苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml) 5补液体积(ml)5
对照品批号100546-202405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10000
标示量(mg)2.5供试品稀释倍数5系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.379178091717917719166891767917410.06
214.359161691619916180.01
单位质量响应值RSD%判断
6384.206384.530.01数据可信
供试品溶液-2024121111批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min128820-2882031.67354.2528.1331.6754.2628.13
258482-5848264.27164.27
343764-4376448.09648.10
440480-4048044.48744.49
559879-5987965.80665.81
664784-6478471.19671.20
10min165773-6577372.28377.225.7472.6077.765.89
273022-7302280.25080.89
367341-6734174.00774.49
466839-6683973.45573.90
573831-7383181.13981.80
674796-7479682.19982.91
15min171414-7141478.48381.163.9979.5282.484.14
274154-7415481.49482.94
372831-7283180.04081.26
470417-7041777.38778.57
575992-7599283.51484.98
678314-7831486.06687.60
20min173166-7316680.40882.113.1082.2384.243.27
275824-7582483.32985.59
372518-7251879.69681.72
472459-7245979.63181.58
576401-7640183.96386.27
677939-7793985.65488.05
30min174859-7485982.26982.852.8584.9085.802.99
275766-7576683.26586.36
373409-7340980.67583.49
473042-7304280.27283.02
576386-7638683.94787.09
678865-7886586.67189.92
45min174416-7441681.78282.802.6185.2386.572.78
276415-7641583.97987.90
373833-7383381.14184.77
472737-7273779.93783.49
576916-7691684.52988.51
677731-7773185.42589.54
60min175249-7524982.69783.142.1086.9787.742.26
275093-7509382.52687.29
374841-7484182.24986.69
473604-7360480.88985.24
577479-7747985.14889.98
677624-7762485.30790.28
极限179790-7979087.68888.330.6992.7893.770.71
279917-7991787.82793.42
380485-8048588.45293.71
481226-8122689.26694.43
580083-8008388.01093.69
680762-8076288.75694.58
苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml) 5补液体积(ml)5
对照品批号100546-202405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10000
标示量(mg)2.5供试品稀释倍数5系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.379037290362904599058290516904580.11
214.359021690076901460.11
单位质量响应值RSD%判断
6294.926281.950.15数据可信
供试品溶液-2024121111批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min152140-5214058.17550.7915.8558.1850.7915.85
250597-5059756.45456.45
336040-3604040.21240.21
449274-4927454.97754.98
536679-3667940.92540.92
648395-4839553.99754.00
10min172394-7239480.77380.433.5981.3680.943.61
270675-7067578.85679.42
367558-6755875.37875.78
473709-7370982.24182.79
573836-7383682.38282.79
674351-7435182.95783.50
15min173962-7396282.52382.842.4683.9184.162.46
274595-7459583.22984.58
371979-7197980.31081.47
476610-7661085.47786.85
575865-7586584.64685.88
672486-7248680.87682.25
20min174499-7449983.12282.881.1585.3485.031.24
274744-7474483.39585.58
372767-7276781.19083.15
475258-7525883.96986.20
573979-7397982.54284.62
674470-7447083.09085.27
30min174985-7498583.66484.162.0086.7187.142.01
275096-7509683.78886.81
373274-7327481.75584.53
477787-7778786.79189.86
576273-7627385.10188.01
675183-7518383.88586.89
45min175064-7506483.75384.171.9087.6487.981.92
275613-7561384.36588.22
373147-7314781.61485.20
477049-7704985.96789.90
576844-7684485.73989.49
674922-7492283.59487.44
60min176436-7643685.28384.881.2090.0089.541.26
276422-7642285.26889.97
374527-7452783.15387.56
476949-7694985.85690.65
576659-7665985.53290.15
675462-7546284.19788.88
极限180799-8079990.15189.690.4895.7295.190.44
280262-8026289.55295.11
380748-8074890.09495.33
480521-8052189.84195.49
580224-8022489.51094.98
679767-7976789.00094.53
苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml) 5补液体积(ml)5
对照品批号100546-202405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10000
标示量(mg)2.5供试品稀释倍数5系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.379046790616903919022490303904000.17
214.359040190470904360.06
单位质量响应值RSD%判断
6290.886302.160.13数据可信
供试品溶液-20241216111批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min161419-6141968.44051.5520.4568.4451.5520.45
242588-4258847.45647.46
337213-3721341.46741.47
436514-3651440.68840.69
550384-5038456.14456.14
649462-4946255.11655.12
10min176639-7663985.40079.537.0086.0880.057.07
270185-7018578.20878.68
363595-6359570.86571.28
468429-6842976.25176.66
576167-7616784.87485.44
673239-7323981.61182.16
15min178396-7839687.35881.465.9888.9082.776.07
271561-7156179.74181.00
367125-6712574.79875.92
469774-6977477.75078.92
577043-7704385.85087.26
674732-7473283.27584.64
20min181294-8129490.58782.596.3393.0084.726.41
272980-7298081.32383.38
368327-6832776.13878.01
470245-7024578.27580.22
576915-7691585.70887.98
674957-7495783.52685.73
30min178588-7858887.57282.675.0290.8985.625.14
273569-7356981.97984.85
369203-6920377.11479.75
471143-7114379.27682.01
578100-7810087.02890.15
674535-7453583.05586.09
45min175966-7596684.65082.083.7188.8485.863.87
272910-7291081.24584.93
369638-6963877.59981.00
471928-7192880.15083.67
577062-7706285.87189.87
674466-7446682.97986.84
60min177103-7710385.91782.453.1490.9687.053.35
272673-7267380.98185.48
371332-7133279.48683.67
472008-7200880.24084.56
575920-7592084.59989.45
674906-7490683.46988.16
极限177904-7790486.81089.131.8192.7194.561.62
279540-7954088.63393.94
380699-8069989.92494.90
479413-7941388.49193.62
580155-8015589.31895.02
682220-8222091.61997.15
苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml) 5补液体积(ml)5
对照品批号100546-202405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10000
标示量(mg)2.5供试品稀释倍数5系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.378996290085901629014190190901080.11
214.359031190052901820.21
单位质量响应值RSD%判断
6270.566284.460.16数据可信
供试品溶液-20241216111批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min136973-3697341.32451.1011.0941.3251.1011.09
243746-4374648.89448.89
345781-4578151.16951.17
451065-5106557.07557.07
550014-5001455.90055.90
646728-4672852.22752.23
10min165160-6516072.82979.334.9273.2479.844.96
269056-6905677.18377.67
372131-7213180.62081.13
473607-7360782.27082.84
574853-7485383.66284.22
671063-7106379.42679.95
15min168283-6828376.31981.793.9277.4683.103.97
271599-7159980.02581.29
373430-7343082.07283.39
475592-7559284.48885.88
575924-7592484.85986.26
674239-7423982.97684.29
20min169733-6973377.94082.683.5879.8484.803.64
272032-7203280.50982.57
374249-7424982.98785.13
476698-7669885.72587.96
576107-7610785.06487.31
675028-7502883.85886.00
30min170117-7011778.36983.073.6781.0586.023.73
272103-7210380.58983.45
375724-7572484.63687.60
476662-7666285.68488.78
576993-7699386.05489.15
674339-7433983.08886.07
45min171024-7102479.38382.412.3582.8586.192.45
272991-7299181.58185.25
374647-7464783.43287.25
474832-7483283.63987.59
575871-7587184.80088.76
673044-7304481.64185.46
60min171763-7176380.20983.162.1684.4787.772.27
273686-7368682.35886.85
373940-7394082.64287.29
475876-7587684.80689.59
575877-7587784.80789.61
675298-7529884.16088.79
极限179656-7965689.03189.772.0894.0995.202.03
281647-8164791.25696.57
379587-7958788.95494.43
479498-7949888.85494.49
583010-8301092.77998.43
678507-7850787.74693.22
苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml) 5补液体积(ml)5
