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%
110.051727611729131728451728921730121728850.06
210.091726181726921726550.04
单位质量响应值RSD%判断
17202.4917111.500.38数据可信
供试品溶液-U039846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%
5min18806-88064.6085.046.324.615.046.31
29502-95024.9724.97
39923-99235.1925.19
49144-91444.7854.78
510496-104965.4925.49
69927-99275.1945.19
10min116371-163718.5668.601.488.598.631.49
216527-165278.6488.68
316121-161218.4358.46
416467-164678.6178.64
516840-168408.8128.84
616299-162998.5298.56
15min116975-169758.8828.841.488.968.911.45
217074-170748.9349.01
316711-167118.7448.82
417216-172169.0089.08
516535-165358.6528.73
616811-168118.7978.87
20min116939-169398.8638.801.858.998.921.84
216676-166768.7268.85
316524-165248.6468.77
417241-172419.0229.15
516462-164628.6148.74
617053-170538.9239.05
30min117072-170728.9338.773.119.108.943.06
216961-169618.8759.05
316165-161658.4588.63
417071-170718.9339.11
516046-160468.3968.57
617264-172649.0349.21
45min116857-168578.8218.751.949.048.981.93
216458-164588.6128.83
316310-163108.5348.75
417096-170968.9469.17
516604-166048.6888.91
617053-170538.9239.15
60min117026-170268.9098.721.979.189.001.93
216701-167018.7399.01
316227-162278.4918.76
416980-169808.8859.16
516338-163388.5498.82
616767-167678.7739.05
极限116917-169178.8528.642.749.178.962.68
216256-162568.5068.83
316228-162288.4918.81
416866-168668.8259.15
515854-158548.2968.61
616901-169018.8449.17
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%
111.043049673051303050233051203053053051090.05
211.073046203046873046540.02
单位质量响应值RSD%判断
27636.6827520.690.30数据可信
供试品溶液-U039846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%
5min143730-4373013.09711.1226.3313.1011.1226.36
227026-270268.0958.09
341464-4146412.41912.42
422517-225176.7446.74
545635-4563513.66813.67
642336-4233612.68012.68
10min1105864-10586431.70728.817.4731.7828.887.50
288790-8879026.59326.64
396564-9656428.92228.99
487470-8747026.19826.24
5101934-10193430.53030.61
696616-9661628.93729.01
15min1135145-13514540.47736.066.5140.7336.286.52
2112814-11281433.78933.98
3115967-11596734.73334.96
4118957-11895735.62935.81
5121923-12192336.51736.76
6117637-11763735.23335.46
20min1146645-14664543.92139.316.7944.4039.736.79
2120953-12095336.22636.61
3125112-12511237.47237.89
4134496-13449640.28340.66
5131376-13137639.34839.80
6128853-12885338.59339.02
30min1155954-15595446.70941.586.9347.4342.226.91
2130183-13018338.99139.57
3130771-13077139.16739.80
4142880-14288042.79443.40
5135363-13536340.54241.21
6137892-13789241.30041.94
45min1148066-14806644.34739.946.6745.3240.816.66
2122436-12243636.67137.47
3127422-12742238.16439.01
4136578-13657840.90641.75
5135396-13539640.55241.44
6130193-13019338.99439.86
60min1153742-15374246.04740.946.6847.2742.046.67
2128567-12856738.50739.51
3130981-13098139.23040.29
4139174-13917441.68442.75
5135431-13543140.56341.68
6132309-13230939.62840.72
极限1168170-16817050.36844.946.6551.8546.266.62
2142118-14211842.56543.78
3144165-14416543.17944.46
4155006-15500646.42647.73
5144127-14412743.16744.51
6146721-14672143.94445.25
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%
110.051738751740431742521743341742381741480.11
210.091736361747451741900.46
单位质量响应值RSD%判断
17328.1617263.630.27数据可信
供试品溶液-U039846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%
5min19421-94214.8905.053.094.895.053.11
29972-99725.1765.18
39856-98565.1165.12
49895-98955.1365.14
59282-92824.8184.82
69959-99595.1695.17
10min116210-162108.4148.461.468.448.491.45
216512-165128.5718.60
315976-159768.2928.32
416618-166188.6268.65
516328-163288.4758.50
616156-161568.3868.41
15min117160-171608.9078.862.498.988.932.48
216840-168408.7418.82
316550-165508.5908.66
416919-169198.7828.86
517128-171288.8908.96
617806-178069.2429.32
20min116788-167888.7148.771.908.848.901.86
217259-172598.9589.08
316799-167998.7208.84
416684-166848.6608.79
517328-173288.9949.12
616539-165398.5858.71
30min116990-169908.8198.682.298.998.862.25
217196-171968.9269.10
316582-165828.6078.78
416765-167658.7028.88
516731-167318.6848.86
616084-160848.3488.52
45min116571-165718.6018.641.668.828.861.65
217135-171358.8949.12
