阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
110.982895922889272892812894132894052893240.09
210.962889352889162889260.01
单位质量响应值RSD%判断
26350.0926361.860.04数据可信
中间条件18月-供试品溶液-2023101221批-阿齐沙坦-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%
5min120792-207927.07929.6345.587.0829.6245.57
2132806-13280645.21445.21
383638-8363828.47528.47
494038-9403832.01632.02
5119702-11970240.75340.75
671146-7114624.22224.22
10min1254778-25477886.74091.744.4586.7891.904.51
2283228-28322896.42696.68
3269508-26950891.75591.91
4268596-26859691.44591.62
5282737-28273796.25996.49
6257904-25790487.80487.94
15min1285623-28562397.24299.732.0897.76100.402.15
2296049-296049100.791101.58
3288434-28843498.19998.87
4296051-296051100.792101.48
5301913-301913102.788103.55
6289525-28952598.57099.19
20min1292863-29286399.706100.511.01100.77101.741.08
2297324-297324101.225102.57
3290755-29075598.989100.20
4296022-296022100.782102.03
5298936-298936101.774103.11
6295516-295516100.610101.78
30min1294067-294067100.116100.580.89101.73102.370.93
2294355-294355100.214102.12
3293075-29307599.779101.54
4294910-294910100.403102.21
5300473-300473102.297104.19
6295757-295757100.692102.42
45min1295370-295370100.560100.231.15102.73102.581.18
2296735-296735101.025103.49
3291931-29193199.389101.71
4294937-294937100.413102.78
5298396-298396101.590104.06
6289109-28910998.428100.72
60min1291678-29167899.303100.011.44102.03102.911.48
2295518-295518100.610103.64
3290084-29008498.760101.63
4291076-29107699.098102.02
5301504-301504102.648105.68
6292696-29269699.650102.48
极限1293383-29338399.88399.491.67103.17102.951.69
2296355-296355100.895104.48
3287592-28759297.912101.33
4288089-28808998.081101.55
5299234-299234101.875105.48
6288710-28871098.293101.68
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.127192671554717917169671648717230.20
215.117146971470714700.01
单位质量响应值RSD%判断
4743.584729.980.21数据可信
中间条件18月-供试品溶液-2023101221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%
5min144148-4414860.42768.318.0360.4368.318.03
248614-4861466.54066.54
349569-4956967.84767.85
455716-5571676.26176.26
548433-4843366.29266.29
652971-5297172.50472.50
10min164843-6484388.75389.264.0189.0989.644.02
265491-6549189.64090.01
362668-6266885.77686.15
468142-6814293.26993.69
562004-6200484.86785.24
668140-6814093.26693.67
15min167053-6705391.77891.513.1592.6192.383.16
267711-6771192.67993.55
364547-6454788.34889.20
469645-6964595.32696.27
564214-6421487.89288.73
667963-6796393.02493.94
20min167970-6797093.03392.834.4794.3794.224.46
268387-6838793.60494.99
364992-6499288.95790.30
470923-7092397.07598.55
563634-6363487.09888.43
671030-7103097.22298.66
30min168519-6851993.78593.924.0195.6495.824.01
268824-6882494.20296.10
366970-6697091.66593.50
471416-7141697.75099.76
564365-6436588.09989.91
671622-7162298.032100.01
45min166115-6611590.49493.404.4992.8795.824.47
269053-6905394.51696.94
365716-6571689.94892.30
471927-7192798.449101.00
565025-6502589.00291.30
671594-7159497.994100.52
60min168016-6801693.09693.373.9595.9896.313.94
269143-6914394.63997.59
366773-6677391.39594.24
469957-6995795.75398.85
563847-6384787.39090.19
671546-7154697.928100.99
极限168151-6815193.28193.063.7196.6896.523.71
268616-6861693.91797.39
365788-6578890.04793.40
470469-7046996.454100.09
564313-6431388.02891.31
670584-7058496.611100.22
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
