氨氯地平贝那普利胶囊项目信息
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1000
标示量(mg)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%
114.209358469281509338349290179342139322120.37
214.189374809370679372740.04
单位质量响应值RSD%判断
65648.7366098.310.49数据可信
长期6月-供试品溶液-2023101921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%
5min1556983-55698360.90369.8511.3560.9069.8511.35
2716779-71677978.37578.38
3662815-66281572.47572.47
4539764-53976459.02059.02
5679329-67932974.28174.28
6677165-67716574.04474.04
10min1897181-89718198.101100.113.0298.28100.323.02
2933313-933313102.052102.29
3958342-958342104.789105.01
4923389-923389100.967101.14
5890197-89019797.33897.56
6890739-89073997.39797.62
15min1906206-90620699.088101.343.6399.57101.863.61
2939987-939987102.782103.32
3964088-964088105.417105.95
4964088-964088105.417105.90
5895918-89591897.96398.48
6890718-89071897.39597.91
20min1903047-90304798.743100.423.1799.52101.233.16
2936109-936109102.358103.21
3962187-962187105.209106.06
4928307-928307101.505102.30
5895788-89578897.94998.76
6884639-88463996.73097.54
30min1899692-89969298.376100.443.0699.45101.563.06
2935132-935132102.251103.41
3959265-959265104.890106.05
4933714-933714102.096103.20
5894283-89428397.78498.89
6889554-88955497.26798.36
45min1897612-89761298.14899.582.6599.51101.002.65
2911476-91147699.664101.13
3948865-948865103.753105.23
4928434-928434101.519102.93
5892643-89264397.60599.00
6885355-88535596.80898.20
60min1891655-89165597.49799.732.9999.16101.442.98
2928703-928703101.548103.31
3952449-952449104.145105.93
4924719-924719101.112102.82
5887533-88753397.04698.74
6887289-88728997.02098.70
极限1892125-89212597.54997.531.5399.5099.541.55
2892451-89245197.58499.65
3917783-917783100.354102.46
4886104-88610496.89098.91
5883843-88384396.64398.62
6879239-87923996.14098.11
氨氯地平贝那普利胶囊项目信息
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%
19.267836657774807831497800487814717811630.33
29.277787127850507818810.58
单位质量响应值RSD%判断
84358.8684345.310.02数据可信
长期6月-供试品溶液-2023101921批-贝那普利-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%
5min138144-381444.48616.69136.244.4916.70136.21
223863-238632.8062.81
313399-133991.5761.58
4-0.0000.00
5434839-43483951.13851.14
6341469-34146940.15840.16
10min1839640-83964098.74498.071.1798.7698.121.20
2836127-83612798.33098.34
3825853-82585397.12297.13
4819800-81980096.41096.41
5835249-83524998.22798.38
6846767-84676799.58299.70
15min1853891-853891100.42099.380.89100.7399.720.87
2847700-84770099.69199.99
3841323-84132398.94299.24
4841323-84132398.94299.23
5834059-83405998.08798.54
6851753-851753100.168100.59
20min1850388-850388100.00898.980.88100.6299.620.88
2843678-84367899.21899.82
3839371-83937198.71299.30
4832170-83217097.86598.45
5835232-83523298.22598.97
6848993-84899399.844100.56
30min1846872-84687299.59498.670.80100.5199.610.79
2842204-84220499.04599.95
3837629-83762998.50799.40
4831003-83100397.72898.61
5831765-83176597.81798.85
6844473-84447399.312100.33
45min1843198-84319899.16298.121.02100.3799.361.03
2839474-83947498.72499.92
3823544-82354496.85198.04
4827533-82753397.32098.49
5829719-82971997.57798.91
6842742-84274299.108100.43
60min1840501-84050198.84598.121.11100.3599.651.12
2837283-83728398.46699.96
3830669-83066997.68999.16
4823439-82343996.83898.30
5826359-82635997.18298.80
6847752-84775299.698101.31
极限1840245-84024598.81597.461.17100.6299.281.17
2833480-83348098.01999.81
3819288-81928896.35098.12
4818623-81862396.27298.03
5822911-82291196.77698.69
6837818-83781898.529100.44
