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对照品来源自制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%
110.521805721805911806131808361805511806330.07
210.471807921809601808760.07
单位质量响应值RSD%判断
17170.4417275.640.44数据可信
供试品溶液-2024011221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%
5min112473-124736.5026.645.836.506.645.87
212383-123836.4556.45
313904-139047.2487.25
412645-126456.5916.59
513268-132686.9166.92
611785-117856.1436.14
10min117166-171668.9489.131.238.989.161.22
217710-177109.2319.27
317335-173359.0369.08
417612-176129.1809.22
517576-175769.1629.20
617670-176709.2119.24
15min116679-166798.6949.082.318.789.162.29
217362-173629.0509.14
317630-176309.1909.28
417457-174579.1009.19
517871-178719.3159.40
617484-174849.1149.20
20min116822-168228.7699.072.488.909.212.46
217965-179659.3649.50
316968-169688.8458.99
417532-175329.1399.28
517663-176639.2079.35
617480-174809.1129.25
30min116988-169888.8558.943.929.049.133.81
217257-172578.9959.18
316638-166388.6738.86
416844-168448.7808.97
516737-167378.7248.92
618449-184499.6179.80
45min115889-158898.2828.713.758.518.943.68
217619-176199.1849.42
316217-162178.4538.69
417141-171418.9359.17
516797-167978.7569.00
616564-165648.6348.87
60min115632-156328.1488.412.868.438.702.78
216426-164268.5628.85
315642-156428.1538.44
416788-167888.7519.04
516323-163238.5088.80
616017-160178.3498.64
极限115521-155218.0908.443.268.418.783.18
217008-170088.8659.20
315727-157278.1988.53
416397-163978.5478.88
516297-162978.4958.83
616234-162348.4628.80
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.741481751481151478221481461478451480210.12
210.731481991483581482780.08
单位质量响应值RSD%判断
13782.2213819.010.19数据可信
供试品溶液-2024011221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%
5min197173-9717358.28360.263.6858.2860.263.68
2101714-10171461.00761.01
3104893-10489362.91362.91
4103005-10300561.78161.78
5100969-10096960.56060.56
695029-9502956.99757.00
10min1139653-13965383.76283.681.6684.0984.011.66
2139027-13902783.38783.73
3140392-14039284.20584.55
4143364-14336485.98886.33
5138086-13808682.82283.16
6136557-13655781.90582.22
15min1149261-14926189.52590.471.6490.3191.271.64
2148054-14805488.80189.60
3153198-15319891.88692.70
4153851-15385192.27893.10
5151899-15189991.10791.90
6148774-14877489.23390.00
20min1157500-15750094.46694.051.5895.7595.351.58
2155892-15589293.50294.80
3157052-15705294.19895.53
4161125-16112596.64197.97
5153858-15385892.28293.58
6155431-15543193.22594.49
30min1167938-167938100.72798.103.55102.5499.923.47
2158938-15893895.32997.14
3160742-16074296.41198.26
4161852-16185297.07798.95
5158664-15866495.16596.98
6173169-173169103.864105.65
45min1162286-16228697.33798.331.3299.71100.701.30
2166586-16658699.916102.26
3162846-16284697.673100.06
4166696-16669699.982102.39
5163445-16344598.032100.38
6161799-16179997.04599.41
60min1161243-16124396.71196.952.3399.6299.862.29
2158615-15861595.13598.03
3160756-16075696.41999.35
4169020-169020101.376104.34
5160990-16099096.56099.45
6159228-15922895.50398.40
极限1161431-16143196.82497.431.58100.27100.891.56
2163189-16318997.879101.31
3161069-16106996.607100.07
4167192-167192100.280103.81
5159887-15988795.89899.32
6161900-16190097.105100.54
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对照品来源自制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%
110.521818151818141818591820591818491818790.06
210.471808361811831810100.14
单位质量响应值RSD%判断
17288.8817288.440.01数据可信
供试品溶液-2024011222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%
5min112618-126186.5526.5010.726.556.5010.77
212841-128416.6686.67
311808-118086.1326.13
410619-106195.5145.51
514704-147047.6357.64
612556-125566.5206.52
10min118179-181799.4409.361.499.489.401.52
218074-180749.3859.42
317719-177199.2019.24
417692-176929.1879.22
518377-183779.5439.59
618092-180929.3959.43
15min117854-178549.2719.203.199.369.293.20
218147-181479.4239.51
317294-172948.9809.07
416907-169078.7798.86
518452-184529.5829.68
617617-176179.1489.24
20min117244-172448.9549.091.579.099.221.61
217728-177289.2069.35
