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R075K0对照品来源USP对照品使用方法直接使用
对照品含量(%)99.8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%
110.181657861656271658961658381657251657740.07
210.131662951667121665040.18
单位质量响应值RSD%判断
16284.2816436.720.66数据可信
供试品溶液-2023120821批-10mg/10mg规格-依折麦布-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%
5min19847-98475.4065.979.965.415.979.96
210377-103775.6975.70
310395-103955.7075.71
410445-104455.7345.73
512854-128547.0577.06
611356-113566.2356.23
10min116235-162358.9138.951.328.948.991.32
216587-165879.1079.14
316486-164869.0519.08
416255-162558.9248.96
516323-163238.9629.00
615972-159728.7698.80
15min116604-166049.1168.971.259.209.051.24
216339-163398.9709.05
316533-165339.0779.16
416172-161728.8798.96
516076-160768.8268.91
616301-163018.9509.03
20min116644-166449.1388.861.929.278.991.88
216339-163398.9709.10
316102-161028.8408.97
415995-159958.7828.91
515836-158368.6948.83
615877-158778.7178.85
30min116151-161518.8678.781.679.058.961.64
216027-160278.7998.98
316409-164099.0099.19
415941-159418.7528.93
515728-157288.6358.82
615704-157048.6228.80
45min116948-169489.3058.773.239.539.003.13
215613-156138.5728.80
315949-159498.7568.99
415718-157188.6298.86
515556-155568.5418.77
616069-160698.8229.05
60min115851-158518.7028.621.448.988.901.42
215676-156768.6068.88
315965-159658.7659.05
415810-158108.6808.96
515358-153588.4328.71
615526-155268.5248.80
极限115903-159038.7318.591.139.068.921.07
215427-154278.4708.80
315717-157178.6298.96
415596-155968.5628.89
515494-154948.5068.84
615746-157468.6458.97
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)10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%
111.003010673015553015203012043014283013550.08
211.153026863028713027780.05
单位质量响应值RSD%判断
27395.9127154.980.63数据可信
供试品溶液-2023120821批-10mg/10mg规格-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%
5min164759-6475939.22437.6518.0039.2237.6518.00
264696-6469639.18539.19
369492-6949242.09042.09
440199-4019924.34824.35
570862-7086242.92042.92
662963-6296338.13638.14
10min1112709-11270968.26664.876.5868.4865.086.61
2109444-10944466.28966.51
3113047-11304768.47168.70
493942-9394256.89957.03
5107832-10783265.31265.55
6105655-10565563.99464.21
15min1132282-13228280.12175.853.7780.7276.423.81
2123985-12398575.09675.68
3128115-12811577.59778.21
4118127-11812771.54872.00
5124160-12416075.20275.80
6124720-12472075.54176.11
20min1143485-14348586.90781.913.0287.9582.903.03
2133963-13396381.13982.14
3133485-13348580.85081.90
4132715-13271580.38381.23
5134319-13431981.35582.37
6133417-13341780.80981.80
30min1145663-14566388.22684.172.6089.7585.622.60
2135672-13567282.17483.63
3139663-13966384.59286.09
4138386-13838683.81885.11
5138324-13832483.78185.25
6136085-13608582.42583.86
45min1148910-14891090.19387.022.0292.2188.942.02
2140324-14032484.99286.90
3143315-14331586.80488.77
4143637-14363786.99988.76
5141919-14191985.95887.89
6143959-14395987.19489.09
60min1150068-15006890.89487.322.7093.4189.722.66
2140948-14094885.37087.75
3145783-14578388.29990.75
4146423-14642388.68690.93
5140220-14022084.92987.34
6141549-14154985.73488.11
极限1151595-15159591.81987.682.8294.8490.562.78
2139696-13969684.61287.47
3144431-14443187.48090.42
4146238-14623888.57491.31
5141846-14184685.91488.80
6144784-14478487.69390.55
