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%
110.769665596642965319643396510965540.10
210.809612495881960020.18
单位质量响应值RSD%判断
8973.428889.070.67数据可信
供试品溶液-2024040821批-瑞舒伐他汀钙-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min176156-7615672.86478.004.9372.8678.004.93
288057-8805784.25084.25
383271-8327179.67179.67
479729-7972976.28276.28
581987-8198778.44378.44
679929-7992976.47476.47
10min195969-9596991.82094.882.1692.2395.322.16
299606-9960695.30095.77
3101525-10152597.13697.58
4101422-10142297.03897.46
598501-9850194.24394.68
697991-9799193.75594.18
15min197459-9745993.24697.552.7994.1698.512.78
2102389-10238997.96398.96
3102215-10221597.79698.78
4106397-106397101.797102.76
5101627-10162797.23498.19
6101661-10166197.26698.21
20min1100632-10063296.28298.982.0797.71100.482.07
2102423-10242397.99599.54
3105634-105634101.067102.59
4106341-106341101.744103.27
5102928-10292898.47899.98
6102740-10274098.29999.78
30min1101247-10124796.87098.641.7098.84100.691.69
2101758-10175897.35999.45
3104563-104563100.043102.13
4105799-105799101.225103.32
5102728-10272898.287100.33
6102466-10246698.036100.07
45min1100529-10052996.18398.911.8198.69101.511.82
2103090-10309098.633101.26
3105047-105047100.506103.15
4105575-105575101.011103.67
5103847-10384799.358101.95
6102181-10218197.764100.34
60min1101639-10163997.24599.181.64100.29102.331.64
2103144-10314498.685101.86
3105429-105429100.871104.07
4105869-105869101.292104.51
5103591-10359199.113102.26
6102274-10227497.853100.97
极限1102305-10230597.882100.181.86101.46103.881.86
2105586-105586101.022104.74
3107185-107185102.551106.31
4106059-106059101.474105.25
5104474-10447499.958103.65
6102637-10263798.200101.86
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%
110.778478884908847128489584645847900.14
210.828468384629846560.05
单位质量响应值RSD%判断
7872.797824.030.44数据可信
供试品溶液-2024040821批-依折麦布-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15361-53616.1485.9013.746.155.9013.74
25964-59646.8396.84
35000-50005.7345.73
43991-39914.5774.58
55727-57276.5676.57
64843-48435.5545.55
10min18094-80949.2829.362.609.329.392.61
28584-85849.8449.88
38042-80429.2229.25
48096-80969.2849.31
58152-81529.3489.38
68010-80109.1859.22
15min18294-82949.5119.643.469.609.723.43
28698-86989.97410.07
38503-85039.7519.83
48745-874510.02810.11
58107-81079.2979.39
68074-80749.2599.34
20min18440-84409.6789.442.689.829.582.64
28183-81839.3849.53
38381-83819.6119.75
48419-84199.6549.79
57885-78859.0429.18
68095-80959.2839.42
30min18462-84629.7049.532.109.909.722.06
28410-84109.6449.84
38383-83839.6139.80
48281-82819.4969.68
57977-79779.1489.34
68344-83449.5689.75
45min18266-82669.4799.631.689.739.871.65
28585-85859.84510.10
38435-84359.6739.92
48344-83449.5689.81
58227-82279.4349.68
68510-85109.75910.00
60min18285-82859.5019.570.489.809.860.43
28333-83339.5569.86
38347-83479.5729.87
48338-83389.5629.85
58341-83419.5659.86
68408-84089.6429.93
极限18054-80549.2369.471.789.599.821.70
28304-83049.5239.88
38365-83659.5929.94
48421-84219.65710.00
58106-81069.2959.64
68304-83049.5239.87
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%
110.769599496099961919605996040960770.08
210.809567195684956780.01
单位质量响应值RSD%判断
8929.098859.070.56数据可信
供试品溶液-2024040821批-瑞舒伐他汀钙
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min179825-7982576.69377.804.7976.6977.804.80
283492-8349280.21680.22
381258-8125878.07078.07
487051-8705183.63583.64
577679-7767974.63174.63
676548-7654873.54473.54
10min1100888-10088896.92996.841.6997.3697.271.70
2100102-10010296.17496.62
3101838-10183897.84298.28
4102591-10259198.56599.03
597776-9777693.93994.35
6101548-10154897.56397.97
15min1104601-104601100.49799.531.77101.46100.501.77
2102378-10237898.36199.34
3104735-104735100.625101.60
4105130-105130101.005102.02
5100426-10042696.48597.42
6104293-104293100.201101.15
20min1104131-104131100.04599.931.21101.57101.451.21
2104472-104472100.373101.90
3104737-104737100.627102.16
4103994-10399499.913101.49
5101598-10159897.61199.08
6105131-105131101.006102.51
30min1104291-104291100.199100.931.28102.28103.011.28
2103817-10381799.743101.83
3105730-105730101.581103.68
4106923-106923102.728104.86
5103585-10358599.520101.54
