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(%)99.75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%
110.842820472821002817372817842816782818690.07
210.982802132805182803660.08
单位质量响应值RSD%判断
26002.6825534.241.29数据可信
供试品溶液-6031801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%
5min1119142-11914241.51155.0115.8441.5155.0015.84
2160489-16048955.91855.92
3163435-16343556.94456.94
4195425-19542568.09068.09
5163039-16303956.80656.81
6145700-14570050.76550.76
10min1217983-21798375.95088.548.1076.1888.848.11
2263966-26396691.97192.28
3241611-24161184.18284.50
4268312-26831293.48593.86
5271531-27153194.60794.92
6261256-26125691.02791.31
15min1240167-24016783.67994.976.6384.3395.776.65
2281555-28155598.09998.92
3262994-26299491.63292.42
4279828-27982897.49898.40
5288865-288865100.646101.49
6282001-28200198.25599.04
20min1250649-25064987.33196.865.3188.4598.185.34
2286922-28692299.969101.34
3271605-27160594.63395.93
4283897-28389798.915100.35
5289099-289099100.728102.13
6285761-28576199.565100.90
30min1260172-26017290.64997.543.9392.2599.413.99
2284877-28487799.257101.18
3274313-27431395.57697.39
4284081-28408198.979100.97
5289375-289375100.824102.78
6286959-28695999.982101.87
45min1265038-26503892.34497.933.2094.45100.333.26
2284543-28454399.140101.61
3278839-27883997.15399.50
4279894-27989497.521100.06
5289627-289627100.912103.43
6288406-288406100.486102.93
60min1264509-26450992.16098.213.5994.78101.163.63
2285803-28580399.579102.60
3279299-27929997.313100.20
4279200-27920097.279100.36
5289649-289649100.919104.00
6292771-292771102.007105.01
极限1285477-28547799.466101.951.56102.60105.441.66
2292591-292591101.944105.52
3292549-292549101.930105.36
4294494-294494102.608106.23
5299422-299422104.325107.97
6291073-291073101.416104.98
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(%) 99.90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%
114.697210971985720047203571923720110.10
214.717171971902718100.19
单位质量响应值RSD%判断
4902.044881.710.30数据可信
供试品溶液-6031801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%
5min152915-5291570.13181.348.1770.1381.348.17
262012-6201282.18782.19
365395-6539586.67186.67
458658-5865877.74277.74
566719-6671988.42688.43
662541-6254182.88982.89
10min166663-6666388.35291.173.1988.7491.623.21
270061-7006192.85593.31
368817-6881791.20691.69
465788-6578887.19287.62
571603-7160394.89995.39
669783-6978392.48792.95
15min169506-6950692.12093.072.0393.0094.022.05
269833-6983392.55393.53
371020-7102094.12695.11
467940-6794090.04490.96
571856-7185695.23496.25
671165-7116594.31895.29
20min169997-6999792.77093.341.1294.1694.811.13
270849-7084993.90095.39
370568-7056893.52795.04
469638-6963892.29593.71
569775-6977592.47694.02
671718-7171895.05196.55
30min168807-6880791.19392.961.8793.1094.961.87
268519-6851990.81192.82
371571-7157194.85696.89
469735-6973592.42394.35
571247-7124794.42796.49
670963-7096394.05196.08
45min168969-6896991.40893.232.1993.8295.742.17
269133-6913391.62594.14
371772-7177295.12397.68
470012-7001292.79095.23
569471-6947192.07394.66
672701-7270196.35498.90
60min169500-6950092.11291.665.6595.0394.695.52
269911-6991192.65695.68
370992-7099294.08997.18
461640-6164081.69484.65
569859-6985992.58795.68
673050-7305096.81799.90
极限169511-6951192.12694.241.9095.5697.781.89
269998-6999892.77296.31
370553-7055393.50797.12
471255-7125594.43897.85
572377-7237795.92599.54
672950-7295096.684100.31
