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%
19.191016731016481024241023131019471020010.36
29.121016151017691016920.11
单位质量响应值RSD%判断
11099.1311150.440.33数据可信
中间条件6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%
5min170594-7059471.24669.082.4371.2569.082.43
266060-6606066.67066.67
369785-6978570.43070.43
467215-6721567.83667.84
568222-6822268.85268.85
668809-6880969.44569.44
10min189005-8900589.82786.543.3590.2286.923.35
281975-8197582.73283.10
388612-8861289.43189.82
483197-8319783.96684.34
586739-8673987.54087.92
684929-8492985.71486.10
15min193623-9362394.48891.903.6895.3892.763.68
286949-8694987.75288.58
395995-9599596.88297.77
488219-8821989.03489.88
590968-9096891.80892.68
690595-9059591.43292.29
20min195754-9575496.63993.943.7198.0695.323.70
289979-8997990.81092.13
396303-9630397.19398.62
487766-8776688.57789.91
594978-9497895.85597.23
693706-9370694.57295.94
30min194115-9411594.98493.012.6196.9494.902.63
289376-8937690.20292.02
395350-9535096.23198.20
489778-8977890.60792.44
593018-9301893.87795.79
691298-9129892.14194.04
45min194812-9481295.68892.993.5398.1795.403.52
287807-8780788.61890.94
396197-9619797.08699.59
488959-8895989.78192.11
592701-9270193.55795.99
692352-9235293.20595.61
60min192449-9244993.30392.492.7796.3295.432.78
288977-8897789.79992.61
394988-9498895.86698.91
488338-8833889.15491.99
593055-9305593.91596.87
692080-9208092.93195.86
极限190184-9018491.01790.562.8094.5594.002.80
286811-8681187.61390.93
393769-9376994.63598.21
487298-8729888.10491.43
590290-9029091.12494.60
690033-9003390.86594.31
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%
19.191013141014011015001012911009791012970.20
29.121023361015381019370.56
单位质量响应值RSD%判断
11022.5211177.300.99数据可信
中间条件6月-供试品溶液-2024041311批-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min139424-3942439.87940.772.6239.8840.772.62
238885-3888539.33439.33
340644-4064441.11341.11
441868-4186842.35142.35
540772-4077241.24341.24
640233-4023340.69740.70
10min154913-5491355.54758.623.2255.7758.843.22
256607-5660757.26057.48
358773-5877359.45159.68
459693-5969360.38260.62
559553-5955360.24060.47
658144-5814458.81559.04
15min162553-6255363.27567.304.4363.8167.854.41
264146-6414664.88665.42
366539-6653967.30767.87
470848-7084871.66672.24
568282-6828269.07069.63
666797-6679767.56868.12
20min167982-6798268.76773.083.7169.6574.013.70
270951-7095171.77072.67
371864-7186472.69473.63
475824-7582476.69977.67
573733-7373374.58475.53
673149-7314973.99374.92
30min173714-7371474.56579.863.9475.8381.203.93
278194-7819479.09780.39
378935-7893579.84681.18
483013-8301383.97185.37
580904-8090481.83883.20
678959-7895979.87081.21
45min177347-7734778.24084.684.4179.9286.464.39
282236-8223683.18584.92
383507-8350784.47186.25
486856-8685687.85989.72
587426-8742688.43590.25
684937-8493785.91787.70
60min179826-7982680.74786.374.6382.8688.624.60
282506-8250683.45885.66
385016-8501685.99788.25
490188-9018891.22993.58
589320-8932090.35192.66
685456-8545686.44288.70
极限183784-8378484.75188.933.1887.3191.663.20
286645-8664587.64590.31
388030-8803089.04691.77
491436-9143692.49195.35
590596-9059691.64294.45
687029-8702988.03490.77
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%
19.191006561010671013501010561009751010210.25
29.121008021013991011000.42
单位质量响应值RSD%判断
10992.4911085.530.60数据可信
长期6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%
5min168894-6889470.07271.842.4970.0771.842.49
268536-6853669.70769.71
371695-7169572.92072.92
473026-7302674.27474.27
570079-7007971.27771.28
671563-7156372.78672.79
10min184597-8459786.04386.282.4986.4386.682.48
282978-8297884.39684.78
383180-8318084.60285.01
488551-8855190.06590.48
583809-8380985.24285.64
685861-8586187.32987.73
15min189268-8926890.79491.742.2391.6692.622.23
288925-8892590.44591.30
389287-8928790.81391.69
493677-9367795.27896.19
588471-8847189.98390.85
691547-9154793.11294.00
20min189035-8903590.55792.232.3191.9393.622.31
289694-8969491.22792.59
389688-8968891.22192.60
493127-9312794.71996.16
588970-8897090.49191.86
693562-9356295.16196.57
30min189985-8998591.52390.461.5093.4092.361.48
287875-8787589.37791.24
389129-8912990.65292.54
487914-8791489.41791.39
587744-8774489.24491.12
690971-9097192.52694.46
45min187501-8750188.99790.852.5291.3893.262.49
288306-8830689.81592.18
387004-8700488.49190.88
492936-9293694.52596.99
589347-8934790.87493.24
690860-9086092.41394.86
60min187803-8780389.30490.132.0592.1893.032.04
287771-8777189.27192.13
387651-8765189.14992.03
491455-9145593.01896.01
586762-8676288.24591.12
690226-9022691.76894.73
极限188771-8877190.28889.862.3593.6693.272.32
288005-8800589.50992.87
385581-8558187.04490.42
491229-9122992.78896.30
586647-8664788.12891.49
689885-8988591.42194.89
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%
