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%
115.019329493369932319321693180932580.08
214.939443694468944520.03
单位质量响应值RSD%判断
6213.066326.321.28数据可信
供试品溶液-2025021321批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min163255-6325565.40767.222.6565.4167.222.65
264118-6411866.30066.30
366675-6667568.94468.94
464709-6470966.91166.91
563747-6374765.91665.92
667550-6755069.84969.85
10min187010-8701089.97189.213.9290.0889.323.92
286822-8682289.77689.89
384076-8407686.93787.05
484024-8402486.88386.99
583301-8330186.13686.25
692407-9240795.55195.67
15min185488-8548888.39793.084.8188.6693.344.80
286787-8678789.74090.00
390393-9039393.46993.73
491543-9154394.65894.91
588324-8832491.33091.58
697576-97576100.896101.17
20min193767-9376796.95896.073.8297.3696.483.81
288879-8887991.90392.31
392259-9225995.39895.81
493436-9343696.61697.03
590106-9010693.17293.58
699009-99009102.378102.82
30min194311-9431197.52097.433.6098.0998.013.59
290604-9060493.68794.25
393661-9366196.84897.42
494916-9491698.14698.72
591603-9160394.72095.28
6100263-100263103.675104.29
45min195022-9502298.25598.143.0498.9998.883.05
291927-9192795.05595.77
395240-9524098.48199.22
495224-9522498.46499.20
592163-9216395.29996.02
699899-99899103.298104.09
极限194689-9468997.91198.343.3998.8199.243.39
291359-9135994.46895.35
395491-9549198.74099.64
495998-9599899.265100.17
592502-9250295.65096.53
6100584-100584104.007104.97
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%
111.421758611756151754941756101757781756720.09
211.511764481767461765970.12
单位质量响应值RSD%判断
15382.8415342.920.19数据可信
供试品溶液-2025021321批-阿托伐他汀钙-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min125406-2540613.68915.186.0913.6915.186.09
228679-2867915.45215.45
328833-2883315.53515.54
427196-2719614.65314.65
528509-2850915.36015.36
630476-3047616.42016.42
10min150974-5097427.46427.212.6927.4927.232.68
250391-5039127.15027.18
352112-5211228.07828.10
451669-5166927.83927.86
548896-4889626.34526.37
648951-4895126.37426.40
15min162093-6209333.45534.893.9133.5234.963.90
263167-6316734.03434.10
364611-6461134.81234.88
469447-6944737.41837.49
564290-6429034.63934.71
664958-6495834.99935.07
20min182065-8206544.21641.464.8844.3441.584.87
273468-7346839.58439.71
374396-7439640.08440.21
481247-8124743.77543.91
574471-7447140.12540.25
676026-7602640.96241.09
30min196808-9680852.16048.964.8252.3649.164.80
287054-8705446.90447.10
388643-8864347.76047.96
496048-9604851.75051.96
587662-8766247.23247.43
688964-8896447.93348.13
45min1111047-11104759.83156.014.5360.1256.294.52
299009-9900953.34553.62
3101247-10124754.55154.83
4108215-10821558.30658.60
5100783-10078354.30154.57
6103397-10339755.71055.99
极限1123030-12303066.28862.854.2866.6763.224.27
2112827-11282760.79061.15
3112312-11231260.51360.88
4122480-12248065.99166.38
5112624-11262460.68161.04
6116664-11666462.85863.23
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%
115.019493194930950079519995073950280.12
214.939453294350944410.14
单位质量响应值RSD%判断
6330.986325.590.07数据可信
供试品溶液-2025021321批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min162462-6246263.98462.714.9863.9862.714.98
262231-6223163.74863.75
355492-5549256.84456.84
460266-6026661.73561.73
563102-6310264.64064.64
663766-6376665.32065.32
10min188716-8871690.87885.554.1690.9885.654.16
283461-8346185.49585.60
381394-8139483.37883.47
483104-8310485.12985.23
578658-7865880.57580.68
685752-8575287.84287.95
15min192040-9204094.28390.772.7094.5491.022.70
289005-8900591.17491.42
387373-8737389.50289.74
487981-8798190.12590.37
585107-8510787.18187.42
690181-9018192.37992.63
20min192523-9252394.77892.921.7595.1993.321.76
290880-9088093.09593.50
389849-8984992.03992.42
490803-9080393.01693.41
588122-8812290.27090.66
692060-9206094.30494.71
30min193726-9372696.01093.942.0496.5894.492.04
