沙库巴曲缬沙坦钠片项目信息
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-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.345464455510845509405511675504165500100.37
227.255531725538705535210.09
单位质量响应值RSD%判断
20117.4120312.700.69数据可信
加速6月-供试品溶液-2024032421批-缬沙坦钠-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%
5min164558-645585.1721.76103.245.171.76103.18
210498-104980.8410.84
36346-63460.5080.51
412834-128341.0281.03
530626-306262.4542.45
66974-69740.5590.56
10min1223818-22381817.93210.5955.6117.9410.5955.60
2152963-15296312.25512.26
334630-346302.7752.78
478373-783736.2796.28
5201624-20162416.15416.16
6101558-1015588.1378.14
15min1358714-35871428.74022.1722.1328.7822.1922.17
2277559-27755922.23822.26
3201247-20124716.12416.13
4247208-24720819.80619.82
5338794-33879427.14427.18
6236675-23667518.96218.98
20min1432017-43201734.61330.5412.3234.7030.6012.36
2372600-37260029.85329.91
3324373-32437325.98926.02
4361471-36147128.96129.01
5444000-44400035.57335.65
6352942-35294228.27828.32
30min1496959-49695939.81737.488.0339.9637.588.07
2471941-47194137.81237.92
3431644-43164434.58334.66
4430375-43037534.48234.58
5524310-52431042.00842.14
6451198-45119836.15036.24
45min1541675-54167543.39941.496.3643.6141.666.40
2525247-52524742.08342.25
3487418-48741839.05239.19
4484930-48493038.85339.00
5567530-56753045.47145.68
6500246-50024640.08040.23
60min1579389-57938946.42144.385.6546.7044.625.70
2560421-56042144.90145.14
3523819-52381941.96942.17
4536196-53619642.96043.18
5599645-59964548.04448.33
6524059-52405941.98842.21
极限1595132-59513247.68247.481.5248.0447.801.57
2597748-59774847.89248.21
3585301-58530146.89547.16
4582752-58275246.69046.98
5606734-60673448.61248.97
6588310-58831047.13647.43
沙库巴曲缬沙坦钠片项目信息
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-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.349466809545579548109529839529859524030.35
227.259575469587529581490.09
单位质量响应值RSD%判断
34835.5235161.430.66数据可信
加速6月-供试品溶液-2024032421批-沙库巴曲-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%
5min180471-804713.5181.11116.413.521.10116.48
210521-105210.4600.46
35072-50720.2220.22
413173-131730.5760.58
536700-367001.6051.60
65730-57300.2510.25
10min1295944-29594412.9397.3959.2312.957.3959.24
2196558-1965588.5948.59
338413-384131.6791.68
495246-952464.1644.17
5262496-26249611.47711.48
6124921-1249215.4625.46
15min1485780-48578021.23916.1323.8421.2716.1423.89
2370787-37078716.21116.23
3262601-26260111.48111.48
4326379-32637914.27014.28
5459675-45967520.09820.12
6308411-30841113.48413.49
20min1605640-60564026.48022.9114.0626.5422.9414.11
2512312-51231222.39922.44
3436337-43633719.07719.10
4492720-49272021.54321.57
5620593-62059327.13327.19
6475731-47573120.80020.83
30min1727321-72732131.80029.539.4831.9129.619.52
2683164-68316429.86929.95
3611704-61170426.74526.80
4616826-61682626.96927.04
5771082-77108233.71333.81
6642286-64228628.08228.15
45min1829742-82974236.27834.197.8336.4434.327.88
2797905-79790534.88635.02
3725773-72577331.73231.83
4721579-72157931.54931.66
5871741-87174138.11438.27
6745427-74542732.59132.70
60min1913499-91349939.94037.777.2340.1637.957.27
2878956-87895638.43038.62
3804484-80448435.17435.33
4825788-82578836.10536.27
5955185-95518541.76241.98
6804795-80479535.18735.35
极限1959628-95962841.95741.692.4442.2441.942.49
2968388-96838842.34042.59
3934476-93447640.85741.07
4925575-92557540.46840.69
5988492-98849243.21943.51
6945112-94511241.32241.55
沙库巴曲缬沙坦钠片项目信息
