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DJ301-191212对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75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%
110.972957262960712958972958222959692958970.05
210.942958712958772958740.01
单位质量响应值RSD%判断
26973.2927045.160.19数据可信
供试品溶液-20220127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%
5min1118064-11806439.24323.8243.0139.2423.8143.02
241858-4185813.91313.91
353290-5329017.71317.71
4100119-10011933.27833.28
548266-4826616.04316.04
668306-6830622.70422.70
10min1213617-21361771.00460.4021.6871.2260.5321.69
2175875-17587558.45958.54
3109152-10915236.28136.38
4208624-20862469.34469.53
5175328-17532858.27758.37
6207610-20761069.00769.13
15min1271139-27113990.12386.896.9590.7487.367.03
2263785-26378587.67988.08
3226241-22624175.20075.50
4270480-27048089.90490.47
5260250-26025086.50486.92
6276567-27656791.92792.44
20min1284290-28429094.49493.493.3395.6194.443.42
2284242-28424294.47895.37
3263003-26300387.41988.14
4290038-29003896.40597.47
5284052-28405294.41595.31
6281991-28199193.73094.75
30min1301029-301029100.05897.872.79101.7099.342.88
2301706-301706100.283101.70
3279281-27928192.82994.03
4296171-29617198.443100.05
5292415-29241597.19598.61
6296100-29610098.42099.96
45min1282105-28210593.76895.451.1895.9697.461.18
2288799-28879995.99397.96
3283738-28373894.31196.03
4288721-28872195.96798.12
5290144-29014496.44098.40
6289440-28944096.20698.29
60min1285693-28569394.96195.500.8197.6898.050.68
2287185-28718595.45797.96
3289496-28949696.22598.47
4287278-28727895.48798.17
5290261-29026196.47998.97
6284034-28403494.40997.03
极限1297957-29795799.037100.771.76102.28103.841.64
2297255-29725598.804101.84
3306624-306624101.918104.70
4300814-30081499.987103.20
5310604-310604103.241106.27
6305770-305770101.634104.78
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%
114.917232672333723127250072547724040.16
215.007273772704727200.04
单位质量响应值RSD%判断
4856.074848.000.12数据可信
供试品溶液-20220127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%
5min129125-2912538.91846.9622.8238.9246.9622.82
242285-4228556.50256.50
322146-2214629.59229.59
441065-4106554.87254.87
535623-3562347.60047.60
640608-4060854.26154.26
10min148841-4884165.26373.325.8465.4873.585.87
257700-5770077.10077.41
354205-5420572.43072.59
455789-5578974.54774.85
555587-5558774.27774.54
657112-5711276.31576.62
15min157362-5736276.64982.014.1877.2382.684.17
262370-6237083.34084.08
363838-6383885.30285.87
459212-5921279.12179.84
561924-6192482.74483.42
663555-6355584.92485.65
20min161497-6149782.17486.963.9783.1888.083.93
264982-6498286.83188.04
368974-6897492.16593.21
463124-6312484.34885.51
566015-6601588.21189.35
665858-6585888.00189.20
30min164145-6414585.71290.814.3187.1792.414.28
268497-6849791.52793.22
371262-7126295.22296.77
464825-6482586.62188.25
568407-6840791.40793.03
670609-7060994.35096.04
45min164693-6469386.44490.174.1088.3892.284.05
266932-6693289.43691.63
371036-7103694.92097.00
464012-6401285.53487.64
568910-6891092.07994.21
669320-6932092.62794.84
60min165657-6565787.73389.864.1790.1592.484.09
265876-6587688.02590.72
371520-7152095.56798.18
463616-6361685.00587.59
568982-6898292.17694.82
667850-6785090.66393.39
极限168417-6841791.42193.004.4294.3396.124.33
267916-6791690.75193.93
371658-7165895.75198.89
464900-6490086.72189.78
573200-7320097.812100.97
671516-7151695.56298.79