110.982886822887572890132885252889402887830.07
210.962889522889102889310.02
单位质量响应值RSD%判断
26300.8226362.320.17数据可信
中间条件18月-供试品溶液-2024010621批-阿齐沙坦-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%
5min1153151-15315152.18946.6317.7752.1946.6317.77
2160966-16096654.85254.85
3107562-10756236.65436.65
4161465-16146555.02255.02
5117438-11743840.01940.02
6120484-12048441.05741.06
10min1294126-294126100.22999.082.01100.5299.342.03
2299569-299569102.084102.39
3290213-29021398.89699.10
4291098-29109899.19899.50
5286866-28686697.75597.98
6282707-28270796.33896.57
15min1301292-301292102.671101.471.40103.52102.281.41
2303647-303647103.474104.35
3298324-298324101.660102.41
4292668-29266899.733100.59
5294730-294730100.435101.20
6295917-295917100.840101.60
20min1300632-300632102.446101.741.78103.86103.111.80
2307917-307917104.929106.38
3298154-298154101.602102.92
4293578-293578100.043101.45
5293796-293796100.117101.44
6297275-297275101.302102.63
30min1296233-296233100.947100.481.10102.93102.421.11
2299589-299589102.091104.12
3296687-296687101.102102.98
4290920-29092099.137101.10
5292136-29213699.551101.43
6293672-293672100.075101.96
45min1296442-296442101.019100.621.31103.57103.111.32
2301735-301735102.822105.42
3293820-293820100.125102.57
4290648-29064899.044101.56
5292677-29267799.736102.17
6296241-296241100.950103.39
60min1293994-293994100.18499.481.34103.29102.541.35
2297670-297670101.437104.61
3292831-29283199.788102.79
4286415-28641597.602100.67
5289185-28918598.546101.53
6291516-29151699.340102.34
极限1295434-295434100.67599.861.04104.34103.471.07
2297703-297703101.448105.18
3291528-29152899.344102.90
4291516-29151699.340102.95
5292666-29266699.732103.27
6289348-28934898.601102.16
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.127140171440714207128371356713800.09
215.117141671456714360.04
单位质量响应值RSD%判断
4720.904727.730.11数据可信
中间条件18月-供试品溶液-2024010621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%
5min151098-5109870.12468.4711.6570.1268.4711.65
254825-5482575.23975.24
338652-3865253.04453.04
452506-5250672.05772.06
552965-5296572.68772.69
649297-4929767.65367.65
10min168242-6824293.65291.712.5794.0492.092.58
269093-6909394.82095.24
365693-6569390.15490.45
466408-6640891.13591.54
567139-6713992.13892.54
664388-6438888.36388.74
15min171252-7125297.78395.271.8698.6996.161.86
270678-7067896.99597.94
368988-6898894.67695.47
468132-6813293.50194.41
569248-6924895.03295.95
668217-6821793.61894.48
20min171531-7153198.16696.681.6899.6298.101.69
272127-7212798.983100.47
370055-7005596.14097.46
468974-6897494.65696.08
570347-7034796.54197.98
669676-6967695.62097.01
30min171480-7148098.09697.321.41100.0999.271.41
271766-7176698.488100.52
371201-7120197.71399.57
469418-6941895.26697.22
571693-7169398.388100.37
669910-6991095.94197.86
45min172534-7253499.54298.261.64102.09100.761.63
272382-7238299.333101.91
371799-7179998.533100.93
469379-6937995.21297.69
572179-7217999.055101.58
671336-7133697.898100.35
60min171964-7196498.76098.091.70101.86101.141.68
272331-7233199.263102.40
371724-7172498.430101.38
469098-6909894.82797.84
572289-7228999.206102.28
671457-7145798.064101.06
极限172947-72947100.10998.791.73103.75102.381.70
271971-7197198.769102.45
372533-7253399.541103.03
470109-7010996.21499.75
573390-73390100.717104.34
670981-7098197.411100.95
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
