依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ333-221017对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.67对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.851630491625711627791627731629371628220.12
29.911637971644701641340.29
单位质量响应值RSD%判断
16530.1516562.460.14数据可信
供试品溶液-2022092001批-依折麦布-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15433-54332.9453.1912.192.953.1912.08
25963-59633.2333.23
36240-62403.3833.38
47089-70893.8433.84
55361-53612.9062.91
65176-51762.8062.81
10min114943-149438.1017.717.068.127.737.07
213819-138197.4927.51
314664-146647.9507.97
415173-151738.2268.25
514337-143377.7737.79
612422-124226.7346.75
15min117034-170349.2359.012.319.309.072.36
216793-167939.1049.16
316541-165418.9679.03
416926-169269.1769.24
516482-164828.9358.99
615976-159768.6618.71
20min116123-161238.7418.901.288.859.011.28
216643-166439.0239.13
316551-165518.9739.09
416593-165938.9969.11
516249-162498.8098.92
616350-163508.8648.97
30min116113-161138.7358.952.018.909.112.00
217002-170029.2179.38
316265-162658.8188.98
416745-167459.0789.25
516563-165638.9799.14
616335-163358.8569.01
45min116098-160988.7278.771.788.948.981.75
216679-166799.0429.25
316187-161878.7768.99
416195-161958.7809.00
515796-157968.5648.77
616080-160808.7188.92
60min116055-160558.7048.722.638.968.982.57
216554-165548.9749.24
316343-163438.8609.12
416152-161528.7579.02
515310-153108.3008.56
616095-160958.7268.97
极限115955-159558.6508.553.058.968.862.99
216358-163588.8689.18
315935-159358.6398.95
415828-158288.5818.90
514913-149138.0858.39
615657-156578.4888.78
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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2500
标示量(mg)20供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.003156633153113154053154063156583154890.06
211.053180913189993185450.21
单位质量响应值RSD%判断
28680.8228827.600.37数据可信
供试品溶液-2022092001批-阿托伐他汀钙-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min130636-306368.8019.4914.738.809.4914.72
232638-326389.3769.38
334180-341809.8199.82
440653-4065311.67811.68
534224-342249.8319.83
625854-258547.4277.43
10min193931-9393126.98326.255.4027.0326.305.41
292788-9278826.65526.71
390597-9059726.02526.08
491996-9199626.42726.49
596684-9668427.77427.83
682211-8221123.61623.66
15min1122031-12203135.05534.524.5235.2534.724.53
2120282-12028234.55334.75
3115402-11540233.15133.35
4121719-12171934.96635.18
5128462-12846236.90337.11
6113109-11310932.49232.66
20min1121495-12149534.90135.904.5935.2936.294.58
2122553-12255335.20535.60
3119600-11960034.35734.74
4128674-12867436.96337.37
5134871-13487138.74439.16
6122597-12259735.21835.57
30min1136936-13693639.33739.714.6939.9240.304.68
2135868-13586839.03039.62
3128951-12895137.04337.62
4142218-14221840.85441.47
5148215-14821542.57743.21
6137288-13728839.43839.99
45min1141298-14129840.59039.622.8641.4040.422.87
2135695-13569538.98039.78
3132434-13243438.04438.82
4138180-13818039.69440.53
5143306-14330641.16742.03
6136524-13652439.21839.99
60min1150003-15000343.09041.522.1744.1242.552.14
2142056-14205640.80841.83
3142080-14208040.81441.81
4142331-14233140.88741.95
5145937-14593741.92243.02
6144735-14473541.57742.56
极限1156373-15637344.92044.210.8446.1945.470.84
2152754-15275443.88145.13
3153458-15345844.08345.30
4154170-15417044.28845.57
5153418-15341844.07145.40
6153289-15328944.03445.25
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ333-221017对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.67对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.851643081646321649631653131653391649110.27
29.911633401646561639980.57
单位质量响应值RSD%判断
16742.2316548.740.83数据可信
供试品溶液-2022092001批-依折麦布-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17377-73773.9763.2315.833.983.2315.93
26273-62733.3813.38
36453-64533.4783.48
45314-53142.8642.86
55886-58863.1723.17
64646-46462.5042.50
10min114292-142927.7027.476.087.727.496.08
213762-137627.4177.44
314581-145817.8587.88
413550-135507.3027.32
514606-146067.8717.89
612386-123866.6756.69
15min116773-167739.0398.811.689.108.861.70
216556-165568.9228.98
316311-163118.7908.85
416158-161588.7088.76
516197-161978.7298.79
616046-160468.6488.70
20min116558-165588.9238.801.479.048.901.54
216563-165638.9269.04
316436-164368.8588.97
416269-162698.7688.87
516113-161138.6848.79
615985-159858.6158.71
30min116212-162128.7378.660.948.908.820.99
216159-161598.7088.87
316234-162348.7498.91
415866-158668.5518.70
515949-159498.5958.75
616015-160158.6318.78
45min116208-162088.7358.621.328.958.831.34
