氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.671487485148494014891471486009147308114841320.43
210.751477429148111014792700.18
单位质量响应值RSD%判断
139093.91137606.510.77数据可信
长期24月-供试品溶液-2024041521批-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%
60min161997-619974.1393.5731.214.143.5731.19
265530-655304.3754.38
326667-266671.7801.78
438428-384282.5662.57
565494-654944.3734.37
662580-625804.1784.18
120min1122497-1224978.1797.7813.978.187.7813.98
2117647-1176477.8557.86
390344-903446.0326.03
4105028-1050287.0127.02
5132679-1326798.8588.86
6130957-1309578.7438.75
240min1233364-23336415.58115.355.2915.6015.375.30
2244793-24479316.34416.36
3213507-21350714.25514.27
4219976-21997614.68714.70
5241278-24127816.10916.13
6226840-22684015.14515.16
360min1335296-33529622.38621.884.6122.4321.924.62
2330106-33010622.04022.08
3303311-30331120.25120.28
4324138-32413821.64121.68
5348977-34897723.29923.34
6324073-32407321.63721.68
480min1398474-39847426.60426.626.7226.6826.696.72
2421431-42143128.13728.21
3354770-35477023.68623.75
4381308-38130825.45825.53
5424428-42442828.33728.42
6411695-41169527.48727.56
600min1474471-47447131.67830.684.8631.7930.794.86
2465515-46551531.08031.20
3427427-42742728.53728.64
4458369-45836930.60330.71
5489320-48932032.66932.79
6441910-44191029.50429.62
720min1528576-52857635.29035.174.1235.4535.334.12
2543356-54335636.27736.44
3503968-50396833.64733.79
4535511-53551135.75335.91
5551763-55176336.83837.01
6497591-49759133.22233.38
840min1570488-57048838.08937.782.4638.3037.992.48
2566178-56617837.80138.02
3549076-54907636.65936.85
4563560-56356037.62637.83
5589690-58969039.37139.60
6556412-55641237.14937.36
960min1618180-61818041.27340.752.6641.5541.022.66
2623198-62319841.60841.88
3597474-59747439.89040.14
4609578-60957840.69840.96
5628223-62822341.94342.23
6585797-58579739.11139.38
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1080min1663484-66348444.29843.992.0844.6344.322.09
2670019-67001944.73445.07
3643244-64324442.94643.25
4658480-65848043.96344.29
5675603-67560345.10745.45
6642700-64270042.91043.23
1200min1699780-69978046.72146.991.6847.1247.381.69
2717983-71798347.93648.34
3690600-69060046.10846.48
4699317-69931746.69047.08
5718709-71870947.98548.40
6696171-69617146.48046.87
1320min1751049-75104950.14450.023.9550.6250.483.95
2776435-77643551.83952.32
3709515-70951547.37147.81
4725992-72599248.47148.93
5787719-78771952.59253.08
6744161-74416149.68450.14
1440min1774520-77452051.71152.233.4752.2652.773.46
2812980-81298054.27954.83
3737422-73742249.23449.75
4782963-78296352.27552.81
5807709-80770953.92754.49
6778124-77812451.95152.48
1560min1857119-85711957.22656.353.6057.8556.973.59
2872751-87275158.26958.91
3798593-79859353.31853.90
4846040-84604056.48657.10
5872429-87242958.24858.89
6817149-81714954.55755.17
1680min1889234-88923459.37059.174.6660.0859.874.65
2909641-90964160.73261.46
3828811-82881155.33656.00
4887271-88727159.23959.93
5947151-94715163.23763.97
6855371-85537157.10957.80
1800min1948099-94809963.30062.665.4264.1063.455.39
2974263-97426365.04765.86
3899008-89900860.02260.77
4942934-94293462.95563.74
51003670-100367067.01067.84
6862873-86287357.61058.39
1920min1925078-92507861.76363.783.9362.6664.673.91
21008228-100822867.31468.23
3938119-93811962.63463.47
4965783-96578364.48165.36
5984587-98458765.73666.67
6910066-91006660.76161.63
2040min1926685-92668561.87065.234.5862.8666.214.54
2993358-99335866.32267.34
3960505-96050564.12865.06
41016958-101695867.89768.87
51033426-103342668.99770.03
6930791-93079162.14463.10
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2160min1957557-95755763.93165.653.6065.0166.743.59
21028288-102828868.65469.77
3976329-97632965.18566.21
4982740-98274065.61366.69
51019161-101916168.04469.18
6936106-93610662.49963.55
极限1988504-98850465.99766.242.5267.1767.422.53
21015946-101594667.83069.05
3971508-97150864.86365.99
4993910-99391066.35867.53
51023998-102399868.36769.60
6959190-95919064.04065.18
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.671480378148117614829811488034148266814830470.21
