氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.566523265707654726533565695654880.33
212.556537765250653140.14
单位质量响应值RSD%判断
5214.015204.300.14数据可信
供试品溶液-2025020311批-氨氯地平-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%
5min120614-2061425.65725.126.6625.6625.126.66
219315-1931524.04024.04
319164-1916423.85223.85
422482-2248227.98227.98
520592-2059225.62925.63
618920-1892023.54823.55
10min147628-4762859.27959.023.4459.5659.303.45
247127-4712758.65558.92
345516-4551656.65056.92
448581-4858160.46560.78
549804-4980461.98762.27
645847-4584757.06257.32
15min160515-6051575.31875.951.5976.2676.881.61
260895-6089575.79176.71
360032-6003274.71775.61
461238-6123876.21877.20
562820-6282078.18779.16
660643-6064375.47776.37
20min166347-6634782.57783.882.8084.3685.662.78
266096-6609682.26484.03
367372-6737283.85285.58
467839-6783984.43486.26
570905-7090588.25090.09
665824-6582481.92683.66
30min167823-6782384.41486.941.6087.1189.651.58
269312-6931286.26788.94
370652-7065287.93590.59
470571-7057187.83490.60
570603-7060387.87490.70
670155-7015587.31689.96
45min171480-7148088.96589.002.7392.6092.672.66
267755-6775584.32987.96
372358-7235890.05893.69
473357-7335791.30295.05
572290-7229089.97393.77
671794-7179489.35692.97
60min170784-7078488.09989.101.8492.7293.771.82
270002-7000287.12691.70
372783-7278390.58795.22
471472-7147288.95593.71
573500-7350091.47996.28
671003-7100388.37292.98
极限171077-7107788.46487.593.7394.0793.253.59
265212-6521281.16486.70
371555-7155589.05994.70
471665-7166589.19694.94
572411-7241190.12495.94
670352-7035287.56193.15
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.011357244136613513589161366637136764813633160.36
29.051361327136293113621290.09
单位质量响应值RSD%判断
151311.43150511.490.38数据可信
供试品溶液-2025020311批-厄贝沙坦-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%
5min1578887-57888734.52431.978.6934.5231.978.69
2529142-52914231.55731.56
3494866-49486629.51329.51
4598210-59821035.67635.68
5537201-53720132.03832.04
6477904-47790428.50128.50
10min11224679-122467973.03771.742.2573.4272.092.28
21218279-121827972.65673.01
31169471-116947169.74570.07
41216215-121621572.53372.93
51221689-122168972.85973.22
61166801-116680169.58669.90
15min11418402-141840284.59184.850.8185.7986.010.80
21443051-144305186.06187.22
31415795-141579584.43585.54
41420819-142081984.73585.94
51410668-141066884.12985.29
61428060-142806085.16786.26
20min11498773-149877389.38489.860.5891.5291.950.53
21511654-151165490.15292.27
31520173-152017390.66092.70
41498496-149849689.36791.51
51501172-150117289.52791.63
61509905-150990590.04892.08
30min11490066-149006688.86591.401.5991.9994.501.51
21547719-154771992.30395.42
31545411-154541192.16595.21
41529038-152903891.18994.33
51524876-152487690.94194.04
61558744-155874492.96096.00
45min11541598-154159891.93892.011.4496.0596.121.37
21539659-153965991.82295.96
31556530-155653092.82896.90
41547760-154776092.30596.46
51503108-150310889.64293.75
61568288-156828893.53097.60
60min11531927-153192791.36191.571.4696.5096.701.38
21541222-154122291.91597.08
31550988-155098892.49897.60
41518825-151882590.58095.76
51503774-150377489.68294.78
61565887-156588793.38698.50
极限11518579-151857990.56590.232.6496.7296.382.47
21444852-144485286.16892.35
31538485-153848591.75297.88
41531343-153134391.32697.51
51489778-148977888.84794.95
61554900-155490092.73198.88
