富马酸比索洛尔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10071-202203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%
110.098389183942838408384683797838630.07
210.128388683859838720.03
单位质量响应值RSD%判断
8311.508287.750.21数据可信
中间条件18月-供试品溶液-5543C0421批-富马酸比索-0.005Hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min187433-8743394.62295.642.7394.6295.642.73
287748-8774894.96394.96
390420-9042097.85497.85
486970-8697094.12194.12
585591-8559192.62892.63
692086-9208699.65799.66
10min189400-8940096.75098.713.6696.9198.863.66
290366-9036697.79697.95
394080-94080101.815101.98
488468-8846895.74295.90
588414-8841495.68395.84
696511-96511104.446104.61
15min189012-8901296.33198.723.3596.6599.053.35
290434-9043497.87098.19
393441-93441101.124101.46
488164-8816495.41395.73
590037-9003797.44097.75
696253-96253104.167104.51
20min189698-8969897.07398.713.5997.5599.203.58
290253-9025397.67498.16
393495-93495101.182101.68
488719-8871996.01396.49
588372-8837295.63896.11
696746-96746104.700105.21
30min189835-8983597.22198.893.2897.8699.543.28
290384-9038497.81598.46
393116-93116100.772101.44
488916-8891696.22796.86
589327-8932796.67197.31
696691-96691104.641105.33
45min189636-8963697.00698.743.5497.8199.563.53
290277-9027797.70098.51
393795-93795101.507102.34
488359-8835995.62496.42
588855-8885596.16196.96
696525-96525104.461105.32
极限188599-8859995.88498.243.7096.8599.223.69
289957-8995797.35398.33
392986-92986100.631101.64
488931-8893196.24397.20
587672-8767294.88095.84
696504-96504104.439105.48
富马酸比索洛尔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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.941032441032291032421035261032511032980.13
213.961032231036021034120.26
单位质量响应值RSD%判断
7410.197407.740.03数据可信
中间条件18月-供试品溶液-5543C0421批-洛尔氨氯地平-0.005Hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min183695-8369573.24073.052.7873.2473.052.78
281829-8182971.60771.61
387261-8726176.36076.36
482203-8220371.93471.93
581011-8101170.89170.89
684881-8488174.27774.28
10min198378-9837886.08887.791.6286.2187.921.63
299806-9980687.33887.46
3103128-10312890.24590.37
499813-9981387.34487.46
599712-9971287.25687.37
6101129-10112988.49688.62
15min1103001-10300190.13491.551.2090.4091.821.20
2103752-10375290.79191.06
3106365-10636593.07893.36
4104191-10419191.17591.44
5104683-10468391.60691.87
6105720-10572092.51392.78
20min1104790-10479091.69992.721.1092.1293.141.10
2105995-10599592.75493.17
3106552-10655293.24193.67
4104863-10486391.76392.18
5105633-10563392.43792.85
6107888-10788894.41094.84
30min1104875-10487591.77491.951.2992.3492.521.29
2104981-10498191.86692.44
3104777-10477791.68892.28
4103959-10395990.97291.54
5104132-10413291.12391.69
6107702-10770294.24894.83
45min1104750-10475091.66492.401.4292.3993.131.42
2104663-10466391.58892.31
3105048-10504891.92592.67
4104834-10483491.73892.46
5105710-10571092.50493.23
6108554-10855494.99395.73
极限1104105-10410591.10092.261.6291.9793.141.61
2104901-10490191.79692.67
3105609-10560992.41693.31
4104277-10427791.25092.13
5104949-10494991.83892.71
6108722-10872295.14096.04
富马酸比索洛尔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10071-202203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%
110.098383183758838448375483777837930.06
210.128389383871838820.02
单位质量响应值RSD%判断
8304.568288.740.14数据可信
中间条件18月-供试品溶液-2022110111批-富马酸比索-0.005Hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min183482-8348290.37889.913.2390.3889.913.23
286099-8609993.21193.21
383854-8385490.78190.78
480003-8000386.61286.61
585237-8523792.27892.28
679638-7963886.21786.22
10min189643-8964397.04898.000.8597.2098.150.85
291312-9131298.85599.01
390074-9007497.51597.67
490288-9028897.74697.89
591608-9160899.17599.33
690201-9020197.65297.80
15min191145-9114598.67498.310.7198.9998.620.71
290665-9066598.15598.47
389727-8972797.13997.45
490917-9091798.42798.73
591666-9166699.23899.56
690733-9073398.22898.53
20min192081-9208199.68898.711.09100.1699.181.09
291687-9168799.26199.74
390424-9042497.89498.37
490740-9074098.23698.71
592303-9230399.928100.41
689824-8982497.24497.71
