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%
115.109227992060920079174891571919330.31
215.009007090245901580.14
单位质量响应值RSD%判断
6088.286010.530.91数据可信
供试品溶液-2025010721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%
5min156514-5651460.56368.876.0660.5668.876.07
265124-6512469.78969.79
366305-6630571.05571.06
467089-6708971.89571.90
565916-6591670.63870.64
664657-6465769.28969.29
10min181930-8193087.79988.521.6187.9088.631.61
283746-8374689.74589.86
384173-8417390.20390.32
483177-8317789.13689.26
581926-8192687.79587.91
680660-8066086.43886.55
15min190200-9020096.66296.600.6796.9196.860.67
290653-9065397.14797.41
390448-9044896.92897.20
490340-9034096.81297.08
590271-9027196.73897.00
688955-8895595.32895.59
20min192821-9282199.47199.060.5899.8899.480.58
292933-9293399.591100.02
392533-9253399.16299.59
492399-9239999.01899.45
592512-9251299.13999.56
691433-9143397.98398.40
30min193964-93964100.695100.300.79101.27100.890.78
294511-94511101.282101.88
392549-9254999.17999.77
493720-93720100.434101.03
593926-93926100.655101.25
692903-9290399.558100.14
45min194475-94475101.243100.780.54101.99101.540.53
294445-94445101.211101.97
393658-93658100.368101.13
493919-93919100.647101.41
594467-94467101.235101.99
693296-9329699.980100.73
极限193846-93846100.569100.520.33101.48101.450.33
294129-94129100.872101.80
393684-93684100.395101.32
493662-93662100.372101.30
594144-94144100.888101.82
693354-93354100.042100.96
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%
111.583596123588673585403574243583833585650.23
211.663563753567973565860.09
单位质量响应值RSD%判断
30964.1630581.990.88数据可信
供试品溶液-2025010721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%
5min145340-4534012.17015.229.9512.1715.229.95
258124-5812415.60215.60
359307-5930715.92015.92
459826-5982616.05916.06
557707-5770715.49015.49
659889-5988916.07616.08
10min199506-9950626.71028.634.4626.7328.664.46
2109587-10958729.41629.44
3110022-11002229.53329.56
4112107-11210730.09330.12
5105360-10536028.28128.31
6103443-10344327.76727.79
15min1134822-13482236.19037.683.6736.2537.763.68
2142207-14220738.17238.25
3144576-14457638.80838.88
4147296-14729639.53839.62
5138352-13835237.13737.21
6135041-13504136.24936.32
20min1162343-16234343.57744.252.6843.7044.392.69
2164934-16493444.27344.41
3166965-16696544.81844.96
4171986-17198646.16646.31
5163967-16396744.01344.15
6158928-15892842.66142.79
30min1193482-19348251.93652.082.7552.1352.292.74
2192710-19271051.72951.94
3196614-19661452.77652.99
4203148-20314854.53054.75
5189508-18950850.86951.08
6188631-18863150.63450.84
45min1218523-21852358.65758.683.0758.9458.983.06
2215567-21556757.86458.16
3218159-21815958.56058.86
4230604-23060461.90062.21
5210200-21020056.42356.72
6218600-21860058.67858.97
极限1236400-23640063.45663.451.8863.8463.841.88
2233759-23375962.74763.14
3233530-23353062.68663.09
4245052-24505265.77966.19
5233535-23353562.68763.07
6236001-23600163.34963.74
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%
115.108964289970897788994389746898160.16
215.008846688952887090.39
单位质量响应值RSD%判断
5948.085913.930.41数据可信
供试品溶液-2025010721批-氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min175383-7538382.39383.573.3682.3983.563.37
273700-7370080.55480.55
381037-8103788.57388.57
476764-7676483.90383.90
577071-7707184.23884.24
674789-7478981.74481.74
10min187069-8706995.16696.142.6795.3096.282.67
284249-8424992.08492.22
391348-9134899.84399.99
488593-8859396.83296.97
588872-8887297.13797.28
687632-8763295.78195.92
15min191285-9128599.77499.402.06100.0799.702.06
289019-8901997.29797.59
393862-93862102.591102.90
491205-9120599.68799.99
588773-8877397.02997.33
691510-91510100.020100.32
20min192701-92701101.322100.951.48101.78101.421.48
290643-9064399.07299.52
394542-94542103.334103.82
492116-92116100.682101.15
591315-9131599.807100.27
692872-92872101.509101.97
30min193797-93797102.520101.002.65103.15101.632.64
288335-8833596.55097.16
