富马酸比索洛尔左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.048337283519835218348683660835120.13
210.068352783840836840.27
单位质量响应值RSD%判断
8317.938318.490.01数据可信
长期6月-供试品溶液-2024110221批-富马酸比索洛尔-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%
5min193344-93344100.79397.982.02100.7997.982.02
287946-8794694.96494.96
390775-9077598.01998.02
490273-9027397.47797.48
591990-9199099.33199.33
690127-9012797.31997.32
10min193876-93876101.36798.751.92101.5498.921.92
288748-8874895.83095.99
391786-9178699.11199.27
490996-9099698.25798.42
592575-9257599.962100.13
690740-9074097.98198.14
15min193756-93756101.23898.681.91101.5799.011.91
288554-8855495.62195.94
391649-9164998.96399.29
490925-9092598.18198.51
592455-9245599.833100.17
690990-9099098.25198.58
20min193293-93293100.73898.461.84101.2498.951.84
288426-8842695.48295.96
391807-9180799.13399.63
490943-9094398.20098.69
592184-9218499.540100.04
690455-9045597.67398.16
30min193686-93686101.16298.521.92101.8499.181.92
288505-8850595.56896.20
391553-9155398.85999.52
490816-9081698.06398.72
592308-9230899.674100.34
690595-9059597.82498.48
45min193446-93446100.90398.221.88101.7599.041.88
288333-8833395.38296.18
391372-9137298.66399.49
490660-9066097.89598.71
591737-9173799.05899.89
690213-9021397.41298.23
极限192983-92983100.40398.051.80101.4199.041.80
288226-8822695.26696.22
391295-9129598.58099.57
490193-9019397.39098.37
591806-9180699.132100.13
690324-9032497.53298.51
富马酸比索洛尔左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.064896448759490454946048960490380.53
214.064917749194491860.03
单位质量响应值RSD%判断
3487.773498.290.22数据可信
长期6月-供试品溶液-2024110221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%
5min147201-4720185.31889.084.0285.3289.084.02
250962-5096292.11692.12
350289-5028990.90090.90
448799-4879988.20688.21
551587-5158793.24693.25
646858-4685884.69884.70
10min150997-5099792.17993.781.7792.3293.931.78
252420-5242094.75294.91
352899-5289995.61795.77
451083-5108392.33592.48
552798-5279895.43595.59
651093-5109392.35392.49
15min151052-5105292.27993.931.6092.5794.231.61
251779-5177993.59393.90
352842-5284295.51495.83
452025-5202594.03894.34
552991-5299195.78496.10
651093-5109392.35392.65
20min151893-5189393.79993.651.4494.2594.111.44
252630-5263095.13195.60
352754-5275495.35595.83
451284-5128492.69893.16
551294-5129492.71693.19
651001-5100192.18792.64
30min151088-5108892.34493.191.8492.9593.811.84
251842-5184293.70794.33
352294-5229494.52495.15
451534-5153493.15093.76
552609-5260995.09395.72
649973-4997390.32890.93
45min151659-5165993.37693.142.1494.1493.912.13
252174-5217494.30795.09
352041-5204194.06694.85
451545-5154593.17093.94
552362-5236294.64795.43
649375-4937589.24890.00
极限150653-5065391.55892.221.8692.4793.151.86
251671-5167193.39894.34
352036-5203694.05795.00
449582-4958289.62290.54
551732-5173293.50894.45
650448-5044891.18792.09
富马酸比索洛尔左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.048344483485833698345183409834320.06
210.068389384071839820.15
单位质量响应值RSD%判断
8309.968348.110.33数据可信
长期6月-供试品溶液-2024110321批-富马酸比索洛尔-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%
5min191735-9173598.92798.913.1298.9398.913.12
291064-9106498.20498.20
396414-96414103.973103.97
492300-9230099.53699.54
591283-9128398.44098.44
687498-8749894.35894.36
10min192360-9236099.60199.743.1299.7799.903.12
292073-9207399.29299.46
397277-97277104.904105.08
492598-9259899.858100.02
592389-9238999.63299.80
688219-8821995.13695.29
15min192044-9204499.26099.543.2299.5999.883.21
291812-9181299.01099.34
397194-97194104.814105.16
492762-92762100.035100.37
592140-9214099.36499.69
687889-8788994.78095.10
20min192115-9211599.33799.503.1699.8399.993.16
291743-9174398.93699.43
397031-97031104.638105.16
492484-9248499.735100.23
592331-9233199.570100.07
687867-8786794.75695.23
30min192180-9218099.40799.623.10100.07100.293.10
