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%
113.80 1535551535221534661535471532241534630.09
213.80 1529321523881526600.26
单位质量响应值RSD%判断
11120.5111062.320.38数据可信
供试品溶液-023431批-pH1.2盐酸溶液
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min153522-5352233.98032.775.6633.9832.785.66
250399-5039931.99732.00
355022-5502234.93234.93
446918-4691829.78729.79
553283-5328333.82833.83
650587-5058732.11632.12
10min178157-7815749.62051.654.2250.0052.024.17
285913-8591354.54454.90
379603-7960350.53850.93
484737-8473753.79754.13
582007-8200752.06452.44
677755-7775549.36549.72
15min192560-9256058.76462.915.8959.6963.855.81
2104474-10447466.32867.29
398976-9897662.83763.79
4107286-10728668.11369.04
597549-9754961.93162.89
693736-9373659.51160.42
20min1105448-10544866.94671.195.6868.5372.825.62
2118613-11861375.30477.00
3109668-10966869.62571.27
4121282-12128276.99978.68
5110415-11041570.10071.74
6107332-10733268.14269.71
30min1117693-11769374.72079.646.4477.0582.076.35
2128853-12885381.80584.34
3123077-12307778.13880.56
4140128-14012888.96491.50
5122181-12218177.57079.99
6120730-12073076.64878.97
45min1135073-13507385.75486.611.9488.9189.922.02
2138197-13819787.73891.18
3135002-13500285.70989.00
4140847-14084789.42092.95
5135722-13572286.16689.45
6133655-13365584.85488.03
60min1140478-14047889.18689.571.1393.2993.851.19
2142993-14299390.78395.20
3138561-13856187.96992.21
4142454-14245490.44094.96
5140684-14068489.31793.56
6141367-14136789.75093.87
90min1140866-14086689.43291.101.3994.5396.371.42
2146368-14636892.92598.35
3142287-14228790.33495.55
4143135-14313590.87396.40
5145214-14521492.19397.43
6143093-14309390.84695.96
极限1143419-14341991.05389.911.4597.1596.191.26
2142042-14204290.17996.64
3139020-13902088.26094.48
4139060-13906088.28694.82
5143015-14301590.79697.05
6143149-14314990.88297.01
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%
113.80 1532651529301526191529461528361529190.16
213.80 1523581516661520120.33
单位质量响应值RSD%判断
11081.0911015.360.43数据可信
供试品溶液-023431批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min153344-5334433.99934.123.4134.0034.123.41
252038-5203833.16733.17
353330-5333033.99033.99
457051-5705136.36236.36
552155-5215533.24133.24
653272-5327233.95333.95
10min181423-8142351.89651.442.7052.2751.822.69
282280-8228052.44252.81
376931-7693149.03349.41
482913-8291352.84553.25
579518-7951850.68151.05
681175-8117551.73752.11
15min196612-9661261.57661.782.1962.5362.732.18
298900-9890063.03563.99
396038-9603861.21062.13
4100028-10002863.75464.74
594474-9447460.21461.15
695513-9551360.87661.83
20min1109699-10969969.91768.622.4371.5670.262.39
2109830-10983070.00171.65
3102703-10270365.45867.06
4107896-10789668.76870.47
5108345-10834569.05470.66
6107531-10753168.53670.16
30min1125640-12564080.07879.101.5082.4981.501.50
2125590-12559080.04682.48
3121526-12152677.45579.79
4124747-12474779.50881.97
5122001-12200177.75880.13
6125171-12517179.77982.17
45min1138454-13845488.24586.781.1591.5590.061.13
2137710-13771087.77091.09
3134859-13485985.95389.14
4134761-13476185.89189.24
5135329-13532986.25389.49
6135806-13580686.55789.83
60min1142955-14295591.11390.491.3295.4094.731.30
2144921-14492192.36696.66
3141088-14108889.92394.07
4142542-14254290.85095.15
5140138-14013889.31893.51
6140187-14018789.34993.59
90min1141041-14104189.89391.381.7095.1996.631.65
2147260-14726093.85799.18
3142774-14277490.99896.14
4144778-14477892.27597.59
5140793-14079389.73594.92
6143598-14359891.52396.75
极限1142297-14229790.69490.471.4696.9996.731.43
2145327-14532792.62598.99
3141943-14194390.46896.62
4142337-14233790.71997.06
5139108-13910888.66194.84
6140669-14066989.65695.90
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