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对照品来源中检所对照品使用方法干燥2小时
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%
111.375068855072385072125072085058625068810.12
211.375068315073785071040.08
单位质量响应值RSD%判断
44580.5644600.180.04数据可信
供试品溶液-1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%
5min1138935-13893528.04231.027.5028.0431.027.50
2155079-15507931.30131.30
3174208-17420835.16235.16
4150126-15012630.30130.30
5150655-15065530.40830.41
6153030-15303030.88730.89
10min1258671-25867152.20955.437.5352.3755.607.52
2271569-27156954.81354.99
3315857-31585763.75263.95
4267081-26708153.90754.08
5265908-26590853.67053.84
6268604-26860454.21454.39
15min1345531-34553169.74175.336.8670.1975.816.86
2374064-37406475.50075.98
3420487-42048784.87085.42
4365332-36533273.73874.21
5358981-35898172.45672.92
6374938-37493875.67676.15
20min1413782-41378283.51785.733.2884.3586.633.32
2423206-42320685.41986.32
3451522-45152291.13492.16
4417268-41726884.22085.10
5416283-41628384.02184.89
6426431-42643186.07086.96
30min1466208-46620894.09894.331.4395.4095.711.35
2470167-47016794.89796.27
3457766-45776692.39493.92
4471373-47137395.14196.49
5476233-47623396.12297.46
6462408-46240893.33194.70
45min1471424-47142495.15194.801.2196.9796.691.13
2471387-47138795.14397.04
3460414-46041492.92994.97
4473205-47320595.51097.38
5475999-47599996.07497.94
6465589-46558993.97395.86
60min1470199-47019994.90493.083.4497.2595.503.33
2467193-46719394.29796.73
3451288-45128891.08793.64
4476638-47663896.20398.61
5467949-46794994.45096.85
6433645-43364587.52689.94
极限1462098-46209893.26993.062.1596.1496.002.07
2473922-47392295.65598.61
3450783-45078390.98594.05
4463503-46350393.55296.49
5467787-46778794.41797.35
6448265-44826590.47793.37
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对照品来源中检所对照品使用方法干燥2小时
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%
111.375060975062765072385062225061545063970.10
211.375063885065655064760.03
单位质量响应值RSD%判断
44537.9944544.940.02数据可信
供试品溶液-2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%
5min1159120-15912032.15238.7616.6732.1538.7616.67
2237599-23759948.00948.01
3215600-21560043.56443.56
4190211-19021138.43438.43
5193787-19378739.15639.16
6154733-15473331.26531.27
10min1254100-25410051.34357.3512.4451.5257.5612.46
2337439-33743968.18368.45
3299778-29977860.57360.81
4273158-27315855.19455.41
5298230-29823060.26060.48
6240266-24026648.54848.72
15min1332092-33209267.10271.648.2267.5772.178.26
2392243-39224379.25679.90
3368276-36827674.41374.99
4346202-34620269.95370.47
5374632-37463275.69876.25
6313808-31380863.40863.85
20min1392316-39231679.27182.514.9580.1183.445.01
2428941-42894186.67187.76
3416833-41683384.22585.22
4399832-39983280.79081.70
5430520-43052086.99087.96
6381513-38151377.08877.88
30min1475434-47543496.06696.582.2997.3497.972.36
2495883-495883100.198101.76
3480698-48069897.12998.59
4463907-46390793.73795.09
5481273-48127397.24598.70
6470731-47073195.11596.34
45min1491694-49169499.35196.172.36101.1698.092.32
2484701-48470197.938100.06
3472275-47227595.42797.43
4478185-47818596.62298.50
5461506-46150693.25195.25
6467216-46721694.40596.16
60min1486238-48623898.24996.441.85100.6198.901.88
2488600-48860098.726101.39
3469760-46976094.91997.45
4477636-47763696.51198.93
5474964-47496495.97198.49
6466371-46637194.23496.51
极限1484011-48401197.79995.351.46100.7198.351.43
2473259-47325995.62698.84
3470881-47088195.14698.20
4463206-46320693.59596.55
5471362-47136295.24398.29
6468755-46875594.71697.52
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对照品来源中检所对照品使用方法干燥2小时
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%
111.375071675072545069885072945067365070880.05
211.375062085065935064000.06
单位质量响应值RSD%判断
44598.7744538.260.10数据可信
供试品溶液-3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%
5min1264327-26432753.37737.0022.3753.3837.0022.37
2154915-15491531.28331.28
3160291-16029132.36932.37
4181053-18105336.56136.56
5176610-17661035.66435.66
6162170-16217032.74832.75
10min1333805-33380567.40754.5611.8167.7054.7711.84
2257531-25753152.00552.18
3251318-25131850.75050.93
4263608-26360853.23253.44
5266211-26621153.75853.96
6248686-24868650.21950.40
15min1416114-41611484.02969.8310.2584.7070.3410.29
2343807-34380769.42769.89
3322461-32246165.11765.58
4333827-33382767.41267.91
5336018-33601867.85468.35
6322479-32247965.12065.58
20min1468277-46827794.56283.027.2095.7083.917.25
2415543-41554383.91384.76
3388057-38805778.36379.19
4393831-39383179.52980.40
5403898-40389881.56282.44
6396975-39697580.16480.99
30min1479290-47929096.78692.832.5598.4594.192.65
2466561-46656194.21695.53
3448175-44817590.50391.76
4454826-45482691.84693.16
5449882-44988290.84892.17
6459573-45957392.80594.07
45min1466834-46683494.27194.671.4996.4796.541.45
2463292-46329293.55695.39
3465631-46563194.02895.79
4462298-46229893.35595.18
5479352-47935296.79998.63
6475518-47551896.02497.81
60min1466185-46618594.14094.131.9196.8696.531.89
2474806-47480695.88198.24
3468020-46802094.51096.79
4463874-46387493.67396.02
5473739-47373995.66598.03
6450179-45017990.90893.22
极限1465855-46585594.07393.201.2597.3296.121.29
2470212-47021294.95397.84
3460003-46000392.89195.70
4453525-45352591.58394.45
5459507-45950792.79195.69
6460194-46019492.93095.75
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