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%
1 15.089004690011897668964389463897860.28
2 15.048882388841888320.02
单位质量响应值RSD%判断
5953.985906.380.57数据可信
供试品溶液-24111101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%
5min182035-8203589.67786.122.5289.6886.122.52
277761-7776185.00585.00
378917-7891786.26986.27
478414-7841485.71985.72
579501-7950186.90786.91
676076-7607683.16383.16
10min193019-93019101.68499.031.89101.8399.171.89
289386-8938697.71397.85
391723-91723100.268100.41
490217-9021798.62198.76
590973-9097399.44899.59
688201-8820196.41796.56
15min196038-96038104.985102.532.01105.30102.842.01
292074-92074100.651100.96
395507-95507104.404104.71
493570-93570102.287102.59
594326-94326103.113103.42
691245-9124599.745100.04
20min196911-96911105.939103.452.03106.43103.932.02
292910-92910101.565102.04
396756-96756105.769106.25
493791-93791102.528103.01
595010-95010103.861104.34
692450-92450101.062101.53
30min197493-97493106.575103.982.05107.25104.632.05
293287-93287101.977102.62
397221-97221106.278106.94
494428-94428103.225103.87
595380-95380104.265104.92
692881-92881101.533102.17
45min197138-97138106.187103.751.83107.04104.571.83
293097-93097101.770102.58
396425-96425105.408106.25
494827-94827103.661104.48
595122-95122103.983104.81
692826-92826101.473102.28
极限196318-96318105.291103.091.90106.32104.091.91
292841-92841101.490102.47
396448-96448105.433106.45
493024-93024101.690102.68
594731-94731103.556104.56
692459-92459101.072102.04
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%
1 11.413521473521313509443507463501353512210.26
2 11.483522813523293523050.01
单位质量响应值RSD%判断
30781.8630688.590.22数据可信
供试品溶液-24111101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%
5min1110285-11028529.63928.733.2329.6428.733.23
2109235-10923529.35729.36
3101245-10124527.20927.21
4108100-10810029.05229.05
5108301-10830129.10629.11
6104257-10425728.01928.02
10min1161195-16119543.32142.742.1043.3742.782.11
2159002-15900242.73142.78
3153370-15337041.21841.26
4158989-15898942.72842.78
5163315-16331543.89143.94
6158229-15822942.52442.57
15min1183323-18332349.26849.062.4749.3949.182.46
2181122-18112248.67648.80
3176763-17676347.50547.62
4185451-18545149.84049.96
5189347-18934750.88751.01
6179341-17934148.19748.32
20min1192263-19226351.67051.962.3351.8752.162.33
2191824-19182451.55251.75
3190988-19098851.32851.52
4192700-19270051.78851.99
5202280-20228054.36254.57
6189898-18989851.03551.23
30min1204556-20455654.97454.822.0755.2655.112.06
2200193-20019353.80154.09
3201830-20183054.24154.52
4205961-20596155.35255.64
5211135-21113556.74257.04
6200238-20023853.81354.10
45min1210312-21031256.52156.461.7356.9056.841.73
2206021-20602155.36855.74
3208706-20870656.08956.46
4211829-21182956.92957.31
5216195-21619558.10258.49
6207439-20743955.74956.12
极限1241407-24140764.87864.691.1365.3565.171.12
2237760-23776063.89764.37
3241832-24183264.99265.45
4238340-23834064.05364.53
5245151-24515165.88466.37
6239852-23985264.46064.93
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%
1 15.088840488472884618843088276884090.09
2 15.048880688523886640.23
单位质量响应值RSD%判断
5862.675895.210.40数据可信
供试品溶液-24111102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%
5min175230-7523082.95480.622.7482.9580.622.74
271657-7165779.01479.01
373739-7373981.31081.31
475554-7555483.31283.31
571167-7116778.47478.47
671327-7132778.65178.65
10min189399-8939998.57896.382.2198.7296.522.21
286306-8630695.16795.30
388039-8803997.07897.21
489526-8952698.71898.86
584617-8461793.30593.44
686562-8656295.45095.58
15min189706-8970698.917100.251.7499.22100.541.74
290258-9025899.52599.82
391742-91742101.162101.46
493447-93447103.042103.35
589077-8907798.22398.51
691252-91252100.621100.91
20min194532-94532104.238101.841.95104.71102.311.95
291134-91134100.491100.95
392645-92645102.157102.62
494366-94366104.055104.53
590188-9018899.44899.90
691298-91298100.672101.13
30min194782-94782104.514102.342.03105.15102.972.02
