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%
114.729248992610925149221692441924540.16
214.799299493134930640.11
单位质量响应值RSD%判断
6280.846292.360.13数据可信
长期12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%
5min149905-4990551.46051.995.3751.4652.005.38
255680-5568057.41557.42
350233-5023351.79851.80
447826-4782649.31649.32
549578-4957851.12351.12
649315-4931550.85250.85
10min173141-7314175.42074.034.6175.5174.124.61
277882-7788280.30980.40
370194-7019472.38272.47
468945-6894571.09471.18
569735-6973571.90871.99
670866-7086673.07473.16
15min181592-8159284.13579.265.7084.3579.475.70
283076-8307685.66585.89
373006-7300675.28175.49
473008-7300875.28375.48
575061-7506177.40077.61
675446-7544677.79778.00
20min183928-8392886.54483.924.0286.9084.264.02
286820-8682089.52689.90
378589-7858981.03881.37
480007-8000782.50082.83
579100-7910081.56581.90
679845-7984582.33382.67
30min186528-8652889.22586.223.9889.7286.703.98
288935-8893591.70792.23
381261-8126183.79384.26
481940-8194084.49484.96
580722-8072283.23883.71
682306-8230684.87185.34
45min191680-9168094.53790.303.3395.1890.933.33
289139-8913991.91792.59
384896-8489687.54288.15
486495-8649589.19189.80
584075-8407586.69587.30
689147-8914791.92592.54
极限189948-8994892.75190.522.3493.5591.302.34
288922-8892291.69392.52
387099-8709989.81390.57
485979-8597988.65889.41
585044-8504487.69488.45
689743-8974392.54093.31
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%
112.113682713681653682123680253682353681820.03
212.203718413726033722220.15
单位质量响应值RSD%判断
30403.1430510.000.25数据可信
长期12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%
5min1220403-22040359.90162.234.9359.9062.234.94
2250196-25019667.99868.00
3231765-23176562.98962.99
4219661-21966159.69959.70
5225985-22598561.41861.42
6225840-22584061.37861.38
10min1273802-27380274.41375.683.8274.5175.783.82
2299578-29957881.41981.53
3278619-27861975.72375.83
4273530-27353074.34074.44
5273538-27353874.34274.44
6271638-27163873.82573.93
15min1288008-28800878.27478.743.5478.5078.973.55
2310285-31028584.32984.58
3287105-28710578.02978.26
4285415-28541577.57077.79
5284887-28488777.42677.65
6282572-28257276.79777.02
20min1293047-29304779.64480.153.3680.0080.513.37
2314578-31457885.49585.89
3292989-29298979.62879.99
4291285-29128579.16579.52
5290702-29070279.00679.36
6286805-28680577.94778.30
30min1299078-29907881.28381.562.9881.7782.062.98
2317538-31753886.30086.83
3298743-29874381.19281.69
4297833-29783380.94581.43
5295326-29532680.26380.75
6292126-29212679.39479.88
45min1305030-30503082.90183.332.1883.5283.962.19
2319506-31950686.83587.51
3306046-30604683.17783.81
4305032-30503282.90183.52
5300002-30000281.53482.15
6304091-30409182.64583.26
极限1310114-31011484.28284.311.9585.0485.081.95
2320742-32074287.17187.99
3311296-31129684.60385.37
4307467-30746783.56384.32
5302417-30241782.19082.95
6309364-30936484.07884.83
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%
114.729329993473936219361893537935100.15
214.799264692783927140.11
单位质量响应值RSD%判断
6352.586268.700.94数据可信
长期12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%
5min153482-5348254.94153.493.6454.9453.493.64
252578-5257854.01254.01
351934-5193453.35153.35
448754-4875450.08450.08
554152-5415255.62955.63
651504-5150452.90952.91
10min176133-7613378.21077.865.0378.3077.955.03
274516-7451676.54976.64
373992-7399276.01176.10
473749-7374975.76175.84
583282-8328285.55485.65
673085-7308575.07975.17
15min180873-8087383.07983.586.4183.3083.806.40
279851-7985182.02982.25
379777-7977781.95382.17
479680-7968081.85482.06
591537-9153794.03494.27
676424-7642478.50978.72
20min183763-8376386.04885.557.4686.4185.907.44
282251-8225184.49584.85
380182-8018282.36982.72
482125-8212584.36584.71
594850-9485097.43897.83
676472-7647278.55878.90
30min185008-8500887.32787.527.0487.8388.027.03
283714-8371485.99886.49
381608-8160883.83484.32
485302-8530287.62988.12
