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4000
标示量(mg)2.5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%
110.078598985840858698586785979859090.09
210.088601185748858800.22
单位质量响应值RSD%判断
8531.188519.840.10数据可信
中间条件3月-供试品溶液-2023101321批-富马酸比索洛尔-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%
5min195160-95160100.25599.630.49100.2699.640.49
293861-9386198.88798.89
394790-9479099.86599.87
494289-9428999.33899.34
594524-9452499.58599.59
694799-9479999.87599.87
10min196049-96049101.192100.420.68101.36100.590.68
294420-9442099.47699.64
396002-96002101.142101.31
494837-9483799.915100.08
595252-95252100.352100.52
695353-95353100.459100.63
15min195714-95714100.839100.070.75101.17100.400.75
293941-9394198.97199.30
395604-95604100.723101.06
494354-9435499.40699.74
594976-94976100.061100.39
695318-95318100.422100.76
20min195525-95525100.64099.830.74101.14100.320.74
293652-9365298.66799.16
395260-95260100.361100.86
494239-9423999.28599.78
594746-9474699.819100.32
695088-95088100.179100.68
30min194902-9490299.98399.520.63100.66100.190.63
293616-9361698.62999.29
395025-95025100.113100.78
493832-9383298.85699.52
594677-9467799.746100.41
694732-9473299.804100.47
45min194522-9452299.58398.980.57100.4299.810.57
293320-9332098.31799.14
394419-9441999.475100.31
493356-9335698.35599.18
593831-9383198.85599.69
694235-9423599.281100.12
极限194282-9428299.33098.540.73100.3399.540.73
292776-9277697.74498.73
394114-9411499.153100.16
492738-9273897.70498.70
593374-9337498.37499.37
693926-9392698.95599.96
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%
114.715416754214541315414054245541790.10
214.695486855041549540.23
单位质量响应值RSD%判断
3683.143740.911.11数据可信
中间条件3月-供试品溶液-2023101321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%
5min152472-5247289.25591.111.6789.2691.111.67
254225-5422592.23792.24
354976-5497693.51593.51
453144-5314490.39890.40
553224-5322490.53490.53
653324-5332490.70490.70
10min155144-5514493.80094.340.7693.9594.500.76
255960-5596095.18895.34
355493-5549394.39494.55
454808-5480893.22993.38
555752-5575294.83494.99
655625-5562594.61894.77
15min154354-5435492.45693.640.8592.7693.940.85
255702-5570294.74995.06
355232-5523293.95094.26
455299-5529994.06494.37
554873-5487393.33993.65
654825-5482593.25893.57
20min154557-5455792.80292.670.6493.2693.140.64
255049-5504993.63994.11
354464-5446492.64493.11
454572-5457292.82793.29
554075-5407591.98292.45
654161-5416192.12892.59
30min154262-5426292.30092.400.6092.9193.020.59
254653-5465392.96593.59
354674-5467493.00193.62
454102-5410292.02892.65
553848-5384891.59692.21
654387-5438792.51393.13
45min153557-5355791.10191.760.7091.8792.530.70
254174-5417492.15092.93
353444-5344490.90991.69
454030-5403091.90592.68
554020-5402091.88892.66
654440-5444092.60393.37
极限153322-5332290.70191.090.5991.6292.020.59
253722-5372291.38192.32
353295-5329590.65591.59
453231-5323190.54691.47
553722-5372291.38192.31
654009-5400991.87092.80
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4000
标示量(mg)2.5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%
110.078607386225859478621286198861310.14
210.088550285662855820.14
单位质量响应值RSD%判断
8553.238490.280.53数据可信
中间条件3月-供试品溶液-2023101322批-富马酸比索洛尔-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%
5min192272-9227297.25798.521.4297.2698.521.42
292042-9204297.01497.01
392733-9273397.74397.74
494350-9435099.44799.45
594022-9402299.10199.10
695391-95391100.544100.54
10min192609-9260997.61299.111.4897.7799.281.48
292812-9281297.82697.99
393112-9311298.14298.31
495133-95133100.272100.44
594583-9458399.69399.86
695956-95956101.140101.31
15min192530-9253097.52998.801.5197.8599.131.51
292260-9226097.24497.57
392693-9269397.70198.03
495010-95010100.143100.48
594402-9440299.50299.83
695518-95518100.678101.01
20min192087-9208797.06298.571.5597.5599.061.55
292119-9211997.09697.58
392573-9257397.57498.06
494501-9450199.606100.11
594329-9432999.42599.92
