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%
1 13.881505651504101502031505101503081503990.10
2 13.891502541500971501760.08
单位质量响应值RSD%判断
10835.6610811.810.16数据可信
供试品溶液-2025051921批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min137511-3751124.42928.308.8424.4328.308.83
246253-4625330.12230.12
344460-4446028.95428.95
441581-4158127.07927.08
548465-4846531.56231.56
642510-4251027.68427.68
10min177932-7793250.75255.246.2951.0255.556.29
280413-8041352.36852.70
388635-8863557.72258.04
484869-8486955.27055.57
592611-9261160.31260.66
684441-8444154.99155.30
15min1110170-11017071.74767.177.1272.5868.107.05
295616-9561662.26963.19
3104040-10404067.75568.72
495055-9505561.90362.82
5112810-11281073.46674.49
6101177-10117765.89066.81
20min199543-9954364.82671.567.5166.4673.247.44
2102975-10297567.06168.67
3112727-11272773.41275.13
4110975-11097572.27173.87
5123169-12316980.21282.05
6109930-10993071.59073.24
30min1116366-11636675.78280.986.6378.1383.456.60
2114788-11478874.75477.11
3125552-12555281.76484.30
4125504-12550481.73384.14
5137708-13770889.68092.41
6126130-12613082.14084.59
45min1126148-12614882.15288.926.3585.3592.296.32
2126353-12635382.28685.47
3139743-13974391.00694.45
4139650-13965090.94594.26
5148250-14825096.546100.27
6139079-13907990.57393.93
60min1132472-13247286.27193.265.9390.3897.615.92
2135155-13515588.01892.12
3145673-14567394.86899.32
4145911-14591195.02399.35
5156079-156079101.644106.44
6143892-14389293.70898.07
90min1139215-13921590.66296.875.9495.73102.265.92
2140786-14078691.68596.76
3147146-14714695.827101.33
4153070-15307099.685105.06
5163380-163380106.399112.33
6148854-14885496.939102.35
极限1139879-13987991.09496.044.0697.17102.524.13
2144697-14469794.232100.33
3145052-14505294.463101.03
4152029-15202999.007105.49
5156743-156743102.077109.19
6146479-14647995.392101.88
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%
1 13.881505151499871500921506111502811502970.18
2 13.891508681504701506690.19
单位质量响应值RSD%判断
10828.3110847.300.13数据可信
供试品溶液-2025052021批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min139839-3983925.91129.417.0825.9129.417.08
244893-4489329.19829.20
344151-4415128.71528.72
449013-4901331.87831.88
545693-4569329.71829.72
647738-4773831.04831.05
10min181903-8190353.26956.614.6553.5656.934.64
291415-9141559.45559.78
390628-9062858.94459.26
488277-8827757.41557.77
582401-8240153.59353.92
687578-8757856.96057.30
15min193364-9336460.72364.925.8661.6065.885.79
297479-9747963.39964.38
3106811-10681169.46970.44
493414-9341460.75661.75
5104055-10405567.67668.60
6103814-10381467.52068.50
20min1101703-10170366.14771.236.0767.7072.906.00
2109759-10975971.38673.08
3118494-11849477.06778.81
4103450-10345067.28368.95
5115814-11581475.32477.00
6107857-10785770.14971.88
30min1114639-11463974.56080.345.5276.8582.815.46
2130769-13076985.05187.53
3130612-13061284.94987.55
4117789-11778976.60979.02
5126602-12660282.34184.86
6120764-12076478.54481.05
45min1124855-12485581.20487.224.3584.3290.584.33
2139804-13980490.92794.35
3137416-13741689.37492.92
4130622-13062284.95588.22
5139232-13923290.55593.98
6132655-13265586.27889.66
60min1129987-12998784.54290.864.8688.5695.194.82
2149102-14910296.975101.41
3144248-14424893.81898.36
4136628-13662888.86293.07
5142010-14201092.36296.80
6136227-13622788.60192.94
90min1135668-13566888.23794.254.0693.2099.594.04
2153035-15303599.532105.05
3145528-14552894.650100.23
4141576-14157692.08097.28
5147821-14782196.141101.60
6145866-14586694.870100.19
极限1135096-13509687.86592.422.9693.8198.813.00
2147786-14778696.119102.74
3142166-14216692.46399.10
4140603-14060391.44797.67
5142842-14284292.90399.43
6144127-14412793.739100.12
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%
1 13.881489431484111482141487491482541485140.22
2 13.891482491479931481210.13
单位质量响应值RSD%判断
10699.8610663.860.24数据可信
供试品溶液-2025052121批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min159585-5958539.31938.554.4139.3238.564.40
258158-5815838.37838.38
359192-5919239.06039.06
454021-5402135.64835.65
561785-6178540.77140.77
657807-5780738.14638.15
10min182663-8266354.54855.471.4954.9955.901.48
284800-8480055.95856.38
385357-8535756.32656.76
482767-8276754.61755.01
583480-8348055.08755.54
685331-8533156.30956.73
15min199010-9901065.33565.324.0166.3866.373.94
2101595-10159567.04168.09
3102865-10286567.87968.94
4101070-10107066.69567.70
591888-9188860.63661.70
697526-9752664.35665.41
20min1109609-10960972.33072.172.3474.1073.942.30
2110243-11024372.74874.54
3112052-11205273.94275.76
4109911-10991172.52974.27
5109908-10990872.52774.27
6104465-10446568.93570.70
30min1122304-12230480.70781.612.3083.2884.182.24
2124445-12444582.12084.72
3125625-12562582.89885.53
4125217-12521782.62985.18
5118534-11853478.21980.76
6125939-12593983.10685.64
45min1136198-13619889.87590.842.7393.3494.322.66
2139671-13967192.16795.68
3140493-14049392.71096.27
4136140-13614089.83793.31
5131644-13164486.87090.28
6141830-14183093.59297.05
60min1143655-14365594.79694.112.2599.2698.602.21
2142703-14270394.16898.71
3145832-14583296.233100.82
4141300-14130093.24297.71
5137001-13700190.40594.78
6145195-14519595.812100.31
90min1145134-14513495.77297.042.68101.29102.572.62
2152422-152422100.581106.17
3150666-15066699.423105.08
4145182-14518295.804101.31
5141721-14172193.52098.90
6147201-14720197.136102.69
极限1146105-14610596.41396.192.08103.00102.802.06
2147825-14782597.548104.25
3148974-14897498.306105.07
4144123-14412395.105101.67
5140586-14058692.77199.19
6146947-14694796.968103.61
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