依折麦布辛伐他汀片项目信息
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%
111.169721249720799717249718809721569719930.02
211.129830689835819833240.04
单位质量响应值RSD%判断
87096.1588428.421.08数据可信
供试品溶液-25080101批-依折麦布-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1450540-45054046.09045.1913.3346.0945.1913.33
2355025-35502536.31936.32
3424035-42403543.37843.38
4427137-42713743.69643.70
5536364-53636454.87054.87
6457358-45735846.78746.79
10min1656564-65656467.16666.466.6067.2466.536.61
2588267-58826760.17960.24
3633181-63318164.77464.85
4662358-66235867.75967.83
5719015-71901573.55573.65
6638340-63834065.30265.38
15min1742018-74201875.90876.154.6376.1076.344.64
2704704-70470472.09172.25
3730880-73088074.76874.95
4771746-77174678.94979.13
5797402-79740281.57481.79
6719581-71958173.61373.80
20min1787914-78791480.60381.223.5380.9281.533.54
2766998-76699878.46378.74
3778394-77839479.62979.93
4824487-82448784.34484.66
5833023-83302385.21885.57
6772627-77262779.03979.35
30min1835132-83513285.43385.622.3585.8886.062.37
2811254-81125482.99183.40
3826428-82642884.54384.98
4857552-85755287.72788.18
5862683-86268388.25288.74
6828556-82855684.76185.20
45min1864470-86447088.43588.321.7789.0388.911.79
2837660-83766085.69286.24
3859322-85932287.90888.49
4879471-87947189.96990.57
5878133-87813389.83290.47
6861082-86108288.08888.67
60min1878594-87859489.88089.601.4390.6290.331.45
2851713-85171387.13087.82
3875053-87505389.51790.24
4887582-88758290.79991.55
5881028-88102890.12990.92
6880996-88099690.12590.85
极限1911081-91108193.20392.901.4694.0993.781.47
2882056-88205690.23491.07
3912177-91217793.31594.19
4918566-91856693.96994.87
5908423-90842392.93193.87
6916125-91612593.71994.60
依折麦布辛伐他汀片项目信息
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100601-201906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(%)99.5对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
111.162160312215969921590582159946216008221598190.03
211.122201927218509321935100.55
单位质量响应值RSD%判断
193532.17197258.091.35数据可信
供试品溶液-25080101批-辛伐他汀-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1385562-38556217.67221.0326.8417.6721.0326.84
2308169-30816914.12514.12
3369089-36908916.91716.92
4517763-51776323.73123.73
5629695-62969528.86228.86
6542358-54235824.85924.86
10min1605322-60532227.74529.8513.0727.7729.8813.09
2545240-54524024.99125.01
3590109-59010927.04727.08
4721247-72124733.05833.10
5767300-76730035.16935.22
6678160-67816031.08331.12
15min1720849-72084933.04034.187.1233.1234.267.14
2682837-68283731.29731.36
3714169-71416932.73332.81
4800187-80018736.67636.77
5819458-81945837.55937.67
6736514-73651433.75833.85
20min1790833-79083336.24736.613.5036.3836.753.53
2771032-77103235.34035.46
3788415-78841536.13736.26
4831379-83137938.10638.26
5835494-83549438.29438.46
6775500-77550035.54535.69
30min1860489-86048939.44038.692.0539.6338.892.02
2843198-84319838.64738.82
3857291-85729139.29339.48
4841008-84100838.54738.77
5850160-85016038.96739.20
6812568-81256837.24437.45
45min1902911-90291141.38439.863.3241.6440.123.26
2880040-88004040.33640.58
3898808-89880841.19641.45
4849106-84910638.91839.20
5854912-85491239.18439.48
6831617-83161738.11738.39
60min1922863-92286342.29940.414.1242.6240.744.05
2894436-89443640.99641.30
3922573-92257342.28642.61
4849819-84981938.95139.30
5853749-85374939.13139.49
6846214-84621438.78639.12
极限1958223-95822343.92041.704.4944.3242.104.42
2933885-93388542.80443.18
3947037-94703743.40743.80
