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%
110.652793932797322797642799602798652797430.08
210.682798382796162797270.06
单位质量响应值RSD%判断
26266.9526191.670.21数据可信
长期24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%
5min1114556-11455639.18925.1929.3839.1925.1929.38
253767-5376718.39418.39
371869-7186924.58624.59
476779-7677926.26626.27
563766-6376621.81421.81
661027-6102720.87720.88
10min1256235-25623587.65877.3010.1587.8877.4510.18
2196184-19618467.11467.22
3213289-21328972.96673.10
4249785-24978585.45185.60
5216268-21626873.98574.11
6224059-22405976.65076.77
15min1268071-26807191.70791.152.8392.4191.722.86
2265147-26514790.70791.18
3259101-25910188.63889.18
4279884-27988495.74896.37
5259808-25980888.88089.41
6266636-26663691.21691.76
20min1269483-26948392.19093.602.3193.4094.682.29
2277985-27798595.09896.08
3267339-26733991.45692.49
4283598-28359897.01998.17
5268812-26881291.96092.99
6274428-27442893.88294.93
30min1271561-27156192.90194.662.7794.6396.252.73
2283107-28310796.85198.36
3269431-26943192.17293.71
4285721-28572197.74599.44
5268615-26861591.89393.43
6281714-28171496.37497.94
45min1270600-27060092.57294.802.5594.8196.922.50
2284962-28496297.48599.53
3268221-26822191.75893.81
4284852-28485297.44899.68
5275326-27532694.18996.24
6278694-27869495.34197.45
60min1270171-27017192.42594.941.7795.1897.591.72
2281288-28128896.22898.82
3273204-27320493.46396.03
4282378-28237896.60199.38
5280655-28065596.01298.58
6277434-27743494.91097.55
极限1280046-28004695.80398.711.5399.07101.881.44
2288911-28891198.836101.96
3289231-28923198.946102.03
4289390-28939099.000102.31
5292896-292896100.199103.30
6290700-29070099.448102.61
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%
114.917171671498719927148771960717310.34
214.877146571779716220.32
单位质量响应值RSD%判断
4810.934816.540.09数据可信
长期24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%
5min152414-5241470.59461.4615.9670.5961.4615.96
254361-5436173.21673.22
340559-4055954.62754.63
449448-4944866.59966.60
539145-3914552.72352.72
637849-3784950.97750.98
10min161490-6149082.81883.593.9283.2183.933.94
265839-6583988.67689.08
359230-5923079.77480.08
462461-6246184.12684.50
559881-5988180.65180.94
663477-6347785.49485.78
15min163012-6301284.86888.794.1785.7289.604.13
268438-6843892.17693.08
364699-6469987.14087.89
463831-6383185.97186.81
565535-6553588.26689.01
670041-7004194.33595.09
20min164015-6401586.21990.573.9187.5491.873.87
269958-6995894.22395.63
366305-6630589.30390.53
464946-6494687.47388.79
567836-6783691.36592.60
670431-7043194.86096.14
30min165438-6543888.13692.404.4289.9494.204.36
270099-7009994.41396.35
367844-6784491.37693.10
465825-6582588.65790.46
568776-6877692.63194.37
673635-7363599.176100.99
45min165690-6569088.47592.953.9590.7795.273.90
270997-7099795.62398.08
367768-6776891.27493.51
466560-6656089.64791.94
570557-7055795.03097.28
672506-7250697.655100.02
60min165649-6564988.42093.284.2791.2096.114.20
270762-7076295.30698.30
368612-6861292.41095.15
466102-6610289.03091.82
571699-7169996.56899.35
672715-7271597.937100.84
极限166389-6638989.41693.364.4292.6996.714.33
270260-7026094.63098.15
369378-6937893.44296.70
465068-6506887.63790.92
572102-7210297.111100.43
672715-7271597.937101.38
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%
110.652794362794702796672795872795452795410.04
210.682794392794962794680.02
单位质量响应值RSD%判断
26247.9826167.420.22数据可信
长期24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%
5min1126361-12636143.26436.1034.9343.2636.1034.94
2152565-15256552.23552.24
372616-7261624.86224.86
476244-7624426.10526.10
5135399-13539946.35846.36
669458-6945823.78123.78
10min1260111-26011189.05785.436.6689.3085.636.70
2258532-25853288.51688.81
3254018-25401886.97187.11
4228006-22800678.06578.21
5266862-26686291.36991.63
6229521-22952178.58478.72
15min1276144-27614494.54693.172.9795.2893.843.00
2271778-27177893.05293.83
3282007-28200796.55497.18
4262162-26216289.75990.34
5277563-27756395.03295.80
6263053-26305390.06490.63
20min1277610-27761095.04894.262.6196.3195.462.64
2273499-27349993.64194.94
3285384-28538497.71098.87
4269665-26966592.32893.41
5280088-28008895.89797.19
6265686-26568690.96692.03
30min1276333-27633394.61194.853.0696.4096.563.08
2276837-27683794.78496.60
3288031-28803198.616100.32
4271319-27131992.89594.48
5284653-28465397.46099.29
6264958-26495890.71792.29
