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%
110.662846322844822847382846922842972845680.07
210.712843712841632842670.06
单位质量响应值RSD%判断
26694.9326542.200.41数据可信
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%
5min1114385-11438538.55935.3818.5238.5635.3818.52
275332-7533225.39425.39
3116213-11621339.17539.18
487809-8780929.60029.60
5126947-12694742.79442.79
6108975-10897536.73536.74
10min1287263-28726396.83696.921.7397.0597.121.75
2285823-28582396.35096.49
3290415-29041597.89898.12
4278746-27874693.96594.13
5290131-29013197.80398.04
6292763-29276398.69098.89
15min1292589-29258998.631100.923.2899.38101.653.27
2293926-29392699.08299.76
3318897-318897107.500108.26
4296164-29616499.836100.52
5295536-29553699.625100.41
6299139-299139100.839101.59
20min1289460-28946097.57698.981.0098.88100.281.01
2294491-29449199.272100.50
3298241-298241100.537101.90
4291962-29196298.42099.66
5293328-29332898.880100.21
6294250-29425099.191100.50
30min1289223-28922397.49798.140.5899.3499.980.59
2292421-29242198.575100.35
3293056-29305698.789100.71
4289067-28906797.44499.23
5291052-29105298.113100.00
6291915-29191598.404100.27
45min1285837-28583796.35598.001.1798.74100.401.17
2291109-29110998.132100.46
3295025-29502599.452101.92
4288580-28858097.28099.61
5290014-29001497.763100.19
6293791-29379199.036101.45
60min1285445-28544596.22397.981.4499.14100.911.44
2292136-29213698.479101.35
3296908-296908100.087103.11
4286780-28678096.67399.54
5290065-29006597.780100.75
6292539-29253998.614101.57
极限1293009-29300998.77399.011.08102.23102.501.07
2296861-296861100.071103.49
3297430-297430100.263103.84
4290510-29051097.930101.34
5289866-28986697.713101.23
6294661-29466199.330102.84
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%
114.786715667131677766748867331673760.40
214.796757268038678050.49
单位质量响应值RSD%判断
4558.594584.520.41数据可信
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%
5min136324-3632451.51557.1115.2451.5257.1015.24
237416-3741653.06453.06
349902-4990270.77270.77
435809-3580950.78550.78
536051-3605151.12851.13
646094-4609465.37165.37
10min160534-6053485.85089.804.3686.1490.124.39
263640-6364090.25590.55
365738-6573893.23193.62
461515-6151587.24287.52
561138-6113886.70786.99
667357-6735795.52795.89
15min163402-6340289.91895.834.9990.6896.645.01
267951-6795196.36997.17
373238-73238103.867104.78
466793-6679394.72795.49
565303-6530392.61493.38
668728-6872897.47198.37
20min164507-6450791.48594.982.6292.7596.332.66
268321-6832196.89498.23
368628-6862897.32998.82
466589-6658994.43895.73
565386-6538692.73294.01
668402-6840297.00998.44
30min165138-6513892.38094.881.6794.1596.761.72
267760-6776096.09897.97
367912-6791296.31498.34
467388-6738895.57197.39
565927-6592793.49995.29
667298-6729895.44397.42
45min164570-6457091.57495.242.1893.8697.652.22
268129-6812996.62299.03
368561-6856197.23499.80
467811-6781196.17198.52
566398-6639894.16796.48
667476-6747695.69698.20
60min164906-6490692.05195.171.7594.8498.111.80
267610-6761095.88698.83
368304-6830496.87099.97
467379-6737995.55898.44
566906-6690694.88797.73
667545-6754595.79498.83
极限164709-6470991.77194.911.9495.0898.381.97
267672-6767295.97499.45
367245-6724595.36899.01
467823-6782396.18899.60
566049-6604993.67297.04
668049-6804996.508100.08
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%
110.662848262854152853582846222851092850660.12
210.712845232844922845080.01
单位质量响应值RSD%判断
26741.6526564.710.47数据可信
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%
5min1114883-11488338.67733.5213.4238.6833.5213.42
288976-8897629.95529.95
398099-9809933.02633.03
489856-8985630.25130.25
5117418-11741839.53039.53
688165-8816529.68229.68
10min1285184-28518496.01095.752.0396.2395.942.04
2276362-27636293.04093.21
3284769-28476995.87196.05
4282756-28275695.19395.36
5294183-29418399.04099.26
6283238-28323895.35595.52
15min1296804-29680499.922100.151.02100.67100.871.04
2295814-29581499.589100.27
3299161-299161100.716101.43
4294272-29427299.07099.77
5302740-302740101.921102.69
6296088-29608899.681100.38
20min1294598-29459899.18099.970.68100.48101.250.68
2297451-297451100.140101.38
3297207-297207100.058101.33
4294649-29464999.197100.44
5299619-299619100.870102.21
6298215-298215100.398101.65
30min1293161-29316198.69699.840.67100.55101.670.66
2295807-29580799.587101.38
3297902-297902100.292102.12
4296196-29619699.718101.52
5298039-298039100.338102.23
6298325-298325100.435102.24
45min1292864-29286498.59699.531.09101.00101.911.09
2292927-29292798.617100.96
3296103-29610399.686102.08
4293298-29329898.742101.09
5300742-300742101.248103.70
6297854-297854100.276102.64
60min1289397-28939797.42999.421.23100.38102.361.20
2298736-298736100.573103.47
3294822-29482299.255102.20
4293146-29314698.691101.59
5298541-298541100.507103.52
6297216-297216100.061102.98
极限1288928-28892897.27198.891.01100.76102.380.98
2293666-29366698.866102.32
3293447-29344798.792102.29
4292951-29295198.625102.07
5295688-29568899.547103.12
