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%
1 14.511548141546171541211551461551391547670.28
2 14.551533461535511534480.10
单位质量响应值RSD%判断
10666.2310546.250.80数据可信
供试品溶液-2025052121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%
5min153479-5347935.54337.084.9535.5437.084.95
253567-5356735.60135.60
355442-5544236.84736.85
454971-5497136.53436.53
560959-6095940.51440.51
656314-5631437.42737.43
10min182963-8296355.13855.413.2955.5355.833.29
280513-8051353.51053.91
382186-8218654.62255.03
482408-8240854.76955.18
588539-8853958.84459.29
683663-8366355.60356.02
15min194315-9431562.68366.553.2563.6967.583.24
298516-9851665.47566.46
3101087-10108767.18468.20
4101358-10135867.36468.38
5102732-10273268.27769.38
6102816-10281668.33369.37
20min1107833-10783371.66773.643.2773.3775.413.27
2106967-10696771.09172.81
3110971-11097173.75375.52
4108993-10899372.43874.20
5116259-11625977.26779.13
6113780-11378075.61977.41
30min1117723-11772378.24082.883.7880.7485.463.75
2120802-12080280.28682.79
3127298-12729884.60487.19
4124190-12419082.53885.11
5129839-12983986.29289.01
6128339-12833985.29687.93
45min1130086-13008686.45790.683.4989.8394.183.48
2131034-13103487.08790.49
3138006-13800691.72095.24
4138366-13836691.96095.44
5141922-14192294.32398.00
6139190-13919092.50796.09
60min1132239-13223987.88792.324.0992.2296.834.05
2132604-13260488.13092.50
3138752-13875292.21696.76
4139758-13975892.88597.39
5145837-14583796.925101.65
6144215-14421595.847100.46
90min1137443-13744391.34695.143.4696.65100.683.46
2136984-13698491.04196.39
3143789-14378995.564101.13
4144854-14485496.272101.81
5149205-14920599.163104.97
6146617-14661797.443103.12
极限1134637-13463789.48194.164.3995.80100.764.31
2137729-13772991.53697.89
3140952-14095293.678100.31
4138304-13830491.91898.53
5150233-15023399.847106.75
6148192-14819298.490105.25
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%
1 14.511544311542611538921531311529961537420.43
2 14.551524501528031526260.17
单位质量响应值RSD%判断
10595.5910489.760.71数据可信
供试品溶液-2025052121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%
5min156701-5670137.91136.944.5437.9136.934.54
255507-5550737.11337.11
355565-5556537.15237.15
450856-5085634.00334.00
554535-5453536.46336.46
658291-5829138.97438.97
10min184025-8402556.18055.552.3956.6055.962.37
284896-8489656.76357.18
383298-8329855.69456.11
480674-8067453.94054.32
584967-8496756.81057.22
680636-8063653.91454.35
15min198858-9885866.09867.232.6467.1468.262.59
2103560-10356069.24270.28
399405-9940566.46467.50
4102432-10243268.48769.46
5102385-10238568.45669.49
696691-9669164.64965.68
20min1110401-11040173.81673.932.8375.6075.702.78
2111286-11128674.40776.22
3112942-11294275.51577.28
4112117-11211774.96376.70
5112244-11224475.04876.84
6104440-10444069.83071.58
30min1122284-12228481.76183.203.5584.3685.793.48
2128869-12886986.16488.80
3128283-12828385.77288.38
4125515-12551583.92186.49
5124761-12476183.41786.05
6116886-11688678.15280.68
45min1134416-13441689.87289.922.9493.3893.442.90
2136037-13603790.95694.55
3136136-13613691.02294.58
4137563-13756391.97795.48
5136100-13610090.99894.56
6126692-12669284.70888.10
60min1137722-13772292.08392.102.6296.5996.622.59
2141198-14119894.40799.01
3139497-13949793.27097.84
4138261-13826192.44396.97
5138961-13896192.91197.48
6130812-13081287.46391.80
90min1141182-14118294.39694.853.2499.93100.393.17
2145112-14511297.024102.68
3143872-14387296.195101.80
4145552-14555297.318102.87
5142293-14229395.139100.74
6133136-13313689.01794.32
极限1140046-14004693.63794.013.73100.22100.613.63
2145863-14586397.526104.26
3143705-14370596.083102.76
4143686-14368696.070102.70
5139134-13913493.02799.69
6131225-13122587.73994.04
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