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对照品来源自制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125
标示量(mg)200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%
128.001088652110164711030801103659110084110995760.57
228.071093153109997710965650.45
单位质量响应值RSD%判断
39270.5739065.370.38数据可信
供试品溶液-24111403批-缬沙坦钠-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1413138-41313817.08315.5011.8517.0815.5011.84
2429090-42909017.74317.74
3325844-32584413.47413.47
4331687-33168713.71513.72
5398941-39894116.49616.50
6350329-35032914.48614.49
10min1731842-73184230.26229.636.8730.2929.656.87
2752409-75240931.11231.14
3623188-62318825.76925.79
4707566-70756629.25829.28
5726309-72630930.03330.06
6757519-75751931.32431.35
15min1951041-95104139.32639.825.7639.4039.905.75
2988378-98837840.87040.95
3868726-86872635.92235.99
41031699-103169942.66142.73
5948337-94833739.21439.29
6989857-98985740.93141.01
20min11086831-108683144.94146.467.5245.0946.607.51
21134771-113477146.92347.07
31023774-102377442.33342.46
41277489-127748952.82552.97
51101364-110136445.54245.68
61116654-111665446.17446.32
30min11182304-118230448.88951.164.8549.1151.374.86
21289117-128911753.30553.53
31152530-115253047.65847.85
41297966-129796653.67153.90
51273705-127370552.66852.89
61227115-122711550.74250.96
45min11240738-124073851.30552.573.3051.6152.873.30
21295098-129509853.55353.87
31204793-120479349.81950.09
41289006-128900653.30153.62
51321193-132119354.63254.94
61276851-127685152.79853.10
60min11255497-125549751.91552.742.4852.3053.142.49
21298873-129887353.70954.11
31222255-122225550.54150.90
41277595-127759552.82953.24
51304261-130426153.93254.33
61294694-129469453.53653.93
极限11309841-130984154.16253.871.2854.6454.351.25
21307483-130748354.06554.56
31316834-131683454.45254.89
41269767-126976752.50553.00
51306766-130676654.03554.52
61305984-130598454.00354.49
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对照品来源自制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125
标示量(mg)200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%
128.001879551190191719104161912443190899519026640.72
228.071889733190059218951620.41
单位质量响应值RSD%判断
67952.2967515.570.46数据可信
供试品溶液-24111403批-沙库巴曲-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1712825-71282516.10314.5712.1516.1014.5712.15
2740113-74011316.72016.72
3558099-55809912.60812.61
4570348-57034812.88512.88
5688710-68871015.55915.56
6600213-60021313.55913.56
10min11261527-126152728.49927.867.0028.5327.897.00
21297562-129756229.31329.34
31069463-106946324.16024.18
41217977-121797727.51527.54
51250564-125056428.25228.28
61303632-130363229.45029.47
15min11642106-164210637.09737.575.6937.1737.645.68
21701345-170134538.43538.51
31501766-150176633.92633.99
41776124-177612440.12440.19
51637132-163713236.98537.06
61720059-172005938.85838.93
20min11874310-187431042.34343.717.1842.4843.847.17
21958427-195842744.24344.38
31764002-176400239.85139.97
42183246-218324649.32249.46
51899795-189979542.91843.05
61928169-192816943.55943.70
30min12043734-204373446.17048.224.9346.3848.434.93
22219819-221981950.14850.36
31981238-198123844.75844.94
42242183-224218350.65350.87
52200917-220091749.72149.93
62119265-211926547.87648.09
45min12137738-213773848.29449.523.1548.5849.803.15
22236021-223602150.51450.81
32081018-208101847.01247.27
42229247-222924750.36150.66
52262519-226251951.11351.40
62204640-220464049.80550.09
60min12164816-216481648.90549.712.5549.2750.082.56
22241322-224132250.63451.02
32104812-210481247.55047.89
42209183-220918349.90850.29
52250865-225086550.84951.22
62232612-223261250.43750.81
极限12263359-226335951.13250.831.1851.5851.291.14
22253182-225318250.90251.37
32283387-228338751.58452.00
42203464-220346449.77950.25
52251028-225102850.85351.31
