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%
115.949944699797997229983399731997060.16
216.021003531005471004500.14
单位质量响应值RSD%判断
6255.086270.290.18数据可信
供试品溶液-GF9438批-氨氯地平-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min160234-6023462.34855.386.4462.3555.386.44
251339-5133953.14153.14
353267-5326755.13755.14
452015-5201553.84153.84
550856-5085652.64152.64
653323-5332355.19555.19
10min184161-8416187.11584.373.1987.2284.463.19
277355-7735580.07080.16
380975-8097583.81783.91
479927-7992782.73382.82
583354-8335486.28086.37
683298-8329886.22286.31
15min186035-8603589.05588.133.3589.3088.363.35
281215-8121584.06684.29
382022-8202284.90185.13
486015-8601589.03489.26
587908-8790890.99491.23
687649-8764990.72690.96
20min188862-8886291.98190.742.2092.3891.122.20
284118-8411887.07187.43
387579-8757990.65391.03
487171-8717190.23190.61
589224-8922492.35692.74
689007-8900792.13192.52
30min189348-8934892.48490.572.3393.0491.102.34
284769-8476987.74588.25
385516-8551688.51889.04
487047-8704790.10390.63
589540-8954092.68393.22
688762-8876291.87892.42
45min187878-8787890.96391.371.1591.6792.061.16
286905-8690589.95690.61
387858-8785890.94291.61
488136-8813691.23091.91
589784-8978492.93693.63
689075-8907592.20292.90
极限188363-8836391.46591.871.1292.3292.701.12
287985-8798591.07391.88
389503-8950392.64593.47
487408-8740890.47691.30
589987-8998793.14693.99
689254-8925492.38793.23
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%
111.673583393591983587413594703592443589980.13
211.633636173638033637100.04
单位质量响应值RSD%判断
30762.4731273.431.17数据可信
供试品溶液-GF9438批-阿托伐他汀钙-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1238538-23853863.52655.986.9663.5355.986.97
2201915-20191553.77353.77
3211483-21148356.32156.32
4199155-19915553.03853.04
5201733-20173353.72553.72
6208426-20842655.50755.51
10min1333059-33305988.69984.473.1788.8084.563.17
2302767-30276780.63280.72
3315945-31594584.14184.23
4312169-31216983.13583.22
5317662-31766284.59884.69
6321384-32138485.59085.68
15min1358689-35868995.52492.292.6995.7892.532.70
2330586-33058688.04088.26
3345655-34565592.05392.29
4345208-34520891.93492.16
5347367-34736792.50992.74
6351808-35180893.69293.93
20min1367648-36764897.91095.262.1998.3295.652.19
2343971-34397191.60591.98
3356321-35632194.89495.28
4358525-35852595.48195.86
5358415-35841595.45195.84
6361388-36138896.24396.63
30min1371769-37176999.00897.171.4499.5897.711.44
2356017-35601794.81395.34
3363362-36336296.76997.31
4365766-36576697.40997.95
5367536-36753697.88198.42
6364659-36465997.11497.67
45min1373152-37315299.37698.170.67100.1298.880.69
2365750-36575097.40598.09
3367943-36794397.98998.70
4367641-36764197.90998.61
5368969-36896998.26298.97
6368320-36832098.08998.80
极限1374836-37483699.82599.910.66100.73100.780.66
2374703-37470399.789100.63
3379876-379876101.167102.04
4374973-37497399.861100.73
5372759-37275999.272100.14
6373786-37378699.545100.42
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%
115.949965499715996139949899415995790.13
216.021014901004651009780.72
单位质量响应值RSD%判断
6247.116303.250.64数据可信
供试品溶液-GF9438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%
5min179432-7943282.05877.819.3182.0677.819.31
280104-8010482.75282.75
377347-7734779.90479.90
461553-6155363.58863.59
574717-7471777.18777.19
678760-7876081.36481.36
10min193225-9322596.30793.162.7896.4493.292.79
291064-9106494.07594.21
391346-9134694.36694.50
486532-8653289.39389.50
587782-8778290.68490.81
691131-9113194.14494.28
15min194073-9407397.18394.591.7497.4894.871.75
291293-9129394.31194.61
392207-9220795.25595.55
490040-9004093.01793.27
589742-8974292.70992.99
692006-9200695.04895.34
20min193161-9316196.24193.612.5296.7094.062.51
287291-8729190.17790.63
392294-9229495.34595.79
490273-9027393.25793.67
588720-8872091.65392.09
691965-9196595.00595.46
30min192190-9219095.23894.051.5395.8694.641.54
290731-9073193.73194.33
392860-9286095.93096.54
