沙库巴曲缬沙坦钠氢氯噻嗪片项目信息
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100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数1000
标示量(mg)12.5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%
1 14.033515773515773519803521123515263517540.08
2 14.013517923521093519500.07
单位质量响应值RSD%判断
25071.5625121.340.15数据可信
供试品溶液-24FA489批-氢氯噻嗪-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%
5min1114085-11408532.63233.4022.4032.6333.4022.40
275472-7547221.58721.59
3132475-13247537.89237.89
4153302-15330243.84943.85
5105877-10587730.28430.28
6119463-11946334.17034.17
10min1199420-19942057.04150.8612.3257.1050.9112.33
2143079-14307940.92540.96
3178927-17892751.17951.24
4199275-19927556.99957.07
5183504-18350452.48852.54
6162607-16260746.51146.57
15min1227672-22767265.12258.0710.9965.2758.2110.99
2168439-16843948.17948.28
3204269-20426958.42858.58
4221738-22173863.42463.59
5209845-20984560.02360.16
6186196-18619653.25853.39
20min1248975-24897571.21563.219.7971.4763.449.79
2191065-19106554.65154.84
3222278-22227863.57963.82
4237559-23755967.95068.22
5224239-22423964.14064.38
6201724-20172457.70057.92
30min1269060-26906076.96069.668.0877.3470.008.09
2219452-21945262.77063.05
3241938-24193869.20269.55
4256151-25615173.26873.65
5252477-25247772.21772.56
6222057-22205763.51663.83
45min1285382-28538281.62976.067.9082.1376.527.91
2243058-24305869.52369.90
3265657-26565775.98776.45
4283428-28342881.07081.58
5280178-28017880.14080.61
6237746-23774668.00368.43
60min1295227-29522784.44579.737.9485.0980.317.95
2258666-25866673.98774.48
3277268-27726879.30879.90
4301633-30163386.27786.92
5293083-29308383.83184.43
6246492-24649270.50571.04
极限1311519-31151989.10586.704.9489.8987.424.96
2292962-29296283.79784.42
3304318-30431887.04587.77
4322078-32207892.12592.91
5308293-30829388.18288.92
6279549-27954979.96080.62
沙库巴曲缬沙坦钠氢氯噻嗪片项目信息
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57323100856对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.477
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
122.565926765930885929285941015917875929160.15
2 22.455954685959685957180.06
单位质量响应值RSD%判断
26281.7426535.320.68数据可信
供试品溶液-24FA489批-沙库巴曲-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%
5min16236-62360.4770.9071.130.480.9071.03
212552-125520.9610.96
315585-155851.1931.19
426103-261031.9992.00
54441-44410.3400.34
65326-53260.4080.41
10min154135-541354.1453.8013.904.153.8013.92
248642-486423.7243.73
338352-383522.9372.94
453027-530274.0604.06
557530-575304.4054.41
645763-457633.5043.50
15min168296-682965.2295.0315.365.245.0415.37
259065-590654.5224.53
354011-540114.1364.14
467638-676385.1795.19
583080-830806.3616.37
661793-617934.7314.74
20min1101591-1015917.7796.6117.417.806.6317.41
286739-867396.6416.66
363585-635854.8694.88
494742-947427.2547.27
598133-981337.5147.53
673309-733095.6135.63
30min1140148-14014810.7319.4823.6610.769.5123.65
2111513-1115138.5388.56
379934-799346.1206.14
4126828-1268289.7119.74
5167368-16736812.81512.85
6117312-1173128.9829.01
45min1162005-16200512.40411.9223.5312.4511.9623.50
2132617-13261710.15410.19
3109262-1092628.3668.40
4200376-20037615.34215.39
5195116-19511614.94014.99
6134908-13490810.33010.37
60min1178601-17860113.67513.2521.6013.7413.3221.59
2147844-14784411.32011.38
3129606-1296069.9249.97
4222057-22205717.00217.08
5211206-21120616.17216.25
6149120-14912011.41811.47
极限1257740-25774019.73519.692.8919.8319.782.94
2253704-25370419.42619.50
3245055-24505518.76318.83
4263214-26321420.15420.25
5266042-26604220.37020.47
6257200-25720019.69319.77
沙库巴曲缬沙坦钠氢氯噻嗪片项目信息
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57323100856对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.451
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
122.561093539109022610971061098650109627610951590.31
2 22.451098063109870310983830.05
单位质量响应值RSD%判断
48544.2848925.750.56数据可信
供试品溶液-24FA489批-缬沙坦-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%
5min111309-113090.4440.9377.210.440.9377.37
225023-250230.9820.98
332153-321531.2611.26
455596-555962.1812.18
57997-79970.3140.31
610117-101170.3970.40
10min1112501-1125014.4134.0314.984.414.0314.96
2100662-1006623.9493.95
378439-784393.0773.08
4110354-1103544.3294.33
5121051-1210514.7494.75
692837-928373.6423.64
15min1141552-1415525.5535.2915.945.565.3015.96
2119337-1193374.6814.69
3110282-1102824.3264.33
4137963-1379635.4125.42
5171758-1717586.7386.75
6128158-1281585.0275.03
20min1209324-2093248.2126.9317.988.236.9517.96
2177269-1772696.9546.97
3128669-1286695.0485.06
4192402-1924027.5487.57
5202773-2027737.9557.97
6149488-1494885.8645.88
30min1286058-28605811.2229.8025.3911.259.8325.37
2222923-2229238.7458.77
3157290-1572906.1706.19
4254302-2543029.97610.01
5345767-34576713.56413.60
6232789-2327899.1329.16
45min1324424-32442412.72712.1925.0412.7812.2424.99
2260439-26043910.21710.26
3213213-2132138.3648.40
4405138-40513815.89315.94
5395326-39532615.50815.56
6266354-26635410.44910.49
60min1351822-35182213.80213.3623.5513.8713.4223.52
2285513-28551311.20011.26
3247161-2471619.6969.74
4444293-44429317.42917.50
5424199-42419916.64116.72
6290383-29038311.39111.45
极限1512105-51210520.08920.123.3220.1820.203.40
2503102-50310219.73619.81
3486633-48663319.09019.15
4524678-52467820.58320.69
5535521-53552121.00821.12
6515141-51514120.20820.28
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