62246458-224645850.75051.21
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对照品来源自制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125
标示量(mg)200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%
128.001091866110685611026571101572110111511008130.50
228.071102189110244711023180.02
单位质量响应值RSD%判断
39314.7539270.320.08数据可信
供试品溶液-24111403批-缬沙坦钠-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1221918-2219189.1477.8147.749.157.8147.79
271421-714212.9442.94
3209890-2098908.6518.65
4121415-1214155.0055.00
5179141-1791417.3847.38
6333730-33373013.75613.76
10min1602323-60232324.82722.4015.9524.8422.4215.96
2385628-38562815.89515.90
3601041-60104124.77424.79
4499941-49994120.60720.62
5573676-57367623.64623.66
6598563-59856324.67224.70
15min1588160-58816024.24324.904.6524.3024.964.65
2591903-59190324.39824.43
3653448-65344826.93426.99
4604896-60489624.93324.98
5572606-57260623.60223.65
6614119-61411925.31325.38
20min1589446-58944624.29625.907.6524.3925.997.61
2613754-61375425.29825.37
3616556-61655625.41425.51
4648179-64817926.71726.80
5715454-71545429.49029.58
6587193-58719324.20424.31
30min1573248-57324823.62930.5023.5523.7730.6423.42
2853576-85357635.18435.30
3577394-57739423.80023.94
4919231-91923137.89038.02
5918903-91890337.87638.02
6597040-59704024.60924.76
45min1752682-75268231.02533.969.6331.2034.159.58
2877542-87754236.17136.34
3753701-75370131.06731.25
4886434-88643436.53836.73
5921189-92118937.97138.17
6752055-75205530.99931.19
60min1793328-79332832.70034.597.3632.9334.837.34
2871865-87186535.93736.17
3771835-77183531.81432.05
4900536-90053637.11937.37
5909480-90948037.48837.75
6787797-78779732.47232.71
极限1799691-79969132.96233.893.3733.2534.193.36
2851568-85156835.10135.39
3822851-82285133.91734.20
4836513-83651334.48034.79
5843175-84317534.75535.08
6779653-77965332.13732.43
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对照品来源自制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125
标示量(mg)200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%
128.001892177191955119109671907135191695719093570.57
228.071908198190975219089750.06
单位质量响应值RSD%判断
68191.3268007.660.20数据可信
供试品溶液-24111403批-沙库巴曲-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1383632-3836328.6207.3548.678.627.3548.68
2118800-1188002.6692.67
3362622-3626228.1488.15
4207942-2079424.6724.67
5308835-3088356.9396.94
6580667-58066713.04713.05
10min11095409-109540924.61321.9718.5924.6321.9818.61
2665946-66594614.96414.97
31064370-106437023.91623.93
4871537-87153719.58319.59
51005913-100591322.60222.61
61163612-116361226.14626.17
15min11219265-121926527.39626.865.2127.4526.915.23
21102643-110264324.77624.81
31254799-125479928.19528.25
41175751-117575126.41926.46
51155699-115569925.96826.02
61263639-126363928.39328.46
20min11263206-126320628.38428.805.2628.4828.895.25
21206394-120639427.10727.18
31260241-126024128.31728.42
41295674-129567429.11329.20
51406044-140604431.59331.69
61258503-125850328.27828.39
30min11268905-126890528.51233.1915.7428.6633.3315.65
21602851-160285136.01536.13
31240649-124064927.87728.02
41731012-173101238.89539.03
51719278-171927838.63138.78
61298989-129898929.18829.35
45min11522231-152223134.20436.156.6634.4036.346.63
21666574-166657437.44737.62
31493544-149354433.55933.75
41703637-170363738.28038.48
51740613-174061339.11139.32
61526104-152610434.29134.50
60min11578148-157814835.46036.755.3235.7137.015.30
21668180-166818037.48337.72
31527336-152733634.31934.57
41725208-172520838.76539.03
51737355-173735539.03839.31
61577880-157788035.45435.72
极限11591762-159176235.76636.572.2936.0836.892.27
21668822-166882237.49837.80
31629629-162962936.61736.92
41643683-164368336.93337.26
51657123-165712337.23537.57
61574891-157489135.38735.71
