磷酸西格列汀片项目信息
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101546-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 12.813556633555653558783556883558643557320.04
2 12.853543793549013546400.11
单位质量响应值RSD%判断
27769.8727598.440.44数据可信
供试品溶液-2025030122批-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%
5min1366291-36629192.63194.853.1792.6394.853.17
2384752-38475297.30097.30
3384145-38414597.14697.15
4373789-37378994.52794.53
5356381-35638190.12590.13
6385072-38507297.38197.38
10min1390408-39040898.73098.311.2598.8898.471.25
2390671-39067198.79798.96
3390417-39041798.73398.89
4393616-39361699.54299.70
5379618-37961896.00296.15
6387746-38774698.05798.22
15min1391864-39186499.09898.611.1799.4298.931.17
2389756-38975698.56598.89
3390789-39078998.82799.15
4395880-395880100.114100.44
5381991-38199196.60296.91
6389272-38927298.44398.77
20min1390295-39029598.70298.601.3099.1999.081.30
2391264-39126498.94799.44
3390521-39052198.75999.25
4397551-397551100.537101.03
5382039-38203996.61497.09
6387606-38760698.02298.51
30min1391342-39134298.96698.811.3599.6299.461.35
2391876-39187699.10299.76
3390645-39064598.79099.45
4398639-398639100.812101.47
5382263-38226396.67097.30
6389641-38964198.53699.19
45min1392025-39202599.13999.031.5199.9599.851.51
2392031-39203199.14199.96
3391719-39171999.06299.88
4400772-400772101.351102.18
5382223-38222396.66097.45
6390856-39085698.84499.66
极限1392714-39271499.31399.491.42100.29100.461.42
2394465-39446599.756100.74
3393942-39394299.624100.61
4401991-401991101.659102.65
5384532-38453297.24498.20
6392749-39274999.322100.30
磷酸西格列汀片项目信息
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101546-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 12.813550813547003543693555843556833550830.16
2 12.853549993545333547660.10
单位质量响应值RSD%判断
27719.2027608.250.29数据可信
供试品溶液-2025030222批-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%
5min1380384-38038496.26696.051.4896.2796.051.48
2378001-37800195.66395.66
3379656-37965696.08296.08
4370061-37006193.65393.65
5387074-38707497.95997.96
6381989-38198996.67296.67
10min1389550-38955098.58598.350.9098.7598.520.90
2383573-38357397.07397.23
3389509-38950998.57598.74
4386643-38664397.85098.01
5394063-39406399.72899.89
6388461-38846198.31098.47
15min1389964-38996498.69098.460.7899.0298.780.78
2384305-38430597.25897.58
3389300-38930098.52298.85
4388292-38829298.26798.59
5393643-39364399.62199.95
6388779-38877998.39098.72
20min1387735-38773598.12698.400.9098.6298.890.90
2383991-38399197.17997.66
3387628-38762898.09998.59
4389752-38975298.63799.12
5394665-39466599.880100.38
6389074-38907498.46598.95
30min1389414-38941498.55198.600.8199.2099.260.81
2384520-38452097.31397.96
3389428-38942898.55599.21
4389487-38948798.57099.22
5394364-39436499.804100.47
6390454-39045498.81499.47
45min1388381-38838198.29098.730.9299.1199.540.92
2384705-38470597.35998.17
3389495-38949598.57299.39
4392242-39224299.267100.08
5395251-395251100.028100.86
6390561-39056198.84199.66
极限1392784-39278499.40499.500.79100.38100.480.79
2388045-38804598.20599.17
3392421-39242199.312100.29
4394682-39468299.884100.86
5397358-397358100.562101.56
6393701-39370199.636100.62
磷酸西格列汀片项目信息
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101546-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 12.813543303550433543113548793534633544050.18
2 12.853545573549863547720.09
单位质量响应值RSD%判断
27666.2827608.720.15数据可信
供试品溶液-2025030322批-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%
5min1371938-37193894.21794.341.6394.2294.341.63
2367707-36770793.14693.15
3367984-36798493.21693.22
4372923-37292394.46794.47
5384012-38401297.27697.28
6369867-36986793.69393.69
10min1380506-38050696.38896.201.4096.5496.361.40
2373182-37318294.53394.69
3375339-37533995.07995.23
4380156-38015696.29996.46
5388460-38846098.40398.56
6380949-38094996.50096.66
15min1380492-38049296.38496.471.1996.7096.781.19
2374434-37443494.85095.16
3378080-37808095.77396.09
4382322-38232296.84897.17
5387952-38795298.27498.60
6381607-38160796.66796.98
20min1381626-38162696.67296.501.3097.1596.981.30
2374532-37453294.87495.35
3376660-37666095.41495.89
4381729-38172996.69897.18
5388643-38864398.44998.94
6382415-38241596.87197.35
30min1380964-38096496.50496.831.3697.1497.471.36
2375403-37540395.09595.72
3378556-37855695.89496.53
4384554-38455497.41398.05
5390217-39021798.84899.50
6383903-38390397.24897.89
45min1382641-38264196.92997.251.3297.7398.051.32
2378152-37815295.79196.58
3379308-37930896.08496.88
4386264-38626497.84698.65
5391945-39194599.285100.10
6385193-38519397.57598.38
极限1384263-38426397.33997.771.3198.3098.731.31
2379532-37953296.14197.09
3382065-38206596.78397.74
4389096-38909698.56499.53
5393424-39342499.660100.64
6387382-38738298.13099.09
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