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%
117.821946191946701947981948581947741947440.05
217.841945161946331945740.05
单位质量响应值RSD%判断
10928.4010906.610.15数据可信
供试品溶液-24081201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%
5min1110263-110263102.028104.061.55102.03104.061.55
2112613-112613104.202104.20
3111551-111551103.219103.22
4115143-115143106.543106.54
5111572-111572103.239103.24
6113647-113647105.159105.16
10min1110923-110923102.638104.541.75103.77105.701.74
2112362-112362103.970105.13
3111778-111778103.429104.58
4116519-116519107.816109.00
5112540-112540104.134105.28
6113746-113746105.250106.42
15min1109852-109852101.647103.331.76103.92105.641.76
2110950-110950102.663104.98
3110005-110005101.789104.08
4114709-114709106.141108.52
5111070-111070102.774105.08
6113410-113410104.940107.28
20min1108555-108555100.447102.341.77103.85105.801.76
2110428-110428102.180105.63
3109036-109036100.892104.32
4113702-113702105.210108.77
5109837-109837101.633105.08
6112049-112049103.680107.18
30min1106480-10648098.527100.311.55103.05104.921.55
2108472-108472100.370104.96
3107568-10756899.534104.08
4111210-111210102.904107.63
5107450-10745099.425104.00
6109284-109284101.122105.78
45min1105306-10530697.44199.221.68103.06104.941.67
2106776-10677698.801104.51
3106163-10616398.234103.89
4110324-110324102.084107.96
5106555-10655598.596104.28
6108224-108224100.141105.92
60min1104595-10459596.78398.611.35103.48105.431.36
2106040-10604098.120104.92
3105765-10576597.865104.61
4108291-108291100.203107.21
5106618-10661898.655105.43
6108136-108136100.059106.95
90min1103285-10328595.57197.111.78103.34105.021.77
2104865-10486597.033104.93
3103256-10325695.544103.38
4107941-10794199.879108.00
5104000-10400096.232104.10
6106341-10634198.398106.40
极限1102446-10244694.79496.161.53103.63105.151.52
2103756-10375696.007104.98
3103106-10310695.405104.30
4106980-10698098.990108.22
5103429-10342995.704104.64
6103781-10378196.030105.13
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%
116.19 1974911975601976541976001973541975320.06
216.171959961958691959320.05
单位质量响应值RSD%判断
12200.8612117.010.49数据可信
供试品溶液-24081201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%
5min120732-2073217.49418.763.8717.4918.763.88
222973-2297319.38519.39
323063-2306319.46119.46
422367-2236718.87418.87
522428-2242818.92618.93
621850-2185018.43818.44
10min137069-3706931.28032.723.4031.4732.923.40
240385-4038534.07834.29
339818-3981833.60033.82
438857-3885732.78933.00
539115-3911533.00733.22
637386-3738631.54831.75
15min147634-4763440.19541.312.0240.7441.882.03
250424-5042442.54943.14
349307-4930741.60742.20
448976-4897641.32841.90
549286-4928641.58942.17
648112-4811240.59941.15
20min154467-5446745.96146.812.2246.9547.842.23
257356-5735648.39949.47
356208-5620847.43048.48
455170-5517046.55447.59
555690-5569046.99348.03
653944-5394445.52046.53
30min162342-6234252.60653.783.1754.1155.343.14
267166-6716656.67758.28
363393-6339353.49355.07
464737-6473754.62756.18
563370-6337053.47455.04
661419-6141951.82753.34
45min168937-6893758.17160.665.1660.2662.815.05
275635-7563563.82366.06
369485-6948558.63460.81
476294-7629464.37966.54
573365-7336561.90864.06
667571-6757157.01959.11
60min172536-7253661.20864.866.0163.9467.695.87
281175-8117568.49871.44
374684-7468463.02165.85
481789-8178969.01671.89
579774-7977467.31670.16
671245-7124560.11962.84
90min176407-7640764.47569.586.6567.8873.126.49
286345-8634572.86176.57
383638-8363870.57774.10
489399-8939975.43879.08
583402-8340270.37773.97
675547-7554763.74967.14
极限182013-8201369.20573.264.9273.3377.584.86
289548-8954875.56480.08
388627-8862774.78679.10
491890-9189077.54082.02
587600-8760073.92078.29
681260-8126068.57072.67
