396.08196.76
6808417-80841795.85896.56
30min1796823-79682394.48496.431.5595.5797.441.48
2829818-82981898.39699.28
3826029-82602997.94798.96
4811979-81197996.28197.39
5809468-80946895.98396.95
6805393-80539395.50096.49
45min1795091-79509194.27896.181.5895.6597.481.53
2826839-82683998.04399.22
3825319-82531997.86399.17
4811469-81146996.22097.62
5806456-80645695.62696.88
6801504-80150495.03996.31
60min1791386-79138693.83995.741.6795.4997.331.61
2824771-82477197.79899.27
3821758-82175897.44099.04
4807845-80784595.79197.48
5801894-80189495.08596.63
6797066-79706694.51396.07
极限1788127-78812793.45395.491.6595.3897.371.59
2822170-82217097.48999.26
3819674-81967497.19399.08
4805134-80513495.46997.45
5799806-79980694.83796.67
6797186-79718694.52796.37
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