依折麦布阿托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%
110.934802504812424814514815254814504811840.12
211.014800464803854802160.05
单位质量响应值RSD%判断
44024.1543616.350.66数据可信
供试品溶液-2024031021批-阿托伐他汀钙-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%
5min1470295-47029591.71083.4015.4991.7183.4015.49
2315504-31550461.52561.52
3487330-48733095.03295.03
4425342-42534282.94482.94
5389733-38973376.00076.00
6478035-47803593.21993.22
10min1500672-50067297.63395.313.4197.7995.443.42
2462067-46206790.10590.21
3502678-50267898.02498.18
4479454-47945493.49693.63
5483866-48386694.35694.48
6503725-50372598.22998.38
15min1503314-50331498.14896.402.0998.4696.692.11
2481411-48141193.87794.13
3502722-50272298.03398.35
4486001-48600194.77295.07
5488036-48803695.16995.45
6504481-50448198.37698.70
20min1502620-50262098.01396.601.4998.4997.061.51
2489797-48979795.51395.92
3501665-50166597.82798.31
4488534-48853495.26695.72
5487785-48778595.12095.56
6501983-50198397.88998.37
30min1502216-50221697.93496.981.3498.5897.601.35
2499234-49923497.35397.92
3501632-50163297.82098.47
4490600-49060095.66996.28
5487393-48739395.04495.64
6502888-50288898.06598.71
45min1501455-50145597.78697.131.4398.5997.911.42
2506457-50645798.76199.49
3500467-50046797.59398.40
4492711-49271196.08196.85
5486700-48670094.90995.67
6500848-50084897.66898.48
60min1500382-50038297.57797.131.6398.5598.071.62
2509522-50952299.359100.25
3500056-50005697.51398.49
4492970-49297096.13197.06
5485483-48548394.67195.59
6500080-50008097.51898.49
极限1499170-49917097.34097.101.8998.4798.201.86
2513354-513354100.106101.17
3498265-49826597.16498.30
4493069-49306996.15197.24
5484713-48471394.52195.60
6499054-49905497.31898.45
依折麦布阿托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对照品来源中检院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%
111.044343494342364341324343434343384342800.03
211.034324554328694326620.07
单位质量响应值RSD%判断
39336.9639225.930.20数据可信
供试品溶液-2024031021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%
5min1186547-18654742.74149.6236.4842.7449.6236.48
2126122-12612228.89728.90
3325452-32545274.56674.57
4284787-28478765.24965.25
5143510-14351032.88032.88
6233035-23303553.39253.39
10min1407277-40727793.31493.995.7393.3994.085.76
2391167-39116789.62389.67
3435351-43535199.74699.87
4434851-43485199.63199.74
5376788-37678886.32886.38
6416040-41604095.32295.41
15min1423335-42333596.99398.101.8997.2298.341.92
2428696-42869698.22198.42
3434908-43490899.64599.94
4436360-43636099.977100.25
5414739-41473995.02395.22
6431070-43107098.76599.01
20min1423607-42360797.05598.131.5697.4498.531.58
2431286-43128698.81599.18
3433451-43345199.31199.77
4434982-43498299.661100.10
5417396-41739695.63295.99
6429021-42902198.29698.71
30min1423447-42344797.01998.151.4297.5798.721.44
2431884-43188498.95299.48
3433468-43346899.31599.94
4433510-43351099.32499.93
5418735-41873595.93996.46
6429239-42923998.34698.92
45min1423292-42329296.98398.031.3797.6998.761.40
2431228-43122898.80199.49
3433127-43312799.236100.02
4433141-43314199.240100.01
5418724-41872495.93696.61
6427768-42776898.00998.75
60min1422231-42223196.74097.841.3897.6198.741.40
2430708-43070898.68299.54
3432304-43230499.048100.00
4432002-43200298.97999.92
5417922-41792295.75396.59
6427039-42703997.84298.75
极限1422691-42269196.84597.701.2297.8898.751.25
2429157-42915798.32799.35
3431460-43146098.85599.97
4430788-43078898.70199.80
5418141-41814195.80396.80
6426184-42618497.64698.71
依折麦布阿托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%