4873258-87325840.02540.44
5873580-87358040.04040.47
6872670-87267039.99840.40
依折麦布辛伐他汀片项目信息
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%
111.169770159779439789269787539783039781880.08
211.129838129869689853900.23
单位质量响应值RSD%判断
87651.2588614.210.78数据可信
供试品溶液-25080101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%
5min1391401-39140139.87142.1415.9539.8742.1415.95
2379643-37964338.67338.67
3335916-33591634.21934.22
4499539-49953950.88650.89
5385290-38529039.24839.25
6490280-49028049.94349.94
10min1622759-62275963.43868.2210.8263.5068.2910.82
2637248-63724864.91464.98
3587322-58732259.82859.89
4777105-77710579.16179.25
5657268-65726866.95467.02
6736569-73656975.03275.11
15min1750144-75014476.41580.747.6076.5980.927.62
2755511-75551176.96177.13
3725621-72562173.91674.07
4876783-87678389.31589.53
5796872-79687281.17581.35
6850659-85065986.65486.86
20min1820189-82018983.55086.685.3183.8587.005.32
2809244-80924482.43582.74
3806911-80691182.19782.48
4909865-90986592.68593.05
5864976-86497688.11288.42
6894361-89436191.10591.46
30min1875930-87593089.22891.183.4389.6791.643.45
2857822-85782287.38387.82
3870602-87060288.68589.10
4932140-93214094.95495.47
5916758-91675893.38793.85
6917473-91747393.46093.96
45min1912578-91257892.96193.432.2493.5594.052.26
2887112-88711290.36790.95
3904233-90423392.11192.68
4945769-94576996.34297.02
5927184-92718494.44995.06
6926365-92636594.36695.03
60min1929797-92979794.71594.441.8395.4695.211.85
2899813-89981391.66192.40
3918521-91852193.56694.28
4950752-95075296.85097.69
5933105-93310595.05295.82
6930441-93044194.78195.60
极限1948993-94899396.67195.471.3097.5796.401.31
2918717-91871793.58694.47
3933869-93386995.13096.00
4952215-95221596.99998.00
5936485-93648595.39696.33
6933025-93302595.04496.02
依折麦布辛伐他汀片项目信息
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100601-201906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(%)99.5对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
111.162170356217260221745872173362217357121728960.08
211.122185813219323721895250.24
单位质量响应值RSD%判断
194703.94196899.730.80数据可信
供试品溶液-25080101批-辛伐他汀-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%
5min1884780-88478040.46723.2970.5740.4723.2970.57
2857769-85776939.23139.23
3761727-76172734.83934.84
4200213-2002139.1579.16
5154907-1549077.0857.08
6195882-1958828.9598.96
10min11412327-141232764.59527.41101.8264.6627.45101.72
23616-36160.1650.23
31335584-133558461.08561.14
4297855-29785513.62313.64
5256228-25622811.71911.73
6290591-29059113.29113.31
15min14162-41620.1907.78106.940.377.86105.10
24278-42780.1960.26
34407-44070.2020.36
4344672-34467215.76415.80
5318416-31841614.56314.59
6344426-34442615.75315.79
20min14878-48780.2238.59106.680.408.68105.04
24980-49800.2280.29
35034-50340.2300.39
4377119-37711917.24817.31
5362812-36281216.59416.65
6371516-37151616.99217.06
30min15430-54300.2489.41106.560.429.52105.06
25582-55820.2550.32
35869-58690.2680.43
4406872-40687218.60918.70
5404753-40475318.51218.60
6406150-40615018.57618.67
45min15715-57150.26110.16106.370.4410.28104.97
25968-59680.2730.34
37681-76810.3510.51
4439585-43958520.10520.23
5435244-43524419.90720.02
6438038-43803820.03420.16
60min16575-65750.30110.88106.260.4811.03104.95
26772-67720.3100.38
38093-80930.3700.53
4471103-47110321.54721.70
5466806-46680621.35021.50
6468501-46850121.42821.58
极限17093-70930.32411.47106.230.5011.64105.00
27099-70990.3250.39
38610-86100.3940.56
