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%
115.019222892156919519201191800920290.19
214.939337893494934360.09
单位质量响应值RSD%判断
6131.186258.271.46数据可信
供试品溶液-2025021221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%
5min160380-6038063.19263.141.8963.1963.141.89
259729-5972962.51062.51
359341-5934162.10462.10
461663-6166364.53464.53
559136-5913661.89061.89
661724-6172464.59864.60
10min178352-7835282.00180.571.4782.1180.681.47
275080-7508078.57678.68
376765-7676580.34080.44
476788-7678880.36480.47
577837-7783781.46281.56
677113-7711380.70480.81
15min186615-8661590.64889.202.1090.8989.442.10
282062-8206285.88386.12
384413-8441388.34488.58
485275-8527589.24689.49
586349-8634990.37090.61
686659-8665990.69490.94
20min187731-8773191.81691.551.9892.2191.941.98
284377-8437788.30688.68
386750-8675090.79091.17
488171-8817192.27792.67
589154-8915493.30693.70
688666-8866692.79593.19
30min189421-8942193.58594.341.3094.1394.881.30
288321-8832192.43492.96
389787-8978793.96894.50
491274-9127495.52496.07
591048-9104895.28895.83
691010-9101095.24895.80
45min190442-9044294.65494.771.1195.3695.471.11
289419-8941993.58394.26
389407-8940793.57094.26
490822-9082295.05195.75
591469-9146995.72896.43
691784-9178496.05896.76
极限190909-9090995.14295.821.3796.0096.681.37
290939-9093995.17496.01
390021-9002194.21395.06
491378-9137895.63396.49
592831-9283197.15498.02
693290-9329097.63498.50
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%
111.423506863503373507533502983499693504090.10
211.513612743589253601000.47
单位质量响应值RSD%判断
30683.8031285.841.38数据可信
供试品溶液-2025021221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%
5min168138-6813818.20417.573.5118.2017.573.50
266756-6675617.83517.84
364586-6458617.25517.26
468317-6831718.25218.25
562679-6267916.74616.75
664149-6414917.13917.14
10min1116445-11644531.11128.764.5731.1428.804.57
2105041-10504128.06428.09
3105916-10591628.29728.33
4109743-10974329.32029.35
5106484-10648428.44928.48
6102363-10236327.34827.38
15min1152517-15251740.74837.535.2140.8337.605.21
2135201-13520136.12236.20
3138140-13814036.90736.98
4145129-14512938.77438.85
5139475-13947537.26337.34
6132311-13231135.34935.42
20min1168758-16875845.08742.533.9745.2442.673.97
2151900-15190040.58340.72
3159356-15935642.57542.71
4161841-16184143.23943.38
5160833-16083342.97043.11
6152532-15253240.75240.88
30min1190406-19040650.87149.234.1151.1049.444.11
2174198-17419846.54046.74
3191255-19125551.09751.31
4189082-18908250.51750.73
5184957-18495749.41549.62
6175604-17560446.91647.12
45min1207843-20784355.52954.144.1255.8454.444.11
2189873-18987350.72851.01
3213372-21337257.00657.30
4204019-20401954.50854.81
5204270-20427054.57554.87
6196542-19654252.51052.79
极限1234675-23467562.69860.633.1063.1061.013.10
2215314-21531457.52557.89
3231329-23132961.80462.19
4227226-22722660.70861.10
5230553-23055361.59761.98
6222525-22252559.45259.82
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%
115.019296492506922189216792652925010.36
214.939314293588933650.34
单位质量响应值RSD%判断
6162.626253.521.04数据可信
供试品溶液-2025021221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%
5min142327-4232744.20160.4113.2944.2060.4113.29
262556-6255665.32565.32
361810-6181064.54664.55
459561-5956162.19762.20
560723-6072363.41163.41
660130-6013062.79262.79
10min175037-7503778.35881.052.0578.4381.152.06
279149-7914982.65282.76
377891-7789181.33981.45
476444-7644479.82879.93
578202-7820281.66381.77
678961-7896182.45682.56
15min184846-8484688.60289.391.2988.8189.621.29
286794-8679490.63690.88
386565-8656590.39790.64
483895-8389587.60887.85
585469-8546989.25289.49
686014-8601489.82190.06
20min187415-8741591.28492.470.9391.6492.860.94
289310-8931093.26393.66
388701-8870192.62793.02
487706-8770691.58891.97
588781-8878192.71193.10
689393-8939393.35093.74
30min188865-8886592.79893.751.6893.3094.291.68
