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
217.821945161946331945740.05
单位质量响应值RSD%判断
10928.4010918.860.07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%
5min1110263-110263101.970104.011.55101.97104.001.55
2112613-112613104.144104.14
3111551-111551103.161103.16
4115143-115143106.483106.48
5111572-111572103.181103.18
6113647-113647105.100105.10
10min1110923-110923102.581104.481.75103.71105.641.74
2112362-112362103.911105.07
3111778-111778103.371104.52
4116519-116519107.756108.94
5112540-112540104.076105.22
6113746-113746105.191106.36
15min1109852-109852101.590103.271.76103.86105.581.76
2110950-110950102.606104.92
3110005-110005101.732104.03
4114709-114709106.082108.46
5111070-111070102.717105.02
6113410-113410104.881107.22
20min1108555-108555100.391102.281.77103.79105.741.76
2110428-110428102.123105.57
3109036-109036100.836104.26
4113702-113702105.151108.71
5109837-109837101.576105.02
6112049-112049103.622107.12
30min1106480-10648098.472100.261.55102.99104.861.55
2108472-108472100.314104.90
3107568-10756899.478104.02
4111210-111210102.846107.57
5107450-10745099.369103.94
6109284-109284101.065105.72
45min1105306-10530697.38699.161.68103.00104.881.68
2106776-10677698.746104.45
3106163-10616398.179103.83
4110324-110324102.027107.90
5106555-10655598.541104.22
6108224-108224100.085105.86
60min1104595-10459596.72998.561.35103.42105.371.36
2106040-10604098.065104.86
3105765-10576597.811104.55
4108291-108291100.147107.15
5106618-10661898.599105.37
6108136-108136100.003106.89
90min1103285-10328595.51797.051.78103.29104.971.77
2104865-10486596.978104.87
3103256-10325695.490103.32
4107941-10794199.823107.94
5104000-10400096.178104.05
6106341-10634198.343106.34
极限1102446-10244694.74196.101.53103.57105.091.52
2103756-10375695.953104.92
3103106-10310695.352104.24
4106980-10698098.934108.16
5103429-10342995.650104.59
6103781-10378195.976105.07
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%
116.191974911975601976541976001973541975320.06
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
217.821945451950421947940.19
单位质量响应值RSD%判断
10924.3510931.200.05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%
5min1116228-116228107.446105.431.24107.45105.441.24
2113785-113785105.187105.19
3113956-113956105.345105.35
4114726-114726106.057106.06
5111933-111933103.475103.48
6113669-113669105.080105.08
10min1115345-115345106.630104.861.59107.82106.031.59
2112759-112759104.239105.41
3112409-112409103.915105.09
4115081-115081106.385107.56
5110673-110673102.311103.46
6114299-114299105.663106.83
15min1113688-113688105.098103.591.26107.48105.931.26
2111996-111996103.534105.86
3110224-110224101.895104.22
4113504-113504104.928107.29
5110733-110733102.366104.65
6112197-112197103.719106.06
20min1112103-112103103.633102.411.35107.18105.901.35
2111534-111534103.107106.58
3109637-109637101.353104.81
4111631-111631103.196106.72
5108278-108278100.097103.52
6111525-111525103.098106.59
30min1109191-109191100.941101.041.22105.64105.661.21
2109797-109797101.501106.12
3108645-108645100.436105.02
4111195-111195102.793107.47
5107217-10721799.116103.65
6109736-109736101.444106.08
45min1107404-10740499.28999.681.48105.11105.431.45
2109607-109607101.325107.08
3106098-10609898.081103.78
4109164-109164100.916106.73
5105929-10592997.925103.56
6108789-108789100.569106.34
60min1107596-10759699.46698.961.24106.39105.811.23
2108303-108303100.120107.00
3106438-10643898.396105.18
4108265-108265100.085107.02
5104830-10483096.909103.63
6106830-10683098.758105.64
90min1104671-10467196.76299.195.41104.79107.155.04
2119089-119089110.091118.08
3104413-10441396.524104.41
4105821-10582197.825105.87
5104368-10436896.482104.28
6105445-10544597.478105.46
极限1103948-10394896.09496.471.75105.20105.531.71
2106749-10674998.683107.90
3102789-10278995.022103.98
4106341-10634198.306107.44
5102323-10232394.591103.47
6103989-10398996.132105.20
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%
116.191950891950331951881949431950301950570.05
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
217.821946601947361946980.03
单位质量响应值RSD%判断
10912.7410925.810.09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%
5min1113176-113176104.706104.291.01104.71104.301.01
2113939-113939105.412105.41
3112378-112378103.968103.97
4110960-110960102.656102.66
5113801-113801105.284105.28
6112134-112134103.742103.74
10min1111799-111799103.432103.940.87104.60105.100.87
2113674-113674105.167106.34
3112672-112672104.240105.39
4110929-110929102.627103.77
5112985-112985104.529105.70
6112027-112027103.643104.80
15min1110032-110032101.797102.520.75104.11104.830.75
2112128-112128103.736106.08
3110830-110830102.535104.85
4110125-110125101.883104.16
5111404-111404103.067105.40
6110339-110339102.081104.39
20min1108659-108659100.527101.651.16103.97105.101.14
2111842-111842103.472106.96
3109773-109773101.558105.01
4108422-108422100.308103.72
5109965-109965101.735105.21
6110587-110587102.311105.75
30min1107996-10799699.914100.290.82104.47104.870.82
2109953-109953101.724106.37
3107441-10744199.400103.98
4107867-10786799.794104.32
5108796-108796100.654105.26
6108359-108359100.249104.82
45min1106159-10615998.21499.010.94103.88104.710.92
2108685-108685100.551106.32
3106673-10667398.690104.38
4106891-10689198.891104.53
5107657-10765799.600105.33
6106056-10605698.119103.81
60min1105680-10568097.77197.991.03104.53104.791.01
2107909-10790999.833106.72
3105444-10544497.553104.33
4104677-10467796.843103.58
5106082-10608298.143104.97
6105734-10573497.821104.60
90min1103454-10345495.71296.620.97103.56104.500.96
2105756-10575697.841105.84
3103641-10364195.885103.75
4103745-10374595.981103.79
5105567-10556797.666105.59
6104447-10444796.630104.50
极限1102166-10216694.52094.800.76103.43103.760.75
2103110-10311095.393104.48
3102817-10281795.122104.05
4101044-10104493.482102.36
5102961-10296195.255104.26
6102724-10272495.036103.98
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%
116.191925401926611926661929161929331927430.09
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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