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%
110.994425790443151244331294436189443960144332440.12
210.994396090439736043967250.03
单位质量响应值RSD%判断
403388.90400065.970.59数据可信
供试品溶液-25031批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min135640-356400.7950.4276.390.800.4276.37
2-0.0000.00
336251-362510.8090.81
417885-178850.3990.40
510847-108470.2420.24
612785-127850.2850.29
10min1670688-67068814.96612.3414.9614.9712.3414.97
2551357-55135712.30312.30
3495584-49558411.05811.06
4566934-56693412.65112.65
5600175-60017513.39213.39
6432186-4321869.6449.64
15min11331412-133141229.70927.3613.4729.7427.3813.46
21301897-130189729.05129.07
31113528-111352824.84724.87
41405468-140546831.36231.38
51249968-124996827.89227.91
6954214-95421421.29221.31
20min11961290-196129043.76441.2512.6943.8441.3212.69
21958490-195849043.70243.77
31720359-172035938.38838.45
42148445-214844547.94048.01
51834067-183406740.92540.99
61469429-146942932.78932.84
30min12930311-293031165.38762.409.3065.5462.549.31
23010211-301021167.17067.31
32713929-271392960.55960.68
42970941-297094166.29466.45
52841356-284135663.40263.54
62311704-231170451.58351.69
45min13705079-370507982.67580.175.8482.9380.405.85
23744544-374454483.55683.81
33586439-358643980.02880.25
43629216-362921680.98281.25
53709294-370929482.76983.01
63181383-318138370.98971.18
60min14093886-409388691.35188.575.1791.7588.945.18
24131083-413108392.18192.57
33989473-398947389.02189.38
43893959-389395986.89087.29
54112944-411294491.77692.16
63593283-359328380.18180.49
极限14208894-420889493.91794.082.1794.4794.612.18
24317012-431701296.33096.88
34254489-425448994.93595.44
44129928-412992892.15592.70
54297659-429765995.89896.43
64090288-409028891.27191.72
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%
110.994422325442133144233234423208442098644222350.03
210.994400003439898843994960.02
单位质量响应值RSD%判断
402387.17400318.110.37数据可信
供试品溶液-25031批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1318993-3189937.12510.0921.497.1210.0921.50
2427413-4274139.5469.55
3446274-4462749.9679.97
4394419-3944198.8098.81
5587478-58747813.12113.12
6536285-53628511.97811.98
10min11245404-124540427.81631.367.6527.8331.387.66
21410014-141001431.49231.51
31403689-140368931.35131.37
41327943-132794329.65929.67
51502838-150283833.56533.59
61533768-153376834.25634.28
15min12044831-204483145.67149.895.3745.7349.965.38
22242457-224245750.08450.15
32260474-226047450.48750.56
42157041-215704148.17748.24
52310918-231091851.61351.69
62387020-238702053.31353.39
20min12707820-270782060.47864.904.2460.6165.054.24
22920166-292016665.22165.37
32920973-292097365.23965.39
42841416-284141663.46263.61
52971728-297172866.37266.54
63071379-307137968.59868.76
30min13587361-358736180.12283.912.6280.3684.172.63
23757558-375755883.92484.18
33777546-377754684.37084.63
43726001-372600183.21983.47
53814881-381488185.20485.48
63879189-387918986.64086.92
45min14192959-419295993.64895.781.5894.0296.181.59
24268802-426880295.34295.74
34348616-434861697.12597.53
44263026-426302695.21395.60
54275201-427520195.48595.90
64382218-438221897.87598.30
60min14383427-438342797.90299.181.6198.4399.741.61
24407870-440787098.44899.01
34507663-4507663100.677101.24
44397654-439765498.22098.77
54394348-439434898.14698.72
64552576-4552576101.680102.27
极限14409250-440925098.47999.961.7599.17100.691.76
24426685-442668598.86899.59
34572151-4572151102.117102.85
44418143-441814398.67899.39
54449483-444948399.378100.12
64578104-4578104102.250103.01
