依折麦布瑞舒伐他汀钙片项目信息
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RSF-703-230318-D对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)98.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.934813744842744839404844574841894836470.27
211.014858284855294856780.05
单位质量响应值RSD%判断
44249.5044112.440.22数据可信
供试品溶液-2023122321批-瑞舒伐他汀钙-pH7.0(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1482239-48223993.46381.6610.1193.4681.6610.11
2424233-42423382.22182.22
3419205-41920581.24781.25
4353269-35326968.46868.47
5406084-40608478.70478.70
6443093-44309385.87785.88
10min1501412-50141297.17996.212.5297.3496.342.53
2495509-49550996.03596.17
3499132-49913296.73896.87
4472156-47215691.50991.62
5507303-50730398.32198.45
6502852-50285297.45997.60
15min1503348-50334897.55597.211.1997.8797.501.20
2497114-49711496.34696.64
3502729-50272997.43597.73
4492726-49272695.49695.76
5509945-50994598.83399.13
6503567-50356797.59797.90
20min1502531-50253197.39697.340.8397.8897.790.83
2496859-49685996.29796.75
3502466-50246697.38497.84
4499251-49925196.76197.19
5509127-50912798.67599.13
6503076-50307697.50297.97
30min1501650-50165097.22697.230.7797.8797.860.76
2495416-49541696.01796.64
3501247-50124797.14797.77
4502784-50278497.44598.03
5507388-50738898.33898.96
6501681-50168197.23297.86
45min1499764-49976496.86097.090.8897.6697.880.87
2493984-49398495.74096.52
3499758-49975896.85997.64
4504762-50476297.82998.58
5506500-50650098.16698.95
6501061-50106197.11197.90
60min1499402-49940296.79096.900.9297.7697.850.91
2492609-49260995.47396.41
3498790-49879096.67197.62
4503955-50395597.67298.58
5505716-50571698.01498.97
6499355-49935596.78197.74
极限1498137-49813796.54596.690.8797.6797.800.86
2492158-49215895.38696.48
3497558-49755896.43297.54
4502384-50238497.36898.44
5504581-50458197.79498.91
6498587-49858796.63297.75
依折麦布瑞舒伐他汀钙片项目信息
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ZT-705-231101-1-D对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
111.044347474347844345654348784346184347180.03
211.034363104362344362720.02
单位质量响应值RSD%判断
39376.6339553.220.32数据可信
供试品溶液-2023122321批-依折麦布-pH7.0(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1308317-30831770.31252.2518.4670.3152.2518.46
2213749-21374948.74648.75
3210982-21098248.11548.11
4198429-19842945.25245.25
5198725-19872545.32045.32
6244423-24442355.74155.74
10min1423830-42383096.65593.442.2696.7793.532.27
2408281-40828193.10993.19
3397712-39771290.69990.78
4409536-40953693.39593.47
5403229-40322991.95792.03
6415921-41592194.85294.94
15min1434072-43407298.99198.901.0299.2799.141.02
2431270-43127098.35298.59
3434843-43484399.16799.40
4426323-42632397.22497.45
5436593-43659399.56699.79
6438857-438857100.082100.33
20min1434023-43402398.98099.270.8799.4299.680.86
2433171-43317198.78599.19
3437359-43735999.740100.14
4429477-42947797.94398.34
5439020-439020100.119100.51
6438784-438784100.065100.48
30min1434045-43404598.98599.230.7399.5999.800.73
2433177-43317798.78799.35
3436855-43685599.626100.19
4430325-43032598.13698.69
5438751-438751100.058100.62
6437461-43746199.764100.35
45min1432417-43241798.61399.090.6599.3999.820.64
2432018-43201898.52299.25
3436213-43621399.479100.21
4431568-43156898.42099.14
5437846-43784699.852100.58
6436891-43689199.634100.38
60min1431902-43190298.49698.940.6299.4399.850.62
2431415-43141598.38599.28
3435256-43525699.261100.16
4431351-43135198.37099.25
5437721-43772199.823100.72
6435578-43557899.334100.25
极限1431259-43125998.34998.760.6199.4599.830.61
2430687-43068798.21999.28
3434713-43471399.137100.20
4430265-43026598.12399.17
5436586-43658699.564100.63
6434789-43478999.154100.24
依折麦布瑞舒伐他汀钙片项目信息
