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101028-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.4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%
111.254805734817784813904800904833284814320.26
211.374818144781114799620.55
单位质量响应值RSD%判断
42793.9642213.020.97数据可信
中间条件24月-供试品溶液-2024030821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%
5min1309129-30912961.83675.9616.3661.8475.9616.36
2373725-37372574.75874.76
3335921-33592167.19667.20
4356102-35610271.23371.23
5424967-42496785.00885.01
6478465-47846595.70995.71
10min1487878-48787897.59297.241.8197.7097.361.82
2477547-47754795.52695.65
3480228-48022896.06296.17
4478898-47889895.79695.91
5492672-49267298.55198.69
6499454-49945499.908100.07
15min1495084-49508499.03498.931.2299.3099.221.24
2494226-49422698.86299.15
3487548-48754897.52697.80
4488320-48832097.68197.96
5499545-49954599.926100.23
6502761-502761100.569100.90
20min1496538-49653899.32599.131.1899.7699.581.19
2495233-49523399.06499.51
3491157-49115798.24898.68
4487123-48712397.44197.88
5500365-500365100.090100.56
6502941-502941100.605101.10
30min1494816-49481698.98099.190.5799.5899.810.59
2495120-49512099.04199.65
3491191-49119198.25598.85
4496792-49679299.37599.98
5498710-49871099.759100.40
6498544-49854499.726100.39
45min1492993-49299398.61698.821.0499.3899.601.06
2492513-49251398.52099.30
3490775-49077598.17298.93
4487738-48773897.56498.33
5501773-501773100.372101.18
6498240-49824099.665100.49
60min1492961-49296198.60998.281.1199.5399.231.11
2493431-49343198.70399.65
3487979-48797997.61398.54
4484353-48435396.88797.82
5500068-500068100.031101.00
6489094-48909497.83698.83
极限1493295-49329598.67698.690.9799.7799.810.98
2492872-49287298.59199.70
3488762-48876297.76998.86
4487826-48782697.58298.68
5497704-49770499.558100.70
6499832-49983299.984101.14
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%
111.434599784600574581764587804583334590650.20
211.614606904602134604520.08
单位质量响应值RSD%判断
40163.1739659.950.90数据可信
中间条件24月-供试品溶液-2024030821批-阿托伐他汀钙-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%
5min1133172-13317229.95641.8834.9429.9641.8834.93
2213366-21336647.99548.00
3124644-12464428.03828.04
4133158-13315829.95329.95
5232347-23234752.26552.27
6280357-28035763.06563.06
10min1387107-38710787.07788.876.0387.1388.946.05
2406758-40675891.49891.58
3386605-38660586.96487.01
4355764-35576480.02780.08
5412242-41224292.73192.82
6421909-42190994.90695.01
15min1422089-42208994.94695.451.3795.1495.661.39
2426043-42604395.83696.07
3425051-42505195.61395.80
4414033-41403393.13493.32
5430590-43059096.85997.10
6428083-42808396.29596.56
20min1426382-42638295.91296.020.8296.2796.400.83
2425384-42538495.68796.08
3430925-43092596.93497.28
4421094-42109494.72295.06
5429434-42943496.59997.00
6428079-42807996.29496.72
30min1425743-42574395.76896.260.8696.2896.800.84
2425039-42503995.61096.16
3427851-42785196.24296.76
4435127-43512797.87998.38
5427263-42726396.11096.67
6426679-42667995.97996.56
45min1427325-42732596.12496.160.3996.8096.850.39
2425810-42581095.78396.49
3429604-42960496.63797.31
4426346-42634695.90496.56
5429381-42938196.58797.31
6426368-42636895.90996.65
60min1426457-42645795.92995.990.4196.7696.850.41
2424277-42427795.43896.31
3429275-42927596.56397.40
4425836-42583695.78996.61
5428075-42807596.29397.18
6426562-42656295.95296.86
极限1427889-42788996.25196.180.5297.2497.200.50
2423628-42362895.29296.32
3429760-42976096.67297.67
4429291-42929196.56697.55
5428075-42807596.29397.34
6426904-42690496.02997.09
