非布司他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241101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%
110.837045470353702157042470393703680.14
211.087272272675726980.05
单位质量响应值RSD%判断
6497.516561.190.69数据可信
供试品溶液-1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%
5min113507-1350718.56122.4629.2518.5622.4629.25
222513-2251330.93630.94
316745-1674523.01023.01
412943-1294317.78617.79
521491-2149129.53229.53
610875-1087514.94414.94
10min133816-3381646.46848.627.1946.5048.667.21
238743-3874353.23953.29
335484-3548448.76048.80
433743-3374346.36846.40
538066-3806652.30852.36
632441-3244144.57944.60
15min143296-4329659.49560.333.2059.6060.453.22
245473-4547362.48762.63
343654-4365459.98760.11
443694-4369460.04260.15
545501-4550162.52562.66
641813-4181357.45757.56
20min148299-4829966.37067.001.5166.5867.221.53
249353-4935367.81868.06
348696-4869666.91667.14
449155-4915567.54667.75
549489-4948968.00568.25
647556-4755665.34965.54
30min153428-5342873.41874.031.0273.7474.361.03
254045-5404574.26674.62
353654-5365473.72974.06
454620-5462075.05675.38
554318-5431874.64175.00
653189-5318973.09073.39
45min157862-5786279.51179.621.1879.9580.081.17
257757-5775779.36779.85
357312-5731278.75579.21
459263-5926381.43681.88
557867-5786779.51880.00
657589-5758979.13679.56
60min159912-5991282.32882.500.9682.9083.090.94
259738-5973882.08982.70
359519-5951981.78882.37
461114-6111483.98084.56
559749-5974982.10482.72
660190-6019082.71083.27
极限161155-6115584.03684.281.0484.7585.001.04
261337-6133784.28685.04
360787-6078783.53184.25
462560-6256085.96786.69
561235-6123584.14684.89
660923-6092383.71784.41
非布司他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101278-202405对照品来源中检所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%
110.845310705315095310175315845316705313700.06
211.105500705488465494580.16
单位质量响应值RSD%判断
49019.3749500.720.70数据可信
供试品溶液-1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%
5min1121098-12109822.10326.3327.3422.1026.3427.34
2193161-19316135.25735.26
3147289-14728926.88426.88
4115794-11579421.13521.14
5189056-18905634.50834.51
699277-9927718.12118.12
10min1269788-26978849.24351.185.4949.2851.235.52
2299506-29950654.66754.73
3281021-28102151.29351.34
4271674-27167449.58749.62
5297980-29798054.38954.45
6262501-26250147.91347.94
15min1330758-33075860.37260.881.9260.4961.011.94
2340105-34010562.07862.23
3331518-33151860.51060.64
4333908-33390860.94761.06
5341073-34107362.25562.40
6323913-32391359.12259.23
20min1362396-36239666.14766.360.8366.3766.590.84
2364728-36472866.57266.83
3361399-36139965.96566.20
4366107-36610766.82467.04
5367281-36728167.03867.29
6359444-35944465.60865.82
30min1395295-39529572.15172.440.6572.4872.780.65
2396325-39632572.33972.70
3393685-39368571.85872.20
4400864-40086473.16873.50
5398793-39879372.79073.15
6396281-39628172.33172.65
45min1423943-42394377.38077.560.8577.8378.020.83
2422287-42228777.07877.56
3421178-42117876.87677.34
4431338-43133878.73079.18
5424750-42475077.52878.01
6426087-42608777.77278.21
60min1441551-44155180.59480.610.7581.1781.210.73
2438539-43853980.04580.66
3438010-43801079.94880.54
4446528-44652881.50382.09
5441049-44104980.50381.12
6444293-44429381.09581.66
极限1453529-45352982.78182.790.7683.4983.510.75
2451183-45118382.35283.10
3449856-44985682.11082.83
4459763-45976383.91884.64
5453023-45302382.68883.44
6453976-45397682.86283.57
