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%
114.181577801576441579541585711587111581320.31
214.191594941595601595270.03
单位质量响应值RSD%判断
11151.7611242.210.58数据可信
供试品溶液-js1y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%
5min160318-6031839.02038.867.9339.0238.867.94
268543-6854344.34044.34
358842-5884238.06538.06
455454-5545435.87335.87
555927-5592736.17936.18
661336-6133639.67839.68
10min192877-9287760.08259.955.1860.5260.385.18
299972-9997264.67265.16
386517-8651755.96856.39
491564-9156459.23359.63
589192-8919257.69858.10
695873-9587362.02062.46
15min1110727-11072771.62971.815.3572.7372.915.34
2122229-12222979.07080.28
3105120-10512068.00269.05
4111367-11136772.04373.10
5108554-10855470.22371.27
6108023-10802369.88071.01
20min1132810-13281085.91581.355.2687.8183.255.24
2135530-13553087.67489.76
3120399-12039977.88679.69
4122412-12241279.18881.05
5122061-12206178.96180.78
6121338-12133878.49380.40
30min1143304-14330492.70391.453.1295.5594.263.17
2148578-14857896.11599.18
3137270-13727088.80091.47
4142913-14291392.45095.19
5138700-13870089.72592.43
6137481-13748188.93691.71
45min1161557-161557104.511101.584.71108.39105.394.70
2169970-169970109.953114.09
3150939-15093997.642101.29
4154781-154781100.128103.89
5152606-15260698.721102.42
6152266-15226698.501102.27
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%
114.181604071595591598551585121584301593530.55
214.191603241626531614881.02
单位质量响应值RSD%判断
11237.8711380.410.90数据可信
供试品溶液-js1y批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min152898-5289833.88135.9910.1033.8835.9910.11
259613-5961338.18238.18
358465-5846537.44737.45
453291-5329134.13334.13
564323-6432341.19941.20
648528-4852831.08231.08
10min186509-8650955.40953.526.9755.7953.926.98
287717-8771756.18356.61
387790-8779056.22956.65
476281-7628148.85849.24
587183-8718355.84156.30
675849-7584948.58148.93
15min1101490-10149065.00465.366.2266.0066.356.23
2107720-10772068.99570.04
3108382-10838269.41970.46
498276-9827662.94663.87
5104676-10467667.04568.12
691680-9168058.72159.61
20min1115414-11541473.92373.346.8675.6475.066.86
2119632-11963276.62478.44
3121723-12172377.96379.78
4105048-10504867.28368.90
5120747-12074777.33879.16
6104493-10449366.92868.47
30min1130337-13033783.48184.147.1786.0286.687.16
2140244-14024489.82692.49
3138441-13844188.67191.35
4124022-12402279.43681.81
5138323-13832388.59691.28
6116847-11684774.84077.12
45min1147192-14719294.27692.387.2197.7495.867.20
2151565-15156597.077100.74
3151578-15157897.085100.75
4135027-13502786.48589.74
5152355-15235597.583101.25
6127712-12771281.79984.91
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