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%
111.015058074855664856744856024857814896861.85
211.024861844860744861290.02
单位质量响应值RSD%判断
44476.4844113.340.58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%
5min1175361-17536135.63137.393.5535.6337.393.55
2178719-17871936.31336.31
3184125-18412537.41237.41
4190799-19079938.76838.77
5183104-18310437.20437.20
6191946-19194639.00139.00
10min1342753-34275369.64370.413.8769.8470.623.86
2347155-34715570.53770.74
3356861-35686172.51072.72
4361877-36187773.52973.74
5323350-32335065.70165.91
6347168-34716870.54070.76
15min1441824-44182489.77390.682.7090.3691.282.69
2442633-44263389.93790.53
3464757-46475794.43395.04
4454061-45406192.25992.88
5429381-42938187.24587.82
6445018-44501890.42291.03
20min1482878-48287898.11599.002.1999.20100.102.20
2488760-48876099.310100.40
3503379-503379102.280103.42
4494487-494487100.473101.61
5473524-47352496.21497.27
6480458-48045897.62398.73
30min1473378-47337896.18499.112.0797.81100.772.06
2486759-48675998.903100.55
3504959-504959102.601104.30
4486150-48615098.779100.47
5487865-48786599.128100.72
6487688-48768899.092100.75
45min1471285-47128595.75998.242.2697.92100.442.24
2488089-48808999.173101.37
3502441-502441102.090104.36
4481162-48116297.766100.01
5482126-48212697.962100.10
6475910-47591096.69998.90
60min1482409-48240998.01998.511.86100.71101.261.84
2481012-48101297.735100.48
3502177-502177102.036104.88
4475935-47593596.70499.49
5484177-48417798.378101.06
6483182-48318298.176100.92
极限1476800-47680096.88097.691.87100.12100.991.87
2478631-47863197.252100.54
3498740-498740101.338104.75
4477034-47703496.927100.25
5474232-47423296.35899.59
6479283-47928397.384100.67
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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