596468-9646899.10099.65
679064-7906481.22181.70
45min187471-8747189.85788.496.2590.5189.136.24
284586-8458686.89487.53
383276-8327685.54886.18
487281-8728189.66290.29
595134-9513497.72998.45
679066-7906681.22381.83
极限187537-8753789.92587.964.9390.7288.764.93
286450-8645088.80889.59
379650-7965081.82382.59
487593-8759389.98390.76
590963-9096393.44594.33
681568-8156883.79384.54
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%
112.113723033727203726883727423725493726000.05
212.203709353712383710860.06
单位质量响应值RSD%判断
30767.9630416.890.82数据可信
长期12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%
5min1244319-24431966.10863.405.9766.1163.405.97
2237070-23707064.14664.15
3237754-23775464.33164.33
4206621-20662155.90755.91
5236436-23643663.97563.97
6243586-24358665.90965.91
10min1298468-29846880.75978.503.9780.8778.613.97
2288716-28871678.12178.23
3290104-29010478.49678.60
4268622-26862272.68472.78
5300771-30077181.38281.49
6294055-29405579.56579.68
15min1308411-30841183.45081.334.0183.6981.564.01
2299836-29983681.12981.37
3300664-30066481.35481.59
4279105-27910575.52075.73
5314800-31480085.17885.42
6300644-30064481.34881.59
20min1311738-31173884.35082.293.8484.7382.663.84
2303469-30346982.11282.48
3303680-30368082.17082.54
4284046-28404676.85777.20
5318857-31885786.27686.66
6302999-30299981.98582.36
30min1314571-31457185.11683.063.7285.6483.573.73
2306325-30632582.88583.39
3306221-30622182.85783.37
4287919-28791977.90578.37
5321968-32196887.11887.65
6304781-30478182.46782.98
45min1317151-31715185.81583.613.6786.4884.263.67
2308057-30805783.35484.00
3308097-30809783.36584.01
4290941-29094178.72379.32
5324316-32431687.75388.43
6305453-30545382.64983.30
极限1318857-31885786.27683.104.5187.0983.894.50
2309833-30983383.83484.62
3291568-29156878.89279.68
4290879-29087978.70679.44
5324661-32466187.84788.67
6306973-30697383.06183.85
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%
114.729395294157941059411994120940910.09
214.799335993276933180.07
单位质量响应值RSD%判断
6392.056309.530.92数据可信
长期12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%
5min149800-4980050.83553.794.4550.8453.784.44
253214-5321454.32054.32
350416-5041651.46451.46
452550-5255053.64253.64
556108-5610857.27457.27
654058-5405855.18255.18
10min173400-7340074.92677.272.3175.0177.362.31
276761-7676178.35678.45
373857-7385775.39275.48
475627-7562777.19977.29
577764-7776479.38079.48
676746-7674678.34178.43
15min179261-7926180.90884.213.0481.1284.433.03
284287-8428786.03986.26
380273-8027381.94182.15
481578-8157883.27383.49
585594-8559487.37387.60
683974-8397485.71985.94
20min179859-7985981.51985.903.6981.8686.263.69
286260-8626088.05388.42
381002-8100282.68683.03
484977-8497786.74387.10
587904-8790489.73190.10
684902-8490286.66787.03
30min181852-8185283.55387.033.4484.0387.533.43
287710-8771089.53390.04
381721-8172183.41983.91
485655-8565587.43587.94
588744-8874490.58891.11
685856-8585687.64088.15
45min183325-8332585.05787.614.3085.6888.264.28
288388-8838890.22590.89
382343-8234384.05484.68
487497-8749789.31589.96
591091-9109192.98493.66
682300-8230084.01084.67
极限181625-8162583.32188.253.8184.0889.053.80
285535-8553587.31388.12
384618-8461886.37787.14
487439-8743989.25690.05
591108-9110893.00293.83
688422-8842290.26091.06
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%
112.113757673761333752943761723759233758580.10
212.203732573736393734480.08
单位质量响应值RSD%判断
31036.9930610.490.98数据可信
长期12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%
5min1228943-22894361.48363.913.0161.4863.903.01
2235326-23532663.19763.20
3234124-23412462.87562.87
4236210-23621063.43563.43
5245878-24587866.03166.03
6247288-24728866.41066.41
10min1288554-28855477.49279.261.7077.5979.371.70
2293029-29302978.69478.80
3295467-29546779.34979.45
4292075-29207578.43878.54
5300021-30002180.57280.68
6301746-30174681.03581.15
15min1298725-29872580.22382.181.9080.4682.421.90
2303858-30385881.60281.84
