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)0
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%
110.761685261696161687171693741692111690890.27
210.801729431732051730740.11
单位质量响应值RSD%判断
15714.5916025.371.39数据可信
供试品溶液-25110501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%
5min1141114-14111476.14677.5910.6476.1577.5810.64
2164113-16411388.55788.56
3118719-11871964.06264.06
4138382-13838274.67274.67
5152228-15222882.14482.14
6148127-14812779.93179.93
10min1166574-16657489.88592.693.4990.3193.123.50
2182325-18232598.38498.88
3172571-17257193.12193.48
4168406-16840690.87391.29
5173926-17392693.85294.31
6166825-16682590.02090.46
15min1166039-16603989.59694.674.3790.5295.614.37
2188408-188408101.667102.71
3176130-17613095.04195.91
4173660-17366093.70894.63
5178085-17808596.09697.07
6170306-17030691.89992.84
20min1165433-16543389.26994.043.8190.6995.513.81
2184256-18425699.426101.03
3176341-17634195.15596.56
4175445-17544594.67296.11
5175738-17573894.83096.34
6168433-16843390.88892.34
30min1165751-16575189.44193.763.0191.3695.763.02
2179823-17982397.03499.19
3177772-17777295.92797.86
4172795-17279593.24295.21
5176222-17622295.09197.13
6170207-17020791.84593.80
45min1163990-16399088.49093.373.1690.9095.883.15
2178736-17873696.44899.14
3175709-17570994.81497.28
4176147-17614795.05097.53
5174481-17448194.15296.72
6169093-16909391.24493.71
60min1161074-16107486.91793.044.0589.8296.074.01
2179489-17948996.854100.08
3176670-17667095.33398.32
4176276-17627695.12098.13
5174041-17404193.91497.00
6166991-16699190.11093.09
极限1162448-16244887.65892.904.1991.0596.454.14
2180607-18060797.457101.23
3178543-17854396.34399.86
4173771-17377193.76897.31
5172498-17249893.08196.69
6165070-16507089.07392.55
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)0
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%
111.682039122030492048542042192044392040950.34
211.722092922075872084400.58
单位质量响应值RSD%判断
17473.8917784.981.25数据可信
供试品溶液-25110501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%
5min1123421-12342162.85553.6326.9162.8653.6326.91
2137661-13766170.10770.11
359180-5918030.13930.14
493889-9388947.81547.82
595494-9549448.63348.63
6122179-12217962.22262.22
10min1180135-18013591.73884.208.0492.0984.508.11
2176198-17619889.73390.12
3142461-14246172.55272.72
4162329-16232982.67082.94
5162799-16279982.90983.18
6168128-16812885.62385.97
15min1186512-18651294.98692.583.8095.8493.343.88
2190039-19003996.78297.67
3169982-16998286.56787.14
4179987-17998791.66392.39
5183676-18367693.54194.27
6180512-18051291.93092.75
20min1188923-18892396.21394.951.8097.6096.231.85
2187834-18783495.65997.08
3181827-18182792.60093.65
4188756-18875696.12897.36
5188820-18882096.16197.41
6182467-18246792.92694.26
30min1189569-18956996.54295.991.0298.4697.800.93
2185922-18592294.68596.64
3189959-18995996.74198.31
4188400-18840095.94797.72
5190567-19056797.05198.84
6186446-18644694.95296.80
45min1188611-18861196.05595.751.8098.5198.091.70
2184299-18429993.85996.34
3189352-18935296.43298.54
4192781-19278198.178100.48
5189147-18914796.32798.65
6183872-18387293.64196.02
60min1184957-18495794.19495.762.2197.1898.622.07
2184597-18459794.01097.01
3190706-19070697.12199.76
4193697-19369798.645101.49
5190557-19055797.04699.90
6183630-18363093.51896.41
极限1185753-18575394.59994.881.4298.1198.281.35
2185054-18505494.24397.77
3186532-18653294.99698.17
4189861-18986196.691100.09
5188351-18835195.92299.32
6182286-18228692.83396.25
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)0
