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%
110.244042708403432240395694034332403348140368820.11
210.284060725406228740615060.03
单位质量响应值RSD%判断
394226.76395088.130.16数据可信
供试品溶液-25031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%
5min13503860-350386079.58556.7443.3279.5856.7443.32
23014835-301483568.47768.48
3808458-80845818.36318.36
41486954-148695433.77433.77
53037911-303791169.00169.00
63135733-313573371.22371.22
10min14553334-4553334103.422100.532.60103.55100.622.62
24299872-429987297.66597.78
34315966-431596698.03098.06
44430927-4430927100.641100.70
54568660-4568660103.770103.88
64386230-438623099.62699.74
15min14562695-4562695103.634102.212.21103.94102.472.20
24403687-4403687100.023100.30
34422390-4422390100.447100.64
44622271-4622271104.987105.21
54579866-4579866104.024104.31
64407849-4407849100.117100.40
20min14551507-4551507103.380102.261.83103.86102.691.83
24480200-4480200101.761102.20
34416254-4416254100.308100.67
44599779-4599779104.477104.88
54563266-4563266103.647104.11
64402017-440201799.985100.44
30min14534036-4534036102.983102.042.46103.63102.642.45
24393451-439345199.790100.40
34407159-4407159100.102100.63
44661524-4661524105.879106.45
54559378-4559378103.559104.19
64398553-439855399.906100.52
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%
110.244015591406870040268814070441407647040516170.70
210.284091195409278840919920.03
单位质量响应值RSD%判断
395665.72398053.700.43数据可信
供试品溶液-25031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%
5min12672780-267278060.37233.0344.6060.3733.0344.60
21397833-139783331.57431.57
31612957-161295736.43336.43
4868199-86819919.61019.61
5977619-97761922.08222.08
61245295-124529528.12828.13
10min14538886-4538886102.52299.682.97102.6299.732.98
24426231-442623199.978100.03
34505331-4505331101.764101.83
44439656-4439656100.281100.31
54399975-439997599.38599.42
64167396-416739694.13194.18
15min14622950-4622950104.421103.002.39104.69103.222.38
24469244-4469244100.949101.17
34546226-4546226102.688102.92
44526032-4526032102.232102.43
54452863-4452863100.579100.78
64744168-4744168107.159107.36
20min14573408-4573408103.302103.062.13103.75103.462.13
24490525-4490525101.430101.82
34540314-4540314102.554102.96
44552861-4552861102.838103.21
54474628-4474628101.071101.44
64745367-4745367107.186107.57
30min14588758-4588758103.649102.912.15104.27103.472.15
24471120-4471120100.992101.55
34527252-4527252102.259102.83
44549546-4549546102.763103.30
54467010-4467010100.899101.44
64731624-4731624106.876107.44
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%
110.244058099410609140638724105015410647940879110.61
210.284102614410310641028600.01
单位质量响应值RSD%判断
399210.06399110.890.02数据可信
供试品溶液-25032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%
5min12376840-237684053.37763.0718.8453.3863.0818.84
22700866-270086660.65460.65
33360594-336059475.46975.47
43215249-321524972.20572.21
53166172-316617271.10371.10
62032236-203223645.63845.64
10min14613102-4613102103.597102.681.46103.69102.781.45
24484143-4484143100.701100.80
34536247-4536247101.871102.00
44533480-4533480101.809101.93
54596650-4596650103.228103.35
64668770-4668770104.847104.92
15min14633873-4633873104.064103.321.42104.33103.591.40
24525289-4525289101.625101.89
34538870-4538870101.930102.23
44589763-4589763103.073103.36
54614738-4614738103.634103.92
64701492-4701492105.582105.83
20min14610104-4610104103.530103.101.36103.96103.551.35
24554473-4554473102.280102.72
34531682-4531682101.769102.23
44534101-4534101101.823102.28
54624975-4624975103.864104.33
64690344-4690344105.332105.76
30min14665514-4665514104.774103.901.06105.38104.521.04
24640554-4640554104.214104.82
34579891-4579891102.851103.49
44581777-4581777102.894103.53
54594091-4594091103.170103.81
64696700-4696700105.474106.08