45min1276949-27694994.82295.212.7097.1497.462.69
2273003-27300393.47195.82
3290489-29048999.458101.71
4274401-27440193.95096.06
5283317-28331797.00299.37
6270392-27039292.57794.66
60min1280077-28007795.89395.152.9598.7397.922.94
2271674-27167493.01695.88
3290716-29071699.536102.34
4274166-27416693.86996.50
5282532-28253296.73499.64
6268320-26832091.86894.46
极限1294339-294339100.77699.951.95104.15103.261.95
2283763-28376397.155100.54
3298884-298884102.332105.69
4291350-29135099.753102.90
5296127-296127101.388104.83
6287147-28714798.314101.42
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%
114.917142571631716237169371673716090.15
214.877166371837717500.18
单位质量响应值RSD%判断
4802.754825.150.33数据可信
长期24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%
5min157300-5730077.17262.9421.3777.1762.9421.37
255575-5557574.84974.85
339032-3903252.56852.57
435637-3563747.99648.00
554354-5435473.20473.20
638481-3848151.82651.83
10min167898-6789891.44582.698.7691.8783.048.81
262208-6220883.78284.20
356822-5682276.52876.82
455740-5574075.07175.34
567568-6756891.00191.41
658146-5814678.31178.60
15min169606-6960693.74687.965.5494.6888.775.60
264923-6492387.43988.32
360918-6091882.04582.76
463086-6308684.96485.65
569743-6974393.93094.84
663598-6359885.65486.38
20min169421-6942193.49689.184.6894.9590.484.74
265199-6519987.81089.18
361968-6196883.45984.63
465765-6576588.57389.73
570229-7022994.58596.02
664710-6471087.15288.35
30min170116-7011694.43291.394.1796.4193.184.23
267622-6762291.07492.93
364549-6454986.93588.57
468010-6801091.59693.24
571825-7182596.73498.69
665022-6502287.57289.25
45min170914-7091495.50792.922.5898.0195.222.66
267654-6765491.11793.48
368021-6802191.61193.73
468972-6897292.89295.05
571346-7134696.08998.59
667049-6704990.30292.47
60min171604-7160496.43793.533.1099.4796.343.14
268359-6835992.06694.93
368780-6878092.63395.26
470128-7012894.44997.12
571694-7169496.55899.59
666096-6609689.01891.69
极限171687-7168796.54895.991.64100.1299.331.58
269339-6933993.38696.76
371086-7108695.73998.88
472925-7292598.216101.41
571497-7149796.29299.86
671114-7111495.77798.94
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%
110.652798272799322796032797962797512797820.05
210.682800132799552799840.02
单位质量响应值RSD%判断
26270.6126215.730.15数据可信
长期24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%
5min1107293-10729336.68541.9820.8636.6941.9820.86
2101414-10141434.67534.68
3167522-16752257.27957.28
4121673-12167341.60241.60
5102726-10272635.12435.12
6136048-13604846.51746.52
10min1250740-25074085.73286.594.4685.9486.824.50
2240567-24056782.25482.45
3268888-26888891.93892.26
4261413-26141389.38289.61
5241182-24118282.46482.66
6256673-25667387.76188.02
15min1275980-27598094.36394.141.9395.0494.861.96
2265614-26561490.81891.47
3278625-27862595.26796.10
4278662-27866295.28096.01
5273350-27335093.46394.12
6279726-27972695.64396.39
20min1282969-28296996.75295.582.0997.9696.822.09
2269310-26931092.08293.24
3279245-27924595.47996.84
4286812-28681298.06699.32
5279583-27958395.59496.77
6279374-27937495.52396.80
30min1280905-28090596.04695.491.5197.7997.261.49
2272561-27256193.19394.86
3277414-27741494.85396.74
4282986-28298696.75898.56
5283877-28387797.06398.77
6277910-27791095.02296.83
45min1278456-27845695.20994.591.4497.4896.891.41
2272267-27226793.09395.28
3274067-27406793.70896.12
4281832-28183296.36398.70
5280027-28002795.74697.99
6273249-27324993.42995.76
60min1278328-27832895.16594.821.2997.9797.641.26
2274894-27489493.99196.69
3273499-27349993.51496.45
4283221-28322196.83899.71
5278836-27883695.33998.11
6275058-27505894.04796.90
极限1281234-28123496.15996.951.7999.49100.301.72
2286120-28612097.830101.05
3279215-27921595.46998.92
4292138-29213899.887103.30
5283863-28386397.058100.36
6278699-27869995.29298.67
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(%)99.9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%
114.917194471940717207187571945718850.14
214.877200971940719740.07
单位质量响应值RSD%判断
4821.264840.220.28数据可信
长期24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%
5min150564-5056467.86367.897.5067.8667.897.49
246304-4630462.14662.15
353007-5300771.14271.14
456712-5671276.11476.11
547747-4774764.08264.08
649171-4917165.99365.99
10min164913-6491387.12183.616.5187.5083.996.50
257218-5721876.79377.14
358259-5825978.19178.59
468021-6802191.29291.72
