氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.741412387141305714123761411560141235514123470.04
211.231458816145873414587750.01
单位质量响应值RSD%判断
131503.45129899.820.87数据可信
影响因素30天-高温50℃-供试品溶液-2024022621批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1184786-18478612.53611.576.6712.5411.576.68
2167409-16740911.35711.36
3162590-16259011.03011.03
4181116-18111612.28712.29
5154630-15463010.49010.49
6172450-17245011.69911.70
480min1319148-31914821.65120.515.0021.6720.525.00
2292412-29241219.83719.85
3286806-28680619.45719.47
4320216-32021621.72321.74
5288910-28891019.60019.62
6306343-30634320.78220.80
720min1411562-41156227.92026.903.6127.9726.953.62
2383470-38347026.01526.06
3380406-38040625.80725.85
4412693-41269327.99728.05
5388467-38846726.35426.40
6402858-40285827.33027.38
960min1598085-59808540.57439.512.3040.6739.602.30
2569330-56933038.62338.71
3575631-57563139.05139.14
4596696-59669640.48040.57
5567997-56799738.53338.62
6586671-58667139.80039.89
1200min1638076-63807643.28742.942.4343.4443.082.43
2620165-62016542.07242.22
3622748-62274842.24742.39
4653430-65343044.32944.48
5616413-61641341.81741.96
6646630-64663043.86744.02
1440min1-0.0000.00-0.220.222.55
2-0.0000.21
3-0.0000.21
4-0.0000.22
5-0.0000.21
6-0.0000.22
极限1-0.0000.00-0.220.222.55
2-0.0000.21
3-0.0000.21
4-0.0000.22
5-0.0000.21
6-0.0000.22
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.741413152141215514115811410631140978914114620.10
211.231485012148413114845720.05
单位质量响应值RSD%判断
131421.04132196.970.42数据可信
影响因素30天-高温50℃-供试品溶液-2024022621批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1146041-1460419.82410.6711.659.8210.6711.68
2126580-1265808.5158.51
3170482-17048211.46811.47
4172278-17227811.58911.59
5170397-17039711.46211.46
6166167-16616711.17811.18
480min1282697-28269719.01619.189.4319.0319.209.44
2232189-23218915.61915.63
3300481-30048120.21320.23
4301972-30197220.31320.33
5299738-29973820.16320.18
6293628-29362819.75219.77
720min1381083-38108325.63525.687.5225.6825.727.52
2324845-32484521.85221.89
3391068-39106826.30626.35
4396182-39618226.65026.70
5396128-39612826.64726.69
6401213-40121326.98927.04
960min1592133-59213339.83238.902.3939.9138.982.40
2558906-55890637.59737.67
3569914-56991438.33738.42
4579083-57908338.95439.04
5573778-57377838.59738.68
6595500-59550040.05840.15
1200min1646909-64690943.51642.661.7943.6642.801.81
2615415-61541541.39841.52
3634420-63442042.67642.82
4627161-62716142.18842.33
5640127-64012743.06043.21
6640901-64090143.11243.26
1440min1-0.0000.00-0.210.213.96
2-0.0000.19
3-0.0000.21
4-0.0000.21
5-0.0000.21
6-0.0000.21
极限1-0.0000.00-0.210.213.96
2-0.0000.19
3-0.0000.21
4-0.0000.21
5-0.0000.21
6-0.0000.21
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.741403789140448714038821404820140490214043760.04
211.231462654146347014630620.04
单位质量响应值RSD%判断
130761.27130281.570.26数据可信
影响因素30天-高温50℃-供试品溶液-2024022621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%
240min1277359-27735918.84118.014.3918.8418.014.38
2281454-28145419.12019.12
3254764-25476417.30617.31
4264124-26412417.94217.94
5257220-25722017.47317.47
6255776-25577617.37517.38
480min1538673-53867336.59334.914.0036.6234.944.01
2531832-53183236.12836.16
3488120-48812033.15933.18
4524192-52419235.60935.64
5495754-49575433.67733.70
6505077-50507734.31134.34
720min1749226-74922650.89648.892.4850.9848.972.48
2724679-72467949.22849.31
3699279-69927947.50347.58
4720657-72065748.95549.04
5703349-70334947.77947.86
6720789-72078948.96449.04
960min1952467-95246764.70261.852.6364.8662.002.63
2899132-89913261.07961.24
3897114-89711460.94261.09
4903158-90315861.35361.51
5886887-88688760.24760.40
6923722-92372262.75062.90
1200min11268952-126895286.20277.975.3886.4678.225.37
21110468-111046875.43675.68
31120348-112034876.10776.35
41111578-111157875.51175.76
51118655-111865575.99276.23
61156521-115652178.56478.81
1440min11519845-1519845103.24599.293.18103.6399.663.17
21410235-141023595.79996.16
31451262-145126298.58698.94
41409453-140945395.74696.11
51476384-1476384100.293100.65
61502853-1502853102.091102.45
极限11519807-1519807103.242102.031.78103.78102.541.78
21466954-146695499.652100.16
31521232-1521232103.339103.84
41472188-1472188100.008100.51
51502420-1502420102.061102.56
61529432-1529432103.896104.41
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.741403823140433414045021404266140403114041910.02
211.231450491144987714501840.03
单位质量响应值RSD%判断
130744.04129134.820.88数据可信
影响因素30天-高温50℃-供试品溶液-2024022621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%
240min1223856-22385615.27518.248.3715.2818.248.35
2263725-26372517.99618.00
3275855-27585518.82418.82
4284622-28462219.42219.42
5279048-27904819.04219.04
6276749-27674918.88518.88
480min1421443-42144328.75834.5710.0028.7834.6010.00
2487791-48779133.28633.31
3510404-51040434.82934.86
4573274-57327439.11939.15
5533363-53336336.39636.42
6513429-51342935.03535.06
720min1612841-61284141.81948.527.9841.8948.607.98
2712823-71282348.64248.72
3710851-71085148.50748.59
4787711-78771153.75253.84
5734169-73416950.09850.18
6707775-70777548.29748.38
960min1817624-81762455.79360.976.2555.9261.126.26
2925289-92528963.14063.29
3884062-88406260.32760.48
4978169-97816966.74866.92
5900987-90098761.48261.64
6854711-85471158.32458.48
1200min11024528-102452869.91275.286.3770.1275.526.37
21172408-117240880.00380.25
31108696-110869675.65575.90
41194180-119418081.48881.76
51087604-108760474.21674.47
61031486-103148670.38770.63
1440min11306126-130612689.12795.256.1989.4495.616.19
21505480-1505480102.731103.10
31376146-137614693.90594.26
41489469-1489469101.638102.03
51392098-139209894.99495.36
61305952-130595289.11689.46
极限11388421-138842194.74399.843.5995.19100.333.60
21529260-1529260104.354104.87
31468412-1468412100.201100.70
41512079-1512079103.181103.72
51452369-145236999.10799.61
61427761-142776197.42897.91
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