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R075K0对照品来源USP对照品使用方法直接使用
对照品含量(%)99.8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%
110.181657181658431659771656491657521657880.08
210.131652871653761653320.04
单位质量响应值RSD%判断
16285.6616321.030.16数据可信
供试品溶液-2023120821批-10mg/10mg规格-依折麦布-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%
5min111247-112476.1965.874.626.205.874.67
29919-99195.4655.46
310471-104715.7695.77
410395-103955.7275.73
511100-111006.1156.12
610801-108015.9515.95
10min116053-160538.8448.811.308.888.841.30
215631-156318.6128.64
316037-160378.8358.87
416230-162308.9428.97
516111-161118.8768.91
615911-159118.7668.80
15min116491-164919.0858.911.179.178.991.16
216047-160478.8418.92
316259-162598.9589.04
416016-160168.8248.91
516168-161688.9078.99
616004-160048.8178.90
20min115976-159768.8028.851.118.948.981.08
216306-163068.9839.11
316073-160738.8558.99
415987-159878.8088.94
515803-158038.7068.84
616199-161998.9259.06
30min115643-156438.6188.641.548.808.821.49
215697-156978.6488.83
315731-157318.6678.85
416065-160658.8519.03
515679-156798.6388.82
615311-153118.4358.62
45min115355-153558.4608.621.288.698.841.22
215951-159518.7889.01
315622-156228.6078.83
415708-157088.6548.88
515528-155288.5558.78
615698-156988.6498.88
60min115269-152698.4128.622.398.698.902.31
215620-156208.6068.88
315687-156878.6428.92
416344-163449.0049.28
515604-156048.5978.87
615396-153968.4828.76
极限115106-151068.3228.341.448.658.661.39
215515-155158.5488.87
315200-152008.3748.70
415063-150638.2998.63
515046-150468.2898.61
614866-148668.1908.51
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)10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%
111.003023823016443011833016953021393018090.16
211.152992943000812996880.19
单位质量响应值RSD%判断
27437.1826877.851.46数据可信
供试品溶液-2023120821批-10mg/10mg规格-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%
5min171967-7196743.78242.175.8643.7842.175.86
262564-6256438.06238.06
368772-6877241.83941.84
468144-6814441.45741.46
569900-6990042.52542.52
674571-7457145.36745.37
10min1113190-11319068.86166.613.8269.1066.843.82
2102235-10223562.19662.41
3108077-10807765.75165.98
4109004-10900466.31566.54
5110823-11082367.42167.66
6113595-11359569.10869.36
15min1128223-12822378.00776.522.7978.6377.132.80
2120122-12012273.07873.64
3125089-12508976.10076.70
4123809-12380975.32175.92
5127887-12788777.80278.41
6129582-12958278.83479.47
20min1135138-13513882.21482.152.0483.2783.182.05
2133542-13354281.24382.21
3134034-13403481.54282.56
4131946-13194680.27281.29
5135474-13547482.41883.46
6140021-14002185.18486.26
30min1137832-13783283.85384.341.4785.3785.821.48
2135948-13594882.70684.12
3137801-13780183.83485.31
4138113-13811384.02385.49
5141289-14128985.95687.46
6140786-14078685.65087.20
45min1143473-14347387.28487.711.4089.2789.661.42
2142497-14249786.69188.56
3142084-14208486.43988.38
4144100-14410087.66689.60
5145301-14530188.39690.37
6147538-14753889.75791.78
60min1143877-14387787.53088.641.6590.0091.081.64
2142323-14232386.58588.94
3144786-14478688.08390.50
4147749-14774989.88692.30
5148286-14828690.21292.68
6147191-14719189.54692.07
极限1139476-13947684.85385.751.3087.8188.691.28
2141021-14102185.79388.63
3141532-14153286.10389.01
4138259-13825984.11287.03
5142272-14227286.55489.52
6143193-14319387.11490.13
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R075K0对照品来源USP对照品使用方法直接使用
