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%
111.311694511695321695211700571692651695650.18
211.361680651681051680850.02
单位质量响应值RSD%判断
14992.4814796.210.94数据可信
供试品溶液-CLB01071批-瑞舒伐他汀钙-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%
5min1155800-15580089.57385.124.7689.5785.124.76
2147264-14726484.66684.67
3157785-15778590.71590.71
4142232-14223281.77381.77
5142512-14251281.93481.93
6142734-14273482.06182.06
10min1165609-16560995.21395.332.1895.7195.802.18
2170251-17025197.88298.35
3169069-16906997.20297.71
4166107-16610795.49995.95
5160463-16046392.25492.71
6163366-16336693.92394.38
15min1167793-16779396.46896.572.0197.4997.572.02
2172120-17212098.95699.97
3171215-17121598.43699.48
4168158-16815896.67897.66
5163335-16333593.90594.87
6165216-16521694.98795.96
20min1167558-16755896.33397.132.5697.9098.672.56
2173664-17366499.844101.41
3173234-17323499.597101.19
4170950-17095098.28399.81
5164451-16445194.54796.04
6163793-16379394.16995.67
30min1168876-16887697.09198.722.0999.19100.802.08
2175163-175163100.706102.82
3176284-176284101.350103.49
4171325-17132598.499100.57
5171738-17173898.736100.75
6166914-16691495.96397.99
45min1170402-17040297.96898.892.33100.61101.522.32
2173439-17343999.714102.39
3177601-177601102.107104.81
4174827-174827100.512103.13
5166747-16674795.86798.43
6169054-16905497.19399.76
60min1169155-16915597.25198.492.37100.43101.672.37
2175167-175167100.708103.94
3177030-177030101.779105.05
4171460-17146098.577101.75
5166602-16660295.78498.88
6168483-16848396.86599.97
极限1169666-16966697.54599.232.25101.27102.962.23
2174956-174956100.587104.38
3178152-178152102.424106.26
4173659-17365999.841103.56
5167289-16728996.17999.81
6171884-17188498.820102.46
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%
111.081840271847001848051851571844701846320.23
211.171822201828401825300.25
单位质量响应值RSD%判断
16663.5416341.091.39数据可信
供试品溶液-CLB01071批-依折麦布-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%
5min110888-108885.9245.4312.495.925.4312.46
29016-90164.9054.91
312098-120986.5826.58
49175-91754.9924.99
59585-95855.2155.21
69130-91304.9674.97
10min115406-154068.3828.375.398.418.405.37
214986-149868.1538.18
316646-166469.0579.09
415073-150738.2018.23
514259-142597.7587.79
615948-159488.6778.70
15min115019-150198.1718.441.888.258.521.85
215831-158318.6138.69
315543-155438.4568.54
415357-153578.3558.43
515700-157008.5428.61
615646-156468.5128.59
20min115732-157328.5598.511.968.688.631.94
216051-160518.7338.85
315770-157708.5808.71
415664-156648.5228.64
515534-155348.4528.57
615127-151278.2308.35
30min113989-139897.6118.596.697.788.766.55
216252-162528.8429.01
316115-161158.7688.95
416031-160318.7228.89
517084-170849.2959.46
615268-152688.3078.48
45min115321-153218.3368.152.988.558.372.91
214325-143257.7948.01
314973-149738.1468.38
415358-153588.3568.57
515347-153478.3508.57
614566-145667.9258.14
60min114674-146747.9848.262.488.248.532.47
215263-152638.3048.57
315606-156068.4918.77
415230-152308.2868.55
514809-148098.0578.32
615527-155278.4488.71
极限114631-146317.9608.422.938.278.732.84
215405-154058.3818.69
315658-156588.5198.84
415934-159348.6698.98
515717-157178.5518.86
615544-155448.4578.76
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%
111.311696371703391702701707881695971701260.30
211.361688801690081689440.06
单位质量响应值RSD%判断
15042.0914871.830.81数据可信
供试品溶液-CLB01071批-瑞舒伐他汀钙-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%
5min1137751-13775178.86483.413.0678.8683.413.06
2144655-14465582.81782.82
3145191-14519183.12483.12
4148576-14857685.06285.06
5147518-14751884.45684.46
6150482-15048286.15386.15
10min1156700-15670089.71392.792.8090.1593.252.79
2163776-16377693.76494.22
3169615-16961597.10797.57
4159185-15918591.13591.61
5159954-15995491.57692.04
6163189-16318993.42893.91
15min1154502-15450288.45494.044.1089.3995.024.08
2169515-16951597.04998.03
3173958-17395899.593100.59
4162424-16242492.99093.97
5162071-16207192.78893.77
6163088-16308893.37094.37
20min1157748-15774890.31394.873.1991.7496.373.19
2167696-16769696.00897.53
3173330-17333099.234100.79
4163261-16326193.46994.96
5164122-16412293.96295.46
6168057-16805796.21597.73
30min1162433-16243392.99594.892.6594.9296.922.63
2171922-17192298.427100.48
3168310-16831096.36098.47
4160095-16009591.65693.67