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-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.345531525528565532195530785536085531830.05
227.255507505518665513080.15
单位质量响应值RSD%判断
20233.4720231.490.01数据可信
加速6月-供试品溶液-2024032521批-缬沙坦钠-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%
5min172456-724565.8002.8578.925.802.8578.94
24730-47300.3790.38
317794-177941.4241.42
447804-478043.8273.83
559772-597724.7854.78
611260-112600.9010.90
10min1226141-22614118.10213.1028.4618.1113.1028.47
2120411-1204119.6399.64
3124263-1242639.9479.95
4189385-18938515.16015.17
5198396-19839615.88215.89
6123112-1231129.8559.86
15min1357403-35740328.61023.8312.6828.6523.8612.70
2269787-26978721.59621.61
3272045-27204521.77721.80
4307310-30731024.60024.63
5320742-32074225.67525.71
6259062-25906220.73820.76
20min1417657-41765733.43331.985.6833.5232.055.71
2376334-37633430.12530.18
3388331-38833131.08631.14
4429368-42936834.37134.44
5410118-41011832.83032.91
6375544-37554430.06230.11
30min1469006-46900637.54437.604.6637.6937.724.68
2454857-45485736.41136.51
3476771-47677138.16538.27
4506935-50693540.58040.71
5468007-46800737.46437.60
6442630-44263035.43235.53
45min1515037-51503741.22841.563.7041.4341.743.71
2519807-51980741.61041.77
3525749-52574942.08642.26
4549910-54991044.02044.22
5513752-51375241.12641.32
6490818-49081839.29039.45
60min1546789-54678943.77044.082.4544.0444.332.45
2553422-55342244.30144.53
3552338-55233844.21444.46
4574534-57453445.99146.26
5537529-53752943.02943.29
6539015-53901543.14843.38
极限1607031-60703148.59348.081.1848.9448.411.21
2599610-59961047.99848.31
3598904-59890447.94248.26
4610361-61036148.85949.21
5597404-59740447.82248.16
6590742-59074247.28947.59
沙库巴曲缬沙坦钠片项目信息
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-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.349573399576169575499571969583349576070.05
227.259524409540379532380.12
单位质量响应值RSD%判断
35025.8634981.210.10数据可信
加速6月-供试品溶液-2024032521批-沙库巴曲-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%
5min189309-893093.9041.8486.333.901.8486.43
22375-23750.1040.10
319302-193020.8440.84
456100-561002.4522.45
575049-750493.2813.28
610492-104920.4590.46
10min1295574-29557412.9219.0631.1912.939.0631.21
2145709-1457096.3706.37
3154832-1548326.7686.77
4238912-23891210.44410.45
5256858-25685811.22811.23
6151672-1516726.6306.63
15min1483986-48398621.15717.2914.1721.1917.3114.21
2353457-35345715.45115.46
3357779-35777915.64015.65
4406324-40632417.76217.78
5432886-43288618.92318.95
6339278-33927814.83114.84
20min1588615-58861525.73124.066.4525.7924.116.48
2514228-51422822.47922.52
3531807-53180723.24823.29
4586398-58639825.63425.69
5569964-56996424.91624.97
6511619-51161922.36522.40
30min1692598-69259830.27729.764.7430.3829.854.76
2658302-65830228.77728.85
3689526-68952630.14230.22
4728003-72800331.82431.92
5682868-68286829.85129.95
6633393-63339327.68827.76
45min1788296-78829634.46034.423.8534.6234.563.86
2793707-79370734.69734.82
3797641-79764134.86935.00
4828365-82836536.21236.36
5780664-78066434.12634.27
6735238-73523832.14132.26
60min1860967-86096737.63737.622.8537.8537.812.85
2869343-86934338.00338.18
3862992-86299237.72537.91
4900017-90001739.34439.55
5839273-83927336.68836.89
6830427-83042736.30236.48
极限1989803-98980343.26942.451.9143.5542.711.94
2975950-97595042.66342.91
3968375-96837542.33242.58
4988087-98808743.19443.47
5964677-96467742.17042.44
6939393-93939341.06541.30
沙库巴曲缬沙坦钠片项目信息
