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%
110.482740272761292758992752782759792754620.32
210.532748542754912751720.17
单位质量响应值RSD%判断
26284.5426132.190.42数据可信
加速6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%
5min138042-3804213.02525.7737.4313.0225.7737.44
242257-4225714.46814.47
379781-7978127.31527.31
497708-9770833.45333.45
592943-9294331.82131.82
6100902-10090234.54634.55
10min1155136-15513653.11572.9318.5853.1973.0818.62
2171653-17165358.77058.85
3224968-22496877.02377.18
4246781-24678184.49284.68
5234565-23456580.30980.49
6244975-24497583.87384.07
15min1220674-22067475.55386.738.8275.9287.288.90
2229191-22919178.46978.88
3264858-26485890.68191.26
4272695-27269593.36494.02
5266497-26649791.24291.86
6265999-26599991.07191.73
20min1240912-24091282.48290.855.6883.2791.885.79
2252990-25299086.61787.46
3271371-27137192.91093.99
4279897-27989795.83097.00
5274463-27446393.96995.10
6272541-27254193.31194.47
30min1260776-26077689.28396.054.2490.5397.584.36
2272014-27201493.13194.45
3289993-28999399.286100.89
4290855-29085599.581101.29
5286929-28692998.23799.89
6282636-28263696.76798.45
45min1273948-27394893.79397.122.2295.5399.192.36
2281972-28197296.54098.38
3282074-28207496.57598.73
4291551-29155199.820102.08
5289603-28960399.153101.35
6282914-28291496.86399.08
60min1279368-27936895.64897.911.4197.91100.521.48
2289545-28954599.133101.51
3288903-28890398.913101.60
4287835-28783598.547101.36
5287431-28743198.409101.16
6282771-28277196.81499.57
极限1295750-295750101.257101.581.30104.05104.731.23
2300301-300301102.815105.74
3298170-298170102.086105.32
4298683-298683102.261105.62
5297776-297776101.951105.25
6289478-28947899.110102.41
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%
115.267384173815738367364674031738340.19
215.327369074021738560.32
单位质量响应值RSD%判断
4838.404820.890.26数据可信
加速6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%
5min149700-4970066.71875.7412.0666.7275.7412.06
246180-4618061.99361.99
358070-5807077.95577.95
460925-6092581.78781.79
561758-6175882.90582.91
661880-6188083.06983.07
10min167476-6747690.58189.711.8690.9590.131.86
265894-6589488.45888.80
366222-6622288.89889.33
469037-6903792.67793.13
566511-6651189.28689.75
665817-6581788.35488.82
15min169948-6994893.90091.951.4494.7792.871.43
267928-6792891.18892.02
367121-6712190.10591.03
469173-6917392.86093.83
568592-6859292.08093.04
668228-6822891.59192.54
20min171385-7138595.82993.022.4997.2294.452.45
269496-6949693.29394.64
366452-6645289.20790.63
470648-7064894.84096.32
569225-6922592.92994.40
668561-6856192.03893.50
30min170204-7020494.24495.721.7896.1797.661.79
270710-7071094.92396.78
370392-7039294.49696.42
473025-7302598.031100.04
572806-7280697.73799.72
670669-7066994.86896.84
45min172774-7277497.69495.512.12100.1597.992.09
271175-7117595.54797.94
368525-6852591.99094.44
472155-7215596.86399.42
571751-7175196.32098.85
670495-7049594.63497.13
60min172619-7261997.48695.051.65100.4898.061.63
270411-7041194.52197.44
369146-6914692.82395.78
471361-7136195.79798.89
571002-7100295.31598.38
670293-7029394.36397.39
极限172254-7225496.99694.261.96100.5397.801.93
269419-6941993.19096.63
368372-6837291.78495.26
470995-7099595.30598.93
570685-7068594.88998.48
669570-6957093.39296.94
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%
110.482753492757212750622749872748222751880.13
210.532732792732632732710.01
单位质量响应值RSD%判断
26258.4025951.660.84数据可信
加速6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%
5min184141-8414128.92340.5619.1428.9240.5619.14
2122313-12231342.04442.04
3123553-12355342.47042.47
4104209-10420935.82135.82
5121915-12191541.90741.91
6151889-15188952.21052.21
10min1202076-20207669.46182.279.9469.6282.509.96
2245201-24520184.28584.52
3245851-24585184.50984.74
4230716-23071679.30679.51
5237078-23707881.49381.73
6275114-27511494.56794.86
15min1228662-22866278.60089.476.8179.1590.156.85
2268634-26863492.34093.04
3260411-26041189.51390.22
4259045-25904589.04489.68
5262422-26242290.20590.89
6282533-28253397.11897.93
20min1238125-23812581.85392.085.7082.8493.265.75
2277858-27785895.51196.73
3268676-26867692.35493.56
4270253-27025392.89694.03
5271862-27186293.44994.64
6280432-28043296.39597.75
30min1250797-25079786.20994.884.8387.6596.564.89
2281662-28166296.81898.56
3278261-27826195.64997.36
4278917-27891795.87597.52
5276074-27607494.89796.60
