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%
113.861531001531871534171530961533201532240.10
213.831533351530651532000.13
单位质量响应值RSD%判断
11055.1211077.370.15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%
5min165633-6563341.80639.2210.4541.8139.2210.45
253401-5340134.01534.01
366063-6606342.08042.08
453984-5398434.38634.39
562035-6203539.51439.51
668318-6831843.51643.52
10min192291-9229158.78654.778.3859.2555.218.39
279404-7940450.57850.96
390071-9007157.37257.84
474599-7459947.51747.90
588969-8896956.67057.11
690599-9059957.70858.19
15min1110007-11000770.07165.657.4271.1966.707.45
295643-9564360.92161.86
3106653-10665367.93469.04
491638-9163858.37059.28
5104931-10493166.83767.91
6109533-10953369.76970.89
20min1119550-11955076.14970.747.9878.0572.527.99
2101102-10110264.39866.02
3113218-11321872.11673.98
499020-9902063.07264.63
5114894-11489473.18374.99
6118592-11859275.53977.44
30min1130842-13084283.34279.806.4186.0882.366.46
2115391-11539173.50075.83
3129437-12943782.44785.11
4115700-11570073.69775.96
5125912-12591280.20182.83
6134432-13443285.62888.37
45min1140264-14026489.34385.884.8393.0189.324.93
2126940-12694080.85684.01
3139266-13926688.70892.28
4128055-12805581.56784.64
5132580-13258084.44987.96
6141861-14186190.36094.05
60min1142770-14277090.93987.583.7895.6091.983.93
2132636-13263684.48488.53
3141037-14103789.83694.40
4130391-13039183.05487.04
5136340-13634086.84491.30
6141836-14183690.34595.04
90min1145127-14512792.44190.252.7698.1195.622.96
2139068-13906888.58193.57
3143901-14390191.66097.22
4135262-13526286.15791.06
5141733-14173390.27995.70
6145031-14503192.38098.08
极限1143286-14328691.26889.212.7997.9795.592.97
2138438-13843888.18094.15
3141495-14149590.12796.71
4133538-13353885.05990.92
5139317-13931788.74095.16
6144275-14427591.89898.62
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%
113.861538611536421537781545831541111539950.25
213.831527091532011529550.23
单位质量响应值RSD%判断
11110.7511059.650.33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%
5min148077-4807730.57134.5510.5030.5734.5510.50
260786-6078638.65238.65
352770-5277033.55533.56
462020-6202039.43739.44
551335-5133532.64332.64
650978-5097832.41632.42
10min170837-7083745.04450.4710.2645.3850.8610.26
289702-8970257.04057.47
375569-7556948.05348.43
489451-8945156.88057.32
574105-7410547.12247.48
676577-7657748.69449.05
15min187544-8754455.66760.449.7356.5161.399.73
2103871-10387166.04967.11
390982-9098257.85358.76
4109419-10941969.57770.65
590378-9037857.46958.36
688113-8811356.02956.93
20min191854-9185458.40866.689.1459.8768.309.15
2112735-11273571.68673.48
3102872-10287265.41466.96
4118976-11897675.65477.50
5100850-10085064.12865.65
6101925-10192564.81266.34
30min1102695-10269565.30275.158.9967.4177.519.01
2126195-12619580.24582.84
3115154-11515473.22475.50
4133630-13363084.97287.66
5116247-11624773.91976.16
6115210-11521073.26075.50
45min1114091-11409172.54881.858.3575.3885.048.39
2137390-13739087.36390.85
3124479-12447979.15382.24
4144575-14457591.93295.56
5127054-12705480.79183.85
6124746-12474679.32382.38
60min1120927-12092776.89585.546.9080.5389.656.99
2140929-14092989.61494.07
3131264-13126483.46887.44
4147901-14790194.04798.70
5135345-13534586.06390.02
6130814-13081483.18287.12
90min1127023-12702380.77188.856.2085.2693.906.32
2146136-14613692.92598.38
3137338-13733887.33092.23
4152100-15210096.717102.41
5139642-13964288.79593.71
6136138-13613886.56791.43
极限1124257-12425779.01287.525.7384.4093.555.86
2141432-14143289.93496.42
3135968-13596886.45992.33
4148276-14827694.285101.05
5138683-13868388.18594.08
6137164-13716487.22093.04
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%
113.861520891523071522081530381527261524740.26
213.831553201551351552280.09
单位质量响应值RSD%判断
11001.0111224.011.42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%
5min157304-5730436.35236.4810.4436.3536.4810.44
251318-5131832.55532.55
361810-6181039.21139.21
461676-6167639.12639.13
549279-4927931.26131.26
663670-6367040.39140.39
10min181607-8160751.77051.398.9252.1751.808.93
274518-7451847.27247.63
385981-8598154.54454.98
485663-8566354.34354.78
570078-7007844.45644.80
688239-8823955.97756.43
15min196323-9632361.10560.547.6162.0861.527.65
287479-8747955.49556.38
3101405-10140564.32965.37
4100440-10044063.71764.76
585379-8537954.16255.00
6101576-10157664.43765.51
20min1107367-10736768.11167.365.3969.7769.015.46
2103804-10380465.85167.35
3109644-10964469.55671.31
4108469-10846968.81070.56
595901-9590160.83762.28
6111959-11195971.02472.81
30min1118794-11879475.36075.087.7377.7777.487.71
2109517-10951769.47571.71
3121465-12146577.05479.58
4120270-12027076.29678.81
5107391-10739168.12670.25
6132714-13271484.19186.77
45min1129209-12920981.96781.745.7685.2284.975.82
2121185-12118576.87779.88
3130574-13057482.83386.22
4135736-13573686.10889.47
5119117-11911775.56578.44
6137288-13728887.09290.60
60min1137099-13709986.97284.645.5191.1488.785.57
2124764-12476479.14783.01
3136868-13686886.82691.13
4133925-13392584.95989.27
5124743-12474379.13482.85
6143112-14311290.78795.27
90min1138580-13858087.91287.124.9593.0492.205.04
2129716-12971682.28987.03
3141017-14101789.45894.73
4138990-13899088.17293.43
5129088-12908881.89086.49
6146621-14662193.01398.50
极限1135904-13590486.21485.704.8592.3291.754.95
2128457-12845781.49087.15
3139102-13910288.24394.51
4136893-13689386.84293.08
5126444-12644480.21385.72
6143786-14378691.21497.74
点击查看处理图标(自动生成)
 
原始图谱下载图谱(谢鑫慧 于 2025-12-29 12:02:16 完成)
生成报告数据部分(等待生成报告)
Current page cost:83 ms