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%
117.821954441953261955641958091954511955190.10
217.841950321953111951720.11
单位质量响应值RSD%判断
10971.8910940.130.21数据可信
供试品溶液-24081901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%
5min1113537-113537104.688103.930.90104.69103.930.90
2112971-112971104.166104.17
3113758-113758104.892104.89
4112961-112961104.157104.16
5111982-111982103.254103.25
6111087-111087102.429102.43
10min1112747-112747103.959103.311.35105.12104.471.35
2112949-112949104.146105.30
3113632-113632104.775105.94
4112277-112277103.526104.68
5111259-111259102.587103.73
6109421-109421100.893102.03
15min1112202-112202103.457102.501.38105.78104.801.37
2109770-109770101.215103.53
3113155-113155104.336106.67
4111678-111678102.974105.28
5111073-111073102.416104.70
6109076-109076100.575102.83
20min1108943-108943100.452101.321.54103.92104.761.51
2110159-110159101.573105.01
3111792-111792103.079106.57
4110148-110148101.563105.01
5111164-111164102.500105.92
6107079-10707998.733102.11
30min1109389-109389100.86399.781.41105.45104.351.40
2107835-10783599.430104.00
3109941-109941101.372106.01
4108247-10824799.810104.39
5108334-10833499.890104.45
6105559-10555997.332101.81
45min1108126-10812699.69998.441.63105.40104.121.60
2105612-10561297.381103.05
3109135-109135100.629106.39
4107085-10708598.739104.43
5106308-10630898.022103.70
6104318-10431896.187101.74
60min1104259-10425996.13396.001.36102.95102.771.34
2105347-10534797.136103.89
3105658-10565897.423104.30
4104296-10429696.167102.95
5103312-10331295.260102.02
6101809-10180993.874100.50
90min1103004-10300494.97694.701.06102.86102.541.07
2101943-10194393.998101.83
3103946-10394695.844103.81
4103496-10349695.430103.28
5102890-10289094.871102.69
6100975-10097593.105100.77
极限1101903-10190393.96193.800.80102.90102.690.83
2101749-10174993.819102.70
3102901-10290194.881103.91
4101922-10192293.978102.89
5101489-10148993.579102.45
6100409-10040992.583101.28
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%
116.191995951994081993571994111992371994020.07
216.171991391989241990320.08
单位质量响应值RSD%判断
12316.3712308.720.05数据可信
供试品溶液-24081901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%
5min126529-2652922.10721.095.6622.1121.095.67
226480-2648022.06622.07
326613-2661322.17722.18
424876-2487620.72920.73
523512-2351219.59219.59
623810-2381019.84119.84
10min145337-4533737.77936.364.6038.0236.604.61
244774-4477437.31037.56
345939-4593938.28138.53
443037-4303735.86336.09
541487-4148734.57134.79
641260-4126034.38234.60
15min156502-5650247.08345.523.8947.7546.163.91
255247-5524746.03746.70
357166-5716647.63648.31
454398-5439845.33045.96
552673-5267343.89244.49
651746-5174643.12043.72
20min161979-6197951.64751.333.2552.8452.483.26
262333-6233351.94253.11
364214-6421453.50954.71
462064-6206451.71852.85
560844-6084450.70151.79
658183-5818348.48449.57
30min170944-7094459.11757.862.6860.8859.582.71
269183-6918357.65059.40
371538-7153859.61261.41
469771-6977158.14059.85
568959-6895957.46359.12
666242-6624255.19956.82
45min177720-7772064.76463.623.5167.1865.983.48
274307-7430761.92064.31
380579-8057967.14669.60
476782-7678263.98266.34
575714-7571463.09265.38
672989-7298960.82163.06
60min179632-7963266.35765.843.1969.5068.913.20
278545-7854565.45168.53
382998-8299869.16272.37
479673-7967366.39169.46
577929-7792964.93867.93
675315-7531562.76065.67
90min184611-8461170.50669.543.3174.3873.343.30
282342-8234268.61572.42
387462-8746272.88276.85
484394-8439470.32574.13
582678-8267868.89572.61
679226-7922666.01969.63
极限187900-8790073.24772.192.5477.9176.762.59
287245-8724572.70177.27
389400-8940074.49779.28
486960-8696072.46377.05
585150-8515070.95575.43
683144-8314469.28473.62
