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DSMF-387-240606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(%)99.75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%
110.021729281728441727991728731728871728660.03
210.111730291732181731240.08
单位质量响应值RSD%判断
17252.1017124.040.53数据可信
供试品溶液-U039846批-依折麦布-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%
5min16737-67373.5193.8016.673.523.8016.73
27456-74563.8943.89
37240-72403.7823.78
49508-95084.9664.97
55959-59593.1123.11
66728-67283.5143.51
10min115811-158118.2588.505.168.288.525.19
216738-167388.7438.76
316258-162588.4928.51
417694-176949.2429.27
515501-155018.0968.11
615594-155948.1458.16
15min117717-177179.2549.292.529.329.362.52
218157-181579.4849.55
317085-170858.9248.99
417996-179969.4009.48
518270-182709.5439.61
617483-174839.1329.20
20min117776-177769.2859.301.419.409.421.40
217870-178709.3349.46
317417-174179.0979.21
417772-177729.2839.41
518198-181989.5059.62
617804-178049.2999.41
30min116867-168678.8108.982.038.989.161.99
217390-173909.0839.26
316691-166918.7188.89
417229-172298.9999.18
517557-175579.1709.34
617467-174679.1239.29
45min116961-169618.8598.881.419.089.101.38
217433-174339.1069.33
316756-167568.7528.97
416878-168788.8169.05
517091-170918.9279.15
616889-168898.8219.04
60min116629-166298.6868.722.018.958.991.99
217063-170638.9129.19
316213-162138.4688.73
416813-168138.7829.06
517008-170088.8849.15
616425-164258.5798.85
极限115859-158598.2838.532.498.608.852.44
216792-167928.7719.10
316073-160738.3958.71
416273-162738.5008.83
516844-168448.7989.12
616103-161038.4118.73
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%
110.993094603094483094613094453095723094770.02
211.093100553103643102100.08
单位质量响应值RSD%判断
28159.8727972.050.48数据可信
供试品溶液-U039846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%
5min138268-3826811.26313.3012.1711.2613.3012.17
240700-4070011.97811.98
349377-4937714.53214.53
450600-5060014.89214.89
541975-4197512.35412.35
650293-5029314.80214.80
10min1154323-15432345.41944.5424.8945.4844.6124.87
2127826-12782637.62037.69
3147034-14703443.27443.35
4224061-22406165.94366.03
5121180-12118035.66435.73
6133597-13359739.31939.40
15min1273056-27305680.36379.324.9880.6879.645.04
2260733-26073376.73677.01
3267584-26758478.75379.07
4294799-29479986.76287.21
5259920-25992076.49776.76
6260998-26099876.81477.12
20min1305468-30546889.90290.392.2590.6691.152.27
2304437-30443789.59990.30
3296380-29638087.22887.99
4315963-31596392.99193.92
5312907-31290792.09292.78
6307618-30761890.53591.26
30min1308123-30812390.68493.913.1191.9495.183.05
2324156-32415695.40296.60
3305964-30596490.04891.29
4319692-31969294.08995.54
5329090-32909096.85498.06
6327586-32758696.41297.64
45min1317505-31750593.44595.343.0095.2197.122.92
2332579-33257997.88199.61
3309725-30972591.15592.90
4320360-32036094.28596.26
5334637-33463798.487100.23
6328833-32883396.77998.54
60min1317460-31746093.43295.083.3895.7297.403.33
2328888-32888896.79599.07
3304116-30411689.50491.75
4324834-32483495.60298.10
5335007-33500798.596100.88
6328098-32809896.56398.87
极限1312183-31218391.87995.782.2894.6898.622.24
2328454-32845496.66799.48
3324862-32486295.61098.36
4327314-32731496.33299.36
5334725-33472598.513101.35
6325020-32502095.65798.50
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DSMF-387-240606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(%)99.75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%
110.021730371733031732461732711732611732240.07
210.111746811760651753730.56
单位质量响应值RSD%判断
17287.8217346.490.24数据可信
供试品溶液-U039846批-依折麦布-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%
5min17218-72183.7423.7810.493.743.7810.53
26002-60023.1123.11
38227-82274.2654.27
47870-78704.0804.08
57329-73293.7993.80
67089-70893.6753.68
10min116675-166758.6458.703.018.678.723.01
215897-158978.2418.26
317321-173218.9809.00
417159-171598.8968.92
516955-169558.7908.81
616662-166628.6388.66
15min117683-176839.1679.131.219.249.201.21
217249-172498.9429.01
317519-175199.0829.16
417624-176249.1379.21
517710-177109.1819.25
617875-178759.2679.34
20min117585-175859.1169.141.179.249.271.12
218006-180069.3359.45
317712-177129.1829.31
417603-176039.1269.25
517524-175249.0859.21
617410-174109.0269.15
30min117579-175799.1139.101.519.289.271.47
217866-178669.2629.43
317841-178419.2499.42
417432-174329.0379.21
517322-173228.9809.15