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101028-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.4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%
111.254807634785794781024793864794024792460.22
211.374785624776724781170.14
单位质量响应值RSD%判断
42599.6442050.750.92数据可信
中间条件24月-供试品溶液-2024030921批-依折麦布
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1435745-43574587.53187.299.0587.5387.309.05
2433485-43348587.07787.08
3478407-47840796.10196.10
4467480-46748093.90693.91
5366513-36651373.62473.62
6425768-42576885.52785.53
10min1490025-49002598.43498.412.0498.5898.562.04
2473882-47388295.19295.34
3500936-500936100.626100.79
4482943-48294397.01297.17
5495164-49516499.46799.59
6496604-49660499.75699.90
15min1488712-48871298.17199.051.6498.4899.361.63
2484113-48411397.24797.55
3503378-503378101.117101.44
4485563-48556397.53897.86
5499952-499952100.428100.72
6496947-49694799.825100.13
20min1492062-49206298.84398.941.4799.3299.411.47
2485679-48567997.56198.03
3502157-502157100.871101.37
4483757-48375797.17597.66
5499190-499190100.275100.73
6492314-49231498.89499.37
30min1488624-48862498.15398.881.5498.7999.521.54
2484681-48468197.36197.99
3501075-501075100.654101.32
4483733-48373397.17097.81
5499364-499364100.310100.93
6496027-49602799.640100.28
45min1490395-49039598.50998.811.3399.3199.611.33
2486364-48636497.69998.49
3501274-501274100.694101.53
4483412-48341297.10697.91
5495823-49582399.599100.39
6494031-49403199.239100.05
60min1486171-48617197.66098.341.3698.6399.301.35
2489050-48905098.23899.19
3497240-49724099.884100.88
4478615-47861596.14297.11
5494663-49466399.366100.32
6491492-49149298.72999.70
极限1484266-48426697.27799.434.2498.41100.564.21
2484168-48416897.25898.38
3536011-536011107.672108.84
4478787-47878796.17797.30
5496185-49618599.672100.79
6490447-49044798.51999.66
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%
111.434560314568904555564579254585564569920.28
211.614571044566644568840.07
单位质量响应值RSD%判断
39981.8039352.631.13数据可信
中间条件24月-供试品溶液-2024030921批-阿托伐他汀钙
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1234208-23420853.00950.4924.5553.0150.5024.55
2209869-20986947.50147.50
3282008-28200863.82863.83
4286065-28606564.74664.75
5156696-15669635.46635.47
6169737-16973738.41738.42
10min1411301-41130193.09293.003.4193.1893.093.41
2422350-42235095.59295.67
3420517-42051795.17895.28
4413271-41327193.53893.65
5383754-38375486.85786.92
6414221-41422193.75393.82
15min1424891-42489196.16896.681.5996.4196.921.60
2435229-43522998.50798.75
3433404-43340498.09498.36
4420194-42019495.10495.37
5419153-41915394.86995.07
6430097-43009797.34697.57
20min1422090-42209095.53496.531.2695.9496.931.26
2435516-43551698.57298.98
3425886-42588696.39396.82
4420832-42083295.24995.67
5425046-42504696.20396.56
6429467-42946797.20397.59
30min1421895-42189595.48996.580.8396.0597.140.82
2432608-43260897.91498.48
3426248-42624896.47597.06
4425242-42524296.24796.83
5426459-42645996.52297.04
6427948-42794896.85997.40
45min1423439-42343995.83996.581.0296.5697.301.02
2433040-43304098.01298.74
3428401-42840196.96297.71
4422885-42288595.71496.45
5422758-42275895.68596.37
6429844-42984497.28997.99
60min1419226-41922694.88596.361.5695.7797.251.55
2433968-43396898.22299.12
3428072-42807296.88897.80
4417866-41786694.57895.48
5423576-42357695.87096.71
6431830-43183097.73898.61
极限1418485-41848594.71897.433.4695.7698.473.44
2430947-43094797.53898.60
3459177-459177103.928105.00
4420512-42051295.17696.24
5424278-42427896.02997.03
6429298-42929897.16598.20
