诺氟沙星胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
19.983978192397327339708603973777397955239751310.10
210.103974734397556239751480.02
单位质量响应值RSD%判断
398309.72393579.010.85数据可信
供试品溶液-24042301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%
5min1628195-62819514.22314.154.6314.2214.154.63
2629430-62943014.25114.25
3671349-67134915.20015.20
4586215-58621513.27213.27
5603575-60357513.66513.67
6631216-63121614.29114.29
10min11560202-156020235.32433.227.0935.4833.387.07
21505866-150586634.09334.25
31502080-150208034.00834.18
41343608-134360830.42030.57
51331113-133111330.13730.29
61561645-156164535.35635.51
15min12251148-225114850.96748.136.9951.5248.666.98
22207070-220707049.96950.51
32192605-219260549.64150.19
41943372-194337243.99944.48
51928618-192861843.66544.15
62232138-223213850.53651.09
20min12790198-279019863.17158.597.5064.2959.657.48
22701642-270164261.16662.26
32675014-267501460.56361.66
42358336-235833653.39454.37
52329133-232913352.73253.70
62671933-267193360.49461.61
30min13453504-345350478.18973.426.4180.0175.146.42
23362351-336235176.12577.90
33349724-334972475.83977.61
43044044-304404468.91870.49
52926772-292677266.26367.82
63321986-332198675.21177.00
45min13833574-383357486.79381.735.7389.4884.265.74
23715887-371588784.12986.75
33745014-374501484.78887.40
43475326-347532678.68381.02
53269621-326962174.02576.32
63620222-362022281.96384.58
60min13900934-390093488.31984.824.5191.9788.264.57
23872063-387206387.66591.22
33865135-386513587.50891.06
43630674-363067482.20085.41
53472301-347230178.61481.73
63738526-373852684.64288.17
极限14040688-404068891.48388.803.1296.1293.183.22
24005740-400574090.69195.22
34016390-401639090.93295.46
43887980-388798088.02592.15
53722735-372273584.28488.27
63859905-385990587.39091.86
诺氟沙星胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
19.983962991396058439598313958124396060539604270.05
210.103955420397889039671550.42
单位质量响应值RSD%判断
396836.37392787.620.73数据可信
供试品溶液-24042301批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1277362-2773626.2987.5513.386.307.5513.37
2306528-3065286.9606.96
3358777-3587778.1468.15
4302266-3022666.8636.86
5397002-3970029.0149.01
6352587-3525878.0068.01
10min1698830-69883015.86717.916.9915.9418.007.02
2786337-78633717.85417.93
3810341-81034118.39918.49
4764726-76472617.36317.44
5863559-86355919.60719.71
6810340-81034018.39918.49
15min11062742-106274224.13025.373.8324.3825.653.87
21123858-112385825.51725.79
31114582-111458225.30725.60
41086002-108600224.65824.93
51187845-118784526.97027.29
61128730-112873025.62825.92
20min11310596-131059629.75731.223.0430.2731.783.08
21381773-138177331.37331.93
31413789-141378932.10032.68
41337082-133708230.35930.90
51400786-140078631.80532.42
61405210-140521031.90532.48
30min11611063-161106336.57938.273.0637.4239.183.09
21705076-170507638.71439.62
31722166-172216639.10240.03
41629228-162922836.99237.87
51716981-171698138.98439.96
61728151-172815139.23840.17
45min11818632-181863241.29242.262.2742.5443.602.29
21856267-185626742.14743.48
31897590-189759043.08544.45
41820555-182055541.33642.63
51850816-185081642.02343.43
61924119-192411943.68745.06
60min11865608-186560842.35943.501.8644.0745.311.90
21902420-190242043.19545.00
31925199-192519943.71245.56
41900157-190015743.14344.89
51932302-193230243.87345.74
61970441-197044144.73946.59
极限11938465-193846544.01344.491.2246.1946.781.20
21985158-198515845.07347.36
31923274-192327443.66846.00
41970623-197062344.74346.97
51977169-197716944.89247.25
61961401-196140144.53446.88
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