110.982890522891632887992893272894392891560.09
210.962890002887062888530.08
单位质量响应值RSD%判断
26334.7926355.200.06数据可信
中间条件18月-供试品溶液-2024010721批-阿齐沙坦-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%
5min1120077-12007740.89841.7114.2740.9041.7114.27
2154777-15477752.71652.72
3119401-11940140.66840.67
4111824-11182438.08738.09
5103838-10383835.36735.37
6124780-12478042.50042.50
10min1294511-294511100.30998.771.32100.5499.001.34
2294529-294529100.315100.61
3288154-28815498.14498.37
4284977-28497797.06297.27
5289292-28929298.53298.73
6288494-28849498.26098.50
15min1302286-302286102.957101.351.10103.74102.131.11
2300799-300799102.451103.30
3294048-294048100.152100.92
4295248-295248100.560101.31
5296836-296836101.101101.85
6296230-296230100.895101.68
20min1302021-302021102.867101.610.98104.22102.961.00
2301756-301756102.777104.20
3295262-295262100.565101.89
4297654-297654101.380102.69
5295852-295852100.766102.07
6297492-297492101.325102.67
30min1299497-299497102.007100.331.25103.94102.241.26
2296201-296201100.885102.88
3292218-29221899.528101.41
4288798-28879898.363100.24
5294760-294760100.394102.26
6295895-295895100.781102.69
45min1298090-298090101.528100.270.94104.02102.740.95
2296264-296264100.906103.46
3291164-29116499.169101.61
4295771-295771100.738103.16
5291677-29167799.344101.77
6293414-29341499.936102.40
60min1295196-295196100.54399.920.70103.60102.940.70
2294931-294931100.452103.56
3290630-29063098.987101.98
4294529-294529100.315103.29
5293918-293918100.107103.08
6290978-29097899.106102.13
极限1298477-298477101.66099.661.36105.28103.241.36
2295612-295612100.684104.35
3288978-28897898.425101.96
4290140-29014098.821102.36
5288756-28875698.349101.88
6293711-293711100.037103.61
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.127177071800716407175571715717360.09
215.117154871576715620.03
单位质量响应值RSD%判断
4744.444736.070.13数据可信
中间条件18月-供试品溶液-2024010721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%
5min153293-5329372.89170.874.7172.8970.874.71
253677-5367773.41673.42
346990-4699064.27064.27
452226-5222671.43171.43
552164-5216471.34771.35
652541-5254171.86271.86
10min168492-6849293.67991.801.9094.0892.191.92
268233-6823393.32593.73
364894-6489488.75889.11
467068-6706891.73192.13
567097-6709791.77192.17
666907-6690791.51191.91
15min169263-6926394.73393.832.0595.6694.732.06
270641-7064196.61897.54
366438-6643890.87091.72
468996-6899694.36895.27
568092-6809293.13294.04
668181-6818193.25494.16
20min169383-6938394.89895.261.5396.3596.691.54
271363-7136397.60699.07
368435-6843593.60194.96
470133-7013395.92397.35
568704-6870493.96995.39
669877-6987795.57397.00
30min171008-7100897.12095.511.5499.1097.471.54
271227-7122797.42099.43
368831-6883194.14396.02
468817-6881794.12396.09
569233-6923394.69296.64
669887-6988795.58797.54
45min171086-7108697.22796.561.5699.7599.041.56
272020-7202098.504101.05
369762-6976295.41697.81
471531-7153197.835100.32
569325-6932594.81897.29
669846-6984695.53198.02
60min170746-7074696.76296.431.8999.8299.461.87
271815-7181598.224101.32
369671-6967195.29198.22
472287-7228798.869101.90
569082-6908294.48697.48
669437-6943794.97197.99
极限171496-7149697.78896.981.33101.38100.531.33
271779-7177998.175101.81
370326-7032696.18799.64
471572-7157297.892101.47
569315-6931594.80598.33
670938-7093897.024100.57
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
