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%
114.728998990048900218998089867899810.08
214.799041590362903880.05
单位质量响应值RSD%判断
6112.846111.430.02数据可信
中间条件12月-供试品溶液-2025021021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%
5min151779-5177954.91753.074.9454.9253.074.94
251971-5197155.12055.12
352084-5208455.24055.24
448513-4851351.45351.45
545892-4589248.67348.67
649988-4998853.01753.02
10min173289-7328977.73074.693.2877.8274.783.28
272686-7268677.09177.18
371003-7100375.30675.40
468207-6820772.34072.43
567698-6769871.80071.88
669637-6963773.85773.95
15min182077-8207787.05181.824.6187.2782.044.61
279717-7971784.54884.77
377632-7763282.33682.55
476403-7640381.03381.24
571893-7189376.25076.45
675164-7516479.71979.93
20min183086-8308688.12183.993.7588.4984.343.75
281288-8128886.21486.58
380162-8016285.02085.37
478891-7889183.67284.01
575080-7508079.63079.96
676638-7663881.28281.63
30min187458-8745892.75887.434.6793.2787.924.66
286032-8603291.24591.75
382852-8285287.87388.37
480566-8056685.44885.93
577093-7709381.76582.23
680589-8058985.47285.95
45min186808-8680892.06890.383.0092.7491.013.00
287728-8772893.04493.70
387993-8799393.32593.97
482800-8280087.81788.44
582770-8277087.78688.38
683187-8318788.22888.85
极限187654-8765492.96691.163.8593.7991.953.83
284129-8412989.22790.04
390827-9082796.33197.13
481048-8104885.95986.73
585489-8548990.66991.41
686590-8659091.83792.61
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%
112.113640523638253635083634513636773637030.07
212.203669253666943668100.05
单位质量响应值RSD%判断
30033.2830066.390.08数据可信
中间条件12月-供试品溶液-2025021021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%
5min1238149-23814965.60064.752.5765.6064.752.57
2232100-23210063.93363.93
3238473-23847365.68965.69
4240308-24030866.19466.19
5224089-22408961.72761.73
6237193-23719365.33665.34
10min1290408-29040879.99577.743.0280.1077.843.02
2280357-28035777.22677.33
3284953-28495378.49278.60
4290611-29061180.05180.16
5267993-26799373.82073.92
6278923-27892376.83176.94
15min1301736-30173683.11580.483.1983.3680.723.19
2290391-29039179.99080.23
3294623-29462381.15681.40
4301184-30118482.96383.21
5276817-27681776.25176.48
6288371-28837179.43479.67
20min1305906-30590684.26481.593.2184.6481.963.21
2295378-29537881.36481.73
3299063-29906382.37982.75
4304755-30475583.94784.33
5280254-28025477.19877.55
6291761-29176180.36780.74
30min1309855-30985585.35183.073.0685.8783.583.06
2301759-30175983.12183.63
3306240-30624084.35684.87
4308486-30848684.97485.50
5285055-28505578.52079.00
6298014-29801482.09082.59
45min1312701-31270186.13585.052.2986.8085.702.29
2306919-30691984.54385.19
3316054-31605487.05987.71
4312464-31246486.07086.73
5295975-29597581.52882.14
6308506-30850684.98085.62
极限1314598-31459886.65886.031.7287.4786.821.73
2309753-30975385.32386.11
3320002-32000288.14788.95
4313328-31332886.30887.12
5303883-30388383.70684.45
6312436-31243686.06286.84
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%
114.729080390876909449098391117909450.14
214.799142291507914640.07
单位质量响应值RSD%判断
6178.336184.180.07数据可信
中间条件12月-供试品溶液-2025021021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%
5min151830-5183054.35653.604.8754.3653.604.87
255437-5543758.13958.14
350754-5075453.22853.23
447901-4790150.23650.24
550691-5069153.16253.16
650049-5004952.48852.49
10min174465-7446578.09476.772.7578.1876.862.75
276117-7611779.82779.92
371970-7197075.47875.57
472324-7232475.84975.93
573841-7384177.44077.53
670479-7047973.91474.00
15min179644-7964483.52683.253.2283.7583.463.22
282127-8212786.13086.36
380612-8061284.54184.76
477328-7732881.09781.31
581166-8116685.12285.34
675386-7538679.06079.27
20min182346-8234686.35985.641.9486.7285.991.94
281164-8116485.12085.49
383645-8364587.72288.08
479773-7977383.66184.01
582968-8296887.01287.37
680047-8004783.94884.29
30min185601-8560189.77388.783.5890.2889.283.58
288327-8832792.63293.15
386273-8627390.47890.98