316634-166348.6348.85
416550-165508.5908.81
516718-167188.6788.90
616300-163008.4618.68
60min116827-168278.7348.543.799.008.803.69
216989-169898.8189.09
315283-152837.9338.20
416577-165778.6048.87
516754-167548.6968.97
616251-162518.4358.70
极限116731-167318.6848.591.509.008.911.44
216797-167978.7199.04
316431-164318.5298.84
416776-167768.7089.02
516298-162988.4608.78
616265-162658.4428.76
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%
111.043068613071473072443072533070883071190.06
211.073070603087423079010.39
单位质量响应值RSD%判断
27818.7527814.000.02数据可信
供试品溶液-U039846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%
5min147207-4720714.01810.7424.1414.0210.7424.13
226527-265277.8777.88
337147-3714711.03111.03
425047-250477.4387.44
539305-3930511.67211.67
641823-4182312.41912.42
10min197555-9755528.96927.047.9529.0527.107.99
284580-8458025.11625.16
393594-9359427.79227.85
479715-7971523.67123.71
594285-9428527.99828.06
696712-9671228.71828.79
15min1120999-12099935.93033.926.6336.1734.136.67
2105351-10535131.28431.47
3119287-11928735.42235.64
4103892-10389230.85031.02
5119074-11907435.35935.58
6116694-11669434.65234.88
20min1130640-13064038.79337.326.3139.2337.716.34
2118157-11815735.08635.44
3132584-13258439.37039.78
4114269-11426933.93234.28
5133099-13309939.52339.94
6125236-12523637.18937.61
30min1141648-14164842.06239.586.0542.7240.196.07
2125050-12505037.13337.69
3140431-14043141.70142.33
4123240-12324036.59637.13
5138621-13862141.16341.80
6130800-13080038.84139.47
45min1139047-13904741.29038.896.1442.1839.726.16
2122883-12288336.49037.25
3137185-13718540.73741.60
4121183-12118335.98536.72
5137834-13783440.92941.79
6127731-12773137.92938.77
60min1142278-14227842.24939.795.8743.3740.845.89
2125206-12520637.18038.14
3134527-13452739.94741.04
4126717-12671737.62838.56
5144096-14409642.78943.88
6131211-13121138.96340.02
极限1151688-15168845.04344.193.9446.4045.453.98
2141471-14147142.00943.18
3151242-15124244.91146.22
4146158-14615843.40144.55
5157669-15766946.81948.15
6144616-14461642.94344.21
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%
110.051739681738321739361740301739521739440.05
210.091745861751971748920.25
单位质量响应值RSD%判断
17307.8617333.200.11数据可信
供试品溶液-X013993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%
5min18328-83284.3174.6510.454.324.6510.43
29391-93914.8684.87
39241-92414.7904.79
49743-97435.0505.05
59769-97695.0635.06
67390-73903.8303.83
10min115833-158338.2068.274.168.238.294.16
216215-162158.4048.43
316288-162888.4428.47
416579-165798.5938.62
516093-160938.3418.37
614692-146927.6157.64
15min116924-169248.7728.743.638.848.823.63
217362-173628.9999.07
317395-173959.0169.09
416859-168598.7388.81
516971-169718.7968.87
615712-157128.1448.21
20min116498-164988.5518.601.798.678.721.83
216781-167818.6988.82
316650-166508.6308.75
416979-169798.8008.92
516566-165668.5868.71
616102-161028.3468.45
30min116950-169508.7858.643.098.958.813.10
216773-167738.6948.87
317236-172368.9349.11
416882-168828.7508.92
516424-164248.5138.68
615770-157708.1748.33
45min116400-164008.5008.541.888.718.751.90
216543-165438.5748.79
316785-167858.7008.92
416756-167568.6858.91
516379-163798.4898.71
615945-159458.2658.47
60min117312-173128.9738.583.249.238.843.18
216878-168788.7489.02
316665-166658.6388.91
416532-165328.5698.84
516102-161028.3468.61
615822-158228.2018.45
极限117248-172488.9408.692.769.259.002.75
217038-170388.8319.15
317079-170798.8529.17
416839-168398.7289.05
516356-163568.4788.79
616067-160678.3288.62
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%
111.043062063059193061073062023060173060900.05
211.073073133082583077860.22
单位质量响应值RSD%判断
27725.5427803.610.20数据可信
供试品溶液-X013993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%
5min148129-4812914.31810.6321.2514.3210.6321.26
227466-274668.1718.17
331175-311759.2759.27
434649-3464910.30810.31
541100-4110012.22712.23
631823-318239.4679.47
10min1115327-11532734.31031.165.8134.3931.225.82
2103394-10339430.76030.81
3103991-10399130.93830.99
4107184-10718431.88731.94
597720-9772029.07229.14
6100877-10087730.01130.06
15min1149484-14948444.47240.936.0844.7441.166.08
2134917-13491740.13840.35
