氨氯地平阿托伐他汀钙片项目信息
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%
1 14.999217592409924189204292293922670.18
2 14.999239392069922310.25
单位质量响应值RSD%判断
6155.246152.840.03数据可信
中间条件6月-供试品溶液-2025021021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%
5min155129-5512958.07248.6314.2158.0748.6314.21
240596-4059642.76342.76
336834-3683438.80038.80
449520-4952052.16352.16
548432-4843251.01751.02
646465-4646548.94548.95
10min176234-7623480.30372.676.1680.4072.766.17
263729-6372967.13167.20
368466-6846672.12072.19
470070-7007073.81073.90
569373-6937373.07673.16
666080-6608069.60769.69
15min182004-8200486.38182.323.7286.6182.523.72
276136-7613680.20080.38
381087-8108785.41585.60
478332-7833282.51382.72
576712-7671280.80781.01
674613-7461378.59678.79
20min184872-8487289.40287.073.8689.7887.413.85
284165-8416588.65788.97
386694-8669491.32191.65
482230-8223086.61986.97
579266-7926683.49783.84
678709-7870982.91083.24
30min185446-8544690.00789.533.4390.5390.023.41
285287-8528789.83990.30
390255-9025595.07295.55
484220-8422088.71589.21
582162-8216286.54787.03
682609-8260987.01887.49
45min186179-8617990.77990.693.1391.4591.323.11
286194-8619490.79591.41
391012-9101295.87096.51
485565-8556590.13290.77
583043-8304387.47588.10
684580-8458089.09589.71
极限190007-9000794.81193.233.6595.6494.023.64
290046-9004694.85295.62
392639-9263997.58498.38
488598-8859893.32794.12
583442-8344287.89688.67
686321-8632190.92891.69
氨氯地平阿托伐他汀钙片项目信息
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.613617553609533614563604773610933611470.14
211.653625043610923617980.28
单位质量响应值RSD%判断
31106.5531055.620.12数据可信
中间条件6月-供试品溶液-2025021021批-阿托伐他汀钙-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%
5min1240757-24075764.11855.0213.5464.1255.0213.53
2187267-18726749.87249.87
3163177-16317743.45743.46
4219455-21945558.44558.44
5224288-22428859.73259.73
6204734-20473454.52454.52
10min1302359-30235980.52374.315.2080.6374.405.21
2262504-26250469.90969.99
3274496-27449673.10373.18
4284048-28404875.64775.74
5284453-28445375.75575.85
6266403-26640370.94871.04
15min1321021-32102185.49382.233.6185.7382.443.60
2309899-30989982.53182.73
3318211-31821184.74584.94
4308112-30811282.05582.28
5305808-30580881.44281.67
6289563-28956377.11577.32
20min1326550-32655086.96685.353.5287.3585.703.51
2327446-32744687.20487.54
3333258-33325888.75289.09
4320330-32033085.30985.67
5313005-31300583.35883.72
6302335-30233580.51780.85
30min1328427-32842787.46687.423.1587.9987.923.13
2335406-33540689.32489.81
3342672-34267291.25991.74
4329683-32968387.80088.30
5318026-31802684.69685.20
6315331-31533183.97884.45
45min1330490-33049088.01588.002.9488.6988.652.92
2336619-33661989.64790.28
3343742-34374291.54492.18
4333205-33320588.73889.39
5319863-31986385.18585.83
6318777-31877784.89685.51
极限1343617-34361791.51190.944.2092.3391.724.18
2347176-34717692.45993.24
3353298-35329894.08994.88
4356672-35667294.98895.78
5322134-32213485.79086.57
6325845-32584586.77887.53
氨氯地平阿托伐他汀钙片项目信息
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%
1 14.999171591839921019191691864918870.16
2 14.999302493020930220.01
单位质量响应值RSD%判断
6129.896205.600.87数据可信
中间条件6月-供试品溶液-2025021121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%
5min148381-4838150.85250.694.0950.8550.694.09
251934-5193454.58654.59
347618-4761850.05050.05
446802-4680249.19249.19
548196-4819650.65850.66
646428-4642848.79948.80
10min169844-6984473.41172.732.6273.5072.822.61
270623-7062374.23074.32
370930-7093074.55374.64
469934-6993473.50673.59
566843-6684370.25770.34
667012-6701270.43570.52
15min175375-7537579.22579.904.5879.4380.114.57
276035-7603579.91880.13
380598-8059884.71484.92
479242-7924283.28983.49
573682-7368277.44577.65
671186-7118674.82275.02
20min178883-7888382.91283.254.2083.2583.594.19
278945-7894582.97783.32
382570-8257086.78787.14
483317-8331787.57287.92
574532-7453278.33978.67
676972-7697280.90381.23
30min180540-8054084.65385.604.3285.1386.084.31
280928-8092885.06185.55
385373-8537389.73390.23
485683-8568390.05990.55
576568-7656880.47980.94
679554-7955483.61784.08
45min180135-8013584.22886.624.4184.8587.244.40
282133-8213386.32886.96
386147-8614790.54791.19
486991-8699191.43492.07
577391-7739181.34481.94
681655-8165585.82586.42
极限180312-8031284.41487.445.3585.1788.205.33
283004-8300487.24388.02
389287-8928793.84794.64
487535-8753592.00692.80
577598-7759881.56182.29
681395-8139585.55286.29
氨氯地平阿托伐他汀钙片项目信息
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.613619313611893607773607063600903609390.19