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%
117.821949711946971950731955131955261951560.19
217.841949231952171950700.11
单位质量响应值RSD%判断
10951.5210934.420.12数据可信
供试品溶液-24081902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%
5min1109568-109568101.149101.550.61101.15101.550.61
2109701-109701101.271101.27
3110414-110414101.930101.93
4109090-109090100.707100.71
5110908-110908102.386102.39
6110342-110342101.863101.86
10min1108734-108734100.379101.240.93101.50102.370.92
2110888-110888102.367103.49
3109003-109003100.627101.76
4108564-108564100.222101.34
5110510-110510102.018103.16
6110292-110292101.817102.95
15min1106136-10613697.980100.311.23100.22102.571.21
2108852-108852100.488102.75
3109293-109293100.895103.15
4108655-108655100.306102.54
5110052-110052101.595103.87
6109000-109000100.624102.89
20min1106627-10662798.43499.140.56101.76102.510.56
2107576-10757699.310102.69
3107465-10746599.207102.58
4106828-10682898.619101.97
5107565-10756599.299102.70
6108291-10829199.970103.35
30min1106733-10673398.53198.651.01102.95103.120.99
2106372-10637298.198102.68
3107033-10703398.808103.28
4105102-10510297.026101.47
5107947-10794799.652104.16
6107977-10797799.680104.17
45min1103978-10397895.98896.990.86101.50102.550.84
2104454-10445496.427102.00
3106223-10622398.061103.63
4104429-10442996.404101.93
5105776-10577697.648103.26
6105507-10550797.400103.00
60min1105075-10507597.00196.910.36103.58103.550.37
2104898-10489896.837103.48
3105003-10500396.934103.60
4104284-10428496.271102.86
5105354-10535497.258103.95
6105246-10524697.159103.84
90min1102825-10282594.92495.270.41102.58102.990.42
2103597-10359795.636103.36
3102853-10285394.950102.69
4102818-10281894.917102.58
5103729-10372995.758103.53
6103401-10340195.455103.22
极限1101416-10141693.62394.420.78102.34103.200.75
2102836-10283694.934103.72
3102813-10281394.913103.71
4101588-10158893.782102.50
5103294-10329495.357104.20
6101745-10174593.927102.75
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%
116.191991141992971989411992911992151991720.08
216.171988771988731988750.01
单位质量响应值RSD%判断
12302.1612299.010.02数据可信
供试品溶液-24081902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%
5min120937-2093717.46417.726.0317.4617.726.04
222737-2273718.96518.97
322387-2238718.67318.67
421710-2171018.10818.11
519388-1938816.17216.17
620293-2029316.92716.93
10min137061-3706130.91331.124.8231.1131.324.83
240136-4013633.47833.69
338007-3800731.70231.91
437180-3718031.01231.21
534589-3458928.85129.03
636865-3686530.74930.94
15min146403-4640338.70539.313.2839.2439.843.31
249121-4912140.97241.55
347874-4787439.93240.49
447949-4794939.99540.54
544675-4467537.26437.76
646713-4671338.96439.49
20min153945-5394544.99644.512.6045.9645.492.62
254171-5417145.18446.22
354049-5404945.08346.09
453964-5396445.01246.00
550575-5057542.18543.10
653453-5345344.58645.55
30min162174-6217451.86051.312.1853.3352.792.17
260704-6070450.63452.17
361469-6146951.27252.78
462973-6297352.52654.02
559319-5931949.47850.86
662477-6247752.11253.57
45min168160-6816056.85356.592.4358.9058.632.41
266647-6664755.59157.69
368781-6878157.37159.44
469998-6999858.38660.46
565321-6532154.48556.42
668159-6815956.85258.89
60min172788-7278860.71360.571.9863.3963.242.00
272850-7285060.76563.48
373004-7300460.89363.60
474410-7441062.06664.79
569996-6999658.38460.92
672634-7263460.58463.25
90min176733-7673364.00464.011.7967.3567.351.81
276941-7694164.17767.57
377090-7709064.30167.69
478540-7854065.51168.92
574302-7430261.97665.16
676807-7680764.06567.41
极限180619-8061967.24567.431.8771.3171.491.89
282036-8203668.42772.54
381237-8123767.76071.86
482254-8225468.60972.75
578070-7807065.11968.99
680845-8084567.43371.49
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%