291862-9186299.06499.72
397201-97201104.822105.52
492667-9266799.932100.60
592152-9215299.377100.04
688225-8822595.14295.77
45min191984-9198499.19699.343.14100.02100.173.14
291647-9164798.83299.66
396928-96928104.527105.40
492273-9227399.507100.34
592038-9203899.254100.08
687848-8784894.73595.53
极限191830-9183099.03099.183.21100.02100.183.21
291399-9139998.56599.55
396839-96839104.431105.48
492102-9210299.323100.32
592070-9207099.288100.28
687583-8758394.45095.40
富马酸比索洛尔左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.064897348840488194891349514490120.59
214.064853548258483960.41
单位质量响应值RSD%判断
3485.923442.110.90数据可信
长期6月-供试品溶液-2024110321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%
5min150339-5033991.75692.081.7991.7692.081.79
250939-5093992.84992.85
351214-5121493.35193.35
451617-5161794.08594.09
549311-4931189.88289.88
649690-4969090.57390.57
10min152221-5222195.18695.831.1295.3495.991.12
253399-5339997.33397.49
352596-5259695.87096.03
452844-5284496.32296.48
552726-5272696.10796.26
651666-5166694.17594.33
15min151427-5142793.73994.622.2394.0594.932.23
252222-5222295.18895.50
352294-5229495.31995.63
453806-5380698.07598.39
550407-5040791.88092.19
651310-5131093.52693.83
20min152323-5232395.37295.131.1995.8495.601.19
252522-5252295.73596.21
351597-5159794.04994.52
452990-5299096.58897.07
552380-5238095.47695.94
651316-5131693.53794.00
30min151777-5177794.37794.230.7695.0094.860.76
251962-5196294.71495.35
352120-5212095.00295.63
451894-5189494.59095.23
551328-5132893.55894.18
651114-5111493.16893.79
45min151853-5185394.51593.831.7295.3094.621.71
250559-5055992.15792.95
352043-5204394.86295.65
452430-5243095.56796.37
551776-5177694.37595.15
650216-5021691.53292.31
极限151535-5153593.93694.320.8994.8895.260.89
251558-5155893.97894.92
352116-5211694.99595.94
452488-5248895.67396.63
551515-5151593.89994.83
651273-5127393.45894.39
富马酸比索洛尔左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.048404384056839658408584169840640.09
210.068407883808839430.23
单位质量响应值RSD%判断
8372.918344.230.25数据可信
长期6月-供试品溶液-2024110421批-富马酸比索洛尔-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%
5min193265-93265100.22298.751.45100.2298.751.45
292611-9261199.51999.52
391590-9159098.42298.42
493169-93169100.118100.12
590223-9022396.95396.95
690532-9053297.28597.28
10min193723-93723100.71499.541.37100.8899.701.37
293566-93566100.545100.71
392464-9246499.36199.52
493743-93743100.735100.90
590793-9079397.56597.73
691490-9149098.31498.48
15min194128-94128101.14999.591.59101.4899.921.59
293545-93545100.522100.86
392535-9253599.43799.77
493955-93955100.963101.30
590565-9056597.32097.64
691351-9135198.16598.49
20min193890-93890100.89399.381.57101.4099.871.57
293339-93339100.301100.80
392303-9230399.18899.68
493790-93790100.786101.29
590539-9053997.29297.78
691002-9100297.79098.28
30min193846-93846100.84699.241.58101.5299.901.58
293334-93334100.296100.96
392271-9227199.15399.81
493421-93421100.389101.06
590265-9026596.99897.65
690959-9095997.74498.40
45min193636-93636100.62099.041.54101.4699.871.54
292908-9290899.838100.67
391932-9193298.78999.62
493464-93464100.435101.27
590251-9025196.98397.79
690803-9080397.57698.39
极限193612-93612100.59498.851.56101.6099.841.56
292813-9281399.736100.74
391897-9189798.75199.74
493019-9301999.957100.96
590081-9008196.80097.77
690516-9051697.26798.25
富马酸比索洛尔左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.064883148851485734929448791488680.54
214.064901348895489540.18
单位质量响应值RSD%判断
3475.683481.790.13数据可信
长期6月-供试品溶液-2024110421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%
5min148486-4848688.00190.521.6588.0090.521.65
249294-4929489.46789.47
350070-5007090.87690.88
450369-5036991.41891.42
550630-5063091.89291.89
650384-5038491.44691.45
10min150490-5049091.63894.351.9491.7894.501.94
250977-5097792.52292.67
352752-5275295.74395.89