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(%)99.75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%
110.842800822803252802212798792800882801190.06
210.982800602802472801540.05
单位质量响应值RSD%判断
25841.2425514.940.90数据可信
供试品溶液-6032501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%
5min199922-9992234.93654.0825.8734.9454.0925.87
2141229-14122949.37849.38
3208616-20861672.93972.94
4173715-17371560.73660.74
5180110-18011062.97262.97
6124554-12455443.54843.55
10min1224546-22454678.50890.667.8778.7090.967.92
2261938-26193891.58291.86
3273459-27345995.61096.02
4281331-28133198.36298.70
5266515-26651593.18293.53
6248038-24803886.72286.96
15min1255275-25527589.25296.384.9289.8897.184.97
2284849-28484999.592100.38
3275192-27519296.21697.15
4294119-294119102.833103.72
5277480-27748097.01697.88
6267038-26703893.36594.09
20min1265290-26529092.75498.573.7293.8899.913.78
2290286-290286101.493102.83
3282325-28232598.710100.18
4294509-294509102.970104.42
5283616-28361699.161100.57
6275603-27560396.35997.60
30min1277880-27788097.15699.162.9598.80101.052.98
2289390-289390101.180103.08
3279551-27955197.74099.76
4298087-298087104.221106.25
5279673-27967397.78299.74
6277167-27716796.90698.68
45min1275748-27574896.41098.872.7998.59101.312.84
2287990-287990100.690103.15
3278256-27825697.28799.85
4295111-295111103.180105.79
5284472-28447299.460101.96
6275127-27512796.19398.51
60min1281027-28102798.25699.211.40100.97102.201.48
2287238-287238100.427103.45
3282298-28229898.700101.80
4290115-290115101.433104.61
5281375-28137598.378101.43
6280465-28046598.059100.91
极限1289056-289056101.063102.641.79104.33106.181.80
2285593-28559399.852103.43
3299719-299719104.791108.44
4296098-296098103.525107.27
5294513-294513102.971106.57
6296372-296372103.621107.02
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(%) 99.90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%
114.697172471784717537189771749717810.10
214.717173671839717880.11
单位质量响应值RSD%判断
4886.394880.220.09数据可信
供试品溶液-6032501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%
5min156683-5668375.25679.648.8475.2679.648.84
261715-6171581.93781.94
362922-6292283.54083.54
453595-5359571.15671.16
568169-6816990.50690.51
656826-5682675.44675.45
10min169202-6920291.87790.275.8192.3090.725.81
270539-7053993.65394.11
366998-6699888.95189.42
460701-6070180.59180.99
571938-7193895.51096.01
668582-6858291.05491.47
15min168585-6858591.05891.434.2891.9992.384.28
271578-7157895.03296.01
366154-6615487.83188.79
464609-6460985.77986.62
571296-7129694.65895.69
670987-7098794.24795.17
20min171164-7116494.48291.197.4195.9292.647.35
271678-7167895.16596.67
360130-6013079.83381.28
464996-6499686.29387.61
573596-7359697.71199.27
670536-7053693.64995.10
30min167231-6723189.26191.855.3791.2293.815.36
273188-7318897.17099.20
368316-6831690.70192.59
463359-6335984.12085.92
572833-7283396.69898.80
670176-7017693.17195.14
45min172922-7292296.81691.407.7899.2793.877.66
271550-7155094.99597.57
359157-5915778.54180.93
465956-6595687.56889.83
572196-7219695.85298.49
671274-7127494.62897.11
60min172481-7248196.23193.283.9199.2296.263.90
269473-6947392.23795.34
369516-6951692.29495.12
465500-6550086.96289.72
571754-7175495.26698.44
672833-7283396.69899.71
极限171608-7160895.07294.181.9098.6097.681.92
269312-6931292.02395.64
369640-6964092.45995.80
470386-7038693.44996.69
572115-7211595.74599.45
672545-7254596.31699.87
