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)5补液体积(ml)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5000
标示量(mg)10供试品稀释倍数5系数0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.251807991792221803781801251807671802580.36
211.331797661792611795140.20
单位质量响应值RSD%判断
16022.9315844.130.80数据可信
长期24月-供试品溶液-2023122121批-瑞舒伐他汀钙-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1162180-16218087.15984.717.7987.1684.717.79
2165293-16529388.83288.83
3163014-16301487.60787.61
4169253-16925390.96090.96
5136617-13661773.42173.42
6149418-14941880.30180.30
10min1184450-18445099.12797.833.1399.6198.303.14
2176789-17678995.01095.50
3181603-18160397.59798.08
4192245-192245103.317103.82
5178387-17838795.86996.28
6178697-17869796.03696.48
15min1187464-187464100.74799.632.36101.78100.642.35
2180835-18083597.18598.21
3180398-18039896.95097.98
4192090-192090103.233104.31
5185714-18571499.807100.75
6185761-18576199.832100.81
20min1187783-187783100.91999.752.99102.51101.322.98
2184697-18469799.260100.82
3179506-17950696.47098.04
4195174-195174104.891106.54
5185237-18523799.550101.05
6181227-18122797.39598.93
30min1184509-18450999.15998.352.14101.31100.462.15
2181884-18188497.74899.86
3180093-18009396.78698.89
4189972-189972102.095104.33
5182413-18241398.033100.08
6179095-17909596.25098.32
45min1182810-18281098.24698.991.93100.95101.661.94
2185751-18575199.827102.48
3180368-18036896.93499.57
4190385-190385102.317105.12
5184040-18404098.907101.50
6181820-18182097.714100.32
60min1179722-17972296.58796.621.6099.8499.841.61
2178812-17881296.09899.31
3176267-17626794.73097.91
4184596-18459699.206102.58
5181209-18120997.386100.53
6178142-17814295.73798.89
极限1181469-18146997.52596.141.66101.3199.891.68
2177068-17706895.16098.90
3175705-17570594.42898.13
4183325-18332598.523102.45
5178914-17891496.15299.84
6176844-17684495.04098.72
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)5补液体积(ml)5
对照品批号DSMF-387-240606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(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.121925221959001943211939121929551939220.69
211.071943241937701940470.21
单位质量响应值RSD%判断
17439.0317529.090.37数据可信
长期24月-供试品溶液-2023122121批-依折麦布-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1121343-12134362.30661.7710.7062.3161.7710.70
2141038-14103872.41972.42
3124343-12434363.84763.85
4121706-12170662.49362.49
5104768-10476853.79553.80
6108610-10861055.76855.77
10min1176189-17618990.46889.062.9890.8189.402.97
2172729-17272988.69189.09
3176816-17681690.79091.14
4174119-17411989.40589.75
5177283-17728391.03091.33
6163536-16353683.97184.28
15min1184661-18466194.81895.271.3795.6796.101.33
2182739-18273993.83194.73
3184747-18474794.86295.72
4185610-18561095.30596.15
5190301-19030197.71498.52
6185135-18513595.06195.84
20min1188027-18802796.54696.371.4897.9297.731.46
2186077-18607795.54596.96
3184827-18482794.90396.29
4191904-19190498.53799.91
5189813-18981397.46498.81
6185418-18541895.20796.51
30min1184323-18432394.64595.851.0596.5697.761.02
2184395-18439594.68296.63
3188379-18837996.72798.64
4188931-18893197.01198.93
5186970-18697096.00497.89
6187078-18707896.05997.89
45min1185111-18511195.04996.851.0597.4999.281.01
2188052-18805296.55999.03
3188913-18891397.00199.45
4189938-18993897.52899.99
5188846-18884696.96799.39
6190827-19082797.984100.35
60min1180397-18039792.62994.461.1995.5997.431.14
2183675-18367594.31297.32
3185126-18512695.05798.05
4182677-18267793.79996.80
5186102-18610295.55898.52
6185767-18576795.38698.30
极限1182244-18224493.57793.880.2797.0697.380.24
2182443-18244393.67997.21
3182895-18289593.91197.43
4182698-18269893.81097.33
5183204-18320494.07097.56
6183535-18353594.24097.68
