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%
127.785720745797525758785740705779195759390.53
227.725782255775955779100.08
单位质量响应值RSD%判断
20732.1520848.120.40数据可信
长期12月-供试品溶液-TAWW4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%
5min1147360-14736011.48013.4814.0911.4813.4814.09
2138501-13850110.79010.79
3197829-19782915.41115.41
4180621-18062114.07114.07
5192263-19226314.97814.98
6181976-18197614.17614.18
10min1378348-37834829.47430.364.8029.4930.384.81
2359751-35975128.02628.04
3397591-39759130.97431.00
4387994-38799430.22630.25
5411671-41167132.07032.10
6402775-40277531.37731.40
15min1543576-54357642.34642.654.6142.4142.724.61
2507037-50703739.50039.56
3571642-57164244.53344.61
4531062-53106241.37141.45
5567825-56782544.23544.31
6563541-56354143.90243.98
20min1638898-63889849.77249.481.5749.9149.621.57
2624002-62400248.61248.74
3622560-62256048.49948.65
4635843-63584349.53449.68
5641706-64170649.99150.14
6647525-64752550.44450.59
30min1650812-65081250.70050.771.4050.9251.001.40
2650776-65077650.69750.91
3639489-63948949.81850.05
4647536-64753650.44550.67
5667073-66707351.96752.20
6654485-65448550.98651.22
45min1642660-64266050.06550.551.1250.3750.861.11
2653486-65348650.90851.20
3639276-63927649.80150.12
4647108-64710850.41250.72
5658393-65839351.29151.61
6652676-65267650.84551.16
60min1643068-64306850.09750.721.6350.4951.121.62
2656189-65618951.11951.50
3636732-63673249.60350.00
4646588-64658850.37150.76
5660601-66060151.46351.87
6663297-66329751.67352.08
极限1645124-64512450.25750.491.2850.7350.971.27
2648466-64846650.51750.98
3642195-64219550.02950.51
4642071-64207150.01950.50
5664143-66414351.73952.23
6647025-64702550.40550.89
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%
127.789745729894559872579807839811619826460.60
227.729867359856679862010.08
单位质量响应值RSD%判断
35372.4335577.240.41数据可信
长期12月-供试品溶液-TAWW4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%
5min1244915-24491510.56412.5114.8010.5612.5114.81
2229336-2293369.8929.89
3333656-33365614.39214.39
4302417-30241713.04413.04
5324405-32440513.99313.99
6305939-30593913.19613.20
10min1641683-64168327.67828.495.0127.7028.515.02
2606666-60666626.16826.18
3673390-67339029.04629.07
4657584-65758428.36428.39
5698507-69850730.13030.15
6684875-68487529.54129.56
15min1924830-92483039.89240.194.5939.9640.264.59
2862820-86282037.21737.28
3971773-97177341.91741.99
4904639-90463939.02139.09
5966654-96665441.69641.77
6959263-95926341.37741.45
20min11088218-108821846.93946.671.5847.0746.801.58
21062202-106220245.81745.94
31060012-106001245.72345.86
41086198-108619846.85246.99
51092678-109267847.13247.27
61101996-110199647.53447.67
30min11109372-110937247.85247.931.3748.0648.141.37
21110342-111034247.89448.09
31091012-109101247.06047.28
41105323-110532347.67747.89
51137588-113758849.06949.29
61113595-111359548.03448.25
45min11095940-109594047.27247.701.0747.5648.001.07
21112915-111291548.00548.28
31091652-109165247.08747.38
41100838-110083847.48447.78
51122633-112263348.42448.73
61111605-111160547.94848.25
60min11095829-109582947.26847.901.7847.6348.281.77
21118387-111838748.24148.60
31085081-108508146.80447.18
41100690-110069047.47747.85
51128403-112840348.67349.06
61134872-113487248.95249.33
极限11098303-109830347.37447.611.2147.8248.071.21
21106286-110628647.71948.16
31092379-109237947.11947.57
41093633-109363347.17347.62
51128452-112845248.67549.14
61104094-110409447.62448.09
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%
