厄贝沙坦片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-201804对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数800
标示量(mg)150供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.167205677204727201227200947198347202180.05
212.167205627208937207280.04
单位质量响应值RSD%判断
59228.4559270.390.06数据可信
长期36月-供试品溶液-20210227批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1137708-13770819.36819.3415.9919.3719.3415.98
2132135-13213518.58518.58
3128621-12862118.09018.09
4113588-11358815.97615.98
5134070-13407018.85718.86
6179021-17902125.17925.18
10min1443486-44348662.37663.719.0362.4763.819.04
2457478-45747864.34464.44
3435782-43578261.29261.38
4390155-39015554.87554.95
5481808-48180867.76667.86
6509294-50929471.63171.76
15min1630996-63099688.74987.832.2989.1688.242.30
2599988-59998884.38784.80
3630161-63016188.63189.03
4617854-61785486.90087.25
5626109-62610988.06188.49
6641660-64166090.24890.73
20min1681313-68131395.82693.281.9896.6894.141.97
2642940-64294090.42891.27
3655430-65543092.18593.03
4663036-66303693.25594.04
5669946-66994694.22795.10
6666761-66676193.77994.71
30min1673352-67335294.70695.522.3896.0496.842.36
2659875-65987592.81094.10
3696402-69640297.94899.25
4687787-68778796.73697.99
5662552-66255293.18794.53
6694963-69496397.74599.15
45min1691498-69149897.25896.351.2199.0698.141.16
2680216-68021695.67197.42
3688835-68883596.88498.67
4696155-69615597.91399.65
5677021-67702195.22297.03
6676413-67641395.13697.03
60min1699443-69944398.37696.890.82100.6799.170.81
2687830-68783096.74298.97
3684851-68485196.32398.60
4688137-68813796.78599.01
5683707-68370796.16298.45
6689443-68944396.96999.34
极限1700365-70036598.50596.042.47101.2998.812.38
2675752-67575295.04397.76
3705778-70577899.267102.02
4681582-68158295.86398.58
5669725-66972594.19696.96
6663990-66399093.38996.24
厄贝沙坦片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-201804对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数800
标示量(mg)150供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.167197707196657195937196327194717196260.02
212.167185507183897184700.02
单位质量响应值RSD%判断
59179.7759084.700.12数据可信
长期36月-供试品溶液-20210301批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min198983-9898313.94914.6514.3813.9514.6514.37
286488-8648812.18912.19
3100531-10053114.16814.17
497245-9724513.70413.70
5110283-11028315.54215.54
6130241-13024118.35418.35
10min1409183-40918357.66550.7814.7457.7350.8614.73
2277621-27762139.12439.19
3336933-33693347.48347.55
4361819-36181950.99051.06
5351152-35115249.48749.56
6425475-42547559.96160.05
15min1603724-60372485.08180.427.4385.4480.747.46
2491487-49148769.26469.52
3568919-56891980.17680.48
4574275-57427580.93181.25
5574861-57486181.01481.34
6610460-61046086.03086.42
20min1658920-65892092.86093.153.6793.6493.883.69
2626468-62646888.28688.89
3648819-64881991.43692.15
4699224-69922498.54099.27
5660248-66024893.04793.78
6672232-67223294.73695.56
30min1685389-68538996.59095.431.0197.8496.621.04
2676125-67612595.28496.33
3675250-67525095.16196.33
4676161-67616195.28996.51
5666259-66625993.89495.09
6683569-68356996.33397.63
45min1675837-67583795.24495.281.7996.9796.951.76
2688758-68875897.06598.59
3659862-65986292.99294.63
4663305-66330593.47895.17
5682563-68256396.19297.86
6686160-68616096.69998.48
60min1678488-67848895.61796.311.4197.8298.451.35
2699275-69927598.547100.55
3675866-67586695.24897.35
4674741-67474195.08997.25
5681504-68150496.04298.19
6690413-69041397.29899.56
极限1685368-68536896.58796.420.5199.2799.050.54
2684090-68409096.40798.91
3677386-67738695.46298.05
4687081-68708196.82899.47
5685351-68535196.58599.21
6685902-68590296.66299.41