291329-91329100.706101.33
392970-92970102.516103.15
494645-94645104.363105.01
589982-8998299.22199.84
693153-93153102.718103.34
45min194587-94587104.299102.081.98105.11102.881.98
290763-90763100.082100.87
393027-93027102.579103.39
494330-94330104.015104.84
590117-9011799.370100.15
692623-92623102.133102.93
极限193859-93859103.496102.732.03104.49103.712.02
290456-9045699.744100.70
392226-92226101.695102.67
495844-95844105.685106.68
594274-94274103.954104.90
692350-92350101.832102.80
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%
1 11.413504163504043504023504773498583503110.08
2 11.483528783529653529220.02
单位质量响应值RSD%判断
30702.1030742.330.10数据可信
供试品溶液-24111102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%
5min199684-9968426.80125.355.2126.8025.355.21
291516-9151624.60524.61
391323-9132324.55324.55
491819-9181924.68724.69
5101408-10140827.26527.26
690025-9002524.20424.20
10min1143318-14331838.53337.103.9038.5837.143.90
2137503-13750336.96937.01
3133453-13345335.88035.92
4138270-13827037.17537.22
5144578-14457838.87138.92
6130820-13082035.17235.21
15min1148643-14864339.96442.194.3040.0742.304.29
2159709-15970942.94043.04
3154288-15428841.48241.58
4160788-16078843.23043.33
5166800-16680044.84644.96
6151331-15133140.68740.79
20min1177059-17705947.60445.963.6447.7846.133.64
2171051-17105145.98946.16
3162959-16295943.81343.98
4172831-17283146.46846.64
5177484-17748447.71947.90
6164177-16417744.14144.31
30min1189606-18960650.97849.442.7251.2349.692.72
2184741-18474149.67049.92
3178074-17807447.87748.12
4185973-18597350.00150.25
5187445-18744550.39750.66
6177517-17751747.72747.97
45min1202455-20245554.43252.882.3054.7753.212.30
2199215-19921553.56153.89
3191495-19149551.48651.81
4197943-19794353.21953.56
5197861-19786153.19753.55
6191031-19103151.36151.68
极限1232935-23293562.62762.211.7863.0662.641.78
2231370-23137062.20662.63
3224244-22424460.29060.70
4233026-23302662.65263.08
5236575-23657563.60664.04
6230218-23021861.89762.30
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%
1 15.088807387952879648821387983880370.13
2 15.048877888843888100.06
单位质量响应值RSD%判断
5838.005904.920.81数据可信
供试品溶液-24111101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%
5min155395-5539561.16260.312.9961.1660.312.98
254072-5407259.70159.70
355402-5540261.17061.17
456987-5698762.92062.92
552439-5243957.89857.90
653445-5344559.00959.01
10min169554-6955476.79579.304.1576.9079.404.14
268024-6802475.10675.21
375713-7571383.59583.70
472364-7236479.89880.00
570632-7063277.98578.08
674634-7463482.40482.50
15min173360-7336080.99784.254.9281.2384.484.91
271534-7153478.98179.21
380709-8070989.11189.35
476776-7677684.76985.01
574963-7496382.76782.99
680490-8049088.87089.11
20min173907-7390781.60185.154.5881.9785.524.58
272953-7295380.54880.90
381402-8140289.87790.27
477312-7731285.36185.74
576128-7612884.05384.42
681034-8103489.47089.85
30min174326-7432682.06486.185.3382.5686.695.32
273129-7312980.74281.23
382830-8283091.45391.99
477715-7771585.80686.33
577289-7728985.33585.84
683014-8301491.65692.19
45min174909-7490982.70885.815.0483.3586.475.03
272584-7258480.14180.77
381056-8105689.49590.19
477552-7755285.62686.29
576965-7696584.97885.62
683239-8323991.90592.59
极限176082-7608284.00391.427.6784.7892.227.62
287619-8761996.74197.50
389747-8974799.09099.93
478361-7836186.51987.33
576785-7678584.77985.57
688183-8818397.36498.20
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%
1 11.413517883516993511963505343491923508820.31
2 11.483536393539273537830.06
单位质量响应值RSD%判断
30752.1530817.330.15数据可信
供试品溶液-24111101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%
5min1226707-22670760.82961.983.1060.8361.983.10
2224066-22406660.12060.12
3242785-24278565.14365.14
4231760-23176062.18562.18
5225400-22540060.47860.48
6235304-23530463.13663.14
10min1262089-26208970.32273.455.1570.4273.565.15
2257640-25764069.12969.23
3293895-29389578.85678.97
