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%
112.002867182869522868862870372868332868850.05
212.042866162866322866240.01
单位质量响应值RSD%判断
23907.0823805.980.30数据可信
供试品溶液-2023101221批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15442-54422.0473.27102.532.053.27102.65
23971-39711.4941.49
35403-54032.0322.03
426789-2678910.07610.08
56415-64152.4132.41
64134-41341.5551.55
10min159387-5938722.33724.1312.4422.3524.1512.43
261776-6177623.23623.24
356336-5633621.18921.20
462849-6284923.63923.70
579165-7916529.77629.79
665390-6539024.59524.60
15min1140153-14015352.71552.991.7852.8553.141.79
2143145-14314553.84053.98
3137202-13720251.60551.73
4139825-13982552.59252.78
5144169-14416954.22654.40
6140848-14084852.97653.12
20min1183252-18325268.92670.842.8269.3571.292.82
2188103-18810370.75071.19
3188884-18888471.04471.46
4185067-18506769.60870.09
5198345-19834574.60375.08
6186458-18645870.13270.57
30min1222057-22205783.52186.802.4384.3387.642.43
2234669-23466988.26589.09
3230327-23032786.63287.44
4229231-22923186.22087.09
5238643-23864389.76090.65
6229673-22967386.38687.21
45min1244813-24481392.08095.512.1793.3696.832.17
2258285-25828597.14798.47
3256062-25606296.31197.60
4255904-25590496.25297.60
5258767-25876797.32998.72
6249703-24970393.92095.23
60min1258168-25816897.10399.591.8598.89101.441.85
2271456-271456102.101103.96
3264625-26462599.532101.36
4266565-266565100.262102.14
5267562-267562100.637102.57
6260320-26032097.91399.74
极限1257201-25720196.740100.272.1799.07102.682.15
2267161-267161100.486102.91
3271975-271975102.297104.68
4272970-272970102.671105.11
5266566-266566100.262102.76
6263697-26369799.183101.56
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%
115.127165071189717337162971572715550.30
215.147137171801715860.43
单位质量响应值RSD%判断
4732.474728.270.07数据可信
供试品溶液-2023101221批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min117639-1763924.17627.9362.4224.1827.9362.42
221600-2160029.60529.60
323679-2367932.45432.45
4-0.0000.00
539703-3970354.41754.42
619665-1966526.95326.95
10min152922-5292272.53485.118.2672.6785.268.26
261557-6155784.37084.53
361689-6168984.55084.73
466052-6605290.53090.53
567635-6763592.70093.00
662735-6273585.98486.13
15min165900-6590090.32294.472.5490.8695.102.52
268605-6860594.02994.66
369916-6991695.82696.48
471117-7111797.47297.98
568685-6868594.13994.96
669321-6932195.01195.64
20min168385-6838593.72895.291.6994.7796.441.64
269031-6903194.61395.77
371017-7101797.33598.52
470875-7087597.14198.19
568408-6840893.75995.10
669412-6941295.13696.29
30min167872-6787293.02594.411.3394.5896.091.29
268562-6856293.97195.65
368395-6839593.74295.46
470346-7034696.41698.00
568525-6852593.92095.78
669592-6959295.38297.07
45min167333-6733392.28692.921.7294.3695.121.61
268320-6832093.63995.84
367790-6779092.91295.16
469728-6972895.56997.69
566301-6630190.87293.25
667283-6728392.21894.43
60min167267-6726792.19692.400.6794.7895.120.61
267733-6773392.83495.56
367581-6758192.62695.39
468036-6803693.25095.90
566871-6687191.65394.54
666994-6699491.82194.55
极限165404-6540489.64291.182.0892.7494.411.99
265718-6571890.07393.31
368018-6801893.22596.50
468520-6852093.91397.08
565466-6546689.72793.12
666015-6601590.48093.72
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%
112.002864302868302865152866472861292865100.10
212.042867142869872868500.07
单位质量响应值RSD%判断
23875.8323824.750.16数据可信
供试品溶液-2024010621批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17095-70952.6692.9844.802.672.9844.84
26703-67032.5222.52
311660-116604.3874.39
45356-53562.0152.02
53914-39141.4731.47
612852-128524.8354.84
10min156153-5615321.12622.0219.4721.1422.0419.44
277698-7769829.23229.25
