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101278-202104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%
110.293917666391256039155303913944390859539136590.09
210.433950186395468239524340.09
单位质量响应值RSD%判断
380336.15378948.610.26数据可信
供试品溶液-2024091311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%
5min11294195-129419530.68133.1315.0230.6833.1315.01
21763775-176377541.81341.81
31483152-148315235.16035.16
41175841-117584127.87527.88
51407555-140755533.36833.37
61260895-126089529.89229.89
10min12811732-281173266.65772.094.5466.7272.164.54
23178809-317880975.35975.45
33059027-305902772.51972.60
42971620-297162070.44770.51
53176205-317620575.29775.37
63048305-304830572.26572.33
15min13645427-364542786.42188.491.1886.6488.721.18
23752506-375250688.95989.22
33764798-376479889.25189.49
43754300-375430089.00289.22
53740756-374075688.68188.92
63738090-373809088.61788.84
20min13940157-394015793.40894.450.5693.8294.880.57
23984956-398495694.47094.93
33996523-399652394.74495.18
44000866-400086694.84795.26
53994263-399426394.69095.13
63988221-398822194.54794.97
30min14140074-414007498.14798.920.6698.7699.560.66
24161871-416187198.66499.33
34158453-415845398.58399.23
44166604-416660498.77699.40
54216496-421649699.959100.61
64191469-419146999.365100.00
45min14226301-4226301100.191100.351.35101.03101.211.34
24245472-4245472100.646101.53
34230021-4230021100.279101.15
44154301-415430198.48499.33
54329318-4329318102.633103.50
64212465-421246599.863100.72
60min14259039-4259039100.967101.480.83102.02102.560.83
24282476-4282476101.523102.63
34256334-4256334100.903101.99
44252075-4252075100.802101.87
54346531-4346531103.041104.14
64287649-4287649101.646102.72
极限14270813-4270813101.246101.750.82102.53103.060.83
24307203-4307203102.109103.45
34261774-4261774101.032102.35
44281301-4281301101.495102.78
54356113-4356113103.269104.60
64274296-4274296101.329102.63
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101278-202104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%
110.293918053391906839209703920628391749639192430.04
210.433983707398495039843280.03
单位质量响应值RSD%判断
380878.81382006.520.21数据可信
供试品溶液-2024091311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%
5min11733536-173353640.90241.6419.1540.9041.6419.15
21797414-179741442.40942.41
32140860-214086050.51350.51
42080919-208091949.09949.10
51210010-121001028.55028.55
61625752-162575238.35938.36
10min13134632-313463273.96176.059.3774.0576.149.38
23346536-334653678.96079.05
33620930-362093085.43585.55
43403735-340373580.31080.42
52752637-275263764.94865.01
63080307-308030772.67972.76
15min13810637-381063789.91190.153.6390.1790.423.65
23906472-390647292.17292.44
34012047-401204794.66394.97
43856239-385623990.98791.27
53619561-361956185.40285.61
63720501-372050187.78488.03
20min14127500-412750097.38795.642.1997.8496.102.21
24098117-409811796.69497.17
34147856-414785697.86798.38
44048238-404823895.51796.01
53928642-392864292.69593.09
63969474-396947493.65894.10
30min14262600-4262600100.57599.211.15101.2599.881.18
24237762-423776299.989100.68
34239583-4239583100.032100.76
44183753-418375398.71499.42
54145562-414556297.81398.42
64159074-415907498.13298.78
45min14306669-4306669101.614100.410.88102.51101.310.90
24279093-4279093100.964101.88
34279166-4279166100.966101.92
44226594-422659499.725100.65
54224446-422444699.674100.50
64217663-421766399.514100.38
60min14323575-4323575102.013100.790.85103.13101.900.87
24295155-4295155101.343102.48
34288371-4288371101.183102.36
44250774-4250774100.296101.44
54239064-4239064100.019101.06
64232768-423276899.871100.96
极限14322029-4322029101.977100.810.90103.32102.150.92
24291905-4291905101.266102.63
34300183-4300183101.461102.86
44253174-4253174100.352101.72
54246802-4246802100.202101.47
64220244-422024499.575100.89