4271706-27170672.90373.01
5270278-27027872.52072.62
6286916-28691676.98477.09
15min1269501-26950172.31175.975.5672.5376.205.55
2264613-26461371.00071.22
3304453-30445381.68981.93
4280726-28072675.32375.55
5280874-28087475.36375.58
6298662-29866280.13680.37
20min1271024-27102472.72076.595.7373.0676.945.73
2266237-26623771.43571.77
3308313-30831382.72583.10
4282964-28296475.92476.27
5283667-28366776.11276.46
6300562-30056280.64581.01
30min1271895-27189572.95476.785.6973.4177.265.68
2267000-26700071.64072.09
3308130-30813082.67683.19
4283258-28325876.00276.48
5284466-28446676.32776.80
6302201-30220181.08581.59
45min1272428-27242873.09776.885.6373.6877.495.62
2267388-26738871.74472.32
3308698-30869882.82883.48
4283713-28371376.12476.73
5285185-28518576.51977.12
6301700-30170080.95181.59
极限1278654-27865474.76782.018.3575.4782.748.30
2324912-32491287.17987.87
3337161-33716190.46591.26
4283544-28354476.07976.81
5286523-28652376.87877.61
6323054-32305486.68087.45
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%
1 15.088846288427884188831188419884070.07
2 15.048843288512884720.07
单位质量响应值RSD%判断
5862.535882.450.24数据可信
供试品溶液-24111102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%
5min153929-5392959.53159.144.9459.5359.144.94
249290-4929054.41054.41
351561-5156156.91756.92
454974-5497460.68560.68
555652-5565261.43361.43
656056-5605661.87961.88
10min169996-6999677.26779.045.4777.3779.145.47
265870-6587072.71372.80
369573-6957376.80076.90
472450-7245079.97680.08
576192-7619284.10784.21
675511-7551183.35583.46
15min174665-7466582.42183.856.9182.6584.086.90
268766-6876675.90976.12
371418-7141878.83779.06
478322-7832286.45886.69
580554-8055488.92289.16
682017-8201790.53790.78
20min176497-7649784.44485.487.0184.8185.857.01
269384-6938476.59276.93
373383-7338381.00681.36
479654-7965487.92988.31
583757-8375792.45892.85
681927-8192790.43890.83
30min175484-7548483.32585.736.6983.8386.246.69
270560-7056077.89078.36
374232-7423281.94382.43
479804-7980488.09488.62
584881-8488193.69994.24
681027-8102789.44489.99
45min176027-7602783.92586.226.8784.5786.876.86
271252-7125278.65479.25
373466-7346681.09881.72
480110-8011088.43289.10
583642-8364292.33193.03
684124-8412492.86393.56
极限187259-8725996.32493.184.9197.1193.984.91
282114-8211490.64491.37
377187-7718785.20585.97
484770-8477093.57694.40
587686-8768696.79597.65
687465-8746596.55197.40
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%
1 11.413526793525933526843522213523343525020.07
2 11.483543853545303544580.03
单位质量响应值RSD%判断
30894.1330876.130.05数据可信
供试品溶液-24111102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%
5min1233808-23380862.53062.842.9862.5362.842.98
2223504-22350459.77559.77
3230915-23091561.75761.76
4242033-24203364.73064.73
5240169-24016964.23164.23
6239257-23925763.98863.99
10min1276616-27661673.97975.524.8874.0875.634.88
2261649-26164969.97670.08
3274410-27441073.38973.49
4291747-29174778.02678.13
5297881-29788179.66679.77
6292035-29203578.10378.21
15min1287066-28706676.77478.495.5477.0078.725.54
2270183-27018372.25872.47
3282326-28232675.50675.73
4302171-30217180.81381.05
5312658-31265883.61883.86
6306460-30646081.96082.20
20min1289466-28946677.41679.095.6477.7779.455.64
2272304-27230472.82673.16
3283837-28383775.91076.26
4303613-30361381.19981.57
5316430-31643084.62785.01
6308679-30867982.55482.93
30min1289868-28986877.52379.505.8478.0179.995.83
2273468-27346873.13773.60
3284788-28478876.16476.64
4304850-30485081.53082.04
5318592-31859285.20585.73
6311908-31190883.41883.93
45min1290354-29035477.65379.495.7878.2780.125.77
2273541-27354173.15773.74
3284738-28473876.15176.76
4304724-30472481.49682.14
5318317-31831785.13285.79
6311667-31166783.35384.00
极限1329785-32978588.19986.654.2288.9487.414.21
2317485-31748584.90985.61
3299252-29925280.03380.76
4335150-33515089.63390.41
5333925-33392589.30690.11
6328429-32842987.83688.62
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