多替诺雷非布司他片项目信息
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%
19.733147231415318223167431644316050.52
29.723185631911318840.13
单位质量响应值RSD%判断
3248.203280.250.70数据可信
供试品溶液-25120201批-多替诺雷-pH5.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min110001-1000127.49025.5612.3027.4925.5612.30
27734-773421.25821.26
38809-880924.21324.21
410210-1021028.06428.06
58416-841623.13323.13
610618-1061829.18629.19
10min119228-1922852.85251.741.8952.9051.791.89
218250-1825050.16350.20
318909-1890951.97552.02
419129-1912952.58052.63
518641-1864151.23851.28
618786-1878651.63751.69
15min122914-2291462.98363.300.9263.1263.430.93
222730-2273062.47862.60
323060-2306063.38563.51
423372-2337264.24264.38
523027-2302763.29463.42
623070-2307063.41263.55
20min125198-2519869.26169.181.0069.5069.411.00
225244-2524469.38869.61
324877-2487768.37968.61
425443-2544369.93570.18
524858-2485868.32768.56
625388-2538869.78470.02
30min127510-2751075.61675.951.1675.9776.301.16
227809-2780976.43876.78
327449-2744975.44975.80
427999-2799976.96077.32
527145-2714574.61374.96
627879-2787976.63176.99
45min128946-2894679.56380.370.7380.0480.850.72
229555-2955581.23781.70
329090-2909079.95980.43
429218-2921880.31180.80
529288-2928880.50380.97
629350-2935080.67481.16
60min129991-2999182.43683.030.7683.0583.640.76
230150-3015082.87383.47
330056-3005682.61483.22
430275-3027583.21683.84
530144-3014482.85683.46
630631-3063184.19584.81
极限130546-3054683.96184.060.6484.7184.800.63
230789-3078984.62985.37
330380-3038083.50584.25
430331-3033183.37084.13
530694-3069484.36885.11
630742-3074284.50085.26
多替诺雷非布司他片项目信息
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101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.432490442488532508872508792504802500290.41
210.382532922535392534160.07
单位质量响应值RSD%判断
23972.1024413.871.30数据可信
供试品溶液-25120201批-非布司他-pH5.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min185741-8574131.86729.1211.2931.8729.1211.29
265140-6514024.21024.21
374717-7471727.77027.77
484931-8493131.56631.57
572681-7268127.01327.01
686891-8689132.29532.29
10min1151063-15106356.14554.312.0156.2054.362.02
2142291-14229152.88552.93
3145085-14508553.92353.97
4147102-14710254.67354.73
5146483-14648354.44354.49
6144798-14479853.81753.87
15min1176750-17675065.69264.510.9465.8464.650.94
2172813-17281364.22964.36
3173462-17346264.47064.61
4172893-17289364.25964.40
5173318-17331864.41764.55
6172201-17220164.00264.15
20min1191679-19167971.24169.911.0771.5070.161.07
2188543-18854370.07570.31
3188081-18808169.90470.15
4185750-18575069.03769.29
5187319-18731969.62069.86
6187240-18724069.59169.84
30min1211358-21135878.55576.621.4978.9376.981.49
2207677-20767777.18777.54
3206543-20654376.76577.13
4203748-20374875.72776.09
5204344-20434475.94876.31
6203244-20324475.53975.91
45min1220841-22084182.07981.741.0282.5982.231.01
2222911-22291182.84983.33
3219903-21990381.73182.22
4216951-21695180.63481.13
5217770-21777080.93881.42
6221130-22113082.18782.68
60min1229205-22920585.18884.600.6285.8385.230.62
2228339-22833984.86685.49
3228171-22817184.80485.43
4225223-22522383.70884.33
5226872-22687284.32184.94
6227922-22792284.71185.34
极限1234565-23456587.18086.361.1287.9687.121.11
2235280-23528087.44688.21
3232350-23235086.35787.12
4227938-22793884.71785.48
5232136-23213686.27787.04
6231810-23181086.15686.93
多替诺雷非布司他片项目信息