292503-9250394.75795.31
391189-9118993.41193.95
491510-9151093.74094.29
588387-8838790.54191.08
692906-9290695.17095.74
45min186369-8636988.47493.382.9289.2194.082.89
294006-9400696.29797.01
391597-9159793.82994.52
491833-9183394.07194.78
590264-9026492.46493.15
692852-9285295.11595.84
极限194328-9432896.62794.571.5797.5195.431.58
293412-9341295.68996.56
391338-9133893.56494.41
491622-9162293.85594.72
590428-9042892.63293.47
692788-9278895.04995.93
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%
111.421787181787531790121792621794641790420.19
211.511808361809481808920.05
单位质量响应值RSD%判断
15677.9315716.070.18数据可信
供试品溶液-2025021321批-阿托伐他汀钙-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min128221-2822114.88214.623.3214.8814.623.33
228577-2857715.06915.07
327376-2737614.43614.44
426326-2632613.88213.88
527152-2715214.31814.32
628648-2864815.10715.11
10min149873-4987326.29925.093.2526.3225.113.25
248342-4834225.49225.52
347560-4756025.08025.10
445161-4516123.81523.84
547077-4707724.82524.85
647458-4745825.02625.05
15min164184-6418433.84632.642.9533.9132.702.93
259735-5973531.50031.57
362208-6220832.80432.87
459668-5966831.46431.53
562766-6276633.09833.16
662813-6281333.12333.19
20min172999-7299938.49438.071.7838.6238.191.78
269635-6963536.72036.84
372911-7291138.44838.57
472260-7226038.10438.22
572853-7285338.41738.54
672490-7249038.22638.35
30min185621-8562145.15044.732.2045.3444.912.20
281263-8126342.85243.03
386645-8664545.69045.87
484640-8464044.63344.81
585560-8556045.11845.30
685235-8523544.94745.13
45min196716-9671651.00150.771.9851.2751.021.98
292755-9275548.91249.16
398117-9811751.74052.00
495882-9588250.56150.81
597672-9767251.50551.76
696501-9650150.88751.15
极限1108259-10825957.08856.812.8257.4457.152.81
2101645-10164553.60053.93
3108980-10898057.46857.81
4109065-10906557.51357.85
5109912-10991257.95958.30
6108518-10851857.22457.57
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%
115.019461594802948339499095298949080.27
214.939444394453944480.01
单位质量响应值RSD%判断
6322.986326.050.04数据可信
供试品溶液-2025021421批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min164383-6438365.99164.862.6865.9964.862.68
264017-6401765.61665.62
360688-6068862.20462.20
463516-6351665.10365.10
561868-6186863.41463.41
665224-6522466.85366.85
10min181282-8128283.31281.241.8383.4281.351.83
279257-7925781.23781.35
376915-7691578.83678.94
480144-8014482.14682.25
578951-7895180.92381.03
679026-7902681.00081.11
15min187169-8716989.34787.401.6689.6087.651.66
285669-8566987.80988.05
382926-8292684.99885.23
485891-8589188.03788.28
584718-8471886.83487.07
685270-8527087.40087.65
20min188820-8882091.03988.721.7791.4489.111.77
286738-8673888.90589.30
384086-8408686.18786.56
487077-8707789.25289.64
586142-8614288.29488.68
686491-8649188.65289.04
30min190760-9076093.02789.782.6693.5890.312.66
288316-8831690.52291.06
383602-8360285.69086.21
487583-8758389.77190.31
587074-8707489.24989.78
688192-8819290.39590.93
45min191348-9134893.63091.661.4094.3392.341.40
290078-9007892.32893.02
387573-8757389.76190.42
489043-8904391.26791.96
589146-8914691.37392.05
689363-8936391.59592.29
极限192581-9258194.89492.221.6495.7593.061.64
289557-8955791.79492.64
388143-8814390.34591.16
489435-8943591.66992.51
589731-8973191.97392.81
690394-9039492.65293.50
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%
111.421796321796411797271801581802561798830.17
211.511799031796611797820.10
单位质量响应值RSD%判断
15751.5815619.640.60数据可信
供试品溶液-2025021421批-阿托伐他汀钙-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min129976-2997615.81915.593.5715.8215.603.56
228133-2813314.84614.85
328308-2830814.93914.94
430238-3023815.95715.96
530588-3058816.14216.14
630059-3005915.86315.86
10min150897-5089726.85926.192.6326.8926.222.63
249375-4937526.05626.08
348517-4851725.60325.63
451555-5155527.20627.23
