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%
114.959606096361963969609995722961280.29
215.099689197164970280.20
单位质量响应值RSD%判断
6429.976429.950.01数据可信
供试品溶液-24082101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%
5min168792-6879269.35472.174.0769.3572.174.07
275803-7580376.42376.42
371325-7132571.90871.91
468082-6808268.63868.64
571879-7187972.46672.47
673650-7365074.25274.25
10min183161-8316183.84185.682.6783.9685.802.67
287914-8791488.63388.76
384166-8416684.85484.97
482286-8228682.95983.07
584990-8499085.68585.81
687394-8739488.10888.23
15min188145-8814588.86590.182.3789.1290.442.37
292099-9209992.85293.13
387671-8767188.38888.65
487094-8709487.80688.06
590099-9009990.83591.10
691573-9157392.32192.59
20min189400-8940090.13191.892.1390.5392.302.14
293402-9340294.16594.60
389967-8996790.70291.11
489369-8936990.09990.50
591135-9113591.88092.29
693611-9361194.37694.80
30min191540-9154092.28893.321.5592.8493.881.56
293931-9393194.69995.29
391573-9157392.32192.88
491131-9113191.87692.42
592569-9256993.32693.89
694628-9462895.40195.98
45min192380-9238093.13593.721.5393.8494.441.54
294628-9462895.40196.15
391612-9161292.36193.07
491392-9139292.13992.84
593158-9315893.91994.64
694568-9456895.34196.08
极限192669-9266993.42694.021.5494.2994.901.54
295145-9514595.92396.83
392089-9208992.84293.71
492075-9207592.82893.68
592551-9255193.30794.19
695004-9500495.78096.68
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100590-202005 对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9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%
111.563651503645583636603637143630093640180.24
211.513677073688143682600.22
单位质量响应值RSD%判断
31489.4531994.791.13数据可信
供试品溶液-24082101批-阿托伐他汀钙-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%
5min1123550-12355032.15235.067.2232.1535.067.22
2146638-14663838.16138.16
3141910-14191036.93036.93
4122820-12282031.96331.96
5138230-13823035.97335.97
6135294-13529435.20935.21
10min1216377-21637756.31059.013.8756.3659.063.87
2240550-24055062.60062.66
3232314-23231460.45760.52
4219601-21960157.14957.20
5224895-22489558.52658.59
6226734-22673459.00559.06
15min1267971-26797169.73672.142.3969.8872.302.40
2286824-28682474.64374.81
3279743-27974372.80072.96
4271595-27159570.68070.83
5278467-27846772.46872.63
6278622-27862272.50872.67
20min1296055-29605577.04579.461.8777.3179.741.88
2312519-31251981.33081.62
3308689-30868980.33380.62
4302002-30200278.59378.86
5306475-30647579.75780.03
6306275-30627579.70579.98
30min1322978-32297884.05186.681.7884.4487.081.78
2336909-33690987.67788.10
3338709-33870988.14588.56
4329135-32913585.65486.05
5334905-33490587.15587.57
6335778-33577887.38287.79
45min1338833-33883388.17790.771.7288.7191.321.73
2351967-35196791.59592.17
3354560-35456092.27092.83
4344199-34419989.57490.11
5351659-35165991.51592.07
6351485-35148591.47092.03
极限1358910-35891093.40295.051.1394.0895.751.13
2369176-36917696.07496.80
3370178-37017896.33597.05
4364488-36448894.85495.54
5363459-36345994.58695.30
6365166-36516695.03095.74
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%
114.959682997224970159679396905969530.18
215.099637796451964140.06
单位质量响应值RSD%判断
6485.156389.261.06数据可信
供试品溶液-24082102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%
5min183114-8311483.70479.245.6383.7079.245.63
281207-8120781.78381.78
378391-7839178.94778.95
481155-8115581.73181.73
577603-7760378.15378.15
670641-7064171.14271.14
10min194026-9402694.69392.473.3994.8392.603.39
293940-9394094.60694.74
392719-9271993.37793.51
493161-9316193.82293.96
591229-9122991.87692.01
685833-8583386.44286.56
15min197779-9777998.47396.882.9798.7797.162.97
298075-9807598.77199.06
396668-9666897.35497.64
497665-9766598.35898.65
596444-9644497.12897.41
690528-9052891.17091.43
20min198888-9888899.58998.163.09100.0598.603.09
298894-9889499.596100.05
398668-9866899.36899.82
499163-9916399.866100.32
597763-9776398.45698.90
691414-9141492.06292.48
30min1100176-100176100.88799.412.87101.51100.022.87
2100222-100222100.933101.56
3100041-100041100.751101.37
4100141-100141100.851101.47