617240-172408.9389.11
45min117252-172528.9448.912.139.169.132.07
217582-175829.1159.33
317520-175209.0839.31
416906-169068.7648.99
516624-166248.6188.84
617189-171898.9119.13
60min116604-166048.6088.722.048.889.001.99
217062-170628.8459.11
317383-173839.0129.29
416770-167708.6948.97
516427-164278.5168.79
616724-167248.6708.94
极限117880-178809.2698.693.599.599.013.47
216908-169088.7659.08
316730-167308.6739.00
416270-162708.4358.76
516507-165078.5588.87
616280-162808.4408.76
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%
110.993097473102013101263101473101723100790.07
211.093130543153313141920.52
单位质量响应值RSD%判断
28214.6528331.110.30数据可信
供试品溶液-U039846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%
5min144308-4430812.94511.6412.6512.9411.6412.67
235539-3553910.38310.38
343429-4342912.68812.69
437348-3734810.91110.91
545067-4506713.16713.17
633353-333539.7449.74
10min1145755-14575542.58342.0020.2942.6542.0620.26
2177136-17713651.75151.81
3126847-12684737.05937.13
4108629-10862931.73631.80
5179198-17919852.35352.43
6124911-12491136.49336.55
15min1273654-27365479.94975.298.4180.2675.588.44
2267556-26755678.16878.51
3239865-23986570.07870.35
4228245-22824566.68366.92
5285457-28545783.39783.76
6251421-25142173.45473.71
20min1313705-31370591.65086.906.5592.4087.626.58
2307411-30741189.81190.59
3284511-28451183.12183.79
4265286-26528677.50478.11
5315561-31556192.19293.02
6298220-29822087.12687.79
30min1333308-33330897.37792.526.2698.6493.726.29
2320772-32077293.71594.99
3307226-30722689.75790.88
4281108-28110882.12783.16
5332102-33210297.02598.36
6325577-32557795.11996.27
45min1339275-33927599.12193.775.97100.9295.485.99
2324561-32456194.82296.62
3313846-31384691.69193.32
4285934-28593483.53785.03
5330240-33024096.48198.36
6331909-33190996.96998.65
60min1338214-33821498.81193.565.48101.1695.795.51
2319624-31962493.37995.71
3315580-31558092.19894.33
4288419-28841984.26386.22
5330172-33017296.46198.88
6329371-32937196.22798.44
极限1330968-33096896.69495.521.2599.6098.281.36
2323699-32369994.57097.41
3325526-32552695.10497.75
4323728-32372894.57897.00
5333171-33317197.337100.29
6324706-32470694.86497.61
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DSMF-387-240606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(%)99.75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%
110.021735681737871738191738851737881737690.07
210.111729491730881730180.06
单位质量响应值RSD%判断
17342.2217113.550.94数据可信
供试品溶液-X013993批-依折麦布-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%
5min16993-69933.6444.4514.383.644.4614.40
210011-100115.2175.22
38308-83084.3304.33
48651-86514.5084.51
59862-98625.1395.14
67456-74563.8863.89
10min115872-158728.2718.513.318.298.543.32
216990-169908.8548.88
316685-166858.6958.72
416543-165438.6218.65
516398-163988.5458.57
615533-155338.0958.12
15min117416-174169.0769.012.239.149.092.22
217911-179119.3349.41
317416-174169.0769.15
417265-172658.9979.07
516848-168488.7808.86
616928-169288.8228.89
20min117308-173089.0208.922.309.149.042.30
217700-177009.2249.35
317292-172929.0119.13
416925-169258.8208.94
516785-167858.7478.87
616655-166558.6798.79
30min116831-168318.7718.811.878.948.981.86
217296-172969.0139.19
317239-172398.9849.16
416788-167888.7498.92
516453-164538.5748.75
616812-168128.7618.92
45min117276-172769.0038.712.789.228.942.76
217155-171558.9409.17
316838-168388.7759.00
416589-165898.6458.87
516428-164288.5618.78
616039-160398.3588.57
60min116492-164928.5948.561.508.868.821.49
216606-166068.6548.93
316654-166548.6798.95
416529-165298.6148.88
516113-161138.3978.67
616104-161048.3928.65
极限116513-165138.6058.501.678.928.821.66
216643-166438.6739.00
316282-162828.4858.80
416334-163348.5128.83
516249-162498.4688.78
615851-158518.2608.57
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%
110.993097663100583100843102523100453100410.06
211.093085353088653087000.08
单位质量响应值RSD%判断
28211.1927835.890.95数据可信
供试品溶液-X013993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%
5min140716-4071612.00212.3815.8712.0012.3815.87
244688-4468813.17213.17
336239-3623910.68210.68
452864-5286415.58215.58
534229-3422910.09010.09
643259-4325912.75112.75
10min1222953-22295365.71954.5221.8365.7954.5921.81
2169174-16917449.86749.94
3141616-14161641.74441.80
4239283-23928370.53270.62
5191496-19149656.44656.50
6145220-14522042.80642.88
15min1288688-28868885.09583.863.3085.5384.243.37