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对照品来源自制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125
标示量(mg)200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%
128.001090097110423311008421098241109995610986740.48
228.071106794111503411109140.53
单位质量响应值RSD%判断
39238.3639576.560.61数据可信
供试品溶液-24111403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%
5min1111291-1112914.5744.1626.194.574.1626.13
2119651-1196514.9184.92
370926-709262.9152.92
485958-859583.5333.53
5139702-1397025.7425.74
680182-801823.2953.30
10min1337636-33763613.87714.5310.6013.8814.5410.61
2410275-41027516.86216.87
3307777-30777712.65012.65
4347400-34740014.27814.28
5385044-38504415.82515.83
6333140-33314013.69213.70
15min1562634-56263423.12423.5910.0623.1523.6210.06
2679230-67923027.91627.95
3509930-50993020.95820.98
4578475-57847523.77523.80
5575766-57576623.66423.70
6537756-53775622.10222.13
20min1770403-77040331.66330.658.6731.7330.728.68
2843469-84346934.66634.75
3652660-65266026.82426.88
4766846-76684631.51731.59
5733785-73378530.15830.23
6707488-70748829.07729.14
30min1921852-92185237.88837.035.7338.0137.165.74
2943971-94397138.79738.94
3808824-80882433.24233.35
4923967-92396737.97538.10
5935371-93537138.44338.57
6872109-87210935.84335.96
45min11014832-101483241.70940.184.5541.8940.374.55
2997526-99752640.99841.20
3897703-89770336.89537.06
41002931-100293141.22041.41
5999511-99951141.07941.27
6953690-95369039.19639.37
60min11079128-107912844.35242.783.6444.6143.033.66
21052037-105203743.23843.51
3970322-97032239.88040.10
41063226-106322643.69843.95
51047678-104767843.05943.32
61033206-103320642.46442.70
极限11223036-122303650.26649.582.2150.5949.902.22
21239522-123952250.94451.29
31171389-117138948.14448.43
41207879-120787949.64349.97
51178201-117820148.42448.75
61217700-121770050.04750.36
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对照品来源自制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125
标示量(mg)200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%
128.001886804191328419045931901073190390319019310.51
228.071919503192986819246860.39
单位质量响应值RSD%判断
67926.1168567.370.67数据可信
供试品溶液-24111403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%
5min1146014-1460143.2742.9028.413.272.9028.39
2158698-1586983.5583.56
389438-894382.0052.01
4104379-1043792.3402.34
5179157-1791574.0174.02
698994-989942.2202.22
10min1454916-45491610.20010.6212.3510.2110.6212.37
2569519-56951912.76912.78
3404978-4049789.0809.08
4459328-45932810.29910.30
5512368-51236811.48811.49
6439940-4399409.8649.87
15min1782951-78295117.55517.7011.8117.5817.7311.80
2961671-96167121.56221.59
3688926-68892615.44715.47
4792685-79268517.77317.79
5781200-78120017.51617.54
6729942-72994216.36616.39
20min11092824-109282424.50323.4810.4724.5523.5310.47
21220190-122019027.35927.42
3902623-90262320.23820.28
41078434-107843424.18024.23
51012485-101248522.70122.76
6976816-97681621.90221.95
30min11351053-135105330.29329.237.1430.3929.337.14
21409594-140959431.60531.71
31148349-114834925.74825.83
41334323-133432329.91830.01
51336676-133667629.97030.06
61243104-124310427.87227.96
45min11537421-153742134.47132.805.8934.6132.945.90
21536813-153681334.45834.62
31318267-131826729.55829.68
41498394-149839433.59633.74
51481895-148189533.22633.37
61403771-140377131.47531.61
60min11673658-167365837.52635.774.9637.7335.974.98
21658592-165859237.18837.41
31461536-146153632.77032.94
41634722-163472236.65336.85
51589384-158938435.63635.83
61554714-155471434.85935.04
极限11982456-198245644.45043.532.9344.7143.792.94
22017771-201777145.24245.52
31862637-186263741.76341.99
41932041-193204143.31943.58
51896302-189630242.51842.78
61958119-195811943.90444.14
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对照品来源自制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125