对照品批号100546-202405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10000
标示量(mg)2.5供试品稀释倍数5系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.379012390242899738991189909900320.17
214.359053490715906240.15
单位质量响应值RSD%判断
6265.276315.260.57数据可信
供试品溶液-20241223111批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min144209-4420949.31249.9515.8549.3149.9515.85
248110-4811053.66453.66
353895-5389560.11760.12
442186-4218647.05647.06
547460-4746052.93952.94
632813-3281336.60136.60
10min169599-6959977.63376.614.8878.1377.114.93
268260-6826076.14076.68
371955-7195580.26180.86
465746-6574673.33673.81
572460-7246080.82581.35
664050-6405071.44471.81
15min173039-7303981.47179.194.1582.7480.464.21
271569-7156979.83181.13
373709-7370982.21883.62
468271-6827176.15277.36
572909-7290981.32682.66
666485-6648574.16075.24
20min174036-7403682.58380.523.4984.6782.573.57
272541-7254180.91583.01
373938-7393882.47384.70
469493-6949377.51579.48
574465-7446583.06185.21
668630-6863076.55378.37
30min174048-7404882.59681.763.0885.5184.623.17
273262-7326281.71984.62
375700-7570084.43987.49
471935-7193580.23982.98
575217-7521783.90086.88
669631-6963177.66980.26
45min174626-7462683.24182.082.1086.9885.762.21
274910-7491083.55887.28
374641-7464183.25887.15
471800-7180080.08983.63
574053-7405382.60286.42
671462-7146279.71283.08
60min175607-7560784.33582.352.4088.9086.852.49
272903-7290381.31985.88
375413-7541384.11988.85
472392-7239280.74985.09
575128-7512883.80188.45
671523-7152379.78083.94
极限182186-8218691.67489.131.6297.0994.461.65
280121-8012189.37094.74
378943-7894388.05693.62
479094-7909488.22593.38
580337-8033789.61195.10
678754-7875487.84592.80
苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml) 5补液体积(ml)5
对照品批号100546-202405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10000
标示量(mg)2.5供试品稀释倍数5系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.379021390472901029031790301902810.16
214.359080490831908180.03
单位质量响应值RSD%判断
6282.606328.780.52数据可信
供试品溶液-20241223111批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min142421-4242147.20249.705.4747.2049.705.47
247658-4765853.02953.03
345685-4568550.83450.83
443158-4315848.02248.02
547027-4702752.32752.33
642038-4203846.77646.78
10min169479-6947977.31076.711.5277.7877.211.54
269477-6947777.30877.84
369196-6919676.99577.50
467554-6755475.16875.65
570181-7018178.09178.61
667765-6776575.40375.87
15min173261-7326181.51879.421.8282.7680.681.81
271384-7138479.43080.73
370801-7080178.78180.06
470190-7019078.10179.33
572553-7255380.73082.03
670068-7006877.96579.19
20min173407-7340781.68180.311.3283.7482.371.32
271913-7191380.01882.12
372273-7227380.41982.48
471208-7120879.23481.25
573113-7311381.35383.46
671142-7114279.16081.16
30min173771-7377182.08681.460.7884.9684.320.80
273768-7376882.08284.98
372788-7278880.99283.86
472654-7265480.84383.65
573628-7362881.92784.85
672650-7265080.83883.63
45min175323-7532383.81382.261.3687.5185.931.36
273988-7398882.32786.05
373350-7335081.61785.30
473534-7353481.82285.44
574784-7478483.21386.96
672560-7256080.73884.34
60min174701-7470183.12081.551.7187.6686.061.63
273023-7302381.25385.80
374791-7479183.22187.72
472015-7201580.13284.56
571916-7191680.02284.60
673316-7331681.57985.99
极限179600-7960088.57288.700.7093.9494.010.65
280063-8006389.08794.44
380389-8038989.45094.78
479420-7942088.37193.60
578832-7883287.71793.09
679986-7998689.00194.23
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