352860-5286019.88719.91
458922-5892222.16822.18
562194-6219423.39923.41
643352-4335216.31016.34
15min1131954-13195449.64450.5810.0649.7850.7210.07
2155207-15520758.39258.57
3125487-12548747.21147.35
4137194-13719451.61551.75
5140984-14098453.04153.18
6115838-11583843.58143.70
20min1176613-17661366.44667.486.4666.8567.906.49
2197451-19745174.28574.79
3171310-17131064.45164.85
4177533-17753366.79267.21
5187807-18780770.65771.09
6165379-16537962.21962.58
30min1217104-21710481.67983.793.9782.4684.584.01
2235667-23566788.66389.58
3217560-21756081.85182.61
4222806-22280683.82584.62
5230529-23052986.73087.56
6212580-21258079.97780.68
45min1243984-24398491.79293.062.6493.0294.322.68
2254261-25426195.65997.06
3244023-24402391.80793.02
4243886-24388691.75593.01
5256917-25691796.65897.97
6241126-24112690.71791.87
60min1259880-25988097.77398.272.5799.51100.042.60
2267312-267312100.569102.51
3255763-25576396.22497.94
4253819-25381995.49297.26
5271118-271118102.001103.84
6259271-25927197.54499.20
极限1263751-26375199.22999.850.90101.51102.180.92
2265970-265970100.064102.56
3263437-26343799.111101.37
4263146-26314699.001101.30
5269029-269029101.215103.63
6267139-267139100.504102.70
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%
115.127132471720714137166971698715650.26
215.147164371914717780.27
单位质量响应值RSD%判断
4733.134740.950.12数据可信
供试品溶液-2024010621批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min124135-2413533.03332.8133.5333.0332.8133.53
239722-3972254.36654.37
319881-1988127.21027.21
417267-1726723.63323.63
521584-2158429.54129.54
621249-2124929.08329.08
10min160351-6035182.60080.748.5482.7880.938.58
265992-6599290.32190.62
356341-5634177.11277.26
451624-5162470.65670.79
562398-6239885.40285.57
657264-5726478.37578.54
15min168663-6866393.97691.482.3494.6292.112.39
267436-6743692.29793.10
366129-6612990.50891.09
464111-6411187.74688.27
567177-6717791.94392.58
667499-6749992.38392.98
20min169182-6918294.68793.451.7695.8594.591.76
267442-6744292.30593.62
367591-6759192.50993.59
466657-6665791.23192.24
569476-6947695.08996.24
669332-6933294.89296.00
30min167430-6743092.28993.541.0793.9895.200.99
267720-6772092.68694.52
368474-6847493.71895.31
468821-6882194.19395.71
568187-6818793.32595.00
669427-6942795.02296.66
45min167017-6701791.72491.351.3893.9393.521.31
265250-6525089.30591.65
366958-6695891.64393.76
466086-6608690.44992.49
567396-6739692.24294.44
667738-6773892.71094.88
60min167209-6720991.98691.711.4094.7094.391.36
265852-6585290.12992.97
366741-6674191.34693.97
466143-6614390.52793.07
568157-6815793.28495.99
667938-6793892.98495.66
极限166679-6667991.26190.851.4694.4894.041.34
264837-6483788.74092.08
367013-6701391.71894.85
466581-6658191.12794.17
565664-6566489.87293.10
667491-6749192.37295.57
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%
112.002861482866962868672865962866712865960.10
212.042862622863332862980.02
单位质量响应值RSD%判断
23883.0023778.900.31数据可信
供试品溶液-2024010721批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min126062-260629.8134.7281.379.814.7281.40
212353-123534.6514.65
35238-52381.9721.97
43433-34331.2931.29
54172-41721.5711.57
624036-240369.0509.05
10min162359-6235923.48019.5022.8923.5319.5222.85
234651-3465113.04713.07
359054-5905422.23622.25
447205-4720517.77417.78
564100-6410024.13624.14
643351-4335116.32316.37
15min1137240-13724051.67547.3211.5951.8647.4611.60
2103232-10323238.87038.97
3136124-13612451.25551.39
4116857-11685744.00044.11
5140082-14008252.74552.89
6120486-12048645.36645.51
20min1181819-18181968.46065.047.9068.9365.447.94
2152814-15281457.53957.85
3178123-17812367.06867.49
4162149-16214961.05461.40
5190285-19028571.64872.08