对照品含量(%)99.8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%
110.181664031667871670591672211671571669250.21
210.131667821680261674040.53
单位质量响应值RSD%判断
16397.3516525.570.56数据可信
供试品溶液-2023120822批-10mg/10mg规格-依折麦布-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%
5min111024-110246.0156.097.256.026.107.28
211394-113946.2176.22
311018-110186.0126.01
411860-118606.4716.47
511982-119826.5386.54
69738-97385.3145.31
10min115344-153448.3728.561.698.418.601.70
215935-159358.6958.73
315628-156288.5278.56
415934-159348.6948.73
515893-158938.6728.71
615433-154338.4218.45
15min115594-155948.5098.622.358.598.702.36
215778-157788.6098.69
316197-161978.8388.92
415993-159938.7278.81
516065-160658.7668.85
615188-151888.2878.36
20min115900-159008.6768.561.508.808.691.46
215629-156298.5288.66
315837-158378.6418.77
415763-157638.6018.73
515248-152488.3208.45
615760-157608.5998.72
30min114421-144217.8698.121.818.048.301.80
214930-149308.1478.32
315139-151398.2618.44
414739-147398.0428.22
515080-150808.2288.41
615022-150228.1978.37
45min114785-147858.0678.242.378.298.472.27
215044-150448.2098.43
314609-146097.9718.20
415317-153178.3588.58
515480-154808.4478.67
615419-154198.4138.63
60min115526-155268.4728.322.018.748.591.91
215530-155308.4748.74
315290-152908.3438.61
415029-150298.2018.47
514762-147628.0558.33
615402-154028.4048.67
极限115090-150908.2348.072.158.548.382.04
215080-150808.2288.54
314905-149058.1338.45
414244-142447.7728.09
514655-146557.9968.31
614757-147578.0528.36
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)10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%
111.003031733024723031463034953027073029990.14
211.153028343047973038160.46
单位质量响应值RSD%判断
27545.3627248.070.77数据可信
供试品溶液-2023120822批-10mg/10mg规格-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%
5min157881-5788134.90332.9523.9834.9032.9423.97
253744-5374432.40832.41
360728-6072836.62036.62
465443-6544339.46339.46
560931-6093136.74236.74
629080-2908017.53617.54
10min197572-9757258.83757.199.3159.0357.389.35
291202-9120254.99655.18
3101076-10107660.95061.15
4100187-10018760.41460.63
5100569-10056960.64460.85
678464-7846447.31547.41
15min1116473-11647370.23469.982.1170.7670.482.15
2117045-11704570.57971.06
3113231-11323168.27968.82
4119646-11964672.14872.70
5116588-11658870.30470.84
6113318-11331868.33268.69
20min1123540-12354074.49675.912.0375.4176.802.04
2123246-12324674.31975.20
3130057-13005778.42679.35
4126425-12642576.23677.19
5127061-12706176.61977.55
6124985-12498575.36776.11
30min1123462-12346274.44977.092.9475.7778.402.88
2124642-12464275.16076.45
3131816-13181679.48680.84
4125301-12530175.55876.94
5131215-13121579.12480.48
6130581-13058178.74279.90
45min1135315-13531581.59682.943.1683.3384.683.08
2132735-13273580.04181.75
3133730-13373080.64082.44
4138354-13835483.42985.23
5142938-14293886.19387.99
6142229-14222985.76587.36
60min1142489-14248985.92285.441.9388.1187.641.82
2141687-14168785.43987.59
3144123-14412386.90889.15
4138798-13879883.69785.96
5138160-13816083.31285.59
6144841-14484187.34189.41
极限1139307-13930784.00383.931.7686.6786.611.67
2139033-13903383.83886.47
3140838-14083884.92787.66
4134550-13455081.13583.86
5140071-14007184.46487.20
6141351-14135185.23687.79
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R075K0对照品来源USP对照品使用方法直接使用
