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%
114.799118991120911209120690857910980.16
214.829221191683919470.41
单位质量响应值RSD%判断
6159.436204.250.52数据可信
长期12月-供试品溶液-2025021521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%
5min145308-4530847.51247.2814.3147.5147.2814.31
250670-5067053.13553.14
332692-3269234.28334.28
449607-4960752.02052.02
546674-4667448.94548.94
645571-4557147.78847.79
10min175509-7550979.18376.976.3679.2677.046.37
276569-7656980.29480.38
364686-6468667.83367.89
476808-7680880.54580.63
575242-7524278.90378.98
671563-7156375.04575.12
15min186698-8669890.91688.823.9291.1389.033.93
285834-8583490.01090.23
378279-7827982.08782.26
487181-8718191.42291.64
586101-8610190.29090.50
684132-8413288.22588.43
20min191955-9195596.42994.312.9396.7994.662.94
288416-8841692.71893.09
386034-8603490.22090.53
492809-9280997.32497.70
591697-9169796.15896.52
688688-8868893.00393.35
30min195214-9521499.84697.013.84100.3797.523.84
288401-8840192.70293.23
388379-8837992.67993.14
497067-97067101.789102.32
592459-9245996.95797.48
693532-9353298.08298.59
45min195449-95449100.09399.952.47100.78100.622.47
292878-9287897.39798.08
393371-9337197.91498.53
499525-99525104.367105.07
595550-95550100.199100.88
695116-9511699.744100.41
极限195913-95913100.579100.041.40101.44100.881.41
293235-9323597.77198.61
395311-9531199.948100.72
497376-97376102.113102.99
595253-9525399.887100.74
695288-9528899.924100.76
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%
111.821829041822751824551826511825491825670.13
211.881854321844491849400.38
单位质量响应值RSD%判断
15445.6015567.340.56数据可信
长期12月-供试品溶液-2025021521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%
5min1100076-10007653.42250.6412.3853.4250.6412.38
2102550-10255054.74254.74
371339-7133938.08238.08
497241-9724151.90851.91
5101231-10123154.03854.04
696785-9678551.66551.66
10min1139452-13945274.44172.726.1774.5372.806.18
2141118-14111875.33075.42
3119422-11942263.74963.81
4138983-13898374.19174.28
5141570-14157075.57275.66
6136801-13680173.02673.11
15min1160252-16025285.54484.033.8785.7684.243.89
2158071-15807184.38084.60
3145694-14569477.77377.94
4160967-16096785.92686.14
5162592-16259286.79487.01
6156918-15691883.76583.97
20min1170913-17091391.23589.732.7591.5990.082.76
2166379-16637988.81589.17
3159874-15987485.34385.64
4171775-17177591.69692.05
5171841-17184191.73192.09
6167804-16780489.57689.92
30min1177614-17761494.81293.772.2795.3294.262.28
2173158-17315892.43492.94
3169157-16915790.29890.74
4180570-18057096.39096.90
5177043-17704394.50895.02
6176371-17637194.14994.65
45min1181232-18123296.74495.791.4797.4196.441.49
2177218-17721894.60195.26
3175692-17569293.78694.38
4182929-18292997.65098.32
5179879-17987996.02296.69
6179720-17972095.93796.59
极限1183511-18351197.96097.041.3498.7997.851.35
2179572-17957295.85896.67
3178078-17807895.06095.81
4184326-18432698.39599.22
5182432-18243297.38498.22
6182751-18275197.55598.37
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%
114.799171992021919079165691907918420.17
214.829230992773925410.36
单位质量响应值RSD%判断
6209.746244.330.40数据可信
长期12月-供试品溶液-2025021521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%
5min137098-3709838.62045.3113.9338.6245.3113.94
247749-4774949.70849.71
349894-4989451.94151.94
443686-4368645.47945.48
547458-4745849.40549.41
635248-3524836.69436.69
10min166349-6634969.07276.105.7169.1476.175.72
270838-7083873.74573.83
378041-7804181.24381.33
473905-7390576.93877.01
576467-7646779.60579.69
672979-7297975.97476.03
15min179518-7951882.78187.494.1882.9687.694.18
281026-8102684.35184.56
389442-8944293.11293.33
485347-8534788.84989.05
585093-8509388.58588.80
683811-8381187.25087.44
20min186458-8645890.00692.453.2990.3292.793.29
286403-8640389.94990.29
393719-9371997.56597.94
490259-9025993.96394.31
589336-8933693.00293.36
686648-8664890.20490.54
30min192113-9211395.89396.512.1996.3697.012.20
290712-9071294.43494.93