395714-95714104.615105.27
492424-92424101.019101.65
591841-91841100.382101.01
692317-92317100.902101.53
45min193875-93875102.605101.911.08103.41102.711.08
291831-91831100.371101.15
394542-94542103.334104.17
492956-92956101.601102.40
592487-92487101.088101.89
693742-93742102.460103.26
极限193266-93266101.939101.621.55102.91102.591.56
291381-9138199.879100.82
395439-95439104.314105.32
491795-91795100.332101.30
592632-92632101.246102.21
693346-93346102.027103.00
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%
111.583563163565023558723560243557513560930.09
211.663568303569773569040.03
单位质量响应值RSD%判断
30750.6930609.260.33数据可信
供试品溶液-2025010721批-阿托伐他汀钙-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1161185-16118543.39644.302.5543.4044.302.54
2160118-16011843.10943.11
3170294-17029445.84945.85
4166256-16625644.76244.76
5167932-16793245.21345.21
6161545-16154543.49343.49
10min1262339-26233970.63070.832.1570.7070.902.15
2256550-25655069.07269.14
3269002-26900272.42472.50
4263398-26339870.91570.99
5269898-26989872.66572.74
6257235-25723569.25669.33
15min1310917-31091783.70983.221.6683.9083.411.66
2301148-30114881.07981.27
3312175-31217584.04884.24
4309357-30935783.28983.48
5315543-31554384.95485.15
6305443-30544382.23582.42
20min1336600-33660090.62489.881.6690.9590.211.66
2326590-32659087.92988.25
3340022-34002291.54591.88
4330744-33074489.04789.38
5339156-33915691.31291.65
6329869-32986988.81189.14
30min1361195-36119597.24595.752.1197.7396.242.11
2347544-34754493.57094.04
3366151-36615198.58099.07
4350217-35021794.29094.77
5358988-35898896.65197.14
6349856-34985694.19394.67
45min1372936-372936100.40698.751.48101.0599.391.48
2359897-35989796.89697.52
3370760-37076099.821100.47
4362248-36224897.52998.17
5370847-37084799.844100.50
6363972-36397297.99398.62
极限1375413-375413101.07399.831.61101.88100.641.61
2365446-36544698.39099.18
3378832-378832101.994102.81
4363557-36355797.88198.68
5373088-373088100.447101.27
6368439-36843999.19699.99
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%
115.108864588608885588856888471885700.08
215.008750387738876200.19
单位质量响应值RSD%判断
5865.565841.330.30数据可信
供试品溶液-2025010721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%
5min137059-3705941.04246.8912.5741.0446.8912.57
245890-4589050.82250.82
346585-4658551.59251.59
448550-4855053.76853.77
536193-3619340.08340.08
639771-3977144.04544.05
10min163367-6336770.17774.184.0870.2574.264.08
265323-6532372.34372.43
371276-7127678.93679.02
468522-6852275.88675.98
566204-6620473.31973.39
667187-6718774.40874.48
15min171911-7191179.64084.873.7779.8285.073.77
274443-7444382.44482.65
379142-7914287.64887.87
477148-7714885.43985.66
578953-7895387.43887.63
678210-7821086.61686.81
20min174963-7496383.02088.684.3883.3489.024.38
276621-7662184.85685.20
382765-8276591.66092.02
480270-8027088.89789.26
582815-8281591.71592.05
683019-8301991.94192.28
30min175316-7531683.41090.665.4783.8791.145.46
278150-7815086.54987.03
385081-8508194.22594.74
480848-8084889.53790.04
585863-8586395.09195.58
685887-8588795.11895.61
45min177039-7703985.31991.074.4385.9191.704.42
279005-7900587.49688.12
384179-8417993.22693.90
481791-8179190.58191.24
584957-8495794.08894.73
686396-8639695.68196.33
极限177068-7706885.35190.914.0286.0991.704.01
279511-7951188.05688.83
383201-8320192.14392.97
482737-8273791.62992.44
586370-8637095.65296.46
683633-8363392.62193.43
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%
111.583556853557283557523545213549043553180.17
211.663575393581043578220.12
单位质量响应值RSD%判断
30683.7730687.990.01数据可信
供试品溶液-2025010721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%
5min1197946-19794653.28357.808.6653.2857.808.66
2222804-22280459.97459.97
3234037-23403762.99863.00
4231268-23126862.25362.25
5187628-18762850.50650.51
6214659-21465957.78257.78
10min1280181-28018175.41978.903.5575.5178.993.55
2284581-28458176.60376.70
3309880-30988083.41383.52
4293444-29344478.98979.09