6290362-29036299.809101.70
45min1266539-26653991.62096.293.1493.5498.513.21
2287049-28704998.670100.95
3277721-27772195.46397.71
4286188-28618898.374100.56
5274416-27441694.32796.56
6288893-28889399.304101.75
60min1267339-26733991.89596.763.0194.3299.523.09
2287164-28716498.709101.54
3278194-27819495.62698.40
4287109-28710998.690101.42
5278983-27898395.89798.65
6290237-29023799.766102.76
极限1290543-29054399.871101.361.23102.81104.651.32
2296688-296688101.983105.36
3292106-292106100.408103.72
4299546-299546102.966106.24
5292620-292620100.585103.87
6297746-297746102.347105.90
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%
115.267425673764740057390773457738780.41
215.327346173449734550.02
单位质量响应值RSD%判断
4841.284794.710.69数据可信
加速6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%
5min153070-5307071.41678.836.6671.4278.836.66
256653-5665376.23876.24
358394-5839478.58178.58
458935-5893579.30979.31
559421-5942179.96379.96
664986-6498687.45187.45
10min166896-6689690.02291.042.8490.4291.482.84
267462-6746290.78391.21
365118-6511887.62988.07
469819-6981993.95594.40
566621-6662189.65290.10
670018-7001894.22394.71
15min168197-6819791.77292.453.4092.6793.403.39
269728-6972893.83394.76
364704-6470487.07288.00
470659-7065995.08696.05
567891-6789191.36192.30
671030-7103095.58596.59
20min168478-6847892.15192.772.6393.5694.232.63
269598-6959893.65895.11
365846-6584688.60990.02
470628-7062895.04496.53
568408-6840892.05693.51
670673-7067395.10496.64
30min168291-6829191.89995.182.8693.8297.162.86
269743-6974393.85395.82
369215-6921593.14295.04
473107-7310798.380100.40
570969-7096995.50397.46
673071-7307198.331100.40
45min171538-7153896.26896.661.8498.7099.161.85
272163-7216397.10999.60
370603-7060395.01097.43
473592-7359299.032101.60
570163-7016394.41896.91
672894-7289498.093100.71
60min170590-7059094.99396.671.7397.9699.711.75
272256-7225697.235100.27
370574-7057494.97197.92
473691-7369199.166102.28
571277-7127795.91798.93
672631-7263197.739100.90
极限170971-7097195.50596.861.3499.00100.441.36
272431-7243197.470101.04
371876-7187696.723100.20
473322-7332298.669102.34
570820-7082095.30298.85
672456-7245697.504101.21
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%
110.482753422749582749292749322746002749520.10
210.532745032741682743360.09
单位质量响应值RSD%判断
26235.8826052.800.50数据可信
加速6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%
5min1149185-14918551.20253.9422.6751.2053.9422.67
2204743-20474370.27170.27
3145544-14554449.95349.95
4188035-18803564.53664.54
5152079-15207952.19652.20
6103317-10331735.46035.46
10min1236507-23650781.17386.577.0781.4686.877.11
2274951-27495194.36794.76
3248330-24833085.23085.51
4273986-27398694.03694.39
5243441-24344183.55283.84
6236166-23616681.05681.25
15min1252863-25286386.78691.734.4587.5292.514.51
2283207-28320797.20198.12
3265363-26536391.07691.83
4280003-28000396.10196.98
5261810-26181089.85790.61
6260335-26033589.35190.00
20min1263158-26315890.32093.132.8791.5494.422.95
2280387-28038796.23397.69
3273869-27386993.99695.25
4280001-28000196.10097.52
5265414-26541491.09492.35
6265239-26523991.03492.18
30min1261096-26109689.61293.962.5891.3395.762.61
2277413-27741395.21297.20
3280971-28097196.43398.21
4278173-27817395.47397.42
5273058-27305893.71795.48
6271846-27184693.30194.95
45min1262291-26229190.02294.322.6992.2496.652.72
2281179-28117996.50599.02
3282058-28205896.80699.12
4276152-27615294.77997.26
5276508-27650894.90197.18
6270659-27065992.89495.06
60min1267292-26729291.73894.412.1394.4697.262.19
2278372-27837295.54198.60
3281695-28169596.68299.53
4279653-27965395.98198.99
5274099-27409994.07596.88
6269299-26929992.42795.11
极限1290890-29089099.838101.581.30103.06104.951.25
2291509-291509100.050103.64
3298974-298974102.612106.00
4298402-298402102.416105.95
5296448-296448101.745105.08
6299489-299489102.789105.99
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%
115.267273173947738497365873496735360.66
215.327414074045740920.10
单位质量响应值RSD%判断
4818.874836.290.26数据可信
加速6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%
5min158541-5854178.62076.989.0478.6276.989.04
258906-5890679.11179.11
360400-6040081.11781.12
458148-5814878.09378.09
560928-6092881.82681.83
646976-4697663.08963.09
10min167648-6764890.85188.833.3691.2989.253.38
266561-6656189.39189.83
367196-6719690.24490.69
464814-6481487.04587.48
568302-6830291.72992.18