110.934820114819834821534820284821094820570.02
211.014801634803604802620.03
单位质量响应值RSD%判断
44104.0343620.530.78数据可信
供试品溶液-2024031021批-阿托伐他汀钙-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%
5min1494574-49457496.35387.168.8396.3587.168.83
2488623-48862395.19395.19
3438486-43848685.42685.43
4403705-40370578.65078.65
5404543-40454378.81378.81
6454342-45434288.51588.51
10min1510972-51097299.54797.312.9899.7197.452.99
2510824-51082499.51899.68
3504670-50467098.31998.46
4474045-47404592.35392.48
5489136-48913695.29395.42
6507213-50721398.81598.96
15min1512265-51226599.79998.971.38100.1399.281.39
2512246-51224699.795100.12
3510694-51069499.49399.80
4495741-49574196.58096.86
5503612-50361298.11398.40
6513582-513582100.056100.37
20min1510975-51097599.54899.110.55100.0499.580.57
2509924-50992499.34399.83
3510548-51054899.46599.94
4503469-50346998.08598.53
5507896-50789698.94899.40
6509677-50967799.29599.77
30min1510837-51083799.52199.130.48100.1899.770.48
2509176-50917699.19799.85
3509182-50918299.19899.84
4504757-50475798.33698.95
5511372-51137299.625100.24
6507682-50768298.90699.55
45min1509140-50914099.19099.110.67100.0199.920.68
2513922-513922100.122100.94
3508354-50835499.03799.84
4503933-50393398.17698.95
5510477-51047799.451100.24
6506688-50668898.71399.52
60min1507676-50767698.90598.740.5299.9099.710.53
2506676-50667698.71099.70
3507314-50731498.83599.80
4501872-50187297.77498.71
5509486-50948699.258100.21
6508024-50802498.97399.95
极限1507434-50743498.85898.520.49100.0199.660.50
2507763-50776398.922100.08
3506517-50651798.67999.81
4501311-50131197.66598.77
5506720-50672098.71999.83
6504522-50452298.29199.43
依折麦布阿托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对照品来源中检院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%
111.044346884345954346304345564346474346230.02
211.034328714330194329450.03
单位质量响应值RSD%判断
39368.0339251.590.21数据可信
供试品溶液-2024031021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%
5min1300070-30007068.70150.4821.9868.7050.4721.98
2256711-25671158.77458.77
3169393-16939338.78338.78
4191745-19174543.90043.90
5200799-20079945.97345.97
6204076-20407646.72346.72
10min1419914-41991496.14095.382.5896.2595.472.59
2424064-42406497.09097.19
3402027-40202792.04492.11
4416807-41680795.42895.50
5430511-43051198.56698.64
6406378-40637893.04193.12
15min1441952-441952101.18599.211.12101.4699.461.14
2432096-43209698.92999.19
3428244-42824498.04798.26
4429636-42963698.36698.60
5433552-43355299.26299.50
6434586-43458699.49999.73
20min1442260-442260101.25699.121.09101.7099.531.10
2430848-43084898.64399.07
3429319-42931998.29398.67
4431203-43120398.72499.12
5432595-43259599.04399.45
6431330-43133098.75399.15
30min1442285-442285101.26298.991.16101.8799.561.18
2430500-43050098.56399.15
3428347-42834798.07098.62
4431014-43101498.68199.24
5431973-43197398.90199.47
6429979-42997998.44499.01
45min1441189-441189101.01198.981.18101.7999.711.19
2435064-43506499.608100.36
3427462-42746297.86898.58
4430197-43019798.49499.22
5431039-43103998.68799.42
6428840-42884098.18398.91
60min1439824-439824100.69898.601.10101.6599.501.11
2428083-42808398.01098.93
3426715-42671597.69798.57
4428577-42857798.12399.01
5430235-43023598.50399.40
6430550-43055098.57599.47
极限1438872-438872100.48098.321.10101.6099.381.12
2428545-42854598.11699.20
3426245-42624597.58998.62
4427868-42786897.96199.01
5428211-42821198.03999.10
6426853-42685397.72898.78
依折麦布阿托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%
