坎地沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.187198572087718437191671860719380.14
215.207303673577733060.53
单位质量响应值RSD%判断
4739.004822.761.24数据可信
中间条件24月-供试品溶液-2023022721批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17006-70068.22711.7525.598.2311.7525.60
210004-1000411.74811.75
310742-1074212.61412.61
414192-1419216.66616.67
57657-76578.9928.99
610416-1041612.23112.23
10min128183-2818333.09537.2912.6433.1137.3212.65
228678-2867833.67733.70
331694-3169437.21837.24
438804-3880445.56745.60
529530-2953034.67734.69
633664-3366439.53239.55
15min145307-4530753.20456.546.0153.2756.626.02
247358-4735855.61255.69
347299-4729955.54355.63
453611-5361162.95563.06
546656-4665654.78854.86
648651-4865157.13157.22
20min155136-5513664.74668.394.3564.9068.574.37
258653-5865368.87669.04
357800-5780067.87468.05
462691-6269173.61873.83
556754-5675466.64666.81
658409-5840968.59068.77
30min167233-6723378.95281.712.6879.2282.002.70
269510-6951081.62581.91
369234-6923481.30181.59
472935-7293585.64785.98
568913-6891380.92481.20
669678-6967881.82382.12
45min176418-7641889.73891.961.6490.1392.381.66
277605-7760591.13191.55
378683-7868392.39792.82
479307-7930793.13093.60
577867-7786791.43991.85
679983-7998393.92494.36
60min177977-7797791.56895.252.3392.1195.832.33
282815-8281597.25097.82
382105-8210596.41696.99
481681-8168195.91896.55
582420-8242096.78697.35
679681-7968193.56994.16
极限180687-8068794.75197.341.7595.4598.081.75
284216-8421698.89599.63
384046-8404698.69599.43
483185-8318597.68498.47
583687-8368798.27499.00
681556-8155695.77196.52
坎地沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.187652475248764497607076431761440.70
215.207522274461748420.72
单位质量响应值RSD%判断
5016.074923.821.32数据可信
中间条件24月-供试品溶液-2023022721批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110632-1063212.01012.1915.7612.0112.2015.76
29999-999911.29511.30
310380-1038011.72611.73
411165-1116512.61212.61
58745-87459.8799.88
613843-1384315.63815.64
10min134878-3487839.39939.789.9939.4239.809.99
232424-3242436.62736.65
334043-3404338.45638.48
438255-3825543.21443.24
531228-3122835.27635.29
640447-4044745.69045.72
15min151596-5159658.28558.725.4758.3758.815.48
249248-4924855.63255.71
350969-5096957.57657.66
454829-5482961.93762.03
549249-4924955.63355.71
655999-5599963.25963.36
20min162071-6207170.11869.843.7370.3070.023.74
259665-5966567.40067.57
361061-6106168.97769.16
463006-6300671.17471.37
559498-5949867.21167.38
665627-6562774.13574.34
30min172775-7277582.20982.121.5182.5182.431.52
271563-7156380.84081.13
373264-7326482.76283.06
472653-7265382.07282.39
571524-7152480.79681.08
674419-7441984.06684.40
45min179636-7963689.96089.471.3690.4089.911.38
278648-7864888.84489.26
379959-7995990.32590.76
479243-7924389.51689.97
577374-7737487.40587.82
680378-8037890.79891.27
60min181276-8127691.81291.910.9892.4092.490.98
281679-8167992.26892.84
382230-8223092.89093.47
480474-8047490.90691.51
580391-8039190.81391.37
682103-8210392.74793.37
极限182427-8242793.11392.421.9493.8593.161.92
284207-8420795.12395.84
381888-8188892.50493.24
480652-8065291.10791.86
579587-7958789.90490.62
682102-8210292.74593.52
坎地沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.187439073612743897480673921742240.63
215.207376273481736220.27
单位质量响应值RSD%判断
4889.594843.550.67数据可信
中间条件24月-供试品溶液-2023022821批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min111377-1137713.12414.0825.2913.1214.0825.31
212941-1294114.92814.93
311558-1155813.33313.33
411099-1109912.80312.80
58491-84919.7959.79
617769-1776920.49820.50
10min132236-3223637.18639.5814.2737.2139.6114.27
230473-3047335.15235.18
334355-3435539.63139.65
434429-3442939.71639.74
530714-3071435.43035.45
643677-4367750.38450.42
15min149152-4915256.70057.787.5156.7857.867.52
247153-4715354.39454.48
348814-4881456.31056.40
449347-4934756.92557.01
548451-4845155.89155.97
657592-5759266.43666.55
20min162561-6256172.16871.054.6372.3571.234.64
259533-5953368.67568.85
361102-6110270.48570.67
461104-6110470.48770.67
558566-5856667.55967.73
666666-6666676.90377.13
30min172340-7234083.44884.133.5383.7584.433.55
271418-7141882.38582.67
372781-7278183.95784.26
470546-7054681.37981.68
572588-7258883.73584.02
677897-7789789.85990.22
45min181822-8182294.38692.462.3394.8292.902.34
278851-7885190.95991.39
379264-7926491.43691.88
478127-7812790.12490.56
579870-7987092.13592.56
682964-8296495.70496.21
60min182186-8218694.80694.101.5095.4094.701.52
281201-8120193.67094.25
379954-7995492.23292.82
481456-8145693.96494.55
581056-8105693.50394.08
683570-8357096.40397.07
极限185026-8502698.08297.102.2698.8497.852.24
286837-86837100.172100.91
385338-8533898.44299.19
481850-8185094.41995.16
582410-8241095.06595.79
683571-8357196.40497.23
坎地沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.187542374234742697456875121747230.71
215.207375573960738580.20
单位质量响应值RSD%判断
4922.464859.080.92数据可信
中间条件24月-供试品溶液-2023022821批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min114957-1495717.16912.3522.7517.1712.3622.76
210355-1035511.88611.89
312341-1234114.16614.17
48888-888810.20210.20
59243-924310.61010.61
68790-879010.09010.09
10min137864-3786443.46339.875.3843.4939.895.38
233724-3372438.71138.73
333013-3301337.89537.92
435599-3559940.86340.88
533078-3307837.96937.99
635136-3513640.33240.35
15min151801-5180159.46158.222.2659.5658.312.26
251419-5141959.02259.11
350676-5067658.17058.26
451099-5109958.65558.74
548549-4854955.72855.81
650801-5080158.31358.40
20min161239-6123970.29569.301.8970.4969.481.89
260823-6082369.81770.00
359669-5966968.49268.68
461233-6123370.28870.47
558367-5836766.99867.17
660882-6088269.88570.07
30min171285-7128581.82681.461.2282.1481.761.22
272222-7222282.90283.20
370710-7071081.16681.46
470630-7063081.07481.37
569654-6965479.95480.24
671294-7129481.83682.13
45min177622-7762289.10089.221.3589.5589.651.34
278865-7886590.52790.96
377918-7791889.44089.87
476564-7656487.88688.32
578873-7887390.53690.95
676510-7651087.82488.26
60min179586-7958691.35593.881.9291.9694.461.91
282481-8248194.67895.27
384267-8426796.72897.31
481903-8190394.01494.60
581545-8154593.60394.17
680925-8092592.89293.47
极限181413-8141393.45292.591.3194.2193.331.30
282097-8209794.23794.98
380766-8076692.70993.45
479592-7959291.36292.10
580780-8078092.72593.45
679344-7934491.07791.81
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