奥美沙坦酯口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100864-202205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)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.221005431007541009021006491008451007390.15
29.201006481008111007300.12
单位质量响应值RSD%判断
10926.1410948.910.15数据可信
长期12月-供试品溶液-2024041311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%
5min172364-7236474.28371.763.3274.2871.763.32
271382-7138273.27573.27
371933-7193373.84073.84
468568-6856870.38670.39
568617-6861770.43670.44
666569-6656968.33468.33
10min183490-8349085.70484.873.3786.1285.263.36
287183-8718389.49489.90
381896-8189684.06784.48
479082-7908281.17981.57
583565-8356585.78186.17
680829-8082982.97283.35
15min188788-8878891.14291.301.2392.0392.171.23
290510-9051092.91093.81
388925-8892591.28392.16
489639-8963992.01692.86
587262-8726289.57690.44
688511-8851190.85891.70
20min191086-9108693.50193.002.5694.9094.382.54
293300-9330095.77497.19
391016-9101693.42994.81
489959-8995992.34493.70
591800-9180094.23495.60
686452-8645288.74490.09
30min191166-9116693.58393.421.9195.5095.311.90
293163-9316395.63397.59
390039-9003992.42694.33
492676-9267695.13397.00
590525-9052592.92594.81
688463-8846390.80892.65
45min189559-8955991.93392.501.2394.3794.921.23
292130-9213094.57397.06
390599-9059993.00195.42
489681-8968192.05994.45
589080-8908091.44293.85
689639-8963992.01694.36
60min191701-9170194.13292.292.0597.0895.222.02
292126-9212694.56997.58
387360-8736089.67692.61
490437-9043792.83595.74
588864-8886491.22094.13
688949-8894991.30794.16
极限187505-8750589.82590.702.5893.2994.142.53
291745-9174594.17797.71
390271-9027192.66496.10
485565-8556587.83491.26
586842-8684289.14492.56
688200-8820090.53893.90
奥美沙坦酯口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100864-202205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)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.221014441011391011831009221011161011610.19
29.201020661023791022220.22
单位质量响应值RSD%判断
10971.9111111.090.90数据可信
中间条件12月-供试品溶液-2024041311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%
5min171334-7133472.53968.733.1472.5468.733.13
267581-6758168.72268.72
365029-6502966.12766.13
467387-6738768.52568.52
566297-6629767.41667.42
667897-6789769.04469.04
10min185684-8568487.13182.373.5787.5382.753.57
280172-8017281.52681.91
376844-7684478.14278.51
482205-8220583.59383.97
580465-8046581.82482.20
680655-8065582.01782.40
15min191073-9107392.61187.023.4993.5087.863.49
285454-8545486.89787.73
382235-8223583.62484.43
485898-8589887.34888.19
584100-8410085.52086.35
684689-8468986.11986.96
20min194045-9404595.63389.573.8597.0390.893.84
287231-8723188.70490.02
383647-8364785.05986.33
488246-8824689.73691.07
586977-8697788.44689.75
688330-8833089.82291.14
30min192860-9286094.42889.253.2196.3691.073.22
288292-8829289.78391.59
384542-8454285.97087.71
487718-8771889.19991.03
586245-8624587.70189.50
686925-8692588.39390.21
45min191707-9170793.25689.222.7395.7191.542.74
286517-8651787.97890.29
384404-8440485.82988.05
487962-8796289.44791.77
587652-8765289.13291.41
688184-8818489.67391.98
60min191043-9104392.58087.853.0395.5690.663.04
286210-8621087.66690.46
382990-8299084.39187.08
486477-8647787.93790.76
585527-8552786.97189.75
686082-8608287.53690.34
极限189987-8998791.50787.173.3595.0090.473.35
285667-8566787.11490.40
381770-8177083.15186.31
487653-8765389.13392.44
583822-8382285.23788.50
685444-8544486.88790.18