6297679-297679100.217103.69
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%
114.786767567548679746773068059677970.32
214.796811467804679590.33
单位质量响应值RSD%判断
4587.084594.930.13数据可信
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%
5min136532-3653251.59056.2812.3551.5956.2812.35
240742-4074257.53657.54
338350-3835054.15854.16
433842-3384247.79247.79
548089-4808967.91167.91
641567-4156758.70158.70
10min159915-5991584.61286.852.9784.9087.163.00
262280-6228087.95288.27
361156-6115686.36586.67
459149-5914983.53083.80
564186-6418690.64391.02
662298-6229887.97788.30
15min163334-6333489.44091.922.2690.2092.722.29
265797-6579792.91993.73
365714-6571492.80193.58
463141-6314189.16889.90
565967-6596793.15994.04
666594-6659494.04494.86
20min164171-6417190.62292.751.9391.8894.051.95
266229-6622993.52994.85
366979-6697994.58895.88
463996-6399690.37591.60
566242-6624293.54794.95
666437-6643793.82295.16
30min164413-6441390.96493.962.1892.7295.782.19
266700-6670094.19496.04
367964-6796495.97997.80
465217-6521792.09993.83
566954-6695494.55296.47
667952-6795295.96297.82
45min164616-6461691.25193.602.1393.5195.942.15
265803-6580392.92795.29
367632-6763295.51097.86
464757-6475791.45093.69
567586-6758695.44597.89
667300-6730095.04197.43
60min163731-6373190.00193.762.5192.7796.622.52
267388-6738895.16598.05
367429-6742995.22398.11
464859-6485991.59494.34
567644-6764495.52798.50
667297-6729795.03797.96
极限164457-6445791.02693.802.2394.3097.182.24
266670-6667094.15197.56
366911-6691194.49297.91
465010-6501091.80795.06
566939-6693994.53198.04
668541-6854196.794100.24
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%
110.662837672842592842102830202823632835240.29
210.712838832840602839720.05
单位质量响应值RSD%判断
26597.0026514.660.22数据可信
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%
5min1114160-11416038.57435.5511.6538.5735.5511.64
2125895-12589542.53942.54
3101837-10183734.41034.41
496739-9673932.68732.69
596127-9612732.48132.48
696478-9647832.59932.60
10min1281134-28113494.99396.001.3795.2196.191.37
2286489-28648996.80397.04
3287793-28779397.24397.43
4281253-28125395.03395.21
5288369-28836997.43897.62
6279555-27955594.46094.64
15min1291102-29110298.36199.991.2399.10100.721.23
2300621-300621101.578102.35
3298848-298848100.979101.71
4294535-29453599.521100.23
5297302-297302100.456101.18
6293107-29310799.03999.74
20min1292407-29240798.802100.441.32100.09101.731.32
2298783-298783100.957102.30
3302638-302638102.259103.55
4297456-297456100.508101.77
5299199-299199101.097102.38
6293025-29302599.011100.27
30min1292118-29211898.705100.551.19100.54102.391.19
2299053-299053101.048102.95
3302795-302795102.312104.17
4297617-297617100.563102.38
5298059-298059100.712102.55
6295851-29585199.966101.77
45min1292721-29272198.908100.221.05101.29102.621.05
2296959-296959100.340102.80
3301420-301420101.848104.28
4294690-29469099.574101.95
5298632-298632100.906103.31
6295215-29521599.751102.11
60min1291421-29142198.46999.531.08101.40102.481.07
2295496-29549699.846102.86
3298526-298526100.870103.86
4291917-29191798.637101.57
5297815-297815100.630103.59
6292159-29215998.718101.63
极限1288441-28844197.46299.331.33100.94102.841.30
2291990-29199098.661102.23
3299042-299042101.044104.60
4293265-29326599.092102.57
5297743-297743100.605104.13
6293285-29328599.099102.56
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%
114.786766167622672456725966959673490.44
214.796766267837677500.19
单位质量响应值RSD%判断
4556.774580.800.38数据可信
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%
5min148196-4819668.39460.7910.9668.3960.7910.96
244542-4454263.20963.21
337114-3711452.66852.67
441677-4167759.14359.14
547455-4745567.34267.34
638042-3804253.98553.98
10min162617-6261788.85888.282.8389.2488.622.83
261357-6135787.07087.42
364133-6413391.01091.30
461637-6163787.46887.80
564010-6401090.83591.21
659518-5951884.46184.76
15min165392-6539292.79692.411.7593.6793.231.76
265428-6542892.84793.68
366133-6613393.84894.65
464837-6483792.00992.82
565917-6591793.54194.42
662993-6299389.39290.16
20min166361-6636194.17194.052.3795.5695.392.36
265850-6585093.44694.80
367993-6799396.48797.81
466997-6699795.07496.40
567004-6700495.08496.48
663434-6343490.01891.28
30min166974-6697495.04195.141.8596.9597.001.84
267146-6714695.28597.16
369204-6920498.206100.06
466532-6653294.41496.27
567005-6700595.08597.01
665399-6539992.80694.57
45min167227-6722795.40095.282.0897.8497.672.08
267188-6718895.34597.74
369096-6909698.053100.45
466116-6611693.82496.20
568078-6807896.60899.06
665146-6514692.44794.73
60min166805-6680594.80194.931.9297.7797.851.92
266661-6666194.59797.53
368398-6839897.062100.01
466531-6653194.41397.31
568135-6813596.68999.68
664845-6484592.02094.82
极限166581-6658194.48495.162.2997.9898.612.27
266032-6603293.70597.16
369143-6914398.119101.60
466172-6617293.90397.33
568836-6883697.684101.21
665573-6557393.05396.36
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