211.653644553645783645160.03
单位质量响应值RSD%判断
31088.6331288.930.46数据可信
中间条件6月-供试品溶液-2025021121批-阿托伐他汀钙-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%
5min1223096-22309659.21058.863.9659.2158.863.96
2234991-23499162.36762.37
3212490-21249056.39556.39
4222325-22232559.00559.01
5226128-22612860.01460.01
6211627-21162756.16656.17
10min1285301-28530175.71975.522.3875.8275.622.38
2289263-28926376.77076.87
3284331-28433175.46175.56
4292577-29257777.65077.75
5283161-28316175.15175.25
6272786-27278672.39772.49
15min1304041-30404180.69280.893.1080.9281.123.10
2307467-30746781.60281.83
3310365-31036582.37182.59
4317676-31767684.31184.54
5298720-29872079.28079.51
6290487-29048777.09577.31
20min1308576-30857681.89682.813.5282.2683.163.52
2314823-31482383.55483.92
3318888-31888884.63384.99
4328399-32839987.15787.53
5302883-30288380.38580.74
6298463-29846379.21279.55
30min1313243-31324383.13584.083.4583.6384.583.44
2316736-31673684.06284.57
3324750-32475086.18986.69
4333837-33383788.60089.11
5305139-30513980.98481.48
6307092-30709281.50281.98
45min1313050-31305083.08384.723.2683.7285.363.25
2318954-31895484.65085.30
3326900-32690086.75987.40
4335545-33554589.05489.71
5307077-30707781.49882.12
6313878-31387883.30383.91
极限1314328-31432883.42385.763.7384.2086.543.71
2321858-32185885.42186.21
3335623-33562389.07489.86
4339041-33904189.98190.79
5308081-30808181.76582.53
6319962-31996284.91885.67
氨氯地平阿托伐他汀钙片项目信息
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%
1 14.999186192283921529228492289921740.20
2 14.999266192426925440.18
单位质量响应值RSD%判断
6149.036173.720.29数据可信
中间条件6月-供试品溶液-2025021221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%
5min159899-5989963.02156.0717.8063.0256.0717.80
264912-6491268.29668.30
358153-5815361.18461.18
449687-4968752.27752.28
548273-4827350.78950.79
638829-3882940.85340.85
10min178473-7847382.56379.005.1582.6779.095.16
279212-7921283.34183.45
377981-7798182.04682.15
470634-7063474.31674.40
571903-7190375.65175.74
672292-7229276.06076.13
15min182053-8205386.33085.573.4086.5785.793.40
283420-8342087.76888.02
383459-8345987.80988.05
476745-7674580.74580.96
579201-7920183.32983.54
683097-8309787.42887.62
20min184667-8466789.08088.293.1689.4788.663.16
285055-8505589.48989.89
385280-8528089.72590.11
480569-8056984.76985.11
580789-8078985.00085.35
687126-8712691.66792.01
30min184654-8465489.06789.682.9889.6090.202.97
285915-8591590.39390.94
386464-8646490.97191.51
482455-8245586.75387.24
582730-8273087.04287.53
689209-8920993.85994.35
45min185226-8522689.66889.743.0290.3590.403.01
285889-8588990.36691.06
385439-8543989.89390.58
482226-8222686.51287.14
583306-8330687.64888.28
689684-8968494.35995.01
极限186400-8640090.90490.452.4491.7491.272.44
286613-8661391.12891.98
386334-8633490.83491.67
483056-8305687.38588.16
584303-8430388.69789.48
689118-8911893.76394.57
氨氯地平阿托伐他汀钙片项目信息
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.613608293629843619273625523626113621810.24
211.653643213639083641140.09
单位质量响应值RSD%判断
31195.6131254.420.14数据可信
中间条件6月-供试品溶液-2025021221批-阿托伐他汀钙-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%
5min1267569-26756970.93063.7215.4270.9363.7215.42
2281796-28179674.70174.70
3257632-25763268.29568.30
4227577-22757760.32860.33
5229012-22901260.70960.71
6178584-17858447.34147.34
10min1320760-32076085.03081.994.7785.1582.094.79
2326925-32692586.66486.79
3319587-31958784.71984.83
4294284-29428478.01278.11
5294213-29421377.99378.09
6299959-29995979.51679.59
15min1332787-33278788.21886.683.4688.4886.923.46
2337592-33759289.49289.76
3331298-33129887.82488.08
4312244-31224482.77383.00
5313015-31301582.97783.21
6334853-33485388.76688.98
20min1335110-33511088.83488.043.4889.2488.433.47
2339237-33923789.92890.35
3335529-33552988.94589.35
4317701-31770184.21984.59
5318652-31865284.47184.84
6346414-34641491.83192.19
30min1335856-33585689.03288.863.3689.5989.393.35
2341599-34159990.55491.12
3337859-33785989.56390.11
4323052-32305285.63886.15
5321635-32163585.26285.77
6351135-35113593.08293.59
45min1337356-33735689.42989.093.4590.1389.773.44
2342061-34206190.67791.40
3337791-33779189.54590.24
4322935-32293585.60786.26
5323187-32318785.67386.33
6353095-35309593.60294.27
极限1338423-33842389.71289.363.3590.5690.203.34
2342703-34270390.84791.72
3339310-33931089.94790.80
4323799-32379985.83686.63
5324867-32486786.11986.91
6353561-35356193.72594.55
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