诺氟沙星胶囊项目信息
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130450-201907对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100
标示量(mg)100 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%
110.244098497408264440779094086136408570040861770.19
210.284111048411137841112130.01
单位质量响应值RSD%判断
399040.72399923.440.16数据可信
供试品溶液-25031批-100mg-pH4.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1481181-48118110.79711.0544.9710.8011.0444.97
2701126-70112615.73315.73
3284895-2848956.3936.39
4423102-4231029.4949.49
5805772-80577218.08118.08
6257406-2574065.7765.78
10min12938112-293811265.92978.768.6465.9578.788.63
23816216-381621685.63285.66
33627050-362705081.38881.40
43609099-360909980.98581.00
53452758-345275877.47777.51
63616269-361626981.14681.16
15min14006565-400656589.90495.503.0990.0395.653.10
24355981-435598197.74497.91
34216148-421614894.60694.75
44336748-433674897.31397.46
54303691-430369196.57196.73
64317561-431756196.88297.03
20min14328670-432867097.13199.092.5897.4199.402.58
24425203-442520399.29799.63
34264415-426441595.69095.99
44424078-442407899.27299.59
54595507-4595507103.119103.44
64456756-4456756100.006100.31
30min14374664-437466498.16399.971.9198.60100.441.92
24445644-444564499.756100.25
34389196-438919698.49098.95
44468685-4468685100.273100.75
54612828-4612828103.508104.00
64439953-443995399.628100.10
诺氟沙星胶囊项目信息
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130450-201907对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100
标示量(mg)100 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%
110.244110126411322741101754109968411191141110810.04
210.284106241410454241053920.03
单位质量响应值RSD%判断
401472.75399357.200.38数据可信
供试品溶液-25031批-100mg-pH4.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1478674-47867410.7168.73105.5910.728.73105.60
2469106-46910610.50210.50
31132301-113230125.34925.35
4130122-1301222.9132.91
531649-316490.7090.71
696968-969682.1712.17
10min13872085-387208586.68476.9713.5286.7076.9913.53
23251916-325191672.80072.82
33835129-383512985.85785.90
42670271-267027159.77959.78
53274689-327468973.31073.31
63725876-372587683.41183.41
15min14404423-440442398.60295.455.6498.7695.595.65
24220954-422095494.49494.63
34408653-440865398.69698.88
43806916-380691685.22585.33
54285311-428531195.93596.06
64455201-445520199.73899.88
20min14386760-438676098.20698.553.0998.5398.853.11
24486681-4486681100.443100.74
34474125-4474125100.162100.51
44135195-413519592.57492.82
54451416-445141699.65499.94
64479134-4479134100.274100.58
30min14416411-441641198.87099.821.8599.36100.281.87
24558263-4558263102.046102.51
34495342-4495342100.637101.15
44317918-431791896.66597.07
54485546-4485546100.418100.87
64478232-4478232100.254100.73
诺氟沙星胶囊项目信息
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130450-201907对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100
标示量(mg)100 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%
110.244148283414685041503424148971415071341490320.04
210.284085705408509940854020.02
单位质量响应值RSD%判断
405178.91397412.651.37数据可信
供试品溶液-25032批-100mg-pH4.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1551734-55173412.32617.10110.5512.3317.10110.55
2406575-4065759.0839.08
3520518-52051811.62811.63
4302224-3022246.7526.75
52481160-248116055.42855.43
6331138-3311387.3987.40
10min14170992-417099293.17991.357.7693.2091.387.78
24344095-434409597.04697.06
33973436-397343688.76588.78
43843470-384347085.86285.87
54524019-4524019101.065101.16
63679047-367904782.18982.20
15min14390726-439072698.088100.362.3798.26100.542.39
24601494-4601494102.796102.97
34515183-4515183100.868101.04
44338038-433803896.91197.06
54587998-4587998102.495102.76
64522536-4522536101.032101.18
20min14387712-438771298.020101.322.6398.36101.672.65
24615636-4615636103.112103.46
34563775-4563775101.954102.29
44391940-439194098.11598.43
54674800-4674800104.434104.87
64578772-4578772102.289102.61
30min14375957-437595797.758101.402.4598.26101.922.46
24634541-4634541103.534104.05
34595343-4595343102.659103.16
44420655-442065598.75699.24
54617622-4617622103.156103.76
64590879-4590879102.559103.05
诺氟沙星胶囊项目信息
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130450-201907对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100
标示量(mg)100 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%
110.244094011409783740904914093454409264940936880.07
210.284100315410064841004820.01
单位质量响应值RSD%判断
399774.22398879.570.16数据可信
供试品溶液-25032批-100mg-pH4.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1630811-63081114.16014.4152.7214.1614.4152.71
21032838-103283823.18523.18
31012497-101249722.72822.73
4635796-63579614.27214.27
5316622-3166227.1077.11
6222259-2222594.9894.99
10min14065038-406503891.25186.1514.1191.2786.1814.11
24268053-426805395.80895.85
34025348-402534890.36090.40
43765243-376524384.52184.55
54118742-411874292.45792.47
62785086-278508662.51962.53
15min14453246-445324699.96699.382.94100.1499.552.96
24594482-4594482103.136103.33
34335768-433576897.32897.52
44363183-436318397.94498.11
54554685-4554685102.243102.41
64261937-426193795.67195.78
20min14563786-4563786102.447101.111.68102.79101.441.69
24586850-4586850102.965103.33
34416431-441643199.13999.49
44424951-442495199.33099.66
54560325-4560325102.369102.71
64472254-4472254100.392100.66
30min14604562-4604562103.362101.641.81103.88102.141.80
24609105-4609105103.464104.01
34423893-442389399.30799.82
44435005-443500599.556100.05
54531060-4531060101.712102.22
64563903-4563903102.450102.89
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