非布司他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241101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%
110.837186971769715297164471491716600.23
211.087197472165720700.19
单位质量响应值RSD%判断
6616.816504.511.22数据可信
供试品溶液-2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%
5min122089-2208930.21028.1212.0930.2128.1212.10
220005-2000527.36027.36
317973-1797324.58124.58
423756-2375632.49032.49
517522-1752223.96423.96
622007-2200730.09830.10
10min139200-3920053.61251.454.0953.6651.504.10
237694-3769451.55351.60
335293-3529348.26948.31
439112-3911253.49253.55
536394-3639449.77549.81
638018-3801851.99652.05
15min146145-4614563.11161.862.3763.2561.992.38
245674-4567462.46762.60
343522-4352259.52359.64
445968-4596862.86963.01
544287-4428760.57060.69
645796-4579662.63362.77
20min150198-5019868.65467.821.9968.9068.052.00
249922-4992268.27668.51
347990-4799065.63465.85
449850-4985068.17868.43
548869-4886966.83667.06
650692-5069269.32969.57
30min154307-5430774.27474.051.1474.6374.401.15
254741-5474174.86775.22
353188-5318872.74373.07
454090-5409073.97774.34
553746-5374673.50673.84
654803-5480374.95275.31
45min158129-5812979.50178.961.6079.9879.431.60
258575-5857580.11180.58
356380-5638077.10977.56
457619-5761978.80379.29
556977-5697777.92578.38
658708-5870880.29380.77
60min159538-5953881.42881.161.3882.0481.761.38
260152-6015282.26882.88
358166-5816679.55180.13
459077-5907780.79781.41
558833-5883380.46481.05
660295-6029582.46383.08
极限160885-6088583.27083.091.4084.0283.831.41
261425-6142584.00984.75
359408-5940881.25081.96
460511-6051182.75983.51
560467-6046782.69883.42
661843-6184384.58085.33
非布司他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101278-202405对照品来源中检所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%
110.845446015438085424535431035427935433520.16
211.105538775557005547880.24
单位质量响应值RSD%判断
50124.7249980.900.21数据可信
供试品溶液-2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%
5min1192955-19295534.66132.3811.4534.6632.3811.45
2176767-17676731.75331.75
3158931-15893128.54928.55
4206569-20656937.10637.11
5154404-15440427.73627.74
6192081-19208134.50434.50
10min1309873-30987355.66353.423.7955.7253.483.80
2298921-29892153.69553.75
3280592-28059250.40350.45
4306893-30689355.12755.19
5287701-28770151.68051.73
6300340-30034053.95054.01
15min1351115-35111563.07161.752.1663.2261.902.17
2348250-34825062.55662.70
3331849-33184959.61059.74
4346795-34679562.29562.45
5337594-33759460.64260.77
6347085-34708562.34762.49
20min1374708-37470867.30966.491.7667.5666.731.77
2375329-37532967.42167.67
3358971-35897164.48264.71
4371249-37124966.68866.95
5365972-36597265.74065.97
6374529-37452967.27767.53
30min1403704-40370472.51872.011.2972.8972.361.30
2405856-40585672.90473.26
3392666-39266670.53570.87
4399486-39948671.76072.13
5397933-39793371.48171.82
6405514-40551472.84373.21
45min1431120-43112077.44276.701.4077.9377.181.41
2432710-43271077.72878.21
3416768-41676874.86475.32
4427382-42738276.77177.26
5423602-42360276.09276.55
6430404-43040477.31477.80
60min1445763-44576380.07379.511.2880.6980.121.29
2447782-44778280.43581.05
3433006-43300677.78178.36
4442038-44203879.40480.02
5439772-43977278.99779.59
6447374-44737480.36280.98
极限1455366-45536681.79881.491.3382.5582.221.34
2459010-45901082.45283.20
3442751-44275179.53280.24
4453779-45377981.51382.26
5452053-45205381.20381.92
6458913-45891382.43583.18
