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D230603FK对照品来源自制对照品使用方法直接使用
对照品含量(%)97.04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%
114.111578881576451576661577571575121576940.09
214.171576851570201573520.30
单位质量响应值RSD%判断
11176.0511104.590.46数据可信
供试品溶液-24102101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%
5min160221-6022137.76939.084.2237.7739.084.22
266496-6649641.70541.70
363116-6311639.58539.58
461753-6175338.73038.73
563238-6323839.66139.66
659031-5903137.02337.02
10min189435-8943556.09254.951.5856.5155.381.57
288034-8803455.21355.68
385819-8581953.82454.26
488779-8877955.68056.11
587101-8710154.62855.07
686505-8650554.25454.67
15min1103030-10303064.61864.192.3465.6665.232.32
2103717-10371765.04966.13
3101220-10122063.48364.52
4105815-10581566.36567.41
598863-9886362.00563.05
6101417-10141763.60664.62
20min1117894-11789473.94071.633.2575.7073.393.21
2117986-11798673.99875.80
3109800-10980068.86470.61
4115811-11581172.63474.42
5113929-11392971.45473.19
6109862-10986268.90370.62
30min1128265-12826580.44579.941.1483.0382.491.08
2125134-12513478.48181.10
3128744-12874480.74583.25
4127662-12766280.06782.66
5128623-12862380.66983.20
6126324-12632479.22881.71
45min1140860-14086088.34487.112.7691.8290.562.66
2132808-13280883.29486.79
3140422-14042288.06991.48
4143924-14392490.26693.75
5138581-13858186.91590.34
6136781-13678185.78689.15
60min1144743-14474390.78090.871.9895.2495.281.90
2140843-14084388.33492.75
3149088-14908893.50597.89
4145799-14579991.44295.93
5146098-14609891.62996.02
6142751-14275189.53093.85
90min1151447-15144794.98494.552.02100.4599.971.92
2144865-14486590.85696.26
3150759-15075994.55399.98
4151802-15180295.207100.71
5153646-15364696.363101.77
6151997-15199795.329100.64
极限1149551-14955193.79592.891.49100.3299.361.44
2143919-14391990.26396.67
3147663-14766392.61199.08
4149848-14984893.981100.54
5149232-14923293.595100.08
6148435-14843593.09599.47
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D230603FK对照品来源自制对照品使用方法直接使用
对照品含量(%)97.04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%
114.111620861617471622141620951619951620270.11
214.171616991617921617460.05
单位质量响应值RSD%判断
11483.1311414.680.43数据可信
供试品溶液-24102101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%
5min158806-5880635.88835.221.5135.8935.221.51
257663-5766335.19035.19
358303-5830335.58135.58
457664-5766435.19135.19
557629-5762935.16935.17
656223-5622334.31134.31
10min190633-9063355.31154.703.5455.7155.093.52
288742-8874254.15754.55
385575-8557552.22452.62
495071-9507158.01958.41
589709-8970954.74755.14
688063-8806353.74254.12
15min1107850-10785065.81864.812.4566.8365.812.44
2106560-10656065.03166.02
3105705-10570564.50965.48
4108328-10832866.11067.15
5107491-10749165.59966.60
6101253-10125361.79262.77
20min1120886-12088673.77373.633.5975.5275.353.55
2122034-12203474.47476.19
3117998-11799872.01173.70
4128108-12810878.18179.95
5119525-11952572.94374.67
6115397-11539770.42472.09
30min1137818-13781884.10681.213.0586.6783.743.02
2135469-13546982.67385.22
3129934-12993479.29581.79
4134847-13484782.29384.93
5133623-13362381.54684.08
6126698-12669877.32079.77
45min1143366-14336687.49287.733.3890.9991.163.34
2145169-14516988.59392.05
3139512-13951285.14088.51
4150025-15002591.55695.11
5147371-14737189.93693.38
6137051-13705183.63886.94
60min1145790-14579088.97289.632.9993.4494.042.96
2148243-14824390.46894.91
3144925-14492588.44492.76
4151209-15120992.27996.85
5151293-15129392.33096.77
6139750-13975085.28589.52
90min1149105-14910590.99591.413.2796.4596.823.23
2150557-15055791.88197.33
3145776-14577688.96394.27
4155357-15535794.810100.41
5154854-15485494.50399.97
6143023-14302387.28392.47
极限1146815-14681589.59790.132.4396.0796.552.44
2148034-14803490.34196.81
3144728-14472888.32394.61
4152748-15274893.21899.87
5150606-15060691.91198.43
6143170-14317087.37393.53
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