19.191004931014401014831017001013221012880.46
29.121020721026611023660.41
单位质量响应值RSD%判断
11021.5511224.341.29数据可信
长期6月-供试品溶液-2024041311批-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min138841-3884139.20940.382.3439.2140.382.34
241560-4156041.95441.95
339292-3929239.66539.66
440013-4001340.39240.39
540269-4026940.65140.65
640047-4004740.42740.43
10min157955-5795558.50558.211.6758.7258.441.67
259151-5915159.71259.95
357297-5729757.84058.06
456646-5664657.18357.41
556730-5673057.26857.49
658203-5820358.75558.98
15min165745-6574566.36967.042.4066.9167.592.38
267711-6771168.35368.92
364790-6479065.40465.95
464493-6449365.10565.65
567833-6783368.47669.02
667878-6787868.52269.07
20min170809-7080971.48172.212.0072.3973.132.00
274148-7414874.85175.80
371009-7100971.68272.59
470073-7007370.73871.64
571128-7112871.80372.73
672017-7201772.70073.63
30min175626-7562676.34376.563.0577.6577.883.01
278112-7811278.85380.21
377432-7743278.16679.47
473886-7388674.58775.88
572396-7239673.08374.41
677620-7762078.35679.69
45min182364-8236483.14582.493.1084.8884.243.07
284991-8499185.79787.60
381119-8111981.88883.63
477287-7728778.02079.73
582603-8260383.38685.12
681919-8191982.69684.47
60min183871-8387184.66684.642.4686.8686.842.43
285578-8557886.39088.66
385673-8567386.48688.68
480017-8001780.77682.92
584212-8421285.01187.20
683696-8369684.49086.72
极限187404-8740488.23387.212.1690.9089.892.15
288304-8830489.14191.90
385696-8569686.50989.18
482996-8299683.78386.38
587045-8704587.87190.54
686923-8692387.74790.45
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%
19.191014171020531022671020061020241019530.32
29.121019571026461023020.48
单位质量响应值RSD%判断
11093.9111217.320.79数据可信
加速6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%
5min155787-5578756.14858.392.7056.1558.392.70
257850-5785058.22558.22
357521-5752157.89357.89
457321-5732157.69257.69
559908-5990860.29660.30
659719-5971960.10660.11
10min175004-7500475.49078.252.5375.8078.582.53
278011-7801178.51678.84
376715-7671577.21277.53
476921-7692177.41977.74
579473-7947379.98880.32
680381-8038180.90181.24
15min181465-8146581.99284.892.5282.7285.642.52
285222-8522285.77486.53
384584-8458485.13285.88
483496-8349684.03784.79
583468-8346884.00884.79
687804-8780488.37289.16
20min184563-8456385.11187.542.0486.3088.772.04
288622-8862289.19690.43
386973-8697387.53688.76
485543-8554386.09787.31
586957-8695787.52088.77
689216-8921689.79491.07
30min184178-8417884.72388.533.0086.3890.242.99
290032-9003290.61592.35
387978-8797888.54890.26
486806-8680687.36889.06
587049-8704987.61389.34
691702-9170292.29694.07
45min184835-8483585.38488.042.3087.5190.252.30
288778-8877889.35391.59
388646-8864689.22091.42
485409-8540985.96288.14
587278-8727887.84390.06
689902-8990290.48492.77
60min183950-8395084.49487.602.7387.1090.302.72
288681-8868189.25591.99
387097-8709787.66190.36
485493-8549386.04788.71
586361-8636186.92089.63
690653-9065391.24094.03
极限184691-8469185.23988.822.5988.3192.002.58
289395-8939589.97493.20
388503-8850389.07692.26
486684-8668487.24590.38
588975-8897589.55192.74
691256-9125691.84795.14
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%
19.191015161021021020351021301017781019120.26
29.121017711027151022430.66
单位质量响应值RSD%判断
11089.4511210.860.77数据可信
加速6月-供试品溶液-2024041311批-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min136399-3639936.65337.383.1636.6537.383.15
236936-3693637.19337.19
336198-3619836.45036.45
438119-3811938.38538.38
538977-3897739.24939.25
636125-3612536.37736.38
10min154372-5437254.75155.271.7654.9555.471.76
254111-5411154.48854.69
355020-5502055.40355.61
455443-5544355.82956.04
556458-5645856.85157.07
653905-5390554.28154.48
15min162948-6294863.38764.572.5463.8965.082.54
262784-6278463.22163.73
364024-6402464.47064.98
465010-6501065.46365.99
566957-6695767.42367.96
663015-6301563.45463.96
20min168813-6881369.29270.002.5170.1570.882.50
267996-6799668.47069.33
370641-7064171.13372.00
470533-7053371.02471.91
571797-7179772.29773.21
667322-6732267.79168.65
30min173269-7326973.77976.993.7075.0278.253.68
275630-7563076.15777.40
378905-7890579.45580.72
477320-7732077.85979.14
580143-8014380.70182.01
673490-7349074.00275.23
45min179205-7920579.75782.562.4481.4184.262.44
282408-8240882.98284.65
382378-8237882.95284.66
482447-8244783.02184.74
585048-8504885.64187.40
680463-8046381.02482.67
60min182994-8299483.57285.672.0485.6787.822.04
284354-8435484.94287.07
385951-8595186.55088.72
485091-8509185.68487.86
587964-8796488.57790.81
684087-8408784.67386.77
极限187658-8765888.26989.361.4390.8391.981.46
288702-8870289.32091.92
389030-8903089.65092.30
489518-8951890.14292.79
590523-9052391.15493.88
687013-8701387.61990.18
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