6171220-17122064.46964.86
30min1228941-22894186.20382.564.5887.0683.324.64
2202350-20235076.19176.82
3219619-21961982.69383.48
4214078-21407880.60781.30
5228821-22882186.15886.99
6221743-22174383.49384.24
45min1259061-25906197.54493.223.9298.8894.443.97
2233697-23369787.99489.05
3243125-24312591.54492.79
4241385-24138590.88892.03
5254830-25483095.95197.26
6253348-25334895.39396.61
60min1270640-270640101.90498.472.59103.78100.202.66
2252132-25213294.93596.48
3258123-25812397.19198.95
4257914-25791497.11298.75
5263229-26322999.113100.96
6267030-267030100.545102.29
极限1268043-268043100.92699.111.79103.37101.391.81
2259518-25951897.71699.79
3257060-25706096.79199.09
4264466-26446699.579101.76
5261412-26141298.429100.83
6268788-268788101.206103.51
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%
115.127134472364722957244871834720570.65
215.147204172043720420.01
单位质量响应值RSD%判断
4765.674758.390.11数据可信
供试品溶液-2024010721批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.00013.02110.060.0013.02110.06
2-0.0000.00
317339-1733923.60723.61
420457-2045727.85227.85
519570-1957026.64426.64
6-0.0000.00
10min165955-6595589.79682.858.9489.8082.938.90
256312-5631276.66876.67
352257-5225771.14771.28
463805-6380586.86987.02
561751-6175184.07384.22
665052-6505288.56788.57
15min169306-6930694.35992.203.0994.8692.743.10
266994-6699491.21191.64
363792-6379286.85287.38
469126-6912694.11494.75
568574-6857493.36293.98
668531-6853193.30493.80
20min170224-7022495.60993.802.2496.6394.842.21
269645-6964594.82095.75
366290-6629090.25391.26
467815-6781592.32993.49
570060-7006095.38596.52
669330-6933094.39195.40
30min170574-7057496.08594.381.5497.6495.951.53
270042-7004295.36196.82
367457-6745791.84193.35
469488-6948894.60796.28
569342-6934294.40896.07
669035-6903593.99095.52
45min169779-6977995.00392.801.7397.0994.891.70
268110-6811092.73094.72
366303-6630390.27092.29
467584-6758492.01494.21
568364-6836493.07695.26
668815-6881593.69095.75
60min169096-6909694.07392.631.0196.6995.240.98
268117-6811792.74095.24
367220-6722091.51994.04
467575-6757592.00294.71
567725-6772592.20694.91
668505-6850593.26895.85
极限167303-6730391.63290.881.8094.7794.001.73
267732-6773292.21695.24
365314-6531488.92491.95
467576-6757692.00395.22
565121-6512188.66191.88
667456-6745691.84094.94
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%
112.002869292868172866542861532863022865710.12
212.042866242865802866020.02
单位质量响应值RSD%判断
23880.9223804.150.23数据可信
供试品溶液-2024010921批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16291-62912.3684.4976.392.374.4976.41
212269-122694.6174.62
321032-210327.9157.92
43516-35161.3231.32
524721-247219.3049.30
63785-37851.4241.42
10min152480-5248019.75118.5118.0419.7618.5417.98
235423-3542313.33113.36
354258-5425820.42020.46
461034-6103422.97022.98
544155-4415516.61816.67
647804-4780417.99118.00
15min1132737-13273749.95547.1210.6650.0847.2510.66
2102658-10265838.63538.73
3131838-13183849.61749.77
4140134-14013452.73952.87
5126198-12619847.49447.64
6117694-11769444.29444.40
20min1179537-17953767.56864.856.3867.9765.246.40
2154247-15424758.05058.36
3171859-17185964.67865.11
4186068-18606870.02670.45
5175035-17503565.87466.28
6167093-16709362.88563.24
30min1223002-22300283.92682.063.9484.7082.813.97
2204897-20489777.11277.75
3212186-21218679.85580.65
4227048-22704885.44886.27
5225211-22521184.75785.53
6215949-21594981.27181.97
45min1249692-24969293.97092.483.4595.2193.693.47
2235184-23518488.51089.58
3236585-23658589.03890.27
4253691-25369195.47596.77
5254826-25482695.90397.15
6244464-24446492.00393.16
60min1259129-25912997.52296.852.2299.2998.562.25
2249628-24962893.94695.50
3250573-25057394.30296.03