483273-8327387.33287.82
584964-8496489.10589.61
679479-7947983.35383.83
45min186884-8688491.11989.582.5691.7790.222.56
287239-8723991.49192.16
387667-8766791.94092.59
484712-8471288.84189.47
583718-8371887.79888.45
682259-8225986.26886.89
极限185966-8596690.15690.533.3690.9691.333.35
291234-9123495.68196.50
387417-8741791.67792.48
484668-8466888.79589.57
586025-8602590.21891.02
682633-8263386.66087.43
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100590-202406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%
112.113683183685653688333689993689353687300.08
212.203719123721663720390.05
单位质量响应值RSD%判断
30448.3930495.000.11数据可信
中间条件12月-供试品溶液-2025021021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%
5min1235415-23541563.94962.926.4463.9562.926.44
2251865-25186568.41768.42
3231116-23111662.78162.78
4205820-20582055.91055.91
5229809-22980962.42662.43
6235727-23572764.03464.03
10min1290319-29031978.86378.264.0278.9778.364.03
2301359-30135981.86281.98
3288667-28866778.41478.52
4266679-26667972.44172.53
5293447-29344779.71379.82
6288028-28802878.24178.35
15min1300535-30053581.63881.133.7581.8881.373.75
2311722-31172284.67784.93
3300530-30053081.63781.87
4278145-27814575.55675.77
5303622-30362282.47782.71
6297537-29753780.82481.06
20min1303618-30361882.47682.023.7682.8582.393.77
2315332-31533285.65886.05
3304107-30410782.60882.98
4281181-28118176.38176.72
5306900-30690083.36783.74
6300544-30054481.64182.01
30min1306682-30668283.30883.123.9383.8283.633.94
2321319-32131987.28487.82
3309051-30905183.95184.46
4284690-28469077.33477.80
5310393-31039384.31684.83
6303918-30391882.55783.07
45min1309485-30948584.06983.804.0384.7284.454.03
2325383-32538388.38889.07
3311720-31172084.67685.33
4287360-28736078.05978.66
5312159-31215984.79685.45
6304867-30486782.81583.46
极限1310759-31075984.41584.214.1185.2185.004.11
2328271-32827189.17290.00
3313407-31340785.13585.92
4288910-28891078.48079.21
5312463-31246384.87885.67
6306203-30620383.17883.96
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%
114.729087991058910589109291065910300.10
214.799120591238912220.03
单位质量响应值RSD%判断
6184.106167.820.19数据可信
中间条件12月-供试品溶液-2025021121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%
5min145562-4556247.82452.825.7847.8252.825.78
248587-4858750.99951.00
351874-5187454.44954.45
451933-5193354.51154.51
553716-5371656.38256.38
650265-5026552.76052.76
10min167641-6764170.99977.044.4971.0877.134.49
276300-7630080.08780.17
372118-7211875.69875.79
473866-7386677.53377.62
576642-7664280.44680.54
673814-7381477.47877.57
15min174054-7405477.73084.054.5877.9384.274.58
282606-8260686.70686.92
380613-8061384.61484.83
480752-8075284.76084.98
584467-8446788.66088.89
677974-7797481.84482.06
20min176463-7646380.25886.164.1480.5986.524.14
285301-8530189.53589.90
381713-8171385.76986.13
481634-8163485.68686.05
585942-8594290.20890.58
681476-8147685.52085.87
30min177542-7754281.39187.534.0481.8588.034.05
286709-8670991.01391.53
383538-8353887.68588.19
483223-8322387.35487.86
586677-8667790.97991.51
682637-8263786.73987.23
45min177825-7782581.68888.124.3082.2988.774.30
288082-8808292.45493.12
384418-8441888.60889.26
483696-8369687.85188.50
586925-8692591.24091.92
682769-8276986.87787.52
极限178086-7808681.96288.554.2682.7089.344.26
288611-8861193.00993.83
385150-8515089.37790.17
483412-8341287.55288.35
586699-8669991.00391.83
684221-8422188.40289.19
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%
112.113706243706523708433706213709833707450.05
212.203729903731433730660.03
单位质量响应值RSD%判断
30614.7830579.180.09数据可信
中间条件12月-供试品溶液-2025021121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%
5min1212948-21294857.60962.375.4557.6162.375.44
2215943-21594358.41958.42
3238156-23815664.42864.43
4240169-24016964.97364.97
5237953-23795364.37464.37
6238189-23818964.43764.44
10min1270327-27032773.13278.253.5673.2378.353.57
2284394-28439476.93777.03
3293504-29350479.40279.51
4295590-29559079.96680.07
