左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217 对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数20000
标示量(mg)0.8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.001776741772841775521775281773271774730.10
216.061773611773731773670.01
单位质量响应值RSD%判断
11092.0611044.020.31数据可信
供试品溶液-24032702批-叶酸-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%
5min120789-2078919.27118.155.0219.2718.155.02
218243-1824316.91116.91
319559-1955918.13118.13
418720-1872017.35317.35
519669-1966918.23318.23
620486-2048618.99018.99
10min134737-3473732.20131.902.5932.4232.102.60
232914-3291430.51130.70
334245-3424531.74531.95
434080-3408031.59231.78
535418-3541832.83233.03
635088-3508832.52632.74
15min141308-4130838.29238.252.5138.8638.802.52
239415-3941536.53837.06
341323-4132338.30638.86
441038-4103838.04238.59
542288-4228839.20139.77
642175-4217539.09639.67
20min144590-4459041.33541.283.1642.3342.263.14
242656-4265639.54240.47
345560-4556042.23443.21
443052-4305239.90940.88
546159-4615942.78943.79
645183-4518341.88542.89
30min148046-4804644.53944.496.2346.0045.936.09
247291-4729143.83945.21
349373-4937345.76947.22
442456-4245639.35740.77
550611-5061146.91648.39
650170-5017046.50747.98
45min151779-5177947.99948.145.4849.9550.075.39
251007-5100747.28349.14
352716-5271648.86850.83
446944-4694443.51745.36
554257-5425750.29652.30
654869-5486950.86352.85
60min152927-5292749.06349.633.8851.5552.103.87
251595-5159547.82850.21
354250-5425050.29052.79
450943-5094347.22449.55
556118-5611852.02154.58
655401-5540151.35753.91
90min153667-5366749.74950.343.5452.7853.363.54
252201-5220148.39051.31
355745-5574551.67554.73
452040-5204048.24151.10
556281-5628152.17255.31
655873-5587351.79454.92
极限158166-5816653.92054.783.5457.5058.363.52
257884-5788453.65857.11
359712-5971255.35358.99
456669-5666952.53255.92
562709-6270958.13161.85
659434-5943455.09558.80
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.091885971887121892931890041884611888130.18
216.981886491886021886260.02
单位质量响应值RSD%判断
11048.1611108.720.39数据可信
供试品溶液-24032702批-左氨氯地平-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%
5min1113597-113597103.586100.792.19103.59100.792.20
2107705-10770598.21498.21
3109806-109806100.129100.13
4112845-112845102.901102.90
5108154-10815498.62398.62
6111106-111106101.315101.31
10min1111574-111574101.742100.751.65102.89101.871.65
2107481-10748198.00999.10
3109710-109710100.042101.15
4111928-111928102.064103.21
5109940-109940100.252101.35
6112285-112285102.390103.52
15min1111244-111244101.44199.771.98103.72102.011.98
2105605-10560596.29998.48
3109462-10946299.816102.04
4111305-111305101.496103.77
5108432-10843298.876101.09
6110446-110446100.713102.98
20min1109784-109784100.10999.091.63103.52102.441.64
2106262-10626296.898100.15
3107537-10753798.060101.39
4110356-110356100.631104.04
5107584-10758498.103101.41
6110487-110487100.750104.13
30min1107825-10782598.32395.753.83102.84100.193.65
2104291-10429195.10099.43
3106825-10682597.411101.83
497317-9731788.74193.26
5105647-10564796.337100.74
6108088-10808898.563103.06
45min1107407-10740797.94295.781.68103.56101.291.67
2102793-10279393.73499.12
3104641-10464195.420100.92
4105860-10586096.531102.04
5103362-10336294.25399.72
6106143-10614396.789102.39
60min1106685-10668597.28395.591.45103.98102.171.45
2102808-10280893.748100.17
3103632-10363294.499101.06
4105532-10553296.232102.81
5104228-10422895.043101.56
6106111-10611196.760103.43
90min1101927-10192792.94592.871.13100.73100.511.13
2100427-10042791.57799.04
3101938-10193892.955100.57
4103210-10321094.115101.77
5100621-10062191.75499.33
6102924-10292493.854101.60
极限1103447-10344794.33192.022.04103.15100.691.98
297708-9770889.09797.58
399869-9986991.06899.72
4102590-10259093.549102.25
5100411-10041191.562100.15
6101421-10142192.483101.27
