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%
115.089460494346943669469194550945110.16
215.059466794774947200.08
单位质量响应值RSD%判断
6267.316293.690.30数据可信
长期6月-供试品溶液-2025021321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%
5min150221-5022151.83752.917.2551.8452.917.25
244468-4446845.89945.90
352905-5290554.60754.61
454886-5488656.65256.65
553706-5370655.43455.43
651388-5138853.04153.04
10min173642-7364276.01177.814.7776.1077.904.77
269585-6958571.82471.90
379675-7967582.23882.33
478251-7825180.76880.86
576329-7632978.78478.88
674817-7481777.22477.31
15min183531-8353186.21886.573.4386.4386.793.44
279482-7948282.03982.24
388031-8803190.86391.09
484851-8485187.58187.81
585021-8502187.75687.98
682323-8232384.97185.19
20min188615-8861591.46690.773.0791.8291.133.07
284820-8482087.54987.88
392699-9269995.68196.06
486411-8641189.19189.57
586854-8685489.64890.02
688224-8822491.06291.42
30min191722-9172294.67394.053.4195.1894.563.40
287278-8727890.08690.56
396385-9638599.486100.02
488915-8891591.77592.30
591605-9160594.55295.07
690791-9079193.71294.22
45min190521-9052193.43394.093.0994.1094.763.09
289355-8935592.23092.86
396463-9646399.566100.27
488733-8873391.58892.26
589991-8999192.88693.56
691877-9187794.83395.50
极限192562-9256295.54095.292.8496.3696.122.84
289403-8940392.27993.06
396515-9651599.620100.49
489617-8961792.50093.33
593112-9311296.10796.94
692712-9271295.69596.52
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%
111.871807121813031812061808731805681809320.18
211.851822771826401824580.15
单位质量响应值RSD%判断
15242.8015397.300.72数据可信
长期6月-供试品溶液-2025021321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%
5min1101191-10119154.67554.365.7854.6754.365.78
291821-9182149.61249.61
3103129-10312955.72255.72
4109326-10932659.07059.07
597650-9765052.76252.76
6100504-10050454.30454.30
10min1143672-14367277.62876.643.9577.7276.733.95
2135289-13528973.09873.18
3147209-14720979.53979.63
4147745-14774579.82979.93
5135043-13504372.96573.05
6142071-14207176.76376.85
15min1162985-16298588.06386.503.3688.2886.723.36
2154253-15425383.34583.55
3166560-16656089.99590.22
4162987-16298788.06488.30
5152933-15293382.63282.84
6160797-16079786.88187.10
20min1172195-17219593.03991.503.3893.4191.873.38
2164064-16406488.64688.99
3175791-17579194.98295.36
4169403-16940391.53191.91
5161108-16110887.04987.40
6173549-17354993.77194.13
30min1179059-17905996.74894.613.2497.2795.133.24
2172252-17225293.07093.56
3182661-18266198.69499.23
4173492-17349293.74094.27
5166472-16647289.94790.44
6176726-17672695.48796.01
45min1180614-18061497.58895.523.0698.2796.203.06
2174861-17486194.48095.13
3184048-18404899.444100.14
4174602-17460294.34095.03
5168510-16851091.04891.69
6178103-17810396.23196.91
极限1180950-18095097.77095.743.0698.6296.573.06
2174959-17495994.53395.34
3184625-18462599.755100.62
4174740-17474094.41495.26
5169199-16919991.42092.21
6178669-17866996.53797.38
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%
115.089463494452945309468594871946340.17
215.059541895476954470.05
单位质量响应值RSD%判断
6275.466341.990.75数据可信
长期6月-供试品溶液-2025021321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%
5min147760-4776049.07748.797.6849.0848.807.69
246531-4653147.81447.81
342673-4267343.85043.85
444744-4474445.97845.98
552297-5229753.73953.74
650903-5090352.30752.31
10min174725-7472576.78673.696.7276.8773.786.72
274507-7450776.56276.64
365660-6566067.47167.54
465366-6536667.16867.25
575483-7548377.56477.65
674557-7455776.61376.70
15min183520-8352085.82383.595.8186.0383.795.81
286057-8605788.43088.64
377707-7770779.85080.04
473722-7372275.75575.94
584883-8488387.22487.44
682186-8218684.45284.67
20min187903-8790390.32788.485.2190.6888.825.21
292024-9202494.56294.92
383402-8340285.70286.02
479030-7903081.20981.52
588296-8829690.73191.09
685983-8598388.35488.71
30min191390-9139093.91092.104.6694.4192.594.66
296025-9602598.67399.19
