多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D241101对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.037176871736718567175371717717660.08
211.037197172027719990.06
单位质量响应值RSD%判断
6506.446527.560.23数据可信
供试品溶液-J057M批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110504-1050414.46114.114.6514.4614.104.64
210383-1038314.29514.29
310018-1001813.79213.79
410402-1040214.32114.32
59406-940612.94912.95
610761-1076114.81514.81
10min119884-1988427.37526.194.3727.4026.214.36
218153-1815324.99225.02
318855-1885525.95825.98
419835-1983527.30727.33
517975-1797524.74724.77
619420-1942026.73626.76
15min126406-2640636.35435.202.8236.4235.262.82
225475-2547535.07235.14
325403-2540334.97335.04
426232-2623236.11436.18
524383-2438333.56933.63
625488-2548835.09035.16
20min131570-3157043.46341.752.7943.5941.872.79
230042-3004241.36041.48
330168-3016841.53341.66
430927-3092742.57842.71
529091-2909140.05040.17
630135-3013541.48841.62
30min137460-3746051.57250.302.1451.7750.492.14
236448-3644850.17950.37
336661-3666150.47250.67
437014-3701450.95851.16
535149-3514948.39148.58
636471-3647150.21150.41
45min144070-4407060.67258.951.8160.9659.231.81
242644-4264458.70958.99
342535-4253558.55958.84
443401-4340159.75160.04
542003-4200357.82758.09
642269-4226958.19358.47
60min148242-4824266.41664.951.5566.8165.321.56
247146-4714664.90765.28
347082-4708264.81965.19
447755-4775565.74666.13
546289-4628963.72764.09
646543-4654364.07764.45
90min153470-5347073.61472.221.6374.1172.701.63
252283-5228371.97972.46
352776-5277672.65873.14
453198-5319873.23973.73
551260-5126070.57171.04
651751-5175171.24771.73
120min157149-5714978.67976.601.7079.3077.211.71
255326-5532676.16976.77
355774-5577476.78677.39
456183-5618377.34977.97
554599-5459975.16875.75
654807-5480775.45476.06
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限158214-5821480.14579.141.6480.9079.881.64
257275-5727578.85279.58
357796-5779679.56980.30
458741-5874180.87081.62
556460-5646077.73078.44
656424-5642477.68078.41
多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D241101对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.033578835693357553565535595356970.22
211.033589036143360160.50
单位质量响应值RSD%判断
3236.363265.280.63数据可信
供试品溶液-J187N批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15477-547715.11715.207.7015.1215.207.71
25540-554015.29015.29
35099-509914.07314.07
45686-568615.69315.69
55045-504513.92413.92
66203-620317.12017.12
10min110865-1086529.98729.563.3730.0129.583.37
210560-1056029.14629.17
310602-1060229.26229.29
411082-1108230.58630.61
510119-1011927.92927.95
611031-1103130.44630.47
15min114465-1446539.92439.531.4740.0039.611.47
214263-1426339.36639.44
314133-1413339.00739.08
414669-1466940.48740.56
514126-1412638.98839.06
614286-1428639.42939.51
20min116819-1681946.42146.581.9546.5646.721.95
217057-1705747.07747.22
316770-1677046.28546.42
417416-1741648.06848.21
516447-1644745.39445.53
616750-1675046.23046.38
30min120539-2053956.68856.241.7656.9156.461.76
220514-2051456.61956.84
320211-2021155.78356.00
420936-2093657.78458.01
520096-2009655.46555.68
619958-1995855.08455.31
45min124150-2415066.65465.451.9266.9765.761.92
223907-2390765.98466.30
323687-2368765.37665.68
424180-2418066.73767.06
523196-2319664.02164.32
623154-2315463.90564.22
60min126268-2626872.50071.271.8472.9271.691.83
225973-2597371.68672.11
325682-2568270.88371.30
426329-2632972.66873.10
525625-2562570.72571.13
625059-2505969.16369.58
90min128867-2886779.67378.921.7580.2279.461.75
229083-2908380.26980.81
328381-2838178.33278.87
429065-2906580.22080.77
528347-2834778.23878.77
627816-2781676.77277.31
120min130495-3049584.16683.261.7584.8483.931.75
230428-3042883.98284.66
330004-3000482.81183.48
430849-3084985.14385.83
529828-2982882.32682.98
629390-2939081.11781.78
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限131424-3142486.73086.071.0687.5586.881.06
231401-3140186.66787.48
330719-3071984.78585.59
431488-3148886.90787.74
531239-3123986.22087.01
630828-3082885.08685.88
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