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%
1 10.173983219398232039895653979051398373239835770.10
2 10.134005901400093040034160.09
单位质量响应值RSD%判断
391698.82395203.950.63数据可信
中间条件6月-供试品溶液-25031批-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%
5min1600713-60071313.68611.63103.0513.6911.63103.06
21486678-148667833.87233.87
3136603-1366033.1123.11
4292923-2929236.6746.67
5519707-51970711.84111.84
625929-259290.5910.59
10min13478942-347894279.26269.8117.7279.2969.8317.73
23779654-377965486.11486.17
32311359-231135952.66152.67
43211206-321120673.16273.17
52624171-262417159.78859.81
62979287-297928767.87867.88
15min14292886-429288697.80793.286.4397.9693.426.44
24280247-428024797.51997.72
33832503-383250387.31887.41
44234740-423474096.48296.62
53689773-368977384.06684.19
64235528-423552896.50096.61
20min14435609-4435609101.05899.703.52101.3899.993.53
24455341-4455341101.508101.87
34429501-4429501100.919101.16
44480689-4480689102.086102.38
54068553-406855392.69692.96
64385560-438556099.918100.19
30min14504984-4504984102.639102.252.00103.13102.712.00
24522151-4522151103.030103.56
34589869-4589869104.573104.98
44543499-4543499103.517103.98
54424946-4424946100.816101.23
64342746-434274698.94399.38
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%
1 10.174012530400465540122024005894400097040072500.13
2 10.133997170400622240016960.16
单位质量响应值RSD%判断
394026.55395034.160.19数据可信
中间条件6月-供试品溶液-25032批-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%
5min11986959-198695945.14523.4351.3845.1523.4351.38
2858905-85890519.51519.51
3840820-84082019.10419.10
4381815-3818158.6758.68
51077227-107722724.47524.48
61041626-104162623.66623.67
10min14238321-423832196.29893.574.4996.3793.614.49
24261048-426104896.81496.85
34265527-426552796.91696.95
43801593-380159386.37586.39
54004160-400416090.97791.02
64138398-413839894.02794.07
15min14287568-428756897.41799.892.5297.65100.092.50
24582919-4582919104.127104.32
34466724-4466724101.487101.68
44385198-438519899.63599.79
54326121-432612198.29398.49
64330478-433047898.39298.59
20min14300111-430011197.70299.912.9598.10100.272.93
24589771-4589771104.283104.65
34477968-4477968101.743102.11
44453908-4453908101.196101.52
54262914-426291496.85697.21
64299481-429948197.68798.05
30min14284384-428438497.344100.272.7597.91100.802.73
24593592-4593592104.370104.91
34479988-4479988101.789102.32
44460414-4460414101.344101.84
54287875-428787597.42497.94
64371463-437146399.32399.85
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%
1 10.173989580398753839958083993331399269139917900.09
2 10.133981574398110839813410.01
单位质量响应值RSD%判断
392506.39393024.780.10数据可信
中间条件6月-供试品溶液-25033批-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%
5min140459-404590.9233.8388.330.923.8388.40
2249838-2498385.7025.70
3392890-3928908.9678.97
450533-505331.1531.15
5239386-2393865.4635.46
635035-350350.8000.80
10min13611133-361113382.41670.7910.2682.4270.8010.26
22982982-298298268.08068.09
33257621-325762174.34874.36
43109903-310990370.97770.98
52659734-265973460.70360.71
62989452-298945268.22868.23
15min14284078-428407897.77593.764.2597.9193.894.26
24157928-415792894.89595.02
34249073-424907396.97697.11
44089646-408964693.33793.46
53795899-379589986.63386.74
64073178-407317892.96193.08
20min14519201-4519201103.141100.693.15103.44100.973.15
24422476-4422476100.933101.21
34363364-436336499.58499.88
44300781-430078198.15698.43
54247421-424742196.93897.19
64618869-4618869105.415105.69
30min14529007-4529007103.365101.411.97103.84101.861.97
24408796-4408796100.621101.07
34377239-437723999.901100.37
44338565-433856599.01899.46
54443718-4443718101.418101.83
64563407-4563407104.150104.60
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%
1 10.174005141400208540020653998066399833140011380.08
2 10.133979653397753239785920.04
单位质量响应值RSD%判断
393425.57392753.410.13数据可信
长期6月-供试品溶液-25032批-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%
5min11438907-143890732.81324.7869.5532.8124.7869.55
21336682-133668230.48230.48
3193487-1934874.4124.41
42122377-212237748.39948.40
5203749-2037494.6464.65
61224882-122488227.93227.93
10min14154199-415419994.73293.094.4494.7993.134.44
23945104-394510489.96490.01
34196222-419622295.69195.70
44124325-412432594.05194.13
53790951-379095186.44986.46
64282205-428220597.65197.70
15min14375866-437586699.78799.271.42100.0099.471.41
24253074-425307496.98797.19
34373424-437342499.73199.90
44305019-430501998.17298.41
54399896-4399896100.335100.49
64413061-4413061100.635100.84
20min14368458-436845899.61899.630.85100.0099.990.85
24356646-435664699.34999.71
34386504-4386504100.030100.36
44333405-433340598.81999.22
54336235-433623598.88399.20
64431810-4431810101.063101.44
30min14380714-438071499.898100.290.78100.44100.820.76
24375289-437528999.774100.30
34398729-4398729100.309100.81
44361306-436130699.455100.02
54456531-4456531101.627102.11
64414822-4414822100.676101.22
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