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-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.345513635534875532655539955545035533230.22
227.255519005507095513040.16
单位质量响应值RSD%判断
20238.5920231.340.03数据可信
加速6月-供试品溶液-2024032621批-缬沙坦钠-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%
5min18586-85860.6873.6067.560.693.6067.54
250899-508994.0744.07
394434-944347.5587.56
460343-603434.8304.83
530165-301652.4142.41
625817-258172.0662.07
10min1167711-16771113.42414.9814.0913.4214.9814.12
2173324-17332413.87313.88
3231003-23100318.48918.50
4207280-20728016.59116.60
5178525-17852514.28914.29
6164717-16471713.18413.19
15min1312162-31216224.98525.327.1725.0125.357.18
2301825-30182524.15824.19
3347462-34746227.81127.85
4340000-34000027.21327.25
5307004-30700424.57324.60
6289452-28945223.16823.19
20min1388534-38853431.09832.493.2831.1632.563.29
2411447-41144732.93233.00
3422273-42227333.79933.89
4399859-39985932.00532.09
5395560-39556031.66031.73
6417691-41769133.43233.50
30min1496549-49654939.74439.534.5139.8639.664.49
2525644-52564442.07242.20
3479548-47954838.38338.53
4488110-48811039.06839.20
5462963-46296337.05537.18
6510303-51030340.84440.96
45min1544280-54428043.56442.895.0843.7543.085.06
2570352-57035245.65145.85
3528423-52842342.29542.50
4524549-52454941.98542.18
5492539-49253939.42339.61
6555156-55515644.43544.62
60min1572295-57229545.80645.303.7346.0645.563.73
2593891-59389147.53547.81
3565470-56547045.26045.54
4554264-55426444.36344.63
5532310-53231042.60642.85
6577679-57767946.23746.50
极限1606032-60603248.50748.541.9148.8448.881.92
2621348-62134849.73250.08
3610640-61064048.87549.23
4607063-60706348.58948.93
5585879-58587946.89447.21
6607971-60797148.66249.00
沙库巴曲缬沙坦钠片项目信息
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-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.349542319575789574069600909587669576140.23
227.259551259532639541940.14
单位质量响应值RSD%判断
35026.1235016.290.02数据可信
加速6月-供试品溶液-2024032621批-沙库巴曲-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%
5min110980-109800.4802.5468.330.482.5468.32
265644-656442.8682.87
3122477-1224775.3515.35
479653-796533.4803.48
536193-361931.5811.58
634561-345611.5101.51
10min1214397-2143979.36810.5715.179.3710.5815.17
2223081-2230819.7479.75
3301992-30199213.19513.20
4271566-27156611.86511.87
5230557-23055710.07410.08
6210192-2101929.1849.19
15min1418436-41843618.28318.508.3018.3018.528.32
2398569-39856917.41417.44
3469322-46932220.50620.54
4462988-46298820.22920.25
5408329-40832917.84117.86
6383045-38304516.73616.75
20min1534097-53409723.33624.453.4823.3824.513.50
2561228-56122824.52124.57
3589171-58917125.74225.81
4555915-55591524.28924.35
5545639-54563923.84023.89
6572215-57221525.00125.05
30min1711507-71150731.08831.054.3031.1731.144.27
2753075-75307532.90432.99
3697495-69749530.47530.58
4701964-70196430.67130.77
5665486-66548629.07729.17
6734281-73428132.08332.17
45min1816210-81621035.66235.135.3435.8035.285.32
2858088-85808837.49237.64
3796260-79626034.79134.95
4784976-78497634.29834.45
5734849-73484932.10732.24
6834218-83421836.44936.59
60min1887095-88709538.75938.224.4938.9638.424.47
2928805-92880540.58240.79
3874549-87454938.21138.43
4850457-85045737.15937.37
5814004-81400435.56635.76
6892942-89294239.01539.22
极限1979676-97967642.80442.652.4043.0742.912.40
21004256-100425643.87844.15
3983753-98375342.98343.26
4968446-96844642.31442.58
5934693-93469340.83941.09
6985411-98541143.05543.32
沙库巴曲缬沙坦钠片项目信息
