沙库巴曲缬沙坦钠氨氯地平片项目信息
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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.711023491021771021351021731019511021570.14
215.601026141036171031160.69
单位质量响应值RSD%判断
6502.676610.001.16数据可信
供试品溶液-25102301批-氨氯地平-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%
5min170864-7086470.07178.657.8870.0778.647.88
273123-7312372.30472.30
385451-8545184.49484.49
483882-8388282.94382.94
584618-8461883.67183.67
679277-7927778.39078.39
10min195823-9582394.75097.174.6494.8797.304.64
2103839-103839102.677102.80
3100088-10008898.96899.11
495268-9526894.20294.34
5102442-102442101.295101.43
692177-9217791.14591.28
15min194401-9440193.34495.333.1393.6295.623.13
295781-9578194.70995.00
399571-9957198.45698.76
495450-9545094.38294.68
5100496-10049699.37199.68
692749-9274991.71191.99
20min191771-9177190.74493.893.5091.1794.343.50
296783-9678395.70096.15
398627-9862797.52397.99
493049-9304992.00792.46
598236-9823697.13697.61
691254-9125490.23390.67
30min191761-9176190.73493.712.8491.3294.322.84
297351-9735196.26196.87
398185-9818597.08697.72
493723-9372392.67493.28
595474-9547494.40595.04
692122-9212291.09191.68
45min191665-9166590.63993.823.0091.3794.583.01
295464-9546494.39595.16
398087-9808796.98997.78
493937-9393792.88593.65
598104-9810497.00697.80
692007-9200790.97791.71
60min191152-9115290.13294.153.2291.0295.073.22
296699-9669995.61796.54
398641-9864197.53798.49
494394-9439493.33794.25
598013-9801396.91697.87
692410-9241091.37692.26
极限195608-9560894.53894.602.9395.5795.682.92
297241-9724196.15297.24
399131-9913198.02199.14
494396-9439693.33994.41
596653-9665395.57196.69
690979-9097989.96191.00
沙库巴曲缬沙坦钠氨氯地平片项目信息
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57323100856对照品来源ZZ对照品使用方法直接使用
对照品含量(%)100对照品水分(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.477
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 22.611590399158987615872481584363158103415865840.25
2 22.501598867162155716102121.00
单位质量响应值RSD%判断
70171.7871564.981.40数据可信
供试品溶液-25102301批-沙库巴曲-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%
5min1260226-2602267.4258.5417.277.438.5417.29
2347573-3475739.9189.92
3256970-2569707.3337.33
4363978-36397810.38610.39
5322729-3227299.2099.21
6244758-2447586.9846.98
10min1784329-78432922.38027.229.6322.3927.249.63
2999574-99957428.52228.54
3970004-97000427.67927.69
4970121-97012127.68227.70
51057169-105716930.16630.18
6942704-94270426.90026.91
15min11230968-123096835.12541.858.3835.1741.918.39
21505613-150561342.96243.03
31557731-155773144.44944.51
41465964-146596441.83141.89
51566866-156686644.71044.78
61471952-147195242.00242.06
20min11579719-157971945.07750.084.9545.1850.214.96
21803190-180319051.45351.59
31802764-180276451.44151.57
41789988-178998851.07751.21
51782665-178266550.86851.01
61772680-177268050.58350.71
30min11748258-174825849.88651.251.4550.0751.461.47
21819995-181999551.93352.15
31805281-180528151.51351.73
41815086-181508651.79352.01
51798477-179847751.31951.54
61788248-178824851.02751.24
45min11778703-177870350.75551.270.8051.0251.570.82
21808704-180870451.61151.92
31794544-179454451.20751.51
41818229-181822951.88252.19
51790014-179001451.07751.39
61790608-179060851.09451.39
60min11783231-178323150.88451.260.6651.2351.640.67
21809174-180917451.62452.02
31794932-179493251.21851.61
41811900-181190051.70252.09
51791065-179106551.10751.50
61787618-178761851.00951.39
极限11800790-180079051.38551.270.9451.8251.740.93
21824704-182470452.06752.55
31787780-178778051.01451.49
41804042-180404251.47851.95
51783387-178338750.88851.37
61779277-177927750.77151.24
沙库巴曲缬沙坦钠氨氯地平片项目信息
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57323100856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(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.451
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 22.611035576103637810337001033062103099910339430.21
2 22.501041089105360310473460.85
单位质量响应值RSD%判断
45729.4646548.711.26数据可信
供试品溶液-25102301批-缬沙坦-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%
5min1156808-1568086.4987.6318.166.507.6318.15
2212843-2128438.8208.82
3157520-1575206.5276.53
4227039-2270399.4089.41
5200434-2004348.3068.31
6149573-1495736.1986.20
10min1464534-46453419.25024.8611.9119.2624.8811.91
2626784-62678425.97325.99
3616483-61648325.54625.56
4615905-61590525.52225.54
5676844-67684428.04728.06
6599391-59939124.83824.85
15min1733393-73339330.39138.4810.8430.4338.5410.84
2952472-95247239.46939.53
31001785-100178541.51341.57
4934566-93456638.72738.79
51008366-100836641.78541.85
6941270-94127039.00539.06
20min1945197-94519739.16846.287.5739.2646.397.58
21155848-115584847.89748.02
31163602-116360248.21848.34
41146010-114601047.48947.61
51151186-115118647.70447.83
61138625-113862547.18347.30
30min11058333-105833343.85647.603.9144.0147.803.94
21175850-117585048.72648.93
31168864-116886448.43648.64
41170358-117035848.49848.70
51165330-116533048.29048.50
61153350-115335047.79347.99
45min11095423-109542345.39347.802.5345.6248.082.56
21169149-116914948.44848.73
31163027-116302748.19448.48
41175232-117523248.70048.98
51160835-116083548.10348.39
61157679-115767947.97348.25
60min11113373-111337346.13747.951.9246.4448.301.95
21171509-117150948.54648.91
31164203-116420348.24348.61
41173076-117307648.61148.97
51161514-116151448.13248.50
61159181-115918148.03548.39
极限11158632-115863248.01248.210.9348.4048.640.94
21182506-118250649.00149.45
31159634-115963448.05448.50
41169290-116929048.45448.90
51156952-115695247.94248.39
61153171-115317147.78648.22
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