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%
117.821946071947331947691946291946221946720.04
217.841945451950421947940.19
单位质量响应值RSD%判断
10924.3510918.950.04数据可信
供试品溶液-1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%
5min1116228-116228107.506105.491.24107.51105.491.24
2113785-113785105.246105.25
3113956-113956105.405105.40
4114726-114726106.117106.12
5111933-111933103.533103.53
6113669-113669105.139105.14
10min1115345-115345106.689104.921.59107.88106.091.59
2112759-112759104.297105.47
3112409-112409103.974105.14
4115081-115081106.445107.62
5110673-110673102.368103.52
6114299-114299105.722106.89
15min1113688-113688105.157103.651.26107.54105.991.26
2111996-111996103.592105.92
3110224-110224101.953104.28
4113504-113504104.987107.35
5110733-110733102.423104.71
6112197-112197103.778106.12
20min1112103-112103103.691102.471.35107.24105.961.35
2111534-111534103.164106.64
3109637-109637101.410104.87
4111631-111631103.254106.78
5108278-108278100.153103.58
6111525-111525103.156106.65
30min1109191-109191100.997101.101.22105.70105.721.21
2109797-109797101.558106.18
3108645-108645100.492105.08
4111195-111195102.851107.53
5107217-10721799.171103.71
6109736-109736101.501106.14
45min1107404-10740499.34499.741.48105.17105.491.45
2109607-109607101.382107.14
3106098-10609898.136103.84
4109164-109164100.972106.79
5105929-10592997.980103.62
6108789-108789100.625106.40
60min1107596-10759699.52299.011.24106.45105.871.23
2108303-108303100.176107.06
3106438-10643898.451105.24
4108265-108265100.141107.08
5104830-10483096.963103.69
6106830-10683098.813105.70
90min1104671-10467196.816102.628.45104.85110.587.79
2119089-119089110.152118.15
3104413-10441396.578104.46
4105821-10582197.880105.93
5126244-126244116.770124.58
6105445-10544597.532105.52
极限1103948-10394896.14896.531.75105.26105.631.66
2106749-10674998.738107.96
3102789-10278995.076104.04
4106341-10634198.361107.50
5102323-10232394.645103.75
6103989-10398996.186105.26
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%
116.19 1950891950331951881949431950301950570.05
216.171939141936711937920.09
单位质量响应值RSD%判断
12047.9911984.660.38数据可信
供试品溶液-1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%
5min122395-2239519.12219.753.0219.1219.753.03
222388-2238819.11619.12
323945-2394520.44520.45
423341-2334119.93019.93
522850-2285019.51019.51
623877-2387720.38720.39
10min138711-3871133.05333.882.3133.2734.102.31
238380-3838032.77132.98
340137-4013734.27134.50
440034-4003434.18334.40
540156-4015634.28734.50
640668-4066834.72434.95
15min147803-4780340.81641.671.3941.4042.261.40
248130-4813041.09641.67
349143-4914341.96042.57
449021-4902141.85642.46
549552-4955242.31042.91
649152-4915241.96842.58
20min153383-5338345.58146.321.3746.6147.381.38
253532-5353245.70846.74
354620-5462046.63747.71
454083-5408346.17847.24
554521-5452146.55247.62
655367-5536747.27548.35
30min160192-6019251.39551.921.6252.9353.491.61
259427-5942750.74152.28
360984-6098452.07153.66
460808-6080851.92153.50
562365-6236553.25054.84
661054-6105452.13153.73
45min166958-6695857.17256.341.7759.2858.491.72
264860-6486055.38057.49
365113-6511355.59657.77
465106-6510655.59057.75
567721-6772157.82360.00
666158-6615856.48958.67
60min169614-6961459.44058.811.6962.1961.591.66
267570-6757057.69460.41
368277-6827758.29861.09
468065-6806558.11760.89
570743-7074360.40363.22
668994-6899458.91061.72
90min171212-7121260.80461.504.4764.2164.934.26
270668-7066860.33963.70
370879-7087960.52063.96
470344-7034460.06363.48
570503-7050360.19963.69
678561-7856167.07970.54
极限178423-7842366.96169.752.7471.0473.872.63
283169-8316971.01375.04
380855-8085569.03873.15
480452-8045268.69372.78
582564-8256470.49774.66
684704-8470472.32476.53