3141502-14150242.09742.32
4137803-13780340.99741.23
5123972-12397236.88237.11
6137784-13778440.99141.21
20min1146685-14668543.63940.495.5844.1640.955.58
2132692-13269239.47639.92
3135014-13501440.16740.62
4137492-13749240.90441.37
5124171-12417136.94137.38
6140475-14047541.79242.24
30min1160022-16002247.60743.905.9048.3744.585.90
2142697-14269742.45343.11
3150545-15054544.78745.47
4148513-14851344.18344.87
5133940-13394039.84740.49
6149636-14963644.51745.20
45min1149993-14999344.62342.373.9045.6543.303.93
2137310-13731040.85041.74
3143020-14302042.54943.48
4143006-14300642.54543.48
5134987-13498740.15941.02
6146211-14621143.49844.42
60min1156769-15676946.63943.224.5047.9144.384.52
2140902-14090241.91943.04
3145393-14539343.25544.42
4143608-14360842.72443.89
5137836-13783641.00642.09
6147159-14715943.78044.95
极限1169382-16938250.39147.594.1451.9248.994.17
2154481-15448145.95847.31
3162686-16268648.39949.81
4158869-15886947.26448.67
5150993-15099344.92146.23
6163336-16333648.59350.00
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%
110.051747251749081751161752651753521750730.15
210.091759251768711763980.38
单位质量响应值RSD%判断
17420.2017482.460.26数据可信
供试品溶液-X013993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%
5min110555-105555.4304.8911.675.434.8911.68
29742-97425.0125.01
39857-98575.0715.07
48675-86754.4634.46
57715-77153.9693.97
610494-104945.3985.40
10min115728-157288.0918.081.448.128.111.46
215922-159228.1918.22
315800-158008.1288.16
415622-156228.0368.06
515311-153117.8767.90
615889-158898.1748.20
15min116446-164468.4608.441.058.548.521.08
216615-166158.5478.62
316362-163628.4178.49
416505-165058.4918.56
516106-161068.2858.35
616433-164338.4548.53
20min116776-167768.6308.591.018.758.711.00
216513-165138.4958.62
316713-167138.5988.72
416673-166738.5778.69
516542-165428.5108.62
616974-169748.7328.85
30min116431-164318.4538.461.668.628.621.65
216728-167288.6058.77
316204-162048.3368.50
416720-167208.6018.77
516050-160508.2578.42
616488-164888.4828.65
45min116641-166418.5618.602.058.788.812.03
217025-170258.7588.97
316825-168258.6558.87
416326-163268.3998.61
516331-163318.4018.61
617127-171278.8119.03
60min116242-162428.3558.442.218.628.702.18
216634-166348.5578.82
316685-166858.5838.85
415878-158788.1688.43
516191-161918.3298.58
616822-168228.6548.92
极限116458-164588.4678.471.098.788.781.05
216797-167978.6418.95
316439-164398.4578.77
416256-162568.3638.67
516455-164558.4658.76
616401-164018.4378.75
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%
111.043067563069503073893075583076433072590.13
211.073091343106673099000.35
单位质量响应值RSD%判断
27831.4327994.580.42数据可信
供试品溶液-X013993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%
5min136250-3625010.72710.6019.6810.7310.6019.71
230819-308199.1209.12
341857-4185712.38612.39
435036-3503610.36810.37
545070-4507013.33713.34
625798-257987.6347.63
10min195852-9585228.36529.357.7528.4229.417.77
291525-9152527.08427.13
3104408-10440830.89730.97
494151-9415127.86127.92
5112149-11214933.18733.26
697011-9701128.70828.75
15min1125482-12548237.13337.627.0137.3537.847.01
2115834-11583434.27834.48
3129100-12910038.20438.44
4120820-12082035.75335.97
5141810-14181041.96542.22
6129673-12967338.37338.57
20min1137625-13762540.72641.518.6641.1541.948.65
2124849-12484936.94637.34
3140702-14070241.63742.09
4131789-13178938.99939.41
5159650-15965047.24447.74
6146931-14693143.48043.90
30min1130737-13073738.68839.937.3639.3440.607.36
2123715-12371536.61037.21
3134526-13452639.80940.49
4128021-12802137.88438.51
5150886-15088644.65045.40
6141812-14181241.96542.62
45min1134961-13496139.93841.858.4140.8042.738.38
2130824-13082438.71439.51
3145105-14510542.94043.84
4128365-12836537.98638.82
5157669-15766946.65847.66
6151604-15160444.86345.75
60min1132139-13213939.10341.018.7340.1942.138.70
2128423-12842338.00339.02
3144271-14427142.69343.84
4124340-12434036.79537.84
5155276-15527645.95047.21
6147131-14713143.53944.68
极限1147942-14794243.77944.824.6445.0846.164.73
2146540-14654043.36444.59
3155243-15524345.94047.32
4143887-14388742.57943.83
5163187-16318748.29149.81
6151951-15195144.96646.35
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