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%
110.761659261654001652911658031668011658440.37
210.801693581705041699310.48
单位质量响应值RSD%判断
15413.0115734.351.46数据可信
供试品溶液-25110502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%
5min1147082-14708280.87874.6810.7180.8874.6810.70
2110924-11092460.99561.00
3128956-12895670.91070.91
4138437-13843776.12476.12
5151685-15168583.40983.41
6137743-13774375.74275.74
10min1167729-16772992.23191.595.0592.6892.005.07
2150850-15085082.95083.29
3167750-16775092.24392.64
4173172-17317295.22495.65
5174275-17427595.83196.29
6165592-16559291.05691.48
15min1174128-17412895.75094.774.0996.7195.694.11
2159780-15978087.86088.66
3172778-17277895.00795.91
4178115-17811597.94298.89
5179239-17923998.56099.56
6170034-17003493.49894.43
20min1174799-17479996.11994.733.2697.6196.183.29
2162252-16225289.21990.51
3172967-17296795.11196.55
4178891-17889198.36999.86
5174040-17404095.70197.24
6170650-17065093.83795.28
30min1172373-17237394.78594.122.5896.8196.102.63
2164023-16402390.19391.98
3171234-17123494.15896.12
4175575-17557596.54598.59
5175397-17539796.44798.52
6168410-16841092.60594.57
45min1169199-16919993.03994.241.9995.5996.732.03
2167901-16790192.32694.61
3169898-16989893.42495.91
4175482-17548296.49499.07
5175843-17584396.69399.30
6169921-16992193.43695.92
60min1170779-17077993.90893.922.4096.9896.942.45
2164812-16481290.62793.42
3169233-16923393.05896.06
4175634-17563496.57899.69
5175176-17517696.32699.47
6169167-16916793.02296.02
极限1167562-16756292.13993.912.1795.7397.452.18
2168363-16836392.58095.88
3168514-16851492.66396.18
4176026-17602696.793100.44
5174911-17491196.18099.86
6169271-16927193.07996.60
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)0
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%
111.682006532010362000122016952017452010280.37
211.722025892037642031760.41
单位质量响应值RSD%判断
17211.3017335.840.51数据可信
供试品溶液-25110502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%
5min1108046-10804656.15542.2529.7556.1542.2529.75
268482-6848235.59235.59
345300-4530023.54423.54
481353-8135342.28242.28
5108218-10821856.24456.24
676396-7639639.70539.71
10min1168624-16862487.63984.817.6987.9585.047.74
2169433-16943388.06088.26
3138990-13899072.23772.37
4166444-16644486.50686.74
5174123-17412390.49790.81
6161471-16147183.92284.14
15min1184851-18485196.07395.313.0996.8796.023.16
2186519-18651996.94097.63
3173013-17301389.92090.45
4185076-18507696.19096.91
5189216-18921698.34299.16
6181599-18159994.38395.07
20min1188316-18831697.87497.361.3399.2198.601.41
2189027-18902798.24399.47
3183016-18301695.11996.15
4189735-18973598.61199.86
5188019-18801997.71999.08
6185906-18590696.62197.83
30min1187090-18709097.23796.991.2899.1198.761.35
2186518-18651896.93998.71
3184785-18478596.03997.60
4185617-18561796.47198.27
5191029-19102999.284101.19
6184605-18460595.94597.69
45min1184702-18470295.99596.711.2198.4199.021.26
2186955-18695597.16699.48
3183428-18342895.33397.43
4184412-18441295.84598.18
5189289-18928998.379100.84
6187662-18766297.53499.81
60min1186011-18601196.67696.271.1399.6399.121.21
2184035-18403595.64998.50
3182590-18259094.89897.52
4184719-18471996.00498.87
5188738-18873898.093101.10
6185255-18525596.28399.11
极限1183226-18322695.22895.921.4598.7299.311.51
2185419-18541996.36899.75
3180543-18054393.83496.98
4185449-18544996.38499.78
5188535-18853597.988101.54
6184181-18418195.72599.08
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)0
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%