598625-9862599.32599.93
693080-9308093.74094.31
45min1100982-100982101.698100.032.71102.49100.802.72
2100444-100444101.157101.95
3100720-100720101.434102.22
4100771-100771101.486102.28
598997-9899799.699100.47
694032-9403294.69995.42
极限1100550-100550101.263100.002.62102.23100.952.63
2100918-100918101.634102.60
3100736-100736101.451102.40
4100633-100633101.347102.31
598696-9869699.396100.34
694259-9425994.92895.81
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100590-202005 对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9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%
111.563688283701333703783706293706803701300.21
211.513708853707363708100.03
单位质量响应值RSD%判断
32018.1732216.330.44数据可信
供试品溶液-24082102批-阿托伐他汀钙-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%
5min1148519-14851938.19735.934.8538.2035.934.85
2141744-14174436.45436.45
3137667-13766735.40635.41
4145223-14522337.34937.35
5134773-13477334.66234.66
6130287-13028733.50833.51
10min1241800-24180062.18760.112.5162.2560.172.51
2236822-23682260.90760.97
3234200-23420060.23360.29
4233745-23374560.11660.18
5231613-23161359.56759.63
6224116-22411657.63957.70
15min1290209-29020974.63773.292.1974.8073.462.19
2290901-29090174.81574.98
3285427-28542773.40873.57
4285809-28580973.50673.67
5283963-28396373.03173.19
6273617-27361770.37070.52
20min1318740-31874081.97580.932.3082.2781.212.30
2321572-32157282.70482.99
3316876-31687681.49681.78
4316364-31636481.36481.65
5313496-31349680.62780.91
6300951-30095177.40077.67
30min1348946-34894689.74488.142.2990.1788.562.29
2349361-34936189.85090.28
3344368-34436888.56688.98
4344673-34467388.64589.07
5340707-34070787.62588.04
6328159-32815984.39884.80
45min1365199-36519993.92492.182.1794.5092.742.17
2364221-36422193.67294.25
3361423-36142392.95393.52
4360281-36028192.65993.23
5354917-35491791.27991.84
6344426-34442688.58189.12
极限1371631-37163195.57894.031.6896.3194.741.69
2369868-36986895.12595.86
3370752-37075295.35296.07
4364739-36473993.80594.53
5358391-35839192.17392.88
6358217-35821792.12892.81
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%
114.959655896785969229687396884968040.16
215.099699997340971700.25
单位质量响应值RSD%判断
6475.186439.360.40数据可信
供试品溶液-24082101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%
5min136842-3684236.98635.4818.8936.9935.4818.89
228493-2849328.60528.60
345856-4585646.03646.04
438721-3872138.87338.87
528339-2833928.45028.45
633785-3378533.91733.92
10min162525-6252562.77062.5612.0162.8362.6212.01
250713-5071350.91250.96
371259-7125971.53871.61
468300-6830068.56768.63
557149-5714957.37357.42
663961-6396164.21164.27
15min167333-6733367.59772.5511.4267.7672.7111.42
258480-5848058.70958.84
378792-7879279.10179.30
480423-8042380.73880.92
572216-7221672.49972.64
676351-7635176.65076.81
20min177083-7708377.38578.1110.2377.6678.3910.23
262518-6251862.76362.99
381705-8170582.02582.35
485307-8530785.64185.95
580086-8008680.40080.66
680126-8012680.44080.73
30min178783-7878379.09280.7310.2779.5081.1410.27
264633-6463364.88665.22
384836-8483685.16885.63
487187-8718787.52887.98
584941-8494185.27485.67
682115-8211582.43782.86
45min179716-7971680.02881.879.9080.5782.429.90
266126-6612666.38566.83
385822-8582286.15886.76
487786-8778688.13088.73
586390-8639086.72887.27
683451-8345183.77884.34
极限182811-8281183.13584.479.5383.8185.169.53
268693-6869368.96269.52
385969-8596986.30687.06
488152-8815288.49789.25
588643-8864388.99089.67
690563-9056390.91891.62
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100590-202005 对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9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%
111.563693403689203695853682823693553690960.14
211.513722543726563724550.08
单位质量响应值RSD%判断
31928.7232359.250.95数据可信
供试品溶液-24082101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%
5min1174286-17428644.78842.9817.7044.7942.9817.70
2135170-13517034.73634.74
3212517-21251754.61354.61
4185212-18521247.59647.60
5138117-13811735.49335.49
6158179-15817940.64940.65
10min1264760-26476068.03867.1810.6068.1167.2510.60
2219224-21922456.33656.39
