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%
110.562864342865322865072865122864962864960.02
210.622864032864332864180.01
单位质量响应值RSD%判断
27130.3026969.680.42数据可信
加速3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%
5min161385-6138520.36329.0332.2020.3629.0232.20
2113311-11331137.58837.59
3107525-10752535.66835.67
496740-9674032.09132.09
5102291-10229133.93233.93
643745-4374514.51114.51
10min1204745-20474567.91875.3711.4968.0375.5211.53
2255859-25585984.87485.08
3237649-23764978.83379.03
4247037-24703781.94882.13
5230272-23027276.38676.57
6187607-18760762.23362.31
15min1244871-24487181.22985.946.8981.7286.526.95
2280334-28033492.99393.67
3259462-25946286.06986.71
4274717-27471791.13091.76
5262093-26209386.94287.55
6232957-23295777.27777.70
20min1255570-25557084.77888.394.9685.7289.445.05
2284417-28441794.34795.54
3264726-26472687.81588.93
4276255-27625591.64092.78
5269289-26928989.32990.42
6248426-24842682.40883.26
30min1270812-27081289.83490.453.9891.2592.004.06
2287338-28733895.31697.04
3268337-26833789.01390.62
4279886-27988692.84494.49
5274210-27421090.96292.55
6255490-25549084.75286.07
45min1282149-28214993.59592.343.0795.5194.393.14
2287143-28714395.25297.50
3271182-27118289.95792.05
4282549-28254993.72895.89
5282466-28246693.70095.80
6264671-26467187.79789.58
60min1280177-28017792.94192.842.4895.3795.412.52
2290590-29059096.39599.17
3269952-26995289.54992.15
4283320-28332093.98396.67
5279239-27923992.63095.25
6276011-27601191.55993.83
极限1289101-28910195.90195.311.9298.8598.391.73
2283055-28305593.89697.21
3279347-27934792.66695.76
4287655-28765595.42298.63
5289760-28976096.12099.25
6295079-29507997.884100.66
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%
114.837154771550715907150171615715610.07
214.957149271583715380.09
单位质量响应值RSD%判断
4825.424785.150.60数据可信
加速3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%
5min143734-4373459.00864.9514.5859.0164.9514.58
252857-5285771.31771.32
349082-4908266.22466.22
450057-5005767.53967.54
556425-5642576.13176.13
636680-3668049.49049.49
10min161013-6101382.32283.914.0782.6584.284.11
262115-6211583.80984.20
364881-6488187.54187.91
461786-6178683.36583.74
565047-6504787.76588.19
658319-5831978.68778.96
15min164723-6472387.32788.473.0888.1189.293.12
265395-6539588.23489.10
367944-6794491.67392.53
465208-6520887.98288.82
567648-6764891.27492.18
662488-6248884.31285.02
20min165523-6552388.40790.164.1289.6891.484.13
264197-6419786.61887.97
369078-6907893.20394.57
466700-6670089.99591.32
571077-7107795.90197.32
664363-6436386.84288.02
30min166857-6685790.20791.823.6591.9793.643.68
266685-6668589.97591.81
369550-6955093.84095.72
468177-6817791.98893.81
572044-7204497.20599.16
664994-6499487.69389.36
45min169556-6955693.84893.513.9996.1195.844.00
268369-6836992.24794.58
370248-7024894.78297.18
468006-6800691.75794.10
573946-7394699.772102.26
665690-6569088.63290.78
60min168698-6869892.69193.543.1695.4796.393.20
269186-6918693.34996.19
369781-6978194.15297.08
468825-6882592.86295.71
573101-7310198.631101.68
666366-6636689.54492.19
极限169999-6999994.44694.883.1597.7498.253.17
268180-6818091.99295.36
370577-7057795.22698.68
469702-6970294.04597.41
574505-74505100.526104.12
668951-6895193.03296.17
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%
110.562868802869292869892866492870162868930.06
210.622856982857572857280.02
单位质量响应值RSD%判断
27167.9026904.710.69数据可信
加速3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%
5min1126523-12652341.99243.6514.8941.9943.6514.89
2144139-14413947.83947.84
3136380-13638045.26445.26
4134551-13455144.65744.66
5151894-15189450.41350.41
695689-9568931.75931.76
10min1232991-23299177.32983.849.6477.5684.089.60
2239996-23999679.65379.92
3222367-22236773.80274.05
4262013-26201386.96187.21
5280725-28072593.17193.45
6277576-27757692.12692.30
15min1256050-25605084.98289.298.0785.6490.008.05
2259517-25951786.13286.84
3236330-23633078.43779.10
4285179-28517994.64995.38
5287566-28756695.44296.24
6289582-28958296.11196.80
20min1265952-26595288.26891.146.4289.4092.356.42
2269190-26919089.34390.53
3245874-24587481.60482.70
4286644-28664495.13696.39
5290400-29040096.38297.71
6289653-28965396.13497.36
30min1272620-27262090.48192.666.8192.1194.376.79
2275751-27575191.52093.20
3246125-24612581.68883.24
4290632-29063296.45998.24
5291641-29164196.79498.66
6298403-29840399.038100.79