127.785779255789185795245795155781805788120.13
227.725819865812875816360.09
单位质量响应值RSD%判断
20835.5720982.540.50数据可信
长期12月-供试品溶液-TAWW4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%
5min1188559-18855914.60614.828.9014.6114.828.89
2175500-17550013.59413.59
3199063-19906315.41915.42
4176809-17680913.69613.70
5221336-22133617.14517.14
6186794-18679414.46914.47
10min1399956-39995630.98130.053.9631.0130.083.96
2382603-38260329.63729.66
3397160-39716030.76430.79
4384126-38412629.75429.78
5402391-40239131.16931.20
6361524-36152428.00428.03
15min1542666-54266642.03539.925.5342.1139.995.53
2514603-51460339.86139.93
3556846-55684643.13343.21
4495492-49549238.38138.45
5486613-48661337.69337.77
6496047-49604738.42438.49
20min1621101-62110148.11145.946.6948.2646.086.67
2607114-60711447.02747.17
3632846-63284649.02049.17
4545231-54523142.23442.37
5541214-54121441.92342.07
6610717-61071747.30647.44
30min1647311-64731150.14148.684.3550.3748.904.34
2640912-64091249.64549.86
3636901-63690149.33449.57
4591918-59191845.85046.06
5596737-59673746.22346.44
6656921-65692150.88551.10
45min1639571-63957149.54149.801.9049.8550.101.89
2655844-65584450.80251.10
3640241-64024149.59349.91
4625811-62581148.47548.76
5637692-63769249.39649.69
6658232-65823250.98751.29
60min1646973-64697350.11550.151.9850.5150.541.97
2659804-65980451.10951.49
3638711-63871149.47549.87
4628967-62896748.72049.08
5647211-64721150.13350.51
6663167-66316751.36951.75
极限1643587-64358749.85250.091.9350.3350.561.92
2657002-65700250.89251.36
3635835-63583549.25249.73
4630384-63038448.83049.27
5650349-65034950.37650.83
6662875-66287551.34651.82
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%
127.789869139869939870519880309865109870990.06
227.729921069941709931380.15
单位质量响应值RSD%判断
35532.7235827.490.59数据可信
长期12月-供试品溶液-TAWW4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%
5min1318253-31825313.64913.869.2713.6513.869.28
2295310-29531012.66512.66
3336566-33656614.43414.43
4297513-29751312.75912.76
5375799-37579916.11716.12
6314984-31498413.50913.51
10min1676214-67621429.00028.223.9029.0228.243.90
2650068-65006827.87927.90
3673441-67344128.88128.91
4651957-65195727.96027.98
5683075-68307529.29529.32
6613378-61337826.30626.33
15min1924697-92469739.65737.515.8339.7337.585.81
2873130-87313037.44537.51
3947853-94785340.65040.72
4837790-83779035.93036.00
5823802-82380235.33035.41
6840765-84076536.05736.12
20min11056442-105644245.30743.246.9645.4443.386.94
21033445-103344544.32144.45
31080813-108081346.35246.49
4924282-92428239.63939.77
5916614-91661439.31039.44
61038560-103856044.54044.67
30min11101685-110168547.24745.864.5047.4646.064.48
21087085-108708546.62146.82
31086810-108681046.60946.83
41005264-100526443.11243.31
51013724-101372443.47543.68
61120946-112094648.07348.27
45min11092334-109233446.84646.971.9247.1447.251.92
21116839-111683947.89748.18
31091453-109145346.80847.10
41061013-106101345.50345.77
51091442-109144246.80847.08
61118302-111830247.96048.24
60min11103853-110385347.34047.341.9747.7147.701.97
21127114-112711448.33848.70
31089798-108979846.73747.11
41072675-107267546.00346.34
51100853-110085347.21247.56
61129215-112921548.42848.79
极限11098003-109800347.08947.321.8747.5447.761.86
21118969-111896947.98948.43
31089767-108976746.73647.19
41075193-107519346.11146.53
51105724-110572447.42047.85
61132707-113270748.57849.02
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%
127.781155174115876011548451158729115615511567330.17
227.721159951115915011595500.05