3290877-29087774.75074.84
4290042-29004274.53574.61
5242613-24261362.34762.41
6261007-26100767.07467.14
15min1293343-29334375.38375.599.7075.5775.779.71
2241850-24185062.15162.30
3314315-31431580.77380.99
4324412-32441283.36783.57
5293745-29374575.48775.65
6297167-29716776.36676.55
20min1303714-30371478.04979.129.6478.3679.439.63
2251926-25192664.74065.00
3323120-32312083.03583.39
4337258-33725886.66987.01
5319667-31966782.14882.44
6311548-31154880.06280.37
30min1309994-30999479.66281.369.7380.1181.809.72
2259790-25979066.76167.12
3333131-33313185.60886.10
4345816-34581688.86889.35
5334999-33499986.08886.51
6315866-31586681.17181.61
45min1315643-31564381.11481.679.2581.6982.259.25
2262394-26239467.43067.90
3330577-33057784.95285.58
4343435-34343588.25688.89
5338372-33837286.95587.52
6316506-31650681.33681.91
极限1323227-32322783.06384.628.7883.7785.338.77
2274873-27487370.63771.22
3331938-33193885.30286.07
4343242-34324288.20688.99
5349258-34925889.75290.47
6353209-35320990.76891.48
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%
114.959819098153985809851998658984200.24
215.099900499325991640.23
单位质量响应值RSD%判断
6583.286571.500.13数据可信
供试品溶液-24082102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%
5min139534-3953438.96434.3216.5838.9634.3216.58
243920-4392043.28643.29
330932-3093230.48630.49
434391-3439133.89533.89
530950-3095030.50430.50
629231-2923128.80928.81
10min168923-6892367.92965.298.8067.9965.358.80
270797-7079769.77669.85
365151-6515164.21164.26
470580-7058069.56269.62
566821-6682165.85765.91
655229-5522954.43254.48
15min179648-7964878.49978.774.5178.6878.934.51
282476-8247681.28681.47
378235-7823577.10777.26
484145-8414582.93183.10
581093-8109379.92380.08
673918-7391872.85272.99
20min184023-8402382.81184.092.2483.1284.392.24
285962-8596284.72285.05
383525-8352582.32082.61
487982-8798286.71387.02
586919-8691985.66585.96
683531-8353182.32682.59
30min186177-8617784.93486.342.1385.3886.782.14
288772-8877287.49287.96
386565-8656585.31685.74
489270-8927087.98288.44
589659-8965988.36688.80
685182-8518283.95384.35
45min187831-8783186.56488.331.6487.1588.911.63
290025-9002588.72689.34
387738-8773886.47287.04
490924-9092489.61290.21
590357-9035789.05489.64
690873-9087389.56290.10
极限197273-9727395.87093.803.1896.6094.533.16
291223-9122389.90790.67
394271-9427192.91193.62
499442-9944298.00898.76
596068-9606894.68295.41
692763-9276391.42592.11
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100590-202005 对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9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%
111.563761333756813771183755923771443763340.21
211.513794673805773800220.21
单位质量响应值RSD%判断
32554.8433016.681.00数据可信
供试品溶液-24082102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%
5min1167360-16736042.16738.1013.8042.1738.1013.80
2185112-18511246.63946.64
3139083-13908335.04235.04
4146924-14692437.01837.02
5138431-13843134.87834.88
6130297-13029732.82832.83
10min1260887-26088765.73165.176.9765.8065.236.97
2273502-27350268.90968.99
3256342-25634264.58664.64
4271575-27157568.42468.49
5265336-26533666.85266.91
6224298-22429856.51256.57
15min1290187-29018773.11375.492.8573.2975.662.85
2302684-30268476.26276.45
3299014-29901475.33775.50
4305886-30588677.06877.24
5310608-31060878.25878.43
6289385-28938572.91173.06
20min1301002-30100275.83879.352.5676.1479.652.54
2313574-31357479.00579.33
3313676-31367679.03179.32
4317560-31756080.01080.31
5325173-32517381.92882.23
6318669-31866980.28980.56
30min1306604-30660477.24981.503.3877.6881.933.35
2319543-31954380.50980.96
3321478-32147880.99781.42
4322782-32278281.32581.76
5332569-33256983.79184.23
6337858-33785885.12485.53
45min1308778-30877877.79782.063.4578.3582.633.42
2322182-32218281.17481.76
3323941-32394181.61782.18
4323451-32345181.49482.07
5334465-33446584.26984.85
6341369-34136986.00886.55
极限1346562-34656287.31787.813.5588.0088.513.52
2325909-32590982.11382.83
3354147-35414789.22889.92
4358768-35876890.39291.10
5358857-35885790.41491.13
6346801-34680187.37788.07
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