4261520-26152098.422100.24
5262172-26217298.667100.44
6260976-26097698.21799.88
极限1262537-26253798.80599.642.23101.11101.892.25
2258857-25885797.42099.50
3258402-25840297.24899.50
4271262-271262102.088104.46
5271814-271814102.296104.62
6265600-26560099.957102.17
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%
115.127141872082717887175171790717660.33
215.147243671522719790.90
单位质量响应值RSD%判断
4746.434754.230.12数据可信
供试品溶液-2024010921批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0009.04154.930.009.04154.93
2-0.0000.00
3-0.0000.00
419816-1981627.04627.05
5-0.0000.00
619941-1994127.21627.22
10min139443-3944353.83379.9017.3053.8379.9517.34
256572-5657277.21177.21
359013-5901380.54380.54
464479-6447988.00388.15
566610-6661090.91290.91
665133-6513388.89689.05
15min167365-6736591.94293.942.5992.2494.432.66
266191-6619190.34090.77
369127-6912794.34794.79
469180-6918094.41995.06
571126-7112697.07597.58
669962-6996295.48796.13
20min170841-7084196.68695.731.3697.5096.741.31
271089-7108997.02597.96
368590-6859093.61494.59
469516-6951694.87896.04
570108-7010895.68696.73
670686-7068696.47597.65
30min170610-7061096.37194.971.9997.7296.511.96
270444-7044496.14497.61
366932-6693291.35192.84
469469-6946994.81496.50
569601-6960194.99496.57
670427-7042796.12197.83
45min169551-6955194.92693.232.2396.8195.302.18
268995-6899594.16796.17
365476-6547689.36491.36
467852-6785292.60794.82
569413-6941394.73796.84
668551-6855193.56195.81
60min168829-6882993.94092.151.7396.3594.751.66
268141-6814193.00195.53
365781-6578189.78092.28
466476-6647690.72993.46
567637-6763792.31394.94
668252-6825293.15395.92
极限168887-6888794.01991.981.9496.9595.081.89
267438-6743892.04295.09
365082-6508288.82691.82
466979-6697991.41594.65
568127-6812792.98296.12
667823-6782392.56795.85
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%
112.002893372901732907722911792908812904680.26
212.042889362898082893720.22
单位质量响应值RSD%判断
24205.6724034.220.51数据可信
供试品溶液-2023101221批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113620-136205.0671.8685.215.071.8685.30
22867-28671.0671.07
32740-27401.0191.02
42666-26660.9920.99
54145-41451.5421.54
64018-40181.4951.49
10min134706-3470612.91118.6118.9012.9418.6218.85
245446-4544616.90716.91
355076-5507620.48920.50
453648-5364819.95819.96
548952-4895218.21118.22
662319-6231923.18423.19
15min1102724-10272438.21547.1111.1638.3247.2211.15
2124938-12493846.47946.58
3134373-13437349.99050.11
4135034-13503450.23550.35
5120245-12024544.73444.84
6142509-14250953.01653.15
20min1156664-15666458.28265.006.2758.5965.386.30
2178015-17801566.22566.58
3174825-17482565.03865.44
4181640-18164067.57467.97
5169006-16900662.87463.23
6188227-18822770.02470.46
30min1207525-20752577.20482.153.9077.8482.883.93
2228114-22811484.86385.59
3215273-21527380.08680.84
4225329-22532983.82784.60
5218630-21863081.33582.04
6230024-23002485.57486.39
45min1238484-23848488.72192.393.4489.7993.583.46
2257691-25769195.86697.06
3238553-23855388.74789.95
4251872-25187293.70294.94
5246813-24681391.81992.98
6256691-25669195.49496.79
60min1252734-25273494.02296.702.4895.5898.402.49
2266254-26625499.052100.78
3251204-25120493.45395.15
4260677-26067796.97798.73
5264293-26429398.32299.99
6264379-26437998.354100.18
极限1261140-26114097.14999.542.2099.23101.782.23
2274205-274205102.010104.29
3262865-26286597.791100.01
4264578-26457898.428100.72
5267551-26755199.534101.75
6275045-275045102.322104.70
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%
115.127407874244744017452474343743180.23
215.147402673620738230.39
单位质量响应值RSD%判断
4915.214876.020.57数据可信
供试品溶液-2023101221批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.00021.9362.940.0021.9362.95