单位质量响应值RSD%判断
41639.0641830.810.33数据可信
长期12月-供试品溶液-TYN28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%
5min1362637-36263714.07312.5313.7614.0712.5313.76
2270059-27005910.48010.48
3383479-38347914.88214.88
4292517-29251711.35211.35
5333933-33393312.95912.96
6294888-29488811.44411.44
10min1686116-68611626.62626.476.3526.6526.496.35
2630913-63091324.48424.50
3732078-73207828.41028.43
4630641-63064124.47324.49
5691515-69151526.83626.86
6720739-72073927.97027.99
15min1918221-91822135.63335.997.0635.7036.057.06
2865770-86577033.59833.66
3950379-95037936.88136.95
4839265-83926532.56932.63
5999529-99952938.78938.86
6990823-99082338.45138.52
20min11125202-112520243.66643.626.5143.7943.756.51
21040811-104081140.39140.51
31139384-113938444.21644.35
41036612-103661240.22840.34
51199208-119920846.53846.67
61203420-120342046.70146.83
30min11273236-127323649.41148.094.9849.6148.294.98
21177862-117786245.70945.89
31246162-124616248.36048.57
41152796-115279644.73744.92
51271191-127119149.33149.54
61313793-131379350.98451.19
45min11343986-134398652.15649.793.7752.4450.073.77
21285489-128548949.88650.14
31280668-128066849.69949.99
41200836-120083646.60146.86
51271368-127136849.33849.63
61315769-131576951.06151.35
60min11341194-134119452.04850.112.4452.4250.472.45
21289713-128971350.05050.39
31282832-128283249.78350.15
41245833-124583348.34748.68
51281644-128164449.73750.11
61306702-130670250.70951.09
极限11344077-134407752.16050.122.3652.6250.562.36
21305220-130522050.65251.08
31273366-127336649.41649.87
41258699-125869948.84649.26
51275123-127512349.48449.94
61292479-129247950.15750.62
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%
127.781968454197273819765511973299197888619739860.21
227.721986257198224019842480.15
单位质量响应值RSD%判断
71057.8171581.820.52数据可信
长期12月-供试品溶液-TYN28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%
5min1614062-61406213.17511.7113.8713.1711.7113.88
2454257-4542579.7469.75
3648575-64857513.91513.92
4495135-49513510.62310.62
5564293-56429312.10712.11
6499368-49936810.71410.71
10min11160749-116074924.90424.816.7224.9324.836.72
21064944-106494422.84922.86
31248587-124858726.78926.81
41065573-106557322.86222.88
51173083-117308325.16925.19
61225070-122507026.28426.30
15min11557796-155779633.42333.837.0633.4933.907.06
21476146-147614631.67131.73
31615184-161518434.65434.72
41425876-142587630.59330.65
51700238-170023836.47936.54
61686192-168619236.17836.24
20min11924239-192423941.28541.146.6141.4041.266.61
21768845-176884537.95138.06
31939387-193938741.61041.74
41770028-177002837.97638.08
52053308-205330844.05444.18
62049434-204943443.97144.09
30min12161516-216151646.37645.184.9746.5645.364.98
22004826-200482643.01443.18
32112190-211219045.31845.51
41957229-195722941.99342.16
52167086-216708646.49546.69
62230454-223045447.85548.05
45min12280124-228012448.92146.893.8249.1947.153.82
22191236-219123647.01447.26
32188753-218875346.96047.23
42041020-204102043.79144.03
52160425-216042546.35246.63
62250524-225052448.28648.56
60min12276194-227619448.83647.162.3949.1847.502.39
22207597-220759747.36547.68
32179884-217988446.77047.12
42122155-212215545.53145.84
52174627-217462746.65747.01
62227498-222749847.79248.15
极限12292894-229289449.19547.252.2949.6247.672.28
22221121-222112147.65548.05
32171435-217143546.58947.02
42157760-215776046.29546.68
52168418-216841846.52446.95
62202814-220281447.26247.70
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%
127.781162693116091011663201165992116017611632180.25