216184-161848.7228.93
315911-159118.5758.78
415767-157678.4978.70
516155-161558.7068.91
615761-157618.4948.69
60min115818-158188.5258.502.248.798.762.20
215767-157678.4978.75
315766-157668.4978.75
415343-153438.2698.52
516396-163968.8369.09
615561-155618.3868.63
极限115543-155438.3768.311.948.698.611.88
215779-157798.5048.81
314888-148888.0238.33
415530-155308.3698.66
515360-153608.2788.58
615365-153658.2818.57
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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2500
标示量(mg)20供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.003189623194683199373204693203473198370.20
211.053174473195813185140.48
单位质量响应值RSD%判断
29076.0928824.800.62数据可信
供试品溶液-2022092001批-阿托伐他汀钙-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min138832-3883211.0808.9018.2211.088.9018.22
229377-293778.3828.38
334630-346309.8819.88
427101-271017.7327.73
533974-339749.6939.69
623232-232326.6296.63
10min186573-8657324.70125.605.7124.7625.665.72
292909-9290926.50926.56
393549-9354926.69126.75
488795-8879525.33525.38
595075-9507527.12727.18
681535-8153523.26423.30
15min1121503-12150334.66734.713.9834.8734.904.00
2125474-12547435.80035.99
3121492-12149234.66434.87
4120212-12021234.29934.48
5127621-12762136.41336.62
6113607-11360732.41432.58
20min1132419-13241937.78237.294.8938.1737.684.90
2133494-13349438.08938.48
3128415-12841536.63937.04
4128477-12847736.65737.03
5140260-14026040.01940.43
6121119-12111934.55834.90
30min1147117-14711741.97640.946.6742.5841.536.63
2144136-14413641.12541.73
3136604-13660438.97639.58
4139595-13959539.82940.41
5160154-16015445.69546.32
6133317-13331738.03838.58
45min1150928-15092843.06341.459.0843.9042.278.99
2144861-14486141.33242.16
3134415-13441538.35139.17
4137898-13789839.34540.14
5168828-16882848.17049.05
6134792-13479238.45939.21
60min1154443-15444344.06642.508.6745.1443.558.59
2147548-14754842.09843.16
3136762-13676239.02140.05
4141303-14130340.31741.33
5172154-17215449.11950.27
6141534-14153440.38341.35
极限1160903-16090345.90945.144.8547.2346.424.87
2159326-15932645.45946.76
3147941-14794142.21143.46
4155540-15554044.37945.62
5170863-17086348.75150.17
6154595-15459544.10945.30
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ333-221017对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.67对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.851655681647321646221644991641991647240.32
29.911624891628681626780.17
单位质量响应值RSD%判断
16723.2516415.541.32数据可信
供试品溶液-2022092201批-依折麦布-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110990-109905.9505.656.195.955.666.17
210230-102305.5395.54
39486-94865.1365.14
49966-99665.3965.40
510911-109115.9075.91
611062-110625.9895.99
10min115710-157108.5068.470.928.548.510.88
215843-158438.5788.61
315745-157458.5258.55
415583-155838.4378.47
515581-155818.4368.47
615444-154448.3628.40
15min116493-164938.9308.921.499.019.001.47
216729-167299.0579.14
316749-167499.0689.14
416458-164588.9118.99
516368-163688.8628.94
616089-160898.7118.79
20min116361-163618.8588.870.888.999.000.86
216496-164968.9319.06
316509-165098.9389.06
416413-164138.8869.01
516392-163928.8759.00
616111-161118.7238.85
30min116165-161658.7528.771.868.938.941.83
216507-165078.9379.12
316505-165058.9369.11
416206-162068.7748.95
516063-160638.6978.88
615703-157038.5028.68
45min115727-157278.5158.592.048.748.821.98
215461-154618.3718.60
316232-162328.7889.01
416092-160928.7138.94
516104-161048.7198.95
615555-155558.4228.65
60min115760-157608.5338.712.998.818.982.89
216149-161498.7439.02
316843-168439.1199.39
416312-163128.8329.10
516029-160298.6788.95
615440-154408.3608.63
极限115646-156468.4718.642.538.798.962.48
216219-162198.7819.10
316383-163838.8709.20
415904-159048.6118.93
516220-162208.7829.11
615332-153328.3018.62
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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2500
标示量(mg)20供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.003193183183663179653176683171893181010.26
211.053148803148553148680.01
单位质量响应值RSD%判断
28918.2728494.841.05数据可信
供试品溶液-2022092201批-阿托伐他汀钙-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min146597-4659713.40913.225.9013.4113.225.91
241883-4188312.05212.05
348344-4834413.91113.91
448666-4866614.00414.00
546717-4671713.44313.44
643485-4348512.51312.51
10min186012-8601224.75025.524.7724.8225.604.77
286173-8617324.79724.86
392587-9258726.64226.72
493173-9317326.81126.89
591343-9134326.28426.36
682911-8291123.85823.93