5163825-16382593.79295.81
6167907-16790796.12998.18
45min1163860-16386093.81298.013.1596.26100.573.13
2176743-176743101.187103.79
3177813-177813101.800104.44
4171723-17172398.313100.84
5167439-16743995.86198.40
6169617-16961797.10899.69
60min1166771-16677195.47897.342.3198.45100.442.29
2167080-16708095.65598.82
3177181-177181101.438104.65
4168367-16836796.39299.46
5169132-16913296.83099.90
6171604-17160498.245101.37
极限1166700-16670095.43897.583.0898.94101.223.04
2172207-17220798.591102.28
3177939-177939101.872105.64
4165412-16541294.70098.31
5165782-16578294.91298.52
6174558-17455899.937103.61
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%
111.081831621826831840941850631842151838430.51
211.171824661826231825440.07
单位质量响应值RSD%判断
16592.3316342.351.08数据可信
供试品溶液-CLB01071批-依折麦布-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%
5min17333-73333.9984.2213.114.004.2213.10
27225-72253.9393.94
36457-64573.5203.52
49319-93195.0815.08
57632-76324.1614.16
68491-84914.6294.63
10min113658-136587.4467.366.157.477.386.16
212970-129707.0717.09
312080-120806.5866.61
414293-142937.7937.82
514037-140377.6537.68
613950-139507.6067.63
15min114331-143317.8138.334.817.888.404.75
216472-164728.9819.04
314957-149578.1558.21
414937-149378.1448.22
515664-156648.5408.61
615327-153278.3568.42
20min115345-153458.3668.173.378.478.283.28
215331-153318.3588.47
315337-153378.3628.46
414116-141167.6967.81
514630-146307.9768.09
615109-151098.2378.35
30min113667-136677.4518.057.117.608.206.95
215087-150878.2258.38
316639-166399.0729.22
414689-146898.0088.17
514488-144887.8998.06
613996-139967.6317.79
45min114998-149988.1778.054.978.378.254.84
215159-151598.2658.47
314365-143657.8328.03
414431-144317.8688.07
515850-158508.6418.84
613749-137497.4967.70
60min114713-147138.0227.782.288.268.022.17
214389-143897.8458.09
314099-140997.6877.93
413738-137387.4907.74
514311-143117.8028.05
614318-143187.8068.05
极限114866-148668.1057.991.118.398.271.08
214730-147308.0318.32
314611-146117.9668.25
414444-144447.8758.16
514742-147428.0378.33
614488-144887.8998.19
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%
111.311703871711631711231706641706941708060.20
211.361699611702381701000.12
单位质量响应值RSD%判断
15102.2114973.590.61数据可信
供试品溶液-CLB03646批-瑞舒伐他汀钙-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%
5min1162989-16298992.81083.935.9392.8183.935.93
2139291-13929179.31579.32
3150224-15022485.54185.54
4148311-14831184.45284.45
5142071-14207180.89880.90
6141464-14146480.55380.55
10min1169963-16996396.78192.472.5697.3092.932.57
2159249-15924990.68091.12
3164045-16404593.41193.89
4159679-15967990.92591.39
5159499-15949990.82291.27
6161879-16187992.17892.63
15min1172175-17217598.04093.572.4999.0994.552.49
2162012-16201292.25393.20
3162549-16254992.55993.55
4160952-16095291.65092.62
5164993-16499393.95194.90
6163248-16324892.95793.92
20min1172299-17229998.11194.132.3899.7195.632.39
2160923-16092391.63393.09
3166036-16603694.54596.05
4162513-16251392.53994.02
5165432-16543294.20195.68
6164663-16466393.76395.24
30min1173619-17361998.86395.182.49101.0197.202.50
2162898-16289892.75894.72
3170288-17028896.96699.00
4163316-16331692.99694.99
5166872-16687295.02197.02
6165891-16589194.46296.46
45min1174149-17414999.16496.302.16101.8698.862.16
2165416-16541694.19296.67
3170473-17047397.07199.64
4164661-16466193.76296.28
5168629-16862996.02198.55
6171437-17143797.620100.14
60min1176194-176194100.32996.552.24103.5799.642.24
2167934-16793495.62598.63
3168432-16843295.90999.02
4167718-16771895.50298.54
5165520-16552094.25197.31
6171595-17159597.710100.77
极限1173335-17333598.70196.331.36102.5099.951.38
2169237-16923796.36799.90
3166580-16658094.85498.50
4169366-16936696.441100.01
5168738-16873896.08399.67
6167731-16773195.51099.12
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%
111.081872141883671869441878621875751875920.30
211.171865221857881861550.28
单位质量响应值RSD%判断
16930.6916665.621.12数据可信
供试品溶液-CLB03646批-依折麦布-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%
5min112328-123286.5895.5912.086.595.5912.06
210637-106375.6855.69
310803-108035.7745.77
410553-105535.6405.64
59927-99275.3065.31
68453-84534.5184.52
10min116316-163168.7208.334.548.768.364.57
215731-157318.4088.44
316059-160598.5838.62
415964-159648.5328.56