非布司他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241101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%
110.837033070309703267019770383703090.10
211.087205771929719930.13
单位质量响应值RSD%判断
6492.066497.560.06数据可信
供试品溶液-3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%
5min121389-2138929.54724.1229.8529.5524.1229.84
220750-2075028.66528.66
37810-781010.78910.79
417021-1702123.51323.51
521341-2134129.48129.48
616432-1643222.70022.70
10min138381-3838153.02149.2610.0453.0749.3010.06
237730-3773052.12152.17
328797-2879739.78139.80
435777-3577749.42349.46
537932-3793252.40052.45
635356-3535648.84248.88
15min145009-4500962.17760.664.8962.3160.784.91
244845-4484561.95062.08
339586-3958654.68554.77
444435-4443561.38461.51
545213-4521362.45862.59
644387-4438761.31761.44
20min148790-4879067.40067.071.9567.6467.291.99
248999-4899967.68867.93
346683-4668364.48964.66
448886-4888667.53267.76
549331-4933168.14768.39
648614-4861467.15767.38
30min153490-5349073.89274.140.6874.2574.480.71
253677-5367774.15174.50
353068-5306873.31073.59
453911-5391174.47474.81
554119-5411974.76175.12
653746-5374674.24674.58
45min157114-5711478.89979.590.8879.3880.050.86
257073-5707378.84279.32
358061-5806180.20780.61
458315-5831580.55881.02
557707-5770779.71880.20
657425-5742579.32879.79
60min158861-5886181.31281.960.6881.9282.550.66
258925-5892581.40182.01
359612-5961282.35082.89
459876-5987682.71483.31
559215-5921581.80182.41
659480-5948082.16782.76
极限160178-6017883.13183.700.5383.8884.430.51
260289-6028983.28584.03
360838-6083884.04384.72
461018-6101884.29285.02
560584-6058483.69284.44
660652-6065283.78684.51
非布司他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101278-202405对照品来源中检所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%
110.845410405389355384115384755381225389970.22
211.105567815563485565640.06
单位质量响应值RSD%判断
49722.9750140.900.60数据可信
供试品溶液-3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%
5min1188461-18846133.93627.8028.8533.9427.8028.85
2182218-18221832.81232.81
371547-7154712.88312.88
4150945-15094527.18027.18
5186705-18670533.62033.62
6146536-14653626.38626.39
10min1303240-30324054.60451.038.4254.6651.088.44
2296344-29634453.36253.42
3237556-23755642.77642.80
4284083-28408351.15451.20
5296877-29687753.45853.51
6282357-28235750.84450.89
15min1343893-34389361.92460.233.7962.0760.363.81
2339285-33928561.09461.24
3309154-30915455.66955.76
4336672-33667260.62460.75
5340199-34019961.25961.40
6337760-33776060.82060.95
20min1367000-36700066.08565.291.6466.3465.521.67
2365012-36501265.72765.97
3350753-35075363.15963.35
4363150-36315065.39265.62
5365500-36550065.81566.06
6364172-36417265.57665.81
30min1395559-39555971.22871.360.3271.5971.700.34
2395179-39517971.15971.51
3394757-39475771.08371.37
4397498-39749871.57771.92
5397173-39717371.51871.88
6397497-39749771.57771.92
45min1422810-42281076.13576.280.4576.6176.740.45
2421385-42138575.87876.35
3422780-42278076.12976.54
4427005-42700576.89077.35
5424036-42403676.35576.83
6423678-42367876.29176.75
60min1435564-43556478.43179.150.6579.0479.740.62
2436790-43679078.65279.25
3441740-44174079.54380.08
4440865-44086579.38679.97
5439710-43971079.17879.78
6442698-44269879.71680.30
极限1448214-44821480.70981.100.5181.4581.820.48
2447082-44708280.50581.24
3452894-45289481.55282.22
4452120-45212081.41282.13
5451201-45120181.24781.98
6450705-45070581.15881.88
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