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-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.345506145537915512775518815518935518910.22
227.255506595525925516260.25
单位质量响应值RSD%判断
20186.2120243.160.20数据可信
长期6月-供试品溶液-2024032421批-缬沙坦钠-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%
5min111528-115280.9242.8686.390.922.8686.48
241216-412163.3023.30
376243-762436.1096.11
47495-74950.6010.60
59887-98870.7920.79
667991-679915.4475.45
10min1107258-1072588.59413.9027.278.6013.9027.27
2204748-20474816.40416.41
3218261-21826117.48717.50
4144011-14401111.53811.54
5146113-14611311.70711.71
6220368-22036817.65617.66
15min1251105-25110520.11923.9913.2420.1324.0113.27
2328146-32814626.29126.32
3346018-34601827.72327.76
4269866-26986621.62221.64
5271934-27193421.78721.81
6329289-32928926.38326.42
20min1348630-34863027.93231.319.2827.9831.389.30
2393076-39307631.49331.57
3444618-44461835.62335.71
4357750-35775028.66328.72
5382708-38270830.66330.72
6417699-41769933.46633.55
30min1437886-43788635.08337.277.4335.1837.387.45
2453635-45363536.34536.47
3529819-52981942.44942.59
4437315-43731535.03835.14
5458023-45802336.69736.81
6474062-47406237.98238.12
45min1487268-48726839.04040.846.1839.1941.026.21
2506285-50628540.56440.75
3568665-56866545.56245.78
4482268-48226838.63938.80
5497273-49727339.84240.01
6516768-51676841.40441.61
60min1519211-51921141.59943.294.9741.8243.545.00
2542393-54239343.45743.71
3590485-59048547.31047.60
4517349-51734941.45041.68
5530133-53013342.47442.71
6542653-54265343.47743.75
极限1584992-58499246.87047.811.9647.1648.132.01
2604789-60478948.45648.79
3615266-61526649.29549.67
4587108-58710847.03947.34
5590454-59045447.30747.61
6597737-59773747.89148.23
沙库巴曲缬沙坦钠片项目信息
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-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.349523039578839543259543509562019550120.23
227.259515049550329532680.27
单位质量响应值RSD%判断
34930.9434982.310.11数据可信
长期6月-供试品溶液-2024032421批-沙库巴曲-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%
5min113873-138730.6072.0385.320.612.0385.30
252197-521972.2852.28
397799-977994.2814.28
410830-108300.4740.47
514552-145520.6370.64
688945-889453.8933.89
10min1138866-1388666.0799.8828.136.089.8928.15
2270056-27005611.82111.83
3283567-28356712.41312.42
4184150-1841508.0618.06
5187906-1879068.2258.23
6290130-29013012.70012.71
15min1337161-33716114.75917.6314.0714.7717.6514.09
2445704-44570419.51019.53
3469168-46916820.53720.56
4357209-35720915.63615.65
5362586-36258615.87215.89
6445199-44519919.48819.52
20min1479560-47956020.99223.6510.0421.0323.7010.06
2550495-55049524.09724.15
3621811-62181127.21927.28
4489042-48904221.40721.45
5523906-52390622.93322.97
6577359-57735925.27325.33
30min1628428-62842827.50829.358.3227.5829.448.35
2659674-65967428.87628.97
3774887-77488733.91934.03
4622589-62258927.25327.33
5653250-65325028.59528.67
6684014-68401429.94230.04
45min1731041-73104132.00033.437.3632.1233.577.37
2760981-76098133.31133.45
3870168-87016838.09038.25
4713391-71339131.22731.35
5735711-73571132.20432.33
6771097-77109733.75333.91
60min1801264-80126435.07436.456.1935.2436.646.22
2836109-83610936.59936.80
3930284-93028440.72240.95
4786377-78637734.42234.60
5808026-80802635.37035.55
6834021-83402136.50836.72
极限1937291-93729141.02841.902.9541.2642.162.99
2971884-97188442.54342.80
31006534-100653444.05944.35
4931101-93110140.75740.99
5941367-94136741.20741.45
6955497-95549741.82542.09
沙库巴曲缬沙坦钠片项目信息