227.721135992114086211384270.31
单位质量响应值RSD%判断
41872.5041068.801.38数据可信
长期12月-供试品溶液-TYN28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%
5min1324968-32496812.69311.6415.5812.6911.6415.58
2324093-32409312.65812.66
3343081-34308113.40013.40
4238944-2389449.3339.33
5239121-2391219.3409.34
6317326-31732612.39412.39
10min1662015-66201525.85725.006.3625.8825.026.36
2672687-67268726.27426.29
3615036-61503624.02224.04
4650260-65026025.39825.41
5569223-56922322.23322.25
6671442-67144226.22526.25
15min1898455-89845535.09234.845.6835.1634.905.67
2957489-95748937.39737.46
3859879-85987933.58533.65
4937974-93797436.63536.69
5820434-82043432.04432.10
6877801-87780134.28534.35
20min11058994-105899441.36242.953.2441.4843.073.24
21135446-113544644.34844.48
31080619-108061942.20742.32
41150155-115015544.92345.04
51094679-109467942.75642.86
61078352-107835242.11842.24
30min11180221-118022146.09748.654.5246.2948.844.50
21259141-125914149.17949.38
31306846-130684651.04351.23
41245129-124512948.63248.83
51302695-130269550.88051.06
61179502-117950246.06946.26
45min11293579-129357950.52449.952.7950.7950.222.77
21261353-126135349.26649.55
31319338-131933851.53051.80
41256189-125618949.06449.34
51313785-131378551.31451.58
61229490-122949048.02148.29
60min11307116-130711651.05350.292.1051.4150.642.08
21257522-125752249.11649.48
31318584-131858451.50151.86
41252026-125202648.90149.26
51296325-129632550.63250.98
61293832-129383250.53450.88
极限11304796-130479650.96250.522.9651.4050.962.93
21259144-125914449.17949.63
31318982-131898251.51751.96
41234062-123406248.20048.64
51312292-131229251.25551.69
61332032-133203252.02652.46
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%
127.781982824198673719777041983036198113219822870.17
227.721935083194873219419080.50
单位质量响应值RSD%判断
71356.6270054.401.31数据可信
长期12月-供试品溶液-TYN28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%
5min1549086-54908611.88410.8616.2711.8810.8616.26
2552041-55204111.94811.95
3579062-57906212.53312.53
4398096-3980968.6168.62
5397935-3979358.6138.61
6533651-53365111.55011.55
10min11118404-111840424.20623.506.4324.2323.526.43
21140260-114026024.67924.70
31043922-104392222.59422.61
41103546-110354623.88423.90
5963848-96384820.86120.88
61143982-114398224.75924.78
15min11522142-152214232.94432.795.7933.0032.845.78
21625127-162512735.17335.23
31467421-146742131.76031.82
41597185-159718534.56834.62
51385934-138593429.99630.05
61491085-149108532.27232.33
20min11798553-179855338.92640.513.4439.0440.623.43
21930287-193028741.77841.90
31838369-183836939.78839.90
41966439-196643942.56042.67
51865368-186536840.37340.47
61830323-183032339.61439.73
30min12007702-200770243.45345.814.5143.6345.994.48
22144289-214428946.40946.60
32213913-221391347.91648.09
42121415-212141545.91446.10
52214130-221413047.92148.09
61999140-199914043.26843.45
45min12212260-221226047.88047.172.8648.1347.422.83
22144342-214434246.41046.68
32247984-224798448.65448.91
42140965-214096546.33746.60
52236960-223696048.41548.66
62092870-209287045.29645.55
60min12220150-222015048.05147.471.9348.3847.801.91
22144652-214465246.41746.76
32241983-224198348.52448.86
42137753-213775346.26846.60
52206500-220650047.75648.08
62207953-220795347.78748.12
极限12222441-222244148.10147.783.0948.5148.203.06
22152932-215293246.59647.02
32259255-225925548.89849.32
42098763-209876345.42445.84
52237838-223783848.43448.84
62275085-227508549.24049.65
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