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(%)99.75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%
110.842806702804852806442809072807552806920.06
210.982800782800982800880.01
单位质量响应值RSD%判断
25894.1025508.931.06数据可信
供试品溶液-6032601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%
5min1147052-14705251.36853.0319.3551.3753.0319.35
2155159-15515954.20054.20
3197480-19748068.98368.98
4121736-12173642.52542.52
5120342-12034242.03842.04
6169135-16913559.08259.08
10min1266338-26633893.03790.216.5093.3290.516.52
2273239-27323995.44795.75
3272566-27256695.21295.60
4251334-25133487.79688.03
5228907-22890779.96180.19
6257126-25712689.81990.15
15min1286453-286453100.06395.924.19100.8796.724.21
2282016-28201698.51399.34
3279767-27976797.72898.64
4274811-27481195.99696.72
5254067-25406788.75089.43
6270528-27052894.50095.33
20min1286442-286442100.05997.423.81101.4298.763.83
2284694-28469499.449100.83
3282872-28287298.812100.27
4286961-286961100.241101.50
5260246-26024690.90992.08
6272167-27216795.07396.43
30min1283781-28378199.13098.043.08101.0499.913.09
2285243-28524399.641101.57
3282774-28277498.778100.78
4290317-290317101.413103.23
5265755-26575592.83394.51
6276107-27610796.44998.33
45min1283982-28398299.20098.472.58101.66100.882.60
2284645-28464599.432101.92
3283271-28327198.952101.50
4290188-290188101.368103.75
5268531-26853193.80395.99
6280701-28070198.054100.47
60min1281565-28156598.35698.092.10101.37101.052.13
2283484-28348499.026102.06
3281319-28131998.270101.37
4288621-288621100.821103.76
5270790-27079094.59297.30
6279055-27905597.479100.44
极限1289185-289185101.018101.911.34104.58105.411.25
2296348-296348103.520107.11
3285319-28531999.667103.32
4293594-293594102.558106.06
5292641-292641102.225105.46
6293274-293274102.446105.95
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(%) 99.90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%
114.697207871967717367185672001719280.19
214.717165671669716620.02
单位质量响应值RSD%判断
4896.394871.650.36数据可信
供试品溶液-6032601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%
5min161620-6162081.79979.907.1581.8079.907.15
262324-6232482.73482.73
364427-6442785.52685.53
463184-6318483.87683.88
555305-5530573.41673.42
654257-5425772.02572.03
10min168439-6843990.85291.195.1091.3191.635.10
271342-7134294.70595.16
370387-7038793.43793.91
469752-6975292.59593.06
570411-7041193.46993.88
661817-6181782.06182.46
15min168776-6877691.29992.744.1592.2693.694.14
272924-7292496.80597.79
369546-6954692.32193.32
469694-6969492.51893.50
572987-7298796.88997.82
665238-6523886.60287.46
20min170474-7047493.55392.982.7195.0294.442.71
270231-7023193.23094.75
372399-7239996.10897.62
468250-6825090.60192.10
571466-7146694.87096.34
667421-6742189.50090.84
30min171983-7198395.55693.393.8797.5495.373.82
272540-7254096.29698.34
371837-7183795.36297.40
471406-7140694.79096.79
565451-6545186.88588.88
668893-6889391.45493.29
45min169966-6996692.87994.212.5795.4096.712.58
272056-7205695.65398.23
372078-7207895.68298.25
472271-7227195.93898.46
571757-7175795.25697.73
667682-6768289.84792.19
60min172059-7205995.65794.582.7498.6997.612.72
271620-7162095.07498.18
370851-7085194.05397.16
471548-7154894.97998.04
573654-7365497.774100.78
667755-6775589.94492.79
极限170112-7011293.07293.313.3196.6496.863.18
270497-7049793.58497.22
370745-7074593.91397.54
466602-6660288.41392.00
573882-7388298.077101.62
669912-6991292.80796.15