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101028-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.4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%
111.254803464806564800904769264797094795450.32
211.374773964776554775260.04
单位质量响应值RSD%判断
42626.2241998.771.05数据可信
中间条件24月-供试品溶液-2024031021批-依折麦布
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1375554-37555475.46381.7311.0775.4681.7311.07
2486752-48675297.80797.81
3385398-38539877.44177.44
4360653-36065372.46972.47
5415900-41590083.57083.57
6416201-41620183.63183.63
10min1488493-48849398.15797.936.5498.2898.066.54
2516071-516071103.699103.86
3479472-47947296.34596.47
4428629-42862986.12886.25
5511222-511222102.724102.86
6500258-500258100.521100.66
15min1491879-49187998.83899.924.6299.13100.224.62
2518660-518660104.219104.55
3497313-49731399.930100.22
4455119-45511991.45191.72
5513960-513960103.275103.59
6506505-506505101.777102.08
20min1492573-49257398.977100.813.1399.43101.283.15
2518103-518103104.107104.62
3499364-499364100.342100.80
4476225-47622595.69296.11
5514367-514367103.356103.84
6509505-509505102.379102.86
30min1495770-49577099.619101.501.93100.24102.131.95
2520115-520115104.511105.19
3502340-502340100.940101.56
4495294-49529499.524100.10
5512634-512634103.008103.66
6504530-504530101.380102.03
45min1490461-49046198.553101.261.9099.34102.061.92
2516045-516045103.694104.55
3500065-500065100.483101.27
4497985-497985100.065100.81
5512205-512205102.922103.75
6506866-506866101.849102.67
60min1488385-48838598.136101.162.0099.08102.142.01
2517292-517292103.944104.97
3501946-501946100.860101.82
4498853-498853100.239101.15
5511197-511197102.719103.72
6503057-503057101.084102.07
极限1489641-48964198.388100.641.8999.50101.781.91
2514742-514742103.432104.64
3495839-49583999.633100.76
4494101-49410199.284100.36
5507990-507990102.075103.24
6502686-502686101.009102.16
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%
111.434587254595784597334553834560844579010.45
211.614569974587824578900.28
单位质量响应值RSD%判断
40061.3339439.281.11数据可信
中间条件24月-供试品溶液-2024031021批-阿托伐他汀钙
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1110989-11098925.06837.8818.8925.0737.8818.89
2195042-19504244.05244.05
3175741-17574139.69339.69
4176477-17647739.85939.86
5153693-15369334.71334.71
6194473-19447343.92443.92
10min1361129-36112981.56586.754.9781.6186.814.98
2391416-39141688.40688.48
3378351-37835185.45585.52
4416267-41626794.01994.08
5371171-37117183.83383.89
6386056-38605687.19587.27
15min1417320-41732094.25695.571.8294.4395.781.83
2421429-42142995.18495.41
3419964-41996494.85495.06
4434715-43471598.18598.41
5415115-41511593.75893.96
6430233-43023397.17397.39
20min1430604-43060497.25797.560.9397.5997.930.95
2431243-43124397.40197.78
3428084-42808496.68897.05
4437356-43735698.78299.17
5428136-42813696.69997.05
6436380-43638098.56198.94
30min1431350-43135097.42597.690.5897.9298.220.59
2435748-43574898.41998.96
3429859-42985997.08897.62
4435146-43514698.28398.83
5430157-43015797.15697.67
6432761-43276197.74498.29
45min1428577-42857796.79997.240.4597.4697.930.47
2431695-43169597.50398.21
3428268-42826896.72997.42
4432596-43259697.70798.42
5429609-42960997.03297.71
6432342-43234297.64998.36
60min1426402-42640296.30897.260.8397.1398.110.84
2436115-43611598.50199.37
3427627-42762796.58497.44
4432802-43280297.75398.63
5429545-42954597.01897.86
6431132-43113297.37698.25
极限1427209-42720996.49096.960.6597.4797.980.66
2434633-43463398.16799.20
3427660-42766096.59297.60
4429442-42944296.99498.04
5427681-42768196.59797.60
6429235-42923596.94897.98
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