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%
110.994331660433513643332814331476433653443336170.06
210.994381840438325743825480.03
单位质量响应值RSD%判断
394323.66398775.980.80数据可信
供试品溶液-25032批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1224146-2241465.0673.0544.685.073.0544.74
278212-782121.7681.77
3110239-1102392.4922.49
4174676-1746763.9493.95
5153573-1535733.4723.47
668331-683311.5451.54
10min1890027-89002720.12018.7219.4920.1318.7219.49
2789820-78982017.85417.86
3927216-92721620.96020.96
4802532-80253218.14218.15
51012864-101286422.89622.90
6544910-54491012.31812.32
15min11520274-152027434.36733.7915.0634.4133.8315.06
21525110-152511034.47634.51
31431596-143159632.36232.40
41510067-151006734.13634.17
51842929-184292941.66141.70
61139294-113929425.75525.78
20min11999967-199996745.21147.8412.0745.3147.9312.07
22199491-219949149.72149.81
32103113-210311347.54247.64
42124943-212494348.03648.13
52525250-252525057.08557.20
61745071-174507139.44939.51
30min12715670-271567061.39068.2010.1261.5668.3710.12
23151798-315179871.24971.42
33104747-310474770.18570.36
43020564-302056468.28268.46
53469919-346991978.44078.65
62638235-263823559.63959.77
45min13342517-334251775.56085.548.0875.8485.838.09
23931707-393170788.87989.17
33956122-395612289.43189.72
43779963-377996385.44985.74
54173649-417364994.34894.69
63521376-352137679.60379.83
60min13758018-375801884.95393.095.7385.3693.525.74
24210660-421066095.18595.62
34296884-429688497.13497.57
44119171-411917193.11793.55
54389469-438946999.22799.72
63933280-393328088.91589.28
极限14093253-409325392.53197.523.3293.0898.103.35
24423463-442346399.995100.59
34382185-438218599.06299.66
44289170-428917096.96097.54
54478367-4478367101.237101.90
64216217-421621795.31095.82
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%
110.994389779439388543908744391325438976243911250.04
210.994387242438884543880440.03
单位质量响应值RSD%判断
399556.41399276.070.05数据可信
供试品溶液-25033批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1108840-1088402.4432.4355.922.442.4355.88
2194746-1947464.3714.37
374145-741451.6641.66
429316-293160.6580.66
581801-818011.8361.84
6160555-1605553.6033.60
10min1574896-57489612.90214.9724.0412.9114.9724.05
2870429-87042919.53519.54
3818274-81827418.36418.37
4441286-4412869.9049.90
5603208-60320813.53813.54
6694029-69402915.57615.58
15min11185022-118502226.59528.6914.4426.6228.7214.45
21542195-154219534.61134.65
31360125-136012530.52530.56
41027055-102705523.05023.07
51172955-117295526.32426.35
61383339-138333931.04631.08
20min11753142-175314239.34541.9212.0139.4242.0012.02
22190506-219050649.16149.26
31988723-198872344.63244.72
41594291-159429135.78035.84
51692640-169264037.98838.06
61986833-198683344.59044.67
30min12623333-262333358.87562.606.9459.0162.756.95
23041656-304165668.26368.44
32933756-293375665.84266.00
42627791-262779158.97559.09
52602586-260258658.40958.54
62907153-290715365.24565.40
45min13416990-341699076.68780.994.4376.9281.244.45
23785142-378514284.94985.24
33695958-369595882.94783.22
43632690-363269081.52881.74
53407726-340772676.47976.71
63714911-371491183.37383.64
60min13890098-389009887.30589.932.3987.6790.322.40
24090655-409065591.80692.24
34062331-406233191.17091.58
44058065-405806591.07491.42
53879827-387982787.07487.43
64062611-406261191.17691.58
极限14232702-423270294.99397.181.3995.5097.721.39
24346161-434616197.54098.13
34336623-433662397.32697.88
44413876-441387699.06099.56
54302434-430243496.55897.06
64349495-434949597.61598.17
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