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)5补液体积(ml)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5000
标示量(mg)10供试品稀释倍数5系数0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.251805181821421824091826321824891820380.48
211.331813371788791801080.97
单位质量响应值RSD%判断
16181.1615896.561.26数据可信
长期24月-供试品溶液-2023122221批-瑞舒伐他汀钙-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1113652-11365260.68180.7112.7560.6880.7112.75
2164096-16409687.61487.61
3148588-14858879.33479.33
4155957-15595783.26883.27
5163040-16304087.05087.05
6161644-16164486.30586.30
10min1175624-17562493.76996.782.7994.1197.232.81
2178258-17825895.17595.66
3178736-17873695.43095.87
4185424-18542499.00199.46
5189140-189140100.985101.47
6180415-18041596.32796.81
15min1183731-18373198.09799.291.5198.96100.281.53
2183194-18319497.81198.83
3186533-18653399.593100.56
4187117-18711799.905100.92
5190730-190730101.834102.88
6184449-18444998.48199.50
20min1185060-18506098.80799.511.95100.21101.051.95
2181692-18169297.00998.57
3186184-18618499.407100.93
4189715-189715101.292102.86
5191447-191447102.217103.83
6184140-18414098.31699.88
30min1181647-18164796.98598.711.8898.94100.801.89
2182681-18268197.53799.63
3183754-18375498.110100.19
4190875-190875101.912104.04
5187040-18704099.864102.04
6183237-18323797.83499.94
45min1180723-18072396.49198.521.2198.98101.161.24
2184392-18439298.450101.09
3186116-18611699.371101.99
4187079-18707999.885102.58
5185143-18514398.851101.58
6183654-18365498.056100.71
60min1180585-18058596.41896.810.8899.4499.990.91
2179437-17943795.80598.99
3179757-17975795.97699.15
4182879-18287997.642100.89
5183060-18306097.739101.02
6182173-18217397.265100.46
极限1179441-17944195.80796.811.6599.37100.541.64
2180306-18030696.26999.99
3179684-17968495.93799.64
4186814-18681499.743103.54
5182642-18264297.516101.34
6179037-17903795.59199.33
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)5补液体积(ml)5
对照品批号DSMF-387-240606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(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.121943661940321948501965801956121950880.53
211.071928671945581937120.62
单位质量响应值RSD%判断
17543.8817498.830.19数据可信
长期24月-供试品溶液-2023122221批-依折麦布-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1102285-10228552.40856.229.1652.4156.229.16
2108655-10865555.67255.67
3115378-11537859.11759.12
4103483-10348353.02253.02
5101320-10132051.91451.91
6127221-12722165.18565.18
10min1169491-16949186.84387.802.8687.1388.112.87
2164339-16433984.20384.51
3177762-17776291.08191.41
4174936-17493689.63389.93
5168282-16828286.22486.51
6173307-17330788.79889.16
15min1184739-18473994.65695.421.7095.4396.221.70
2182437-18243793.47694.25
3191852-19185298.30099.13
4187018-18701895.82396.62
5186110-18611095.35896.13
6185269-18526994.92795.78
20min1186922-18692295.77496.851.7197.0798.181.70
2183798-18379894.17495.47
3191378-19137898.05799.44
4192252-19225298.50599.83
5190993-19099397.86099.16
6188748-18874896.71098.09
30min1189060-18906096.87097.301.1398.7099.171.12
2188644-18864496.65798.48
3189439-18943997.06498.99
4194219-19421999.513101.39
5188774-18877496.72398.56
6189247-18924796.96698.89
45min1185005-18500594.79297.481.5197.1699.901.50
2190985-19098597.856100.21
3192849-19284998.811101.28
4192712-19271298.741101.17
5190187-19018797.44799.83
6189822-18982297.26099.72
60min1184922-18492294.75095.910.8997.6598.860.87
2186724-18672495.67398.57
3186352-18635295.48298.50
4188276-18827696.46899.44
5189725-18972597.210100.13
6187082-18708295.85698.86
极限1184088-18408894.32295.321.0697.7498.801.04
2185785-18578595.19298.62
3184718-18471894.64598.19
4189727-18972797.211100.72
5185740-18574095.16998.63
6186134-18613495.37198.90