110.934807914809404808104806624804734807350.04
211.014798604800694799640.04
单位质量响应值RSD%判断
43983.0743593.460.63数据可信
供试品溶液-CLB05410批-阿托伐他汀钙-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%
5min1383826-38382674.90278.458.6474.9078.458.64
2420930-42093082.14382.14
3414441-41444180.87780.88
4339419-33941966.23666.24
5421697-42169782.29382.29
6431660-43166084.23784.24
10min1467551-46755191.24193.151.5291.3793.281.53
2473647-47364792.43192.57
3484447-48444794.53894.67
4473990-47399092.49892.61
5477503-47750393.18393.32
6486903-48690395.01795.16
15min1492091-49209196.03095.881.0796.3196.171.07
2482988-48298894.25394.54
3494608-49460896.52196.81
4490754-49075495.76996.03
5489060-48906095.43895.73
6498481-49848197.27797.58
20min1492208-49220896.05395.871.0796.4996.311.07
2482418-48241894.14294.59
3496659-49665996.92197.37
4490960-49096095.80996.23
5489034-48903495.43395.88
6496237-49623796.83997.30
30min1491406-49140695.89695.711.0796.4996.311.07
2481742-48174294.01094.62
3495795-49579596.75397.37
4489931-48993195.60896.19
5488186-48818695.26895.88
6495530-49553096.70197.32
45min1489005-48900595.42895.431.1496.1896.201.14
2480412-48041293.75194.51
3494784-49478496.55597.33
4488475-48847595.32496.07
5486254-48625494.89195.66
6495281-49528196.65297.44
60min1497653-49765397.11595.491.3798.0396.421.37
2479593-47959393.59194.51
3493788-49378896.36197.30
4487495-48749595.13396.04
5484475-48447594.54495.47
6493050-49305096.21797.16
极限1487932-48793295.21894.930.9996.3096.010.99
2478169-47816993.31394.39
3491000-49100095.81796.91
4486065-48606594.85495.91
5484551-48455194.55895.64
6490913-49091395.80096.90
依折麦布阿托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对照品来源中检院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%
111.044335144333974332354330764331014332650.05
211.034322274325154323710.05
单位质量响应值RSD%判断
39245.0239199.550.09数据可信
供试品溶液-CLB05410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%
5min1108657-10865724.93336.6022.4524.9336.6022.46
2152727-15272735.04535.04
3209519-20951948.07748.08
4155840-15584035.75935.76
5189646-18964643.51643.52
6140660-14066032.27632.28
10min1307664-30766470.59788.3410.4570.6488.4010.46
2389070-38907089.27789.33
3423851-42385197.25797.34
4393744-39374490.34990.41
5407088-40708893.41193.48
6388417-38841789.12789.18
15min1425877-42587797.722101.162.0397.88101.372.05
2438539-438539100.628100.84
3447274-447274102.632102.87
4445629-445629102.255102.46
5450494-450494103.371103.60
6437401-437401100.367100.57
20min1442349-442349101.502101.751.13101.82102.131.14
2439815-439815100.921101.30
3446559-446559102.468102.88
4445428-445428102.209102.59
5450174-450174103.298103.70
6436339-436339100.123100.49
30min1443714-443714101.815101.621.11102.31102.171.12
2439091-439091100.754101.30
3445165-445165102.148102.73
4444268-444268101.942102.49
5449481-449481103.139103.71
6435463-43546399.922100.46
45min1441955-441955101.412101.331.02102.07102.041.03
2437866-437866100.473101.18
3443911-443911101.860102.61
4443043-443043101.661102.38
5447681-447681102.726103.47
6435063-43506399.830100.53
60min1447970-447970102.792101.351.29103.62102.241.28
2437003-437003100.275101.15
3443960-443960101.872102.80
4442155-442155101.458102.35
5446137-446137102.371103.29
6433013-43301399.360100.23
极限1440620-440620101.105100.841.09102.11101.901.09
2435757-43575799.989101.04
3441507-441507101.309102.40
4441088-441088101.213102.27
5445689-445689102.268103.35
6432235-43223599.181100.22
依折麦布阿托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%