45min1277601-27760192.13492.904.8094.2695.134.83
2274205-27420591.00793.20
3257112-25711285.33487.34
4286621-28662195.12897.45
5290076-29007696.27598.68
6293833-29383397.52299.83
60min1275198-27519891.33792.975.0693.9895.725.08
2277325-27732592.04394.74
3255587-25558784.82887.31
4287879-28787995.54698.40
5290598-29059896.44899.38
6294164-29416497.632100.48
极限1286305-28630595.02394.611.0198.1797.871.12
2283629-28362994.13597.34
3280575-28057593.12196.07
4289139-28913995.96499.34
5285750-28575094.83998.31
6285028-28502894.59997.99
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%
114.837154671521716427158171565715710.07
214.957129571347713210.06
单位质量响应值RSD%判断
4826.104770.640.82数据可信
加速3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%
5min155877-5587775.50269.8419.4075.5069.8419.40
258515-5851579.06679.07
356648-5664876.54476.54
448360-4836065.34565.34
558068-5806878.46278.46
632662-3266244.13344.13
10min166550-6655089.92384.1614.3090.3484.5514.32
269565-6956593.99794.44
363478-6347885.77286.20
458952-5895279.65780.02
569155-6915593.44393.88
645997-4599762.15262.40
15min168957-6895793.17687.5312.5694.0988.3912.59
270435-7043595.17396.13
365723-6572388.80689.71
463557-6355785.87986.68
570807-7080795.67696.63
649207-4920766.48967.08
20min171069-7106996.03089.7611.4997.4791.1011.54
271397-7139796.47397.96
367660-6766091.42392.82
464484-6448487.13288.41
571985-7198597.26798.75
651984-5198470.24271.20
30min169972-6997294.54791.818.1996.5293.668.31
271285-7128596.32198.35
367896-6789691.74293.65
466808-6680890.27292.04
573918-7391899.879101.91
657816-5781678.12279.47
45min172881-7288198.47894.695.27100.9797.045.42
272374-7237497.793100.35
371254-7125496.28098.69
466251-6625189.51991.79
573093-7309398.764101.35
664624-6462487.32189.11
60min172192-7219297.54795.833.66100.5998.713.81
273317-7331799.067102.17
370995-7099595.93098.88
466993-6699390.52293.29
573352-7335299.114102.24
668696-6869692.82395.09
极限173847-7384799.78398.911.22103.37102.321.34
274149-74149100.191103.85
372219-7221997.583101.06
473994-7399499.982103.25
572673-7267398.197101.88
672333-7233397.737100.52
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%
110.562861132860642865192861802859592861670.08
210.622856692856872856780.01
单位质量响应值RSD%判断
27099.1526900.000.53数据可信
加速3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%
5min1167868-16786855.79050.4620.7855.7950.4620.79
2170076-17007656.52456.52
3100715-10071533.47233.47
4132606-13260644.07144.07
5150518-15051850.02450.02
6189287-18928762.90862.91
10min1278637-27863792.60384.438.3592.9184.718.38
2274888-27488891.35791.67
3226279-22627975.20275.39
4234974-23497478.09278.34
5248632-24863282.63182.91
6260820-26082086.68287.03
15min1298258-29825899.12491.966.8299.9592.706.86
2295414-29541498.17999.00
3249944-24994483.06783.67
4261645-26164586.95687.63
5274250-27425091.14591.88
6280614-28061493.26094.09
20min1291855-29185596.99693.245.1798.3794.505.23
2296410-29641098.51099.88
3258670-25867085.96787.03
4267726-26772688.97790.14
5284399-28439994.51895.76
6284248-28424894.46895.82
30min1290749-29074996.62895.053.8498.5496.833.92
2301127-301127100.077101.99
3270849-27084990.01591.56
4276000-27600091.72793.38
5286763-28676395.30497.07
6290576-29057696.57198.44
45min1291777-29177796.97094.683.5199.4296.993.59
2297886-29788699.000101.47
3271399-27139990.19892.24
4275220-27522091.46793.63
5287096-28709695.41497.71
6286012-28601295.05497.46
60min1289832-28983296.32495.343.4499.3198.173.51
2301124-301124100.076103.10
3276719-27671991.96694.51
4274689-27468991.29193.96
5291423-29142396.85299.68
6287440-28744095.52998.47
极限1292037-29203797.05697.881.71100.58101.241.81
2300833-30083399.980103.56
3286939-28693995.36298.42
4292471-29247197.201100.38
5298204-29820499.106102.47
6296628-29662898.582102.05
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%
114.837137771260713737134271360713420.07
214.957118271298712400.12
单位质量响应值RSD%判断
4810.654765.220.68数据可信
加速3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%
5min157414-5741477.74780.958.2577.7580.958.25
262470-6247084.59384.59
350994-5099469.05369.05
460465-6046581.87881.88
564273-6427387.03587.03
663057-6305785.38885.39
10min166837-6683790.50793.042.5390.9493.482.55
270179-7017995.03295.50
366688-6668890.30590.69
468322-6832292.51892.97
570882-7088295.98496.47
669317-6931793.86594.34
