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%
110.098389283871838678374983763838280.08
210.128363283612836220.02
单位质量响应值RSD%判断
8308.038263.040.39数据可信
长期18月-供试品溶液-2022110111批-比索洛尔-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%
5min182696-8269689.64891.743.2089.6591.743.20
282111-8211189.01489.01
386810-8681094.10894.11
481793-8179388.66988.67
586641-8664193.92593.92
687717-8771795.09195.09
10min192488-92488100.26398.471.57100.4198.621.57
290251-9025197.83897.99
390787-9078798.41998.58
488680-8868096.13596.28
590455-9045598.05998.22
692346-92346100.109100.27
15min194723-94723102.68699.621.88103.0099.941.87
291414-9141499.09999.41
391478-9147899.16899.49
489850-8985097.40397.71
590897-9089798.53898.86
692996-92996100.814101.14
20min195116-95116103.11299.731.99103.60100.211.98
291515-9151599.20899.68
391597-9159799.29799.78
490042-9004297.61198.08
590716-9071698.34298.83
693000-93000100.818101.31
30min194859-94859102.83399.521.87103.49100.171.87
291401-9140199.08599.73
391380-9138099.06299.71
490129-9012997.70698.34
590509-9050998.11898.77
692560-92560100.341101.00
45min194818-94818102.78999.511.93103.62100.331.92
291291-9129198.96599.77
391220-9122098.88899.71
489897-8989797.45498.25
590726-9072698.35399.16
692831-92831100.635101.46
极限194478-94478102.42099.171.96103.42100.151.95
291043-9104398.69799.67
391183-9118398.84899.83
489735-8973597.27998.24
589889-8988997.44698.42
692523-92523100.301101.30
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%
113.941048031045301046021043601045951045780.16
213.961038141042671040400.31
单位质量响应值RSD%判断
7502.017452.720.47数据可信
长期18月-供试品溶液-2022110111批-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%
5min167300-6730058.35567.279.7458.3567.279.74
271029-7102961.58861.59
386657-8665775.13975.14
475578-7557865.53265.53
583503-8350372.40472.40
681450-8145070.62470.62
10min186036-8603674.60079.906.8674.7080.026.87
285154-8515473.83573.94
399087-9908785.91686.04
489096-8909677.25377.36
599342-9934286.13886.26
694204-9420481.68281.80
15min195249-9524982.58985.495.2082.8185.745.21
292111-9211179.86880.09
3103983-10398390.16290.43
495644-9564482.93183.17
5104802-10480290.87291.14
699813-9981386.54686.80
20min1101616-10161688.10988.704.0688.4789.094.08
296789-9678983.92484.28
3106333-10633392.19992.62
498488-9848885.39785.77
5107119-10711992.88193.30
6103474-10347489.72090.12
30min1107854-10785493.51892.412.5694.0292.942.57
2103398-10339889.65490.15
3110063-11006395.43496.01
4103579-10357989.81190.33
5108512-10851294.08994.66
6106028-10602891.93592.48
45min1112988-11298897.97094.362.1798.6395.052.15
2106629-10662992.45693.10
3110097-11009795.46396.19
4107267-10726793.00993.68
5108122-10812293.75194.48
6107840-10784093.50694.21
极限1113259-11325998.20594.382.5499.0395.222.53
2106067-10606791.96992.77
3111143-11114396.37097.26
4106993-10699392.77293.59
5107749-10774993.42794.31
6107859-10785993.52294.38
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%
110.098364783673837088361183561836400.07
210.128387883809838440.06
单位质量响应值RSD%判断
8289.408284.980.04数据可信
长期18月-供试品溶液-2022110311批-比索洛尔-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%
5min179016-7901685.64189.124.8285.6489.124.82
284763-8476391.87091.87
381373-8137388.19588.20
484786-8478691.89591.89
576515-7651582.93082.93
686877-8687794.16194.16
10min187821-8782195.18496.861.9495.3397.011.94
290296-9029697.86798.02
387617-8761794.96395.11
491149-9114998.79198.94
588053-8805395.43695.57
691292-9129298.94699.10
15min189118-8911896.59097.921.4796.8998.231.48
290946-9094698.57198.89
388554-8855495.97996.28
491534-9153499.20899.53
590090-9009097.64397.94
691849-9184999.55099.87
20min189496-8949697.00098.041.2997.4698.511.30
291077-9107798.71399.19
388839-8883996.28796.75
491302-9130298.95799.44
590137-9013797.69498.15
691885-9188599.589100.08
30min189565-8956597.07497.801.1397.7098.441.14
290701-9070198.30698.95
388752-8875296.19396.82
491001-9100198.63199.28
589876-8987697.41198.03
691506-9150699.17899.83
45min189346-8934696.83797.661.1297.6298.461.13
290667-9066798.26999.08
388734-8873496.17496.96
491147-9114798.78999.60
589652-8965297.16997.95
691113-9111398.75299.57
极限188886-8888696.33897.631.3797.2998.591.37
290615-9061598.21299.18
388640-8864096.07297.02
491217-9121798.86599.84
589550-8955097.05898.01
691550-9155099.226100.21
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%