317269-172698.9679.10
417246-172468.9559.09
517833-178339.2609.41
617659-176599.1709.31
30min117066-170668.8628.742.619.058.932.60
217068-170688.8639.06
316274-162748.4518.64
416264-162648.4458.63
517094-170948.8769.08
617219-172198.9419.13
45min116778-167788.7128.672.018.958.902.04
216429-164298.5318.77
316349-163498.4908.72
416444-164448.5398.77
517191-171918.9279.18
616931-169318.7929.03
60min116813-168138.7318.692.399.028.982.40
216876-168768.7639.05
316240-162408.4338.71
416313-163138.4718.75
517315-173158.9919.29
616849-168498.7499.04
极限116591-165918.6158.541.368.958.871.39
216688-166888.6669.00
316151-161518.3878.71
416195-161958.4108.73
516471-164718.5538.90
616588-165888.6148.95
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.741489221488601490381489161483361488140.19
210.731484061483401483730.04
单位质量响应值RSD%判断
13856.0513827.870.15数据可信
供试品溶液-2024011222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%
5min195279-9527956.97658.033.3756.9858.033.37
2103037-10303761.61661.62
394169-9416956.31356.31
495802-9580257.28957.29
598453-9845358.87458.87
695482-9548257.09857.10
10min1135632-13563281.10780.991.5581.4281.311.56
2137985-13798582.51482.86
3132860-13286079.45079.76
4137263-13726382.08382.40
5133115-13311579.60279.93
6135779-13577981.19581.51
15min1147075-14707587.95087.701.5188.7288.481.50
2149550-14955089.43090.23
3144241-14424186.25587.01
4144071-14407186.15486.93
5148429-14842988.76089.53
6146611-14661187.67388.44
20min1149974-14997489.68491.121.5890.9492.381.56
2153763-15376391.94993.25
3151046-15104690.32591.56
4155656-15565693.08194.33
5149897-14989789.63890.90
6153935-15393592.05293.31
30min1157256-15725694.03892.681.8495.7994.451.82
2156063-15606393.32595.13
3150338-15033889.90191.64
4155091-15509192.74494.51
5153175-15317591.59893.36
6158024-15802494.49896.26
45min1155628-15562893.06593.621.3495.3495.901.32
2155241-15524192.83395.16
3154546-15454692.41894.65
4158867-15886795.00297.29
5155495-15549592.98595.25
6159515-15951595.38997.68
60min1158861-15886194.99895.291.3597.7998.091.34
2162435-16243597.13599.98
3155756-15575693.14195.89
4159676-15967695.48598.30
5159727-15972795.51698.30
6159607-15960795.44498.27
极限1159581-15958195.42994.611.0698.7597.941.05
2158606-15860694.84698.23
3155839-15583993.19196.46
4160390-16039095.91299.26
5156994-15699493.88297.20
6157844-15784494.39097.74
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对照品来源自制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%
110.521806251804991807361807011806081806340.06
210.471808611810791809700.09
单位质量响应值RSD%判断
17170.5317284.620.47数据可信
供试品溶液-2024011223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%
5min112718-127186.6286.079.436.636.079.41
210200-102005.3155.32
311026-110265.7465.75
412044-120446.2766.28
510921-109215.6915.69
612953-129536.7506.75
10min117995-179959.3789.211.859.419.241.87
217612-176129.1789.21
317098-170988.9108.94
417696-176969.2229.26
517658-176589.2029.23
617977-179779.3689.41
15min117779-177799.2659.342.349.359.432.31
217885-178859.3209.40
318570-185709.6779.76
417282-172829.0069.09
518042-180429.4029.48
618026-180269.3949.48
20min117518-175189.1299.082.309.279.212.27
217614-176149.1799.31
316794-167948.7528.89
417075-170758.8989.03
517856-178569.3059.44
617649-176499.1979.34
30min117028-170288.8748.961.989.069.141.94
217118-171188.9209.10
316789-167898.7498.93
416984-169848.8519.04
517668-176689.2079.39
617524-175249.1329.32
45min116944-169448.8308.751.559.078.981.54
216675-166758.6908.92
316416-164168.5558.79
416680-166808.6928.93
517177-171778.9519.19
616801-168018.7559.00
60min116404-164048.5488.612.528.848.902.48
216570-165708.6358.92
316035-160358.3568.64
416155-161558.4198.70
516816-168168.7639.05
617144-171448.9349.23
极限116655-166558.6798.723.559.029.053.44
217696-176969.2229.55
315953-159538.3138.64
416339-163398.5158.84
516753-167538.7309.07
616972-169728.8449.19
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.741472061471591471531471641471201471600.03
210.731476371477941477160.08
单位质量响应值RSD%判断