标示量(mg)200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%
128.001104898111394611103151109523111244111102250.32
228.071106754110634411065490.03
单位质量响应值RSD%判断
39650.8939421.050.42数据可信
供试品溶液-24111403批-缬沙坦钠-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%
5min1375589-37558915.38613.3318.7415.3913.3218.74
2360509-36050914.76814.77
3316650-31665012.97212.97
4295194-29519412.09312.09
5222109-2221099.0999.10
6381632-38163215.63415.63
10min1684452-68445228.03928.5312.9328.0628.5512.93
2779599-77959931.93731.96
3756528-75652830.99231.01
4560825-56082522.97522.99
5623106-62310625.52625.54
6774343-77434331.72131.75
15min1890684-89068436.48738.6413.0836.5638.7113.07
21113724-111372445.62445.70
3899374-89937436.84336.92
4789446-78944632.34032.40
5895464-89546436.68336.74
61071126-107112643.87943.96
20min11006493-100649341.23244.4913.0441.3644.6213.03
21309665-130966553.65153.81
3994947-99494740.75940.89
4924707-92470737.88137.99
51097634-109763444.96545.08
61182701-118270148.45048.60
30min11118237-111823745.80948.278.5746.0148.488.58
21320198-132019854.08354.33
31092295-109229544.74644.95
41064592-106459243.61243.79
51238869-123886950.75150.94
61235167-123516750.59950.83
45min11209447-120944749.54650.166.2949.8250.456.30
21322216-132221654.16554.50
31154306-115430647.28747.56
41123709-112370946.03346.28
51288674-128867452.79153.07
61248901-124890151.16251.48
60min11269011-126901151.98651.464.1852.3551.834.22
21321160-132116054.12254.55
31216459-121645949.83350.19
41174883-117488348.13048.45
51289809-128980952.83853.20
61265004-126500451.82252.22
极限11313646-131364653.81453.611.0654.2654.061.08
21323478-132347854.21754.73
31324132-132413254.24454.68
41296204-129620453.10053.50
51292033-129203352.92953.38
61302260-130226053.34853.84
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对照品来源自制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125
标示量(mg)200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%
128.001910459191876319174591917027192535219178120.28
228.071917697191488619162920.11
单位质量响应值RSD%判断
68493.2968268.330.24数据可信
供试品溶液-24111403批-沙库巴曲-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%
5min1644974-64497414.43312.4419.3314.4312.4419.33
2617997-61799713.82913.83
3542288-54228812.13512.13
4499643-49964311.18111.18
5374860-3748608.3888.39
6654718-65471814.65114.65
10min11175562-117556226.30626.8313.1726.3326.8613.17
21351472-135147230.24230.27
31303424-130342429.16729.19
4959816-95981621.47821.50
51074774-107477424.05024.06
61330218-133021829.76629.79
15min11533308-153330834.31136.3413.0234.3836.4113.02
21919467-191946742.95243.03
31549402-154940234.67134.74
41359986-135998630.43330.49
51543251-154325134.53434.59
61839070-183907041.15341.23
20min11733699-173369938.79541.8713.1438.9242.0013.13
22256140-225614050.48650.63
31716531-171653138.41138.54
41586450-158645035.50035.61
51891184-189118442.31942.43
62043394-204339445.72545.87
30min11922621-192262143.02345.428.7043.2145.628.71
22272030-227203050.84251.07
31874330-187433041.94242.13
41834898-183489841.06041.22
52141947-214194747.93148.11
62133953-213395347.75247.97
45min12094648-209464846.87247.236.3747.1347.506.38
22281977-228197751.06451.38
31979102-197910244.28744.55
41937929-193792943.36543.60
52219593-221959349.66849.93
62150035-215003548.11248.41
60min12184019-218401948.87248.384.2649.2148.734.28
22284917-228491751.13051.53
32090167-209016746.77247.11
42026748-202674845.35345.66
52218649-221864949.64749.99
62168544-216854448.52648.90
极限12270703-227070350.81250.631.1151.2351.061.12
22292966-229296651.31051.79
32286839-228683951.17351.59
42251691-225169150.38650.77
52231278-223127849.93050.36
62241211-224121150.15250.61
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