他克莫司缓释颗粒项目信息
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%
114.861571731571371571981550441577021568510.67
214.821579221578781579000.02
单位质量响应值RSD%判断
10555.2510654.520.67数据可信
供试品溶液-2025052121批-pH4.4
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min165868-6586843.78242.902.4643.7842.902.45
264407-6440742.81142.81
362716-6271641.68741.69
463793-6379342.40342.40
566953-6695344.50344.50
663528-6352842.22642.23
10min193507-9350762.15362.361.8962.6462.841.89
294805-9480563.01663.49
392046-9204661.18261.65
494533-9453362.83563.31
596324-9632464.02664.52
691665-9166560.92961.40
15min1108462-10846272.09471.901.6473.2773.071.63
2106695-10669570.91972.09
3107214-10721471.26472.41
4107142-10714271.21672.39
5111535-11153574.13675.34
6107961-10796171.76172.91
20min1120501-12050180.09678.961.2082.0780.931.20
2117771-11777178.28180.24
3116955-11695577.73979.67
4118441-11844178.72680.69
5120407-12040780.03382.06
6118676-11867678.88380.83
30min1132237-13223787.89786.821.2990.7689.671.29
2128934-12893485.70188.53
3129564-12956486.12088.92
4130495-13049586.73989.57
5133092-13309288.46591.38
6129412-12941286.01988.84
45min1142224-14222494.53592.422.0298.3896.231.98
2135010-13501089.74093.53
3139227-13922792.54396.30
4138113-13811391.80295.60
5142170-14217094.49998.40
6137527-13752791.41395.19
60min1143808-14380895.58893.352.48100.4898.182.42
2135780-13578090.25295.03
3141496-14149694.05198.83
4139367-13936792.63697.45
5144583-14458396.103101.05
6137605-13760591.46596.26
90min1145210-14521096.52093.982.44102.4899.862.38
2137515-13751591.40597.19
3143088-14308895.109100.94
4139505-13950592.72798.58
5144937-14493796.338102.36
6138113-13811391.80297.61
极限1142451-14245194.68692.683.01101.7299.602.91
2134586-13458689.45896.26
3141211-14121193.861100.75
4137698-13769891.52698.41
5145214-14521496.522103.61
6135477-13547790.05096.88
他克莫司缓释颗粒项目信息
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%
114.861571611574791574361573431575261573890.10
214.821593551594321593940.04
单位质量响应值RSD%判断
10591.4510755.331.09数据可信
供试品溶液-2025052121批-pH4.6
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min163334-6333441.82943.412.4741.8343.412.47
267895-6789544.84144.84
365674-6567443.37443.37
464775-6477542.78042.78
567057-6705744.28844.29
665637-6563743.35043.35
10min189042-8904258.80861.793.6859.2762.273.67
295810-9581063.27763.78
394579-9457962.46462.95
491076-9107660.15160.63
598546-9854665.08465.58
692280-9228060.94661.43
15min1102525-10252567.71272.213.7168.8373.383.70
2113073-11307374.67975.88
3110578-11057873.03174.21
4107653-10765371.09972.24
5113427-11342774.91376.13
6108743-10874371.81972.98
20min1117237-11723777.42979.103.4079.3081.083.37
2122547-12254780.93682.97
3119628-11962879.00881.00
4113199-11319974.76276.70
5124465-12446582.20384.25
6121565-12156580.28782.24
30min1127134-12713483.96586.822.9486.7089.672.94
2134485-13448588.82091.75
3132400-13240087.44390.31
4126197-12619783.34686.11
5135380-13538089.41192.37
6133131-13313187.92690.77
45min1133188-13318887.96491.173.0491.6394.993.05
2141362-14136293.36297.28
3138982-13898291.79095.63
4133292-13329288.03291.72
5143521-14352194.78898.74
6137945-13794591.10594.93
60min1132563-13256387.55192.123.5392.1996.953.50
2145055-14505595.801100.76
3141093-14109393.18598.04
4136154-13615489.92394.59
5144431-14443195.389100.40
6137623-13762390.89395.73
90min1133788-13378888.36092.413.4293.9798.263.40
2144842-14484295.661101.68
3141962-14196293.75899.65
4135772-13577289.67095.34
5145152-14515295.865101.93
6138030-13803091.16297.01
极限1131093-13109386.58090.673.5093.1897.553.47
2143528-14352894.793101.87
3139058-13905891.84198.77
4133107-13310787.91094.57
5141168-14116893.234100.37
6135764-13576489.66596.53
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