非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
19.753774845377725037762063778055377633837765390.04
29.793800574380498338027780.09
单位质量响应值RSD%判断
387337.33388434.930.21数据可信
供试品溶液-4225B批-pH6.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12059476-205947647.78541.2219.4147.7941.2219.41
21639455-163945538.04038.04
32023973-202397346.96246.96
41149778-114977826.67826.68
51976686-197668645.86545.86
61809456-180945641.98441.98
10min13485208-348520880.86674.809.6280.9774.899.63
22965662-296566268.81168.90
33452419-345241980.10680.21
42722995-272299563.18163.24
53412769-341276979.18679.29
63303917-330391776.66076.75
15min13812739-381273988.46685.803.3088.7586.063.33
23668326-366832685.11585.35
33767540-376754087.41787.70
43471974-347197480.55980.76
53764123-376412387.33887.62
63702597-370259785.91086.17
20min13956531-395653191.80290.691.7092.2891.141.72
23973461-397346192.19592.62
33931355-393135591.21891.69
43787022-378702287.86988.25
53903813-390381390.57991.05
63899243-389924390.47390.93
30min14117223-411722395.53195.001.4696.2295.651.46
24203875-420387597.54198.17
34080956-408095694.68995.37
44038896-403889693.71394.29
54067639-406763994.38095.05
64057930-405793094.15594.81
45min14169752-416975296.75096.991.7997.6597.861.75
24313154-4313154100.077100.93
34132505-413250595.88596.78
44218142-421814297.87298.65
54122226-412222695.64796.53
64125477-412547795.72296.59
60min14182925-418292597.05597.311.5798.1798.391.55
24320966-4320966100.258101.33
34186293-418629397.13398.24
44170019-417001996.75697.76
54127724-412772495.77496.87
64176441-417644196.90597.98
极限14207557-420755797.62797.881.2398.9699.171.22
24314535-4314535100.109101.40
34213958-421395897.77599.09
44171232-417123296.78498.00
54178278-417827896.94798.26
64224551-422455198.02199.31
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
19.753809392380278838046603794052379008938001960.21
29.793810742381147738111100.02
单位质量响应值RSD%判断
389763.69389286.010.09数据可信
供试品溶液-4225B批-pH6.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11814382-181438241.92140.579.9341.9240.589.92
21576151-157615136.41736.42
31931453-193145344.62644.63
41502079-150207934.70634.71
51837028-183702842.44542.44
61875450-187545043.33243.33
10min13212287-321228774.22074.074.3974.3174.164.40
22998803-299880369.28869.37
33311509-331150976.51376.61
43073943-307394371.02471.10
53288116-328811675.97276.07
63349140-334914077.38277.48
15min13745464-374546486.53985.131.6286.8085.391.63
23615084-361508483.52783.76
33711276-371127685.74986.02
43604510-360451083.28283.52
53707260-370726085.65785.92
63723524-372352486.03286.30
20min13956704-395670491.42090.131.3491.8790.571.35
23834291-383429188.59289.01
33883060-388306089.71890.18
43859529-385952989.17589.59
53964355-396435591.59792.05
63907473-390747390.28290.74
30min14143503-414350395.73694.591.1396.3995.231.13
24042702-404270293.40794.02
34052486-405248693.63394.29
44119661-411966195.18595.80
54141457-414145795.68996.35
64063385-406338593.88594.54
45min14226308-422630897.64996.981.4498.5297.841.43
24209112-420911297.25298.08
34157345-415734596.05696.92
44176510-417651096.49997.33
54293672-429367299.206100.08
64120802-412080295.21196.08
60min14215180-421518097.39296.701.3998.4897.771.39
24165037-416503796.23497.27
34138994-413899495.63296.71
44166863-416686396.27697.32
54289239-428923999.103100.19
64137189-413718995.59096.67
极限14222617-422261797.56497.050.6398.8698.330.65
24171694-417169496.38797.64
34192190-419219096.86198.15
44175483-417548396.47597.73
54238825-423882597.93899.25
64200815-420081597.06098.35