117.821951921945011954081950091951051950430.18
217.841949271945371947320.15
单位质量响应值RSD%判断
10945.1710915.470.20数据可信
供试品溶液-24081901批-左氨氯地平-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%
5min1111271-111271102.840102.070.89102.84102.070.89
2109190-109190100.916100.92
3109788-109788101.469101.47
4111102-111102102.683102.68
5111529-111529103.078103.08
6109737-109737101.422101.42
10min1111790-111790103.319101.811.70104.46102.941.69
2107565-10756599.414100.54
3108762-108762100.521101.65
4110538-110538102.162103.30
5112543-112543104.015105.16
6109719-109719101.405102.53
15min1109972-109972101.639100.761.04103.93103.031.05
2107848-10784899.676101.90
3107712-10771299.550101.79
4109416-109416101.125103.40
5110484-110484102.112104.41
6108720-108720100.482102.74
20min1108704-108704100.46799.211.43103.89102.601.42
2104910-10491096.961100.29
3106919-10691998.817102.17
4107524-10752499.377102.78
5109186-109186100.913104.35
6106843-10684398.747102.12
30min1107460-10746099.31798.071.43103.85102.561.42
2103543-10354395.697100.11
3105523-10552397.527101.98
4106188-10618898.142102.65
5107758-10775899.593104.15
6106203-10620398.156102.62
45min1106512-10651298.44197.161.42104.08102.741.41
2102435-10243594.673100.15
3104588-10458896.663102.20
4105609-10560997.607103.20
5106313-10631398.257103.92
6105290-10529097.312102.87
60min1104066-10406696.18195.791.15102.91102.451.16
2101607-10160793.908100.43
3103083-10308395.272101.88
4104658-10465896.728103.41
5104833-10483396.889103.64
6103619-10361995.767102.41
90min1103333-10333395.50394.921.54103.31102.641.51
2100151-10015192.562100.13
3101935-10193594.211101.88
4102818-10281895.027102.78
5104861-10486196.915104.75
6103128-10312895.314103.02
极限1101968-10196894.24294.181.64103.10102.951.60
299407-9940791.875100.47
3100525-10052592.908101.62
4103140-10314095.325104.13
5103876-10387696.005104.91
6102477-10247794.712103.47
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%
116.191988291989371996381985101989481989720.21
216.171985951981161983560.18
单位质量响应值RSD%判断
12289.8112266.910.14数据可信
供试品溶液-24081901批-叶酸-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%
5min128181-2818123.54923.105.1423.5523.105.13
229023-2902324.25224.25
328105-2810523.48523.49
428639-2863923.93123.93
525269-2526921.11521.12
626629-2662922.25222.25
10min146058-4605838.48738.184.3638.7538.444.36
246728-4672839.04739.32
345217-4521737.78438.05
448811-4881140.78741.05
544159-4415936.90037.13
643180-4318036.08236.33
15min154851-5485145.83446.614.1746.5247.294.16
257624-5762448.15248.85
355615-5561546.47347.15
458879-5887949.20049.92
555518-5551846.39247.04
652167-5216743.59244.24
20min160384-6038450.45851.224.3151.6652.424.29
263003-6300352.64653.88
360950-6095050.93152.13
464732-6473254.09155.36
561730-6173051.58352.74
656945-5694547.58448.72
30min167478-6747856.38656.723.8358.1458.483.79
269334-6933457.93759.76
366181-6618155.30257.07
469943-6994358.44660.31
570560-7056058.96160.69
663754-6375453.27454.94
45min174236-7423662.03362.403.8064.4264.803.77
276067-7606763.56366.03
372899-7289960.91663.29
476619-7661964.02466.54
578013-7801365.18967.58
670200-7020058.66060.91
60min177928-7792865.11866.425.3068.1969.515.21
279941-7994166.80069.97
376715-7671564.10467.16
485229-8522971.21974.45
583208-8320869.53072.64
673883-7388361.73864.64
90min183441-8344169.72571.796.1673.5275.626.02
287303-8730372.95276.87
381395-8139568.01571.78
492190-9219077.03681.05
591576-9157676.52280.41
679599-7959966.51470.11
极限190780-9078075.85777.054.3180.4381.684.29
294241-9424178.74983.48
389090-8909074.44578.97
496209-9620980.39485.27
596247-9624780.42685.16
686681-8668172.43276.76
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%