396621-96621100.586101.13
492605-9260596.40596.91
591978-9197895.75296.27
692205-9220595.98996.47
45min195480-9548099.39897.772.71100.0398.442.71
289677-8967793.35794.01
397214-97214101.203101.91
494459-9445998.33599.00
593581-9358197.42198.10
693106-9310696.92797.57
极限195107-9510799.01097.962.6099.8098.792.60
292583-9258396.38297.19
398000-98000102.021102.90
494437-9443798.31299.15
593685-9368597.52998.37
690788-9078894.51395.32
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%
111.821851161848111846551843051848321847440.17
211.881857831860121858980.09
单位质量响应值RSD%判断
15629.7815647.980.09数据可信
长期12月-供试品溶液-2025021521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%
5min175424-7542439.92149.5111.9139.9249.5111.91
2106705-10670556.47756.48
399498-9949852.66352.66
490414-9041447.85547.85
5100546-10054653.21753.22
688639-8863946.91546.92
10min1118515-11851562.72872.286.8262.7972.366.82
2143872-14387276.14976.24
3140233-14023374.22374.31
4136235-13623572.10772.19
5142765-14276575.56375.65
6137732-13773272.89972.98
15min1143998-14399876.21683.694.4776.3983.904.48
2161819-16181985.64885.87
3162307-16230785.90786.12
4159503-15950384.42284.62
5162143-16214385.82086.03
6158976-15897684.14384.34
20min1158193-15819383.72989.183.1384.0389.523.14
2172803-17280391.46291.83
3171516-17151690.78191.14
4169192-16919289.55189.89
5170448-17044890.21590.57
6168819-16881989.35389.69
30min1168888-16888889.39093.232.1489.8393.722.16
2179345-17934594.92495.44
3178672-17867294.56895.07
4176283-17628393.30493.79
5177436-17743693.91494.42
6176289-17628993.30793.80
45min1173675-17367591.92395.051.6592.5195.701.67
2181610-18161096.12396.80
3180887-18088795.74196.40
4180292-18029295.42696.07
5181104-18110495.85596.52
6179974-17997495.25795.90
极限1175662-17566292.97595.521.5493.7196.331.56
2184072-18407297.42698.26
3181345-18134595.98396.81
4180404-18040495.48596.29
5181454-18145496.04196.87
6179896-17989695.21696.02
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%
114.799226192060921349213792147921480.08
214.829224692603924240.28
单位质量响应值RSD%判断
6230.436236.440.07数据可信
中间条件12月-供试品溶液-2025021521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%
5min153228-5322855.35553.0210.4455.3553.0210.44
242398-4239844.09244.09
353327-5332755.45855.46
453777-5377755.92655.93
546646-4664648.51048.51
656515-5651558.77358.77
10min175978-7597879.01477.155.5379.1177.245.53
270688-7068873.51373.59
377221-7722180.30780.40
473534-7353476.47276.57
568424-6842471.15871.24
679255-7925582.42282.52
15min183912-8391287.26587.573.0287.4987.793.02
283015-8301586.33286.53
385545-8554588.96389.19
486346-8634689.79690.02
579866-7986683.05783.26
686534-8653489.99290.23
20min184300-8430087.66993.103.8788.0493.463.86
289896-8989693.48893.83
394427-9442798.20098.57
490284-9028493.89294.26
587188-8718890.67291.01
691018-9101894.65595.04
30min193865-9386597.61696.983.5298.1397.503.51
294991-9499198.78799.28
398156-98156102.078102.62
489227-8922792.79293.32
590091-9009193.69194.18
693182-9318296.90597.45
45min195146-9514698.94898.603.4599.6399.283.43
296239-96239100.085100.74
398665-98665102.608103.32
488799-8879992.34793.03
594853-9485398.64399.29
695173-9517398.97699.68
极限195682-9568299.50599.591.84100.35100.441.84
295504-9550499.320100.15
398951-98951102.905103.78
494110-9411097.87198.71
594236-9423698.00298.81
696106-9610699.946100.82
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%
111.821868281858691868211867981865121865660.23
211.881863421872271867840.34
单位质量响应值RSD%判断
15783.9315722.560.28数据可信
中间条件12月-供试品溶液-2025021521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%
5min1104575-10457554.94852.0810.7954.9552.0810.79
284584-8458444.44444.44
3104020-10402054.65754.66
4106356-10635655.88455.88
586429-8642945.41445.41
6108774-10877457.15557.15
10min1146737-14673777.10274.596.7977.1974.686.79
2133252-13325270.01670.09
3148712-14871278.14078.23
4145904-14590476.66476.76