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217 对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数20000
标示量(mg)0.8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.001787941795961786571792651787451790110.23
216.061781291783051782170.07
单位质量响应值RSD%判断
11188.1911096.950.58数据可信
供试品溶液-24041201批-叶酸-pH1.2.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%
5min122192-2219220.43520.561.7620.4320.561.77
221960-2196020.22120.22
322380-2238020.60820.61
422122-2212220.37020.37
522221-2222120.46120.46
623073-2307321.24621.25
10min136016-3601633.16432.564.1533.3932.794.13
235821-3582132.98433.21
334286-3428631.57131.80
434996-3499632.22532.45
533431-3343130.78431.01
637615-3761534.63634.87
15min141967-4196738.64438.064.4039.2438.654.38
242024-4202438.69639.29
339766-3976636.61737.20
439945-3994536.78237.37
539921-3992136.76037.33
644379-4437940.86541.49
20min144966-4496641.40540.654.1942.4341.674.17
244198-4419840.69841.72
342747-4274739.36240.35
442683-4268339.30340.30
542875-4287539.48040.46
647417-4741743.66244.74
30min148106-4810644.29643.913.8045.7845.373.80
248141-4814144.32945.80
345742-4574242.12043.54
447372-4737243.62145.05
546004-4600442.36143.78
650738-5073846.72048.28
45min150902-5090246.87145.794.9448.8547.744.89
250295-5029546.31248.28
348598-4859844.74946.64
448498-4849844.65746.57
546477-4647742.79644.68
653602-5360249.35751.44
60min151463-5146347.38846.322.8949.8948.782.79
252679-5267948.50750.99
349475-4947545.55747.95
449892-4989245.94148.35
548994-4899445.11447.48
649332-4933245.42548.05
90min153012-5301248.81448.213.9451.8451.183.90
252453-5245348.29951.32
350755-5075546.73649.63
451452-5145247.37750.30
550400-5040046.40949.27
656040-5604051.60254.73
极限158284-5828453.66853.213.9057.2456.723.82
256456-5645651.98555.54
355153-5515350.78554.20
459193-5919354.50557.95
556330-5633051.86955.25
661292-6129256.43860.14
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.091908531911651910011908921909141909650.07
216.981883301885921884610.10
单位质量响应值RSD%判断
11174.0811099.000.48数据可信
供试品溶液-24041201批-左氨氯地平-pH1.2.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%
5min1110688-110688100.407100.022.46100.41100.022.46
2112620-112620102.160102.16
3108940-10894098.82298.82
4112413-112413101.972101.97
5111433-111433101.083101.08
6105459-10545995.66495.66
10min1110245-110245100.00699.272.51101.12100.382.51
2110478-110478100.217101.35
3108822-10882298.71599.81
4112028-112028101.623102.76
5110812-110812100.520101.64
6104243-10424394.56195.62
15min1109311-10931199.15898.572.45101.39100.782.45
2109925-10992599.715101.96
3108770-10877098.668100.86
4110487-110487100.225102.49
5110094-11009499.869102.11
6103372-10337293.77195.88
20min1107221-10722197.26296.572.56100.5999.882.55
2107452-10745297.472100.83
3105304-10530495.52398.81
4109866-10986699.662103.04
5107129-10712997.179100.53
6101761-10176192.31095.47
30min1106128-10612896.27195.911.79100.68100.291.82
2106537-10653796.642101.08
3105589-10558995.782100.13
4107231-10723197.272101.75
5106817-10681796.896101.33
6102062-10206292.58396.76
45min1103887-10388794.23894.972.1299.72100.422.12
2105768-10576895.944101.46
3105298-10529895.518100.93
4107007-10700797.068102.63
5105529-10552995.728101.23
6100670-10067091.32096.53
60min1103931-10393194.27895.550.99100.80102.050.95
2104923-10492395.178101.76
3105112-10511295.349101.83
4107075-10707597.130103.77
5105214-10521495.442102.01
6105713-10571395.895102.12
90min1103640-10364094.01493.242.58101.59100.812.53
2104929-10492995.183102.82
3101818-10181892.36199.90
4104477-10447794.773102.49
5104027-10402794.365102.00
697849-9784988.76196.05
极限1102051-10205192.57392.232.68101.19100.842.62
2101937-10193792.469101.16
3101534-10153492.104100.67
4104299-10429994.612103.39
5103668-10366894.039102.72
696579-9657987.60995.89