氨氯地平贝那普利胶囊项目信息
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1000
标示量(mg)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%
114.209312049317579316309312349318729315390.04
214.189367259379909373580.10
单位质量响应值RSD%判断
65601.3466104.230.54数据可信
长期6月-供试品溶液-2023102021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%
5min1487647-48764753.33854.3311.6753.3454.3311.68
2523643-52364357.27557.28
3568130-56813062.14162.14
4394617-39461743.16343.16
5489081-48908153.49553.50
6516939-51693956.54256.54
10min1863787-86378794.48095.350.7294.6495.520.74
2881837-88183796.45496.63
3874756-87475695.68095.87
4867085-86708594.84194.97
5871616-87161695.33695.50
6871572-87157295.33195.50
15min1875376-87537695.74896.350.4896.1996.800.49
2887777-88777797.10497.57
3881534-88153496.42196.89
4878574-87857496.09796.51
5879924-87992496.24596.69
6882088-88208896.48296.94
20min1872838-87283895.47096.120.4396.2096.850.44
2881395-88139596.40697.16
3881162-88116296.38097.14
4875463-87546395.75796.46
5881933-88193396.46597.20
6879637-87963796.21496.96
30min1872073-87207395.38696.040.7196.4097.060.72
2884071-88407196.69997.74
3881561-88156196.42497.48
4869553-86955395.11196.10
5883854-88385496.67597.70
6877056-87705695.93196.96
45min1867630-86763094.90095.750.7196.2097.060.71
2879360-87936096.18397.52
3877478-87747895.97797.32
4872593-87259395.44396.72
5884292-88429296.72398.04
6870794-87079495.24696.57
60min1865032-86503294.61695.510.6596.2097.110.65
2878321-87832196.07097.69
3872983-87298395.48697.11
4870358-87035895.19996.76
5880584-88058496.31797.92
6871773-87177395.35396.96
极限1861539-86153994.23495.150.7496.1197.040.74
2871557-87155795.33097.24
3869716-86971695.12897.04
4864979-86497994.61096.46
5880241-88024196.28098.17
6871490-87149095.32297.22
氨氯地平贝那普利胶囊项目信息
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%
19.267798797799187781757799537795667794980.10
29.277838787851337845060.12
单位质量响应值RSD%判断
84179.0584628.480.38数据可信
长期6月-供试品溶液-2023102021批-贝那普利-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%
5min1-0.00017.23165.870.0017.23165.87
2214901-21490125.25825.26
3613026-61302672.05072.05
4-0.0000.00
5-0.0000.00
651756-517566.0836.08
10min1822921-82292196.71998.192.3296.7298.242.37
2838324-83832498.52998.60
3857372-857372100.768100.98
4859371-859371101.003101.00
5817330-81733096.06296.06
6817407-81740796.07196.09
15min1835582-83558298.20799.032.2698.5099.372.30
2842728-84272899.04799.42
3859265-859265100.990101.51
4870268-870268102.284102.59
5821937-82193796.60396.89
6825517-82551797.02497.33
20min1831301-83130197.70498.692.4298.2999.342.45
2839945-83994598.72099.39
3857954-857954100.836101.66
4869096-869096102.146102.76
5818653-81865396.21796.80
6821248-82124896.52297.12
30min1831312-83131297.70598.582.3898.5899.522.41
2838105-83810598.50399.47
3856773-856773100.698101.82
4867534-867534101.962102.88
5817028-81702896.02696.89
6821583-82158396.56297.45
45min1825414-82541497.01298.012.4598.1899.252.49
2834072-83407298.02999.29
3852211-852211100.161101.59
4863659-863659101.507102.73
5813572-81357295.62096.77
6814658-81465895.74896.92
60min1824543-82454396.90997.722.3798.3799.252.40
2832453-83245397.83999.39
3849319-84931999.821101.55
4859113-859113100.973102.50
5810276-81027695.23396.67
6812908-81290895.54297.01
极限1821664-82166496.57197.332.2698.3299.162.29
2827352-82735297.24099.09
3844224-84422499.223101.25
4855890-855890100.594102.42
5809065-80906595.09096.82
6810723-81072395.28597.04
氨氯地平贝那普利胶囊项目信息
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1000