695511-95511100.671101.17
30min191699-9169996.65398.161.6597.3098.821.65
291437-9143796.37797.03
392210-9221097.19197.84
494329-9432999.425100.09
594050-9405099.13199.79
695052-95052100.187100.86
45min191329-9132996.26397.791.6297.0798.621.62
291224-9122496.15296.96
392011-9201196.98297.80
493456-9345698.50599.34
593716-9371698.77999.61
694950-94950100.079100.92
极限191043-9104395.96197.251.5396.9398.231.53
290603-9060395.49896.47
391660-9166096.61297.59
492877-9287797.89498.89
593072-9307298.10099.09
694326-9432699.422100.43
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%
114.715410154090542685427954473542420.29
214.695428853989541380.40
单位质量响应值RSD%判断
3687.423685.360.04数据可信
中间条件3月-供试品溶液-2023101322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%
5min150404-5040486.32887.212.3686.3387.212.36
251365-5136587.97487.97
349436-4943684.67184.67
451168-5116887.63787.64
552913-5291390.62690.63
650212-5021286.00086.00
10min151794-5179488.70990.701.4888.8590.851.48
253108-5310890.96091.11
352772-5277290.38490.53
454113-5411392.68192.83
553369-5336991.40791.56
652581-5258190.05790.20
15min152479-5247989.88290.801.1790.1791.101.16
253625-5362591.84592.14
352392-5239289.73390.03
453854-5385492.23792.54
552651-5265190.17790.48
653101-5310190.94891.24
20min152237-5223789.46890.941.4889.9191.391.48
253307-5330791.30191.75
352473-5247389.87290.31
454442-5444293.24493.70
553286-5328691.26591.72
652844-5284490.50890.95
30min152393-5239389.73590.181.4490.3390.781.44
252401-5240189.74990.35
351603-5160388.38288.97
453702-5370291.97792.59
553352-5335291.37891.98
652454-5245489.84090.44
45min151910-5191088.90889.732.0489.6590.482.03
251991-5199189.04789.80
350703-5070386.84187.58
453351-5335191.37692.14
553540-5354091.70092.46
652841-5284190.50291.25
极限151815-5181588.74589.650.9289.6390.550.92
252269-5226989.52390.42
351763-5176388.65689.54
452918-5291890.63491.55
552644-5264490.16591.08
652660-5266090.19291.09
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4000
标示量(mg)2.5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%
110.078577885847858528576085850858170.06
210.088507785207851420.11
单位质量响应值RSD%判断
8522.058446.630.63数据可信
中间条件3月-供试品溶液-2023101323批-富马酸比索洛尔-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%
5min191065-9106596.40897.041.6296.4197.041.62
289544-8954494.79894.80
391657-9165797.03597.04
493948-9394899.46199.46
592511-9251197.93997.94
691250-9125096.60496.60
10min191732-9173297.11597.511.5997.2897.671.58
290053-9005395.33795.50
391881-9188197.27297.43
494483-94483100.027100.19
592746-9274698.18898.35
691719-9171997.10197.26
15min191719-9171997.10197.701.6497.4298.021.64
290414-9041495.71996.04
392275-9227597.68998.01
494791-94791100.353100.69
593055-9305598.51598.84
691460-9146096.82797.15
20min191434-9143496.79997.531.7697.2898.021.76
290155-9015595.44595.92
392027-9202797.42797.91
495047-95047100.624101.12
592370-9237097.79098.28
691713-9171397.09597.58
30min191443-9144396.80997.111.7497.4597.761.74
289747-8974795.01395.65
391838-9183897.22797.88
494457-94457100.000100.67
592155-9215597.56298.22
690737-9073796.06196.71
45min190914-9091496.24996.621.7097.0697.431.70
289476-8947694.72695.52
391044-9104496.38697.20
493995-9399599.510100.34
591829-9182997.21798.03
690347-9034795.64896.45
极限190122-9012295.41096.161.6196.3897.131.61
288943-8894394.16295.11
390864-9086496.19697.17
493309-9330998.78499.78
591332-9133296.69197.67
690385-9038595.68996.65
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%
114.715384554223541195402353549539520.50
214.695313253082531070.07
单位质量响应值RSD%判断
3667.713615.181.03数据可信
中间条件3月-供试品溶液-2023101323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%
5min151345-5134589.03088.630.9389.0388.630.93
250655-5065587.83487.83
351016-5101688.46088.46
450985-5098588.40688.41
551946-5194690.07290.07
650748-5074887.99588.00
10min152305-5230590.69589.312.1390.8489.462.13
