替米沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源原料药对照品使用方法直接使用
对照品含量(%)100.00对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.074954054954584954924951344948024952580.06
2 11.124969814968414969110.02
单位质量响应值RSD%判断
44738.7544686.240.09数据可信
供试品溶液-F90166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%
5min1106341-10634121.40522.694.5721.4022.704.57
2116394-11639423.42823.43
3113699-11369922.88622.89
4108934-10893421.92721.93
5110731-11073122.28922.29
6120392-12039224.23324.23
10min1238161-23816147.93847.121.2248.0647.251.21
2231808-23180846.66046.79
3232346-23234646.76846.90
4230903-23090346.47846.60
5235583-23558347.42047.54
6235868-23586847.47747.61
15min1334781-33478167.38766.543.3867.7766.933.37
2326591-32659165.73866.13
3316631-31663163.73364.12
4321805-32180564.77565.15
5347469-34746969.94170.33
6336233-33623367.67968.08
20min1430225-43022586.59884.444.5987.3685.204.56
2395720-39572079.65380.41
3408936-40893682.31383.05
4414755-41475583.48484.22
5451504-45150490.88191.66
6415791-41579183.69384.47
30min1477866-47786696.18899.692.8297.43100.922.79
2482335-48233597.08798.28
3490624-49062498.75699.95
4510478-510478102.752103.96
5500131-500131100.669101.95
6510217-510217102.700103.94
45min1482543-48254397.129103.063.3498.90104.843.28
2510868-510868102.831104.57
3523255-523255105.324107.07
4533301-533301107.346109.12
5508961-508961102.447104.29
6513151-513151103.290105.10
60min1484269-48426997.47799.502.7499.79101.852.70
2496903-496903100.020102.33
3478003-47800396.21598.55
4488516-48851698.331100.70
5503222-503222101.292103.70
6514983-514983103.659106.04
极限1506268-506268101.905101.311.36104.76104.221.32
2504724-504724101.594104.46
3500094-500094100.662103.53
4497471-497471100.134103.05
5496576-49657699.954102.93
6514733-514733103.609106.57
替米沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源原料药对照品使用方法直接使用
对照品含量(%)100.00对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.074988004984614985244983444983504984960.04
2 11.124993374993614993490.01
单位质量响应值RSD%判断
45031.2644905.490.20数据可信
供试品溶液-F66942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%
5min191089-9108918.23119.646.1118.2319.646.12
2103579-10357920.73020.73
3100725-10072520.15920.16
4100158-10015820.04620.05
5103144-10314420.64320.64
690108-9010818.03418.03
10min1171955-17195534.41534.692.0334.5234.802.03
2172923-17292334.60934.72
3171089-17108934.24234.35
4175675-17567535.16035.27
5179050-17905035.83535.95
6169305-16930533.88533.99
15min1249058-24905849.84746.694.3150.1446.994.27
2228400-22840045.71246.02
3219129-21912943.85744.16
4238665-23866547.76748.07
5231894-23189446.41246.73
6232572-23257246.54746.84
20min1321383-32138364.32257.836.8664.8958.396.81
2278018-27801855.64356.20
3261633-26163352.36452.91
4286673-28667357.37557.95
5290802-29080258.20158.77
6295074-29507459.05659.60
30min1408937-40893781.84578.063.6582.7778.943.63
2404040-40404080.86581.74
3370471-37047174.14674.98
4385907-38590777.23678.13
5387662-38766277.58778.48
6383037-38303776.66177.54
45min1503959-503959100.863100.071.48102.24101.381.48
2504860-504860101.043102.36
3493674-49367498.804100.05
4487872-48787297.64398.96
5505365-505365101.144102.47
6504202-504202100.912102.21
60min1498145-49814599.699100.933.70101.64102.803.62
2473657-47365794.79896.68
3505345-505345101.140102.94
4518352-518352103.744105.61
5502279-502279100.527102.41
6527933-527933105.661107.52
极限1504316-504316100.934101.384.72103.43103.814.63
2500012-500012100.073102.48
3467550-46755093.57695.94
4514368-514368102.946105.38
5541029-541029108.282110.73
6511954-511954102.463104.91
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