5294554-29455479.68679.79
6297122-29712280.38180.49
15min1282157-28215776.33281.083.0676.5581.323.06
2297295-29729580.42780.65
3304046-30404682.25482.49
4304397-30439782.34982.59
5304098-30409882.26882.51
6306361-30636182.88083.12
20min1286175-28617577.41981.862.8077.7682.232.80
2300869-30086981.39481.75
3306666-30666682.96283.34
4306625-30662582.95183.33
5306629-30662982.95283.33
6308551-30855183.47283.85
30min1288857-28885778.14582.422.6878.6282.922.68
2303210-30321082.02882.52
3309597-30959783.75584.27
4307958-30795883.31283.83
5307659-30765983.23183.75
6310623-31062384.03384.55
45min1290740-29074078.65482.812.5679.2683.452.56
2305422-30542282.62683.26
3310535-31053584.00984.66
4308560-30856083.47584.13
5309528-30952883.73784.39
6311754-31175484.33985.00
极限1292295-29229579.07583.052.4679.8183.832.46
2306431-30643182.89983.67
3311637-31163784.30785.10
4309308-30930883.67784.47
5309360-30936083.69184.49
6312834-31283484.63185.43
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%
114.729075190947911549097791028909710.17
214.799027690236902560.04
单位质量响应值RSD%判断
6180.106102.500.90数据可信
中间条件12月-供试品溶液-2025021121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%
5min155881-5588158.98856.612.6258.9956.612.62
253669-5366956.65356.65
354189-5418957.20257.20
451612-5161254.48254.48
553287-5328756.25056.25
653144-5314456.09956.10
10min176595-7659580.85480.672.7080.9580.762.69
274905-7490579.07079.16
378742-7874283.12083.22
474298-7429878.42978.52
579026-7902683.42083.51
674956-7495679.12479.22
15min181324-8132485.84686.672.1786.0886.902.17
281331-8133185.85386.08
383985-8398588.65588.89
480180-8018084.63884.86
584649-8464989.35689.59
681155-8115585.66785.89
20min183114-8311487.73588.452.3988.1188.822.39
282958-8295887.57187.94
385985-8598590.76691.15
481400-8140085.92686.29
586494-8649491.30391.68
682775-8277587.37787.75
30min184162-8416288.84289.672.4089.3690.192.39
283991-8399188.66189.18
387970-8797092.86193.39
482186-8218686.75687.26
586485-8648591.29491.83
684889-8488989.60990.12
45min184601-8460189.30590.013.6089.9890.683.59
285485-8548590.23890.90
388620-8862093.54794.24
479871-7987184.31284.96
587745-8774592.62493.31
685311-8531190.05590.72
极限186050-8605090.83591.192.9391.6592.002.93
286232-8623291.02791.84
389216-8921694.17795.02
482486-8248687.07287.86
589090-8909094.04494.88
685231-8523189.97090.78
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%
112.113707003708183710263707083708863708280.04
212.203696123692183694150.08
单位质量响应值RSD%判断
30621.6430279.920.80数据可信
中间条件12月-供试品溶液-2025021121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%
5min1254528-25452869.19066.672.2669.1966.672.26
2244769-24476966.53766.54
3247958-24795867.40467.40
4244634-24463466.50166.50
5240068-24006865.26065.26
6239603-23960365.13365.13
10min1303733-30373382.56681.262.0082.6881.372.00
2294892-29489280.16380.27
3305399-30539983.01983.13
4298765-29876581.21681.33
5301380-30138081.92682.04
6289381-28938178.66578.77
15min1311316-31131684.62783.971.9284.8884.221.92
2305246-30524682.97783.22
3315688-31568885.81686.07
4308335-30833583.81784.06
5313439-31343985.20585.45
6299456-29945681.40381.64
20min1314102-31410285.38584.631.8885.7885.011.88
2308671-30867183.90884.29
3317968-31796886.43686.83
4309837-30983784.22584.61
5315518-31551885.77086.16
6301785-30178582.03782.41
30min1316278-31627885.97685.341.7886.5185.871.78
2312145-31214584.85385.38
3321213-32121387.31887.86
4311072-31107284.56185.09
5317541-31754186.32086.85
6305460-30546083.03683.55
45min1317379-31737986.27685.611.8886.9686.281.88
2313014-31301485.08985.75
3323204-32320487.85988.54
4311542-31154284.68985.36
5318175-31817586.49287.17
6306325-30632583.27183.92
极限1318999-31899986.71685.921.8587.5486.731.85
2313707-31370785.27786.08
3323909-32390988.05188.88
4312377-31237784.91685.72
5319578-31957886.87387.69
6307802-30780283.67284.46
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