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217 对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数20000
标示量(mg)0.8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.001773031781541771161778211773751775540.24
216.061769941771181770560.05
单位质量响应值RSD%判断
11097.1211024.660.47数据可信
供试品溶液-24041202批-叶酸-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%
5min122296-2229620.68220.981.8720.6820.981.88
222960-2296021.29821.30
321954-2195420.36520.36
422581-2258120.94620.95
523007-2300721.34121.34
622886-2288621.22921.23
10min140223-4022337.31138.462.6137.5438.692.60
242231-4223139.17439.41
340653-4065337.71037.94
440764-4076437.81338.05
543009-4300939.89540.13
641857-4185738.82739.06
15min151870-5187048.11549.493.0048.7650.152.98
254011-5401150.10150.77
351954-5195448.19348.84
453601-5360149.72050.37
556102-5610252.04052.72
652602-5260248.79449.46
20min158012-5801253.81255.842.7954.9957.052.78
260695-6069556.30157.53
359008-5900854.73655.92
460878-6087856.47157.68
562833-6283358.28459.54
659739-5973955.41456.62
30min164925-6492560.22563.203.8362.0065.033.80
268710-6871063.73665.59
366161-6616161.37163.16
468168-6816863.23365.07
572549-7254967.29769.20
668282-6828263.33965.16
45min170409-7040965.31268.084.8367.7670.614.74
270222-7022265.13867.70
372210-7221066.98269.45
474276-7427668.89971.43
579833-7983374.05376.71
673383-7338368.07070.60
60min173608-7360868.27970.434.7571.4573.724.67
272859-7285967.58470.87
373339-7333968.02971.24
476891-7689171.32474.63
582417-8241776.45079.93
676434-7643470.90074.19
90min176425-7642570.89271.442.5674.8275.522.44
277873-7787372.23576.27
375049-7504969.61673.59
480569-8056974.73678.83
575800-7580070.31274.64
676403-7640370.87274.94
极限183769-8376977.70480.893.5682.4285.753.51
286275-8627580.02984.87
385964-8596479.74084.48
487311-8731180.99085.91
593001-9300186.26891.38
686884-8688480.59485.45
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.091881671883141882591886121884121883530.10
216.981886261885841886050.02
单位质量响应值RSD%判断
11021.2411107.480.56数据可信
供试品溶液-24041202批-左氨氯地平-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%
5min1108492-10849299.058102.241.7299.06102.241.72
2111892-111892102.162102.16
3111770-111770102.051102.05
4114238-114238104.304104.30
5112646-112646102.851102.85
6112806-112806102.997103.00
10min1109366-10936699.856101.450.83100.96102.590.83
2112097-112097102.349103.48
3111221-111221101.549102.68
4111159-111159101.493102.65
5111414-111414101.726102.87
6111423-111423101.734102.88
15min1108152-10815298.747100.781.61100.96103.051.60
2110231-110231100.646102.92
3109724-109724100.183102.44
4113514-113514103.643105.93
5110818-110818101.182103.45
6109861-109861100.308102.58
20min1106606-10660697.33698.991.87100.64102.381.84
2107831-10783198.454101.84
3108587-10858799.145102.52
4112321-112321102.554105.99
5107329-10732997.996101.39
6107862-10786298.483101.87
30min1106687-10668797.41098.410.75101.80102.890.77
2107725-10772598.357102.84
3107852-10785298.473102.95
4109117-10911799.628104.21
5107949-10794998.562103.05
6107365-10736598.029102.51
45min1104822-10482295.70796.591.78101.18102.161.74
2105229-10522996.079101.66
3104506-10450695.418100.99
4109510-10951099.987105.67
5104842-10484295.725101.31
6105812-10581296.611102.18
60min1102273-10227393.38096.212.2299.91102.862.15
2104149-10414995.092101.74
3105952-10595296.739103.37
4109325-10932599.818106.61
5105537-10553796.360103.00
6105018-10501895.886102.53
90min1101167-10116792.37094.511.5099.94102.221.48
2104551-10455195.459103.16
3103594-10359494.586102.29
4105525-10552596.349104.25
5102374-10237493.472101.19
6103833-10383394.804102.52
极限199706-9970691.03694.092.0099.63102.861.94
2102417-10241793.511102.27
3103260-10326094.281103.04
4106043-10604396.822105.80
5103099-10309994.134102.89
6103768-10376894.745103.51
