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%
19.793826583383149038291593830885382222638280690.10
29.783834088384318238386350.17
单位质量响应值RSD%判断
391018.28392498.470.27数据可信
中间条件12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%
5min1295324-2953246.7578.6784.286.768.6884.27
274412-744121.7031.70
313768-137680.3150.32
4624473-62447314.28914.29
5842548-84254819.27919.28
6424117-4241179.7049.70
10min13876776-387677688.70778.9416.2088.7278.9516.20
24147602-414760294.90394.91
32561481-256148158.61158.61
43190328-319032873.00073.02
53330277-333027776.20276.23
63592174-359217482.19482.21
15min14340754-434075499.32398.443.4499.4898.593.46
24497594-4497594102.912103.07
34059342-405934292.88492.98
44353269-435326999.60999.75
54221674-422167496.59896.76
64341615-434161599.34399.50
20min14359211-435921199.745101.411.24100.07101.721.23
24500026-4500026102.967103.30
34423334-4423334101.213101.47
44473017-4473017102.349102.66
54380735-4380735100.238100.56
64455583-4455583101.951102.27
30min14380968-4380968100.243101.921.48100.73102.401.48
24520686-4520686103.440103.94
34447833-4447833101.773102.19
44542669-4542669103.943104.43
54391590-4391590100.486100.97
64442307-4442307101.647102.14
极限14357849-435784999.714101.691.53100.37102.341.53
24526206-4526206103.567104.24
34442882-4442882101.660102.25
44506752-4506752103.121103.78
54374945-4374945100.105100.76
64456729-4456729101.977102.63
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%
19.793827368382062438279113820137382851538249110.11
29.783829672382351438265930.12
单位质量响应值RSD%判断
390695.71391267.180.11数据可信
中间条件12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%
5min1900128-90012820.63718.4775.1920.6418.4775.19
21779799-177979940.80540.81
3664267-66426715.23015.23
41111573-111157325.48525.48
5158400-1584003.6323.63
6219204-2192045.0265.03
10min14124283-412428394.55792.576.3994.5992.606.41
24246910-424691097.36997.44
33946241-394624190.47590.50
44175129-417512995.72395.77
53553686-355368681.47581.48
64178613-417861395.80395.81
15min14472816-4472816102.548101.571.39102.74101.761.39
24361244-436124499.990100.22
34430664-4430664101.582101.76
44481545-4481545102.748102.95
54349559-434955999.72299.86
64485284-4485284102.834103.00
20min14534439-4534439103.961102.621.02104.32102.971.01
24402005-4402005100.924101.32
34509907-4509907103.398103.74
44467133-4467133102.418102.79
54460618-4460618102.268102.58
64481320-4481320102.743103.08
30min14591274-4591274105.264102.701.57105.80103.231.55
24370520-4370520100.203100.77
34477784-4477784102.662103.18
44471553-4471553102.519103.06
54475482-4475482102.609103.09
64491084-4491084102.967103.48
极限14615520-4615520105.820103.061.43106.53103.751.42
24423759-4423759101.423102.16
34476343-4476343102.629103.32
44495530-4495530103.069103.78
54470774-4470774102.501103.15
64487840-4487840102.892103.57
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%
19.793824645382823638224473832969382488138266360.11
29.783833048382690538299760.12
单位质量响应值RSD%判断
390871.91391613.090.14数据可信
长期12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%
5min133399-333990.7655.1549.070.775.1649.01
2308794-3087947.0757.07
3336500-3365007.7107.71
4274397-2743976.2876.29
5218891-2188915.0155.02
6177564-1775644.0684.07
10min13211448-321144873.58084.108.9273.5884.108.92
23700234-370023484.77884.79
33347603-334760376.69976.71
43912783-391278389.64889.66
54050097-405009792.79492.80
63800760-380076087.08287.09
15min14089438-408943893.69697.602.5293.8297.752.53
24282313-428231398.11598.27
34217578-421757896.63296.77
44324322-432432299.07799.24
54405664-4405664100.941101.10
64239261-423926197.12897.28
20min14301349-430134998.55199.311.4598.8399.621.45
24435458-4435458101.624101.94
34321745-432174599.01899.32
44313789-431378998.83699.16
54376941-4376941100.283100.61
64257905-425790597.55697.87
30min14268361-426836197.79599.041.5098.2499.521.51
24401834-4401834100.853101.34
34357778-435777899.844100.31
44302609-430260998.58099.07
54371648-4371648100.162100.66
64234838-423483897.02797.50
极限14271863-427186397.87599.271.6598.4899.911.65
24400039-4400039100.812101.47
34357459-435745999.837100.47
44298812-429881298.49399.15
54420947-4420947101.291101.96
64246267-424626797.28997.93
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%
19.793817024380931338063333810681380711138100920.12
29.783844537384653538455360.04
单位质量响应值RSD%判断
389182.02393204.090.73数据可信
长期12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%
5min1566908-56690812.99112.1834.7912.9912.1834.78
2830904-83090419.04019.04
3482668-48266811.06011.06
4277374-2773746.3566.36
5595768-59576813.65213.65
6436472-43647210.00210.00
10min13844175-384417588.09088.686.9088.1188.706.91
24068919-406891993.24093.27
33947238-394723890.45190.47
43362207-336220777.04577.06
53899566-389956689.35989.38
64096961-409696193.88293.90
15min14247402-424740297.33098.663.6897.5098.833.69
24450051-4450051101.973102.16
34451321-4451321102.003102.17
44026694-402669492.27292.41
54351923-435192399.72599.90
64305206-430520698.65498.83
20min14261867-426186797.66199.422.6997.9999.752.70
24412752-4412752101.119101.48
34475849-4475849102.565102.90
44155844-415584495.23295.52
54401707-4401707100.866101.20
64323566-432356699.07599.41
30min14255917-425591797.52599.452.9298.0299.952.93
24472236-4472236102.482103.01
34462281-4462281102.254102.76
44144419-414441994.97095.42
54381933-4381933100.413100.92
64323281-432328199.06999.57
极限14282166-428216698.12699.722.6798.78100.392.68
24431671-4431671101.552102.25
34501298-4501298103.148103.83
44183785-418378595.87296.48
54407286-4407286100.993101.67
64304853-430485398.64699.31
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