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101278-202104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%
110.293949649394995339539813948154395199739507470.06
210.433967488396779139676400.01
单位质量响应值RSD%判断
383940.43380406.520.66数据可信
供试品溶液-2024091312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%
5min11128296-112829626.57136.5318.3226.5736.5218.32
21546255-154625536.41436.41
31753528-175352841.29641.30
41336621-133662131.47731.48
51914433-191443345.08545.08
61626900-162690038.31438.31
10min12609402-260940261.45171.718.2061.5171.798.21
23152845-315284574.25074.33
33218765-321876575.80275.89
42928004-292800468.95569.02
53301754-330175477.75677.86
63059586-305958672.05372.14
15min13486072-348607282.09788.963.8482.2989.203.86
23855463-385546390.79691.04
33833505-383350590.27990.54
43797388-379738889.42989.65
53866198-386619891.04991.32
63827566-382756690.13990.38
20min13993883-399388394.05696.111.1094.4396.541.13
24123636-412363697.11297.56
34083757-408375796.17396.63
44094818-409481896.43396.85
54096966-409696696.48496.96
64092333-409233396.37596.82
30min14290148-4290148101.033100.210.67101.62100.860.64
24292007-4292007101.077101.74
34240168-424016899.856100.53
44237874-423787499.802100.44
54228217-422821799.575100.26
64243826-424382699.942100.60
45min14352923-4352923102.511101.500.76103.32102.380.73
24349179-4349179102.423103.31
34285169-4285169100.916101.81
44294979-4294979101.147102.00
54280521-4280521100.806101.72
64298094-4298094101.220102.10
60min14364325-4364325102.780101.660.75103.82102.760.73
24350537-4350537102.455103.57
34297279-4297279101.201102.32
44294404-4294404101.133102.22
54288273-4288273100.989102.12
64305289-4305289101.390102.50
极限14376888-4376888103.076101.740.91104.34103.070.88
24363539-4363539102.761104.10
34290199-4290199101.034102.38
44301672-4301672101.304102.61
54292172-4292172101.081102.44
64297232-4297232101.200102.53
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101278-202104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%
110.293950042394943939559243948023395169539510250.08
210.433972102396520239686520.13
单位质量响应值RSD%判断
383967.44380503.550.65数据可信
供试品溶液-2024091312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%
5min11375778-137577832.39436.5412.7132.3936.5412.72
21281473-128147330.17430.17
31727755-172775540.68240.68
41771284-177128441.70741.71
51506323-150632335.46835.47
61647872-164787238.80138.80
10min12795353-279535365.82072.269.9465.8972.349.94
22758235-275823564.94665.01
33322674-332267478.23678.33
43524136-352413682.98083.07
53089923-308992372.75672.83
62921897-292189768.80068.89
15min13561830-356183083.86788.305.2284.0988.545.23
23524611-352461182.99183.20
33883153-388315391.43391.70
43973560-397356093.56293.84
53645563-364556385.83986.08
63911822-391182292.10892.35
20min13925807-392580792.43894.142.8592.8494.582.88
23856494-385649490.80691.20
34119952-411995297.00997.48
44141255-414125597.51198.00
53934479-393447992.64293.07
64009783-400978394.41594.86
30min14179319-417931998.40798.451.4599.0299.101.48
24098820-409882096.51297.11
34264565-4264565100.414101.10
44226390-422639099.515100.22
54130746-413074697.26397.90
64186793-418679398.58399.24
45min14245620-424562099.96899.741.28100.80100.611.30
24155398-415539897.84498.66
34309987-4309987101.484102.39
44276278-4276278100.690101.61
54212986-421298699.200100.05
64215454-421545499.258100.13
60min14248992-4248992100.048100.301.06101.10101.391.09
24181378-418137898.45599.48
34314540-4314540101.591102.72
44289060-4289060100.991102.14
54267259-4267259100.478101.55
64258053-4258053100.261101.35
极限14267338-4267338100.479100.391.20101.75101.701.23
24185887-418588798.56299.81
34315063-4315063101.603102.96
44318342-4318342101.680103.05
54268669-4268669100.511101.81
64226833-422683399.526100.84
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