291145-9114595.17995.73
390410-9041094.41294.96
488235-8823592.14192.68
588317-8831792.22692.77
691709-9170995.76896.32
45min190786-9078694.80495.281.0495.4695.981.04
292396-9239696.48697.20
390969-9096994.99695.70
489770-8977093.74394.43
591556-9155695.60996.31
691980-9198096.05196.76
极限189794-8979493.76995.301.0594.5996.151.06
292099-9209996.17697.05
392157-9215796.23697.10
490439-9043994.44295.29
591336-9133695.37996.24
691718-9171895.77896.64
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%
111.423550153520803510393510803525303523490.47
211.513573473582423577940.18
单位质量响应值RSD%判断
30853.6831085.490.53数据可信
供试品溶液-2025021221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%
5min142215-4221511.28316.2215.4211.2816.2215.43
260705-6070516.22516.23
365463-6546317.49717.50
462451-6245116.69216.69
567077-6707717.92817.93
666124-6612417.67417.67
10min193852-9385225.08527.714.9025.1027.744.92
2106216-10621628.38928.42
3108171-10817128.91228.94
4106041-10604128.34328.37
5104070-10407027.81627.85
6103753-10375327.73127.76
15min1128082-12808234.23436.012.7934.2936.082.80
2137629-13762936.78536.86
3136017-13601736.35536.43
4137325-13732536.70436.78
5132513-13251335.41835.49
6136853-13685336.57836.65
20min1145673-14567338.93541.273.8739.0541.403.88
2156887-15688741.93342.07
3158378-15837842.33142.47
4157821-15782142.18242.32
5148008-14800839.55939.69
6159634-15963442.66742.80
30min1158533-15853342.37346.595.4542.5646.795.45
2178405-17840547.68447.89
3178167-17816747.62047.83
4179425-17942547.95748.16
5167286-16728644.71244.91
6184044-18404449.19149.40
45min1178608-17860847.73851.214.7547.9951.494.75
2197404-19740452.76253.05
3193652-19365251.75952.05
4194008-19400851.85452.14
5183063-18306348.92949.20
6202882-20288254.22654.52
极限1204844-20484454.75158.053.3355.0858.413.35
2221818-22181859.28759.66
3222830-22283059.55859.93
4218239-21823958.33158.70
5212444-21244456.78257.14
6222862-22286259.56659.95
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%
115.019476894341945409449694477945240.17
214.939610295374957380.54
单位质量响应值RSD%判断
6297.406412.461.29数据可信
供试品溶液-2025021521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%
5min160999-6099962.22963.314.5362.2363.314.53
265007-6500766.31866.32
362689-6268963.95363.95
460999-6099962.22962.23
565010-6501066.32166.32
657650-5765058.81258.81
10min179851-7985181.46180.502.7881.5680.602.78
280333-8033381.95282.06
380545-8054582.16982.28
477292-7729278.85078.95
580253-8025381.87181.98
675177-7517776.69376.79
15min186139-8613987.87687.692.2888.1287.932.28
287229-8722988.98789.23
387381-8738189.14389.39
484724-8472486.43286.67
587635-8763589.40289.65
682636-8263684.30284.53
20min188892-8889290.68490.132.7091.0790.522.70
289323-8932391.12491.52
390006-9000691.82092.21
486640-8664088.38788.77
590804-9080492.63593.03
684426-8442686.12886.49
30min190769-9076992.59991.402.6293.1491.942.63
290855-9085592.68793.23
391727-9172793.57694.12
487871-8787189.64290.17
590739-9073992.56893.12
685627-8562787.35387.86
45min191466-9146693.31092.072.3294.0092.762.32
291122-9112292.95993.66
391634-9163493.48194.18
488127-8812789.90490.58
592059-9205993.91594.62
687095-8709588.85189.51
极限191908-9190893.76192.692.2694.6193.532.26
292561-9256194.42795.28
391748-9174893.59894.45
488882-8888290.67491.50
592366-9236694.22895.09
687691-8769189.45990.26
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%
111.421805851798111800401793121790161797530.35
211.511850411840161845280.40
单位质量响应值RSD%判断
15740.1916031.971.30数据可信
供试品溶液-2025021521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%
5min128399-2839914.79815.524.2214.8015.524.23
230551-3055115.92015.92
329478-2947815.36115.36
430948-3094816.12716.13
531064-3106416.18716.19
628277-2827714.73514.73
10min148693-4869325.37425.522.6125.4025.542.61
250043-5004326.07726.10