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RSF-703-230318-D对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)98.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.934839304847784846574848324847864845970.08
211.014861714845434853570.24
单位质量响应值RSD%判断
44336.4144083.290.41数据可信
供试品溶液-2023122321批-瑞舒伐他汀钙-pH7.0(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1341969-34196966.23577.3316.2766.2377.3316.27
2479324-47932492.83892.84
3360694-36069469.86169.86
4377180-37718073.05573.05
5352298-35229868.23568.24
6484190-48419093.78193.78
10min1483906-48390693.72695.812.4193.8495.942.41
2501397-50139797.11497.27
3507960-50796098.38598.50
4479350-47935092.84392.97
5490149-49014994.93595.05
6505321-50532197.87498.03
15min1499532-49953296.75297.081.3797.0297.371.37
2500708-50070896.98097.30
3512046-51204699.17699.46
4494481-49448195.77496.05
5494538-49453895.78596.06
6506074-50607498.01998.34
20min1499267-49926796.70197.161.2497.1397.621.24
2499557-49955796.75797.24
3512067-51206799.18099.63
4499210-49921096.69097.13
5494356-49435695.75096.18
6505428-50542897.89498.38
30min1499823-49982396.80996.971.2197.4097.581.21
2498905-49890596.63197.27
3511039-51103998.98199.59
4498439-49843996.54197.14
5492838-49283895.45696.05
6502961-50296197.41798.06
45min1498291-49829196.51296.791.2397.2697.571.23
2497428-49742896.34597.15
3510436-51043698.86499.64
4497439-49743996.34797.11
5492447-49244795.38096.13
6502394-50239497.30798.12
60min1496993-49699396.26196.531.2997.1797.461.30
2497618-49761896.38297.34
3509193-50919398.62499.56
4494747-49474795.82696.74
5490329-49032994.97095.88
6501391-50139197.11298.08
极限1496384-49638496.14396.341.2897.2197.441.28
2496216-49621696.11097.23
3508256-50825698.44299.55
4493980-49398095.67796.76
5489515-48951594.81295.88
6500150-50015096.87298.00
依折麦布瑞舒伐他汀钙片项目信息
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ZT-705-231101-1-D对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
111.044349664352864350444351214350294350890.03
211.034359264349434354340.16
单位质量响应值RSD%判断
39410.2439477.240.13数据可信
供试品溶液-2023122321批-依折麦布-pH7.0(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1181568-18156841.42955.5933.7841.4355.5933.78
2332591-33259175.88875.89
3133410-13341030.44130.44
4269890-26989061.58261.58
5210503-21050348.03148.03
6333900-33390076.18776.19
10min1386321-38632188.14892.665.3988.2292.765.42
2427859-42785997.62697.75
3377817-37781786.20886.26
4415721-41572194.85694.96
5398723-39872390.97891.06
6430164-43016498.15298.28
15min1426703-42670397.36297.841.7197.5898.081.74
2438187-43818799.983100.27
3417034-41703495.15695.35
4425960-42596097.19397.45
5431381-43138198.43098.66
6433438-43343898.89999.19
20min1433024-43302498.80498.601.0399.1899.011.05
2437423-43742399.808100.26
3424744-42474496.91597.27
4429509-42950998.00298.43
5434715-43471599.19099.59
6433296-43329698.86799.32
30min1434347-43434799.10698.620.7599.6599.200.76
2436792-43679299.664100.29
3428922-42892297.86998.38
4429131-42913197.91698.50
5433762-43376298.97399.53
6430403-43040398.20698.83
45min1433081-43308198.81898.630.6199.5399.370.61
2435930-43593099.468100.26
3432058-43205898.58499.26
4428690-42869097.81698.56
5433749-43374998.97099.70
6430011-43001198.11798.90
60min1432161-43216198.60898.370.7099.4899.270.70
2435698-43569899.415100.37
3431401-43140198.43499.28
4426908-42690897.40998.32
5431461-43146198.44899.34
6429004-42900497.88798.83
极限1431412-43141298.43798.160.6899.4799.230.68
2434442-43444299.128100.25
3430761-43076198.28899.29
4425932-42593297.18698.26
5430522-43052298.23499.29
6428189-42818997.70198.81
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