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)5补液体积(ml)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5000
标示量(mg)10供试品稀释倍数5系数0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.251820241814761823871819681817391819190.19
211.331818571817881818220.03
单位质量响应值RSD%判断
16170.5816047.840.54数据可信
长期24月-供试品溶液-2023122321批-瑞舒伐他汀钙-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1144257-14425776.68078.505.3176.6878.505.32
2158399-15839984.19784.20
3143825-14382576.45176.45
4137012-13701272.82972.83
5147719-14771978.52078.52
6154898-15489882.33682.34
10min1188127-18812799.99997.521.65100.4397.961.63
2179203-17920395.25695.72
3183689-18368997.64098.07
4184708-18470898.18298.59
5181445-18144596.44896.88
6183606-18360697.59698.05
15min1187501-18750199.66798.331.67100.6599.301.65
2179285-17928595.29996.30
3184961-18496198.31699.28
4185803-18580398.76499.71
5184594-18459498.12199.09
6187746-18774699.797100.80
20min1188439-188439100.16598.661.77101.70100.181.75
2179661-17966195.49997.03
3186369-18636999.065100.58
4185569-18556998.640100.14
5184924-18492498.29799.81
6188642-188642100.273101.83
30min1187511-18751199.67298.122.14101.76100.192.11
2178354-17835494.80496.86
3182800-18280097.16899.23
4184651-18465198.152100.20
5184421-18442198.029100.09
6189788-189788100.882102.99
45min1188343-188343100.11496.772.74102.7699.382.69
2174304-17430492.65295.24
3182486-18248697.00199.60
4184332-18433297.982100.57
5178355-17835594.80597.41
6184442-18444298.041100.71
60min1186736-18673699.26097.042.04102.46100.192.02
2177048-17704894.11097.21
3180940-18094096.17999.32
4182645-18264597.085100.22
5181289-18128996.36599.50
6186670-18667099.225102.44
极限1184071-18407197.84396.671.49101.60100.371.48
2177623-17762394.41698.04
3182549-18254997.034100.71
4181252-18125296.345100.02
5180565-18056595.98099.65
6185164-18516498.424102.19
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)5补液体积(ml)5
对照品批号DSMF-387-240606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(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.121951831961521959841960271946301955950.34
211.071966191966221966200.01
单位质量响应值RSD%判断
17589.4817761.520.69数据可信
长期24月-供试品溶液-2023122321批-依折麦布-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min195785-9578548.65151.7316.7648.6551.7316.76
2122509-12250962.22562.22
389118-8911845.26545.26
478185-7818539.71239.71
5116782-11678259.31659.32
6108714-10871455.21855.22
10min1167996-16799685.32886.364.0485.6086.654.08
2179960-17996091.40591.75
3166090-16609084.36084.61
4160473-16047381.50781.73
5170608-17060886.65586.98
6175062-17506288.91789.22
15min1180907-18090791.88692.632.3492.6393.402.36
2184880-18488093.90494.76
3179020-17902090.92891.65
4179234-17923491.03691.71
5180301-18030191.57892.39
6189894-18989496.45197.25
20min1186748-18674894.85394.721.9896.1196.001.99
2186988-18698894.97596.35
3185129-18512994.03095.26
4183752-18375293.33194.51
5183042-18304292.97094.29
6193273-19327398.16799.50
30min1186725-18672594.84195.071.6696.6296.881.66
2186334-18633494.64296.55
3185206-18520694.07095.82
4187096-18709695.03096.73
5184504-18450493.71395.55
6193180-19318098.120100.00
45min1188322-18832295.65294.301.9297.9696.641.86
2182658-18265892.77595.20
3185085-18508594.00896.28
4187361-18736195.16497.39
5180598-18059891.72994.09
6189936-18993696.47298.90
60min1188046-18804695.51294.371.8298.3597.231.80
2184897-18489793.91396.86
3183142-18314293.02195.81
4185905-18590594.42597.18
5181766-18176692.32295.19
6191033-19103397.02999.99
极限1184691-18469193.80894.420.9497.1897.800.96
2185867-18586794.40597.87
3186236-18623694.59397.90
4185326-18532694.13197.41
5184166-18416693.54196.92
6189079-18907996.03799.54
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