110.982888012887082900812898452898342894540.23
210.962890632893552892090.08
单位质量响应值RSD%判断
26361.9326387.680.07数据可信
中间条件18月-供试品溶液-2024010921批-阿齐沙坦-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%
5min1167528-16752856.99551.0925.2556.9951.0925.25
2116302-11630239.56739.57
3192646-19264665.54065.54
4135054-13505445.94745.95
5102017-10201734.70734.71
6187401-18740163.75663.76
10min1292095-29209599.37499.690.7699.6999.970.80
2293448-29344899.834100.05
3296772-296772100.965101.33
4293407-29340799.820100.08
5290115-29011598.70098.89
6292259-29225999.43099.78
15min1294268-294268100.113101.330.80100.98102.160.80
2297998-297998101.382102.16
3300082-300082102.091103.02
4295708-295708100.603101.41
5299670-299670101.951102.69
6299296-299296101.824102.73
20min1291339-29133999.117100.791.05100.54102.201.00
2298373-298373101.510102.85
3296452-296452100.856102.35
4295875-295875100.660102.03
5300488-300488102.229103.54
6295076-295076100.388101.86
30min1290799-29079998.933100.821.49100.91102.781.43
2304186-304186103.487105.39
3294302-294302100.125102.18
4295907-295907100.671102.60
5297035-297035101.055102.93
6295843-295843100.649102.68
45min1290568-29056898.854100.021.00101.38102.540.93
2294639-294639100.239102.72
3292835-29283599.626102.23
4296501-296501100.873103.36
5298022-298022101.390103.83
6291356-29135699.123101.71
60min1292082-29208299.370100.581.88102.44103.661.79
2297613-297613101.251104.28
3296137-296137100.749103.91
4292266-29226699.432102.48
5305490-305490103.931106.93
6290336-29033698.776101.92
极限1285348-28534897.07999.381.45100.70103.021.40
2297255-297255101.129104.73
3295434-295434100.510104.23
4290632-29063298.876102.48
5293401-29340199.818103.40
6290690-29069098.896102.58
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.127112471068709887113671047710730.09
215.117135471321713380.04
单位质量响应值RSD%判断
4700.604721.240.31数据可信
中间条件18月-供试品溶液-2024010921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%
5min148152-4815266.27072.494.7866.2772.494.78
253933-5393374.22674.23
351448-5144870.80670.81
455113-5511375.85075.85
553497-5349773.62673.63
653873-5387374.14374.14
10min158471-5847180.47187.484.9480.8487.884.94
266155-6615591.04691.46
361023-6102383.98384.38
465978-6597890.80391.22
565544-6554490.20590.61
664212-6421288.37288.78
15min162733-6273386.33790.973.5787.1591.863.58
267708-6770893.18494.10
363560-6356087.47588.33
466685-6668591.77692.70
567698-6769893.17094.08
668215-6821593.88194.78
20min163810-6381087.81991.993.7189.1193.383.72
268468-6846894.23095.67
363606-6360687.53888.88
467951-6795193.51894.95
569296-6929695.36996.80
667916-6791693.47094.89
30min164572-6457288.86893.464.2690.6595.364.25
270911-7091197.59299.55
363979-6397988.05289.88
469137-6913795.15097.11
569533-6953395.69597.65
669301-6930195.37697.32
45min165020-6502089.48493.163.6191.7695.583.62
269264-6926495.32597.83
364153-6415388.29190.61
469825-6982596.09798.58
568966-6896694.91597.40
668923-6892394.85697.33
60min164957-6495789.39894.154.2792.1797.094.25
270078-7007896.44599.48
364970-6497089.41592.23
469433-6943395.55898.58
572273-7227399.466102.48
668731-6873194.59297.59
极限164136-6413688.26893.034.2791.5496.504.25
270282-7028296.726100.29
363780-6378087.77891.09
468943-6894394.88398.43
569805-6980596.07099.64
668649-6864994.47998.00
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