387983-8798390.40990.87
483370-8337085.66986.12
590246-9024692.73593.25
688737-8873791.18491.69
45min188520-8852090.96193.494.3691.6294.144.36
297442-97442100.129100.81
390451-9045192.94593.56
485676-8567688.03988.63
592395-9239594.94395.61
691425-9142593.94694.60
极限194768-9476897.38194.583.3198.1995.383.32
295542-9554298.17799.02
391651-9165194.17894.95
486975-8697589.37390.11
592106-9210694.64695.47
691196-9119693.71194.52
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%
111.871812491811091809711813691812511811900.09
211.851819651820091819870.02
单位质量响应值RSD%判断
15264.5315357.550.43数据可信
长期6月-供试品溶液-2025021321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%
5min194575-9457551.12950.786.0851.1350.786.07
290944-9094449.16649.17
387782-8778247.45747.46
489298-8929848.27648.28
5102537-10253755.43455.43
698403-9840353.19953.20
10min1139647-13964775.49673.285.7875.5873.365.78
2139664-13966475.50575.59
3128114-12811469.26169.34
4123827-12382766.94467.02
5144244-14424477.98178.07
6137741-13774174.46674.55
15min1159282-15928286.11183.755.7886.3283.955.77
2163044-16304488.14588.35
3149796-14979680.98381.18
4139854-13985475.60875.80
5162749-16274987.98688.21
6154723-15472383.64783.86
20min1169645-16964591.71489.255.1992.0789.605.19
2173613-17361393.85994.21
3162035-16203587.60087.93
4150167-15016781.18481.50
5171362-17136292.64293.01
6163739-16373988.52188.87
30min1176369-17636995.34993.444.6195.8693.944.61
2182299-18229998.55599.07
3171799-17179992.87893.35
4159191-15919186.06286.52
5177315-17731595.86096.38
6170089-17008991.95492.45
45min1177671-17767196.05395.233.8296.7295.883.83
2184861-18486199.940100.62
3177354-17735495.88196.51
4164554-16455488.96189.56
5178682-17868296.59997.28
6173771-17377193.94494.60
极限1183633-18363399.27696.633.63100.1097.443.63
2184832-18483299.924100.77
3182281-18228198.54599.34
4167613-16761390.61591.36
5178837-17883796.68397.53
6175223-17522394.72995.54
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%
115.089485094832948149500794924948850.09
215.059390693735938200.13
单位质量响应值RSD%判断
6292.116233.890.66数据可信
长期6月-供试品溶液-2025021421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%
5min152959-5295954.81652.717.0354.8252.717.03
246031-4603147.64547.65
353013-5301354.87254.87
450992-5099252.78052.78
555233-5523357.17057.17
647319-4731948.97948.98
10min176089-7608978.75876.533.3978.8576.623.39
272950-7295075.50875.59
373203-7320375.77075.86
470613-7061373.09073.18
577601-7760180.32380.42
673155-7315575.72175.80
15min185275-8527588.26687.183.3288.4987.393.32
286091-8609189.11089.32
384350-8435087.30887.53
479253-7925382.03382.24
587151-8715190.20890.44
683218-8321886.13786.34
20min190474-9047493.64791.334.7294.0291.694.71
290653-9065393.83294.19
388274-8827491.37091.73
480019-8001982.82583.17
590965-9096594.15594.53
689050-8905092.17392.52
30min192292-9229295.52993.763.0296.0594.273.01
291666-9166694.88195.39
390254-9025493.41993.93
485212-8521288.20188.69
592001-9200195.22895.76
692070-9207095.29995.80
45min193818-9381897.10895.203.6497.7995.873.63
296101-9610199.471100.14
390587-9058793.76494.44
486247-8624789.27289.90
592575-9257595.82296.52
692513-9251395.75896.42
极限193889-9388997.18296.571.6298.0397.401.62
295206-9520698.54599.38
391005-9100594.19795.02
492125-9212595.35696.14
594157-9415797.45998.31
693431-9343196.70897.53
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%
111.871832551833331832351833581831901832740.04
211.851798401798691798540.02
单位质量响应值RSD%判断
15440.1015177.551.22数据可信
长期6月-供试品溶液-2025021421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%
5min1106351-10635157.50854.755.8757.5154.755.87
290488-9048848.93048.93
3102235-10223555.28255.28
4103610-10361056.02656.03
5105976-10597657.30557.30
698875-9887553.46553.47
10min1148693-14869380.40477.353.2180.5077.443.21
2136820-13682073.98374.06
3142995-14299577.32277.41
4138673-13867374.98575.08
5144378-14437878.07078.17