515005-150058.0208.05
614472-144727.7357.76
15min116054-160548.5808.681.638.678.761.61
216228-162288.6738.75
316704-167048.9289.01
416102-161028.6068.68
515981-159818.5418.62
616336-163368.7318.80
20min115736-157368.4108.262.508.548.392.51
215071-150718.0558.18
316066-160668.5878.72
415457-154578.2618.39
515286-152868.1708.29
615116-151168.0798.20
30min115283-152838.1688.224.688.358.394.61
215190-151908.1198.29
316536-165368.8389.02
415253-152538.1528.32
514330-143307.6597.83
615666-156668.3738.53
45min115375-153758.2178.342.888.448.552.84
215993-159938.5488.76
315876-158768.4858.71
416007-160078.5558.77
515487-154878.2778.49
614860-148607.9428.15
60min114789-147897.9048.134.458.178.394.30
216043-160438.5748.84
314575-145757.7908.06
415673-156738.3778.64
514472-144727.7357.99
615712-157128.3988.65
极限114788-147887.9048.203.158.228.503.05
215510-155108.2908.60
315572-155728.3238.64
415964-159648.5328.84
514726-147267.8718.17
615437-154378.2518.55
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)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%
111.311707811709141718451700061697351706560.49
211.361708521711651710080.13
单位质量响应值RSD%判断
15088.9515053.520.17数据可信
供试品溶液-CLB03646批-瑞舒伐他汀钙-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%
5min1138953-13895378.94780.453.5278.9580.453.52
2147415-14741583.75483.75
3133107-13310775.62575.63
4142906-14290681.19381.19
5142788-14278881.12581.13
6144425-14442582.05682.06
10min1160259-16025991.05291.801.5091.4992.241.51
2166041-16604194.33794.80
3159031-15903190.35490.77
4161985-16198592.03292.48
5160700-16070091.30291.75
6161390-16139091.69492.15
15min1161605-16160591.81692.791.7392.7693.741.73
2167653-16765395.25396.24
3164104-16410493.23694.16
4159970-15997090.88891.85
5161496-16149691.75592.71
6165036-16503693.76694.73
20min1163765-16376593.04493.731.4594.5095.201.44
2168687-16868795.84097.36
3165945-16594594.28295.72
4164069-16406993.21694.68
5165700-16570094.14395.61
6161661-16166191.84893.33
30min1166938-16693894.84694.680.7896.8296.670.78
2168630-16863095.80897.86
3165817-16581794.21096.17
4167357-16735795.08497.07
5166109-16610994.37596.37
6164983-16498393.73695.73
45min1166181-16618194.41694.901.8796.9197.421.85
2172782-17278298.167100.75
3164722-16472293.58796.07
4164007-16400793.18195.69
5167396-16739695.10797.62
6167082-16708294.92897.45
60min1165394-16539493.96994.312.2096.9997.362.16
2172182-17218297.826100.95
3166074-16607494.35697.36
4161680-16168091.85994.89
5163291-16329192.77495.82
6167361-16736195.08798.13
极限1168478-16847895.72195.060.8699.2798.630.86
2168913-16891395.96999.64
3165340-16534093.93897.47
4166223-16622394.44097.98
5166748-16674894.73898.30
6168203-16820395.56599.14
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%
111.081865171864621870471872771860401866690.27
211.171875991880671878330.18
单位质量响应值RSD%判断
16847.3816815.850.14数据可信
供试品溶液-CLB03646批-依折麦布-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%
5min16389-63893.4083.7820.313.413.7820.26
28740-87404.6624.66
34642-46422.4762.48
47745-77454.1314.13
57033-70333.7513.75
67922-79224.2254.23
10min112984-129846.9257.147.056.947.167.10
214347-143477.6527.68
311729-117296.2566.27
413947-139477.4397.46
513942-139427.4367.46
613382-133827.1387.16
15min114102-141027.5227.795.717.587.855.75
215953-159538.5098.58
314023-140237.4797.53
414174-141747.5607.62
514029-140297.4837.54
615340-153408.1828.25
20min113218-132187.0507.655.157.157.755.07
213770-137707.3457.46
314444-144447.7047.79
414443-144437.7037.81
515150-151508.0818.18
615022-150228.0128.12
30min116085-160858.5797.914.538.728.064.43
214887-148877.9408.10
314371-143717.6657.80
414869-148697.9318.08
514552-145527.7627.91
614210-142107.5797.73
45min115171-151718.0927.704.408.287.894.29
214849-148497.9208.12
313932-139327.4317.61
414511-145117.7407.93
514665-146657.8228.01
613443-134437.1707.37
60min114380-143807.6707.595.257.907.825.03
215048-150488.0268.27
315126-151268.0688.28
413835-138357.3797.62
513595-135957.2517.49
613374-133747.1337.37
极限115880-158808.4707.645.888.747.915.67
214327-143277.6427.93
314023-140237.4797.74
413946-139467.4387.72
514375-143757.6677.94
613387-133877.1407.41
点击查看处理图标(自动生成)
 
原始图谱下载图谱(谢超君 于 2024-11-29 11:42:36 完成)
生成报告数据部分下载报告(谢超君 于 2024-11-29 11:43:04 完成)
Current page cost:80 ms