30min191571-9157199.13598.590.6199.7899.240.61
290825-9082598.32898.98
390175-9017597.62498.26
491283-9128398.82499.46
591661-9166199.23399.88
690908-9090898.41899.05
45min191057-9105798.57998.150.6199.3998.950.61
290477-9047797.95198.76
389947-8994797.37798.18
490821-9082198.32399.12
591424-9142498.97699.79
690213-9021397.66598.46
极限191517-9151799.07798.090.81100.0599.060.81
290087-9008797.52998.51
389710-8971097.12198.08
491176-9117698.70899.67
591048-9104898.56999.55
690094-9009497.53698.50
富马酸比索洛尔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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.941031461033901028701036621035271033190.31
213.961032721033521033120.06
单位质量响应值RSD%判断
7411.697400.570.11数据可信
中间条件18月-供试品溶液-2022110111批-洛尔氨氯地平-0.005Hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min177794-7779468.10267.429.3668.1067.429.36
287093-8709376.24276.24
378803-7880368.98568.99
473855-7385564.65464.65
579326-7932669.44369.44
665237-6523757.10957.11
10min188660-8866077.61479.456.5077.7379.566.50
299991-9999187.53387.66
392389-9238980.87880.99
485749-8574975.06675.17
593838-9383882.14782.26
683931-8393173.47473.57
15min195763-9576383.83284.864.9884.0785.104.99
2104366-10436691.36391.64
398648-9864886.35886.61
491692-9169280.26880.50
599131-9913186.78087.03
692010-9201080.54780.76
20min1101008-10100888.42488.463.9588.8188.853.96
2107295-10729593.92794.35
3102000-10200089.29289.69
495635-9563583.72084.09
5102284-10228489.54189.94
698078-9807885.85986.21
30min1106067-10606792.85291.302.8493.3891.832.85
2107287-10728793.92094.50
3105364-10536492.23792.78
4100672-10067288.12988.64
5105907-10590792.71293.26
6100460-10046087.94488.44
45min1106823-10682393.51491.812.2194.2092.492.23
2107238-10723893.87794.62
3105012-10501291.92992.62
4103065-10306590.22490.88
5105857-10585792.66893.37
6101244-10124488.63089.27
极限1107791-10779194.36192.162.0295.2093.002.03
2107499-10749994.10695.00
3104796-10479691.74092.59
4102678-10267889.88590.69
5105668-10566892.50393.36
6103260-10326090.39591.18
富马酸比索洛尔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10071-202203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%
110.098383683973839428397284019839480.09
210.128421484259842360.04
单位质量响应值RSD%判断
8319.928323.720.04数据可信
中间条件18月-供试品溶液-2022110211批-富马酸比索-0.005Hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min188724-8872495.76391.814.4395.7691.814.43
287645-8764594.59894.60
387627-8762794.57994.58
483319-8331989.92989.93
584350-8435091.04291.04
678689-7868984.93284.93
10min192927-92927100.29998.102.96100.4698.252.96
292364-9236499.69199.85
392075-9207599.37999.54
492945-92945100.318100.47
588306-8830695.31195.46
686706-8670693.58593.73
15min193645-93645101.07498.892.53101.4099.202.54
292499-9249999.837100.16
392656-92656100.007100.33
493331-93331100.735101.05
589785-8978596.90897.22
687800-8780094.76595.06
20min193157-93157100.54799.061.91101.0499.541.91
293015-93015100.394100.88
391345-9134598.59299.08
493200-93200100.594101.08
591262-9126298.50298.97
688713-8871395.75196.21
30min193185-93185100.57898.822.24101.2499.472.23
292581-9258199.926100.58
391409-9140998.66199.31
493615-93615101.042101.69
590402-9040297.57498.21
688158-8815895.15295.77
45min193425-93425100.83798.722.64101.6799.542.64
292270-9227099.590100.41
392299-9229999.621100.44
493530-93530100.950101.77
589985-8998597.12497.92
687299-8729994.22595.00
极限192963-92963100.33898.382.26101.3499.362.26
291840-9184099.126100.12
391423-9142398.67699.66
493309-93309100.711101.70
589119-8911996.18997.15
688239-8823995.23996.17
富马酸比索洛尔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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.941034041037941033761039921035691036270.26
213.961035531044301039920.60
单位质量响应值RSD%判断
7433.797449.280.15数据可信
中间条件18月-供试品溶液-2022110211批-洛尔氨氯地平-0.005Hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min181885-8188571.34267.876.7771.3467.876.77
280570-8057070.19670.20
383994-8399473.18073.18
472591-7259163.24563.24
577531-7753167.54967.55
670816-7081661.69861.70
10min197758-9775885.17180.116.6485.2980.226.64