15min1108161-10816131.12431.623.2931.3431.843.27
2108372-10837231.18531.39
3105079-10507930.23730.46
4113771-11377132.73832.96
5114499-11449932.94833.17
6109423-10942331.48731.69
20min1118702-11870234.15735.596.2734.5435.986.22
2113848-11384832.76033.14
3137004-13700439.42439.82
4123843-12384335.63636.05
5123826-12382635.63236.04
6124838-12483835.92336.30
30min1128389-12838936.94539.059.6337.5239.649.51
2123078-12307835.41635.98
3159441-15944145.88046.49
4129340-12934037.21837.82
5132991-13299138.26938.87
6140990-14099040.57141.15
45min1123906-12390635.65537.6711.4236.4338.4811.27
2113715-11371532.72233.48
3155836-15583644.84345.71
4122837-12283735.34736.16
5129167-12916737.16837.98
6140002-14000240.28641.09
60min1129046-12904637.13439.4511.9538.1140.4611.79
2122103-12210335.13636.07
3166544-16654447.92449.04
4126763-12676336.47737.49
5133173-13317338.32139.34
6144899-14489941.69542.72
极限1145278-14527841.80443.896.5242.9945.136.52
2143894-14389441.40642.54
3168783-16878348.56849.95
4144642-14464241.62142.83
5153846-15384644.27045.50
6158790-15879045.69346.95
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ333-221017对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.67对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.851638501633961633201634771633771634840.13
29.911650211666421658320.70
单位质量响应值RSD%判断
16597.3616733.800.58数据可信
供试品溶液-2022092201批-依折麦布-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min111273-112736.0685.954.236.075.954.25
211375-113756.1236.12
311577-115776.2316.23
410281-102815.5345.53
510796-107965.8115.81
610990-109905.9155.92
10min115609-156098.4028.461.888.448.501.89
216192-161928.7168.75
315832-158328.5228.56
415460-154608.3228.35
515394-153948.2868.32
615839-158398.5268.56
15min116241-162418.7428.830.958.828.910.95
216702-167028.9909.07
316384-163848.8198.90
416397-163978.8268.90
516328-163288.7898.87
616422-164228.8398.92
20min116627-166278.9508.811.539.088.941.53
216489-164898.8759.01
316481-164818.8719.00
416158-161588.6978.82
516473-164738.8678.99
615968-159688.5958.72
30min116220-162208.7318.681.388.918.861.33
216027-160278.6278.81
316254-162548.7498.93
416231-162318.7378.91
516340-163408.7958.97
615734-157348.4698.65
45min115539-155398.3648.541.198.598.771.16
215755-157558.4808.71
315998-159988.6118.84
415917-159178.5688.79
516018-160188.6228.85
615982-159828.6038.83
60min115589-155898.3918.490.948.668.760.93
215714-157148.4588.73
315820-158208.5158.79
415698-156988.4508.72
516027-160278.6278.90
615765-157658.4868.76
极限116044-160448.6368.501.128.968.821.09
215606-156068.4008.72
315940-159408.5808.90
415658-156588.4288.75
515817-158178.5148.83
615662-156628.4308.75
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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2500
标示量(mg)20供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.003172243158913160023159923158553161930.19
211.053198063226873212460.64
单位质量响应值RSD%判断
28744.8229072.040.81数据可信
供试品溶液-2022092201批-阿托伐他汀钙-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min152670-5267015.05014.266.6915.0514.266.70
249987-4998714.28314.28
350005-5000514.28814.29
445421-4542112.97912.98
554370-5437015.53615.54
647077-4707713.45213.45
10min193000-9300026.57425.563.2226.6625.643.23
289130-8913025.46825.55
388456-8845625.27525.35
491302-9130226.08926.16
590272-9027225.79425.88
684588-8458824.17024.24
15min1119929-11992934.26832.703.1334.5032.923.13
2111826-11182631.95332.17
3111613-11161331.89232.11
4114905-11490532.83333.05
5117293-11729333.51533.74
6111168-11116831.76531.97
20min1138584-13858439.59936.755.4340.0237.155.40
2122035-12203534.87035.27
3124794-12479435.65936.06
4124981-12498135.71236.11
5136325-13632538.95339.37
6124907-12490735.69136.08
30min1152644-15264443.61640.616.4244.2641.226.38
2133565-13356538.16538.76
3136135-13613538.89939.49
4136831-13683139.09839.70
5154673-15467344.19644.83
6138946-13894639.70240.29
45min1148174-14817442.33940.166.4343.2240.996.37
2132069-13206937.73738.54
3133358-13335838.10638.92
4133591-13359138.17238.99
5153766-15376643.93744.81
6142327-14232740.66841.47
60min1157504-15750445.00542.016.5546.1243.066.50
2139901-13990139.97540.99
3137779-13777939.36940.39
4138567-13856739.59440.62
5158842-15884245.38746.51
6149527-14952742.72643.76
极限1170772-17077248.79645.874.1850.1747.164.20
2154863-15486344.25045.49
3155806-15580644.52045.76
4154646-15464644.18845.44
5166067-16606747.45248.83
6161087-16108746.02947.30
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