251600-5160089.47289.62
349529-4952985.88186.03
452268-5226890.63190.78
552306-5230690.69790.85
651037-5103788.49688.64
15min151225-5122588.82287.811.1689.1288.101.16
250176-5017687.00387.30
350473-5047387.51887.81
451096-5109688.59988.90
551081-5108188.57288.87
649782-4978286.32086.61
20min150991-5099188.41687.350.9588.8687.790.95
250305-5030587.22787.67
349739-4973986.24686.68
450382-5038287.36087.81
550839-5083988.15388.60
650002-5000286.70287.14
30min150476-5047687.52386.612.8188.1287.202.80
250058-5005886.79987.38
349690-4969086.16186.74
451168-5116888.72389.32
550970-5097088.38088.98
647317-4731782.04682.63
45min151454-5145489.21987.961.5289.9688.691.52
249942-4994286.59887.33
349897-4989786.51987.24
451719-5171989.67990.42
550924-5092488.30089.04
650422-5042287.43088.15
极限150748-5074887.99587.750.4288.8888.620.43
250680-5068087.87788.75
350258-5025887.14588.01
450689-5068987.89388.78
550814-5081488.11089.00
650443-5044387.46688.33
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4000
标示量(mg)2.5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%
110.078548785430854508544685478854580.03
210.088553385459854960.07
单位质量响应值RSD%判断
8486.408481.750.04数据可信
中间条件3月-供试品溶液-2024010421批-富马酸比索洛尔-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%
5min191769-9176997.15596.891.2797.1596.891.27
293449-9344998.93498.93
391106-9110696.45396.45
491436-9143696.80296.80
591477-9147796.84696.85
689878-8987895.15395.15
10min192085-9208597.48997.521.2297.6597.681.22
294086-9408699.60899.77
391269-9126996.62696.79
492100-9210097.50597.67
592304-9230497.72197.88
690840-9084096.17196.33
15min192720-9272098.16298.071.2098.4998.401.20
294633-94633100.187100.52
391773-9177397.15997.48
492623-9262398.05998.38
592594-9259498.02898.35
691463-9146396.83197.15
20min192556-9255697.98897.721.1598.4898.211.15
294288-9428899.822100.32
391294-9129496.65297.14
492018-9201897.41997.91
592038-9203897.44097.93
691635-9163597.01397.49
30min191743-9174397.12797.141.0797.7897.781.07
293632-9363299.12799.79
391128-9112896.47697.12
491513-9151396.88497.53
591593-9159396.96997.62
690897-9089796.23296.87
45min191056-9105696.40096.431.1997.2197.241.19
293120-9312098.58599.41
390107-9010795.39596.20
491200-9120096.55397.36
590653-9065395.97396.79
690355-9035595.65896.46
极限190886-9088696.22096.071.1697.1997.041.16
292695-9269598.13599.13
389710-8971094.97595.94
490276-9027695.57496.55
590785-9078596.11397.08
690120-9012095.40996.37
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%
114.715368853618537565348553749536590.21
214.695363754321539790.90
单位质量响应值RSD%判断
3647.793674.540.52数据可信
中间条件3月-供试品溶液-2024010421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%
5min152070-5207089.79888.721.6189.8088.721.61
250434-5043486.97686.98
350673-5067387.38887.39
452297-5229790.18990.19
551046-5104688.03288.03
652155-5215589.94489.94
10min151613-5161389.00989.142.1489.1689.292.14
250903-5090387.78587.93
350608-5060887.27687.42
453763-5376392.71792.87
551662-5166289.09489.24
651577-5157788.94789.10
15min151433-5143388.69989.081.5289.0089.371.52
251842-5184289.40489.70
350631-5063187.31687.61
452714-5271490.90891.21
551008-5100887.96688.26
652284-5228490.16790.46
20min151207-5120788.30988.561.7088.7689.011.69
252024-5202489.71890.16
350521-5052187.12687.56
451604-5160488.99489.45
550259-5025986.67487.12
652516-5251690.56791.02
30min151122-5112288.16388.422.2088.7689.022.19
252258-5225890.12290.71
350603-5060387.26887.85
452076-5207689.80890.41
549415-4941585.21985.81
652159-5215989.95190.55
45min151289-5128988.45187.892.2389.1988.632.22
251537-5153788.87889.62
350704-5070487.44288.17
452063-5206389.78690.54
548830-4883084.21084.94
651368-5136888.58789.34
极限151586-5158688.96389.061.6289.8589.951.61
251745-5174589.23790.13
351165-5116588.23789.11
450924-5092487.82188.73
551214-5121488.32189.19
653237-5323791.81092.71
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