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%
114.20 1628181628271626661624651626001626750.10
214.22 1618291619621618960.06
单位质量响应值RSD%判断
11455.9911385.090.44数据可信
供试品溶液-24051101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%
5min150049-5004931.74334.9915.7931.7434.9915.79
256140-5614035.60635.61
344624-4462428.30228.30
456788-5678836.01736.02
570453-7045344.68444.68
652985-5298533.60533.60
10min165166-6516641.33050.679.3641.6851.069.34
285560-8556054.26554.66
380720-8072051.19551.51
481943-8194351.97152.37
584735-8473553.74254.24
681209-8120951.50551.88
15min185243-8524354.06461.878.9754.8862.828.98
2102864-10286465.24066.24
389549-8954956.79557.68
4106063-10606367.26968.25
5105558-10555866.94868.04
696015-9601560.89661.84
20min1103427-10342765.59772.486.3367.0174.126.39
2118482-11848275.14576.87
3109013-10901369.14070.65
4120568-12056876.46878.19
5121713-12171377.19479.03
6112518-11251871.36372.98
30min1122998-12299878.00983.827.1580.1586.277.15
2144476-14447691.63194.19
3120411-12041176.36878.65
4138938-13893888.11990.69
5136565-13656586.61489.31
6129590-12959082.19084.61
45min1128092-12809281.24092.699.2584.2596.079.17
2158438-158438100.486104.06
3137292-13729287.07590.21
4163886-163886103.942107.50
5148965-14896594.47898.14
6140199-14019988.91992.25
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%
114.20 1623531622591623501627801626371624760.14
214.22 1620301617031618660.15
单位质量响应值RSD%判断
11441.9711382.980.37数据可信
供试品溶液-1批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min145688-4568828.99730.617.2729.0030.617.27
247136-4713629.91629.92
346614-4661429.58529.58
447571-4757130.19230.19
547103-4710329.89529.90
655263-5526335.07435.07
10min167486-6748642.83251.3311.5243.1551.6711.45
289554-8955456.83857.17
386349-8634954.80455.13
489719-8971956.94357.28
572534-7253446.03646.37
679630-7963050.53950.93
15min192784-9278458.88861.976.4859.6962.886.43
2102726-10272665.19866.16
3107188-10718868.03068.97
496797-9679761.43562.40
596226-9622661.07361.92
690106-9010657.18858.14
20min192313-9231358.58967.627.5960.0469.227.54
2108267-10826768.71570.40
3111943-11194371.04872.74
4115269-11526973.15974.81
5103020-10302065.38566.91
6108413-10841368.80770.39
30min1108161-10816168.64779.928.4370.7582.278.35
2125783-12578379.83282.28
3141143-14114389.58092.06
4129733-12973382.33984.80
5124847-12484779.23881.49
6125892-12589279.90182.25
45min1119922-11992276.11289.627.7378.9892.867.63
2143824-14382491.28294.62
3147665-14766593.72097.20
4142330-14233090.33493.71
5150649-15064995.61498.74
6142874-14287490.67993.92
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%
114.20 1622661622491623611621111619241621820.11
214.22 1616941615381616160.07
单位质量响应值RSD%判断
11421.2711365.400.35数据可信
供试品溶液-2批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min135768-3576822.73926.1611.4822.7426.1611.48
240322-4032225.63425.63
340804-4080425.94125.94
448920-4892031.10131.10
543759-4375927.82027.82
637338-3733823.73723.74
10min170701-7070144.94842.367.3745.2042.657.32
257364-5736436.46936.75
367876-6787643.15243.44
466362-6636242.18942.53
570678-7067844.93345.24
666785-6678542.45842.72
15min168562-6856243.58853.2312.6344.3453.9912.42
293463-9346359.41960.11
395309-9530960.59261.36
475033-7503347.70248.52
588220-8822056.08556.89
681794-8179452.00052.74
20min188354-8835456.17160.155.3957.4161.505.38
292891-9289159.05560.41
396785-9678561.53062.97
493980-9398059.74761.09
5103383-10338365.72567.16
692269-9226958.65959.97
30min199824-9982463.46371.218.6365.3273.238.54
2106885-10688567.95169.96
3122929-12292978.15180.28
4108553-10855369.01271.02
5124426-12442679.10381.26
6109418-10941869.56271.53
45min1122249-12224977.71978.192.9680.2881.002.95
2120495-12049576.60479.37
3123339-12333978.41281.40
4117801-11780174.89177.67
5127282-12728280.91983.96
6126729-12672980.56783.31
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%
114.20 1617201615981615971619031618161617270.09
214.22 1636811637691637250.04
单位质量响应值RSD%判断
11389.2311513.710.77数据可信
供试品溶液-3批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min155391-5539135.03732.797.6535.0432.797.65
252026-5202632.90832.91
346081-4608129.14829.15
456697-5669735.86335.86
552019-5201932.90432.90
648827-4882730.88530.88
10min191514-9151457.88554.485.7158.2754.855.71
288097-8809755.72456.09
383355-8335552.72553.05
491199-9119957.68658.08
583347-8334752.72053.09
679296-7929650.15750.50
15min1100934-10093463.84465.468.3164.8866.438.19
2116830-11683073.89974.88
3110743-11074370.04870.96
499824-9982463.14264.18
599094-9909462.68063.63
693505-9350559.14560.05
20min1129995-12999582.22678.468.1683.9780.168.09
2134951-13495185.36187.17
3131167-13116782.96784.66
4123508-12350878.12379.86
5116327-11632773.58075.23
6108326-10832668.52070.08
30min1152298-15229896.33390.398.7798.9992.968.68
2149457-14945794.53697.29
3146465-14646592.64495.25
4153938-15393897.37199.98
5132673-13267383.92086.39
6122540-12254077.51079.83
45min1161485-161485102.144100.588.52105.87104.158.41
2160962-160962101.814105.62
3173129-173129109.510113.15
4166361-166361105.229108.92
5158673-158673100.366103.76
6133469-13346984.42387.60
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