6105953-105953101.796103.86
45min1104358-104358100.263100.432.35102.90103.062.29
2106984-106984102.786105.42
3100311-10031196.37599.03
4105996-105996101.837104.54
5103372-10337299.316101.88
6106148-106148101.983104.62
60min1103404-10340499.347100.411.89102.54103.611.87
2103246-10324699.195102.40
3105335-105335101.202104.40
4107094-107094102.892106.16
5101909-10190997.910101.03
6106072-106072101.910105.11
极限1103962-10396299.88399.831.95103.63103.581.91
2103281-10328199.228102.99
3104484-104484100.384104.14
4104128-104128100.042103.88
5100664-10066496.714100.38
6106919-106919102.724106.49
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%
110.778471884848847858456384858847540.15
210.828452084731846260.18
单位质量响应值RSD%判断
7869.457821.260.44数据可信
供试品溶液-2024040821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%
5min15142-51425.8996.1812.535.906.1812.54
25419-54196.2176.22
34796-47965.5025.50
46686-66867.6707.67
54979-49795.7125.71
65283-52836.0616.06
10min18202-82029.4099.431.939.449.461.94
28338-83389.5659.60
38111-81119.3059.34
48474-84749.7219.76
58072-80729.2609.29
68108-81089.3019.34
15min18519-85199.7739.542.389.869.622.41
28584-85849.8479.94
38098-80989.2909.37
48314-83149.5389.63
58160-81609.3619.44
68218-82189.4289.51
20min18543-85439.8009.652.289.949.792.25
28614-86149.88210.02
38577-85779.8399.97
48264-82649.4809.63
58150-81509.3509.48
68322-83229.5479.68
30min18320-83209.5459.652.079.749.842.09
28419-84199.6589.86
38267-82679.4849.67
48749-874910.03710.24
58378-83789.6119.80
68328-83289.5549.74
45min18558-85589.81810.049.3610.0610.289.17
210375-1037511.90212.15
38371-83719.6039.84
48708-87089.99010.25
58375-83759.6089.85
68125-81259.3219.56
60min18374-83749.6079.722.889.9110.022.81
28329-83299.5559.87
38570-85709.83110.13
48670-86709.94610.26
58123-81239.3199.61
68782-878210.07510.37
极限18147-81479.3469.561.629.709.921.57
28430-84309.67110.04
38531-85319.78710.14
48275-82759.4939.86
58273-82739.4919.84
68329-83299.5559.91
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%
110.769593895866960539603296004959790.08
210.809487594992949340.09
单位质量响应值RSD%判断
8919.988790.191.04数据可信
供试品溶液-2024040921批-瑞舒伐他汀钙
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min182199-8219979.32477.053.5879.3277.053.57
280111-8011177.30977.31
378780-7878076.02576.03
484020-8402081.08281.08
577105-7710574.40974.41
676844-7684474.15774.16
10min197750-9775094.33298.273.1994.7798.693.17
2101359-10135997.81498.24
3100896-10089697.36897.79
4105623-105623101.929102.38
5105746-105746102.048102.46
699587-9958796.10496.52
15min1100698-10069897.17798.902.9498.1499.872.92
2101387-10138797.84198.81
3104421-104421100.769101.73
4101244-10124497.70398.72
5107643-107643103.879104.86
699487-9948796.00896.95
20min1102110-10211098.53999.412.13100.04100.942.11
2101009-10100997.47798.99
3105004-105004101.332102.86
4101781-10178198.22299.78
5106468-106468102.745104.30
6101728-10172898.17199.65
30min1101114-10111497.57898.602.0399.63100.682.02
2101481-10148197.93299.99
3104921-104921101.252103.34
4101804-10180498.244100.35
5104293-104293100.646102.77
699426-9942695.94997.97
45min1102922-10292299.32399.282.00101.92101.901.98
2100860-10086097.33399.93
3104103-104103100.462103.11
4101727-10172798.170100.82
5106302-106302102.585105.27
6101337-10133797.793100.35
60min1102247-10224798.67198.761.76101.82101.931.75
2100619-10061997.100100.24
3103342-10334299.728102.93
4101918-10191898.354101.55
5105320-105320101.637104.89
6100590-10059097.072100.17
极限1101878-10187898.31598.491.53102.01102.211.52
2100680-10068097.159100.84
3104213-104213100.569104.33
4100919-10091997.390101.13
5103759-103759100.131103.95
6100899-10089997.371101.01
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%
110.778469184705850658470084913848150.20
210.828497084887849280.07
单位质量响应值RSD%判断
7875.127849.170.24数据可信
供试品溶液-2024040921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%
5min16870-68707.8647.3518.947.867.3518.93
28683-86839.9409.94
35912-59126.7686.77
45958-59586.8206.82
55696-56966.5206.52
65387-53876.1676.17
10min18846-884610.1269.743.6210.179.783.57
28159-81599.3409.40
38878-887810.16310.20
48273-82739.4709.51
