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%
114.051542501541551542421545581546901543790.15
213.991535931539421537680.17
单位质量响应值RSD%判断
10987.8310991.280.03数据可信
供试品溶液-2025052021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%
5min164295-6429541.23941.213.4741.2441.213.47
260971-6097139.10739.11
364470-6447041.35241.35
467271-6727143.14843.15
565796-6579642.20242.20
662692-6269240.21140.21
10min195786-9578661.43860.343.7961.9060.803.76
293213-9321359.78860.22
3100189-10018964.26264.72
493370-9337059.88860.37
592030-9203059.02959.50
689888-8988857.65558.10
15min1114060-11406073.15970.522.3474.3071.642.29
2110015-11001570.56571.66
3107792-10779269.13970.31
4109067-10906769.95771.10
5107126-10712668.71269.84
6111579-11157971.56872.66
20min1124698-12469879.98277.603.0681.9479.523.00
2125220-12522080.31782.20
3122889-12288978.82280.76
4117138-11713875.13377.06
5118230-11823075.83477.72
6117753-11775375.52877.41
30min1142746-14274691.55986.234.7794.4089.004.67
2137855-13785588.42191.20
3138986-13898689.14791.96
4131719-13171984.48687.24
5126240-12624080.97183.70
6129048-12904882.77385.49
45min1153072-15307298.18293.484.39102.0497.224.31
2144079-14407992.41496.17
3154004-15400498.780102.59
4144228-14422892.50996.20
5139907-13990789.73893.37
6139188-13918889.27692.92
60min1156011-156011100.06795.504.68105.02100.274.59
2153241-15324198.290103.07
3155406-15540699.679104.58
4145742-14574293.48098.20
5143796-14379692.23296.86
6139176-13917689.26993.90
90min1158902-158902101.92197.963.22107.98103.803.21
2155110-15511099.489105.37
3157145-157145100.794106.81
4148821-14882195.455101.22
5148963-14896395.546101.20
6147457-14745794.580100.21
极限1156480-156480100.36895.993.57107.56102.903.54
2152400-15240097.751104.73
3154241-15424198.932106.06
4144544-14454492.71299.53
5144945-14494592.96999.68
6145287-14528793.18899.86
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%
114.051572731568171570571553391551011563170.66
213.991551931547591549760.20
单位质量响应值RSD%判断
11125.7711077.630.31数据可信
供试品溶液-2025052021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%
5min175512-7551247.94541.338.7147.9541.338.71
265826-6582641.79541.80
359700-5970037.90637.91
461330-6133038.94038.94
562350-6235039.58839.59
665800-6580041.77941.78
10min192235-9223558.56358.004.7159.1058.464.71
294723-9472360.14360.61
386603-8660354.98755.41
490233-9023357.29257.72
586871-8687155.15755.60
697392-9739261.83762.30
15min1110269-11026970.01368.334.0771.2069.444.08
2110548-11054870.19171.32
3100767-10076763.98065.01
4109902-10990269.78070.85
5103414-10341465.66166.71
6110822-11082270.36571.52
20min1120144-12014476.28375.473.2778.2477.333.28
2122173-12217377.57279.48
3115403-11540373.27375.02
4121387-12138777.07378.92
5112685-11268571.54773.33
6121371-12137177.06279.00
30min1133271-13327184.61885.464.0287.4388.163.99
2142953-14295390.76693.54
3129271-12927182.07884.64
4131551-13155183.52686.23
5131030-13103083.19585.77
6139534-13953488.59591.38
45min1143591-14359191.17191.003.8594.9294.653.83
2150297-15029795.42999.21
3140709-14070989.34192.81
4140437-14043789.16892.80
5135866-13586686.26689.77
6149035-14903594.62798.40
60min1146633-14663393.10292.703.2397.8697.363.22
2153859-15385997.690102.53
3143347-14334791.01695.48
4141189-14118989.64694.27
5142479-14247990.46594.92
6148448-14844894.25599.08
90min1148958-14895894.57894.793.65100.37100.483.63
2156240-15624099.202105.13
3146341-14634192.91798.39
4145775-14577592.55798.17
5142962-14296290.77196.24
6155490-15549098.726104.60
极限1145954-14595492.67192.653.0599.5299.393.07
2152824-15282497.033104.06
3144196-14419691.55598.06
4142447-14244790.44497.09
5140867-14086789.44195.91
6149199-14919994.731101.70
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