缬沙坦片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.444450400445054744500104450816444938844502320.02
215.394481141448127944812100.01
单位质量响应值RSD%判断
288227.46291176.740.72数据可信
供试品溶液-24072502SP批-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%
5min11829819-182981935.21036.932.5135.2136.932.51
21915235-191523536.85336.85
31973480-197348037.97437.97
41935814-193581437.24937.25
51937310-193731037.27837.28
61924993-192499337.04137.04
10min12814751-281475154.16255.862.9454.2255.922.94
22819213-281921354.24854.31
33032408-303240858.35058.41
42930160-293016056.38356.44
52955722-295572256.87556.94
62866416-286641655.15655.22
15min13430171-343017166.00468.183.0366.1568.333.03
23425705-342570565.91866.07
33699089-369908971.17971.34
43579310-357931068.87469.03
53608914-360891469.44469.60
63515646-351564667.64967.80
20min13845482-384548273.99676.612.9274.2576.882.92
23863321-386332174.33974.60
34149896-414989679.85380.13
44027046-402704677.48977.76
54044815-404481577.83178.10
63957508-395750876.15176.42
30min14349060-434906083.68686.422.4684.0786.822.47
24396189-439618984.59384.98
34660306-466030689.67590.09
44521280-452128087.00087.40
54538046-453804687.32287.72
64481533-448153386.23586.63
45min14667645-466764589.81692.762.1290.3493.302.12
24762702-476270291.64592.17
34975889-497588995.74796.31
44847294-484729493.27393.82
54839587-483958793.12593.67
64831992-483199292.97893.52
60min14804290-480429092.44595.161.8793.1295.861.88
24907547-490754794.43295.11
35087584-508758497.89798.62
44952002-495200295.28895.99
54943161-494316195.11895.82
64977646-497764695.78196.47
90min14848035-484803593.28796.051.8494.1196.901.84
24971260-497126095.65896.49
35129284-512928498.69999.58
44987113-498711395.96396.82
54981598-498159895.85796.72
65031813-503181396.82397.68
120min14868656-486865693.68496.091.6694.6697.111.66
24971932-497193295.67196.67
35119877-511987798.51899.57
44987831-498783195.97797.00
54979910-497991095.82596.85
65035046-503504696.88697.90
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限14846536-484653693.25896.141.8994.4097.311.89
24976491-497649195.75996.91
35136811-513681198.844100.06
44990233-499023396.02397.20
54989637-498963796.01297.19
65038231-503823196.94798.12
缬沙坦片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.444451164445470344545804450612444936244520840.06
215.394463330446371444635220.01
单位质量响应值RSD%判断
288347.41290027.420.42数据可信
供试品溶液-24072503SP批-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%
5min12818674-281867454.33356.192.7354.3356.182.73
22943953-294395356.74856.75
33044320-304432058.68358.68
42905798-290579856.01356.01
52928299-292829956.44656.45
62847708-284770854.89354.89
10min13791287-379128773.08174.592.2873.1774.682.28
23901414-390141475.20475.30
34020471-402047177.49977.60
43830826-383082673.84473.94
53886093-388609374.90975.00
63786347-378634772.98673.08
15min14247665-424766581.87983.002.1682.0983.212.17
24327420-432742083.41683.64
34473030-447303086.22386.45
44252824-425282481.97882.19
54318632-431863283.24783.47
64213885-421388581.22881.44
20min14487369-448736986.49987.501.8586.8587.861.86
24541317-454131787.53987.90
34697363-469736390.54790.92
44492307-449230786.59486.95
54549489-454948987.69788.05
64467423-446742386.11586.46
30min14740217-474021791.37392.211.8791.8792.721.87
24767563-476756391.90092.41
34951197-495119795.44095.96
44729730-472973091.17191.67
54808673-480867392.69393.20
64705049-470504990.69591.19
45min14919598-491959894.83195.001.7495.4895.661.74
24882925-488292594.12494.78
35086296-508629698.04498.72
44881385-488138594.09494.74
54954983-495498395.51396.17
64846530-484653093.42294.07
60min14958079-495807995.57395.921.8496.3896.741.84
24931269-493126995.05695.87
35149369-514936999.260100.10
44924388-492438894.92395.73
54997571-499757196.33497.15
64897135-489713594.39895.20
90min14973622-497362295.87296.301.9296.8397.271.92
24950679-495067995.43096.40
35179392-517939299.839100.85
44939222-493922295.20996.17
55013149-501314996.63497.61
64918714-491871494.81495.77
120min14973206-497320695.86496.431.9096.9997.561.90
24963654-496365495.68096.81
35182956-518295699.907101.08
44949127-494912795.40096.52
55025048-502504896.86498.00
64920910-492091094.85695.97
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限14970150-497015095.80596.221.9297.0997.521.92
24945917-494591795.33896.63
35172006-517200699.696101.04
44932138-493213895.07396.35
55019750-501975096.76198.06
64911006-491100694.66595.94
缬沙坦片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.444503608450418245002584498620449641145006160.08
215.394447857445117844495180.06
单位质量响应值RSD%判断
291490.67289117.480.58数据可信
供试品溶液-24072501-2批-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%
5min11943897-194389737.32736.094.2937.3336.094.29
21850494-185049435.53335.53
31796492-179649234.49734.50
41923887-192388736.94336.94
51785118-178511834.27834.28
61977865-197786537.97937.98
10min12809716-280971653.95352.863.8454.0152.923.85
22690490-269049051.66351.72
32642514-264251450.74250.80
42819658-281965854.14454.21
52653641-265364150.95651.01
62901985-290198555.72455.79
15min13417702-341770265.62764.363.8765.7864.513.86
23240115-324011562.21762.36
33228998-322899862.00462.15
43441826-344182666.09166.24
53248195-324819562.37262.51
63533335-353333567.84868.00
20min13813923-381392373.23672.263.2073.5072.523.20
23649415-364941570.07770.33
33651090-365109070.10970.35
43851362-385136273.95574.22
53679747-367974770.65970.91
63934538-393453875.55275.82
30min14260270-426027081.80681.642.1282.1982.022.13
24172248-417224880.11680.48
34174228-417422880.15480.52
44325391-432539183.05783.44
54189652-418965280.45080.81
64389305-438930584.28484.68
45min14536915-453691587.11987.581.1387.6488.101.14
24533624-453362487.05587.55
34529106-452910686.96987.46
44600207-460020788.33488.86
54519478-451947886.78487.28
64647505-464750589.24289.78
60min14628016-462801688.86889.720.8889.5390.380.89
24674023-467402389.75190.40
34651991-465199189.32889.97
44697740-469774090.20790.88
54643221-464322189.16089.80
64738995-473899590.99991.68
90min14674480-467448089.76090.970.8990.5791.780.89
24757002-475700291.34592.14
34728372-472837290.79591.58
44748125-474812591.17492.00
54717693-471769390.59091.38
64799373-479937392.15892.99
120min14675600-467560089.78291.421.0090.7492.381.00
24800182-480018292.17493.12
34753297-475329791.27492.21
44758532-475853291.37492.35
54768592-476859291.56792.51
64809480-480948092.35293.34
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限14662482-466248289.53091.431.1890.6492.541.17
24803079-480307992.23093.33
34759529-475952991.39392.49
44778676-477867691.76192.89
54744519-474451991.10592.20
64820193-482019392.55893.70
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