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.566677566651661536606466189663660.49
212.556604665953660000.10
单位质量响应值RSD%判断
5283.925258.960.34数据可信
供试品溶液-2025020411批-氨氯地平-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%
5min119419-1941923.88420.0820.7123.8820.0820.71
214121-1412117.36817.37
312998-1299815.98615.99
420983-2098325.80725.81
517175-1717521.12421.12
613281-1328116.33516.33
10min143811-4381153.88449.425.5954.1549.645.64
238586-3858647.45847.65
338220-3822047.00847.19
441649-4164951.22551.51
540464-4046449.76750.00
638349-3834947.16647.35
15min156257-5625769.19265.834.0370.0666.604.09
252127-5212764.11264.83
350839-5083962.52863.23
455341-5534168.06568.92
554536-5453667.07567.86
652030-5203063.99364.70
20min160963-6096374.98071.445.2576.6172.945.28
256042-5604268.92770.36
355488-5548868.24669.64
462218-6221876.52378.14
558805-5880572.32573.86
654993-5499367.63769.05
30min168022-6802283.66277.505.2686.1379.805.27
263092-6309277.59879.80
360213-6021374.05776.21
464346-6434679.14081.60
563808-6380878.47980.82
658600-5860072.07374.24
45min167051-6705182.46779.412.8985.8682.573.00
263745-6374578.40181.46
362889-6288977.34880.32
466380-6638081.64284.98
564834-6483479.74182.95
662489-6248976.85679.83
60min167388-6738882.88277.263.6587.1981.303.63
261159-6115975.22179.15
362300-6230076.62480.46
462274-6227476.59280.84
561516-6151675.66079.75
662247-6224776.55980.38
极限169417-6941785.37781.562.6390.6186.462.70
265971-6597181.13985.91
366170-6617081.38486.07
466770-6677082.12287.22
565232-6523280.23085.17
664323-6432379.11283.79
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.011365388135808013525331352540135303213563150.42
29.051365222136712813661750.10
单位质量响应值RSD%判断
150534.41150958.560.20数据可信
供试品溶液-2025020411批-厄贝沙坦-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%
5min1538964-53896432.17828.3113.5632.1828.3113.57
2461143-46114327.53227.53
3411576-41157624.57224.57
4555825-55582533.18433.18
5479248-47924828.61328.61
6398721-39872123.80523.80
10min11126074-112607467.23066.231.9967.5966.542.04
21097150-109715065.50365.81
31082335-108233564.61964.89
41143626-114362668.27868.65
51101228-110122865.74766.06
61105240-110524065.98666.25
15min11349876-134987680.59281.411.6281.7082.461.56
21353463-135346380.80681.84
31353640-135364080.81681.81
41348734-134873480.52381.65
51369859-136985981.78582.83
61405545-140554583.91584.91
20min11404906-140490683.87785.931.4585.8887.891.38
21446438-144643886.35788.29
31441035-144103586.03487.92
41431828-143182885.48487.51
51443454-144345486.17988.14
61468391-146839187.66789.60
30min11514000-151400090.39090.232.1993.3293.142.08
21537631-153763191.80194.69
31533729-153372991.56894.41
41446948-144694886.38789.36
51516305-151630590.52893.44
61519476-151947690.71793.62
45min11490111-149011188.96490.471.8392.9094.391.74
21534670-153467091.62495.54
31529121-152912191.29395.16
41475216-147521688.07592.01
51515947-151594790.50794.43
61547363-154736392.38296.29
60min11485678-148567888.69988.502.9593.6293.422.79
21516769-151676990.55695.48
31515274-151527490.46695.34
41425137-142513785.08590.00
51431785-143178585.48290.41
61519711-151971190.73195.67
极限11498404-149840489.45990.332.2895.3796.242.16
21534452-153445291.61197.55
31544595-154459592.21798.10
41455771-145577186.91492.77
51502652-150265289.71395.59
61542413-154241392.08798.03