210.751476783147682314768030.01
单位质量响应值RSD%判断
138992.22137377.020.83数据可信
长期24月-供试品溶液-2024041721批-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%
60min155332-553323.6993.716.843.703.716.84
249693-496933.3223.32
354880-548803.6683.67
458241-582413.8933.89
553928-539283.6053.60
660761-607614.0624.06
120min1121116-1211168.0968.064.688.108.074.69
2115360-1153607.7117.72
3113645-1136457.5977.60
4120522-1205228.0568.06
5129105-1291058.6308.64
6123839-1238398.2788.28
240min1223018-22301814.90815.165.0914.9315.185.10
2212771-21277114.22314.24
3214781-21478114.35714.37
4236956-23695615.83915.86
5234244-23424415.65815.68
6239079-23907915.98116.00
360min1281914-28191418.84520.535.7218.8820.565.73
2298675-29867519.96520.00
3295107-29510719.72719.76
4323496-32349621.62421.67
5320637-32063721.43321.47
6322544-32254421.56121.60
480min1373168-37316824.94525.141.7825.0125.211.79
2371275-37127524.81824.89
3367594-36759424.57224.64
4381480-38148025.50025.57
5385549-38554925.77225.85
6377234-37723425.21625.29
600min1424552-42455228.37929.472.1528.4929.582.14
2437148-43714829.22129.33
3439932-43993229.40729.51
4444933-44493329.74229.85
5449591-44959130.05330.17
6449341-44934130.03630.15
720min1477776-47777631.93732.802.2732.0932.962.27
2503644-50364433.66633.82
3496106-49610633.16233.31
4481932-48193232.21532.37
5501721-50172133.53833.70
6483145-48314532.29632.45
840min1526609-52660935.20135.581.2135.4035.781.21
2541765-54176536.21436.41
3523515-52351534.99535.19
4533492-53349235.66135.87
5533872-53387235.68735.89
6534112-53411235.70335.91
960min1550892-55089236.82538.043.4537.0738.293.42
2586743-58674339.22139.47
3569698-56969838.08238.33
4582210-58221038.91839.18
5539829-53982936.08536.35
6584746-58474639.08839.35
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1080min1627236-62723641.92841.693.3942.2342.013.36
2634832-63483242.43642.75
3629487-62948742.07842.39
4614112-61411241.05141.37
5587470-58747039.27039.59
6649297-64929743.40343.72
1200min1636027-63602742.51544.903.3242.8845.273.31
2696494-69649446.55746.93
3671593-67159344.89345.26
4677018-67701845.25645.63
5657744-65774443.96744.34
6691026-69102646.19246.58
1320min1716492-71649247.89448.562.3948.3349.002.38
2735029-73502949.13349.58
3726745-72674548.58049.02
4698129-69812946.66747.11
5733740-73374049.04749.49
6748257-74825750.01850.47
1440min1735708-73570849.17950.494.6149.6851.014.57
2759208-75920850.75051.27
3782357-78235752.29752.81
4707004-70700447.26047.78
5743266-74326649.68450.20
6804750-80475053.79454.32
1560min1790402-79040252.83552.140.7453.4152.730.72
2777247-77724751.95552.55
3774967-77496751.80352.39
4775792-77579251.85852.45
5781764-78176452.25752.85
6779638-77963852.11552.72
1680min1777025-77702551.94153.725.5452.6054.395.48
2829581-82958155.45456.13
3765362-76536251.16151.83
4758310-75831050.69051.35
5818764-81876454.73155.40
6872575-87257558.32859.01
1800min1868815-86881558.07656.694.5758.8157.444.53
2849388-84938856.77857.53
3835348-83534855.83956.58
4801287-80128753.56254.30
5822214-82221454.96155.71
6911753-91175360.94661.72
1920min1899198-89919860.10758.634.9360.9359.464.88
2860445-86044557.51758.36
3858063-85806357.35858.19
4812929-81292954.34155.16
5892671-89267159.67160.50
6938967-93896762.76663.63
2040min1917940-91794061.36064.994.7162.2765.914.63
2985818-98581865.89766.83
3957207-95720763.98564.90
41008747-100874767.43068.33
51034500-103450069.15270.07
6928837-92883762.08863.05
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2160min1952699-95269963.68465.333.4864.6966.353.42
21017497-101749768.01569.04
3971314-97131464.92865.94
4978889-97888965.43466.44
51013216-101321667.72968.75
6930130-93013062.17563.23
极限1985528-98552865.87865.892.3966.9867.012.35
21008287-100828767.39968.53
3963757-96375764.42365.53
4988106-98810666.05067.15
51014025-101402567.78368.91
6954543-95454363.80764.95
点击查看处理图标(自动生成)
 
原始图谱下载图谱(谢超君 于 2026-05-15 12:56:56 完成)
生成报告数据部分下载报告(谢超君 于 2026-05-15 12:57:26 完成)
Current page cost:81 ms