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D230603对照品来源自制对照品使用方法直接使用
对照品含量(%)97.04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%
114.363133831416313163148131263313630.28
2 13.612920829439293240.56
单位质量响应值RSD%判断
2184.052154.590.97数据可信
供试品溶液-123640批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min110529-1052933.91332.886.4833.9132.886.48
210655-1065534.31934.32
310686-1068634.41934.42
48926-892628.75028.75
510168-1016832.75032.75
610294-1029433.15633.16
10min115193-1519348.93549.554.1349.3149.924.10
216461-1646153.01953.40
314543-1454346.84247.22
415312-1531249.31949.64
515170-1517048.86149.23
615623-1562350.32050.69
15min119611-1961163.16561.494.7464.0962.414.68
218812-1881260.59261.56
318319-1831959.00459.91
418666-1866660.12260.99
520690-2069066.64167.55
618450-1845059.42660.35
20min121474-2147469.16668.784.4870.7970.384.44
222067-2206771.07672.72
321406-2140668.94770.51
419789-1978963.73965.27
522520-2252072.53574.18
620877-2087767.24368.83
30min125031-2503180.62378.153.1883.0180.523.13
225037-2503780.64283.08
323567-2356775.90778.23
423547-2354775.84378.09
523578-2357875.94378.40
624826-2482679.96282.30
45min127375-2737588.17386.473.1591.4689.703.13
227607-2760788.92092.25
325581-2558182.39485.56
426030-2603083.84086.93
527489-2748988.54091.84
626996-2699686.95290.18
60min127604-2760488.91088.722.5493.1892.922.52
227707-2770789.24293.56
327041-2704187.09791.18
427010-2701086.99791.01
528833-2883392.86997.15
627079-2707987.21991.41
90min128121-2812190.57591.223.1095.8396.403.02
229367-2936794.58999.90
328628-2862892.20897.26
426760-2676086.19291.18
528314-2831491.19796.51
628728-2872892.53097.69
极限127672-2767289.12989.142.2595.3995.342.25
228613-2861392.16098.52
327527-2752788.66294.74
426938-2693886.76592.71
528142-2814290.64396.97
627163-2716387.49093.68
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D230603对照品来源自制对照品使用方法直接使用
对照品含量(%)97.04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%
114.362929129318289042928329079291750.62
2 13.612771427605276600.28
单位质量响应值RSD%判断
2031.692032.330.03数据可信
供试品溶液-123640批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min19561-956132.87534.156.3832.8734.146.38
210579-1057936.37536.37
39315-931532.02932.03
49564-956432.88532.88
510868-1086837.36937.37
69698-969833.34633.35
10min114397-1439749.50354.406.0349.8754.786.00
217002-1700258.46058.86
315498-1549853.28953.64
415459-1545953.15453.52
515810-1581054.36154.78
616758-1675857.62157.99
15min117895-1789561.53065.286.5962.4566.266.54
221248-2124873.05974.11
319440-1944066.84367.79
417929-1792961.64762.60
518796-1879664.62865.65
618606-1860663.97564.99
20min118747-1874764.46071.637.3166.0673.347.24
222821-2282178.46880.33
322221-2222176.40578.10
419974-1997468.67970.32
520116-2011669.16770.90
621121-2112172.62374.34
30min121913-2191375.34681.385.0677.6683.895.06
224781-2478185.20787.94
324002-2400282.52985.07
422444-2244477.17279.58
524289-2428983.51686.02
624585-2458584.53387.06
45min123406-2340680.47989.356.0383.6392.765.95
226758-2675892.00595.69
325658-2565888.22391.68
425292-2529286.96490.23
527850-2785095.76099.19
626946-2694692.65196.12
60min124352-2435283.73292.315.6387.7896.715.61
228288-2828897.266101.97
326854-2685492.33596.77
425896-2589689.04193.27
528182-2818296.901101.40
627504-2750494.57099.07
90min125091-2509186.27394.616.0591.25100.045.99
228724-2872498.765104.55
327351-2735194.04499.51
426132-2613289.85395.07
529502-29502101.440107.01
628294-2829497.286102.83
极限125049-2504986.12993.915.4992.06100.395.45
228214-2821497.011103.90
327861-2786195.798102.31
426153-2615389.92596.14
529219-29219100.467107.17
627371-2737194.113100.74
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D230603对照品来源自制对照品使用方法直接使用
对照品含量(%)97.04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%
114.363452434493343933415734076343290.59
2 13.613369533847337710.32
单位质量响应值RSD%判断
2390.602481.342.64数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-123640批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min114296-1429641.01842.883.4441.0242.883.45
215452-1545244.33544.34
314584-1458441.84541.84
415645-1564544.88944.89
514815-1481542.50742.51
614876-1487642.68242.68
10min120319-2031958.29956.604.4758.7657.084.44
220178-2017857.89558.39
318105-1810551.94752.41
419677-1967756.45756.96
520540-2054058.93459.41
619534-1953456.04756.52
15min122721-2272165.19164.763.9966.2965.873.96
222147-2214763.54464.68
320970-2097060.16761.21
423353-2335367.00568.13
523299-2329966.85067.98
622939-2293965.81766.91
20min124238-2423869.54470.853.6071.3772.673.57
225128-2512872.09873.94
323610-2361067.74269.45
424864-2486471.34073.21
526131-2613174.97576.85
624179-2417969.37571.20
30min127473-2747378.82679.963.9881.4382.573.93
227444-2744478.74381.39
326065-2606574.78677.25
428422-2842281.54984.21
528636-2863682.16384.87
629159-2915983.66386.26
45min128952-2895283.06984.943.6986.5588.443.64
229553-2955384.79488.31
328060-2806080.51083.80
429373-2937384.27787.85
530872-3087288.57892.19
630815-3081588.41591.94
60min129511-2951184.67387.744.0789.0792.183.96
232615-3261593.57998.04
329156-2915683.65587.84
430281-3028186.88391.39
530813-3081388.40993.01
631102-3110289.23893.75
90min129364-2936484.25187.214.7789.5992.634.66
230652-3065287.94793.45
327974-2797480.26385.38
431326-3132689.88195.35
531387-3138790.05695.64
631672-3167290.87496.38
极限128848-2884882.77186.593.1889.0592.973.04
230386-3038687.18493.66
330074-3007486.28992.30
429912-2991285.82492.29
530036-3003686.18092.76
631810-3181091.27097.78
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