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%
1 9.039821998216982329822196641979060.73
2 9.201015201018111016660.21
单位质量响应值RSD%判断
10842.3011050.651.35数据可信
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%
5min144288-4428845.42944.293.8245.4344.293.82
240939-4093941.99441.99
344378-4437845.52145.52
444669-4466945.82045.82
541294-4129442.35842.36
643518-4351844.63944.64
10min160254-6025461.80662.401.8862.0662.651.88
259702-5970261.24061.47
362313-6231363.91964.17
462003-6200363.60163.86
559706-5970661.24461.48
661025-6102562.59762.85
15min168649-6864970.41871.872.8071.0172.462.79
269071-6907170.85171.42
371746-7174673.59574.20
472746-7274674.62075.23
567637-6763769.38069.96
670544-7054472.36272.96
20min176102-7610278.06377.052.4179.0578.042.40
273957-7395775.86376.83
374813-7481376.74177.76
476209-7620978.17379.19
572313-7231374.17675.14
677308-7730879.30080.30
30min182776-8277684.90985.363.2986.3386.783.27
280808-8080882.89084.28
384396-8439686.57088.01
485139-8513987.33388.79
579478-7947881.52682.90
686727-8672788.96290.40
45min187449-8744989.70290.222.7491.5992.112.74
285752-8575287.96189.81
388994-8899491.28793.21
490637-9063792.97294.91
584692-8469286.87488.70
690174-9017492.49794.43
60min190811-9081193.15192.732.0895.5495.122.08
289165-8916591.46293.80
391328-9132893.68196.11
491180-9118093.52995.99
587308-8730889.55891.87
692595-9259594.98197.43
极限191030-9103093.37594.292.9696.2897.202.94
290815-9081593.15596.00
393045-9304595.44298.39
494428-9442896.86199.84
587501-8750189.75592.56
694689-9468997.129100.10
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%
1 9.031008701007721008261008071007341008020.06
2 9.201025701026551026120.06
单位质量响应值RSD%判断
11163.0111153.480.07数据可信
供试品溶液-TNA3004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%
5min138502-3850238.74138.404.9338.7438.404.94
235623-3562335.84435.84
338213-3821338.45038.45
437853-3785338.08838.09
537401-3740137.63337.63
641389-4138941.64641.65
10min159411-5941159.78059.222.6959.9959.432.69
256755-5675557.10757.31
359989-5998960.36160.57
459470-5947059.83960.05
557006-5700657.36057.57
660493-6049360.86861.10
15min168467-6846768.89268.951.9869.4469.491.98
267621-6762168.04168.56
369718-6971870.15170.70
469295-6929569.72570.27
566319-6631966.73167.26
669722-6972270.15570.72
20min174957-7495775.42274.881.9876.3575.801.98
272988-7298873.44174.34
375676-7567676.14677.08
475477-7547775.94576.88
572154-7215472.60273.50
675227-7522775.69476.65
30min182138-8213882.64881.561.7284.0082.901.73
280534-8053481.03482.34
381583-8158382.08983.45
481698-8169882.20583.56
578453-7845378.94080.24
681949-8194982.45883.84
45min186091-8609186.62585.851.8988.4387.651.89
284971-8497185.49887.25
386566-8656687.10388.92
486192-8619286.72788.54
582228-8222882.73884.48
685890-8589086.42388.26
60min187990-8799088.53688.022.2190.8390.302.20
287162-8716287.70389.93
389108-8910889.66191.96
488206-8820688.75391.05
583768-8376884.28886.49
688639-8863989.18991.51
极限188774-8877489.32589.691.2792.1192.451.29
288365-8836588.91391.63
390300-9030090.86093.66
489525-8952590.08192.87
587511-8751188.05490.72
690339-9033990.90093.71
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