阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.221073211073701073931074791073741073870.06
210.321074051069301071680.32
单位质量响应值RSD%判断
10507.5310384.500.84数据可信
供试品溶液-2023111721批-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%
5min151053-5105343.85543.729.7343.8643.729.73
243919-4391937.72737.73
356212-5621248.28748.29
446208-4620839.69339.69
552497-5249745.09645.10
655473-5547347.65247.65
10min187111-8711174.83069.3212.2675.0769.5612.25
269815-6981559.97260.18
389262-8926276.67876.95
468967-6896759.24459.46
577837-7783766.86367.11
691197-9119778.34078.60
15min195842-9584282.33078.6211.4382.9979.2511.42
279996-7999668.71869.26
3101551-10155187.23487.93
479796-7979668.54669.10
588332-8833275.87976.50
6103630-10363089.02089.72
20min199545-9954585.51182.749.5486.6383.819.55
286582-8658274.37575.30
3106669-10666991.63192.81
488553-8855376.06977.00
589898-8989877.22478.27
6106691-10669191.64992.84
30min1101870-10187087.50886.727.5689.1088.257.60
291216-9121678.35679.69
3111999-11199996.20997.90
495555-9555582.08383.44
598139-9813984.30385.78
6106945-10694591.86893.57
45min1103579-10357988.97686.224.8991.0588.234.99
293649-9364980.44682.22
3106151-10615191.18693.41
497846-9784684.05185.86
596987-9698783.31485.25
6104025-10402589.35991.57
60min1102238-10223887.82487.035.1990.4089.515.27
295782-9578282.27884.50
3108782-10878293.44696.17
498705-9870584.78987.07
596495-9649582.89185.29
6105858-10585890.93493.64
极限1110750-11075095.13694.242.0898.2097.211.99
2108611-10861193.29995.98
3106535-10653591.51594.76
4112457-11245796.60399.35
5108261-10826192.99895.86
6111655-11165595.91499.13
阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.221074281072901072171072821072371072910.08
210.321073591073191073390.03
单位质量响应值RSD%判断
10498.1410401.070.66数据可信
供试品溶液-2023111721批-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%
5min147568-4756840.84743.566.2340.8543.566.23
250728-5072843.56143.56
350381-5038143.26343.26
456254-5625448.30648.31
551588-5158844.29944.30
647822-4782241.06541.07
10min196359-9635982.74574.626.8082.9774.866.78
288494-8849475.99176.23
381137-8113769.67369.91
490268-9026877.51477.78
582278-8227870.65370.90
682824-8282471.12271.35
15min1102840-10284088.31084.006.5389.0084.666.51
2102523-10252388.03888.70
390330-9033077.56778.19
4105174-10517490.31491.01
592512-9251279.44180.08
693576-9357680.35580.98
20min1106767-10676791.68286.976.7792.8688.106.72
2100792-10079286.55187.70
388382-8838275.89576.95
4103820-10382089.15190.35
5106899-10689991.79592.88
6101044-10104486.76887.84
30min1108246-10824692.95288.335.3394.6489.935.32
2104532-10453289.76391.40
393482-9348280.27481.75
4107649-10764992.43994.14
5103036-10303688.47890.07
6100209-10020986.05187.60
45min1107746-10774692.52390.764.7094.7392.864.70
2108894-10889493.50995.64
396625-9662582.97384.90
4110054-11005494.50596.71
5107335-10733592.17094.25
6103488-10348888.86690.90
60min1111374-11137495.63890.664.1298.3693.264.13
2107633-10763392.42695.08
398363-9836384.46586.85
4106676-10667691.60494.34
5103760-10376089.10091.69
6105672-10567290.74293.27
极限1112374-11237496.49794.951.4099.7598.051.43
2109056-10905693.64896.81
3110180-11018094.61397.47
4111260-11126095.54098.78
5111949-11194996.13299.22
6108613-10861393.26796.29
阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.221070661071771067551065571065011068110.29
210.321058021055901056960.15
单位质量响应值RSD%判断
10451.1710241.861.44数据可信
供试品溶液-2023111821批-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%
5min166117-6611757.34643.2820.7857.3543.2820.79
242832-4283237.15037.15
350911-5091144.15744.16
445032-4503239.05839.06
537613-3761332.62332.62
656889-5688949.34249.34
10min195216-9521682.58475.0915.6982.9075.3315.68
292638-9263880.34880.55
376580-7658066.42166.67
482234-8223471.32571.54
567800-6780058.80558.99
6105012-10501291.08191.35
15min1102577-10257788.96984.298.8089.7584.958.83
299918-9991886.66387.32
388759-8875976.98477.60
4103424-10342489.70390.32
584187-8418773.01973.53
6104253-10425390.42291.20
20min1106837-10683792.66487.145.6693.9488.275.74
2100574-10057487.23288.37
396284-9628483.51184.55
4103232-10323289.53790.65
591501-9150179.36280.28
6104383-10438390.53591.82
30min1108260-10826093.89891.232.5995.6892.842.70
2103341-10334189.63191.25
3104744-10474490.84892.35
4107051-10705192.84994.46
5100948-10094887.55688.91
6106788-10678892.62194.41
45min1108283-10828393.91891.912.2496.2394.032.24
2102920-10292089.26691.38
3106360-10636092.25094.26
4109040-10904094.57496.70
5104914-10491490.99692.84
6104301-10430190.46492.76
60min1110462-11046295.80892.801.9198.6495.431.90
2105022-10502291.08993.70
3105891-10589191.84394.37
4105760-10576091.73094.38
5108354-10835493.97996.33
6106504-10650492.37595.18
极限1110375-11037595.73293.591.6899.0996.731.70
2104835-10483590.92794.05
3107428-10742893.17696.21
4108525-10852594.12897.29
5108106-10810693.76496.63
6108160-10816093.81197.13
阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.221060201058111059451059781057591059030.11
210.321057921057361057640.04
单位质量响应值RSD%判断
10362.3310248.450.79数据可信
供试品溶液-2023111821批-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%
5min166533-6653357.93342.9919.0357.9342.9819.03
247590-4759041.43841.44
351294-5129444.66444.66
448730-4873042.43142.43
541232-4123235.90235.90
640822-4082235.54535.55
10min197366-9736684.78071.2310.6685.1071.4710.69
277916-7791667.84468.07
379185-7918568.94969.20
484172-8417273.29273.53
580860-8086070.40870.61
671339-7133962.11762.31
15min1100994-10099487.93980.116.6688.7380.756.69
286194-8619475.05275.66
389768-8976878.16478.80
497722-9772285.09085.73
591230-9123079.43780.03
686131-8613174.99775.54
20min1101304-10130488.20985.454.8289.4986.534.82
290232-9023278.56879.59
395240-9524082.92983.99
4103448-10344890.07691.19
599397-9939786.54987.58
699204-9920486.38087.34
30min1102144-10214488.94089.192.6790.7190.742.64
297514-9751484.90986.37
3101710-10171088.56390.09
4103967-10396790.52892.14
5104131-10413190.67192.18
6105115-10511591.52792.97
45min1104260-10426090.78389.621.5193.0591.671.54
2102553-10255389.29791.23
3100218-10021887.26389.28
4103529-10352990.14692.27
5104417-10441790.92092.94
6102574-10257489.31591.26
60min1105987-10598792.28790.642.8095.0693.182.81
2102755-10275589.47291.90
3103288-10328889.93792.44
4105362-10536291.74294.36
5107706-10770693.78396.31
699454-9945486.59889.04
极限1108760-10876094.70194.421.6297.9897.471.65
2107056-10705693.21896.14
3107065-10706593.22596.23
4110836-11083696.50999.64
5110135-11013595.89998.94
6106777-10677792.97595.90
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