296762-9676284.30484.42
396743-9674384.28784.41
487150-8715075.92976.03
590285-9028578.66178.77
682981-8298172.29772.40
15min1105684-10568492.07786.015.6592.3486.265.65
2101923-10192388.80089.06
3102277-10227789.10989.37
494925-9492582.70382.94
596903-9690384.42684.67
690598-9059878.93379.16
20min1109282-10928295.21289.694.6895.6390.084.68
2105807-10580792.18492.59
3105362-10536291.79692.21
499590-9959086.76887.14
5101629-10162988.54488.93
695979-9597983.62183.98
30min1109535-10953595.43292.111.9596.0192.651.97
2105832-10583292.20692.76
3106048-10604892.39492.96
4104686-10468691.20791.72
5104598-10459891.13191.66
6103659-10365990.31390.81
45min1109156-10915695.10292.511.5795.8393.201.57
2104345-10434590.91091.62
3106035-10603592.38393.10
4104945-10494591.43392.10
5106317-10631792.62893.31
6106280-10628092.59693.24
极限1110014-11001495.84992.721.9296.7493.571.91
2104078-10407890.67891.54
3105138-10513891.60192.47
4105825-10582592.20093.02
5107016-10701693.23794.08
6106491-10649192.78093.58
富马酸比索洛尔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10071-202203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%
110.098402984027839398411784043840310.08
210.128388683787838360.09
单位质量响应值RSD%判断
8328.158284.190.38数据可信
中间条件18月-供试品溶液-2022110311批-富马酸比索-0.005Hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min184699-8469991.59190.891.1091.5990.891.10
284225-8422591.07991.08
384428-8442891.29891.30
483761-8376190.57790.58
582342-8234289.04289.04
684855-8485591.76091.76
10min189275-8927596.54096.270.7796.6996.420.77
288409-8840995.60395.75
389536-8953696.82296.97
488385-8838595.57795.73
588562-8856295.76995.92
690008-9000897.33297.49
15min190236-9023697.57997.361.1197.8997.671.11
288982-8898296.22396.53
390076-9007697.40697.72
488924-8892496.16096.47
590356-9035697.70998.02
691604-9160499.05899.37
20min188995-8899596.23796.901.7396.7197.371.73
288850-8885096.08096.55
388617-8861795.82896.30
489139-8913996.39296.86
589323-8932396.59197.06
692722-92722100.267100.75
30min189491-8949196.77397.251.4397.4197.891.43
289277-8927796.54297.17
390074-9007497.40498.04
488426-8842695.62196.25
590096-9009697.42798.06
692237-9223799.743100.39
45min190567-9056797.93797.041.5098.7397.841.49
288290-8829095.47496.27
389849-8984997.16097.96
488099-8809995.26896.06
590021-9002197.34698.14
691596-9159699.04999.86
极限189277-8927796.54296.671.4297.5097.631.42
288519-8851995.72296.67
389707-8970797.00797.97
488104-8810495.27396.22
589055-8905596.30297.26
691706-9170699.168100.15
富马酸比索洛尔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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.941036211035171039061043681039401038700.32
213.961027991037341032660.65
单位质量响应值RSD%判断
7451.227397.280.52数据可信
中间条件18月-供试品溶液-2022110311批-洛尔氨氯地平-0.005Hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min180316-8031670.13968.346.0270.1468.346.01
281634-8163471.29071.29
382384-8238471.94571.94
478215-7821568.30468.30
577518-7751867.69567.70
669461-6946160.65960.66
10min193406-9340681.57079.276.3881.6979.396.38
293750-9375081.87181.99
395400-9540083.31283.43
493298-9329881.47681.59
589023-8902377.74377.86
679773-7977369.66569.77
15min1100676-10067687.91984.896.2788.1785.146.27
2100226-10022687.52687.78
3103100-10310090.03690.29
499341-9934186.75387.00
593128-9312881.32781.57
686782-8678275.78676.00
20min1103745-10374590.59987.484.7291.0087.874.73
2103196-10319690.12090.52
3102381-10238189.40889.82
4102560-10256089.56489.96
597497-9749785.14385.52
691685-9168580.06780.41
30min1107448-10744893.83390.384.1094.3890.914.11
2105810-10581092.40292.95
3107433-10743393.82094.38
4102431-10243189.45290.00
5101146-10114688.32988.85
696667-9666784.41884.89
45min1108390-10839094.65691.282.7795.3691.962.79
2104858-10485891.57192.28
3106272-10627292.80693.52
4103919-10391990.75191.44
5103959-10395990.78691.45
699725-9972587.08887.71
极限1106966-10696693.41291.332.3994.2892.172.41
2105585-10558592.20693.06
3107373-10737393.76794.64
4103187-10318790.11290.96
5103459-10345990.34991.17
6100911-10091188.12488.89
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