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%
113.861533531535951541571543381542001539290.28
213.831538821538951538880.01
单位质量响应值RSD%判断
11105.9911127.110.14数据可信
加速6月-供试品溶液-2025051921批-pH4.5含0.005%羟丙基千维素
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min169337-6933743.96536.2814.0843.9736.2814.08
265424-6542441.48441.48
353429-5342933.87833.88
450035-5003531.72631.73
552580-5258033.34033.34
652476-5247633.27433.27
10min189976-8997657.05250.8210.4057.5451.2210.42
291524-9152458.03458.49
372580-7258046.02246.40
474902-7490247.49447.85
576638-7663848.59548.97
675280-7528047.73448.10
15min1112054-11205471.05160.9110.6372.1761.8810.64
2104833-10483366.47367.58
385412-8541254.15855.05
489646-8964656.84357.72
590774-9077457.55858.47
693635-9363559.37260.27
20min1119429-11942975.72867.158.5277.6468.798.58
2114635-11463572.68874.53
396449-9644961.15762.65
4100244-10024463.56365.07
5102092-10209264.73566.28
6102525-10252565.00966.57
30min1130422-13042282.69874.448.1485.4576.838.21
2127829-12782981.05483.71
3106194-10619467.33669.50
4112181-11218171.13273.35
5113472-11347271.95174.22
6114298-11429872.47474.76
45min1140840-14084089.30480.976.9692.9884.197.05
2135774-13577486.09289.64
3116878-11687874.11077.03
4123514-12351478.31881.33
5125655-12565579.67682.74
6123546-12354678.33881.43
60min1144120-14412091.38483.866.6496.0587.986.75
2140729-14072989.23493.74
3120550-12055076.43980.18
4128509-12850981.48585.36
5132031-13203183.71887.67
6127597-12759780.90784.86
90min1145725-14572592.40287.055.2898.0892.105.42
2143617-14361791.06596.57
3125958-12595879.86884.46
4137122-13712286.94791.73
5138556-13855687.85692.74
6132692-13269284.13888.99
极限1142320-14232090.24385.434.6996.9591.444.86
2139164-13916488.24194.75
3124667-12466779.04984.53
4133395-13339584.58390.33
5137490-13749087.18093.04
6131320-13132083.26889.06
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%
113.861545881546041554111553051553151550450.27
213.831528581529781529180.06
单位质量响应值RSD%判断
11186.5111056.980.83数据可信
加速6月-供试品溶液-2025052021批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min161950-6195039.26437.539.5139.2637.539.51
251548-5154832.67132.67
364021-6402140.57740.58
465127-6512741.27841.28
559281-5928137.57337.57
653386-5338633.83633.84
10min184908-8490853.81553.167.2254.2553.587.24
276512-7651248.49448.86
392946-9294658.91059.36
487029-8702955.16055.62
583982-8398253.22853.65
677892-7789249.36849.74
15min1100047-10004763.41062.665.9764.4463.676.00
295246-9524660.36861.27
3107590-10759068.19169.30
4102208-10220864.78065.85
597665-9766561.90162.91
690452-9045257.32958.25
20min1111641-11164170.75969.526.9972.5071.236.98
2105902-10590267.12168.69
3120952-12095276.66078.52
4114794-11479472.75774.55
5105367-10536766.78268.48
699493-9949363.05964.62
30min1124495-12449578.90678.015.1081.4380.485.13
2122383-12238377.56779.89
3132972-13297284.27986.99
4125060-12506079.26481.86
5119305-11930575.61678.06
6114247-11424772.41174.67
45min1135474-13547485.86484.554.3889.2787.894.43
2133717-13371784.75187.93
3143116-14311690.70894.36
4133173-13317384.40687.89
5128263-12826381.29484.57
6126660-12666080.27883.34
60min1138027-13802787.48288.173.8991.8492.463.91
2141452-14145289.65393.78
3148816-14881694.32198.98
4137331-13733187.04191.46
5134091-13409184.98889.17
6134990-13499085.55889.52
90min1140758-14075889.21390.644.2494.5495.914.17
2149755-14975594.916100.03
3151691-15169196.143101.85
4138784-13878487.96293.35
5138311-13831187.66292.79
6138799-13879987.97292.88
极限1139967-13996788.71289.514.2395.0395.784.11
2148536-14853694.143100.32
3148079-14807993.854100.63
4137155-13715586.93093.29
5133614-13361484.68590.79
6139994-13999488.72994.62
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%
113.861535171538751544031540441541151539910.22
213.831542611544651543630.10
单位质量响应值RSD%判断
11110.4611161.460.33数据可信
加速6月-供试品溶液-2025052121批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min150739-5073932.11736.0811.8932.1236.0811.89
264291-6429140.69540.69
352614-5261433.30433.30
453958-5395834.15434.15
553536-5353633.88733.89
666832-6683242.30342.30
10min171297-7129745.13050.0910.5145.4950.5010.52
286762-8676254.91955.37
372658-7265845.99146.36
475798-7579847.97948.36
576329-7632948.31548.69
691987-9198758.22658.70
15min187470-8747055.36760.119.9256.2361.069.93
2101176-10117664.04265.10
387389-8738955.31556.20
492149-9214958.32859.24
590395-9039557.21858.13
6111165-11116570.36571.48
20min194618-9461859.89165.618.6461.3667.248.68
2111144-11114470.35272.13
396407-9640761.02462.52
4102289-10228964.74766.31
599874-9987463.21864.77
6117573-11757374.42176.32
30min1109738-10973869.46273.777.3971.6076.137.46
2124283-12428378.66981.22
3107480-10748068.03370.21
4115922-11592273.37675.66
5112467-11246771.18973.44
6129400-12940081.90884.63
45min1114758-11475872.63979.017.6475.5582.187.69
2131234-13123483.06886.50
3114699-11469972.60275.53
4125797-12579779.62782.72
5123249-12324978.01481.06
6139165-13916588.08991.72
60min1119841-11984175.85783.087.9579.5787.137.98
2136958-13695886.69291.04
3120646-12064676.36680.10
4133819-13381984.70588.68
5128958-12895881.62885.54
6147262-14726293.21497.83
90min1124313-12431378.68885.696.6583.2590.676.75
2142087-14208789.93895.25
3126528-12652880.09084.67
4137351-13735186.94091.86
5134229-13422984.96489.78
6147779-14777993.54199.19
极限1122851-12285177.76285.366.8783.2091.286.93
2142228-14222890.02796.34
3124735-12473578.95584.43
4136904-13690486.65792.54
5136554-13655486.43692.20
6145811-14581192.29598.99
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