226319-2631934.85634.86
322788-2278830.17930.18
47281-72819.6439.64
521860-2186028.95028.95
621103-2110327.94827.95
10min158621-5862177.63580.4617.1577.6380.5817.19
268335-6833590.49990.69
361042-6104280.84181.01
441158-4115854.50854.56
567713-6771389.67689.84
667666-6766689.61489.77
15min169356-6935691.85294.422.0992.2894.992.22
272489-7248996.00196.70
371768-7176895.04695.66
469519-6951992.06892.42
572754-7275496.35297.01
671881-7188195.19695.85
20min173815-7381597.75796.211.6798.7097.301.60
273450-7345097.27498.50
370449-7044993.29994.44
473286-7328697.05697.92
572377-7237795.85397.05
672502-7250296.01897.20
30min173276-7327697.04395.521.6898.5397.151.61
272233-7223395.66297.43
369923-6992392.60394.27
472609-7260996.16097.57
572986-7298696.65998.39
671712-7171294.97296.69
45min171587-7158794.80693.921.8896.8396.081.81
271927-7192795.25797.56
368408-6840890.59692.77
471948-7194895.28497.23
570806-7080693.77296.04
670835-7083593.81096.05
60min170653-7065393.56992.601.9196.1295.281.81
270171-7017192.93195.76
367708-6770889.66992.35
471203-7120394.29896.77
570833-7083393.80896.59
668965-6896591.33494.10
极限170074-7007492.80392.551.1795.8795.751.12
270623-7062393.53096.88
368562-6856290.80093.98
470668-7066893.58996.58
570082-7008292.81396.12
669306-6930691.78595.06
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%
112.002909632901992897612889982885402896920.34
212.042883252892702887980.24
单位质量响应值RSD%判断
24141.0023986.540.46数据可信
供试品溶液-2024010621批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min114755-147555.5023.0291.385.503.0291.31
22618-26180.9760.98
320004-200047.4597.46
43936-39361.4681.47
52821-28211.0521.05
64495-44951.6761.68
10min148437-4843718.06219.9717.0218.0919.9817.04
252364-5236419.52619.53
368629-6862925.59125.63
448318-4831818.01718.03
543832-4383216.34416.35
659726-5972622.27122.28
15min1127145-12714547.41148.577.5447.5448.707.57
2133318-13331849.71349.83
3143789-14378953.61753.80
4118177-11817744.06744.18
5121422-12142245.27745.37
6137733-13773351.35951.49
20min1175209-17520965.33366.934.9765.7367.335.01
2178736-17873666.64967.04
3191949-19194971.57572.06
4167405-16740562.42362.78
5176049-17604965.64765.99
6187575-18757569.94470.36
30min1223295-22329583.26484.173.7184.0284.943.73
2220996-22099682.40783.17
3232620-23262086.74187.62
4214349-21434979.92880.63
5225422-22542284.05784.77
6237714-23771488.64189.45
45min1253521-25352194.53595.042.2995.7596.282.32
2252326-25232694.08995.31
3262740-26274097.97399.33
4245846-24584691.67392.82
5258955-25895596.56197.74
6255932-25593295.43496.73
60min1264694-26469498.70199.231.81100.45101.001.86
2261904-26190497.66199.40
3273088-273088101.831103.74
4260168-26016897.01498.67
5267800-26780099.859101.58
6269031-269031100.318102.15
极限1268497-268497100.119100.551.36102.41102.861.39
2265314-26531498.932101.22
3272959-272959101.783104.25
4265658-26565899.061101.25
5273207-273207101.876104.15
6272233-272233101.512103.90
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%
115.127429274088742097386174200741300.23
215.147367173994738320.31
单位质量响应值RSD%判断
4902.784876.620.38数据可信
供试品溶液-2024010621批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min118379-1837924.36928.6942.2224.3728.6942.22
27233-72339.5919.59
335138-3513846.59146.59
421270-2127028.20328.20
525703-2570334.08134.08
622123-2212329.33429.33
10min148838-4883864.75677.5519.0464.8977.7019.07
240432-4043253.61053.66
364652-6465285.72585.98
466309-6630987.92288.08
567237-6723789.15289.34
663433-6343384.10884.27
15min169661-6966192.36693.431.6492.8694.021.70
269367-6936791.97792.33
369278-6927891.85992.59
471676-7167695.03895.68
571064-7106494.22794.91