490447-9044793.43794.00
588901-8890191.84092.43
691086-9108694.09794.71
45min191980-9198095.02192.761.5995.8093.521.59
289084-8908492.02992.79
390439-9043993.42994.20
488938-8893891.87892.60
587957-8795790.86591.61
690347-9034793.33494.10
极限190446-9044693.43691.811.4994.3792.721.50
288137-8813791.05191.96
390286-9028693.27194.19
488257-8825791.17592.05
587051-8705189.92990.82
689050-8905091.99492.92
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%
111.673582873590193587743584893583263585790.09
211.633549493543423546460.13
单位质量响应值RSD%判断
30726.5630494.070.54数据可信
供试品溶液-GF9438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%
5min193106-9310625.12424.2415.4025.1224.2415.41
2103391-10339127.90027.90
388844-8884423.97423.97
463495-6349517.13417.13
597591-9759126.33526.33
692546-9254624.97324.97
10min1179537-17953748.44847.125.4348.4947.165.44
2184586-18458649.81049.86
3172146-17214646.45346.49
4157126-15712642.40042.43
5177853-17785347.99348.04
6176454-17645447.61647.66
15min1218523-21852358.96857.893.1559.0958.003.16
2221693-22169359.82359.95
3212393-21239357.31457.43
4202301-20230154.59054.69
5216722-21672258.48258.61
6215459-21545958.14158.26
20min1241093-24109365.05864.021.8865.2864.241.89
2241382-24138265.13665.37
3235494-23549463.54763.76
4229683-22968361.97962.17
5236268-23626863.75663.98
6239581-23958164.65064.87
30min1267467-26746772.17570.421.5872.5070.741.59
2263074-26307470.99071.33
3258327-25832769.70970.03
4255936-25593669.06469.36
5258857-25885769.85270.18
6262013-26201370.70471.03
45min1283180-28318076.41574.511.6576.8774.951.65
2276434-27643474.59575.05
3270083-27008372.88173.32
4273176-27317673.71674.12
5275138-27513874.24574.69
6278706-27870675.20875.65
极限1289736-28973678.18576.851.0578.7677.411.05
2285347-28534777.00077.58
3283325-28332576.45577.01
4284640-28464076.80977.34
5280599-28059975.71976.29
6285025-28502576.91377.48
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%
115.941012381010031010901010821010081010840.10
216.021020641020401020520.02
单位质量响应值RSD%判断
6341.536370.290.32数据可信
供试品溶液-GF9438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%
5min191111-9111192.92691.281.9692.9391.281.96
289042-8904290.81690.82
388173-8817389.93089.93
490049-9004991.84391.84
591583-9158393.40893.41
687024-8702488.75888.76
10min194874-9487496.76495.921.3296.9296.081.32
294328-9432896.20796.36
392919-9291994.77094.92
494706-9470696.59396.75
595318-9531897.21797.37
692155-9215593.99194.14
15min196656-9665698.58297.641.1198.9097.961.12
295408-9540897.30997.62
395043-9504396.93797.24
495425-9542597.32697.64
597361-9736199.30199.62
694528-9452896.41196.72
20min197014-9701498.94797.880.5999.4398.360.60
295782-9578297.69098.16
395727-9572797.63498.10
495728-9572897.63598.11
596166-9616698.08298.57
695418-9541897.31997.78
30min197730-9773099.67798.491.05100.3299.121.06
296083-9608397.99798.63
396147-9614798.06398.69
496439-9643998.36099.00
597785-9778599.733100.38
695200-9520097.09797.72
45min197426-9742699.36798.470.72100.1899.270.72
296223-9622398.14098.94
396797-9679798.72699.52
496722-9672298.64999.45
596753-9675398.68199.49
695373-9537397.27398.06
极限197037-9703798.97097.921.0299.9598.891.02
294847-9484796.73797.70
395659-9565997.56598.53
495890-9589097.80198.77
597325-9732599.264100.24
695304-9530497.20398.15
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%
111.673655063648883652493654053649253651950.08
211.633621793612353617070.19
单位质量响应值RSD%判断
31293.4931101.200.44数据可信
供试品溶液-GF9438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%
5min1197954-19795452.41252.872.3152.4152.872.31
2200071-20007152.97352.97
3198353-19835352.51852.52
4204220-20422054.07154.07
5205025-20502554.28454.28
6192462-19246250.95850.96
10min1298387-29838779.00478.601.6879.0978.691.68
2296834-29683478.59278.68
3292980-29298077.57277.66
4303174-30317480.27180.36
5300284-30028479.50679.60
6289481-28948176.64576.73