3306031-30603182.18682.42
4301898-30189881.07681.31
5311674-31167483.70183.95
6313873-31387384.29184.54
20min1300705-30070580.75582.881.8481.1283.261.84
2307457-30745782.56882.94
3308031-30803182.72383.10
4305393-30539382.01482.39
5314108-31410884.35584.74
6316052-31605284.87785.26
30min1301608-30160880.99883.502.0881.5084.012.08
2310049-31004983.26583.77
3310444-31044483.37183.88
4307238-30723882.51083.02
5316836-31683685.08785.61
6319383-31938385.77186.30
45min1304600-30460081.80184.112.0782.4484.772.07
2311760-31176083.72484.37
3312320-31232083.87484.53
4309123-30912383.01683.66
5319430-31943085.78486.45
6322010-32201086.47787.15
极限1304728-30472881.83684.282.3082.6185.072.29
2311658-31165883.69784.49
3312595-31259583.94884.74
4309369-30936983.08283.87
5320474-32047486.06486.87
6324104-32410487.03987.85
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%
114.729257692718926749270792823927000.10
214.799390194128940140.18
单位质量响应值RSD%判断
6297.556356.590.66数据可信
长期12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%
5min152077-5207753.35848.979.6853.3648.979.69
250615-5061551.86051.86
339256-3925640.22140.22
450242-5024251.47751.48
546480-4648047.62347.62
648095-4809549.27849.28
10min174190-7419076.01473.047.0176.1073.127.01
269123-6912370.82370.91
362942-6294264.49064.56
474345-7434576.17376.26
570225-7022571.95272.03
676892-7689278.78378.86
15min178695-7869580.63080.523.9980.8580.723.99
274243-7424376.06976.27
376946-7694678.83879.01
478895-7889580.83581.05
578936-7893680.87781.08
683808-8380885.86986.08
20min181674-8167483.68282.524.3784.0382.854.36
276631-7663178.51578.85
381473-8147383.47683.78
480322-8032282.29782.64
576962-7696278.85479.19
686150-8615088.26888.62
30min181668-8166883.67684.454.3784.1784.924.36
277676-7767679.58680.05
384163-8416386.23386.68
481062-8106283.05583.54
581537-8153783.54284.01
688419-8841990.59391.10
45min185189-8518987.28485.814.2587.9186.434.23
278689-7868980.62481.22
386028-8602888.14388.73
480762-8076282.74883.37
583505-8350585.55886.16
688359-8835990.53291.19
极限187244-8724489.38986.664.8890.1687.424.86
278398-7839880.32681.05
386828-8682888.96389.70
481251-8125183.24984.01
584311-8431186.38487.13
689436-8943691.63592.44
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%
112.113720223721883719143719453719993720140.03
212.203783813785653784730.04
单位质量响应值RSD%判断
30719.5731022.380.70数据可信
长期12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%
5min1244264-24426465.49659.8113.3765.5059.8213.37
2246730-24673066.15766.16
3165909-16590944.48644.49
4235921-23592163.25963.26
5223824-22382460.01560.02
6221814-22181459.47659.48
10min1299800-29980080.38776.388.9480.5076.488.94
2295747-29574779.30079.41
3233896-23389662.71662.79
4292128-29212878.33078.44
5287211-28721177.01277.11
6300387-30038780.54480.64
15min1309118-30911882.88680.774.7883.1380.994.79
2304624-30462481.68181.92
3273143-27314373.23973.42
4301335-30133580.79981.03
5305427-30542781.89682.12
6313620-31362084.09384.33
20min1313726-31372684.12181.933.7884.5082.293.80
2307015-30701582.32282.70
3284926-28492676.39976.70
4302155-30215581.01981.39
5307344-30734482.41082.77
6318081-31808185.28985.66
30min1316264-31626484.80282.843.2685.3283.343.27
2309119-30911982.88683.40
3292753-29275378.49878.93
4304646-30464681.68682.19
5308940-30894082.83883.34
6322023-32202386.34686.86
45min1318481-31848185.39683.353.1486.0683.993.16
2309836-30983683.07883.73
3294823-29482379.05379.61
4306393-30639382.15582.80
5313163-31316383.97084.61
6322411-32241186.45087.11
极限1323708-32370886.79883.783.3187.6084.553.32
2311080-31108083.41284.20
3296966-29696679.62780.32
4306320-30632082.13582.91
5312833-31283383.88284.66
6323725-32372586.80287.61
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原始图谱下载图谱(王丹 于 2026-03-13 13:08:55 完成)
生成报告数据部分下载报告( 于 2026-03-15 20:24:31 完成)
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