厄贝沙坦片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-201804对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数800
标示量(mg)150供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.167202077199537199037197667195737198800.04
212.167203127202567202840.01
单位质量响应值RSD%判断
59200.6659233.880.04数据可信
长期36月-供试品溶液-20210302批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1132825-13282518.69219.4216.0718.6919.4216.07
2118249-11824916.64116.64
3128347-12834718.06218.06
4120520-12052016.96016.96
5176087-17608724.78024.78
6151760-15176021.35621.36
10min1460505-46050564.80462.448.8464.9062.538.85
2406219-40621957.16557.25
3437410-43741061.55461.64
4391091-39109155.03655.12
5487113-48711368.54968.67
6479759-47975967.51467.62
15min1578039-57803981.34484.734.4281.7685.144.44
2579387-57938781.53481.90
3599132-59913284.31384.71
4592515-59251583.38283.74
5614679-61467986.50186.97
6648862-64886291.31191.76
20min1626368-62636888.14591.193.6888.9792.023.66
2669221-66922194.17694.95
3612163-61216386.14686.97
4654772-65477292.14392.92
5654001-65400192.03492.93
6671579-67157994.50895.41
30min1658643-65864392.68796.123.2593.9597.403.22
2717729-717729101.002102.25
3684266-68426696.29397.54
4662537-66253793.23594.47
5677594-67759495.35496.71
6697382-69738298.13999.51
45min1683392-68339296.17096.650.9097.9098.420.95
2682559-68255996.05397.81
3683162-68316296.13897.87
4682119-68211995.99197.69
5695127-69512797.82299.66
6694286-69428697.70399.57
60min1663015-66301593.30394.391.4195.5196.641.43
2662002-66200293.16095.39
3664761-66476193.54895.76
4672657-67265794.65996.84
5675392-67539295.04497.37
6686435-68643596.59898.95
极限1670670-67067094.38094.280.9297.0697.000.94
2670404-67040494.34297.04
3659559-65955992.81695.50
4667557-66755793.94296.60
5677310-67731095.31498.11
6674109-67410994.86497.70
厄贝沙坦片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-201804对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数800
标示量(mg)150供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.167207817208567208937207837209887208600.02
212.167206157205217205680.01
单位质量响应值RSD%判断
59281.2559257.240.03数据可信
长期36月-供试品溶液-AA366批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1159856-15985622.47621.944.3922.4821.944.38
2165154-16515423.22123.22
3156728-15672822.03622.04
4145711-14571120.48720.49
5151000-15100021.23121.23
6157966-15796622.21022.21
10min1455811-45581164.08865.703.1764.2065.813.17
2468299-46829965.84365.96
3461866-46186664.93965.05
4453479-45347963.76063.86
5494369-49436969.50969.62
6469820-46982066.05766.17
15min1560319-56031978.78279.282.8179.2179.712.79
2539975-53997575.92176.37
3562482-56248279.08679.52
4565834-56583479.55779.98
5589494-58949482.88483.34
6564860-56486079.42079.86
20min1612131-61213186.06686.121.4886.8986.961.47
2621503-62150387.38488.21
3595536-59553683.73384.56
4613953-61395386.32387.14
5618396-61839686.94787.82
6613768-61376886.29787.14
30min1641496-64149690.19591.303.1391.4592.573.09
2623056-62305687.60288.86
3643763-64376390.51491.76
4683839-68383996.14997.40
5658229-65822992.54893.85
6645957-64595790.82292.09
45min1638826-63882689.82090.492.9791.5392.212.94
2618995-61899587.03288.73
3639678-63967889.94091.64
4660461-66046192.86294.59
5671209-67120994.37396.14
6632339-63233988.90890.63
60min1678975-67897595.46592.253.1497.6294.433.09
2653402-65340291.86994.00
3620199-62019987.20189.35
4657864-65786492.49794.69
5673172-67317294.64996.89
6653227-65322791.84594.01
极限1672459-67245994.54993.742.4997.1896.372.46
2659162-65916292.67995.27
3639511-63951189.91692.50
4669926-66992694.19296.85
5689509-68950996.94699.66
6669550-66955094.14096.77
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