58587-85879.8309.87
68311-83119.5149.55
15min19156-915610.48110.323.1710.5810.423.12
28629-86299.8789.98
38829-882910.10710.20
49339-933910.69110.78
59291-929110.63610.73
68866-886610.14910.24
20min19332-933210.68310.212.8910.8410.372.85
28603-86039.84810.01
38874-887410.15810.31
49110-911010.42810.58
58813-881310.08810.24
68809-880910.08410.23
30min19610-961011.00110.174.7811.2210.384.72
28527-85279.7619.98
38798-879810.07110.28
49145-914510.46910.68
58529-85299.7639.97
68675-86759.93110.13
45min19038-903810.34610.013.1410.6210.283.06
28621-86219.86910.14
38329-83299.5349.80
49057-905710.36810.63
58692-86929.95010.21
68731-87319.99510.25
60min18821-882110.09810.002.0610.4310.322.01
28499-84999.72910.05
38634-86349.88410.20
49022-902210.32810.65
58669-86699.92410.24
68754-875410.02110.33
极限18288-82889.4889.771.869.8810.141.76
28503-85039.73410.11
38532-85329.76710.14
48788-878810.06010.44
58544-85449.78110.15
68533-85339.76810.13
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%
110.769488095350956689527995302952960.30
210.809526495305952840.04
单位质量响应值RSD%判断
8856.518822.590.28数据可信
供试品溶液-2024040921批-瑞舒伐他汀钙
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min183650-8365080.86378.721.7680.8678.721.76
281484-8148478.76978.77
379829-7982977.16977.17
482332-8233279.58879.59
580042-8004277.37577.37
681287-8128778.57878.58
10min197687-9768794.43298.293.0294.8898.733.00
2101342-10134297.96598.40
3100837-10083797.47797.91
4105235-105235101.728102.17
5105344-105344101.834102.26
699647-9964796.32696.76
15min1102912-10291299.48397.992.20100.4698.972.17
2102837-10283799.410100.39
397964-9796494.70095.67
499548-9954896.23197.24
5101283-10128397.90898.90
6103650-103650100.196101.17
20min1102356-10235698.94598.421.62100.4799.941.61
2102124-10212498.721100.26
398898-9889895.60297.10
4102273-10227398.865100.41
5101332-10133297.95599.49
6103878-103878100.417101.94
30min1101878-10187898.48398.531.32100.56100.601.31
2102878-10287899.450101.53
399862-9986296.53498.56
4101697-10169798.308100.40
5101424-10142498.044100.13
6103809-103809100.350102.44
45min1101363-10136397.98598.500.99100.61101.130.97
2102602-10260299.183101.82
3102320-10232098.910101.47
4101368-10136897.990100.63
5100494-10049497.14599.77
6103253-10325399.812102.46
60min1103037-10303799.60497.831.63102.77101.001.59
2101488-10148898.106101.29
399818-9981896.49299.61
4101338-10133897.961101.14
598818-9881895.52598.69
6102744-10274499.320102.52
极限1101895-10189598.50097.972.05102.22101.682.00
2101539-10153998.155101.89
3100482-10048297.134100.78
4101836-10183698.443102.17
597998-9799894.73298.43
6104322-104322100.846104.60
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)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%
110.778425184534849238438284622845420.31
210.828419684194841950.01
单位质量响应值RSD%判断
7849.777781.420.62数据可信
供试品溶液-2024040921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%
5min17144-71448.2276.7317.278.236.7317.28
26907-69077.9547.95
34455-44555.1305.13
45518-55186.3546.35
55434-54346.2586.26
65595-55956.4436.44
10min18791-879110.1239.823.2510.179.863.22
28231-82319.4799.52
38903-890310.25210.28
48241-82419.4909.53
58479-84799.7649.80
68501-85019.7899.83
15min19031-903110.40010.502.0610.5010.592.05
29435-943510.86510.96
39262-926210.66610.75
48967-896710.32610.41
58987-898710.34910.44
69040-904010.41010.50
20min19076-907610.45210.352.1810.6110.502.19
29082-908210.45910.62
38953-895310.31010.45
49274-927410.68010.83
58732-873210.05510.20
68827-882710.16510.31
30min19013-901310.37910.443.6210.6010.643.57
29387-938710.81011.03
39069-906910.44410.65
49482-948210.91911.12
58756-875610.08310.29
68666-86669.97910.18
45min18841-884110.18110.7313.8710.4611.0013.51
28852-885210.19410.47
311948-1194813.75914.02
48903-890310.25210.52
58692-869210.00910.27
68667-86679.98110.24
60min18904-890410.25410.052.8910.5910.382.88
28967-896710.32610.66
38904-890410.25410.59
48689-868910.00610.33
58313-83139.5739.89
68577-85779.87710.19
极限18579-85799.8799.992.1710.2710.372.17
28905-890510.25510.64
38864-886410.20710.60
48724-872410.04610.42
58455-84559.73610.10
68508-85089.79810.17
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