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125
标示量(mg)200供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.071133883113327511334971133076113293011333320.04
228.181124914112550811252110.04
单位质量响应值RSD%判断
40375.2039929.420.79数据可信
供试品溶液-2024032221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%
5min179544-795443.4598.7031.513.468.7031.51
2247237-24723710.75110.75
3251289-25128910.92710.93
4221516-2215169.6329.63
5205279-2052798.9268.93
6195873-1958738.5178.52
10min1380414-38041416.54223.9416.1316.5523.9516.13
2570368-57036824.80224.82
3616675-61667526.81626.83
4599861-59986126.08526.10
5531663-53166323.11923.13
6604363-60436326.28026.29
15min1602311-60231126.19126.292.3526.2226.342.34
2619963-61996326.95927.02
3599510-59951026.06926.13
4608435-60843526.45726.52
5616339-61633926.80126.85
6580378-58037825.23725.30
20min1577750-57775025.12324.633.2525.2024.723.23
2590901-59090125.69525.80
3564000-56400024.52524.63
4552143-55214324.01024.11
5573451-57345124.93625.03
6539994-53999423.48123.58
30min1538641-53864123.42222.735.1323.5422.875.07
2488048-48804821.22221.37
3522528-52252822.72222.87
4494368-49436821.49721.64
5556593-55659324.20324.34
6536070-53607023.31123.45
45min1532966-53296623.17623.704.2023.3323.884.18
2524211-52421122.79522.98
3547475-54747523.80723.99
4521395-52139522.67322.85
5575299-57529925.01725.20
6568512-56851224.72124.90
60min1536958-53695823.34924.201.9323.5524.421.94
2556615-55661524.20424.42
3569162-56916224.75024.97
4561566-56156624.41924.64
5555713-55571324.16524.39
6559093-55909324.31224.53
极限11089739-108973947.38728.2933.1147.6228.5532.77
2560409-56040924.36924.63
3568019-56801924.70024.97
4545341-54534123.71423.97
5576138-57613825.05325.31
6564112-56411224.53024.79
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125
标示量(mg)200供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.071078985107848210784321078605107896710786940.03
228.181089204107939410842990.64
单位质量响应值RSD%判断
38428.7138477.610.09数据可信
供试品溶液-2024032321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%
5min1274923-27492312.48312.4625.9112.4812.4625.91
2167184-1671847.5917.59
3359420-35942016.31916.32
4253813-25381311.52411.52
5346953-34695315.75315.75
6244916-24491611.12011.12
10min1578808-57880826.28022.909.2726.3022.929.27
2471394-47139421.40321.42
3517826-51782623.51223.54
4477211-47721121.66821.69
5529376-52937624.03624.06
6452001-45200120.52320.54
15min1589093-58909326.74727.992.5426.8128.052.52
2624464-62446428.35328.40
3610772-61077227.73227.80
4615603-61560327.95128.01
5633956-63395628.78428.85
6624550-62455028.35728.41
20min1555085-55508525.20327.343.9625.3127.443.93
2617277-61727728.02728.12
3607221-60722127.57127.68
4617827-61782728.05228.15
5612781-61278127.82327.94
6602008-60200827.33427.43
30min1557665-55766525.32025.683.2325.4725.843.21
2571280-57128025.93926.08
3537926-53792624.42424.58
4590731-59073126.82226.97
5577183-57718326.20726.37
6559297-55929725.39525.54
45min1554651-55465125.18425.211.9925.3825.401.98
2542989-54298924.65424.84
3541948-54194824.60724.81
4570201-57020125.89026.08
5561349-56134925.48825.69
6559900-55990025.42225.61
60min1492765-49276522.37424.444.2322.6124.684.19
2552276-55227625.07625.30
3545318-54531824.76025.00
4552070-55207025.06625.30
5547276-54727624.84925.10
6540296-54029624.53224.76
极限1513322-51332223.30724.643.1023.5824.923.07
2553364-55336425.12525.39
3561223-56122325.48225.76
4548584-54858424.90825.19
5544166-54416624.70825.00
6535340-53534024.30724.58
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125
标示量(mg)200供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.071129079112894411289651129160112976611291830.03
228.181133342113206711327040.08
单位质量响应值RSD%判断
40227.4040195.320.06数据可信
供试品溶液-2024032121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%
5min1264725-26472511.4945.7352.9011.495.7352.84
286261-862613.7453.75
3136200-1362005.9145.91
477304-773043.3563.36
5135184-1351845.8705.87
691799-917993.9863.99
10min1624946-62494627.13520.1726.8827.1520.1726.88
2311707-31170713.53413.54
3489109-48910921.23721.25
4367769-36776915.96815.97
5588098-58809825.53525.54
6404981-40498117.58417.59
15min1631919-63191927.43727.402.9427.5027.442.96
2602297-60229726.15126.18
3641164-64116427.83927.88
4618984-61898426.87626.91
5655633-65563328.46728.52
6636668-63666827.64427.68
20min1604687-60468726.25526.843.2626.3726.933.26
2598336-59833625.97926.05
3614564-61456426.68426.78
4631945-63194527.43927.52
5651898-65189828.30528.40
6607776-60777626.38926.47
30min1550966-55096623.92325.212.8624.0825.342.81
2591448-59144825.68025.80
3577674-57767425.08225.22
4590801-59080125.65225.77
5596273-59627325.89026.04
6576316-57631625.02325.15
45min1605834-60583426.30525.192.3526.5025.372.37
2572465-57246524.85625.01
3582236-58223625.28025.46
4566851-56685124.61224.78
5575915-57591525.00625.20
6577976-57797625.09525.26
60min1574418-57441824.94124.840.9725.1825.060.93
2580441-58044125.20225.40
3573826-57382624.91525.14
4570970-57097024.79125.00
5564428-56442824.50724.74
6568408-56840824.68024.89
极限1576083-57608325.01325.061.0125.2925.320.97
2582624-58262425.29725.54
3577749-57774925.08525.35
4584469-58446925.37725.63
5569900-56990024.74525.02
6571562-57156224.81725.07
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