13702.0513766.640.34数据可信
供试品溶液-2024011223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%
5min195515-9551557.56556.613.6857.5756.613.68
292226-9222655.58355.58
390953-9095354.81654.82
495542-9554257.58257.58
590113-9011354.31054.31
699232-9923259.80559.81
10min1133276-13327680.32380.521.7280.6480.841.73
2132620-13262079.92880.24
3130654-13065478.74379.05
4134562-13456281.09881.42
5133024-13302480.17180.47
6137525-13752582.88483.22
15min1146886-14688688.52688.802.3889.2989.562.36
2145084-14508487.44088.19
3152606-15260691.97392.72
4144998-14499887.38888.16
5143878-14387886.71387.46
6150591-15059190.75991.55
20min1148531-14853189.51790.462.2490.7791.712.22
2150250-15025090.55391.79
3144871-14487187.31188.56
4149906-14990690.34691.60
5152250-15225091.75892.99
6154742-15474293.26094.56
30min1152270-15227091.77194.272.0293.5396.022.01
2155769-15576993.87995.62
3154770-15477093.27795.02
4156040-15604094.04395.80
5158034-15803495.24496.98
6161589-16158997.38799.20
45min1159120-15912095.89995.221.2598.1697.501.25
2155629-15562993.79596.06
3155832-15583293.91796.17
4157527-15752794.93997.22
5159650-15965096.21898.49
6160204-16020496.55298.91
60min1155938-15593893.98195.212.3596.7898.022.32
2156689-15668994.43497.22
3154544-15454493.14195.92
4156875-15687594.54697.35
5158877-15887795.75298.55
6164975-16497599.428102.32
极限1157979-15797995.21195.122.1498.5398.462.12
2155633-15563393.79797.11
3153384-15338492.44295.74
4157687-15768795.03598.37
5158875-15887595.75199.09
6163413-16341398.486101.93
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对照品来源自制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%
110.521818691820301820941819061820911819980.06
210.471818791820801819800.08
单位质量响应值RSD%判断
17300.1917381.090.33数据可信
供试品溶液-2024011821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%
5min112937-129376.6986.428.826.706.428.81
212167-121676.2996.30
312432-124326.4366.44
410391-103915.3805.38
513504-135046.9916.99
613018-130186.7406.74
10min118118-181189.3809.512.919.429.542.92
218246-182469.4469.48
318676-186769.6699.70
417483-174839.0519.08
518773-187739.7199.76
618921-189219.7969.83
15min118065-180659.3539.642.119.449.722.10
218994-189949.8349.92
318804-188049.7359.82
418173-181739.4089.49
518835-188359.7519.84
618811-188119.7399.83
20min117484-174849.0529.351.989.199.492.01
218380-183809.5169.66
318081-180819.3619.50
417784-177849.2079.34
518386-183869.5199.67
618198-181989.4219.57
30min116739-167398.6669.132.908.869.322.82
217771-177719.2009.40
318111-181119.3769.57
418111-181119.3769.56
517487-174879.0539.25
617541-175419.0819.28
45min116318-163188.4488.923.558.699.163.47
217136-171368.8729.12
318201-182019.4239.67
417041-170418.8229.06
517206-172068.9089.16
617430-174309.0249.27
60min116410-164108.4968.691.478.788.981.48
216837-168378.7179.01
317025-170258.8149.11
416631-166318.6108.89
516766-167668.6808.98
617063-170638.8349.13
极限116407-164078.4948.661.678.839.001.64
216991-169918.7979.14
316410-164108.4968.84
416618-166188.6038.94
516886-168868.7429.09
617003-170038.8039.15
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.742958012956142960002958652961532958870.07
210.732964412961162962780.08
单位质量响应值RSD%判断
27550.0027612.120.16数据可信
供试品溶液-2024011821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%
5min1135496-13549640.66441.592.4940.6641.582.49
2133330-13333040.01440.01
3140165-14016542.06542.07
4140608-14060842.19842.20
5142428-14242842.74442.74
6139395-13939541.83441.83
10min1227212-22721268.18967.641.4968.4267.871.48
2220961-22096166.31366.54
3226586-22658668.00168.23
4221554-22155466.49166.73
5226714-22671468.04068.28
6229237-22923768.79769.03
15min1257174-25717477.18177.580.8977.7978.180.90
2256160-25616076.87777.47
3257781-25778177.36377.97
4257221-25722177.19577.80
5262072-26207278.65179.27
6260538-26053878.19178.81
20min1273982-27398282.22582.220.9883.2683.260.98
2272040-27204081.64382.66
3270427-27042781.15982.20
4273422-27342282.05783.09
5276084-27608482.85683.91
6277783-27778383.36684.42