549064-4906425.89225.92
648392-4839225.53725.56
15min166777-6677735.23934.562.9835.3134.632.98
265389-6538934.50734.58
364449-6444934.01134.08
468705-6870536.25736.33
564236-6423633.89833.97
663415-6341533.46533.53
20min175326-7532639.75139.513.0439.8839.643.04
275567-7556739.87840.00
373652-7365238.86738.99
478838-7883841.60441.74
573421-7342138.74538.87
672466-7246638.24238.37
30min189303-8930347.12746.832.3547.3247.022.34
290262-9026247.63347.82
388031-8803146.45546.64
491716-9171648.40048.60
586941-8694145.88046.07
686216-8621645.49845.69
45min1101040-10104053.32053.341.7853.6053.611.78
2102424-10242454.05154.32
3101205-10120553.40853.67
4103577-10357754.65954.94
598914-9891452.19952.47
699258-9925852.38052.64
极限1113231-11323159.75459.062.0260.1259.422.02
2112789-11278959.52159.88
3111129-11112958.64559.00
4115106-11510660.74361.12
5110432-11043258.27758.63
6108763-10876357.39657.75
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%
115.019517695177955249523295179952580.16
214.939563695775957060.11
单位质量响应值RSD%判断
6346.306410.310.71数据可信
供试品溶液-2025021421批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min166588-6658867.67865.562.9467.6865.562.94
266917-6691768.01268.01
364316-6431665.36865.37
463949-6394964.99565.00
562206-6220663.22463.22
663026-6302664.05764.06
10min179969-7996981.27782.411.3181.3982.521.31
282044-8204483.38683.50
381700-8170083.03783.15
481952-8195283.29383.40
581290-8129082.62082.73
679568-7956880.87080.98
15min185004-8500486.39588.901.5886.6489.141.58
287188-8718888.61588.87
389155-8915590.61490.86
488158-8815889.60089.85
587637-8763789.07189.31
687660-8766089.09489.34
20min185478-8547886.87790.282.4287.2790.682.41
287704-8770489.13989.54
391950-9195093.45593.85
489052-8905290.50990.91
589457-8945790.92191.31
689347-8934790.80991.20
30min186488-8648887.90391.201.9888.4491.751.97
289979-8997991.45192.00
391713-9171393.21493.77
489336-8933690.79891.35
590514-9051491.99592.54
690384-9038491.86392.40
45min187188-8718888.61591.892.0589.3092.582.05
290004-9000491.47792.18
392575-9257594.09094.80
490057-9005791.53192.23
590986-9098692.47593.17
691629-9162993.12893.82
极限187539-8753988.97192.081.8189.8092.931.80
290492-9049291.97392.83
392129-9212993.63694.50
490435-9043591.91592.77
591434-9143492.93093.78
691554-9155493.05293.90
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%
111.421815331816251818361806921802181811810.39
211.511857201864091860640.27
单位质量响应值RSD%判断
15865.2416165.421.33数据可信
供试品溶液-2025021421批-阿托伐他汀钙-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min130547-3054715.78915.352.7715.7915.342.77
230788-3078815.91415.91
329640-2964015.32115.32
429429-2942915.21215.21
528957-2895714.96814.97
628776-2877614.87414.87
10min150425-5042526.06425.414.5526.0925.444.55
251540-5154026.64026.67
348300-4830024.96624.99
450767-5076726.24126.27
548553-4855325.09625.12
645413-4541323.47323.50
15min164171-6417133.16933.304.3733.2433.364.36
265379-6537933.79433.86
363597-6359732.87332.94
468838-6883835.58235.65
564378-6437833.27633.34
660146-6014631.08931.15
20min171861-7186137.14438.275.0437.2738.395.04
272893-7289337.67837.80
374668-7466838.59538.72
480873-8087341.80241.93
573936-7393638.21738.34
669992-6999236.17836.29
30min183332-8333243.07345.455.9643.2645.645.96
284965-8496543.91744.11
389065-8906546.03746.22
497501-9750150.39750.60
588509-8850945.74945.94
684173-8417343.50843.68
45min194578-9457848.88652.105.9049.1452.365.89
295928-9592849.58449.85
3103814-10381453.66053.92
4110616-11061657.17657.46
5101830-10183052.63552.90
698039-9803950.67550.92
极限1103033-10303353.25757.496.1653.6057.846.15
2105555-10555554.56054.91
3114440-11444059.15359.51
4122220-12222063.17463.55
5112518-11251858.15958.51
6109621-10962156.66256.99
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