662321-6232183.69784.05
15min168313-6831391.74490.871.9092.6991.801.90
268101-6810191.45992.40
366872-6687289.80990.76
465792-6579288.35889.28
569509-6950993.35094.31
667394-6739490.51091.33
20min169717-6971793.63091.821.2095.0893.251.19
268217-6821791.61593.06
368083-6808391.43592.89
467199-6719990.24891.66
568525-6852592.02993.51
668492-6849291.98593.30
30min167897-6789791.18593.012.7893.1694.952.70
267451-6745190.58792.54
369377-6937793.17395.13
467799-6779991.05492.96
570776-7077695.05297.05
672242-7224297.02198.85
45min169771-6977193.70293.931.7596.1896.381.72
268643-6864392.18794.64
369458-6945893.28295.76
469026-6902692.70295.12
571903-7190396.56699.09
670847-7084795.14797.52
60min169869-6986993.83493.971.4196.8396.951.35
268554-6855492.06895.04
369220-6922092.96295.96
470477-7047794.65097.58
570393-7039394.53897.60
671325-7132595.78998.69
极限169648-6964893.53796.063.6797.0699.563.52
268724-6872492.29695.78
370226-7022694.31397.82
472505-7250597.374100.83
572063-7206396.780100.36
676004-76004102.073105.50
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%
110.482751012749342754032751032747442750570.09
210.532733792756802745300.60
单位质量响应值RSD%判断
26245.9026071.230.48数据可信
加速6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%
5min1195061-19506166.91160.9618.7166.9160.9618.71
2130772-13077244.85844.86
3206168-20616870.72170.72
4208727-20872771.59971.60
5182741-18274162.68562.69
6142755-14275548.96948.97
10min1253851-25385187.07888.194.8787.4588.534.91
2246295-24629584.48684.74
3263811-26381190.49490.89
4272716-27271693.54993.95
5265819-26581991.18391.53
6240091-24009182.35882.63
15min1264897-26489790.86795.454.3391.7296.284.34
2282039-28203996.74797.47
3281076-28107696.41797.31
4293976-293976100.842101.76
5284703-28470397.66198.52
6262890-26289090.17890.91
20min1267140-26714091.63696.063.5393.0097.423.53
2282663-28266396.96198.22
3277434-27743495.16796.60
4293339-293339100.623102.10
5287881-28788198.751100.15
6271715-27171593.20694.44
30min1267598-26759891.79396.033.4993.6697.923.48
2277603-27760395.22597.02
3272565-27256593.49795.46
4294229-294229100.929102.97
5287729-28772998.699100.64
6279913-27991396.01897.77
45min1270076-27007692.64397.222.7795.0299.652.78
2285044-28504497.778100.10
3283951-28395197.40399.88
4294129-294129100.894103.49
5286146-28614698.156100.65
6281235-28123596.47198.75
60min1267497-26749791.75996.903.0394.6599.873.02
2285662-28566297.990100.86
3281875-28187596.69199.71
4291907-291907100.132103.29
5288260-28826098.881101.92
6279749-27974995.96298.78
极限1290830-29083099.763101.191.57103.17104.701.57
2297228-297228101.957105.37
3290823-29082399.760103.32
4302482-302482103.760107.47
5292045-292045100.179103.77
6296531-296531101.718105.07
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%
115.267389574082741787391073860739850.19
215.327387174125739980.25
单位质量响应值RSD%判断
4848.304830.160.27数据可信
加速6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%
5min158161-5816177.92279.772.8277.9279.772.82
257871-5787177.53477.53
359165-5916579.26779.27
461521-6152182.42482.42
561729-6172982.70282.70
658802-5880278.78178.78
10min164535-6453586.46287.132.1986.8987.572.18
265756-6575688.09888.53
362974-6297484.37084.81
464107-6410785.88886.35
566854-6685489.56990.03
665972-6597288.38788.82
15min165061-6506187.16789.772.1788.0890.702.16
268336-6833691.55492.47
365291-6529187.47588.38
467467-6746790.39091.33
568085-6808591.21892.18
667788-6778890.82091.75
20min166317-6631788.84990.492.8190.2591.922.79
268750-6875092.10993.54
364553-6455386.48687.88
467493-6749390.42591.86
568209-6820991.38492.85
669920-6992093.67695.11
30min165341-6534187.54291.073.8589.4393.003.81
268233-6823391.41693.36
364640-6464086.60288.48
468778-6877892.14694.09
569107-6910792.58794.56
671733-7173396.10598.06
45min168271-6827191.46793.361.9593.8495.801.95
270731-7073194.76397.21
368182-6818291.34893.70
469803-6980393.52095.97
569510-6951093.12795.61
671624-7162495.95998.45
60min167338-6733890.21792.812.7793.1095.762.74
271654-7165496.00098.97
366681-6668189.33792.20
469491-6949193.10296.07
569902-6990293.65296.66
670586-7058694.56997.59
极限168551-6855191.84293.202.5995.2396.672.56
271562-7156295.87699.38
366691-6669189.35092.71
469852-6985293.58597.07
569509-6950993.12696.65
671234-7123495.43798.98
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