452209-5220994.75894.91
552578-5257895.42895.58
652891-5289195.99696.15
15min151369-5136993.23394.070.8993.5394.380.89
251916-5191694.22694.53
351718-5171893.86794.18
451297-5129793.10393.41
552368-5236895.04695.36
652325-5232594.96895.28
20min150607-5060791.85093.931.6892.3194.391.68
251346-5134693.19293.65
352105-5210594.56995.04
453164-5316496.49196.96
551909-5190994.21394.68
651373-5137393.24193.71
30min150732-5073292.07793.230.8392.6893.850.84
251257-5125793.03093.65
351404-5140493.29793.92
451168-5116892.86893.49
551710-5171093.85294.48
651945-5194594.27994.90
45min150963-5096392.49693.060.9293.2693.830.91
251069-5106992.68993.46
351820-5182094.05294.83
451399-5139993.28894.07
550630-5063091.89292.68
651745-5174593.91694.70
极限150564-5056491.77293.151.1392.6994.081.13
251161-5116192.85693.78
352140-5214094.63395.57
451140-5114092.81893.75
551869-5186994.14195.08
651065-5106592.68293.62
富马酸比索洛尔左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.048305483038831028310283212831020.09
210.068367583550836120.11
单位质量响应值RSD%判断
8277.098311.330.30数据可信
长期6月-供试品溶液-2024110221批-富马酸比索洛尔-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min185293-8529392.36693.193.9392.3793.193.93
287914-8791495.20595.20
383777-8377790.72490.72
481042-8104287.76387.76
590490-9049097.99497.99
687826-8782695.10995.11
10min190597-9059798.11098.262.8198.2698.412.82
290872-9087298.40898.57
388503-8850395.84295.99
487829-8782995.11395.26
595013-95013102.892103.06
691576-9157699.17099.33
15min191334-9133498.90899.492.2699.2399.812.26
291858-9185899.47699.80
389867-8986797.32097.63
490241-9024197.72598.03
595659-95659103.592103.93
692270-9227099.922100.25
20min191498-9149899.08699.902.3799.57100.382.38
292005-9200599.635100.12
389750-8975097.19397.67
490896-9089698.43498.90
595982-95982103.942104.45
693364-93364101.107101.60
30min191711-9171199.316100.601.9199.96101.251.91
292578-92578100.255100.91
391182-9118298.74499.38
492057-9205799.691100.32
595988-95988103.948104.63
693850-93850101.633102.29
45min191799-9179999.412100.731.99100.22101.551.99
292034-9203499.666100.49
391259-9125998.82799.63
492588-92588100.266101.06
596142-96142104.115104.97
694270-94270102.088102.92
极限191782-9178299.393100.942.17100.37101.932.17
292267-9226799.919100.91
391075-9107598.62899.59
492856-92856100.556101.52
596279-96279104.263105.29
695012-95012102.891103.89
富马酸比索洛尔左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.064825048076486764853748261483600.50
214.064836448041482020.48
单位质量响应值RSD%判断
3439.543428.310.24数据可信
长期6月-供试品溶液-2024110221批-左氨氯地平-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min128036-2803651.54947.796.0151.5547.796.01
225225-2522546.38046.38
325298-2529846.51446.51
426983-2698349.61249.61
526742-2674249.16949.17
623667-2366743.51643.52
10min140227-4022773.96472.232.3074.0572.312.31
239138-3913871.96172.04
339041-3904171.78371.86
440244-4024473.99574.08
539256-3925672.17872.26
637807-3780769.51469.59
15min147801-4780187.89082.284.0688.1082.484.05
244897-4489782.55082.75
345194-4519483.09683.29
444511-4451181.84082.05
543767-4376780.47380.67
642326-4232677.82378.01
20min147308-4730886.98384.622.6787.3484.962.67
246718-4671885.89886.23
347280-4728086.93287.27
445197-4519783.10283.44
545121-4512182.96283.30
644508-4450881.83582.15
30min147922-4792288.11285.833.7988.6186.313.78
247115-4711586.62887.11
348960-4896090.02190.50
444937-4493782.62483.10
546844-4684486.13086.60
644307-4430781.46581.92
45min148767-4876789.66686.992.9290.3187.612.92
247188-4718886.76387.38
348628-4862889.41090.04
447772-4777287.83688.45
546297-4629785.12485.74
645210-4521083.12683.72
极限147816-4781687.91786.102.2088.7186.862.19
248131-4813188.49689.26
345929-4592984.44885.23
446636-4663685.74886.51
545500-4550083.65984.42
646950-4695086.32587.05
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