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%
19.733187331956317623200431819318830.31
29.723178731612317000.40
单位质量响应值RSD%判断
3276.773261.320.34数据可信
供试品溶液-25120202批-多替诺雷-pH5.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min16067-606716.65118.8814.1616.6518.8814.16
28209-820922.53022.53
36294-629417.27417.27
47671-767121.05421.05
55782-578215.86915.87
67253-725319.90619.91
10min115194-1519441.70144.9211.0041.7344.9611.00
218620-1862051.10451.14
315323-1532342.05542.08
418034-1803449.49649.53
514031-1403138.50938.54
617008-1700846.68046.71
15min121362-2136258.63060.244.5658.7360.344.58
223108-2310863.42263.54
321220-2122058.24058.34
423063-2306363.29863.42
520733-2073356.90356.99
622200-2220060.93061.04
20min124494-2449467.22668.592.8367.4268.802.85
225854-2585470.95871.19
324494-2449467.22667.42
425781-2578170.75870.98
524204-2420466.43066.62
625129-2512968.96969.18
30min127149-2714974.51376.141.9974.8276.462.00
228516-2851678.26478.61
327110-2711074.40674.71
427966-2796676.75577.10
527647-2764775.87976.18
628067-2806777.03277.36
45min129259-2925980.30481.231.3280.7381.681.33
229845-2984581.91282.39
328980-2898079.53879.97
429704-2970481.52581.99
529821-2982181.84682.27
629971-2997182.25882.71
60min130005-3000582.35183.891.0682.9284.471.06
230726-3072684.33084.94
330355-3035583.31283.88
430696-3069684.24884.85
530780-3078084.47885.04
630826-3082684.60485.20
极限130691-3069184.23486.261.5184.9486.991.51
231749-3174987.13887.89
331020-3102085.13785.84
431902-3190287.55888.30
531681-3168186.95187.65
631543-3154386.57287.31
多替诺雷非布司他片项目信息
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101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.432552872546062547252537472538772544480.26
210.382553032555272554150.07
单位质量响应值RSD%判断
24395.7824606.450.61数据可信
供试品溶液-25120202批-非布司他-pH5.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min154562-5456220.02322.2713.0320.0222.2713.04
271764-7176426.33526.34
355291-5529120.29020.29
467576-6757624.79824.80
552221-5222119.16419.16
662671-6267122.99823.00
10min1126831-12683146.54348.299.5246.5848.329.52
2147334-14733454.06754.11
3126681-12668146.48846.52
4145050-14505053.22953.27
5114168-11416841.89641.93
6129456-12945647.50647.54
15min1166696-16669661.17262.483.8161.2862.603.82
2177909-17790965.28765.42
3165839-16583960.85860.97
4177253-17725365.04665.18
5162044-16204459.46559.57
6171853-17185363.06563.18
20min1195259-19525971.65470.442.4071.8770.662.41
2197185-19718572.36172.60
3186778-18677868.54268.75
4194023-19402371.20171.44
5185958-18595868.24168.44
6192491-19249170.63870.86
30min1211608-21160877.65477.371.1377.9977.711.14
2214456-21445678.69979.06
3207577-20757776.17476.50
4210365-21036577.19877.55
5209212-20921276.77477.09
6211761-21176177.71078.05
45min1228575-22857583.88083.480.7184.3483.950.71
2228145-22814583.72284.22
3225228-22522882.65283.11
4225979-22597982.92783.41
5227447-22744783.46683.91
6229496-22949684.21884.69
60min1236730-23673086.87387.210.8587.4787.820.86
2239632-23963287.93888.57
3234926-23492686.21186.80
4236685-23668586.85687.48
5237651-23765187.21187.79
6240325-24032588.19288.80
极限1244127-24412789.58789.410.8490.3390.160.85
2246187-24618790.34391.12
3240206-24020688.14888.88
4243719-24371989.43790.21
5242795-24279589.09889.83
6244760-24476089.81990.58
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