110.761693241689981680761688411688051688090.28
210.801659091662121660600.13
单位质量响应值RSD%判断
15688.5715375.931.43数据可信
供试品溶液-25110503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%
5min1149040-14904082.17272.9117.7782.1772.9117.77
2120193-12019366.26866.27
393168-9316851.36851.37
4151408-15140883.47883.48
5127076-12707670.06370.06
6152525-15252584.09484.09
10min1174406-17440696.15894.543.3896.6194.943.44
2163864-16386490.34690.71
3165542-16554291.27191.56
4176577-17657797.35597.82
5170680-17068094.10494.49
6177763-17776398.00998.48
15min1176520-17652097.32398.441.0798.3199.371.08
2179017-17901798.70099.57
3178534-17853498.43499.23
4178871-17887198.62099.62
5176651-17665197.39698.31
6181713-181713100.187101.20
20min1172857-17285795.30497.791.5496.8499.271.50
2179365-17936598.892100.31
3178641-17864198.49399.83
4176945-17694597.55899.11
5176056-17605697.06898.52
6180383-18038399.453101.02
30min1174420-17442096.16697.431.1398.2399.451.16
2178083-17808398.185100.15
3174494-17449496.20698.09
4179027-17902798.706100.80
5176103-17610397.09499.09
6178149-17814998.222100.34
45min1175128-17512896.55697.511.6699.15100.071.66
2175045-17504596.51099.02
3177975-17797598.126100.55
4179531-17953198.984101.63
5173008-17300895.38797.92
6180476-18047699.505102.17
60min1169180-16918093.27796.322.3996.4199.422.32
2174895-17489596.42899.48
3178112-17811298.201101.17
4179172-17917298.786101.98
5170160-17016093.81796.88
6176635-17663597.387100.61
极限1171512-17151294.56296.511.8198.21100.151.80
2174242-17424296.06799.65
3175493-17549396.757100.27
4179704-17970499.079102.82
5171974-17197494.81798.40
6177361-17736197.787101.55
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)0
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%
111.682044392038932033672047102040522040920.26
211.722013772015612014690.07
单位质量响应值RSD%判断
17473.6317190.191.16数据可信
供试品溶液-25110503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%
5min1100235-10023551.92337.1440.4951.9237.1440.49
251264-5126426.55526.56
333674-3367417.44317.44
493715-9371548.54548.55
553097-5309727.50527.50
698231-9823150.88550.88
10min1173895-17389590.07980.2412.9990.3780.4513.06
2147005-14700576.15076.30
3123090-12309063.76263.86
4171120-17112088.64288.91
5144601-14460174.90575.06
6169733-16973387.92388.21
15min1184070-18407095.35093.474.4496.1494.124.55
2181266-18126693.89894.47
3166866-16686686.43886.89
4187735-18773597.24998.01
5175509-17550990.91591.48
6187143-18714396.94297.71
20min1183575-18357595.09495.722.3096.4196.892.40
2187043-18704396.89097.98
3177687-17768792.04492.97
4189448-18944898.13699.44
5183196-18319694.89795.97
6187804-18780497.28498.59
30min1186580-18658096.65097.041.9598.5098.752.04
2189208-18920898.01299.64
3181164-18116493.84595.29
4192212-19221299.568101.42
5187148-18714896.94598.55
6187716-18771697.23999.09
45min1186709-18670996.71797.051.9599.1099.292.04
2184948-18494895.80597.98
3186137-18613796.42198.38
4191841-19184199.376101.78
5182829-18282994.70796.85
6191628-19162899.265101.66
60min1181147-18114793.83695.992.0696.7698.772.06
2186164-18616496.43599.14
3186153-18615396.42998.93
4191093-19109398.988101.94
5180891-18089193.70396.37
6186354-18635496.53399.48
极限1182514-18251494.54496.172.2497.9999.492.28
2184934-18493495.79899.04
3183700-18370095.15898.19
4193444-193444100.206103.71
5182521-18252194.54897.73
6186828-18682896.779100.26
点击查看处理图标(自动生成)
 
原始图谱下载图谱(谢超君 于 2025-11-14 15:49:08 完成)
生成报告数据部分下载报告(谢超君 于 2025-11-14 15:49:31 完成)
Current page cost:54 ms