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D230603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%
114.261560401556251558971564421561341560280.20
214.001533741532781533260.05
单位质量响应值RSD%判断
10941.6510951.860.07数据可信
供试品溶液-023200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%
5min146035-4603529.38230.393.1229.3830.393.13
246717-4671729.81829.82
348940-4894031.23631.24
446374-4637429.59929.60
547907-4790730.57730.58
649695-4969531.71831.72
10min175996-7599648.50547.214.0248.8347.553.99
269498-6949844.35844.69
373150-7315046.68947.04
471987-7198745.94646.28
577479-7747949.45249.79
675725-7572548.33248.68
15min188366-8836656.40157.832.9557.2758.702.92
288245-8824556.32357.15
391607-9160758.46959.33
492088-9208858.77659.62
594798-9479860.50661.40
688562-8856256.52657.42
20min1105101-10510167.08265.232.9668.5766.732.92
2100964-10096464.44165.89
3102809-10280965.61967.13
499184-9918463.30564.80
5106151-10615167.75269.31
698947-9894763.15464.67
30min1120680-12068077.02575.602.2579.2677.832.24
2116694-11669474.48176.65
3119565-11956576.31478.56
4116217-11621774.17776.37
5121996-12199677.86580.18
6115522-11552273.73375.95
45min1138229-13822988.22687.123.5591.3290.193.46
2137455-13745587.73290.73
3140673-14067389.78692.88
4126925-12692581.01184.03
5137378-13737887.68390.86
6138284-13828488.26191.30
60min1143147-14314791.36589.723.3595.4493.753.28
2138259-13825988.24592.21
3147647-14764794.23798.33
4133742-13374285.36289.28
5141179-14117990.10994.26
6139417-13941788.98493.00
90min1145059-14505992.58590.493.0397.6795.522.97
2137305-13730587.63692.59
3144790-14479092.41497.55
4135384-13538486.41091.28
5143316-14331691.47396.63
6144759-14475992.39497.40
极限1142733-14273391.10188.472.9797.2294.512.91
2135742-13574286.63992.56
3139904-13990489.29595.46
4131686-13168684.05089.88
5141066-14106690.03796.21
6140502-14050289.67795.71
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D230603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%
114.261562941560951562311562771561511562100.06
214.001524251525441524840.06
单位质量响应值RSD%判断
10954.4210891.710.41数据可信
供试品溶液-023200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%
5min133854-3385421.65521.764.8821.6521.764.88
235501-3550122.70822.71
334277-3427721.92521.93
432716-3271620.92720.93
536064-3606423.06823.07
631656-3165620.24920.25
10min176626-7662649.01448.254.3249.2548.494.32
279530-7953050.87151.12
375356-7535648.20148.45
473242-7324246.84947.08
577468-7746849.55249.81
670360-7036045.00645.23
15min194568-9456860.49059.022.2361.2859.802.24
293476-9347659.79260.61
390510-9051057.89558.67
491218-9121858.34859.10
594120-9412060.20461.01
689690-8969057.37058.10
20min199123-9912363.40464.743.2364.8666.173.21
2106552-10655268.15669.64
3100920-10092064.55365.98
498697-9869763.13264.53
5103615-10361566.27767.75
698366-9836662.92064.28
30min1113540-11354072.62674.992.4274.7977.152.41
2121687-12168777.83780.08
3116613-11661374.59176.73
4116384-11638474.44576.55
5119201-11920176.24778.46
6116008-11600874.20476.27
45min1129240-12924082.66884.512.4685.6487.502.42
2132863-13286384.98688.09
3136736-13673687.46390.43
4129014-12901482.52485.45
5134941-13494186.31589.37
6129960-12996083.12986.01
60min1137274-13727487.80788.651.8691.6992.581.85
2141776-14177690.68794.74
3141723-14172390.65394.59
4138089-13808988.32992.18
5137123-13712387.71191.73
6135581-13558186.72490.53
90min1136431-13643187.26889.953.5692.1394.863.43
2141837-14183790.72695.78
3150100-15010096.011100.96
4137258-13725887.79792.63
5139409-13940989.17394.17
6138742-13874288.74693.52
极限1139552-13955289.26488.942.2495.1094.852.21
2140914-14091490.13696.20
3143429-14342991.74497.76
4137400-13740087.88893.69
5138715-13871588.72994.71
6134285-13428585.89591.65
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D230603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%
114.261522731521651530271525521526331525300.23
214.001517591515701516640.09
单位质量响应值RSD%判断
10696.3510833.140.90数据可信
供试品溶液-023200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%
5min155209-5520935.83536.802.6635.8336.802.67
256891-5689136.92736.93
357300-5730037.19237.19
455845-5584536.24836.25
559314-5931438.49938.50
655618-5561836.10036.10
10min182883-8288353.79853.742.3654.2054.152.35
280923-8092352.52552.94
383541-8354154.22554.64
480356-8035652.15752.56
585748-8574855.65756.08
683329-8332954.08754.49
15min1102304-10230466.40365.241.8467.4066.251.83
298866-9886664.17265.17
3100876-10087665.47666.49
497930-9793063.56464.55
5102575-10257566.57967.63
6100518-10051865.24466.25
20min1115365-11536574.88172.552.8476.6174.282.79
2108929-10892970.70372.41
3115697-11569775.09676.84
4108248-10824870.26171.95
5110564-11056471.76573.55
6111874-11187472.61574.34
30min1125458-12545881.43282.310.8784.0084.850.84
2126354-12635482.01484.51
3128393-12839383.33785.91
4127427-12742782.71085.18
5125898-12589881.71884.30
6127371-12737182.67485.21
45min1141200-14120091.65089.971.2495.1293.431.23
2136664-13666488.70692.11
3138661-13866190.00293.51
4137472-13747289.23092.62
5140048-14004890.90294.39
6137670-13767089.35992.81
60min1144219-14421993.60991.611.6498.1096.061.62
2139002-13900290.22394.61
3141848-14184892.07096.57
4137851-13785189.47693.86
5141798-14179892.03896.54
6142085-14208592.22496.67
90min1143793-14379393.33393.831.8598.8699.301.78
2139983-13998390.86096.25
3145933-14593394.722100.25
4144601-14460193.85799.23
5145053-14505394.15199.67
6148014-14801496.073101.54
极限1142815-14281592.69892.071.9899.2698.581.93
2137776-13777689.42795.83
3145032-14503294.137100.72
4139028-13902890.24096.66
5143129-14312992.90299.47
6143306-14330693.01799.55
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