671725-7172595.10395.73
20min171896-7189695.33095.510.9396.3496.620.95
271729-7172995.10995.97
371043-7104394.19995.44
472175-7217595.70096.87
572309-7230995.87897.09
673060-7306096.87398.03
30min172605-7260596.27094.961.5597.8196.601.49
271531-7153194.84696.24
369747-6974792.48094.25
470990-7099094.12995.83
572391-7239195.98697.73
672427-7242796.03497.73
45min172113-7211395.61894.141.4697.6996.301.29
272340-7234095.91997.84
369623-6962392.31694.60
470554-7055493.55195.78
570582-7058293.58895.86
670764-7076493.82996.06
60min171538-7153894.85593.631.1497.4696.321.02
271135-7113594.32196.77
369410-6941092.03494.83
469976-6997692.78495.53
570548-7054893.54396.34
671062-7106294.22496.98
极限170660-7066093.69193.021.2096.8296.231.08
270880-7088093.98396.96
368556-6855690.90194.21
470187-7018793.06496.33
570548-7054893.54396.86
670098-7009892.94696.22
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%
112.002902362897012912452892642892472899390.29
212.042879942888572884260.22
单位质量响应值RSD%判断
24161.5823955.650.61数据可信
供试品溶液-2024010721批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17184-71842.6792.2680.032.682.2680.08
215359-153595.7285.73
32576-25760.9610.96
43866-38661.4421.44
52607-26070.9720.97
64846-48461.8071.81
10min173649-7364927.46921.6414.6327.4821.6614.60
249906-4990618.61318.65
352619-5261919.62519.63
460912-6091222.71822.73
555179-5517920.58020.59
655902-5590220.85020.86
15min1153292-15329257.17351.276.3757.3451.406.38
2128607-12860747.96748.10
3133386-13338649.74949.86
4140608-14060852.44352.58
5132357-13235749.36549.49
6136527-13652750.92151.05
20min1199585-19958574.43968.265.3974.9268.685.40
2176380-17638065.78566.19
3178340-17834066.51666.91
4183545-18354568.45768.88
5172100-17210064.18864.58
6188152-18815270.17570.58
30min1234557-23455787.48384.333.2188.3885.133.24
2223344-22334483.30184.07
3221825-22182582.73483.49
4226898-22689884.62685.43
5216000-21600080.56281.31
6234035-23403587.28888.09
45min1260615-26061597.20294.342.8798.5995.612.89
2252601-25260194.21395.44
3243497-24349790.81792.04
4256241-25624195.57096.85
5245193-24519391.45092.65
6259551-25955196.80598.09
60min1265861-26586199.15899.331.33101.08101.121.33
2270872-270872101.027102.78
3263156-26315698.15099.87
4269122-269122100.375102.18
5261631-26163197.58199.29
6267358-26735899.717101.54
极限1270550-270550100.90799.881.18103.38102.221.21
2267463-26746399.756102.07
3262844-26284498.033100.30
4271724-271724101.345103.71
5266563-26656399.420101.67
6267643-26764399.823102.20
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%
115.127341373807742507361873785737750.42
215.147353973765736520.22
单位质量响应值RSD%判断
4879.304864.730.22数据可信
供试品溶液-2024010721批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min141552-4155255.29525.8074.9755.3025.8174.97
2-0.0000.00
37019-70199.3419.34
420820-2082027.70627.71
522767-2276730.29730.30
624190-2419032.19132.19
10min167737-6773790.14177.1318.0590.4577.2718.13
251168-5116868.09268.09
340083-4008353.34053.39
465725-6572587.46387.62
561278-6127881.54681.71
661762-6176282.19082.37
15min170488-7048893.80293.291.0994.6193.861.24
269637-6963792.66993.05
368860-6886091.63591.98
470137-7013793.33593.97
570472-7047293.78094.40
671033-7103394.52795.16
20min170656-7065694.02594.561.2795.3595.651.16
271463-7146395.09995.99
372097-7209795.94396.80
470263-7026393.50294.66
569955-6995593.09294.23
671934-7193495.72696.89
30min168113-6811390.64193.751.8892.4995.371.70
271213-7121394.76796.19
371743-7174395.47296.86
470703-7070394.08895.77
569771-6977192.84894.51
671157-7115794.69296.38
45min167837-6783790.27492.781.5092.6394.921.38
270667-7066794.04095.99
369482-6948292.46394.38
