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%
110.482786242778222772132775512779622778340.19
210.532771932772812772370.03
单位质量响应值RSD%判断
26510.8826328.300.49数据可信
长期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%
5min170309-7030923.88030.2033.2723.8830.2033.27
279317-7931726.93926.94
344383-4438315.07415.07
4119155-11915540.47040.47
5118387-11838740.20940.21
6101878-10187834.60234.60
10min1205546-20554669.81178.6714.2369.9478.8414.27
2217600-21760073.90574.05
3185931-18593163.14963.23
4258664-25866487.85288.08
5259595-25959588.16888.39
6262470-26247089.14589.34
15min1250522-25052285.08789.457.3585.6190.067.43
2251979-25197985.58286.14
3236935-23693580.47280.91
4277353-27735394.20094.91
5279660-27966094.98395.70
6283797-28379796.38897.08
20min1272699-27269992.61993.604.1493.6194.704.24
2266850-26685090.63391.67
3259282-25928288.06288.94
4280771-28077195.36196.60
5284297-28429796.55897.80
6289595-28959598.35899.58
30min1278833-27883394.70295.792.5896.2197.412.70
2272459-27245992.53894.08
3275960-27596093.72795.10
4290600-29060098.699100.46
5287008-28700897.47999.26
6287304-28730497.57999.35
45min1285983-28598397.13197.340.6899.1699.500.75
2283564-28356496.30998.36
3287444-28744497.62799.52
4287679-28767997.707100.02
5285851-28585197.08699.40
6289138-28913898.202100.51
60min1283978-28397896.45098.171.2799.02100.861.22
2289070-28907098.179100.77
3294054-29405499.872102.31
4286171-28617197.195100.05
5289052-28905298.173101.03
6291909-29190999.144102.00
极限1296776-296776100.797101.491.13103.91104.731.02
2300224-300224101.968105.10
3303380-303380103.040106.03
4295899-295899100.499103.90
5295054-295054100.212103.62
6301520-301520102.408105.82
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%
115.267347273350732977342573592734270.16
215.327332473567734460.24
单位质量响应值RSD%判断
4811.734794.130.26数据可信
长期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%
5min140735-4073554.98873.6915.2754.9973.6915.27
252910-5291071.42371.42
350613-5061368.32268.32
462306-6230684.10684.11
562433-6243384.27884.28
658549-5854979.03579.03
10min156220-5622075.89188.086.9776.2088.486.99
265127-6512787.91488.31
367200-6720090.71391.09
468239-6823992.11592.58
567161-6716190.66091.13
667530-6753091.15891.60
15min157913-5791378.17690.306.8278.9091.206.85
266846-6684690.23591.12
368157-6815792.00592.89
469584-6958493.93194.91
568572-6857292.56593.54
670302-7030294.90095.85
20min162584-6258484.48292.884.7085.6494.284.75
268606-6860692.61194.00
370988-7098895.82697.22
469331-6933193.58995.09
569827-6982794.25995.75
671511-7151196.53298.00
30min163404-6340485.58994.305.0487.2296.215.08
268320-6832092.22594.13
372104-7210497.33399.26
472623-7262398.033100.05
570742-7074295.49497.50
671933-7193397.10299.11
45min167333-6733390.89295.622.7793.0098.062.86
270441-7044195.08897.50
372574-7257497.967100.43
471912-7191297.07399.64
570391-7039195.02097.56
672377-7237797.701100.25
60min167235-6723590.76095.953.1293.3798.923.20
269959-6995994.43797.38
372721-7272198.165101.18
471653-7165396.72499.83
571556-7155696.59399.66
673371-7337199.043102.13
极限170813-7081395.59097.092.3698.71100.602.33
272246-7224697.524100.99
374232-74232100.205103.76
469521-6952193.84697.49
571507-7150796.527100.13
673246-7324698.874102.52
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%
110.482775352780922769652769002769502772880.19
210.532769262768082768670.04
单位质量响应值RSD%判断
26458.7826293.160.45数据可信
长期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%
5min1109908-10990837.39146.2120.5837.3946.2120.58
2135157-13515745.98045.98
3144353-14435349.10949.11
4108434-10843436.88936.89
5132391-13239145.03945.04
6184812-18481262.87362.87
10min1226051-22605176.90288.968.9077.1189.218.92
2279580-27958095.11395.37
3262081-26208189.16089.43
4262257-26225789.22089.42
5247166-24716684.08684.34
6291761-29176199.25799.61
15min1260645-26064588.67195.584.8789.3196.334.90
2288541-28854198.16198.95
3276847-27684794.18394.95
4290861-29086198.95199.65
5271646-27164692.41493.13
6297137-297137101.086101.99
20min1267417-26741790.97597.003.9292.1098.283.96
2288879-28887998.27699.61
3283606-28360696.48397.77
4296262-296262100.788102.04
5278402-27840294.71295.94
6296233-296233100.778102.24
30min1272253-27225392.62098.273.3194.25100.083.35
2291384-29138499.129101.00
3286249-28624997.38299.21
4300364-300364102.184103.99
5288088-28808898.00799.76