5293294-29329478.94979.03
6297240-29724080.01180.11
15min1305788-30578882.31286.324.0082.5386.553.99
2306106-30610682.39782.63
3335703-33570390.36490.61
4317712-31771285.52185.76
5330055-33005588.84489.06
6328690-32869088.47788.71
20min1312426-31242684.09988.764.6484.4589.134.64
2312235-31223584.04784.41
3343269-34326992.40192.80
4324509-32450987.35187.73
5343293-34329392.40792.77
6342754-34275492.26292.64
30min1317549-31754985.47890.254.9185.9790.784.90
2315599-31559984.95385.46
3348390-34839093.77994.33
4329780-32978088.77089.29
5351210-35121094.53895.06
6349250-34925094.01194.54
45min1318382-31838285.70290.554.7986.3491.224.78
2317426-31742685.44486.09
3348838-34883893.90094.60
4331519-33151989.23889.91
5352221-35222194.81195.49
6349939-34993994.19694.88
极限1319132-31913285.90490.614.7886.6891.434.76
2318288-31828885.67786.47
3348840-34884093.90094.76
4329989-32998988.82689.65
5352332-35233294.84095.67
6351012-35101294.48595.33
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%
115.108755087721873128764587734875920.20
215.008746987586875280.10
单位质量响应值RSD%判断
5800.795835.200.42数据可信
供试品溶液-2025010721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%
5min155616-5561661.96950.4413.6661.9750.4413.66
244211-4421149.26149.26
341030-4103045.71745.72
439049-3904943.50943.51
549417-4941755.06255.06
642281-4228147.11147.11
10min175014-7501483.58374.976.1383.6975.066.14
267141-6714174.81074.89
364206-6420671.54071.62
463654-6365470.92571.00
567885-6788575.63975.73
665828-6582873.34773.43
15min182041-8204191.41284.814.3291.6585.024.33
276679-7667985.43885.64
373396-7339681.78081.98
472804-7280481.12081.31
576105-7610584.79885.02
675654-7565484.29684.50
20min184562-8456294.22188.563.4094.6288.913.41
278916-7891687.93088.28
377789-7778986.67587.01
477586-7758686.44886.77
577727-7772786.60586.96
680299-8029989.47189.81
30min185397-8539795.15291.962.7595.7092.462.76
285070-8507094.78795.28
380866-8086690.10390.58
480588-8058889.79390.26
580427-8042789.61490.12
682872-8287292.33892.83
45min186025-8602595.85193.342.4496.5693.992.45
286699-8669996.60297.26
382713-8271392.16192.79
482299-8229991.70092.32
581990-8199091.35592.01
682889-8288992.35793.00
极限185621-8562195.40196.651.6096.2797.461.58
288028-8802898.08398.90
385574-8557495.34996.13
488318-8831898.40699.18
585303-8530395.04795.85
687606-8760697.61398.41
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%
111.583559873563263549373555493554333556460.15
211.663597993599723598860.04
单位质量响应值RSD%判断
30712.0930865.010.36数据可信
供试品溶液-2025010721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%
5min1252306-25230667.68956.7811.9767.6956.7911.97
2210007-21000756.34156.34
3203096-20309654.48754.49
4183565-18356549.24749.25
5229006-22900661.43861.44
6191986-19198651.50751.51
10min1314589-31458984.39977.844.6284.5177.934.63
2288317-28831777.35177.44
3280046-28004675.13275.22
4279319-27931974.93775.02
5295460-29546079.26779.37
6283089-28308975.94876.03
15min1336982-33698290.40785.682.9890.6685.902.99
2317012-31701285.04985.27
3309970-30997083.16083.38
4312756-31275683.90784.11
5320683-32068386.03486.27
6318671-31867185.49485.71
20min1342762-34276291.95788.682.1192.3689.042.13
2330967-33096788.79389.16
3324110-32411086.95387.31
4324012-32401286.92787.27
5328519-32851988.13688.51
6332870-33287089.30389.66
30min1345547-34554792.70491.001.7193.2691.521.72
2346132-34613292.86193.37
3334759-33475989.81090.31
4332955-33295589.32689.82
5334968-33496889.86690.39
6340891-34089191.45591.96
45min1346907-34690793.06992.191.6893.7892.851.68
2352468-35246894.56195.23
3341546-34154691.63192.28
4338682-33868290.86391.50
5336892-33689290.38291.06
6345205-34520592.61393.27
极限1348044-34804493.37495.921.8394.2496.741.79
2361868-36186897.08397.91
3356359-35635995.60596.41
4364736-36473697.85398.64
5352113-35211394.46695.29
6362078-36207897.13997.95
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