470438-7043893.73595.94
569567-6956792.57694.75
670330-7033093.59295.81
60min168066-6806690.57993.351.8293.4496.001.61
271294-7129494.87497.34
371630-7163095.32297.76
469729-6972992.79295.51
569928-6992893.05795.75
670245-7024593.47896.22
极限167517-6751789.84892.171.5493.2195.341.34
270138-7013893.33696.33
370389-7038993.67096.63
468585-6858591.26994.51
569497-6949792.48395.69
669458-6945892.43195.69
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%
112.002894682882282890302886942889462888730.16
212.042891882889332890600.07
单位质量响应值RSD%判断
24072.7524008.310.19数据可信
供试品溶液-2024010921批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15944-59442.2191.9634.752.221.9634.70
27331-73312.7362.74
34234-42341.5801.58
42885-28851.0771.08
57166-71662.6752.67
63993-39931.4901.49
10min160152-6015222.45121.6619.5122.4621.6719.51
253457-5345719.95319.97
362846-6284623.45723.47
445497-4549716.98216.99
576951-7695128.72228.74
649278-4927818.39318.40
15min1142354-14235453.13350.728.3153.2750.858.33
2134015-13401550.02050.15
3145668-14566854.37054.51
4123913-12391346.25046.35
5147875-14787555.19455.37
6121435-12143545.32545.44
20min1185286-18528669.15768.765.5569.5969.175.58
2181182-18118267.62568.03
3191331-19133171.41371.85
4176394-17639465.83866.20
5199618-19961874.50674.99
6171483-17148364.00564.37
30min1226610-22661084.58185.383.6185.4086.173.65
2223338-22333883.36084.14
3235065-23506587.73788.57
4227749-22774985.00685.73
5241317-24131790.07090.97
6218348-21834881.49782.22
45min1250297-25029793.42295.382.0294.7196.652.05
2252498-25249894.24495.49
3260635-26063597.28198.61
4258004-25800496.29997.49
5261545-26154597.62099.02
6250260-25026093.40894.58
60min1262807-26280798.092100.841.7199.90102.641.70
2270000-270000100.776102.54
3275794-275794102.939104.80
4273763-273763102.181103.91
5271017-271017101.156103.09
6267680-26768099.910101.60
极限1268132-268132100.079102.041.67102.43104.401.69
2269922-269922100.747103.07
3279998-279998104.508106.95
4276263-276263103.114105.41
5275498-275498102.828105.33
6270559-270559100.985103.23
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%
115.127385273720736997371473618737210.12
215.147390473908739060.01
单位质量响应值RSD%判断
4875.734881.510.09数据可信
供试品溶液-2024010921批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min119189-1918925.50129.2361.2425.5029.2361.24
2-0.0000.00
322728-2272830.20430.20
426409-2640935.09635.10
541877-4187755.65255.65
621767-2176728.92728.93
10min154711-5471172.70880.9818.2272.8581.1418.29
241158-4115854.69754.70
364008-6400885.06385.23
468976-6897691.66591.86
569189-6918991.94892.26
667574-6757489.80289.96
15min168269-6826990.72694.442.6691.2795.052.75
269604-6960492.50092.80
371410-7141094.90095.54
472418-7241896.24096.94
571179-7117994.59395.41
673487-7348797.66098.32
20min170668-7066893.91495.572.0094.9696.711.91
273088-7308897.13097.95
371524-7152495.05196.22
472269-7226996.04297.28
570093-7009393.15094.50
673854-7385498.14899.35
30min171283-7128394.73195.351.4396.3097.021.35
272698-7269896.61297.97
370657-7065793.89995.59
472679-7267996.58698.36
570592-7059293.81395.68
672599-7259996.48098.23
45min170109-7010993.17193.851.8995.2796.051.76
272121-7212195.84597.74
369890-6989092.88095.10
471757-7175795.36197.67
568585-6858591.14693.53
671248-7124894.68596.97
60min170004-7000493.03194.602.3595.6597.322.20
273541-7354197.732100.16
370243-7024393.34996.08
472429-7242996.25499.09
569121-6912191.85894.75
671771-7177195.38098.19
极限169448-6944892.29393.431.5695.4296.681.42
271903-7190395.55598.52
370075-7007593.12696.38
470862-7086294.17297.55
568841-6884191.48694.89
670695-7069593.95097.29
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