113.941039421043371038321039091037701039580.22
213.961039681041621040650.14
单位质量响应值RSD%判断
7457.537454.510.03数据可信
长期18月-供试品溶液-2022110311批-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%
5min170282-7028261.11466.488.0461.1166.488.04
277315-7731567.23067.23
379189-7918968.85968.86
477576-7757667.45667.46
568821-6882159.84459.84
685554-8555474.39474.39
10min182029-8202971.32977.628.5271.4377.738.52
290268-9026878.49378.60
390132-9013278.37578.49
489819-8981978.10278.21
581128-8112870.54570.64
6102230-10223088.89489.02
15min188507-8850776.96283.227.4877.1883.467.48
296922-9692284.27984.52
395963-9596383.44583.69
497326-9732684.63084.87
587958-8795876.48476.70
6107522-10752293.49693.77
20min192665-9266580.57786.856.2580.9387.236.26
2101550-10155088.30388.69
399939-9993986.90287.29
4102293-10229388.94989.33
593355-9335581.17781.52
6109444-10944495.16795.60
30min1101393-10139388.16790.764.0888.6591.284.10
2104107-10410790.52791.06
3105016-10501691.31791.85
4106814-10681492.88093.41
598327-9832785.50185.98
6110577-11057796.15396.74
45min1105940-10594092.12092.771.8992.7593.451.92
2105667-10566791.88392.56
3106030-10603092.19992.88
4106753-10675392.82793.51
5105106-10510691.39592.02
6110643-11064396.21096.96
极限1106670-10667092.75593.311.9393.5494.141.95
2105928-10592892.11092.94
3107082-10708293.11493.95
4107579-10757993.54694.39
5105372-10537291.62792.40
6111187-11118796.68397.59
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%
110.098335183292833388320783262832900.08
210.128370783605836560.09
单位质量响应值RSD%判断
8254.718266.400.11数据可信
长期18月-供试品溶液-5543C0421批-比索洛尔-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%
5min188931-8893196.69895.341.9496.7095.341.94
290028-9002897.89197.89
388386-8838696.10596.11
486839-8683994.42394.42
586230-8623093.76193.76
685688-8568893.17293.17
10min191091-9109199.04797.542.4299.2197.702.42
292855-92855100.965101.13
390354-9035498.24598.41
488791-8879196.54696.70
588317-8831796.03096.19
686806-8680694.38794.54
15min190733-9073398.65797.552.5598.9897.872.55
293411-93411101.569101.90
390189-9018998.06698.39
488885-8888596.64896.97
588225-8822595.93096.25
686831-8683194.41594.73
20min190679-9067998.59997.382.3699.0997.862.36
292841-92841100.949101.45
389945-8994597.80098.29
488976-8897696.74797.23
588110-8811095.80596.28
686784-8678494.36394.83
30min190461-9046198.36297.202.3799.0297.852.37
292748-92748100.848101.52
389988-8998897.84798.50
488404-8840496.12596.77
587956-8795695.63896.27
686819-8681994.40195.03
45min190540-9054098.44796.802.7099.2797.612.69
292548-92548100.631101.47
389701-8970197.53598.35
488309-8830996.02296.82
587103-8710394.71095.51
685964-8596493.47294.26
极限190331-9033198.22096.942.6399.2097.912.63
292787-92787100.891101.90
389983-8998397.84298.82
488160-8816095.86096.82
587205-8720594.82195.77
686460-8646094.01194.95
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%
113.941031321035171031611035331035211033730.21
213.961039151038631038890.04
单位质量响应值RSD%判断
7415.577441.910.26数据可信
长期18月-供试品溶液-5543C0421批-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%
5min188646-8864677.36675.884.3977.3775.884.39
287030-8703075.95575.96
388615-8861577.33977.34
480011-8001169.83069.83
586131-8613175.17175.17
691234-9123479.62479.62
10min1102790-10279089.71088.991.3789.8489.111.37
2101141-10114188.27188.40
3100837-10083788.00688.13
4100379-10037987.60687.72
5102627-10262789.56889.69
6103995-10399590.76290.89
15min1107904-10790494.17392.221.5994.4592.501.58
2106241-10624192.72293.00
3103053-10305389.94090.22
4105077-10507791.70691.97
5105030-10503091.66591.94
6106698-10669893.12193.40
20min1109187-10918795.29393.532.1295.7393.962.12
2110044-11004496.04196.47
3103692-10369290.49790.92
4106199-10619992.68593.10
5106587-10658793.02493.45
6107301-10730193.64794.09
30min1109324-10932495.41393.472.2596.0194.062.24
2110545-11054596.47897.07
3104303-10430391.03091.61
4105188-10518891.80392.37
5106446-10644692.90193.48
6106788-10678893.19993.79
45min1109874-10987495.89393.162.7796.6593.902.76
2111002-11100296.87797.63
3103849-10384990.63491.36
4105523-10552392.09592.82
5104709-10470991.38592.12
6105479-10547992.05792.81
极限1110569-11056996.49993.252.9697.4194.142.95
2110791-11079196.69397.60
3103280-10328090.13891.02
4104559-10455991.25492.13
5105293-10529391.89492.78
6106566-10656693.00593.91
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