117.821950741948371947211952441953251950400.14
217.841943061944061943560.04
单位质量响应值RSD%判断
10945.0110894.390.33数据可信
供试品溶液-24081902批-左氨氯地平-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%
5min1112247-112247103.843103.151.63103.84103.161.63
2113761-113761105.244105.24
3112956-112956104.499104.50
4110511-110511102.237102.24
5108846-108846100.697100.70
6110697-110697102.409102.41
10min1113577-113577105.073103.762.17106.23104.912.17
2114199-114199105.649106.82
3114424-114424105.857107.02
4112349-112349103.937105.07
5108584-108584100.454101.57
6109828-109828101.605102.74
15min1111344-111344103.008102.241.81105.33104.541.81
2112538-112538104.112106.46
3112236-112236103.833106.17
4110686-110686102.399104.69
5107482-10748299.435101.67
6108794-108794100.648102.92
20min1111775-111775103.406101.691.77106.87105.121.77
2110801-110801102.505106.01
3112115-112115103.721107.21
4109255-109255101.075104.50
5107444-10744499.400102.74
6108113-108113100.018103.40
30min1109383-109383101.193100.412.11105.81104.982.09
2110455-110455102.185106.82
3110868-110868102.567107.21
4108032-10803299.944104.50
5104592-10459296.761101.21
6107919-10791999.839104.34
45min1107351-10735199.31498.721.95105.05104.401.94
2108259-108259100.154105.93
3109570-109570101.366107.15
4105311-10531197.426103.09
5103933-10393396.151101.67
6105803-10580397.881103.49
60min1106689-10668998.70197.332.26105.54104.112.23
2108343-108343100.231107.12
3106688-10668898.700105.61
4104181-10418196.381103.13
5102402-10240294.735101.32
6102957-10295795.248101.94
90min1105899-10589997.97096.442.08105.91104.302.06
2106980-10698098.970106.97
3105574-10557497.670105.68
4102492-10249294.818102.63
5101736-10173694.119101.76
6102806-10280695.109102.86
极限1104034-10403496.24595.422.45105.27104.352.40
2106030-10603098.091107.19
3105068-10506897.201106.29
4103017-10301795.304104.17
599038-9903891.623100.31
6101670-10167094.058102.87
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%
116.191986131985791982571986741986671985580.09
216.171977021978401977710.05
单位质量响应值RSD%判断
12264.2412230.740.20数据可信
供试品溶液-24081902批-叶酸-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%
5min123845-2384519.97620.705.5519.9820.705.56
225724-2572421.55021.55
326845-2684522.48922.49
424540-2454020.55820.56
523017-2301719.28219.28
624296-2429620.35320.35
10min139925-3992533.44634.873.8633.6735.113.87
243269-4326936.24836.49
342924-4292435.95836.21
442457-4245735.56735.80
539415-3941533.01933.23
641793-4179335.01135.24
15min149069-4906941.10642.273.8541.7042.893.84
252806-5280644.23744.88
350017-5001741.90042.55
452101-5210143.64644.27
547628-4762839.89940.48
651127-5112742.83043.45
20min156164-5616447.05047.273.4448.1048.363.42
258088-5808848.66249.80
354256-5425645.45246.57
458788-5878849.24850.36
554142-5414245.35646.38
657119-5711947.85048.94
30min164164-6416453.75253.295.2255.3254.915.13
265888-6588855.19656.87
358798-5879849.25750.88
467076-6707656.19157.85
560304-6030450.51852.05
665481-6548154.85556.48
45min172473-7247360.71259.215.0462.8861.414.94
273012-7301261.16463.45
364761-6476154.25256.42
473658-7365861.70563.99
567852-6785256.84158.93
672309-7230960.57562.81
60min178892-7889266.09064.323.7768.9367.183.74
279561-7956166.65069.62
375782-7578263.48466.25
478764-7876465.98368.95
571920-7192060.24962.97
675742-7574263.45166.36
90min190083-9008375.46572.826.8979.0476.406.66
295170-9517079.72683.43
389692-8969275.13778.61
485118-8511871.30575.00
578106-7810665.43168.82
683400-8340069.86673.48
极限195837-9583780.28577.525.6684.7081.905.51
299371-9937183.24687.84
394261-9426178.96583.28
490589-9058975.88980.38
584178-8417870.51874.64
690969-9096976.20780.59
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