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(%)99.75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%
110.842778782778412784402777822775142778910.13
210.982758012771942764980.36
单位质量响应值RSD%判断
25635.7025181.971.27数据可信
供试品溶液-6031801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%
5min1151784-15178453.63362.5418.8953.6362.5418.90
2152686-15268653.95253.95
3228698-22869880.81080.81
4142757-14275750.44350.44
5194060-19406068.57168.57
6192039-19203967.85767.86
10min1250232-25023288.42091.447.4088.7291.797.45
2248015-24801587.63687.94
3286938-286938101.390101.84
4232404-23240482.12082.40
5268613-26861394.91495.30
6266420-26642094.14094.52
15min1264392-26439293.42395.805.1094.2196.665.15
2267639-26763994.57095.36
3288575-288575101.968102.98
4249593-24959388.19488.93
5274710-27471097.06997.98
6281819-28181999.581100.48
20min1269839-26983995.34896.524.5596.6697.904.60
2270787-27078795.68396.99
3290904-290904102.791104.37
4255003-25500390.10591.33
5269470-26947095.21796.66
6282923-28292399.971101.42
30min1271593-27159395.96797.213.7397.8199.133.80
2274579-27457997.02398.87
3289645-289645102.346104.50
4258560-25856091.36293.09
5275945-27594597.50599.48
6280296-28029699.043101.05
45min1275612-27561297.38897.683.1099.76100.153.18
2274713-27471397.07099.45
3289173-289173102.179104.90
4263465-26346593.09595.33
5274184-27418496.88399.40
6281539-28153999.482102.04
60min1281035-28103599.30498.262.79102.22101.272.87
2276954-27695497.862100.78
3288259-288259101.856105.14
4265518-26551893.82196.57
5274601-27460197.030100.09
6282110-28211099.684102.80
极限1294903-294903104.204102.431.26107.67105.991.24
2293663-293663103.766107.23
3289141-289141102.168106.02
4285479-285479100.874104.15
5287452-287452101.571105.17
6288723-288723102.020105.69
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(%) 99.90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%
114.696842368742682396819768238683680.34
214.716833068491684100.17
单位质量响应值RSD%判断
4654.054650.580.06数据可信
供试品溶液-6031801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%
5min158074-5807480.93183.466.3980.9383.466.39
266627-6662792.85192.85
356730-5673079.05879.06
459370-5937082.73782.74
561871-6187186.22386.22
656675-5667578.98278.98
10min167018-6701893.39692.263.5193.8592.723.52
270330-7033098.01198.53
364384-6438489.72590.16
463962-6396289.13789.60
566214-6621492.27592.75
665293-6529390.99291.43
15min167608-6760894.21893.412.8695.1994.382.88
270663-7066398.47599.54
365638-6563891.47292.41
466270-6627092.35393.31
566205-6620592.26393.25
665775-6577591.66392.61
20min168719-6871995.76691.763.5597.2693.263.46
263463-6346388.44190.05
365432-6543291.18592.63
467470-6747094.02595.49
562863-6286387.60589.11
667128-6712893.54995.00
30min169061-6906196.24394.291.3998.2796.301.40
268507-6850795.47197.57
367379-6737993.89995.85
467349-6734993.85795.85
567089-6708993.49495.49
666569-6656992.77094.74
45min170373-7037398.07194.563.26100.6397.083.23
270044-7004497.613100.24
364925-6492590.47992.95
468547-6854795.52698.04
567369-6736993.88596.39
665855-6585591.77594.26
60min171976-71976100.30593.085.26103.4196.145.15
269730-6973097.175100.35
363810-6381088.92591.90
462716-6271687.40090.44
566323-6632392.42795.46
666208-6620892.26795.27
极限163761-6376188.85791.564.0292.5295.133.91
270182-7018297.805101.52
366486-6648692.65496.12
466069-6606992.07395.60
562562-6256287.18690.73
665125-6512590.75794.27