30min1284341-28434185.33487.141.8486.8288.641.81
2287957-28795786.41987.89
3295180-29518088.58790.08
4298506-29850689.58591.07
5288176-28817686.48588.00
6288025-28802586.44087.95
45min1297702-29770289.34490.521.2391.3192.501.22
2296814-29681489.07891.03
3302916-30291690.90992.89
4306183-30618391.88993.88
5301737-30173790.55592.55
6304300-30430091.32493.32
60min1306510-30651091.98791.831.0494.4594.321.03
2301054-30105490.35092.80
3308156-30815692.48194.97
4309430-30943092.86495.36
5303316-30331691.02993.53
6307469-30746992.27594.78
极限1310737-31073793.25692.601.5196.2395.591.47
2305876-30587691.79794.75
3300485-30048590.17993.18
4312811-31281193.87896.89
5309433-30943392.86595.87
6311976-31197693.62896.64
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DSMF-387-240606对照品来源自制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%
110.521819671824991829961833381833711828340.33
210.471816931823381820160.26
单位质量响应值RSD%判断
17379.6617384.530.02数据可信
供试品溶液-2024012021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%
5min112287-122876.3466.428.016.356.428.01
213022-130226.7266.73
310488-104885.4175.42
413122-131226.7776.78
512675-126756.5466.55
612946-129466.6866.69
10min118081-180819.3389.351.809.379.381.82
218607-186079.6109.65
317926-179269.2589.29
418080-180809.3389.38
517631-176319.1069.14
618249-182499.4259.46
15min118157-181579.3789.381.799.469.461.79
218224-182249.4129.50
318482-184829.5469.63
418180-181809.3909.48
517537-175379.0589.14
618333-183339.4699.56
20min118005-180059.2999.261.789.449.401.76
218241-182419.4219.56
317564-175649.0719.21
417952-179529.2729.41
517557-175579.0689.21
618295-182959.4499.59
30min116900-169008.7298.822.318.929.012.26
216924-169248.7418.94
317255-172558.9129.10
417386-173868.9809.17
516464-164648.5038.69
617539-175399.0599.25
45min116739-167398.6458.771.078.889.011.11
217074-170748.8189.06
316849-168498.7028.94
417162-171628.8649.11
516855-168558.7058.94
617155-171558.8609.11
60min116542-165428.5448.583.528.838.873.38
217044-170448.8039.10
317234-172348.9019.18
415580-155808.0478.34
516467-164678.5058.79
616806-168068.6808.97
极限117108-171088.8368.851.689.179.191.62
217477-174779.0279.37
317009-170098.7859.12
417289-172898.9299.27
517276-172768.9239.25
616649-166498.5998.94
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.742961782971602976732983092981942975030.30
210.732961432965792963610.11
单位质量响应值RSD%判断
27700.4727619.850.21数据可信
供试品溶液-2024012021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%
5min1130286-13028638.98941.283.4338.9941.283.42
2141527-14152742.35342.35
3139378-13937841.70941.71
4133992-13399240.09840.10
5141279-14127942.27842.28
6141279-14127942.27842.28
10min1218884-21888465.50266.651.9465.7266.881.94
2225028-22502867.34167.58
3225988-22598867.62867.86
4216971-21697164.93065.15
5221493-22149366.28366.52
6227995-22799568.22968.46
15min1248364-24836474.32476.002.0574.9076.602.05
2251353-25135375.21975.83
3259372-25937277.61878.23
4251706-25170675.32475.91
5251455-25145575.24975.85
6261444-26144478.23878.85
20min1267662-26766280.09980.951.6081.0981.971.60
2267955-26795580.18781.21
3267370-26737080.01281.05
4268841-26884180.45281.45
5273037-27303781.70882.73
6278244-27824483.26684.31
30min1280843-28084384.04485.292.0085.4886.761.99
2277810-27781083.13684.61
3288027-28802786.19387.68
4285140-28514085.32986.78
5284068-28406885.00986.48
6294086-29408688.00789.52
45min1295330-29533088.37989.701.7390.2891.641.72
2294162-29416288.02989.96
3299429-29942989.60591.57
4297661-29766189.07691.00
5305084-30508491.29893.25
6306767-30676791.80193.80
60min1302626-30262690.56290.943.7592.9693.383.67
2305015-30501591.27793.70
3311505-31150593.21995.68
4281939-28193984.37286.79
5310967-31096793.05895.51
6311251-31125193.14395.65
极限1314120-31412094.00294.861.9696.9097.811.92
2313625-31362593.85496.78
3315396-31539694.38497.36
4314423-31442394.09296.98
5329591-32959198.632101.60
6314756-31475694.19297.22
点击查看处理图标(自动生成)
 
原始图谱下载图谱(谢鑫慧 于 2024-08-21 11:02:48 完成)
生成报告数据部分下载报告(谢鑫慧 于 2024-08-21 11:03:29 完成)
Current page cost:1.229 s