15min1336745-33674589.16088.551.2089.3888.771.20
2332676-33267688.08288.30
3331037-33103787.64887.87
4338842-33884289.71589.94
5338087-33808789.51589.74
6329233-32923387.17187.38
20min1353248-35324893.52992.810.7493.9093.180.74
2348906-34890692.37992.75
3349826-34982692.62392.99
4354182-35418293.77694.15
5349240-34924092.46892.84
6347717-34771792.06592.42
30min1365853-36585396.86696.031.0097.3996.551.00
2358846-35884695.01195.53
3362428-36242895.96096.48
4367311-36731197.25297.78
5363297-36329796.19096.72
6358381-35838194.88895.40
45min1369752-36975297.89997.160.9198.5897.840.91
2365743-36574396.83797.52
3367128-36712897.20497.88
4371860-37186098.45799.15
5364170-36417096.42197.11
6363138-36313896.14896.82
极限1369257-36925797.76897.090.8398.6297.930.83
2364618-36461896.53997.38
3364376-36437696.47597.31
4371092-37109298.25499.11
5367196-36719697.22298.07
6363553-36355396.25797.09
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%
115.941008491007571006971010031009621008540.13
216.021013461013121013290.03
单位质量响应值RSD%判断
6327.106325.160.03数据可信
供试品溶液-GF9438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%
5min164740-6474066.34068.062.1566.3468.062.15
266577-6657768.22368.22
365211-6521166.82366.82
467553-6755369.22369.22
565924-6592467.55467.55
668487-6848770.18070.18
10min183640-8364085.70886.782.1785.8286.892.17
281733-8173383.75383.87
385908-8590888.03288.14
486956-8695689.10689.22
584584-8458486.67586.79
685285-8528587.39387.51
15min190007-9000792.23293.020.9692.4993.280.96
290399-9039992.63492.89
391748-9174894.01694.27
492012-9201294.28794.55
590315-9031592.54892.80
690193-9019392.42392.69
20min191743-9174394.01194.192.2494.4294.602.24
288598-8859890.78891.20
393904-9390496.22596.64
494032-9403296.35696.78
590734-9073492.97793.39
692482-9248294.76895.18
30min192140-9214094.41895.051.2494.9895.621.24
292535-9253594.82295.38
394202-9420296.53197.11
493817-9381796.13696.72
592814-9281495.10895.67
691043-9104393.29493.87
45min192273-9227394.55494.701.3895.2895.431.37
292630-9263094.92095.64
394387-9438796.72097.46
490461-9046192.69793.44
592775-9277595.06895.79
691978-9197894.25294.98
极限191829-9182994.09994.760.6494.9895.650.63
292790-9279095.08495.96
393026-9302695.32696.22
491728-9172893.99694.89
592424-9242494.70995.59
693063-9306395.36496.25
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100590-202005 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%
111.673620003619103624963634543637483627220.24
211.633606443603863605150.06
单位质量响应值RSD%判断
31081.5830998.710.19数据可信
供试品溶液-GF9438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%
5min1260707-26070769.37670.891.6569.3870.891.65
2267987-26798771.31371.31
3266282-26628270.86070.86
4268302-26830271.39771.40
5262283-26228369.79569.80
6272740-27274072.57872.58
10min1333254-33325488.68189.840.8588.8089.960.85
2337591-33759189.83689.95
3340685-34068590.65990.78
4339084-33908490.23390.35
5335317-33531789.23089.35
6339781-33978190.41890.54
15min1351510-35151093.53994.670.9393.8094.940.93
2356390-35639094.83895.11
3360802-36080296.01296.28
4357696-35769695.18695.45
5353350-35335094.02994.29
6354858-35485894.43094.70
20min1357670-35767095.17996.231.0795.6096.651.07
2360708-36070895.98796.41
3368010-36801097.93098.36
4364138-36413896.90097.33
5358404-35840495.37495.80
6360710-36071095.98896.42
30min1359645-35964595.70496.711.0496.2897.301.04
2362073-36207396.35096.94
3369755-36975598.39598.99
4366082-36608297.41798.01
5361673-36167396.24496.82
6361365-36136596.16296.75
45min1360297-36029795.87896.671.0196.6297.421.01
2362671-36267196.50997.26
3369722-36972298.38699.14
4365224-36522497.18997.94
5360311-36031195.88196.62
6361461-36146196.18796.94
极限1358648-35864895.43996.501.0196.3497.401.01
2362719-36271996.52297.43
3369141-36914198.23199.15
4363691-36369196.78197.69
5360543-36054395.94396.84
6361025-36102596.07196.98
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