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(%)99.60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%
19.95 3962317397218539755523980858397278039727380.18
29.943947648395096739493080.06
单位质量响应值RSD%判断
399270.15397314.690.35数据可信
供试品溶液-24032501批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min13894625-389462587.65386.504.7887.6586.504.78
23786189-378618985.21385.21
33917983-391798388.17988.18
43531940-353194079.49179.49
54087666-408766691.99892.00
63841572-384157286.45986.46
10min14489405-4489405101.040101.121.24101.19101.261.24
24524658-4524658101.833101.97
34544003-4544003102.268102.42
44519449-4519449101.716101.85
54492364-4492364101.106101.26
64387527-438752798.74798.89
15min14506942-4506942101.434101.071.24101.75101.381.24
24454954-4454954100.264100.58
34553379-4553379102.479102.80
44532727-4532727102.015102.32
54495545-4495545101.178101.50
64400455-440045599.03899.35
20min14494912-4494912101.163100.961.16101.65101.451.16
24456669-4456669100.303100.78
34544394-4544394102.277102.77
44534537-4534537102.055102.53
54481684-4481684100.866101.36
64403789-440378999.11399.59
30min14479058-4479058100.807100.661.24101.46101.311.24
24427846-442784699.654100.30
34525254-4525254101.846102.51
44529520-4529520101.942102.58
54484580-4484580100.931101.59
64388023-438802398.75899.40
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(%)99.60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%
19.95 3963714396185439645143963810396412739636040.03
29.944033648401107140223600.40
单位质量响应值RSD%判断
398352.16404663.981.12数据可信
供试品溶液-24032502批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min13956118-395611888.32990.156.3288.3390.156.32
24172932-417293293.17093.17
34057817-405781790.60090.60
44238369-423836994.63194.63
53567955-356795579.66279.66
64233498-423349894.52294.52
10min14430202-443020298.91499.271.3499.0699.421.33
24442487-444248799.18899.34
34521674-4521674100.956101.11
44465994-446599499.71399.87
54473667-447366799.884100.02
64344030-434403096.99097.15
15min14441168-444116899.15999.471.5399.4799.791.53
24449250-444925099.33999.66
34560212-4560212101.817102.14
44439890-443989099.13099.45
54488627-4488627100.219100.52
64352539-435253997.18097.50
20min14429292-442929298.89499.521.3499.37100.001.34
24470635-447063599.817100.30
34546123-4546123101.502101.99
44456918-445691899.511100.00
54476668-447666899.951100.42
64364962-436496297.45797.94
30min14437833-443783399.08499.291.5499.7399.941.54
24448434-444843499.32199.97
34563860-4563860101.898102.56
44448255-444825599.31799.97
54433743-443374398.99399.63
64349814-434981497.11997.76
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(%)99.60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%
19.95 3960802396729339595573965700396896739644640.11
29.943940565393788939392270.05
单位质量响应值RSD%判断
398438.59396300.500.39数据可信
供试品溶液-24032501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%
5min12430764-243076454.83458.575.1054.8358.575.10
22823536-282353663.69563.69
32567820-256782057.92657.93
42605951-260595158.78658.79
52633493-263349359.40859.41
62517130-251713056.78356.78
10min13614901-361490181.54786.273.8881.6486.373.87
23966653-396665389.48289.59
33977577-397757789.72889.82
43683747-368374783.10083.20
53831195-383119586.42686.53
63871702-387170287.34087.43
15min14078371-407837192.00296.583.1992.2396.823.19
24321897-432189797.49697.75
34443215-4443215100.232100.48
44179933-417993394.29394.53
54266197-426619796.23996.48
64397383-439738399.19899.44
20min14281509-428150996.58499.271.9196.9799.681.91
24459244-4459244100.594101.01
34439284-4439284100.144100.56
44386988-438698898.96499.36
54331361-433136197.70998.11
64506003-4506003101.649102.05
30min14314003-431400397.31799.652.8297.86100.222.81
24447327-4447327100.325100.91
34520003-4520003101.965102.54
44395673-439567399.16099.72
54248760-424876095.84696.41
64579430-4579430103.305103.88
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(%)99.60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%
19.95 3955173394910739478843948910394895639500060.08
29.943943652393564739396500.15
单位质量响应值RSD%判断
396985.53396343.060.12数据可信
供试品溶液-24032502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%
5min13405949-340594976.96971.776.6876.9771.776.68
23362879-336287975.99676.00
33108217-310821770.24170.24
42831383-283138363.98563.98
53256151-325615173.58473.58
63091393-309139369.86169.86
10min14185501-418550194.58690.974.3294.7191.094.31
24105219-410521992.77292.90
34127055-412705593.26593.38
43715289-371528983.96084.07
54086608-408660892.35192.47
63934401-393440188.91189.03
15min14196403-419640394.83293.953.7995.1294.223.80
24185952-418595294.59694.88
34222225-422222595.41695.69
43863267-386326787.30487.55
54332841-433284197.91698.19
64142716-414271693.61993.88
20min14278880-427888096.69695.673.3097.1496.103.29
24214004-421400495.23095.67
34289899-428989996.94597.38
44052822-405282291.58891.98
54446551-4446551100.485100.92
64117781-411778193.05693.48
30min14279650-427965096.71496.043.0997.3296.633.10
24215874-421587495.27295.87
34338630-433863098.04698.64
44079425-407942592.18992.73
54440702-4440702100.353100.96
64146113-414611393.69694.27
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