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%
110.33 4134509413468341369704128797413073141331380.08
210.264121261412489841230800.07
单位质量响应值RSD%判断
400110.16401859.650.31数据可信
影响因素10天-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%
5min13423487-342348776.53261.6623.3076.5361.6623.30
22776490-277649062.06962.07
32843657-284365763.57063.57
41579497-157949735.31035.31
53229318-322931872.19272.19
62698060-269806060.31560.32
10min14384320-438432098.012101.742.1498.14101.842.12
24511528-4511528100.855100.96
34537080-4537080101.427101.53
44638700-4638700103.698103.76
54593983-4593983102.699102.82
64641028-4641028103.750103.85
15min14377096-437709697.850102.122.3598.14102.402.33
24559520-4559520101.928102.20
34543986-4543986101.581101.86
44665811-4665811104.304104.54
54596478-4596478102.755103.05
64666553-4666553104.321104.59
20min14390639-439063998.153102.102.2098.61102.542.18
24546352-4546352101.634102.08
34551767-4551767101.755102.20
44660138-4660138104.178104.58
54591087-4591087102.634103.10
64663010-4663010104.242104.69
30min14379233-437923397.898101.872.2198.52102.492.20
24548016-4548016101.671102.28
34537417-4537417101.434102.05
44652695-4652695104.011104.59
54571568-4571568102.198102.83
64653313-4653313104.025104.65
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%
110.33 4085947409339340973844093651409357540927900.11
210.264139690414098941403400.03
单位质量响应值RSD%判断
396204.26403541.911.30数据可信
影响因素10天-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%
5min13204271-320427171.83765.5712.0171.8465.5712.02
22723682-272368261.06261.06
32449800-244980054.92254.92
43221803-322180372.23072.23
53274101-327410173.40273.40
62675122-267512259.97459.97
10min14419665-441966599.08497.653.4299.2097.763.43
24358692-435869297.71897.82
34125731-412573192.49592.59
44474954-4474954100.324100.44
54515958-4515958101.243101.37
64237824-423782495.00895.11
15min14435794-443579499.446100.241.3699.73100.511.36
24484382-4484382100.535100.80
34374332-437433298.06898.31
44504475-4504475100.986101.27
54550312-4550312102.013102.30
64477817-4477817100.388100.65
20min14435738-443573899.445100.201.3799.90100.641.38
24480143-4480143100.440100.87
34370906-437090697.99198.40
44500318-4500318100.893101.35
54551029-4551029102.030102.49
64477884-4477884100.390100.82
30min14448690-444869099.735100.241.35100.35100.851.36
24475985-4475985100.347100.95
34370980-437098097.99398.57
44524622-4524622101.438102.06
54539742-4539742101.776102.41
64468471-4468471100.179100.77
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%
110.33 4137480414315041431324141784413950041410090.06
210.264101756409761040996830.08
单位质量响应值RSD%判断
400872.12399579.240.23数据可信
影响因素10天-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%
5min13961116-396111688.71978.4810.6988.7278.4810.69
23709448-370944883.08283.08
32931633-293163365.66165.66
43241000-324100072.59072.59
53452034-345203477.31777.32
63729399-372939983.52983.53
10min14209143-420914394.274100.603.5394.42100.743.52
24544420-4544420101.783101.92
34500142-4500142100.792100.90
44482007-4482007100.385100.51
54696323-4696323105.186105.31
64518793-4518793101.209101.35
15min14214305-421430594.390100.923.5394.69101.223.52
24549017-4549017101.886102.19
34544519-4544519101.786102.06
44493688-4493688100.647100.94
54697122-4697122105.203105.51
64535958-4535958101.594101.90
20min14220743-422074394.534101.013.5595.00101.483.53
24570053-4570053102.357102.84
34542085-4542085101.731102.18
44506611-4506611100.936101.39
54708109-4708109105.450105.93
64511405-4511405101.044101.52
30min14212448-421244894.348100.963.6494.97101.603.63
24564530-4564530102.234102.88
34521954-4521954101.280101.90
44499278-4499278100.772101.40
54714455-4714455105.592106.25
64534171-4534171101.554102.20
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%
110.33 4104971411013841059744103004410014341048460.10
210.264056178405414040551590.04
单位质量响应值RSD%判断
397371.35395239.670.39数据可信
影响因素10天-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%
5min13212101-321210172.65578.4810.0672.6578.4810.05
23581931-358193181.02081.02
33577678-357767880.92480.92
44068429-406842992.02492.02
53209921-320992172.60572.61
63167161-316716171.63871.64
10min14053369-405336991.68399.815.1091.8099.945.10
24251151-425115196.15796.29
34510566-4510566102.025102.16
44689479-4689479106.072106.23
54469890-4469890101.105101.23
64500768-4500768101.803101.92
15min14067962-406796292.014100.165.0892.29100.455.08
24262110-426211096.40596.70
34527090-4527090102.399102.70
44699027-4699027106.288106.62
54497667-4497667101.733102.02
64514024-4514024102.103102.39
20min14053011-405301191.67599.815.0892.10100.275.08
24248775-424877596.10396.56
34498024-4498024101.741102.22
44684766-4684766105.965106.47
54494832-4494832101.669102.13
64495436-4495436101.683102.14
30min14046597-404659791.53099.725.1692.11100.355.16
24234264-423426495.77596.39
34513045-4513045102.081102.73
44677824-4677824105.808106.49
54482051-4482051101.380102.01
64498040-4498040101.742102.37
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%
110.33 4118912411931341169964119274411877041186530.03
210.264134896413051541327060.08
单位质量响应值RSD%判断
398707.94402797.860.73数据可信
影响因素10天-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%
5min13287181-328718173.52971.435.3073.5371.445.30
23157825-315782570.63670.64
33394314-339431475.92675.93
43153607-315360770.54170.54
53267110-326711073.08073.08
62900795-290079564.88664.89
10min14499649-4499649100.65099.241.91100.7799.361.91
24486244-4486244100.350100.47
34416047-441604798.78098.91
44438996-443899699.29499.41
54499709-4499709100.652100.77
64278882-427888295.71295.82
15min14498492-4498492100.62499.511.80100.9199.791.80
24498763-4498763100.630100.92
34426315-442631599.01099.30
44462488-446248899.819100.10
54507436-4507436100.824101.11
64297677-429767796.13396.40
20min14515965-4515965101.01599.561.94101.47100.011.94
24501303-4501303100.687101.14
34438452-443845299.28199.74
44453385-445338599.615100.06
54508820-4508820100.855101.31
64287398-428739895.90396.33
30min14505848-4505848100.78999.401.92101.42100.021.93
24469164-446916499.968100.59
34434743-443474399.19899.82
44448754-444875499.512100.13
54521841-4521841101.147101.77
64283506-428350695.81696.40
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