6294753-294753100.275102.30
45min1281022-28102295.60498.833.0397.75101.203.08
2291519-29151999.175101.60
3285924-28592497.27199.64
4297200-297200101.107103.49
5283501-28350196.44798.75
6303895-303895103.385105.96
60min1276417-27641794.03797.512.2796.72100.432.35
2287005-28700597.639100.62
3288608-28860898.184101.09
4292550-29255099.525102.46
5281877-28187795.89498.73
6293374-29337499.806102.96
极限1294662-294662100.244102.342.08103.44105.802.07
2298177-298177101.440104.96
3304800-304800103.693107.15
4311587-311587106.002109.49
5297213-297213101.112104.48
6298464-298464101.537105.25
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%
115.267351173657732667320373191733660.29
215.327315673234731950.08
单位质量响应值RSD%判断
4807.734777.740.45数据可信
长期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%
5min157227-5722777.41571.1911.3077.4271.1911.30
244663-4466360.41960.42
352479-5247970.99270.99
449352-4935266.76266.76
550622-5062268.48068.48
661413-6141383.07883.08
10min168769-6876993.02987.656.1893.4688.046.20
259145-5914580.01080.35
364758-6475887.60388.00
460838-6083882.30082.67
566970-6697090.59590.98
668258-6825892.33792.80
15min171443-7144396.64691.045.9497.5991.925.96
260979-6097982.49183.27
367436-6743691.22592.11
464242-6424286.90587.73
569431-6943193.92494.81
670258-7025895.04396.02
20min171313-7131396.47093.064.8697.9594.454.89
262432-6243284.45685.69
370112-7011294.84596.23
467809-6780991.73093.04
570254-7025495.03896.44
670840-7084095.83097.33
30min171057-7105796.12494.694.8898.1496.594.89
263259-6325985.57587.28
371411-7141196.60398.52
470096-7009694.82496.64
572833-7283398.526100.46
671312-7131296.46998.50
45min173282-7328299.13495.754.45101.6998.184.49
265220-6522088.22890.41
371493-7149396.71499.17
469306-6930693.75596.10
571614-7161496.87799.36
673764-7376499.786102.36
60min171546-7154696.78595.434.8399.8998.404.85
264774-6477487.62490.30
371835-7183597.176100.17
468556-6855692.74195.61
572037-7203797.450100.47
674530-74530100.822103.95
极限171492-7149296.71298.141.36100.35101.641.29
272110-7211097.548100.71
371939-7193997.317100.85
474263-74263100.461103.84
573020-7302098.779102.34
672480-7248098.049101.73
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%
110.482771592769352769152768412766172768930.08
210.532770832773002771920.06
单位质量响应值RSD%判断
26421.0926324.030.27数据可信
长期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%
5min1159055-15905554.11751.3811.3354.1251.3811.33
2126163-12616342.92642.93
3169883-16988357.80157.80
4142772-14277248.57748.58
5141145-14114548.02348.02
6167104-16710456.85656.86
10min1249916-24991685.03284.504.1185.3384.784.10
2259538-25953888.30688.54
3258296-25829687.88388.20
4232905-23290579.24479.51
5241005-24100582.00082.27
6248476-24847684.54284.86
15min1266647-26664790.72489.753.9291.5090.503.91
2274208-27420893.29794.03
3274107-27410793.26294.07
4249318-24931884.82885.54
5253840-25384086.36787.09
6264568-26456890.01790.80
20min1279777-27977795.19293.422.6296.4794.682.63
2281443-28144395.75997.01
3280432-28043295.41596.74
4265765-26576590.42491.61
5266110-26611090.54291.74
6273960-27396093.21294.50
30min1288311-28831198.09594.952.4699.9096.722.46
2283626-28362696.50198.28
3282756-28275696.20598.06
4270411-27041192.00593.69
5275391-27539193.69995.40
6273919-27391993.19995.00
45min1285324-28532497.07996.682.4899.4398.982.47
2295453-295453100.525102.84
3287059-28705997.669100.06
4278518-27851894.76396.96
5275334-27533493.68095.91
6283184-28318496.35198.67
60min1287654-28765497.87296.552.08100.7699.382.09
2292376-29237699.478102.35
3284399-28439996.76499.70
4275212-27521293.63896.36
5280966-28096695.59698.34
6281926-28192695.92398.78
极限1300036-300036102.085101.401.51105.52104.781.46
2304992-304992103.771107.20
3291435-29143599.158102.63
4298583-298583101.590104.83
5296920-296920101.024104.30
6296229-296229100.789104.18
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%
115.267327073362733427335373219733090.09
215.327327373142732080.13
单位质量响应值RSD%判断
4804.004778.590.38数据可信
长期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%
5min160184-6018481.43979.807.6481.4479.807.65
250085-5008567.77467.77
361799-6179983.62583.62
461240-6124082.86882.87
558765-5876579.51979.52
661772-6177283.58883.59
10min168223-6822392.31887.616.0692.7788.056.07
257617-5761777.96678.34
366964-6696490.61491.08
466617-6661790.14490.60