奥美沙坦酯口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100864-202205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)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.221008831010891012831010061008271010180.18
29.201014751014931014840.02
单位质量响应值RSD%判断
10956.4011030.870.48数据可信
长期12月-供试品溶液-2024041311批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min140053-4005340.90640.992.2540.9140.992.25
239226-3922640.06140.06
339497-3949740.33840.34
440992-4099241.86441.86
541475-4147542.35842.36
639591-3959140.43440.43
10min158041-5804159.27658.032.6759.5058.262.66
256315-5631557.51457.74
355991-5599157.18357.41
458369-5836959.61159.84
557761-5776158.99059.23
654426-5442655.58455.81
15min164892-6489266.27366.633.6066.8367.183.59
266741-6674168.16268.70
364993-6499366.37666.92
466371-6637167.78468.35
567520-6752068.95769.52
660920-6092062.21762.75
20min172934-7293474.48673.092.1575.4174.012.14
270600-7060072.10373.02
372877-7287774.42875.34
472203-7220373.74074.68
571822-7182273.35174.30
668969-6896970.43771.32
30min176565-7656578.19578.542.7379.5379.872.72
277054-7705478.69480.02
378863-7886380.54281.87
477983-7798379.64380.99
578006-7800679.66681.02
672944-7294474.49775.77
45min184135-8413585.92682.922.6587.7084.682.63
280667-8066782.38484.14
381126-8112682.85384.62
481501-8150183.23685.03
582157-8215783.90685.70
677578-7757879.22980.91
60min187006-8700688.85886.334.3891.1188.564.32
283288-8328885.06187.28
388325-8832590.20592.44
484223-8422386.01688.27
586357-8635788.19590.46
677989-7798979.64981.77
极限187477-8747789.33990.471.8792.0893.171.85
290831-9083192.76495.45
388476-8847690.35993.09
490239-9023992.16094.89
587960-8796089.83292.58
686510-8651088.35190.92
奥美沙坦酯口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100864-202205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)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.221011281010631012251009531008051010350.17
29.201022071020571021320.11
单位质量响应值RSD%判断
10958.2411101.300.92数据可信
中间条件12月-供试品溶液-2024041311批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min138498-3849839.19039.893.2139.1939.893.21
237853-3785338.53338.53
340123-4012340.84440.84
440682-4068241.41341.41
537876-3787638.55738.56
640093-4009340.81340.81
10min157143-5714358.17057.761.7058.3957.981.70
256427-5642757.44157.66
357532-5753258.56658.79
456763-5676357.78358.01
554999-5499955.98756.20
657564-5756458.59858.83
15min164870-6487066.03667.331.9066.5867.881.89
266839-6683968.04068.57
367283-6728368.49269.04
466060-6606067.24767.80
564437-6443765.59566.12
667378-6737868.58969.14
20min170975-7097572.25072.731.5173.1673.641.51
270987-7098772.26373.17
373293-7329374.61075.54
471396-7139672.67973.60
570125-7012571.38572.27
671908-7190873.20074.13
30min177333-7733378.72379.361.4780.0380.681.48
278110-7811079.51480.83
379441-7944180.86982.22
477487-7748778.87980.21
576353-7635377.72579.01
679018-7901880.43881.78
45min182833-8283384.32183.762.4886.0785.522.46
282489-8248983.97185.73
381939-8193983.41185.21
483534-8353485.03586.80
578500-7850079.91181.63
684400-8440085.91787.70
60min185420-8542086.95586.802.4889.1789.032.44
286489-8648988.04390.26
383765-8376585.27087.53
485901-8590187.44589.68
582026-8202683.50085.66
688011-8801189.59391.86
极限187237-8723788.80588.581.5791.5091.291.57
287152-8715288.71891.43
386806-8680688.36691.10
488126-8812689.71092.43
584498-8449886.01688.64
688268-8826889.85492.62
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