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
19.753807812382183938174823806004381815338142580.19
29.793832001383340538327030.03
单位质量响应值RSD%判断
391205.95391491.620.06数据可信
供试品溶液-4225B批-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11005160-100516023.11623.1229.4623.1223.1229.46
21348368-134836831.00931.01
3898927-89892720.67320.67
41174543-117454327.01127.01
5487343-48734311.20811.21
61116977-111697725.68825.69
10min12219817-221981751.05050.8713.5351.1050.9213.55
22435120-243512056.00156.07
32272671-227267152.26652.31
42415101-241510155.54155.60
51624957-162495737.37037.39
62303396-230339652.97253.03
15min12773512-277351263.78462.847.9863.9563.008.00
22880785-288078566.25166.44
32785777-278577764.06664.23
42857763-285776365.72165.90
52296106-229610652.80452.91
62801330-280133064.42364.60
20min13073720-307372070.68869.804.6470.9970.104.68
23115486-311548671.64871.99
33071241-307124170.63170.93
43141675-314167572.25072.58
52755437-275543763.36863.59
63053510-305351070.22370.54
30min13411325-341132578.45277.022.1978.9277.482.23
23373027-337302777.57178.07
33364811-336481177.38277.84
43390155-339015577.96578.45
53206684-320668473.74574.11
63348550-334855077.00877.48
45min13715186-371518685.44082.681.8986.0883.311.91
23575725-357572582.23282.90
33606584-360658482.94283.58
43583310-358331082.40783.07
53507072-350707280.65481.18
63582825-358282582.39683.04
60min13800328-380032887.39885.931.1888.2386.751.19
23702075-370207585.13885.99
33730483-373048385.79186.61
43707478-370747885.26286.11
53697759-369775985.03985.75
63781480-378148086.96487.79
极限13935185-393518590.49988.971.2391.5289.971.21
23819496-381949687.83888.88
33850040-385004088.54189.55
43821440-382144087.88388.92
53874648-387464889.10790.00
63911166-391116689.94790.97
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
19.753842412384045538346333832963383091438362750.13
29.793773946377383737738920.01
单位质量响应值RSD%判断
393464.10385484.371.45数据可信
供试品溶液-4225B批-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1914738-91473821.14024.3213.0021.1424.3212.99
21192688-119268827.56427.56
31130629-113062926.12926.13
41157390-115739026.74826.75
5858396-85839619.83819.84
61060509-106050924.50924.51
10min11996463-199646346.13950.928.3646.1950.978.36
22311742-231174253.42653.49
32302915-230291553.22253.28
42349260-234926054.29354.35
51938836-193883644.80744.85
62319476-231947653.60453.66
15min12559482-255948259.15162.565.1859.3062.735.19
22784325-278432564.34764.53
32784783-278478364.35864.53
42825463-282546365.29865.48
52498557-249855757.74357.89
62788973-278897364.45564.63
20min12845268-284526865.75669.663.4866.0469.973.49
23059509-305950970.70771.03
33079647-307964771.17271.49
43085662-308566271.31171.64
52922200-292220067.53467.81
63093727-309372771.49871.81
30min13242457-324245774.93577.091.8475.3677.561.87
23379720-337972078.10778.59
33347891-334789177.37177.85
43388676-338867678.31478.80
53277968-327796875.75576.18
63378671-337867178.08378.56
45min13516589-351658981.27082.511.3081.8683.141.32
23637460-363746084.06484.72
33560781-356078182.29182.94
43610688-361068883.44584.10
53530724-353072481.59782.19
63564964-356496482.38883.04
60min13665921-366592184.72185.420.7685.5086.240.77
23710562-371056285.75386.59
33661429-366142984.61785.45
43723531-372353186.05386.90
53691333-369133385.30986.08
63724135-372413586.06786.90
极限13793047-379304787.65988.310.7988.6289.320.77
23805228-380522887.94188.97
33807558-380755887.99589.01
43821526-382152688.31789.35
53878472-387847289.63390.59
63821742-382174288.32289.35
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