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对照品来源中检院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0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.795022185022645019325015555018655019670.06
2 11.745020275015215017740.08
单位质量响应值RSD%判断
42575.6642740.550.28数据可信
供试品溶液-CLB03646批-瑞舒伐他汀钙-pH7.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1416407-41640783.41287.493.1083.4187.493.10
2454259-45425990.99490.99
3443438-44343888.82788.83
4434606-43460687.05787.06
5427545-42754585.64385.64
6444410-44441089.02189.02
10min1483457-48345796.84398.211.1296.9898.351.12
2490284-49028498.21098.36
3488716-48871697.89698.04
4499837-499837100.124100.27
5487782-48778297.70997.85
6491601-49160198.47498.62
15min1497471-49747199.65099.891.6199.95100.201.61
2499205-49920599.997100.31
3493503-49350398.85599.17
4513974-513974102.956103.27
5491478-49147898.45098.76
6496324-49632499.42099.73
20min1496916-49691699.53999.881.85100.01100.361.84
2499010-49901099.958100.44
3492690-49269098.69299.17
4516333-516333103.428103.91
5490616-49061698.27798.75
6496057-49605799.36799.85
30min1496396-49639699.43599.671.77100.07100.321.77
2498193-49819399.795100.44
3492374-49237498.62999.27
4514501-514501103.061103.72
5489807-48980798.11598.75
6494267-49426799.00899.65
45min1495393-49539399.23499.551.81100.03100.361.81
2496595-49659599.475100.29
3491699-49169998.49499.30
4514368-514368103.035103.86
5488837-48883797.92198.72
6494939-49493999.14399.95
60min1493799-49379998.91599.371.8299.88100.341.81
2496300-49630099.416100.40
3490184-49018498.19099.16
4513418-513418102.845103.84
5488173-48817397.78898.75
6494483-49448399.052100.03
极限1493349-49334998.82499.101.8899.95100.241.87
2494747-49474799.104100.25
3488817-48881797.91799.05
4512474-512474102.655103.83
5486218-48621897.39698.52
6492608-49260898.67699.82
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DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75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%
1 11.344533374537714533924532044534194534250.05
2 11.394530204530064530130.01
单位质量响应值RSD%判断
39984.5739772.870.38数据可信
供试品溶液-CLB03646批-依折麦布-pH7.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1153443-15344334.54341.1019.7734.5441.1019.77
2227950-22795051.31651.32
3204340-20434046.00146.00
4132412-13241229.80929.81
5172297-17229738.78838.79
6205088-20508846.17046.17
10min1352051-35205179.25489.137.3579.3189.207.36
2398186-39818689.64089.73
3416987-41698793.87393.95
4369587-36958783.20283.25
5413288-41328893.04093.10
6425332-42533295.75195.83
15min1442108-44210899.528100.121.5899.72100.341.59
2442872-44287299.70099.94
3451926-451926101.738101.97
4433937-43393797.68997.88
5444662-444662100.103100.32
6452839-452839101.944102.18
20min1448103-448103100.878100.331.12101.23100.721.13
2442438-44243899.602100.00
3449969-449969101.298101.70
4438648-43864898.74999.10
5443364-44336499.811100.20
6451573-451573101.659102.07
30min1447327-447327100.703100.071.10101.23100.631.11
2440556-44055699.17999.75
3449523-449523101.197101.77
4437606-43760698.51599.03
5443122-44312299.756100.31
6449075-449075101.097101.67
45min1446793-446793100.58399.901.18101.27100.621.19
2439769-43976999.00299.73
3448733-448733101.020101.76
4436654-43665498.30098.98
5441470-44147099.384100.10
6449253-449253101.137101.88
60min1445155-445155100.21499.731.15101.07100.611.15
2439404-43940498.91999.82
3447712-447712100.790101.70
4436098-43609898.17599.02
5440662-44066299.203100.09
6448907-448907101.059101.97
极限1444840-444840100.14399.431.18101.17100.481.19
2437850-43785098.57099.63
3445862-445862100.373101.45
4434568-43456897.83198.84
5439158-43915898.86499.91
6447653-447653100.776101.86
