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130550-202401对照品来源中检所对照品使用方法直接使用
对照品含量(%)97.9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%
113.881488741488091488491489101487231488330.05
213.891490391486961488680.17
单位质量响应值RSD%判断
10722.8410717.640.04数据可信
供试品溶液-2025051921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%
5min150278-5027833.05931.058.8433.0631.058.84
253829-5382935.39435.39
343191-4319128.39928.40
443192-4319228.40028.40
546814-4681430.78130.78
646023-4602330.26130.26
10min192756-9275660.98957.388.9261.3657.738.92
297797-9779764.30464.70
380268-8026852.77853.09
477078-7707850.68151.00
589874-8987459.09459.44
685840-8584056.44256.78
15min1109352-10935271.90168.168.1172.9569.148.12
2115178-11517875.73276.84
392634-9263460.90961.81
495617-9561762.87063.75
5104885-10488568.96469.96
6104274-10427468.56369.53
20min1123555-12355581.24073.878.6483.0875.618.62
2123378-12337881.12483.07
3103414-10341467.99769.58
4101261-10126166.58168.16
5114200-11420075.08976.85
6108246-10824671.17472.90
30min1136132-13613289.51082.748.1292.2685.318.12
2140781-14078192.56795.42
3117023-11702376.94579.28
4117443-11744377.22179.54
5124324-12432481.74684.35
6119350-11935078.47580.99
45min1144876-14487695.25990.226.7299.0093.706.78
2150877-15087799.205103.08
3127446-12744683.79986.99
4128461-12846184.46687.64
5137204-13720490.21593.72
6134453-13445388.40691.79
60min1148083-14808397.36895.034.72102.1799.524.86
2155137-155137102.006106.99
3136574-13657489.80193.92
4138450-13845091.03495.15
5146286-14628696.186100.70
6142636-14263693.78698.16
90min1154784-154784101.77498.234.39107.66103.774.52
2158324-158324104.102110.22
3143597-14359794.41899.54
4144839-14483995.235100.36
5152058-15205899.982105.56
6142724-14272493.84499.26
极限1150488-15048898.94996.904.05105.96103.534.19
2156214-156214102.714109.99
3141921-14192193.31699.48
4143645-14364594.450100.63
5150559-15055998.996105.69
6141393-14139392.96999.42
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130550-202401对照品来源中检所对照品使用方法直接使用
对照品含量(%)97.9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%
113.881494221493011488241488461488171490420.20
213.891493611492051492830.08
单位质量响应值RSD%判断
10737.9010747.520.07数据可信
供试品溶液-2025052021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%
5min144272-4427229.04928.985.8629.0528.985.86
242128-4212827.64227.64
348114-4811431.57031.57
446356-4635630.41630.42
541879-4187927.47927.48
642251-4225127.72327.72
10min183896-8389655.04854.584.8255.3754.904.82
281389-8138953.40353.71
388837-8883758.29058.64
486151-8615156.52856.87
577503-7750350.85351.16
681346-8134653.37553.68
15min198455-9845564.60164.723.9765.5465.653.98
297319-9731963.85664.76
3103890-10389068.16769.17
4102676-10267667.37168.34
594644-9464462.10062.97
694797-9479762.20163.10
20min1112257-11225773.65770.794.2475.3172.444.20
2109757-10975772.01773.63
3110806-11080672.70574.46
4107142-10714270.30172.02
599363-9936365.19766.76
6108015-10801570.87472.47
30min1121477-12147779.70780.843.7582.1883.273.68
2115735-11573575.93978.35
3127507-12750783.66386.23
4125096-12509682.08184.58
5121439-12143979.68281.97
6127949-12794983.95386.33
45min1135583-13558388.96289.231.8592.3292.561.88
2131806-13180686.48489.74
3138204-13820490.68294.18
4138893-13889391.13494.54
5135249-13524988.74391.91
6136220-13622089.38092.69
60min1136782-13678289.74992.332.3294.0996.652.26
2139766-13976691.70795.92
3146212-14621295.937100.44
4139274-13927491.38495.80
5142571-14257193.54897.70
6139670-13967091.64495.95
90min1142510-14251093.50895.231.9098.85100.581.91
2144606-14460694.883100.12
3149632-14963298.181103.75
4144883-14488395.065100.50
5142354-14235493.40598.60
6146792-14679296.317101.64
极限1141692-14169292.97194.302.1099.35100.712.09
2142722-14272293.64799.93
3149692-14969298.220104.88
4142068-14206893.21899.71
5142383-14238393.42499.66
6143757-14375794.326100.72
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130550-202401对照品来源中检所对照品使用方法直接使用
对照品含量(%)97.9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%
113.881474511469361469501469211469851470490.16
213.891472461468151470300.21
单位质量响应值RSD%判断
10594.3110585.310.07数据可信
供试品溶液-2025052121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%
5min161527-6152740.95439.905.0440.9539.905.04
264365-6436542.84342.84
359099-5909939.33839.34
461140-6114040.69640.70
557582-5758238.32838.33
655963-5596337.25037.25
10min187348-8734858.14156.561.5758.6057.001.58
285540-8554056.93757.41
384777-8477756.42956.87
484145-8414556.00956.46
583601-8360155.64756.07
684425-8442556.19556.61
15min1104332-10433269.44665.844.0970.5566.924.06
2100943-10094367.19068.30
396824-9682464.44865.51
4101536-10153667.58568.66
593299-9329962.10263.15
696572-9657264.28065.32
20min1112912-11291275.15772.884.0777.0374.684.03
2111974-11197474.53276.39
3113309-11330975.42177.20
4110989-11098973.87775.70
5102979-10297968.54570.28
6104808-10480869.76271.51
30min1128563-12856385.57481.514.4388.2884.124.36
2123350-12335082.10484.79
3129148-12914885.96488.58
4118510-11851078.88381.53
5117097-11709777.94280.44
6118044-11804478.57381.10
45min1139488-13948892.84688.923.2196.5092.443.18
2134539-13453989.55293.15
3137448-13744891.48895.06
4129347-12934786.09689.62
5129360-12936086.10589.47
6131371-13137187.44390.84
60min1145715-14571596.99192.693.26101.6897.193.25
2141942-14194294.48099.07
3141915-14191594.46299.05
4135257-13525790.03094.51
5135611-13561190.26694.58
6135061-13506189.89994.27
90min1151722-151722100.98995.913.78106.76101.453.74
2145901-14590197.115102.76
3148520-14852098.858104.50
4140089-14008993.24698.73
5140370-14037093.43398.75
6137985-13798591.84697.22
极限1150602-150602100.24493.983.82107.13100.583.77
2141407-14140794.123100.84
3143536-14353695.541102.28
4137763-13776391.69898.21
5135831-13583190.41296.77
6137966-13796691.83398.22
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