562732-6273284.19484.55
662648-6264884.08184.45
15min166516-6651689.27386.546.2890.1387.386.27
259389-5938979.70780.48
359877-5987780.36281.19
469732-6973293.58994.52
565943-6594388.50389.33
665436-6543687.82388.66
20min167792-6779290.98587.876.3192.3489.206.30
260092-6009280.65181.87
361125-6112582.03783.31
470889-7088995.14296.59
567074-6707490.02191.34
665863-6586388.39689.72
30min167671-6767190.82388.835.1792.6990.655.18
262014-6201483.23084.89
362380-6238083.72285.45
470826-7082695.05797.04
567819-6781991.02192.84
666429-6642989.15690.97
45min167768-6776890.95388.905.1593.3291.215.16
261664-6166482.76184.89
362820-6282084.31286.51
470624-7062494.78697.29
568204-6820491.53893.86
666363-6636389.06791.38
60min169164-6916492.82689.925.0395.7092.725.04
262425-6242583.78286.37
363432-6343285.13387.80
470992-7099295.28098.31
568456-6845691.87694.71
667526-6752690.62893.43
极限169335-6933593.05691.833.2296.4495.133.24
268861-6886192.42095.47
364277-6427786.26889.41
470824-7082495.05498.62
568944-6894492.53195.87
668309-6830991.67994.99
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%
110.652796712795002794892795362792022794800.07
210.682796162793612794880.07
单位质量响应值RSD%判断
26242.2526169.290.20数据可信
长期24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%
5min1106258-10625836.38339.3720.9936.3839.3720.99
2143314-14331449.07249.07
377078-7707826.39226.39
4116914-11691440.03240.03
5138292-13829247.35247.35
6107995-10799536.97836.98
10min1241524-24152482.69981.966.0882.9082.186.12
2252276-25227686.38186.65
3215584-21558473.81773.96
4250185-25018585.66585.89
5248333-24833385.03185.29
6228239-22823978.15078.36
15min1268288-26828891.86389.564.2992.5390.244.32
2263896-26389690.36091.11
3242807-24280783.13983.70
4273178-27317893.53894.24
5267294-26729491.52392.26
6253965-25396586.95987.60
20min1272470-27247093.29592.193.1394.4793.363.17
2272295-27229593.23594.49
3252519-25251986.46487.48
4276206-27620694.57595.79
5271225-27122592.86994.11
6270704-27070492.69193.81
30min1282013-28201396.56393.532.7098.2595.212.73
2275029-27502994.17295.94
3260497-26049789.19690.69
4277890-27789095.15196.89
5272737-27273793.38795.15
6270757-27075792.70994.35
45min1274553-27455394.00993.211.1696.2495.421.24
2272389-27238993.26895.56
3267455-26745591.57893.57
4275780-27578094.42996.70
5273558-27355893.66895.95
6269627-26962792.32294.47
60min1276102-27610294.53993.531.3297.2996.261.37
2273322-27332293.58796.40
3268851-26885192.05694.56
4278484-27848495.35598.15
5271524-27152492.97195.77
6270723-27072392.69795.36
极限1283792-28379297.17298.101.62100.45101.341.59
2294991-294991101.007104.34
3288301-28830198.716101.73
4283534-28353497.084100.41
5285928-28592897.904101.22
6282520-28252096.73799.92
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%
114.917143971543709347141471262713180.34
214.877166771755717110.09
单位质量响应值RSD%判断
4783.234822.530.58数据可信
长期24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%
5min151003-5100368.85072.586.5168.8572.586.51
257139-5713977.13377.13
351142-5114269.03869.04
453354-5335472.02472.02
558983-5898379.62379.62
650968-5096868.80368.80
10min161709-6170983.30285.491.9383.6885.901.94
262863-6286384.86085.29
363330-6333085.49185.87
464966-6496687.69988.10
564516-6451687.09287.53
662615-6261584.52584.91
15min163394-6339485.57787.681.8086.4288.561.80
263797-6379786.12187.02
364782-6478287.45188.31
465956-6595689.03689.92
566233-6623389.40990.34
665556-6555688.49689.35
20min163397-6339785.58188.762.1086.9090.132.10
265592-6559288.54489.92
365793-6579388.81590.16
467303-6730390.85492.24
566937-6693790.36091.78
665507-6550788.42989.77
30min164592-6459287.19489.891.9888.9991.751.98
266190-6619089.35191.22
366205-6620589.37291.21
468010-6801091.80893.69
568111-6811191.94593.87
666436-6643689.68391.52
45min164512-6451287.08690.121.9989.3792.481.99
266328-6632889.53891.90
367693-6769391.38093.71
467935-6793591.70794.10
567798-6779891.52293.96
666284-6628489.47891.81
60min165686-6568688.67190.571.4891.4493.431.47
266682-6668290.01692.88
368178-6817892.03594.88
468197-6819792.06194.97
567263-6726390.80093.74
666549-6654989.83692.67
极限163888-6388886.24491.192.9989.5094.552.95
268299-6829992.19895.56
368470-6847092.42995.78
468143-6814391.98895.41
569696-6969694.08497.53
666819-6681990.20093.53
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