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(%)99.75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%
110.842770952757902761132761132765602763340.19
210.982760082753912757000.16
单位质量响应值RSD%判断
25492.0725109.291.07数据可信
供试品溶液-6032501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%
5min1121025-12102542.94650.1722.0742.9550.1822.07
2152298-15229854.04354.04
3109155-10915538.73438.73
4154193-15419354.71654.72
5192661-19266168.36668.37
6119033-11903342.23942.24
10min1248219-24821988.08193.098.1188.3293.368.15
2280802-28080299.64399.94
3232458-23245882.48882.70
4279738-27973899.26699.57
5282062-282062100.090100.47
6250682-25068288.95589.19
15min1270951-27095196.14898.194.7196.8898.994.77
2289774-289774102.827103.68
3258217-25821791.62992.30
4286996-286996101.841102.70
5287070-287070101.868102.80
6267312-26731294.85695.59
20min1279900-27990099.32399.324.11100.59100.664.16
2289810-289810102.840104.26
3262455-26245593.13394.32
4289211-289211102.627104.05
5288125-288125102.242103.74
6269796-26979695.73896.99
30min1283668-283668100.66099.283.49102.47101.173.55
2290162-290162102.965104.96
3263585-26358593.53495.23
4281781-28178199.991101.98
5286349-286349101.612103.68
6273124-27312496.91998.71
45min1284287-284287100.88099.283.71103.25101.723.76
2287907-287907102.165104.73
3260023-26002392.27094.49
4282916-282916100.394102.94
5286453-286453101.649104.28
6277112-27711298.334100.66
60min1289256-289256102.643100.372.68105.58103.372.73
2287387-287387101.980105.12
3269040-26904095.47098.20
4287887-287887102.157105.26
5283586-283586100.631103.83
6280017-28001799.365102.24
极限1293491-293491104.146103.740.70107.65107.290.83
2293474-293474104.140107.84
3288263-288263102.291105.55
4293147-293147104.024107.70
5293261-293261104.064107.82
6292421-292421103.766107.19
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(%) 99.90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%
114.696803167733678666786067874678730.16
214.716841968309683640.12
单位质量响应值RSD%判断
4620.354647.450.42数据可信
供试品溶液-6032501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%
5min160407-6040784.51879.5618.3584.5279.5618.35
264986-6498690.92490.92
337784-3778452.86552.87
460574-6057484.75184.75
565081-6508191.05791.06
652354-5235473.25073.25
10min167512-6751294.45990.728.1294.9391.168.17
268616-6861696.00396.51
354757-5475776.61376.91
467052-6705293.81594.29
567735-6773594.77195.28
663366-6336688.65889.06
15min169079-6907996.65193.386.2497.6594.326.29
270710-7071098.93399.97
359520-5952083.27784.00
469655-6965597.45798.45
566862-6686293.54994.58
664603-6460390.38891.29
20min169379-6937997.07195.214.2898.6096.684.37
271092-7109299.467101.06
363211-6321188.44189.62
469594-6959497.37298.91
569080-6908096.65298.20
665952-6595292.27693.68
30min169396-6939697.09594.653.1099.1796.643.21
269452-6945297.17399.31
363867-6386789.35991.03
467397-6739794.29896.37
568634-6863496.02898.12
667151-6715193.95395.87
45min169791-6979197.64795.283.63100.2697.803.73
270063-7006398.028100.71
363463-6346388.79390.96
468959-6895996.48399.08
569013-6901396.55999.18
667301-6730194.16396.60
60min169806-6980697.66890.027.39100.8293.067.26
260540-6054084.70487.93
360017-6001783.97286.64
469747-6974797.586100.72
565837-6583792.11595.27
660069-6006984.04587.00
极限169727-6972797.55895.072.32101.2598.622.40
269682-6968297.495101.19
366040-6604092.39995.53
468282-6828295.53699.21
566424-6642492.93696.61
667535-6753594.49197.92