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217 对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数20000
标示量(mg)0.8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.001768791769921765991768661773101769290.15
216.061769981766151768060.16
单位质量响应值RSD%判断
11058.0611009.090.32数据可信
供试品溶液-24041203批-叶酸
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min120541-2054119.10118.205.2819.1018.205.28
218135-1813516.86416.86
319612-1961218.23718.24
418675-1867517.36617.37
519643-1964318.26618.27
620803-2080319.34519.34
10min134540-3454032.11931.992.6732.3332.202.68
232900-3290030.59330.78
334437-3443732.02332.23
433942-3394231.56231.76
535474-3547432.98733.19
635145-3514532.68132.90
15min141610-4161038.69338.512.5439.2639.072.55
239505-3950536.73537.26
341529-4152938.61839.18
441161-4116138.27538.82
542319-4231939.35239.92
642382-4238239.41139.99
20min144689-4468941.55641.352.9342.5642.332.92
242759-4275939.76140.70
345235-4523542.06443.05
443042-4304240.02440.99
546083-4608342.85243.86
644967-4496741.81542.83
30min148229-4822944.84845.332.9846.3146.782.97
247285-4728543.97045.35
349430-4943045.96547.42
447008-4700843.71245.13
550364-5036446.83348.32
650162-5016246.64548.13
45min151850-5185048.21548.295.3750.1750.235.24
251151-5115147.56549.43
352550-5255048.86650.83
446990-4699043.69645.60
554255-5425550.45152.45
654757-5475750.91852.92
60min152669-5266948.97749.614.0851.4752.104.03
251460-5146047.85250.25
354119-5411950.32552.83
450568-5056847.02349.41
556242-5624252.29954.86
655056-5505651.19653.76
90min153615-5361549.85650.473.7152.9053.503.68
252008-5200848.36251.29
355721-5572151.81554.88
451978-5197848.33451.24
556499-5649952.53855.68
655814-5581451.90155.03
极限180750-8075075.08977.702.4978.6881.302.45
281331-8133175.62979.09
386008-8600879.97883.62
484072-8407278.17881.62
584289-8428978.38082.11
684912-8491278.95982.67
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.091873191877651874821876511874001875230.10
216.981880341879341879840.04
单位质量响应值RSD%判断
10972.6711070.910.64数据可信
供试品溶液-24041203批-左氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1113416-113416103.954101.402.12103.95101.402.12
2107737-10773798.74998.75
3109997-109997100.820100.82
4112913-112913103.493103.49
5108366-10836699.32599.33
6111320-111320102.033102.03
10min1112018-112018102.673101.461.66103.83102.591.66
2107542-10754298.57099.67
3110245-110245101.048102.17
4111857-111857102.525103.68
5110060-110060100.878101.98
6112440-112440103.059104.19
15min1111326-111326102.038100.471.85104.33102.721.85
2106107-10610797.25599.45
3109798-109798100.638102.88
4111445-111445102.147104.44
5108566-10856699.509101.73
6110452-110452101.237103.52
20min1110069-110069100.88699.751.52104.32103.121.53
2106503-10650397.618100.89
3107875-10787598.875102.24
4110262-110262101.063104.49
5107798-10779898.805102.13
6110439-110439101.225104.63
30min1108518-10851899.46597.991.39104.02102.471.41
2104568-10456895.844100.20
3106750-10675097.844102.30
4108018-10801899.006103.55
5105887-10588797.053101.48
6107708-10770898.722103.25
45min1107087-10708798.15396.281.54103.81101.851.55
2103134-10313494.53099.95
3104080-10408095.397100.94
4106110-10611097.258102.90
5103669-10366995.020100.53
6106183-10618397.324102.95
60min1106405-10640597.52896.131.35104.27102.761.35
2102986-10298694.394100.87
3103678-10367895.028101.64
4105000-10500096.240102.97
5104718-10471895.982102.54
6106467-10646797.585104.29
90min1101877-10187793.37893.401.07101.21101.111.09
2100171-10017191.81499.34
3101937-10193793.433101.10
4103100-10310094.499102.30
5101350-10135092.895100.52
6102977-10297794.386102.18
极限1102281-10228193.74893.581.13102.62102.331.03
2102336-10233693.798102.34
3100157-10015791.801100.50
4102171-10217193.647102.49
5103756-10375695.100103.76
6101917-10191793.414102.25
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