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%
111.014887034855664856744856024857814862650.29
211.024861844860744861290.02
单位质量响应值RSD%判断
44165.7644113.340.09数据可信
供试品溶液-E43216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%
5min1175361-17536135.75637.523.5535.7637.523.55
2178719-17871936.44136.44
3184125-18412537.54337.54
4190799-19079938.90438.90
5183104-18310437.33537.33
6191946-19194639.13839.14
10min1342753-34275369.88770.663.8670.0970.863.86
2347155-34715570.78570.99
3356861-35686172.76472.97
4361877-36187773.78674.00
5323350-32335065.93166.14
6347168-34716870.78771.00
15min1441824-44182490.08791.002.7090.6791.602.70
2442633-44263390.25290.85
3464757-46475794.76395.38
4454061-45406192.58393.21
5429381-42938187.55088.12
6445018-44501890.73991.35
20min1482878-48287898.45899.352.1999.55100.462.20
2488760-48876099.658100.75
3503379-503379102.638103.78
4494487-494487100.825101.97
5473524-47352496.55197.61
6480458-48045897.96599.08
30min1473378-47337896.52199.462.0798.16101.122.06
2486759-48675999.250100.90
3504959-504959102.961104.67
4486150-48615099.125100.83
5487865-48786599.475101.07
6487688-48768899.439101.10
45min1471285-47128596.09498.592.2698.27100.802.24
2488089-48808999.521101.72
3502441-502441102.447104.73
4481162-48116298.108100.36
5482126-48212698.305100.45
6475910-47591097.03899.25
60min1482409-48240998.36398.851.86101.07101.611.84
2481012-48101298.078100.83
3502177-502177102.393105.24
4475935-47593597.04399.84
5484177-48417798.723101.42
6483182-48318298.520101.27
极限1476800-47680097.21998.031.87100.47101.341.87
2478631-47863197.592100.89
3498740-498740101.693105.11
4477034-47703497.267100.60
5474232-47423296.69599.94
6479283-47928397.725101.02
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%
111.014868584864924865084865204864574865670.04
211.024867334872444869880.08
单位质量响应值RSD%判断
44193.1944191.290.01数据可信
供试品溶液-F73104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%
5min1105144-10514421.41319.866.2221.4119.866.21
299492-9949220.26220.26
387350-8735017.78917.79
497175-9717519.79019.79
595049-9504919.35719.36
6101028-10102820.57520.57
10min1174428-17442835.52332.136.5435.6432.246.54
2159966-15996632.57832.69
3146631-14663129.86229.96
4153961-15396131.35531.46
5148653-14865330.27430.38
6163099-16309933.21633.33
15min1247340-24734050.37242.2610.4550.6942.5510.42
2208565-20856542.47542.77
3187345-18734538.15438.42
4208806-20880642.52542.81
5189131-18913138.51838.79
6203764-20376441.49841.80
20min1304568-30456862.02757.597.8762.6258.127.84
2279948-27994857.01357.54
3294052-29405259.88560.36
4295588-29558860.19860.72
5241602-24160249.20449.69
6281022-28102257.23257.76
30min1406406-40640682.76778.624.2883.7179.464.31
2387335-38733578.88379.73
3386573-38657378.72879.54
4395540-39554080.55481.41
5356879-35687972.68073.44
6383577-38357778.11878.96
45min1479171-47917197.58699.271.1498.99100.551.07
2483241-48324198.41599.70
3494063-494063100.619101.87
4490732-49073299.940101.24
5490932-49093299.981101.15
6486559-48655999.091100.37
60min1479268-47926897.60699.541.2699.55101.371.20
2486150-48615099.007100.84
3489390-48939099.667101.47
4498112-498112101.443103.30
5489617-48961799.713101.44
6489939-48993999.779101.61
极限1477907-47790797.32899.081.2499.81101.471.17
2483110-48311098.388100.77
3488581-48858199.502101.86
4493931-493931100.592103.01
5491730-491730100.144102.42
6483858-48385898.540100.93
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%
111.014868474866864870024866684861434866690.07
211.024854314851774853040.04
单位质量响应值RSD%判断
44202.4544038.480.27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%
5min1105103-10510321.44022.664.9321.4422.664.93
2114973-11497323.45323.45
3119354-11935424.34724.35
4110670-11067022.57522.58
5105624-10562421.54621.55
6110655-11065522.57222.57
10min1209314-20931442.69745.005.2142.8245.135.20
2238798-23879848.71248.84
3230662-23066247.05247.19
4215262-21526243.91144.04
5213243-21324343.49943.62
6216438-21643844.15144.28
15min1299301-29930161.05463.453.9961.4163.834.00
2331473-33147367.61668.02
3319424-31942465.15965.56
4300244-30024461.24661.62
5310145-31014563.26663.63
6305836-30583662.38762.76
20min1392422-39242280.04980.153.7980.7480.883.78
2404605-40460582.53483.31
3407721-40772183.17083.93
4371690-37169075.82076.53
5402627-40262782.13182.84
6378542-37854277.21877.94
30min1457003-45700393.22396.422.4094.3697.592.41
2487762-48776299.497100.73
3475572-47557297.01198.23
4474728-47472896.83997.97
5478983-47898397.70798.88
6461866-46186694.21595.36
45min1487427-48742799.42999.950.52101.09101.660.55
2493512-493512100.670102.46
3489886-48988699.931101.69
4488484-48848499.645101.31
5492556-492556100.475102.19
6488122-48812299.571101.24
60min1485684-48568499.07498.870.89101.28101.130.87
2483882-48388298.706101.05
3480991-48099198.116100.43
4489170-48917099.785102.01
5489544-48954499.861102.13
6478862-47886297.68299.90
极限1485367-48536799.00998.660.93101.77101.480.92
2485897-48589799.117102.01
3486555-48655599.251102.11
4488174-48817499.581102.36
5478218-47821897.551100.38
6477752-47775297.456100.22
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