4495934-49593422.68222.88
5492321-49232122.51722.70
6494110-49411022.59922.79
依折麦布辛伐他汀片项目信息
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%
111.169788899813549832159856829843609827000.28
211.129731129732789731950.02
单位质量响应值RSD%判断
88055.5687517.540.44数据可信
供试品溶液-25080101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%
5min1317050-31705032.42340.8122.5132.4240.8122.51
2301541-30154130.83730.84
3418419-41841942.79042.79
4404510-40451041.36841.37
5553000-55300056.55356.55
6399960-39996040.90240.90
10min1552680-55268056.52068.4016.2756.5768.4716.27
2550623-55062356.31056.36
3651761-65176166.65366.72
4702374-70237471.82971.90
5834851-83485185.37785.47
6720832-72083273.71773.78
15min1692622-69262270.83280.9710.9570.9881.1610.96
2705540-70554072.15372.30
3763011-76301178.03078.21
4834824-83482485.37485.56
5915727-91572793.64893.88
6839093-83909385.81186.00
20min1784602-78460280.23887.297.2580.5087.617.27
2799070-79907081.71881.98
3816435-81643583.49483.81
4896893-89689391.72292.05
5937085-93708595.83296.22
6887325-88732590.74391.08
30min1849830-84983086.90991.954.7987.3192.414.82
2867183-86718388.68389.09
3864485-86448588.40788.86
4931994-93199495.31195.80
5947347-94734796.88197.43
6933816-93381695.49895.98
45min1881773-88177390.17593.933.3690.7294.543.40
2900198-90019892.06092.61
3891000-89100091.11991.72
4940938-94093896.22696.87
5951454-95145497.30198.02
6945371-94537196.67997.32
60min1892134-89213491.23594.752.9491.9395.522.98
2913926-91392693.46494.17
3902848-90284892.33193.08
4942725-94272596.40997.21
5958801-95880198.05398.93
6948792-94879297.02997.83
极限1909385-90938592.99995.422.0693.8596.362.11
2928624-92862494.96795.83
3912651-91265193.33394.24
4943470-94347096.48597.45
5950288-95028897.18298.22
6954128-95412897.57598.54
依折麦布辛伐他汀片项目信息
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100601-201906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(%)99.5对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
111.162173616217887121835522188597218600721821290.28
211.122161660216194321618020.01
单位质量响应值RSD%判断
195531.27194406.650.41数据可信
供试品溶液-25080101批-辛伐他汀-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%
5min14983-49830.22928.46111.290.2328.46111.29
24987-49870.2290.23
37245-72450.3330.33
41102952-110295250.65950.66
51512115-151211569.45369.45
61086116-108611649.88649.89
10min19640-96400.44313.66238.170.4413.71237.49
29983-99830.4590.46
312145-121450.5580.56
41743575-174357580.08480.17
55154-51540.2370.35
64236-42360.1950.28
15min113167-131670.6050.4548.750.610.5229.22
213679-136790.6280.63
315280-152800.7020.70
45388-53880.2470.47
55806-58060.2670.38
65193-51930.2390.32
20min116028-160280.7360.5251.860.740.5934.09
216391-163910.7530.76
317284-172840.7940.80
46119-61190.2810.50
56091-60910.2800.40
65615-56150.2580.34
30min119053-190530.8750.6054.420.880.6737.69
219589-195890.9000.90
319777-197770.9080.91
46589-65890.3030.52
56732-67320.3090.43
66333-63330.2910.38
45min121638-216380.9940.6757.101.000.7442.23
222281-222811.0231.03
322492-224921.0331.04
47240-72400.3330.55
57007-70070.3220.44
66659-66590.3060.39
60min124376-243761.1200.7458.831.130.8244.82
225303-253031.1621.17
324915-249151.1441.15
47576-75760.3480.57
57676-76760.3530.47
67237-72370.3320.42
极限126335-263351.2100.8159.091.220.8846.04
227618-276181.2691.28
327318-273181.2551.26
48470-84700.3890.61
58028-80280.3690.49
67854-78540.3610.45
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