15min170582-7058295.57896.882.7696.5197.852.78
272524-7252498.20899.21
368138-6813892.26993.15
471652-7165297.02798.00
573708-7370899.811100.83
672654-7265498.38499.38
20min170077-7007794.89497.153.3296.3698.653.33
272602-7260298.31499.86
367913-6791391.96493.36
472472-7247298.13899.65
574676-74676101.122102.69
672695-7269598.44099.98
30min170703-7070395.74299.392.6897.73101.432.70
273744-7374499.860101.95
371323-7132396.58298.49
474388-74388100.732102.79
575713-75713102.526104.66
674503-74503100.888102.98
45min171205-7120596.42299.742.2298.95102.342.25
274358-74358100.691103.34
372407-7240798.050100.49
474328-74328100.651103.26
575851-75851102.713105.42
673775-7377599.902102.55
60min170738-7073895.789100.102.4698.85103.252.46
275261-75261101.914105.12
373543-7354399.588102.58
474159-74159100.422103.59
575994-75994102.907106.18
673837-7383799.986103.19
极限172329-7232997.944100.401.72101.54104.101.75
274546-74546100.946104.72
373683-7368399.777103.32
474029-74029100.246103.98
576239-76239103.239107.08
674019-74019100.232103.99
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%
110.562863702867902865882866982861212865130.10
210.622867892868612868250.02
单位质量响应值RSD%判断
27131.9127008.000.33数据可信
加速3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%
5min156999-5699918.89440.8527.9918.8940.8528.00
2130879-13087943.38343.38
3134990-13499044.74644.75
4158924-15892452.68052.68
5125052-12505241.45241.45
6132639-13263943.96743.97
10min1213971-21397170.92678.717.4171.0378.947.44
2231508-23150876.73976.98
3250087-25008782.89883.15
4239478-23947879.38179.67
5226281-22628175.00775.24
6263366-26336687.30087.54
15min1250130-25013082.91286.745.9583.4187.415.97
2251337-25133783.31283.98
3267294-26729488.60289.31
4262485-26248587.00887.74
5249238-24923882.61683.26
6289675-28967596.02096.75
20min1263091-26309187.20889.294.8288.1790.444.83
2260819-26081986.45587.59
3276201-27620191.55492.76
4263757-26375787.42988.65
5259513-25951386.02287.13
6292884-29288497.08498.35
30min1275595-27559591.35391.162.7392.8092.802.76
2271120-27112089.87091.48
3281243-28124393.22594.94
4273638-27363890.70492.41
5263640-26364087.39088.97
6284758-28475894.39196.19
45min1287500-28750095.29991.364.1097.2593.514.02
2272884-27288490.45592.56
3283264-28326493.89596.12
4268327-26832788.94491.15
5258002-25800285.52287.59
6283758-28375894.05996.39
60min1305130-305130101.14397.493.11103.62100.143.06
2286056-28605694.82197.43
3294482-29448297.614100.36
4289299-28929995.89698.60
5284710-28471094.37596.92
6304982-304982101.094103.94
极限1303728-303728100.67999.341.62103.72102.541.64
2298174-29817498.838101.98
3301241-30124199.854103.15
4301850-301850100.056103.29
5290560-29056096.31499.38
6302599-302599100.304103.72
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%
114.837158671665716527157871415715790.14
214.957165971714716860.06
单位质量响应值RSD%判断
4826.644795.050.47数据可信
加速3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%
5min139767-3976753.59369.0211.4253.5969.0211.43
251774-5177469.77569.77
352277-5227770.45370.45
456056-5605675.54675.55
552573-5257370.85270.85
654849-5484973.91973.92
10min163432-6343285.48684.001.6885.7884.381.65
261579-6157982.98983.38
362129-6212983.73084.12
461621-6162183.04583.47
561387-6138782.73083.12
663830-6383086.02286.43
15min167119-6711990.45587.482.6091.2388.342.56
263125-6312585.07285.92
364564-6456487.01287.87
464581-6458187.03587.92
563335-6333585.35586.21
666757-6675789.96790.86
20min168995-6899592.98388.992.9794.2690.332.91
264612-6461287.07688.40
365728-6572888.58089.92
464560-6456087.00688.37
564409-6440986.80388.13
667886-6788691.48992.88
30min169630-6963093.83990.592.1295.6392.422.07
267105-6710590.43692.24
367288-6728890.68392.51
467099-6709990.42892.28
565154-6515487.80789.62
667046-6704690.35792.25
45min170685-7068595.26190.673.1997.5793.013.11
267123-6712390.46092.77
368251-6825191.98194.32
465911-6591188.82791.18
564358-6435886.73489.03
667356-6735690.77493.17
60min174757-74757100.74996.952.20103.5999.792.16
270659-7065995.22698.04
371533-7153396.40499.25
470792-7079295.40598.25
571111-7111195.83598.61
672794-7279498.103101.01
极限176284-76284102.80698.712.57106.21102.092.52
272873-7287398.210101.55
373217-7321798.673102.06
472370-7237097.532100.91
570632-7063295.18998.50
674111-7411199.878103.33
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