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(%)99.75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%
110.842764422759232763222766632758502762400.13
210.982762372758652760510.10
单位质量响应值RSD%判断
25483.3925141.260.96数据可信
供试品溶液-6032601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%
5min1119187-11918742.27446.6419.4642.2746.6419.46
299336-9933635.23335.23
3156998-15699855.68555.68
4130497-13049746.28546.29
5166360-16636059.00559.01
6116681-11668141.38541.39
10min1238416-23841684.56384.083.4184.8084.343.42
2234791-23479183.27783.47
3237557-23755784.25884.57
4222735-22273579.00179.26
5245874-24587487.20887.54
6243006-24300686.19186.42
15min1259683-25968392.10692.073.1892.8192.803.17
2264233-26423393.72094.38
3259303-25930391.97192.75
4244108-24410886.58287.28
5262044-26204492.94393.76
6268154-26815495.11095.82
20min1268906-26890695.37795.043.5296.5996.283.49
2273442-27344296.98698.16
3264501-26450193.81595.10
4250944-25094489.00690.18
5272574-27257496.67898.01
6277380-27738098.38399.62
30min1269957-26995795.75096.433.7597.5098.203.72
2276609-27660998.10999.83
3277959-27795998.588100.40
4252494-25249489.55691.23
5273736-27373697.09098.96
6280562-28056299.511101.29
45min1272111-27211196.51497.212.2398.7999.512.24
2277811-27781198.535100.80
3278692-27869298.848101.21
4262938-26293893.26095.43
5274158-27415897.24099.64
6278762-27876298.873101.21
60min1276410-27641098.03997.602.47100.85100.442.46
2282500-282500100.199103.01
3275016-27501697.544100.45
4262315-26231593.03995.73
5277236-27723698.332101.28
6277529-27752998.435101.32
极限1291269-291269103.309103.011.02106.67106.401.00
2292070-292070103.593106.96
3289466-289466102.669106.12
4290198-290198102.929106.13
5294207-294207104.351107.84
6285420-285420101.234104.67
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(%) 99.90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%
114.696851068266685606840868529684550.18
214.716795168203680770.27
单位质量响应值RSD%判断
4659.974627.940.49数据可信
供试品溶液-6032601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%
5min147563-4756366.40378.389.7966.4078.389.79
253617-5361774.85574.86
357373-5737380.09980.10
458037-5803781.02681.03
564248-6424889.69789.70
656025-5602578.21778.22
10min164152-6415289.56391.391.8689.9391.831.87
267059-6705993.62294.04
365203-6520391.03191.48
464064-6406489.44189.89
566421-6642192.73193.23
665868-6586891.95992.39
15min163606-6360688.80192.052.7889.6792.992.76
267361-6736194.04494.98
368040-6804094.99295.94
466285-6628592.54193.49
563820-6382089.10090.11
666469-6646992.79893.74
20min168153-6815395.14992.573.4296.5194.023.36
261857-6185786.35987.82
366829-6682993.30194.78
466585-6658592.96094.42
567690-6769094.50396.01
666714-6671493.14094.60
30min166572-6657292.94292.004.8694.8393.964.78
259866-5986683.58085.52
369188-6918896.59498.59
465691-6569191.71293.69
566318-6631892.58794.62
667731-6773194.56096.54
45min167331-6733194.00293.163.5696.4195.653.50
262404-6240487.12389.53
365634-6563491.63294.17
468161-6816195.16097.65
568353-6835395.42997.98
668504-6850495.63998.14
60min167557-6755794.31793.673.1297.2496.663.00
269105-6910596.47899.36
366289-6628992.54795.59
463383-6338388.49091.51
568846-6884696.11799.19
667375-6737594.06397.10
极限169299-6929996.74993.422.74100.2096.942.62
267678-6767894.48697.91
367651-6765194.44898.01
464823-6482390.50094.01
567424-6742494.13297.74
664605-6460590.19693.75
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