2286598-28659884.47984.83
3275485-27548581.20381.49
4300337-30033788.52989.01
5277149-27714981.69482.06
6278827-27882782.18982.50
20min1302844-30284489.26890.512.4190.1791.352.42
2316667-31666793.34294.16
3302044-30204489.03289.77
4315123-31512392.88793.86
5298590-29859088.01488.84
6307169-30716990.54391.31
30min1303994-30399489.60794.033.3291.0195.373.26
2324684-32468495.70697.04
3320001-32000194.32595.56
4327429-32742996.51598.00
5308304-30830490.87792.19
6329672-32967297.17698.44
45min1316014-31601493.15094.811.9695.0596.671.96
2328539-32853996.84298.71
3321795-32179594.85496.62
4326858-32685896.34698.37
5312428-31242892.09393.91
6324245-32424595.57697.38
60min1308915-30891591.05794.562.9393.4796.942.90
2328749-32874996.90499.31
3320140-32014094.36696.65
4329782-32978297.20899.77
5310022-31002291.38493.71
6327096-32709696.41798.76
极限1315320-31532092.94595.811.7595.8798.731.73
2332354-33235497.966100.91
3325819-32581996.04098.85
4328174-32817496.73499.83
5323293-32329395.29698.13
6325347-32534795.90198.78
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DSMF-387-240606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(%)99.75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%
110.021744041749931751831753811753811750680.24
210.111748691746531747610.09
单位质量响应值RSD%判断
17471.8617285.950.76数据可信
供试品溶液-X013993批-依折麦布-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%
5min18878-88784.5864.3011.354.594.3011.34
27939-79394.1014.10
39028-90284.6644.66
46836-68363.5313.53
59359-93594.8354.83
67864-78644.0624.06
10min116828-168288.6938.422.398.728.442.38
216651-166518.6028.62
316209-162098.3738.40
416130-161308.3338.35
516184-161848.3608.39
615752-157528.1378.16
15min117909-179099.2529.001.829.339.071.83
217669-176699.1289.20
317163-171638.8668.94
417112-171128.8408.91
517228-172288.9008.97
617402-174028.9909.06
20min117802-178029.1968.962.039.329.082.01
217469-174699.0249.15
317338-173388.9579.08
417375-173758.9769.09
516718-167188.6368.76
617342-173428.9599.08
30min117606-176069.0958.901.249.279.081.22
217186-171868.8789.05
317244-172448.9089.08
417288-172888.9319.10
517083-170838.8259.00
616993-169938.7788.95
45min117695-176959.1418.871.659.379.091.64
217007-170078.7869.01
316910-169108.7368.96
417218-172188.8959.11
517201-172018.8869.11
617012-170128.7889.00
60min116910-169108.7368.620.929.018.890.91
216547-165478.5488.82
316799-167998.6788.95
416710-167108.6328.90
516619-166198.5858.85
616517-165178.5338.80
极限116671-166718.6128.511.998.948.831.97
216636-166368.5948.91
316837-168378.6989.02
416572-165728.5618.87
516023-160238.2778.59
616122-161228.3288.64
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%
110.993115513124253127263128803129683125100.19
211.093121133112693116910.20
单位质量响应值RSD%判断
28435.8528105.590.83数据可信
供试品溶液-X013993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%
5min164128-6412818.73713.1823.5418.7413.1823.54
243387-4338712.67712.68
336890-3689010.77910.78
435515-3551510.37710.38
549815-4981514.55514.56
640966-4096611.97011.97
10min1219668-21966864.18455.8916.3364.2955.9616.32
2205589-20558960.07060.14
3213600-21360062.41162.47
4205132-20513259.93759.99
5157544-15754446.03246.11
6146135-14613542.69842.76
15min1293924-29392485.88082.832.6286.3483.222.62
2279865-27986581.77282.18
3272562-27256279.63980.05
4287259-28725983.93384.32
5286713-28671383.77384.11
6280640-28064081.99982.30
20min1315064-31506492.05789.453.3692.9990.293.33
2297843-29784387.02587.88
3289335-28933584.53985.39
4309997-30999790.57691.43
5314111-31411191.77992.58
6310434-31043490.70491.46
30min1328142-32814295.87893.384.6897.3394.734.63
2307765-30776589.92491.27
3295559-29555986.35887.68
4325789-32578995.19196.55
5335876-33587698.13899.45
6324501-32450194.81496.08
45min1333256-33325697.37294.595.4399.3596.455.36
2312108-31210891.19393.03
3293925-29392585.88187.68
4329108-32910896.16098.05
5341750-34175099.854101.71
6332310-33231097.09698.89
60min1324295-32429594.75493.344.8197.2895.734.75
2307043-30704389.71392.06
3296084-29608486.51188.79
4322591-32259194.25696.68
5338807-33880798.994101.41
6327931-32793195.81798.15
极限1324864-32486494.92095.001.1197.9797.901.12
2324424-32442494.79297.64
3323874-32387494.63197.39
4323752-32375294.59697.54
5332147-33214797.048100.01
6321716-32171694.00196.86
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