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%
110.244064919405868040886954091232407793540762920.36
210.284102967407520340890850.49
单位质量响应值RSD%判断
398075.39397770.910.06数据可信
供试品溶液-25032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%
5min12351155-235115552.96464.6219.7752.9664.6219.77
22780646-278064662.64062.64
32578060-257806058.07658.08
43704177-370417783.44483.44
52375370-237537053.51053.51
63421069-342106977.06677.07
10min14411988-441198899.389101.080.9399.48101.190.94
24498409-4498409101.336101.44
34477120-4477120100.856100.95
44536060-4536060102.184102.32
54503409-4503409101.448101.54
64496395-4496395101.290101.42
15min14533663-4533663102.130102.540.85102.38102.810.85
24517590-4517590101.768102.04
34619705-4619705104.068104.33
44561106-4561106102.748103.06
54518126-4518126101.780102.04
64559828-4559828102.719103.02
20min14484947-4484947101.032101.880.87101.46102.330.86
24524904-4524904101.932102.38
34597045-4597045103.557104.00
44506822-4506822101.525102.01
54519623-4519623101.813102.24
64502107-4502107101.419101.89
30min14475867-4475867100.828101.730.80101.42102.350.80
24489252-4489252101.129101.74
34575467-4575467103.071103.68
44534562-4534562102.150102.80
54518921-4518921101.798102.40
64501623-4501623101.408102.05
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%
110.244100985410699340726004068418408104940860090.43
210.284061861406515140635060.06
单位质量响应值RSD%判断
399024.32395282.680.67数据可信
供试品溶液-25033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%
5min11683544-168354437.99938.8752.3338.0038.8752.33
2584127-58412713.18413.18
32413171-241317154.46854.47
43007736-300773667.88867.89
5926696-92669620.91720.92
61717818-171781838.77338.77
10min14535414-4535414102.36998.515.11102.4398.585.11
24571028-4571028103.173103.20
34337923-433792397.91298.00
44546567-4546567102.621102.73
54082574-408257492.14892.18
64114070-411407092.85992.92
15min14603864-4603864103.914103.062.40104.15103.292.40
24691595-4691595105.895106.09
34638390-4638390104.694104.95
44546660-4546660102.623102.91
54375573-437557398.76298.95
64540483-4540483102.484102.70
20min14608241-4608241104.013103.032.17104.42103.432.18
24664722-4664722105.288105.66
34659183-4659183105.163105.59
44547609-4547609102.645103.10
54414236-441423699.63499.99
64492849-4492849101.409101.80
30min14664000-4664000105.272103.072.35105.85103.642.36
24656762-4656762105.108105.65
34639819-4639819104.726105.33
44556611-4556611102.848103.47
54403562-440356299.39399.91
64478501-4478501101.085101.64
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%
110.244053032405028040847634048262404650540565680.40
210.284054097405526640546820.03
单位质量响应值RSD%判断
396149.22394424.320.31数据可信
供试品溶液-25033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%
5min13084655-308465569.95237.3064.7669.9537.3064.75
22648881-264888160.07060.07
31884762-188476242.74142.74
4967338-96733821.93721.94
5466810-46681010.58610.59
6816481-81648118.51618.52
10min14675243-4675243106.022100.185.26106.14100.245.28
24445139-4445139100.804100.90
34475913-4475913101.502101.57
44571942-4571942103.679103.72
54328185-432818598.15298.17
64009296-400929690.92090.95
15min14690955-4690955106.378103.412.29106.67103.632.31
24491620-4491620101.858102.13
34639129-4639129105.203105.44
44622739-4622739104.831105.04
54481625-4481625101.631101.81
64433169-4433169100.532100.71
20min14691392-4691392106.388103.612.00106.86104.012.02
24497481-4497481101.991102.43
34636866-4636866105.152105.57
44617915-4617915104.722105.11
54487947-4487947101.775102.13
64480791-4480791101.612101.96
30min14690612-4690612106.370103.422.05107.02104.002.08
24517246-4517246102.439103.05
34626270-4626270104.911105.50
44602559-4602559104.374104.93
54465529-4465529101.266101.79
64461862-4461862101.183101.70
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