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DJ301-191212对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75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%
110.972959452958282950242956982959272956840.13
210.942967092958292962690.22
单位质量响应值RSD%判断
26953.8727081.260.34数据可信
供试品溶液-20220127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%
5min146091-4609115.31516.6219.8815.3216.6219.86
236943-3694312.27612.28
364865-6486521.55421.55
454422-5442218.08418.08
554661-5466118.16318.16
643193-4319314.35214.35
10min1186115-18611561.84365.7813.8061.9365.8713.81
2172933-17293357.46357.53
3245522-24552281.58381.70
4199202-19920266.19266.29
5209690-20969069.67769.78
6174256-17425657.90357.98
15min1266149-26614988.43789.823.0988.8790.273.15
2258986-25898686.05786.44
3283758-28375894.28994.86
4268528-26852889.22889.70
5274627-27462791.25591.74
6269733-26973389.62890.03
20min1292638-29263897.23994.651.8698.1695.611.87
2277186-27718692.10592.97
3288325-28832595.80696.90
4284824-28482494.64395.61
5282288-28228893.80094.80
6283786-28378694.29895.20
30min1295839-29583998.30395.881.6199.7697.361.61
2282278-28227893.79795.17
3289481-28948196.19097.82
4290001-29000196.36397.85
5285103-28510394.73696.25
6288523-28852395.87297.30
45min1302257-302257100.43697.391.96102.4499.411.92
2287025-28702595.37497.27
3290349-29034996.47998.64
4292167-29216797.08399.11
5289233-28923396.10898.15
6297549-29754998.871100.83
60min1298544-29854499.20296.771.50101.7799.331.49
2286618-28661895.23997.67
3291817-29181796.96799.67
4289992-28999296.36098.92
5287369-28736995.48998.06
6293034-29303497.37199.88
极限1306599-306599101.878101.650.49104.99104.740.40
2308451-308451102.494105.45
3304074-304074101.039104.28
4305570-305570101.537104.64
5305351-305351101.464104.57
6305447-305447101.496104.54
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%
114.917242572293721397209872259722430.19
215.007269872568726330.13
单位质量响应值RSD%判断
4845.274842.200.05数据可信
供试品溶液-20220127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%
5min148958-4895865.53158.1519.1765.5358.1519.17
244857-4485760.04260.04
342232-4223256.52856.53
446006-4600661.58061.58
527647-2764737.00637.01
650966-5096668.21968.22
10min162906-6290684.20179.109.6684.5679.429.70
261128-6112881.82182.15
360827-6082781.41881.73
459115-5911579.12679.47
547806-4780663.98964.19
662808-6280884.06984.45
15min167104-6710489.82088.344.2090.6589.104.27
265962-6596288.29189.08
368955-6895592.29793.06
465476-6547687.64188.42
560930-6093081.55682.12
667574-6757490.44991.29
20min170008-7000893.70791.753.7695.0493.003.82
268551-6855191.75793.04
371231-7123195.34496.62
467570-6757090.44391.71
563980-6398085.63886.65
669937-6993793.61294.96
30min170777-7077794.73692.833.5496.5994.603.60
268909-6890992.23694.02
372333-7233396.81998.63
469112-6911292.50794.28
565047-6504787.06688.56
669961-6996193.64495.51
45min172269-7226996.73395.033.1199.1197.313.19
270001-7000193.69796.00
373075-7307597.812100.16
470184-7018493.94296.23
567431-6743190.25792.23
673007-7300797.721100.11
60min171537-7153795.75394.062.6298.6796.862.71
269697-6969793.29096.11
372426-7242696.94399.83
469754-6975493.36796.17
567182-6718289.92492.40
671020-7102095.06197.99
极限171279-7127995.40894.812.2298.8698.142.30
270399-7039994.23097.57
373284-7328498.092101.52
470107-7010793.83997.16
568573-6857391.78694.76
671363-7136395.52098.98
