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%
115.399307293253926899301292820929690.24
215.459258092118923490.36
单位质量响应值RSD%判断
6040.875977.280.75数据可信
供试品溶液-GF9440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%
5min176004-7600481.99481.911.7381.9981.901.73
275748-7574881.71881.72
377761-7776183.89083.89
476535-7653582.56782.57
573751-7375179.56479.56
675734-7573481.70381.70
10min190126-9012697.22996.241.3597.3796.371.35
289039-8903996.05796.19
390554-9055497.69197.83
488312-8831295.27295.41
589824-8982496.90497.04
687379-8737994.26694.40
15min194147-94147101.567100.650.93101.87100.940.93
293131-93131100.471100.77
394309-94309101.742102.04
492239-9223999.50999.81
593534-93534100.906101.20
692396-9239699.67899.97
20min194369-94369101.807101.471.18102.27101.931.18
294269-94269101.699102.16
395551-95551103.082103.55
492700-92700100.006100.47
594654-94654102.114102.58
692801-92801100.115100.57
30min194774-94774102.244101.330.99102.88101.960.99
294157-94157101.578102.21
394921-94921102.402103.05
492822-92822100.138100.77
594066-94066101.480102.11
692801-92801100.115100.74
45min193830-93830101.225100.981.07102.03101.781.07
293684-93684101.068101.87
395043-95043102.534103.35
492406-9240699.689100.48
594130-94130101.549102.35
692530-9253099.823100.62
极限193814-93814101.208100.371.04102.18101.341.04
293189-93189100.534101.50
394005-94005101.414102.40
491820-9182099.057100.02
593546-93546100.919101.89
691873-9187399.114100.07
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%
111.331743341750611739021740521740171742730.27
211.301747131738241742680.37
单位质量响应值RSD%判断
15381.5515421.950.19数据可信
供试品溶液-GF9440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%
5min123238-2323812.46312.365.7512.4612.365.74
222403-2240312.01512.01
322813-2281312.23512.23
425517-2551713.68513.68
521611-2161111.59011.59
622721-2272112.18512.19
10min155278-5527829.64628.354.9229.6728.384.93
251923-5192327.84627.87
353511-5351128.69828.72
456227-5622730.15530.18
550646-5064627.16227.18
649633-4963326.61826.64
15min176067-7606740.79539.393.1840.8739.463.19
272344-7234438.79838.86
374712-7471240.06840.14
475664-7566440.57940.65
571015-7101538.08638.15
670858-7085838.00138.07
20min188139-8813947.26947.001.4447.4147.141.45
287430-8743046.88947.02
388029-8802947.21047.35
489610-8961048.05848.20
586605-8660546.44746.57
686056-8605646.15246.28
30min1105006-10500656.31555.491.3256.5355.701.33
2104380-10438055.97956.19
3102770-10277055.11655.33
4104529-10452956.05956.28
5101523-10152354.44754.65
6102641-10264155.04755.25
45min1115206-11520661.78562.391.0562.1062.691.04
2117761-11776163.15663.46
3116528-11652862.49462.80
4116911-11691162.70063.01
5114543-11454361.43061.73
6117019-11701962.75863.05
极限1126355-12635567.76567.470.7168.1867.880.71
2125997-12599767.57367.98
3124429-12442966.73267.14
4126887-12688768.05068.47
5125127-12512767.10667.50
6126007-12600767.57867.98
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%
115.399275392312921159251092321924020.27
215.459151991249913840.21
单位质量响应值RSD%判断
6004.035914.821.06数据可信
供试品溶液-LC1771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%
5min173180-7318079.60880.371.7979.6180.371.79
271794-7179478.10078.10
373652-7365280.12180.12
475612-7561282.25382.25
574493-7449381.03681.04
674562-7456281.11181.11
10min189291-8929197.13497.141.6897.2797.281.68
288947-8894796.76096.89
388176-8817695.92196.05
492226-92226100.327100.46
588880-8888096.68796.82
688271-8827196.02496.16
15min192969-92969101.135101.361.50101.43101.661.50
293115-93115101.294101.59
392307-92307100.415100.71
495942-95942104.369104.67
592426-92426100.544100.84
692310-92310100.418100.71
20min193242-93242101.432101.851.67101.90102.321.66
293687-93687101.916102.38
392662-92662100.801101.26
496689-96689105.182105.66
592891-92891101.050101.51
692581-92581100.713101.18
30min193231-93231101.420101.441.41102.05102.081.41
293165-93165101.348101.98
392199-92199100.297100.93
495767-95767104.179104.83
592852-92852101.008101.64
692283-92283100.389101.02
45min192568-92568100.699101.101.45101.50101.901.45
292993-92993101.161101.96
392270-92270100.375101.17
495556-95556103.949104.78
592440-92440100.560101.36
691780-9178099.842100.64
极限192735-92735100.880100.651.74101.85101.631.74
292845-92845101.000101.97
391409-9140999.438100.40
495387-95387103.765104.77
591990-91990100.070101.04
690787-9078798.76199.73