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-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.345525095530065541355523885533765530830.13
227.255503955511935507940.11
单位质量响应值RSD%判断
20229.8120212.620.07数据可信
长期6月-供试品溶液-2024032521批-缬沙坦钠-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%
5min114571-145711.1672.7593.701.172.7593.66
26724-67240.5390.54
36869-68690.5500.55
428836-288362.3102.31
573098-730985.8555.85
676107-761076.0966.10
10min1154756-15475612.39512.2640.4712.4012.2740.50
239374-393743.1543.15
3136740-13674010.95210.95
4185575-18557514.86314.87
5213874-21387417.13017.14
6188448-18844815.09415.10
15min1276179-27617922.12022.7512.7422.1422.7712.78
2225496-22549618.06118.07
3262757-26275721.04521.06
4307853-30785324.65724.69
5317672-31767225.44425.48
6314053-31405325.15425.19
20min1364477-36447729.19230.298.2629.2530.368.28
2336761-33676126.97327.01
3365100-36510029.24229.30
4429648-42964834.41234.48
5385163-38516330.84930.93
6388205-38820531.09331.17
30min1441426-44142635.35637.316.3835.4637.426.37
2471729-47172937.78337.86
3463308-46330837.10837.21
4521916-52191641.80241.93
5450370-45037036.07236.20
6446043-44604335.72535.85
45min1484628-48462838.81641.125.5138.9841.305.49
2538346-53834643.11843.26
3509591-50959140.81540.98
4556667-55666744.58644.78
5491749-49174939.38639.58
6499429-49942940.00140.19
60min1531703-53170342.58643.844.4942.8244.084.47
2572529-57252945.85646.07
3531063-53106342.53542.77
4583354-58335446.72346.99
5524007-52400741.97042.23
6541562-54156243.37643.63
极限1584735-58473546.83447.901.9547.1448.211.95
2606407-60640748.57048.86
3604468-60446848.41448.72
4609626-60962648.82749.18
5582256-58225646.63546.96
6600447-60044748.09248.42
沙库巴曲缬沙坦钠片项目信息
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-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.349557989572399597099560559586969574990.18
227.259524619532079528340.06
单位质量响应值RSD%判断
35021.9134966.390.12数据可信
长期6月-供试品溶液-2024032521批-沙库巴曲-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%
5min118348-183480.8021.9892.550.801.9992.54
29288-92880.4060.41
39642-96420.4220.42
439686-396861.7351.74
595783-957834.1884.19
699599-995994.3554.36
10min1201057-2010578.7918.6741.368.798.6741.36
248405-484052.1172.12
3175354-1753547.6687.67
4239218-23921810.46010.46
5280394-28039412.26112.27
6245199-24519910.72210.73
15min1369416-36941616.15316.6313.1216.1716.6513.15
2302014-30201413.20613.21
3347804-34780415.20815.22
4411225-41122517.98118.00
5427768-42776818.70518.73
6424154-42415418.54718.57
20min1499944-49994421.86122.778.6621.9022.828.67
2462001-46200120.20220.23
3497785-49778521.76621.81
4593317-59331725.94425.99
5531691-53169123.24923.31
6539527-53952723.59223.65
30min1631741-63174127.62429.226.6927.7029.306.67
2675243-67524329.52629.59
3658577-65857728.79728.87
4754167-75416732.97733.07
5646634-64663428.27528.37
6642858-64285828.11028.21
45min1724013-72401331.65833.466.1631.7833.596.13
2812905-81290535.54535.65
3754299-75429932.98333.11
4834207-83420736.47736.63
5724654-72465431.68631.83
6740994-74099432.40132.54
60min1814971-81497135.63636.615.1235.8136.805.10
2887847-88784738.82238.99
3808756-80875635.36435.54
4894124-89412439.09739.31
5793877-79387734.71334.91
6824035-82403536.03236.23
极限1933065-93306540.79941.832.4141.0442.082.40
2977420-97742042.73942.97
3966393-96639342.25742.49
4979527-97952742.83143.11
5924404-92440440.42140.68
6958493-95849341.91142.17
沙库巴曲缬沙坦钠片项目信息