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DJ301-191212对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75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%
110.972959602959862957792960052959892959440.04
210.942953692955572954630.05
单位质量响应值RSD%判断
26977.5827007.590.08数据可信
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%
5min1133259-13325944.32138.8730.2244.3238.8730.23
2152869-15286950.84350.84
370307-7030723.38423.38
4137688-13768845.79445.79
5132895-13289544.20044.20
674279-7427924.70524.70
10min1270025-27002589.80885.2811.2790.0585.5011.28
2278281-27828192.55492.84
3207592-20759269.04369.17
4234511-23451177.99678.25
5277481-27748192.28892.53
6270659-27065990.01990.16
15min1289401-28940196.25293.166.7797.0093.856.81
2298773-29877399.369100.17
3251179-25117983.54084.05
4261835-26183587.08487.77
5288238-28823895.86696.62
6291198-29119896.85097.49
20min1293748-29374897.69895.184.7498.9896.394.79
2293399-29339997.58298.93
3259158-25915886.19487.17
4288651-28865196.00397.17
5287666-28766695.67596.97
6294461-29446197.93599.11
30min1294950-29495098.09895.733.5299.9297.463.60
2294521-29452197.95599.85
3269594-26959489.66591.12
4283067-28306794.14695.85
5289369-28936996.24298.06
6295462-29546298.26899.99
45min1293553-29355397.63396.342.63100.0098.612.73
2296744-29674498.695101.13
3277699-27769992.36094.31
4282896-28289694.08996.32
5291881-29188197.07799.43
6295218-29521898.187100.45
60min1297899-29789999.07996.742.14101.9999.542.25
2295678-29567898.340101.32
3280900-28090093.42595.89
4286751-28675195.37198.12
5291125-29112596.82699.72
6292797-29279797.382100.19
极限1292608-29260897.31996.852.52100.78100.192.55
2288494-28849495.95199.48
3278149-27814992.51095.50
4299062-29906299.465102.75
5292865-29286597.404100.84
6296024-29602498.455101.81
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%
114.917174171769716997170771759717350.05
215.007241572379723970.04
单位质量响应值RSD%判断
4811.204826.470.23数据可信
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%
5min157615-5761577.51764.2832.1777.5264.2832.17
258551-5855178.77778.78
331434-3143442.29242.29
460172-6017280.95880.96
553738-5373872.30172.30
625159-2515933.85033.85
10min167274-6727490.51386.186.9090.9486.547.01
266181-6618189.04289.48
360836-6083681.85182.09
467216-6721690.43590.88
566340-6634089.25689.66
656492-5649276.00676.19
15min167745-6774591.14690.503.3692.0891.343.48
268859-6885992.64593.58
364883-6488387.29687.99
469915-6991594.06695.02
567985-6798591.46992.37
664188-6418886.36186.97
20min169358-6935893.31791.531.9994.7692.872.10
267784-6778491.19992.65
365783-6578388.50789.68
469022-6902292.86594.34
568907-6890792.71094.12
667308-6730890.55991.65
30min168345-6834591.95493.612.4093.9195.452.42
268889-6888992.68694.64
367367-6736790.63892.30
471892-7189296.72698.72
570644-7064495.04796.97
670305-7030594.59196.18
45min170693-7069395.11395.541.6097.5897.901.63
271235-7123595.84298.31
368888-6888892.68494.85
471673-7167396.43198.96
571557-7155796.27598.72
672005-7200596.87899.00
60min171764-7176496.55496.031.5099.5598.931.56
271378-7137896.03499.04
369342-6934293.29595.98
472435-7243597.457100.52
571408-7140896.07599.06
671936-7193696.78599.44
极限169866-6986694.00095.172.9597.5398.602.86
270519-7051994.87998.41
367575-6757590.91894.12
471728-7172896.505100.11
570841-7084195.31298.83
673894-7389499.420102.61