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.566533465809658076553465639656250.31
212.556581165862658360.06
单位质量响应值RSD%判断
5224.925245.900.29数据可信
供试品溶液-2025020511批-氨氯地平-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%
5min118711-1871123.17124.867.2623.1724.867.27
218113-1811322.43122.43
320977-2097725.97825.98
420717-2071725.65625.66
521987-2198727.22827.23
619951-1995124.70724.71
10min143752-4375254.18257.515.7054.4457.795.71
243230-4323053.53553.78
350096-5009662.03862.33
446570-4657057.67157.96
548448-4844859.99760.30
646565-4656557.66557.94
15min158732-5873272.73374.282.2073.5975.192.25
258115-5811571.96972.81
361346-6134675.97076.95
459844-5984474.11075.04
560986-6098675.52476.49
660853-6085375.35976.27
20min163461-6346178.58980.523.1480.2682.263.14
263213-6321378.28279.93
366921-6692182.87484.70
462823-6282377.79979.55
566849-6684982.78584.59
666836-6683682.76984.52
30min169071-6907185.53685.652.8888.0888.292.79
271194-7119488.16590.68
370623-7062387.45890.20
467879-6787984.06086.67
570316-7031687.07889.81
665913-6591381.62584.30
45min170108-7010886.82087.042.8290.3190.632.77
271274-7127488.26491.76
372873-7287390.24593.96
467933-6793384.12787.67
571487-7148788.52892.22
668059-6805984.28387.86
60min170294-7029487.05188.792.7791.5193.352.70
269877-6987786.53491.01
373844-7384491.44796.16
469975-6997586.65691.14
571939-7193989.08893.77
674280-7428091.98796.50
极限169665-6966586.27285.812.2091.7091.352.18
268304-6830484.58690.02
371860-7186088.99094.72
467905-6790584.09289.54
569950-6995086.62592.29
668065-6806584.29089.83
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.011355182136039213627371359193135997313594950.21
29.051364127136470213644140.03
单位质量响应值RSD%判断
150887.35150763.980.06数据可信
供试品溶液-2025020511批-厄贝沙坦-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%
5min1479171-47917128.59331.726.4728.5931.726.48
2499432-49943229.80229.80
3548320-54832032.71932.72
4541805-54180532.33032.33
5566711-56671133.81733.82
6553962-55396233.05633.06
10min11073638-107363864.06668.844.6564.3869.194.66
21113599-111359966.45066.78
31219058-121905872.74373.11
41157692-115769269.08169.44
51158869-115886969.15269.53
61198920-119892071.54171.91
15min11320402-132040278.79081.011.8579.8282.131.87
21354247-135424780.81081.88
31366354-136635481.53282.70
41363982-136398281.39182.52
51345073-134507380.26381.41
61395814-139581483.29084.45
20min11395537-139553783.27484.901.5185.1886.921.54
21417808-141780884.60386.57
31449912-144991286.51988.60
41403988-140398883.77885.81
51426744-142674485.13687.17
61442985-144298586.10588.19
30min11448442-144844286.43187.521.0989.2690.481.12
21452673-145267386.68389.59
31488227-148822788.80591.84
41475428-147542888.04191.00
51477448-147744888.16291.14
61457655-145765586.98190.02
45min11457016-145701686.94288.601.7690.7392.531.73
21510343-151034390.12594.00
31513402-151340290.30794.33
41456473-145647386.91090.85
51472748-147274887.88191.84
61498811-149881189.43693.45
60min11453872-145387286.75588.241.4191.5193.151.40
21485877-148587788.66593.54
31505966-150596689.86394.89
41494187-149418789.16094.07
51456319-145631986.90191.84
61475849-147584988.06693.07
极限11457295-145729586.95987.300.7492.6893.200.70
21477994-147799488.19494.05
31471349-147134987.79893.83
41461917-146191787.23593.13
51462491-146249187.26993.17
61447392-144739286.36892.35
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