350073-5007326.09326.12
448544-4854425.29625.32
549718-4971825.90825.93
646743-4674324.35724.38
15min163071-6307132.86633.981.9532.9334.051.96
265820-6582034.29834.37
366069-6606934.42834.50
465749-6574934.26134.33
566293-6629334.54534.61
664245-6424533.47833.54
20min174083-7408338.60440.062.6938.7340.192.68
277353-7735340.30840.44
378714-7871441.01741.14
476316-7631639.76839.89
579524-7952441.43941.57
675277-7527739.22639.35
30min185790-8579044.70446.982.9744.8947.172.97
290860-9086047.34647.54
393546-9354648.74648.94
489554-8955446.66646.86
592006-9200647.94448.14
689169-8916946.46546.65
45min197210-9721050.65554.093.5050.9254.363.49
2104521-10452154.46554.74
3106802-10680255.65455.93
4103259-10325953.80754.08
5107361-10736155.94556.22
6103626-10362653.99954.26
极限1106958-10695855.73559.653.5156.0860.013.51
2117045-11704560.99161.36
3117068-11706861.00361.37
4115117-11511759.98760.35
5117442-11744261.19861.57
6113185-11318558.98059.33
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%
115.019434893989938599427994206941360.22
214.939236192211922860.12
单位质量响应值RSD%判断
6271.556181.251.03数据可信
供试品溶液-2025021521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%
5min165880-6588068.59366.652.9068.5966.652.90
264626-6462667.28867.29
365112-6511267.79467.79
464150-6415066.79266.79
563791-6379166.41866.42
660537-6053763.03063.03
10min181409-8140984.76283.083.6484.8883.203.63
278917-7891782.16782.28
381740-8174085.10785.22
482948-8294886.36486.48
578862-7886282.11082.22
674897-7489777.98278.09
15min187770-8777091.38589.592.8791.6489.842.86
284360-8436087.83588.08
387588-8758891.19691.45
488907-8890792.56992.82
585260-8526088.77289.02
682397-8239785.79186.03
20min190291-9029194.01092.202.5294.4292.602.52
286861-8686190.43990.83
388975-8897592.64093.05
491704-9170495.48195.89
587770-8777091.38591.78
685693-8569389.22389.60
30min191415-9141595.18093.552.6195.7494.112.60
288177-8817791.80992.36
390770-9077094.50995.07
493138-9313896.97497.54
588822-8882292.48093.03
686794-8679490.36990.90
45min192579-9257996.39294.142.3397.1294.842.33
289013-8901392.67993.38
390366-9036694.08894.81
493211-9321197.05097.78
589473-8947393.15893.86
687828-8782891.44592.12
极限193166-9316697.00394.912.1697.8995.782.16
289196-8919692.87093.72
391699-9169995.47696.35
493417-9341797.26598.16
590698-9069894.43495.29
688766-8876692.42293.25
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%
111.421763461757661744991754261754541754980.39
211.511746471747431746950.04
单位质量响应值RSD%判断
15367.6015177.670.88数据可信
供试品溶液-2025021521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%
5min132233-3223317.47017.195.6617.4717.195.66
232569-3256917.65217.65
333987-3398718.42118.42
428597-2859715.49915.50
531251-3125116.93816.94
631661-3166117.16017.16
10min152095-5209528.23527.243.9028.2627.273.90
251975-5197528.17028.20
351870-5187028.11328.14
449027-4902726.57326.60
549018-4901826.56826.60
647569-4756925.78225.81
15min167965-6796536.83735.442.7436.9135.522.73
266025-6602535.78535.86
365471-6547135.48535.56
465814-6581435.67135.74
564520-6452034.97035.04
662555-6255533.90533.98
20min178768-7876842.69241.402.8642.8341.532.85
276248-7624841.32641.46
374115-7411540.17040.31
479091-7909142.86743.00
575986-7598641.18441.32
674050-7405040.13540.26
30min191148-9114849.40248.283.3649.6148.483.35
287935-8793547.66147.87
385419-8541946.29746.50
493634-9363450.74950.95
589445-8944548.47948.68
686865-8686547.08147.28
45min1104819-10481956.81254.994.1557.1055.274.13
299452-9945253.90354.19
395492-9549251.75652.04
4107056-10705658.02458.31
5102643-10264355.63255.91
699289-9928953.81454.09
极限1113914-11391461.74160.174.2762.1360.544.25
2109068-10906859.11559.49
3103744-10374456.22956.60
4117555-11755563.71564.10
5112338-11233860.88761.26
6109458-10945859.32659.69
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