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DJ301-191212对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75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%
110.972964742960912961592960382955532960630.12
210.942945362950382947870.13
单位质量响应值RSD%判断
26988.4226945.800.12数据可信
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%
5min1114037-11403737.96437.7612.6237.9637.7612.61
294669-9466931.51631.52
3105519-10551935.12835.13
4112155-11215537.33737.34
5116176-11617638.67638.68
6137905-13790545.90945.91
10min1251235-25123583.63883.074.1783.8583.284.19
2235101-23510178.26678.44
3244320-24432081.33681.53
4245199-24519981.62881.84
5256318-25631885.33085.54
6264933-26493388.19888.45
15min1274616-27461691.42190.743.0892.1091.413.10
2260926-26092686.86487.47
3266292-26629288.65089.30
4279436-27943693.02693.69
5270516-27051690.05690.75
6283568-28356894.40195.15
20min1277177-27717792.27492.742.9893.4693.912.99
2264595-26459588.08589.18
3279724-27972493.12294.26
4276210-27621091.95293.13
5287929-28792995.85397.04
6285744-28574495.12696.40
30min1280336-28033693.32592.832.6495.0294.522.66
2265969-26596988.54390.12
3279004-27900492.88294.54
4276299-27629991.98293.67
5286450-28645095.36197.08
6285006-28500694.88096.68
45min1282844-28284494.16093.482.7896.3795.682.80
2267153-26715388.93791.01
3280998-28099893.54695.72
4277746-27774692.46394.66
5288096-28809695.90998.16
6287951-28795195.86198.19
60min1278979-27897992.87492.682.0695.6195.402.09
2267637-26763789.09891.67
3281328-28132893.65696.35
4277030-27703092.22594.94
5283028-28302894.22297.01
6282321-28232193.98696.84
极限1300389-300389100.00197.951.56103.25101.191.55
2293525-29352597.716100.78
3290611-29061196.74699.96
4287710-28771095.78099.01
5296647-29664798.755102.06
6296554-29655498.725102.10
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%
114.917293272792729887295472774728880.14
215.007222872328722780.10
单位质量响应值RSD%判断
4888.534818.531.02数据可信
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%
5min154030-5403072.17871.479.4272.1871.479.42
245235-4523560.42960.43
353284-5328471.18171.18
451634-5163468.97768.98
556575-5657575.57875.58
660228-6022880.45880.46
10min162136-6213683.00684.237.4883.4184.637.47
259996-5999680.14880.48
365854-6585487.97388.37
455640-5564074.32874.71
568111-6811190.98891.41
666573-6657388.93489.38
15min168116-6811690.99589.393.7091.8690.263.68
262613-6261383.64484.42
366232-6623288.47889.36
469876-6987693.34694.14
566624-6662489.00289.93
668035-6803590.88791.83
20min167506-6750690.18090.662.9091.5592.022.94
265025-6502586.86688.11
368472-6847291.47192.85
466407-6640788.71290.03
570380-7038094.01995.44
669386-6938692.69294.14
30min169598-6959892.97592.003.0194.8493.863.03
265494-6549487.49289.22
368132-6813291.01692.90
468334-6833491.28693.09
571531-7153195.55797.50
670115-7011593.66595.63
45min170070-7007093.60592.742.4495.9995.122.48
266652-6665289.03991.25
368594-6859491.63494.02
469148-6914892.37494.69
571358-7135895.32697.80
670720-7072094.47496.95
60min169084-6908492.28891.881.6995.1994.771.75
266975-6697589.47192.18
368738-6873891.82694.72
468194-6819491.09993.93
570450-7045094.11397.12
669223-6922392.47495.48
极限171826-7182695.95194.022.2599.3797.422.21
270818-7081894.60597.81
367899-6789990.70594.11
468968-6896892.13395.47
571343-7134395.30698.83
671446-7144695.44398.96
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