562859-6285985.05985.50
666175-6617589.54690.01
15min168264-6826492.37388.666.4193.3489.606.41
257602-5760277.94678.76
368850-6885093.16694.13
467498-6749891.33792.30
564280-6428086.98287.90
666648-6664890.18691.15
20min170267-7026795.08491.055.8196.5692.485.82
259928-5992881.09382.34
369858-6985894.53096.02
468899-6889993.23294.70
565954-6595489.24790.64
668826-6882693.13494.60
30min170326-7032695.16392.475.5397.1794.405.55
260893-6089382.39984.09
370798-7079895.80297.81
470626-7062695.56997.56
568235-6823592.33494.23
669142-6914293.56195.54
45min168376-6837692.52594.523.9595.0696.963.98
265623-6562388.79990.95
372493-7249398.096100.64
472321-7232197.863100.38
568605-6860592.83595.24
671681-7168196.99799.50
60min171713-7171397.04095.613.25100.0998.583.32
266032-6603289.35392.00
372083-7208397.541100.63
471271-7127196.44299.50
571055-7105596.15099.07
671785-7178597.138100.18
极限171648-7164896.952100.427.39100.54103.927.18
273861-7386199.947103.09
385195-85195115.284118.91
471634-7163496.933100.53
570726-7072695.70599.16
672217-7221797.722101.30
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%
110.482770852774282770322769952767582770600.09
210.532779382779052779220.01
单位质量响应值RSD%判断
26437.0226393.350.12数据可信
长期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%
5min1143504-14350448.74747.967.9448.7547.967.93
2140742-14074247.80947.81
3157649-15764953.55253.55
4135025-13502545.86745.87
5145967-14596749.58449.58
6124169-12416942.17942.18
10min1248939-24893984.56282.824.3484.8383.094.34
2231274-23127478.56278.83
3253109-25310985.97986.28
4256931-25693187.27787.53
5237938-23793880.82581.10
6234715-23471579.73179.96
15min1276196-27619693.82190.883.9994.5691.613.98
2255464-25546486.77987.48
3271193-27119392.12292.90
4282206-28220695.86396.60
5257844-25784487.58788.31
6262409-26240989.13889.82
20min1287696-28769697.72890.625.9898.9991.855.94
2266807-26680790.63291.82
3269368-26936891.50292.79
4278978-27897894.76696.04
5253146-25314685.99187.20
6244630-24463083.09984.27
30min1290585-29058598.70994.272.58100.5196.002.56
2271634-27163492.27293.96
3277808-27780894.36996.16
4273577-27357792.93294.73
5272043-27204392.41194.10
6279471-27947194.93496.57
45min1291267-29126798.94197.121.59101.2999.381.61
2283553-28355396.32098.52
3282689-28268996.02798.35
4292199-29219999.257101.57
5282443-28244395.94398.15
6283257-28325796.22098.38
60min1298843-298843101.51497.692.39104.42100.482.40
2284098-28409896.50699.24
3288144-28814497.880100.73
4291571-29157199.044101.91
5280273-28027395.20697.94
6282502-28250295.96398.66
极限1306546-306546104.131103.330.54107.60106.670.56
2304959-304959103.592106.86
3302059-302059102.607106.00
4304456-304456103.421106.84
5304476-304476103.428106.69
6302665-302665102.813106.04
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%
115.267328673236734417327173265733000.12
215.327316673189731780.03
单位质量响应值RSD%判断
4803.414776.630.40数据可信
长期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%
5min154998-5499874.44277.054.8774.4477.054.87
254407-5440773.64273.64
361949-6194983.85083.85
456396-5639676.33476.33
558053-5805378.57778.58
655732-5573275.43575.44
10min164609-6460987.45189.452.4787.8689.882.47
264337-6433787.08287.49
368552-6855292.78893.25
465483-6548388.63489.06
566240-6624089.65890.09
667316-6731691.11591.53
15min166343-6634389.79892.672.5790.7093.592.56
266553-6655390.08290.97
369279-6927993.77294.75
469022-6902293.42494.34
568627-6862792.88993.82
670967-7096796.05696.98
20min167900-6790091.90590.662.3193.3092.102.27
267389-6738991.21392.61
368285-6828592.42693.93
468175-6817592.27793.71
565590-6559088.77890.23
664563-6456387.38888.85
30min166973-6697390.65093.763.7892.5695.713.72
267227-6722790.99492.89
370734-7073495.74197.76
466758-6675890.35992.31
571071-7107196.19798.14
672875-7287598.639100.58
45min169793-6979394.46796.951.7396.8899.411.73
270517-7051795.44797.85
372891-7289198.661101.21
471625-7162596.94799.40
572564-7256498.218100.70
672357-7235797.938100.43
60min171050-7105096.16997.012.1599.11100.022.14
269323-6932393.83196.77
373469-7346999.443102.54
471153-7115396.30899.30
571830-7183097.224100.25
673202-7320299.081102.12
极限170482-7048295.40096.841.2698.87100.381.28
270417-7041795.31298.77
372437-7243798.046101.69
471599-7159996.912100.44
572042-7204297.511101.08
672311-7231197.875101.46
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