110.934782704780314785324794244799314788380.17
211.014795834794224795020.03
单位质量响应值RSD%判断
43809.5243551.500.42数据可信
供试品溶液-CLB05410批-阿托伐他汀钙-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%
5min1430072-43007284.13380.045.8484.1380.045.84
2410504-41050480.30580.31
3366674-36667471.73171.73
4410521-41052180.30980.31
5403855-40385579.00479.00
6433193-43319384.74484.74
10min1472914-47291492.51494.361.1892.6594.501.18
2488202-48820295.50595.64
3482558-48255894.40194.52
4481889-48188994.27094.40
5488166-48816695.49895.63
6480492-48049293.99794.14
15min1483426-48342694.57195.561.0094.8795.851.00
2496233-49623397.07697.37
3488196-48819695.50495.78
4486646-48664695.20195.49
5492076-49207696.26396.55
6484361-48436194.75495.05
20min1483565-48356594.59895.301.1495.0595.761.14
2495157-49515796.86597.32
3486742-48674295.21995.66
4484286-48428694.73995.19
5492479-49247996.34296.79
6480817-48081794.06094.52
30min1482818-48281894.45295.311.0195.0695.911.00
2494606-49460696.75897.37
3487973-48797395.46096.05
4484553-48455394.79195.40
5490870-49087096.02796.64
6482266-48226694.34494.96
45min1481109-48110994.11794.970.9594.8895.740.95
2492103-49210396.26897.05
3485831-48583195.04195.79
4482731-48273194.43595.20
5489720-48972095.80296.57
6481371-48137194.16994.94
60min1479523-47952393.80794.811.1694.7395.731.16
2492913-49291396.42797.36
3484808-48480894.84195.75
4482188-48218894.32895.25
5489529-48952995.76596.70
6478906-47890693.68694.61
极限1478644-47864493.63594.621.0694.7295.701.05
2491021-49102196.05697.16
3483766-48376694.63795.71
4481211-48121194.13795.22
5488375-48837595.53996.63
6479031-47903193.71194.79
依折麦布阿托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对照品来源中检院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%
111.044311014312754317714321784329884318630.18
211.034324704325614325160.02
单位质量响应值RSD%判断
39118.0339212.690.18数据可信
供试品溶液-CLB05410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%
5min1156050-15605035.86042.0215.9535.8642.0215.95
2169393-16939338.92638.93
3169357-16935738.91738.92
4213018-21301848.95148.95
5163202-16320237.50337.50
6226151-22615151.96851.97
10min1338509-33850977.78888.997.7077.8589.067.70
2373405-37340585.80785.87
3385505-38550588.58788.65
4420648-42064896.66396.74
5390895-39089589.82689.89
6414464-41446495.24295.33
15min1431607-43160799.181101.241.1199.37101.461.12
2444965-444965102.251102.46
3443230-443230101.852102.06
4439375-439375100.966101.21
5443897-443897102.005102.22
6440368-440368101.194101.44
20min1437379-437379100.508101.631.03100.86102.021.02
2447579-447579102.852103.23
3445835-445835102.451102.83
4438127-438127100.679101.09
5445541-445541102.383102.77
6439221-439221100.931101.34
30min1436407-436407100.284101.471.00100.81102.021.00
2446591-446591102.624103.17
3446323-446323102.563103.12
4437823-437823100.610101.19
5443179-443179101.840102.39
6439039-439039100.889101.47
45min1434068-43406899.747101.020.96100.44101.740.96
2444214-444214102.078102.80
3443239-443239101.854102.58
4435606-435606100.100100.85
5442015-442015101.573102.30
6438438-438438100.751101.50
60min1433931-43393199.715100.971.05100.57101.861.05
2444824-444824102.218103.11
3443495-443495101.913102.81
4435518-435518100.080100.99
5441977-441977101.564102.46
6436494-436494100.304101.22
极限1432848-43284899.466100.801.04100.49101.861.03
2443398-443398101.891102.95
3443129-443129101.829102.89
4434611-43461199.872100.95
5441158-441158101.376102.44
6436666-436666100.344101.43
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