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-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.345512715501285501395501845499855503410.10
227.255510245511625510930.02
单位质量响应值RSD%判断
20129.5220223.600.33数据可信
长期6月-供试品溶液-2024032621批-缬沙坦钠-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%
5min168400-684005.4912.9575.575.492.9575.60
211941-119410.9590.96
38625-86250.6920.69
468190-681905.4745.47
546116-461163.7023.70
617349-173491.3931.39
10min1207041-20704116.62012.4827.9916.6312.4828.01
2143749-14374911.53911.54
3121846-1218469.7819.78
4211003-21100316.93816.95
5108163-1081638.6828.69
6140923-14092311.31211.31
15min1310128-31012824.89523.3410.8824.9323.3610.91
2298646-29864623.97323.99
3268976-26897621.59121.61
4336211-33621126.98827.03
5246319-24631919.77219.79
6283944-28394422.79322.81
20min1379756-37975630.48431.558.5930.5631.628.59
2432256-43225634.69834.76
3405053-40505332.51432.57
4414502-41450233.27333.36
5334958-33495826.88826.94
6392015-39201531.46831.53
30min1442684-44268435.53537.677.4535.6637.797.44
2495156-49515639.74739.87
3520432-52043241.77641.88
4477203-47720338.30638.44
5426844-42684434.26434.36
6453391-45339136.39536.51
45min1490662-49066239.38641.246.5939.5741.426.58
2535938-53593843.02143.21
3563856-56385645.26245.44
4525435-52543542.17842.38
5473425-47342538.00338.16
6493143-49314339.58539.76
60min1522807-52280741.96743.944.5442.2244.194.54
2564086-56408645.28045.54
3586461-58646147.07647.33
4550963-55096344.22744.50
5524622-52462242.11242.33
6535603-53560342.99443.23
极限1597771-59777147.98448.221.7348.3148.551.75
2609365-60936548.91549.25
3614902-61490249.35949.69
4602822-60282248.39048.74
5587454-58745447.15647.45
6592123-59212347.53147.84
沙库巴曲缬沙坦钠片项目信息
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-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.349535099522709521709529539519139525630.07
227.259532149533249532690.01
单位质量响应值RSD%判断
34841.3734982.350.29数据可信
长期6月-供试品溶液-2024032621批-沙库巴曲-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%
5min197403-974034.2692.1877.674.272.1877.54
216790-167900.7360.74
310230-102300.4480.45
491664-916644.0184.02
559440-594402.6052.61
623213-232131.0171.02
10min1273077-27307711.9698.9029.6511.988.9029.69
2190728-1907288.3608.36
3157968-1579686.9246.92
4280151-28015112.27912.29
5135636-1356365.9455.95
6180119-1801197.8957.90
15min1419572-41957218.39017.2212.1818.4217.2412.20
2412259-41225918.06918.08
3362476-36247615.88715.90
4459800-45980020.15320.18
5323859-32385914.19514.21
6379143-37914316.61816.63
20min1526665-52666523.08323.9910.1923.1424.0310.19
2617893-61789327.08227.13
3563037-56303724.67824.72
4580136-58013625.42725.49
5453565-45356519.88019.92
6542139-54213923.76223.80
30min1639130-63913028.01329.878.8828.1129.968.87
2743190-74319032.57432.66
3756228-75622833.14533.23
4694166-69416630.42530.53
5602586-60258626.41126.48
6654309-65430928.67828.76
45min1734041-73404132.17333.948.0532.3234.088.03
2834343-83434336.56936.71
3855997-85599737.51837.65
4786848-78684834.48734.64
5696300-69630030.51830.63
6738985-73898532.38932.52
60min1802497-80249735.17337.086.1635.3737.276.16
2896978-89697839.31439.52
3918536-91853640.25940.46
4846900-84690037.11937.33
5789117-78911734.58734.75
6821749-82174936.01736.20
极限1956568-95656841.92642.323.0642.1842.583.08
2997846-99784643.73544.01
3999555-99955543.81044.07
4969118-96911842.47642.75
5924556-92455640.52340.75
6945942-94594241.46041.70
点击查看处理图标(人工保存)
 
原始图谱下载图谱(谢鑫慧 于 2024-10-17 14:57:08 完成)
生成报告数据部分(等待生成报告)
Current page cost:1.022 s