奥美沙坦酯片项目信息
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%
19.179762697770973819781397150975480.29
29.169853998868987040.24
单位质量响应值RSD%判断
10637.7310775.550.92数据可信
长期36月-供试品溶液-20201213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%
5min148134-4813450.47846.274.8250.4846.274.82
243633-4363345.75845.76
344591-4459146.76246.76
443401-4340145.51445.51
542203-4220344.25844.26
642771-4277144.85444.85
10min165027-6502768.19365.303.0068.4765.563.00
261064-6106464.03764.29
363533-6353366.62766.89
462643-6264365.69365.95
559818-5981862.73162.98
661517-6151764.51264.76
15min173772-7377277.36474.122.7878.0274.742.78
269127-6912772.49373.10
371240-7124074.70975.34
471695-7169575.18675.80
568397-6839771.72772.32
669847-6984773.24873.86
20min179564-7956483.43880.062.5884.5381.092.58
274999-7499978.65179.66
376542-7654280.26981.31
477513-7751381.28782.32
574259-7425977.87578.87
675182-7518278.84379.86
30min184456-8445688.56886.422.2690.1287.892.26
281293-8129385.25186.70
381556-8155685.52787.02
485074-8507489.21690.70
580792-8079284.72686.15
681258-8125885.21586.67
45min184077-8407788.17191.282.2490.2293.242.17
287609-8760991.87593.80
387518-8751891.77993.75
489655-8965594.02096.00
585589-8558989.75691.65
687798-8779892.07394.00
60min187227-8722791.47494.241.9194.0196.701.85
289219-8921993.56396.00
389853-8985394.22896.70
492186-9218696.67599.18
589538-8953893.89896.29
691173-9117395.61298.05
极限193176-9317697.71397.812.15100.76100.792.12
294107-9410798.689101.64
392462-9246296.96499.96
496696-96696101.404104.45
590804-9080495.22598.14
692345-9234596.84199.81
奥美沙坦酯片项目信息
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%
19.179782997896977299787297689978030.10
29.169854798574985600.02
单位质量响应值RSD%判断
10665.5410759.830.63数据可信
长期36月-供试品溶液-20201214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%
5min143679-4367945.77944.154.5245.7844.154.52
239302-3930241.19241.19
341359-4135943.34743.35
443772-4377245.87645.88
540849-4084942.81342.81
643798-4379845.90445.90
10min158739-5873961.56360.114.1561.8260.354.14
254869-5486957.50757.74
356637-5663759.36059.60
461149-6114964.08964.34
555089-5508957.73857.98
657615-5761560.38560.64
15min168050-6805071.32269.843.8371.9270.423.83
264708-6470867.81968.37
365963-6596369.13469.70
470617-7061774.01274.62
563434-6343466.48467.04
667034-6703470.25770.85
20min174259-7425977.82975.843.4078.8276.803.41
269960-6996073.32374.25
371559-7155974.99975.95
475594-7559479.22880.25
569405-6940572.74273.67
673363-7336376.89077.87
30min181159-8115985.06183.623.6786.4985.013.67
276776-7677680.46781.80
379758-7975883.59384.96
484448-8444888.50889.97
576616-7661680.29981.63
679949-7994983.79385.20
45min187523-8752391.73190.213.6393.6392.063.63
284097-8409788.14089.92
385599-8559989.71491.55
491622-9162296.02797.98
582982-8298286.97288.75
684584-8458488.65190.52
60min190789-9078995.15495.203.4097.5697.553.40
287268-8726891.46493.73
390585-9058594.94097.27
496287-96287100.916103.40
588658-8865892.92095.18
691385-9138595.77998.14
极限194955-9495599.52098.233.82102.46101.113.81
289482-8948293.78496.56
393223-9322397.705100.57
499300-99300104.074107.12
590349-9034994.69397.47
695011-9501199.579102.48
奥美沙坦酯片项目信息
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%
19.179665396872972739684596928969140.24
29.169809798295981960.15
单位质量响应值RSD%判断
10568.5910720.091.01数据可信
长期36月-供试品溶液-20201215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%
5min136979-3697939.00739.613.6739.0139.613.67
236880-3688038.90238.90
336520-3652038.52338.52
439904-3990442.09242.09
536502-3650238.50438.50
638544-3854440.65840.66
10min153144-5314456.05857.243.1656.2857.463.16
253710-5371056.65556.87
353316-5331656.24056.45
457562-5756260.71960.95
553195-5319556.11256.33
654648-5464857.64557.87
15min163088-6308866.54867.323.0767.0867.863.07
262580-6258066.01266.54
363144-6314466.60767.13
467512-6751271.21471.79
562201-6220165.61266.14
664402-6440267.93468.48
20min170602-7060274.47474.592.4875.3775.502.49
269828-6982873.65774.55
369805-6980573.63374.53
474088-7408878.15179.12
569181-6918172.97573.86
670768-7076874.64975.57
30min175658-7565879.80782.052.9381.1283.382.93
277206-7720681.44082.75
375959-7595980.12581.43
481553-8155386.02587.43
576873-7687381.08982.38
679441-7944183.79785.14
45min183958-8395888.56289.292.3990.3291.082.39
284666-8466689.30991.07
384109-8410988.72190.47
488443-8844393.29395.17
582390-8239086.90888.65
684345-8434588.97090.77
60min186798-8679891.55892.692.3693.8094.962.36
286602-8660291.35193.61
388379-8837993.22695.47
491601-9160196.62499.02
585777-8577790.48192.71
688046-8804692.87495.17
极限192495-9249597.56797.901.95100.32100.701.96
293295-9329598.411101.17
392405-9240597.472100.23
496078-96078101.347104.28
590754-9075495.73198.46
691857-9185796.89499.71
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