标示量(mg)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%
114.209327779330939308009303849301839314470.15
214.189349909342649346270.06
单位质量响应值RSD%判断
65594.8665911.640.35数据可信
长期6月-供试品溶液-2023102121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%
5min1624983-62498368.46360.0023.9068.4660.0023.90
2532120-53212058.29058.29
3302640-30264033.15233.15
4681885-68188574.69674.70
5580998-58099863.64463.64
6563939-56393961.77661.78
10min1838351-83835191.83693.423.2892.0493.603.29
2811375-81137588.88189.06
3849008-84900893.00393.10
4894760-89476098.01598.24
5866104-86610494.87695.07
6857283-85728393.91094.09
15min1848663-84866392.96594.453.4493.4594.913.44
2816527-81652789.44589.89
3861613-86161394.38494.76
4906257-90625799.27499.79
5874857-87485795.83596.31
6865209-86520994.77895.24
20min1850532-85053293.17094.103.4893.9394.843.49
2812925-81292589.05189.76
3855425-85542593.70694.37
4904786-90478699.11399.93
5870909-87090995.40296.17
6859595-85959594.16394.91
30min1848159-84815992.91093.174.1493.9594.204.15
2813292-81329289.09190.07
3809517-80951788.67789.62
4901908-90190898.79899.91
5869537-86953795.25296.30
6860926-86092694.30995.34
45min1846481-84648192.72693.883.2394.0495.193.25
2814619-81461989.23690.48
3857590-85759093.94395.15
4898964-89896498.47699.89
5869476-86947695.24596.58
6855140-85514093.67594.99
60min1841774-84177492.21193.543.1893.8195.123.19
2812036-81203688.95390.47
3855261-85526193.68895.18
4894807-89480798.02099.73
5863912-86391294.63696.26
6855415-85541593.70595.30
极限1839264-83926491.93693.133.3893.8195.003.39
2808228-80822888.53690.31
3847058-84705892.79094.56
4896443-89644398.199100.20
5859015-85901594.09996.00
6850958-85095893.21795.10
氨氯地平贝那普利胶囊项目信息
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%
19.267812277813137793177787737786607798580.17
29.277825477822337823900.03
单位质量响应值RSD%判断
84217.9384400.220.16数据可信
长期6月-供试品溶液-2023102121批-贝那普利-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%
5min1418352-41835249.22424.10164.8549.2224.10164.86
21312-13120.1540.15
31782-17820.2100.21
41436-14360.1690.17
51856-18560.2180.22
6804078-80407894.61094.61
10min1847445-84744599.71299.621.6599.8699.701.73
2840946-84094698.94898.95
3824620-82462097.02797.03
4846703-84670399.62599.63
5853820-853820100.463100.46
6866547-866547101.960102.24
15min1856874-856874100.822100.711.31101.27101.081.37
2848932-84893299.887100.18
3837082-83708298.49398.78
4861224-861224101.334101.63
5864640-864640101.736102.04
6866689-866689101.977102.57
20min1856989-856989100.835100.391.30101.58101.071.37
2846633-84663399.617100.21
3834019-83401998.13398.72
4858346-858346100.995101.60
5859004-859004101.073101.68
6864464-864464101.715102.61
30min1853915-853915100.474100.011.34101.53100.991.39
2843788-84378899.282100.18
3829624-82962497.61698.50
4856107-856107100.732101.64
5857908-857908100.944101.85
6858530-858530101.017102.22
45min1851887-851887100.23599.871.17101.59101.141.22
2844742-84474299.394100.59
3830508-83050897.72098.89
4853658-853658100.443101.65
5857529-857529100.899102.11
6854250-854250100.513102.02
60min1848958-84895899.89099.521.14101.54101.091.19
2842334-84233499.111100.60
3827861-82786197.40898.88
4849726-84972699.981101.49
5853489-853489100.424101.94
6852290-852290100.283102.09
极限1845500-84550099.48499.081.29101.44100.951.33
2837155-83715598.502100.29
3822250-82225096.74898.51
4848388-84838899.823101.63
5851338-851338100.171101.99
6847781-84778199.752101.86
氨氯地平贝那普利胶囊项目信息
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1000
