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230401FK对照品来源原料对照品使用方法直接使用
对照品含量(%)100.6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%
114.241620521624351624961627081627291624840.17
214.321626051627101626580.05
单位质量响应值RSD%判断
11410.3911358.800.33数据可信
供试品溶液-24042201批-含0.005%羟丙基纤维素的pH4.5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%
5min180695-8069551.34153.405.0651.3453.405.06
281141-8114151.62451.62
378948-7894850.22950.23
486106-8610654.78354.78
587168-8716855.45955.46
689573-8957356.98956.99
10min1108229-10822968.85971.053.4869.4371.643.47
2107699-10769968.52169.10
3113393-11339372.14472.70
4118304-11830475.26975.88
5111618-11161871.01571.63
6110756-11075670.46671.10
15min1116678-11667874.23478.293.3575.5779.673.32
2119667-11966776.13677.47
3127857-12785781.34782.71
4125504-12550479.85081.29
5124639-12463979.29980.70
6123942-12394278.85680.27
20min1130388-13038882.95783.231.7785.1285.481.78
2127634-12763481.20583.39
3131655-13165583.76386.03
4134675-13467585.68488.02
5130013-13001382.71885.00
6130514-13051483.03785.33
30min1133984-13398485.24588.081.8588.3391.261.85
2138546-13854688.14791.23
3139611-13961188.82592.02
4141154-14115489.80793.09
5137298-13729887.35390.56
6140051-14005189.10592.32
45min1140187-14018789.19191.101.6593.2295.251.67
2140877-14087789.63093.69
3145928-14592892.84497.03
4145596-14559692.63396.91
5143534-14353491.32195.50
6142966-14296690.95995.16
60min1137780-13778087.66091.332.4292.6896.502.39
2141976-14197690.33095.39
3146690-14669093.32998.54
4146787-14678793.39098.70
5142717-14271790.80195.99
6145355-14535592.47997.70
90min1141070-14107089.75390.922.1595.7597.102.12
2140109-14010989.14295.20
3146961-14696193.50199.75
4145712-14571292.70799.06
5139645-13964588.84795.05
6143901-14390191.55497.80
极限1138682-13868288.23490.132.8895.2397.322.78
2138475-13847588.10295.15
3148502-14850294.482101.77
4144450-14445091.90499.28
5138634-13863488.20395.39
6141212-14121289.84497.10
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230401FK对照品来源原料对照品使用方法直接使用
对照品含量(%)100.6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%
114.241629211628651628541626691626221627860.09
214.321628161627921628040.02
单位质量响应值RSD%判断
11431.6011368.990.39数据可信
供试品溶液-24042202批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min188449-8844956.19758.466.2756.2058.466.27
294918-9491860.30760.31
396821-9682161.51661.52
489775-8977557.03957.04
598641-9864162.67262.67
683467-8346753.03153.03
10min1119225-11922575.75075.463.2776.3776.113.27
2125770-12577079.90980.58
3118808-11880875.48576.17
4115554-11555473.41874.05
5118403-11840375.22875.92
6114844-11484472.96773.56
15min1129185-12918582.07981.213.3983.5482.703.40
2132069-13206983.91185.47
3128034-12803481.34782.87
4126752-12675280.53381.98
5130995-13099583.22984.76
6119905-11990576.18277.58
20min1132244-13224484.02284.152.8286.4086.542.82
2135218-13521885.91288.40
3132270-13227084.03986.46
4135648-13564886.18588.53
5133890-13389085.06887.52
6125403-12540379.67681.92
30min1134080-13408085.18986.782.8988.5090.112.89
2139449-13944988.60092.04
3137342-13734287.26190.62
4139451-13945188.60191.90
5139432-13943288.58991.99
6129785-12978582.46085.59
45min1136589-13658986.78387.913.1891.0492.203.16
2142123-14212390.29994.73
3137775-13777587.53691.87
4142504-14250490.54194.83
5140381-14038189.19293.58
6130779-13077983.09187.14
60min1135508-13550886.09687.082.7091.3292.342.67
2136943-13694387.00892.44
3137277-13727787.22092.52
4142819-14281990.74196.03
5138298-13829887.86993.25
6131488-13148883.54288.51
90min1136602-13660286.79186.482.4092.9792.712.42
2137170-13717087.15293.55
3135111-13511185.84492.11
4138366-13836687.91294.21
5139264-13926488.48294.84
6130114-13011482.66988.57
极限1134432-13443285.41285.321.1192.5692.521.21
2134652-13465285.55292.92
3133286-13328684.68491.91
4135105-13510585.84093.12
5136281-13628186.58793.92
6132013-13201383.87590.69
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230401FK对照品来源原料对照品使用方法直接使用
对照品含量(%)100.6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%
114.241625861626911626931622621622271624920.15
214.321628751627581628160.06
单位质量响应值RSD%判断
11410.9611369.830.26数据可信
供试品溶液-24042203批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min192040-9204058.52960.023.2558.5360.023.25
291588-9158858.24158.24
394977-9497760.39660.40
499844-9984463.49163.49
592722-9272258.96358.96
695181-9518160.52660.53
10min197895-9789562.25262.682.4462.9063.352.44
294836-9483660.30760.95
399174-9917463.06563.74
499573-9957363.31964.02
597842-9784262.21862.87
6102096-10209664.92365.60
15min1139039-13903988.41686.892.7189.7688.262.69
2130386-13038682.91384.23
3134406-13440685.47086.84
4137081-13708187.17188.58
5138452-13845288.04389.39
6140487-14048789.33790.73
20min1138904-13890488.33088.941.4690.6591.271.45
2138180-13818087.87090.11
3140087-14008789.08291.40
4137904-13790487.69490.07
5140752-14075289.50591.83
6143355-14335591.16093.55
30min1144013-14401391.57990.492.4994.8893.802.45
2138872-13887288.31091.52
3143000-14300090.93594.25
4140042-14004289.05492.41
5139614-13961488.78192.10
6148234-14823494.26397.66
45min1140413-14041389.29090.942.9993.6195.262.93
2138236-13823687.90592.10
3144926-14492692.15996.48
4144851-14485192.11296.45
5139920-13992088.97693.28
6149707-14970795.20099.65
60min1146426-14642693.11390.932.7898.4396.272.73
2137395-13739587.37092.54
3143671-14367191.36196.71
4142605-14260590.68396.05
5139853-13985388.93394.23
6148027-14802794.13199.64
90min1141130-14113089.74589.332.1996.1095.682.17
2135081-13508185.89992.04
3142836-14283690.83097.19
4139412-13941288.65395.03
5140641-14064189.43595.72
6143803-14380391.44598.00
极限1140326-14032689.23488.551.7896.5895.881.78
2137309-13730987.31694.41
3139710-13971088.84296.21
4137586-13758687.49294.85
5137052-13705287.15294.43
6143475-14347591.23798.80
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