对照品含量(%)99.8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%
110.181672831672611675671672551673881673510.08
210.131676991682671679830.24
单位质量响应值RSD%判断
16439.1916582.720.62数据可信
供试品溶液-2023120822批-10mg/10mg规格-依折麦布-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%
5min18867-88674.8245.3314.234.825.3314.22
28824-88244.8004.80
38472-84724.6094.61
49579-95795.2115.21
511177-111776.0806.08
611842-118426.4426.44
10min115371-153718.3628.351.818.398.381.85
214933-149338.1248.15
315518-155188.4428.47
415108-151088.2198.25
515464-154648.4138.45
615680-156808.5308.57
15min115713-157138.5488.582.468.628.662.40
216209-162098.8188.89
315973-159738.6908.76
415617-156178.4968.57
515119-151198.2258.31
616023-160238.7178.80
20min115785-157858.5878.571.688.718.691.69
215863-158638.6308.75
315779-157798.5848.70
415224-152248.2828.40
515944-159448.6748.80
615881-158818.6398.77
30min115533-155338.4508.761.898.628.921.85
216309-163098.8729.04
316382-163828.9129.08
416020-160208.7158.88
516195-161958.8108.98
616127-161278.7738.95
45min116381-163818.9118.841.709.139.061.66
216364-163648.9029.12
316465-164658.9579.18
416000-160008.7048.92
515816-158168.6048.83
616474-164748.9629.19
60min116082-160828.7498.751.789.019.021.75
216454-164548.9519.22
316175-161758.7999.07
415928-159288.6658.93
515628-156288.5028.77
616255-162558.8439.12
极限115933-159338.6688.535.268.988.845.05
216134-161348.7779.09
316244-162448.8379.15
415884-158848.6418.95
514028-140287.6317.95
615848-158488.6228.95
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)10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%
111.003030553038573041503032943039873036690.16
211.153047083056203051640.22
单位质量响应值RSD%判断
27606.2727368.970.62数据可信
供试品溶液-2023120822批-10mg/10mg规格-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%
5min142627-4262725.61932.1117.7525.6232.1217.75
261792-6179237.13837.14
349862-4986229.96829.97
460733-6073336.50136.50
542900-4290025.78325.78
662691-6269137.67837.68
10min192743-9274355.73959.426.1355.8859.606.16
2104816-10481662.99563.20
3100429-10042960.35960.53
4100531-10053160.42060.62
590259-9025954.24654.39
6104444-10444462.77262.98
15min1115864-11586469.63571.614.6270.0972.124.65
2125650-12565075.51776.07
3120381-12038172.35072.85
4117638-11763870.70271.24
5110980-11098066.70067.14
6124399-12439974.76575.32
20min1124098-12409874.58476.493.7375.4277.403.75
2133748-13374880.38481.36
3128901-12890177.47178.37
4122822-12282273.81774.75
5122709-12270973.74974.56
6131385-13138578.96479.94
30min1129757-12975777.98581.812.9879.2483.153.02
2140246-14024684.28985.71
3138704-13870483.36284.70
4135214-13521481.26582.61
5133516-13351680.24481.47
6139325-13932583.73685.15
45min1143775-14377586.41086.572.4488.1088.362.47
2146778-14677888.21590.11
3146617-14661788.11889.92
4141023-14102384.75686.55
5138763-13876383.39885.07
6147281-14728188.51790.39
60min1141258-14125884.89786.653.3487.0688.923.36
2149313-14931389.73892.12
3147238-14723888.49190.78
4140695-14069584.55986.82
5137934-13793482.90085.03
6148645-14864589.33791.71
极限1142856-14285685.85885.115.7988.5087.865.72
2146696-14669688.16691.04
3147303-14730388.53091.31
4140807-14080784.62687.36
5125701-12570175.54778.14
6146334-14633487.94890.81
点击查看处理图标(自动生成)
 
原始图谱下载图谱(王丹 于 2024-01-12 13:49:33 完成)
生成报告数据部分下载报告( 于 2025-12-31 19:09:45 完成)
Current page cost:1.461 s