美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D69223050102对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.34209348
209348+0		209352
209352+0		209458
209458+0		209217
209217+0		209386
209386+0		2093520.05
219.40211426
211426+0		210801
210801+0		2111140.21
单位质量响应值RSD%判断
10824.8210882.160.38数据可信
供试品溶液-24040701批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min115635.2
15068+709*0.8		-15635.27.5498.003.077.558.003.06
216738.2
16135+754*0.8		-16738.28.0818.08
316693.8
16049+806*0.8		-16693.88.0608.06
416892.8
16292+751*0.8		-16892.88.1568.16
517071
16467+755*0.8		-170718.2428.24
616441
15741+875*0.8		-164417.9387.94
10min129066.8
28138+1161*0.8		-29066.814.03413.951.6414.1214.041.63
229533.2
28618+1144*0.8		-29533.214.25914.35
328109.4
27231+1098*0.8		-28109.413.57113.66
428720.8
27816+1131*0.8		-28720.813.86713.96
529069.6
28136+1167*0.8		-29069.614.03514.13
628862.2
27975+1109*0.8		-28862.213.93514.02
15min136581.2
35454+1409*0.8		-36581.217.66217.351.1517.9017.591.13
236192.6
35075+1397*0.8		-36192.617.47417.72
335978.4
34848+1413*0.8		-35978.417.37117.61
435793.8
34669+1406*0.8		-35793.817.28217.53
535466.6
34377+1362*0.8		-35466.617.12417.37
635584.6
34495+1362*0.8		-35584.617.18117.42
20min139830.2
38587+1554*0.8		-39830.219.23019.301.6619.6719.741.63
239877.8
38633+1556*0.8		-39877.819.25319.70
339528
38300+1535*0.8		-3952819.08419.52
440510.6
39237+1592*0.8		-40510.619.55920.00
540988.6
39711+1597*0.8		-40988.619.79020.23
639175.4
37957+1523*0.8		-39175.418.91419.35
30min142958.2
41415+1929*0.8		-42958.220.74121.101.0021.3921.750.97
244113.6
42548+1957*0.8		-44113.621.29821.95
343932.8
42364+1961*0.8		-43932.821.21121.86
444045.8
42453+1991*0.8		-44045.821.26621.92
543485.6
41956+1912*0.8		-43485.620.99521.65
643708.4
42174+1918*0.8		-43708.421.10321.75
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min146082
44318+2205*0.8		-4608222.24922.221.5523.1323.111.49
245373.6
43616+2197*0.8		-45373.621.90722.80
346877.8
45025+2316*0.8		-46877.822.63323.51
446882.2
45067+2269*0.8		-46882.222.63523.53
545367
43559+2260*0.8		-4536721.90422.79
645578.4
43804+2218*0.8		-45578.422.00622.88
60min147232
45236+2495*0.8		-4723222.80423.090.8723.9324.220.84
248107.6
46090+2522*0.8		-48107.623.22724.36
347456.2
45457+2499*0.8		-47456.222.91224.04
447763.2
45748+2519*0.8		-47763.223.06024.20
548062
46030+2540*0.8		-4806223.20524.34
648305.4
46271+2543*0.8		-48305.423.32224.45
极限148117.6
45980+2672*0.8		-48117.623.23223.300.6324.6124.690.60
248814.8
46658+2696*0.8		-48814.823.56824.96
348024.2
45881+2679*0.8		-48024.223.18624.57
448210.8
46054+2696*0.8		-48210.823.27724.67
548039.6
45862+2722*0.8		-48039.623.19424.59
648404.6
46215+2737*0.8		-48404.623.37024.75
美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D69223050102对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.34209370
209370+0		209140
209140+0		208926
208926+0		208932
208932+0		209007
209007+0		2090750.09
219.40210820
210820+0		210617
210617+0		2107180.07
单位质量响应值RSD%判断
10810.5010861.750.34数据可信
供试品溶液-24040701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%
5min124058.6
23201+1072*0.8		-24058.611.63412.247.7011.6312.247.71
226421.2
25462+1199*0.8		-26421.212.77712.78
326355
25431+1155*0.8		-2635512.74512.74
427042.4
26100+1178*0.8		-27042.413.07713.08
526076
25184+1115*0.8		-2607612.61012.61
621917.4
21131+983*0.8		-21917.410.59910.60
10min145917
44637+1600*0.8		-4591722.20522.202.9422.3322.332.96
246816.6
45447+1712*0.8		-46816.622.64022.78
345900.8
44604+1621*0.8		-45900.822.19722.34
447519.2
46144+1719*0.8		-47519.222.97923.12
545695.2
44404+1614*0.8		-45695.222.09722.24
643534.2
42303+1539*0.8		-43534.221.05221.17
15min153598.6
52105+1867*0.8		-53598.625.91926.111.4526.3026.491.49
254899.8
53307+1991*0.8		-54899.826.54926.94
353548.8
51984+1956*0.8		-53548.825.89526.28
454892
53320+1965*0.8		-5489226.54526.95
554044.4
52522+1903*0.8		-54044.426.13526.52
652965.8
51481+1856*0.8		-52965.825.61325.96
20min156724.6
55075+2062*0.8		-56724.627.43127.772.1328.0928.442.14
257566.4
55888+2098*0.8		-57566.427.83828.53
358565.4
56839+2158*0.8		-58565.428.32129.00
457842.6
56089+2192*0.8		-57842.627.97228.67
558459.6
56742+2147*0.8		-58459.628.27028.95
655335.2
53720+2019*0.8		-55335.226.75927.40
30min159226.8
56794+3041*0.8		-59226.828.64128.563.2129.6129.543.15
257815.8
55327+3111*0.8		-57815.827.95928.96
358066.6
55701+2957*0.8		-58066.628.08029.07
462542.6
59949+3242*0.8		-62542.630.24431.25
559391.4
56973+3023*0.8		-59391.428.72129.71
657305
54981+2905*0.8		-5730527.71228.65
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min160236.8
57328+3636*0.8		-60236.829.12929.170.9530.4230.470.86
260862
57750+3890*0.8		-6086229.43230.74
360444.2
57493+3689*0.8		-60444.229.23030.53
460131.2
57112+3774*0.8		-60131.229.07830.42
559371.6
56426+3682*0.8		-59371.628.71130.02
660921.2
57942+3724*0.8		-60921.229.46030.70
60min161960.2
58365+4494*0.8		-61960.229.96329.482.3231.5731.102.22
262042.4
58372+4588*0.8		-62042.430.00331.64
358349.2
54954+4244*0.8		-58349.228.21729.84
461850.6
58153+4622*0.8		-61850.629.91031.58
560518.8
56990+4411*0.8		-60518.829.26630.89
661076.8
57608+4336*0.8		-61076.829.53631.10
极限163597.8
59601+4996*0.8		-63597.830.75529.932.2332.7031.882.13
262610.4
58288+5403*0.8		-62610.430.27732.25
360864.4
56946+4898*0.8		-60864.429.43331.37
462918.2
58639+5349*0.8		-62918.230.42632.42
559974.6
56109+4832*0.8		-59974.629.00330.96
661393
57513+4850*0.8		-6139329.68931.59
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