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对照品来源中检院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0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.795011645014775010265010515016935012820.06
2 11.744998545003055000800.07
单位质量响应值RSD%判断
42517.5642596.250.14数据可信
供试品溶液-CLB03646批-瑞舒伐他汀钙-pH7.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1467693-46769393.90884.179.6893.9184.179.68
2394634-39463479.23879.24
3463768-46376893.12093.12
4364589-36458973.20673.21
5402200-40220080.75780.76
6422320-42232084.79784.80
10min1504539-504539101.306100.342.32101.46100.472.33
2507991-507991101.999102.13
3506040-506040101.607101.76
4481561-48156196.69296.81
5509275-509275102.257102.39
6488830-48883098.15298.29
15min1507746-507746101.950102.171.50102.28102.481.49
2517759-517759103.960104.26
3508912-508912102.184102.51
4499802-499802100.355100.64
5517350-517350103.878104.18
6501555-501555100.707101.01
20min1507759-507759101.953102.221.46102.45102.701.46
2517817-517817103.972104.45
3508722-508722102.146102.64
4501464-501464100.689101.14
5517666-517666103.942104.42
6501084-501084100.612101.09
30min1507016-507016101.803102.031.47102.47102.681.47
2516463-516463103.700104.35
3508061-508061102.013102.68
4500176-500176100.430101.05
5517042-517042103.816104.47
6500036-500036100.402101.04
45min1506403-506403101.680101.901.30102.52102.721.30
2514710-514710103.348104.17
3507721-507721101.945102.78
4499827-499827100.360101.15
5515243-515243103.455104.28
6500956-500956100.587101.39
60min1503257-503257101.049101.641.56102.05102.631.55
2515599-515599103.527104.52
3505997-505997101.599102.60
4498210-498210100.035100.99
5515636-515636103.534104.53
6498567-498567100.107101.08
极限1505178-505178101.434101.471.39102.61102.631.40
2513626-513626103.131104.30
3504853-504853101.369102.54
4497163-49716399.825100.94
5513122-513122103.029104.20
6498273-498273100.048101.19
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DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75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%
1 11.344526344526154524204532454533174528460.09
2 11.394517474519124518300.03
单位质量响应值RSD%判断
39933.5139669.010.47数据可信
供试品溶液-CLB03646批-依折麦布-pH7.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1250562-25056256.51744.7119.5956.5244.7119.59
2240555-24055554.26054.26
3197898-19789844.63844.64
4171342-17134238.64838.65
5165183-16518337.25937.26
6163783-16378336.94336.94
10min1419271-41927194.57188.675.2094.6788.745.22
2406570-40657091.70691.80
3407711-40771191.96492.04
4374257-37425784.41884.48
5378949-37894985.47685.54
6371795-37179583.86283.92
15min1456257-456257102.914100.582.07103.17100.812.08
2453191-453191102.222102.47
3439653-43965399.16899.40
4442168-44216899.73699.94
5432624-43262497.58397.79
6451645-451645101.873102.07
20min1455736-455736102.796100.881.64103.22101.271.65
2452309-452309102.023102.44
3441865-44186599.667100.06
4444582-444582100.280100.65
5436810-43681098.52798.89
6452080-452080101.971102.34
30min1454794-454794102.584100.621.65103.18101.181.66
2451356-451356101.808102.39
3440436-44043699.34599.90
4443607-443607100.060100.60
5435766-43576698.29298.82
6450691-450691101.658102.20
45min1454256-454256102.462100.441.74103.23101.171.75
2449501-449501101.390102.14
3440123-44012399.274100.00
4442823-44282399.883100.59
5433837-43383797.85798.55
6451228-451228101.779102.49
60min1451261-451261101.787100.231.54102.72101.121.55
2450021-450021101.507102.43
3438816-43881698.98099.87
4441725-44172599.636100.51
5434895-43489598.09598.95
6449332-449332101.352102.23
极限1453065-453065102.194100.051.77103.30101.111.78
2448415-448415101.145102.24
3437929-43792998.78099.83
4440394-44039499.336100.37
5432593-43259397.57698.60
6449031-449031101.284102.33
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