标示量(mg)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%
114.209301909305299301629292319284789297180.10
214.189341309343329342310.02
单位质量响应值RSD%判断
65473.1065883.710.45数据可信
长期6月-供试品溶液-MU5570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%
5min1435718-43571847.78565.7026.6747.7865.7026.67
2450791-45079149.43849.44
3826602-82660290.65290.65
4643312-64331270.55170.55
5729549-72954980.00980.01
6508493-50849355.76655.77
10min1806731-80673188.47389.268.4788.6289.468.49
2681688-68168874.76074.91
3876926-87692696.17196.44
4825694-82569490.55390.76
5845507-84550792.72692.97
6847135-84713592.90493.07
15min1854149-85414993.67392.722.7294.0893.182.77
2806786-80678688.47988.85
3876736-87673696.15096.71
4837113-83711391.80592.29
5848874-84887493.09593.61
6848984-84898493.10793.55
20min1853193-85319393.56993.251.7394.2694.001.74
2854404-85440493.70194.34
3875637-87563796.03096.88
4833650-83365091.42592.18
5844272-84427292.59093.39
6840712-84071292.20092.93
30min1849743-84974393.19093.943.4294.1694.963.35
2907629-90762999.538100.46
3872020-87202095.63396.77
4825518-82551890.53391.57
5841147-84114792.24793.32
6843318-84331892.48693.49
45min1847853-84785392.98393.713.3594.2395.013.28
2906513-90651399.416100.63
3866083-86608394.98296.41
4826812-82681290.67591.98
5838134-83813491.91793.27
6841457-84145792.28193.56
60min1841294-84129492.26493.023.5893.7994.603.51
2901698-90169898.888100.40
3863965-86396594.75096.46
4818337-81833789.74691.32
5834189-83418991.48493.11
6829552-82955290.97692.53
极限1838317-83831791.93792.783.5093.7494.653.43
2898734-89873498.563100.38
3860960-86096094.42096.41
4817400-81740089.64391.49
5828956-82895690.91092.81
6831747-83174791.21793.05
氨氯地平贝那普利胶囊项目信息
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%
19.267785617787137787307780347767357781550.11
29.277813967807587810770.06
单位质量响应值RSD%判断
84034.0284258.580.19数据可信
长期6月-供试品溶液-MU5570批-贝那普利-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%
5min1-0.00015.87156.070.0015.87156.08
286020-8602010.14110.14
3555998-55599865.54765.55
461307-613077.2277.23
59361-93611.1041.10
694982-9498211.19711.20
10min1803687-80368794.74796.511.0594.7596.561.10
2815253-81525396.11096.14
3828894-82889497.71897.92
4821090-82109096.79896.82
5822590-82259096.97596.98
6820534-82053496.73396.77
15min1826924-82692497.48697.920.7097.7798.260.71
2830844-83084497.94898.27
3832865-83286598.18798.68
4828331-82833197.65297.96
5840546-84054699.09299.39
6824103-82410397.15497.48
20min1825193-82519397.28297.620.7997.8698.250.80
2825853-82585397.36097.97
3831116-83111697.98098.76
4829139-82913997.74798.35
5838245-83824598.82199.41
6818789-81878996.52797.14
30min1822870-82287097.00897.380.6997.8898.310.69
2827344-82734497.53698.44
3827908-82790897.60298.68
4822179-82217996.92797.83
5835788-83578898.53199.42
6820259-82025996.70097.61
45min1820735-82073596.75797.100.6597.9298.320.63
2825243-82524397.28898.49
3822563-82256396.97298.34
4823269-82326997.05598.24
5832947-83294798.19699.38
6817298-81729896.35197.55
60min1815713-81571396.16596.670.8697.6198.180.88
2822473-82247396.96198.45
3824184-82418497.16398.83
4819599-81959996.62398.10
5829208-82920897.75599.23
6808969-80896995.36996.85
极限1815159-81515996.09996.520.6197.8498.320.63
2820211-82021196.69598.47
3821152-82115296.80698.76
4816999-81699996.31698.09
5826511-82651197.43799.21
6812479-81247995.78397.55
点击查看处理图标(自动生成)
 
原始图谱下载图谱(谢鑫慧 于 2024-05-14 15:34:27 完成)
生成报告数据部分下载报告(谢鑫慧 于 2024-05-14 15:38:24 完成)
Current page cost:1.976 s