他克莫司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号2.0对照品来源欧洲对照品使用方法直接使用
对照品含量(%)97.8对照品水分(%)0对照品稀释倍数17500
标示量(mg)1供试品稀释倍数1.4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.873220032262321303214732257321990.19
213.613093330954309440.05
单位质量响应值RSD%判断
2321.492273.621.48数据可信
供试品溶液-24110101批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min111918-1191836.53136.677.3936.5336.677.40
211307-1130734.65834.66
313339-1333940.88640.89
411599-1159935.55335.55
510970-1097033.62533.62
612641-1264138.74738.75
10min117646-1764654.08849.638.1954.4950.048.11
215759-1575948.30448.69
314945-1494545.80946.26
414467-1446744.34444.74
517005-1700552.12352.50
617326-1732653.10753.54
15min118641-1864157.13861.667.1258.1462.626.99
218713-1871357.35858.28
322186-2218668.00468.97
420771-2077163.66664.55
521026-2102664.44865.40
619369-1936959.36960.39
20min122268-2226868.25568.084.4369.9069.724.41
220643-2064363.27464.83
322971-2297170.41072.13
421449-2144965.74567.34
522792-2279269.86171.53
623145-2314570.94372.62
30min124092-2409273.84682.026.4276.2584.426.18
227994-2799485.80688.07
326729-2672981.92984.43
429058-2905889.06791.39
525862-2586279.27181.72
626813-2681382.18684.65
45min127193-2719383.35188.195.6986.5791.505.52
227859-2785985.39288.61
327992-2799285.80089.21
428417-2841787.10390.42
531760-3176097.349100.68
629408-2940890.14093.52
60min129037-2903789.00392.162.5393.1596.452.52
229609-2960990.75694.92
329964-2996491.84496.21
430079-3007992.19796.48
531286-3128695.897100.30
630420-3042093.24297.63
90min129805-2980591.35797.294.4996.49102.614.37
231354-3135496.105101.28
332144-3214498.526103.91
431179-3117995.569100.88
534138-34138104.638110.11
631833-3183397.573102.99
极限130783-3078394.35595.752.81100.51102.152.78
230261-3026192.75599.00
331893-3189397.757104.24
430598-3059893.788100.16
532590-3259099.893106.53
631307-3130795.961102.46
他克莫司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号2.0对照品来源欧洲对照品使用方法直接使用
对照品含量(%)97.8对照品水分(%)0对照品稀释倍数17500
标示量(mg)1供试品稀释倍数1.4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.873098430876307793079530589308050.48
213.612993129985299580.13
单位质量响应值RSD%判断
2220.982201.180.64数据可信
供试品溶液-24110101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%
5min110729-1072934.16934.377.0934.1734.377.08
211353-1135336.15736.16
310593-1059333.73633.74
411933-1193338.00438.00
510399-1039933.11833.12
69739-973931.01631.02
10min115803-1580350.32950.233.7950.7150.613.78
216041-1604151.08751.49
316782-1678253.44753.82
415453-1545349.21449.64
515488-1548849.32549.69
615058-1505847.95648.30
15min120041-2004163.82663.425.7464.7664.365.68
222027-2202770.15171.12
319225-1922561.22762.20
419810-1981063.09064.06
518686-1868659.51060.43
619689-1968962.70563.58
20min122451-2245171.50171.067.2573.1572.717.11
224328-2432877.47979.23
320084-2008463.96365.61
421741-2174169.24070.91
521317-2131767.88969.47
623956-2395676.29477.87
30min125316-2531680.62580.945.3283.0783.385.23
225892-2589282.46085.07
323756-2375675.65778.02
426865-2686585.55888.00
523914-2391476.16078.49
626745-2674585.17687.60
45min127486-2748687.53690.882.6390.8794.222.61
229238-2923893.11696.64
328915-2891592.08795.29
429062-2906292.55595.95
527695-2769588.20291.38
628822-2882291.79195.16
60min130371-3037196.72494.303.81101.0498.653.76
230185-3018596.132100.69
327873-2787388.76992.99
430311-3031196.533100.95
528491-2849190.73794.89
630435-3043596.928101.32
90min131960-31960101.78598.364.53107.17103.754.42
231358-3135899.868105.50
329460-2946093.82399.03
431159-3115999.234104.72
528930-2893092.13597.30
632448-32448103.339108.80
极限131068-3106898.94496.594.78105.46103.084.66
231153-3115399.215105.95
328273-2827390.04396.29
430479-3047997.068103.66
528932-2893292.14198.33
632075-32075102.151108.76
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