6146707-14670779.33079.42
15min1169005-16900591.38788.302.9291.6288.522.91
2163059-16305988.17288.38
3161574-16157487.36987.59
4155602-15560284.13984.36
5162996-16299688.13888.36
6167550-16755090.60090.82
20min1177973-17797396.23692.953.8196.6293.313.80
2171299-17129992.62792.98
3169142-16914291.46191.83
4161554-16155487.35887.72
5171577-17157792.77893.15
6179775-17977597.21197.58
30min1183193-18319399.05996.163.8999.6096.693.88
2180087-18008797.37997.89
3174071-17407194.12694.65
4167020-16702090.31490.82
5176352-17635295.36095.89
6186289-186289100.733101.27
45min1184844-18484499.95297.073.96100.6697.753.95
2181907-18190798.36399.03
3175537-17553794.91995.59
4168580-16858091.15791.81
5177787-17778796.13696.82
6188413-188413101.881102.58
极限1184687-18468799.86798.662.79100.7499.502.77
2181935-18193598.37999.21
3175563-17556394.93395.77
4185311-185311100.204101.01
5177887-17788796.19097.04
6189306-189306102.364103.24
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%
115.089438794462946879467994571945570.14
215.059590995882958960.02
单位质量响应值RSD%判断
6270.366371.831.14数据可信
长期6月-供试品溶液-2025021421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%
5min155178-5517856.59153.673.4156.5953.673.42
252896-5289654.25054.25
351378-5137852.69352.69
452291-5229153.63053.63
549770-4977051.04451.04
652459-5245953.80253.80
10min178096-7809680.09576.723.5180.1976.803.50
273431-7343175.31175.40
377736-7773679.72679.81
473356-7335675.23475.32
574683-7468376.59576.68
671505-7150573.33673.43
15min185302-8530287.48685.633.3087.7185.843.30
281810-8181083.90584.12
387548-8754889.78990.01
482044-8204484.14584.36
584290-8429086.44886.66
679941-7994181.98882.20
20min189714-8971492.01190.643.1092.3891.003.10
285506-8550687.69588.05
391902-9190294.25594.63
488011-8801190.26490.62
590155-9015592.46392.82
684947-8494787.12287.47
30min193323-9332395.71293.333.1896.2493.843.17
288873-8887391.14891.65
394494-9449496.91397.44
488286-8828690.54691.05
592942-9294295.32295.83
688107-8810790.36390.86
45min194211-9421196.62393.823.1497.3194.493.14
289185-8918591.46892.12
395609-9560998.05798.75
490411-9041192.72693.38
591175-9117593.50994.18
688300-8830090.56191.21
极限193109-9310995.49394.532.4196.3495.362.41
291337-9133793.67594.48
395145-9514597.58198.43
491277-9127793.61494.42
593423-9342395.81596.64
688748-8874891.02091.82
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%
111.871813281816361813921813611811681813770.10
211.851845521846581846050.05
单位质量响应值RSD%判断
15280.2915578.481.37数据可信
长期6月-供试品溶液-2025021421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%
5min1107135-10713557.48055.743.6657.4855.743.66
2108530-10853058.22958.23
3103607-10360755.58755.59
4101119-10111954.25254.25
598260-9826052.71952.72
6104696-10469656.17256.17
10min1149180-14918080.03877.992.4880.1378.082.48
2146443-14644378.57078.67
3149560-14956080.24280.33
4140930-14093075.61275.70
5142342-14234276.36976.46
6143714-14371477.10677.20
15min1166961-16696189.57887.772.5989.8187.992.58
2163337-16333787.63487.86
3170180-17018091.30591.53
4159748-15974885.70885.92
5161676-16167686.74386.96
6159614-15961485.63685.86
20min1174561-17456193.65692.332.6694.0392.702.66
2171179-17117991.84192.22
3179376-17937696.23996.62
4168559-16855990.43590.79
5172410-17241092.50292.86
6166425-16642589.29089.66
30min1179279-17927996.18795.522.4196.7296.042.40
2176957-17695794.94195.47
3185507-18550799.528100.07
4174067-17406793.39193.90
5178464-17846495.75096.26
6173923-17392393.31393.83
45min1181027-18102797.12596.132.4497.8296.812.44
2178212-17821295.61496.30
3186451-186451100.035100.74
4175555-17555594.18994.85
5179559-17955996.33797.01
6174229-17422993.47794.15
极限1180449-18044996.81596.892.7797.6797.732.76
2186129-18612999.862100.71
3186412-186412100.014100.89
4175520-17552094.17094.99
5180254-18025496.71097.54
6174771-17477193.76894.59
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