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%
117.821943921945001945071943331945921944650.06
217.841946601947361946980.03
单位质量响应值RSD%判断
10912.7410913.570.01数据可信
供试品溶液-2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%
5min1113176-113176104.765104.351.01104.76104.351.01
2113939-113939105.471105.47
3112378-112378104.026104.03
4110960-110960102.713102.71
5113801-113801105.343105.34
6112134-112134103.800103.80
10min1111799-111799103.490104.000.87104.65105.160.87
2113674-113674105.226106.40
3112672-112672104.298105.45
4110929-110929102.685103.83
5112985-112985104.588105.76
6112027-112027103.701104.85
15min1110032-110032101.854102.570.75104.17104.890.75
2112128-112128103.795106.14
3110830-110830102.593104.91
4110125-110125101.940104.22
5111404-111404103.124105.46
6110339-110339102.138104.44
20min1108659-108659100.583101.711.16104.03105.161.14
2111842-111842103.530107.02
3109773-109773101.615105.07
4108422-108422100.364103.78
5109965-109965101.792105.27
6110587-110587102.368105.81
30min1107996-10799699.970100.350.82104.53104.930.82
2109953-109953101.781106.43
3107441-10744199.456104.04
4107867-10786799.850104.38
5108796-108796100.710105.32
6108359-108359100.306104.88
45min1106159-10615998.26999.070.94103.94104.760.92
2108685-108685100.607106.38
3106673-10667398.745104.43
4106891-10689198.947104.59
5107657-10765799.656105.38
6106056-10605698.174103.87
60min1105680-10568097.82698.051.03104.59104.851.01
2107909-10790999.889106.78
3105444-10544497.607104.39
4104677-10467796.897103.64
5106082-10608298.198105.03
6105734-10573497.876104.66
90min1103454-10345495.76596.670.97103.62104.560.95
2105756-10575697.896105.90
3103641-10364195.938103.81
4103745-10374596.035103.85
5105567-10556797.721105.65
6104447-10444796.684104.56
极限1102166-10216694.57394.850.76103.49103.820.75
2103110-10311095.447104.54
3102817-10281795.176104.11
4101044-10104493.534102.42
5102961-10296195.309104.32
6102724-10272495.089104.03
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%
116.19 1925401926611926661929161929331927430.09
216.171916571914531915550.08
单位质量响应值RSD%判断
11905.0611846.320.35数据可信
供试品溶液-2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%
5min119259-1925916.63915.225.0416.6415.225.04
217695-1769515.28815.29
317264-1726414.91514.92
417048-1704814.72914.73
517669-1766915.26515.27
616733-1673314.45714.46
10min134065-3406529.43127.254.2329.6227.424.24
231487-3148727.20327.37
330855-3085526.65726.82
431148-3114826.91027.07
531511-3151127.22427.39
630179-3017926.07326.23
15min143438-4343837.52834.444.5538.0434.914.55
239530-3953034.15234.62
339046-3904633.73434.20
439552-3955234.17134.63
539353-3935333.99934.47
638282-3828233.07433.52
20min149636-4963642.88339.414.4543.8140.264.44
245488-4548839.30040.15
344324-4432438.29439.13
445255-4525539.09839.94
544610-4461038.54139.39
644380-4438038.34239.16
30min157072-5707249.30845.394.5650.7146.684.54
251972-5197244.90146.19
350483-5048343.61544.88
453041-5304145.82547.10
550960-5096044.02745.31
651682-5168244.65145.89
45min163456-6345654.82351.164.7456.7852.954.69
259222-5922251.16552.95
356172-5617248.53050.28
459324-5932451.25353.04
556188-5618848.54450.31
660905-6090552.61954.36
60min167191-6719158.05054.625.9160.6156.995.78
263239-6323954.63656.99
359444-5944451.35753.64
463097-6309754.51356.87
558731-5873150.74153.05
667636-6763658.43460.76
90min171595-7159561.85558.687.2865.0661.657.07
267649-6764958.44661.41
362572-6257254.05956.92
467983-6798358.73461.70
562606-6260654.08956.96
675116-7511664.89767.87
极限176432-7643266.03462.095.5069.9365.715.42
271020-7102061.35864.97
367778-6777858.55762.01
471108-7110861.43465.05
568044-6804458.78762.26
676815-7681566.36570.06
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