5126714-12671466.58166.66
6150442-15044279.04979.14
15min1165312-16531286.86285.294.7787.0885.504.77
2157953-15795382.99583.19
3169149-16914988.87889.10
4164955-16495586.67586.90
5148676-14867678.12178.31
6167877-16787788.21088.44
20min1173766-17376691.30490.323.5591.6790.683.57
2170153-17015389.40689.73
3178109-17810993.58693.96
4172180-17218090.47190.84
5160882-16088284.53484.85
6176317-17631792.64593.02
30min1180368-18036894.77394.061.9495.2994.571.96
2178379-17837993.72894.21
3183432-18343296.38396.91
4177900-17790093.47693.99
5173203-17320391.00891.47
6180837-18083795.02095.55
45min1182387-18238795.83495.351.7496.5196.011.76
2181545-18154595.39296.03
3186107-18610797.78998.47
4179521-17952194.32895.00
5176732-17673292.86393.47
6182529-18252995.90996.60
极限1183620-18362096.48295.631.5697.3296.451.57
2182111-18211195.68996.48
3185817-18581797.63698.49
4179602-17960294.37195.20
5177969-17796993.51394.28
6182895-18289596.10196.95
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%
114.799214991819922979249692378922280.29
214.829277492315925440.36
单位质量响应值RSD%判断
6235.846244.530.10数据可信
中间条件12月-供试品溶液-2025021521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%
5min152145-5214554.17054.614.6854.1754.614.69
254118-5411856.22056.22
349403-4940351.32251.32
456341-5634158.52958.53
552686-5268654.73254.73
650722-5072252.69252.69
10min169719-6971972.42676.874.5172.5276.964.50
276508-7650879.47979.57
370941-7094173.69673.78
478162-7816281.19781.29
575726-7572678.66778.76
672895-7289575.72675.81
15min181354-8135484.51387.484.0084.7287.704.00
284783-8478388.07588.30
380037-8003783.14583.35
489690-8969093.17393.41
584485-8448587.76687.99
684921-8492188.21988.43
20min185751-8575189.08192.313.3589.4392.683.35
289016-8901692.47392.85
385850-8585089.18489.53
493204-9320496.82397.21
588059-8805991.47991.85
691285-9128594.83095.19
30min189294-8929492.76295.473.4393.2695.993.42
288855-8885592.30692.83
390714-9071494.23794.73
497322-97322101.101101.65
591716-9171695.27895.80
693500-9350097.13197.65
45min191183-9118394.72497.122.8595.3897.802.85
292577-9257796.17296.85
391535-9153595.09095.74
498285-98285102.102102.82
592600-9260096.19696.88
694758-9475898.43899.12
极限191049-9104994.58597.252.6495.4098.092.65
292644-9264496.24297.08
392411-9241196.00096.81
498045-98045101.852102.74
592794-9279496.39897.24
694728-9472898.40799.25
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%
111.821856381857471864621867701868171862870.31
211.881881191873001877100.31
单位质量响应值RSD%判断
15760.3215800.510.19数据可信
中间条件12月-供试品溶液-2025021521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%
5min198873-9887351.86352.343.5151.8652.343.52
2100297-10029752.61052.61
393955-9395549.28349.28
4102674-10267453.85653.86
5103921-10392154.51054.51
698941-9894151.89851.90
10min1136201-13620171.44373.364.0171.5373.444.01
2139937-13993773.40273.49
3131027-13102768.72968.81
4143748-14374875.40175.49
5146801-14680177.00377.09
6141401-14140174.17074.26
15min1155250-15525081.43483.103.4081.6483.313.40
2156649-15664982.16882.38
3149986-14998678.67378.87
4162853-16285385.42385.64
5163159-16315985.58385.80
6162687-16268785.33585.55
20min1163312-16331285.66387.343.1786.0087.683.17
2164706-16470686.39586.74
3158306-15830683.03783.37
4170710-17071089.54489.90
5170419-17041989.39189.75
6171542-17154289.98090.33
30min1168118-16811888.18490.392.9588.6790.882.95
2169766-16976689.04989.54
3165710-16571086.92187.39
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6177620-17762093.16893.67
45min1169891-16989189.11491.412.7589.7592.062.75
2172090-17209090.26890.91
3168207-16820788.23188.84
4178294-17829493.52294.18
5178096-17809693.41894.08
6179068-17906893.92894.59
极限1170315-17031589.33792.072.5090.1292.862.50
2172376-17237690.41891.21
3172299-17229990.37791.14
4178562-17856293.66394.48
5178538-17853893.65094.47
6181033-18103394.95995.77
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