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%
111.331742531738061734781744101740711740040.22
211.301744601739771742180.20
单位质量响应值RSD%判断
15357.8115417.520.28数据可信
供试品溶液-LC1771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%
5min124331-2433113.06113.767.5813.0613.767.60
223887-2388712.82212.82
325214-2521413.53513.53
424618-2461813.21513.21
526670-2667014.31614.32
629073-2907315.60615.61
10min149976-4997626.82726.702.1126.8526.732.11
248959-4895926.28126.30
348016-4801625.77525.80
450382-5038227.04527.07
550471-5047127.09327.12
650679-5067927.20427.23
15min171415-7141538.33538.511.9938.4038.581.99
269739-6973937.43637.50
370710-7071037.95738.02
473715-7371539.57039.64
572628-7262838.98639.06
672230-7223038.77338.84
20min186177-8617746.25946.982.5546.3947.112.55
284233-8423345.21645.34
387422-8742246.92847.06
490771-9077148.72548.86
588736-8873647.63347.77
687750-8775047.10447.24
30min1103307-10330755.45556.723.3455.6656.933.33
2100794-10079454.10654.31
3107813-10781357.87458.08
4109514-10951458.78759.00
5108793-10879358.40058.61
6103756-10375655.69655.91
45min1115395-11539561.94462.942.9162.2463.242.90
2115585-11558562.04662.34
3115831-11583162.17862.48
4120332-12033264.59464.91
5122560-12256065.79066.10
6113765-11376561.06961.38
极限1123086-12308666.07267.122.5166.4867.522.50
2124641-12464166.90767.30
3124075-12407566.60367.01
4128432-12843268.94269.36
5129005-12900569.24969.67
6120946-12094664.92365.33
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%
115.399052090074899458983590150901050.30
215.458889188777888340.10
单位质量响应值RSD%判断
5854.785749.771.28数据可信
供试品溶液-LA6362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%
5min162697-6269770.05366.389.9570.0566.389.95
263965-6396571.47071.47
356617-5661763.26063.26
465135-6513572.77772.78
558695-5869565.58265.58
649325-4932555.11255.11
10min182863-8286392.58592.921.3892.7093.021.39
284874-8487494.83294.95
383310-8331093.08593.19
483684-8368493.50293.62
582824-8282492.54292.65
681402-8140290.95391.04
15min187741-8774198.03599.181.0998.3199.441.09
289901-89901100.449100.73
389611-89611100.125100.39
489145-8914599.60499.88
588577-8857798.97099.23
687598-8759897.87698.12
20min188380-8838098.749100.621.0299.18101.051.02
290503-90503101.122101.57
390896-90896101.561101.99
490637-90637101.271101.71
589698-89698100.222100.65
690189-90189100.771101.18
30min188600-8860098.995100.921.1099.59101.521.10
291342-91342102.059102.67
391030-91030101.710102.31
490804-90804101.458102.07
590056-90056100.622101.22
690104-90104100.676101.25
45min188777-8877799.193100.781.0299.96101.551.02
291385-91385102.107102.89
390951-90951101.622102.39
490255-90255100.844101.63
589990-89990100.548101.31
689842-89842100.383101.13
极限188425-8842598.800100.260.8499.73101.200.84
290677-90677101.316102.27
390063-90063100.630101.57
490002-90002100.562101.51
589528-89528100.032100.96
689717-89717100.243101.15
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%
111.333521713505313497233495893507353505500.30
211.303471293468983470140.05
单位质量响应值RSD%判断
30939.9830709.200.53数据可信
供试品溶液-LA6362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%
5min148268-4826812.93411.5712.1412.9311.5712.15
245061-4506112.07512.08
339611-3961110.61510.61
446952-4695212.58212.58
544902-4490212.03212.03
634349-343499.2059.20
10min1105658-10565828.31326.625.4128.3326.635.42
2102896-10289627.57327.59
397752-9775226.19526.21
499967-9996726.78826.81
599744-9974426.72926.75
689923-8992324.09724.11
15min1145960-14596039.11337.703.1639.1837.763.17
2142048-14204838.06538.13
3141193-14119337.83637.90
4140765-14076537.72137.79
5141703-14170337.97238.04
6132451-13245135.49335.55
20min1166968-16696844.74344.591.7144.8844.721.71
2168922-16892245.26645.40
3166460-16646044.60744.73
4166702-16670244.67144.80
5168433-16843345.13545.26
6160990-16099043.14143.26
30min1183912-18391249.28350.272.0249.4950.472.02
2187736-18773650.30850.51
3189232-18923250.70950.91
4185747-18574749.77549.98
5194180-19418052.03552.24
6184676-18467649.48849.67
45min1194708-19470852.17654.893.8052.4755.173.78
2206523-20652355.34255.63
3208492-20849255.87056.15
4202988-20298854.39554.68
5217007-21700758.15258.44
6199247-19924753.39353.66
极限1217553-21755358.29859.991.9558.6860.371.95
2224082-22408260.04860.43
3226670-22667060.74161.12
4224298-22429860.10660.48
5229921-22992161.61262.00
6220657-22065759.13059.49
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