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%
114.191596791595971594621592571594701594930.11
214.111583241583061583150.01
单位质量响应值RSD%判断
11239.8211220.060.13数据可信
供试品溶液-023200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%
5min136113-3611322.64422.841.7022.6422.841.70
236388-3638822.81722.82
337143-3714323.29023.29
436239-3623922.72322.72
537126-3712623.27923.28
635543-3554322.28722.29
10min175600-7560047.40446.901.5547.6647.151.55
274924-7492446.98047.23
375378-7537847.26547.52
472517-7251745.47145.72
575491-7549147.33647.59
674881-7488146.95347.20
15min197603-9760361.20158.323.4761.9859.103.43
288555-8855555.52756.30
394762-9476259.41960.20
494494-9449459.25160.01
591394-9139457.30858.09
691252-9125257.21957.99
20min1105139-10513965.92667.263.4067.3868.693.32
2102279-10227964.13365.53
3105593-10559366.21167.66
4112505-11250570.54571.96
5108804-10880468.22469.65
6109298-10929868.53469.94
30min1119249-11924974.77477.914.5876.9680.084.47
2121478-12147876.17178.28
3121929-12192976.45478.63
4134746-13474684.49186.69
5126597-12659779.38181.56
6121469-12146976.16678.33
45min1135559-13555985.00186.062.8488.0289.102.80
2130828-13082882.03484.99
3138209-13820986.66289.69
4141992-14199289.03492.17
5136788-13678885.77188.83
6140114-14011487.85790.87
60min1142642-14264289.44291.203.2793.4195.193.17
2142550-14255089.38493.25
3154139-15413996.651100.64
4147634-14763492.57296.70
5144030-14403090.31294.33
6141652-14165288.82192.81
90min1140249-14024987.94289.851.6992.9094.861.69
2141570-14157088.77093.63
3144322-14432290.49595.56
4147075-14707592.22297.38
5144135-14413590.37895.40
6142439-14243989.31594.29
极限1139169-13916987.26488.461.4093.2094.471.38
2140146-14014687.87793.72
3139684-13968487.58793.66
4143109-14310989.73595.92
5143954-14395490.26596.29
6140419-14041988.04894.02
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%
114.193278232827326863258332537326830.39
214.113268832733327100.10
单位质量响应值RSD%判断
2303.242318.210.46数据可信
供试品溶液-123640批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min113898-1389842.35341.343.2342.3541.333.23
213487-1348741.10041.10
313751-1375141.90541.90
413156-1315640.09140.09
514112-1411243.00543.00
612981-1298139.55839.56
10min120192-2019261.53358.684.2262.0059.134.20
218441-1844156.19756.65
318589-1858956.64857.11
418569-1856956.58757.03
520073-2007361.17061.65
619662-1966259.91860.36
15min122465-2246568.45968.643.2769.6169.763.25
222890-2289069.75570.84
322810-2281069.51170.61
421155-2115564.46765.54
523310-2331071.03572.19
622522-2252268.63369.74
20min124824-2482475.64875.484.0677.5677.364.01
224679-2467975.20677.06
325280-2528077.03878.91
424252-2425273.90575.70
526291-2629180.11982.07
623287-2328770.96472.83
30min127512-2751283.84083.321.7286.6086.031.74
227481-2748183.74586.44
327459-2745983.67886.40
427164-2716482.77985.39
527910-2791085.05287.89
626517-2651780.80783.46
45min129562-2956290.08787.552.1193.7791.182.11
228868-2886887.97291.59
328584-2858487.10690.76
428076-2807685.55889.09
529211-2921189.01792.80
628073-2807385.54989.10
60min129466-2946689.79487.862.8194.4892.472.74
229467-2946789.79794.40
329386-2938689.55094.17
428355-2835586.40990.89
528866-2886687.96692.74
627444-2744483.63288.14
90min128721-2872187.52486.632.7393.2192.222.69
228871-2887187.98193.58
328517-2851786.90292.52
427997-2799785.31890.76
529336-2933689.39895.15
627122-2712282.65188.09
极限128339-2833986.36084.285.2393.0290.835.00
228395-2839586.53093.11
328449-2844986.69593.28
427112-2711282.62189.01
528705-2870587.47594.22
624934-2493475.98382.34
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