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500
标示量(mg)20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%
110.063813672381162338111613807729381098238110330.06
210.173831234382901738301260.05
单位质量响应值RSD%判断
378830.32376610.230.42数据可信
供试品溶液-2024112521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%
5min12376056-237605656.61565.357.3156.6265.357.31
22712984-271298464.64364.64
32721255-272125564.84064.84
42821202-282120267.22267.22
52890822-289082268.88168.88
62934610-293461069.92469.92
10min13813012-381301290.85490.690.5890.9890.840.58
23786666-378666690.22690.37
33781531-378153190.10490.25
43794436-379443690.41190.56
53829899-382989991.25691.41
63831833-383183391.30291.46
15min14032485-403248596.08395.720.5696.4196.060.55
23991020-399102095.09595.44
34006673-400667395.46895.81
43996699-399669995.23195.58
54046073-404607396.40796.76
64030062-403006296.02696.38
20min14100722-410072297.70997.310.3598.2597.860.35
24073010-407301097.04997.60
34068306-406830696.93797.49
44076785-407678597.13997.70
54101074-410107497.71898.29
64082961-408296197.28697.86
30min14153090-415309098.95798.540.4399.7299.320.42
24123808-412380898.25999.03
34124782-412478298.28399.05
44112807-411280797.99798.78
54154343-415434398.98799.77
64145212-414521298.76999.56
45min14176946-417694699.52698.940.43100.5099.940.42
24147926-414792698.83499.82
34139881-413988198.64299.63
44128180-412818098.36499.36
54164707-416470799.234100.24
64157583-415758399.064100.07
60min14170439-417043999.37198.900.42100.57100.110.41
24147421-414742198.822100.03
34145642-414564298.78099.99
44121028-412102898.19399.41
54154960-415496099.002100.23
64163413-416341399.203100.43
极限14157088-415708899.05298.690.36100.47100.130.36
24144400-414440098.750100.18
34126815-412681598.33199.76
44120724-412072498.18699.62
54152572-415257298.945100.39
64150548-415054898.897100.34
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500
标示量(mg)20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%
110.063818023382439938189713816240381196838179200.12
210.173847483385082338491530.07
单位质量响应值RSD%判断
379514.91378481.120.20数据可信
供试品溶液-2024112521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%
5min12028216-202821648.16448.4513.1248.1648.4513.13
22060139-206013948.92248.92
31892798-189279844.94844.95
42548523-254852360.51960.52
51927969-192796945.78345.78
61785215-178521542.39342.39
10min13537985-353798584.01684.623.9184.1284.723.92
23560207-356020784.54484.65
33524627-352462783.69983.80
43826204-382620490.86090.99
53522079-352207983.63883.74
63409026-340902680.95481.05
15min14068296-406829696.60995.172.6496.9095.472.65
24031758-403175895.74296.04
33985616-398561694.64694.93
44123219-412321997.91498.25
54023836-402383695.55495.84
63814367-381436790.57990.85
20min14129651-412965198.06697.680.7998.5798.190.79
24126179-412617997.98498.49
34102305-410230597.41797.91
44103058-410305897.43597.99
54156988-415698898.71599.22
64062378-406237896.46996.94
30min14168688-416868898.99398.161.0999.7298.881.09
24120194-412019497.84298.57
34153992-415399298.64499.36
44114190-411419097.69998.47
54183632-418363299.348100.07
64059977-405997796.41297.10
45min14166836-416683698.94997.591.1899.9098.541.18
24096821-409682197.28798.23
34129638-412963898.06699.00
44094750-409475097.23798.23
54141281-414128198.34299.28
64028587-402858795.66696.57
60min14083813-408381396.97896.151.2498.1497.311.24
24033968-403396895.79496.95
34065322-406532296.53997.69
44028300-402830095.66096.86
54113456-411345697.68298.84
63969630-396963094.26695.38
极限14044160-404416096.03695.211.2297.4296.581.22
23989062-398906294.72896.10
34037068-403706895.86897.23
43996673-399667394.90896.32
54061038-406103896.43797.81
63927596-392759693.26894.59
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500
标示量(mg)20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%
110.063824762382596238242873818902381905838225940.09
210.173924306392485439245800.01
单位质量响应值RSD%判断
379979.52385897.741.10数据可信
供试品溶液-2024112521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%
5min1969008-96900822.77528.3426.2222.7828.3426.21
2722300-72230016.97716.98
31258894-125889429.58929.59
41603410-160341037.68637.69
51262534-126253429.67429.67
61419268-141926833.35833.36
10min12385451-238545156.06758.168.3856.1258.228.40
22098187-209818749.31649.35
32516345-251634559.14459.21
42585595-258559560.77160.86
52667167-266716762.68962.75
62593496-259349660.95761.03
15min13082294-308229472.44671.613.0172.6271.803.04
22862979-286297967.29167.44
33056620-305662071.84272.04
43108514-310851473.06273.28
53093237-309323772.70372.91
63076235-307623572.30372.51
20min13286887-328688777.25576.621.2877.5976.971.31
23194024-319402475.07275.37
33234540-323454076.02476.38
43312642-331264277.86078.24
53258121-325812176.57876.95
63272699-327269976.92177.29
30min13442621-344262180.91580.550.9881.4281.071.00
23388710-338871079.64880.11
33395979-339597979.81980.34
43480140-348014081.79782.35
53422891-342289180.45180.99
63432447-343244780.67681.22
45min13557096-355709683.60683.391.0184.2984.091.03
23512724-351272482.56383.20
33528810-352881082.94183.64
43613278-361327884.92685.66
53528059-352805982.92383.64
63547830-354783083.38884.11
60min13622325-362232585.13985.011.0386.0185.901.05
23576998-357699884.07384.90
33585363-358536384.27085.16
43678550-367855086.46087.38
53603647-360364784.70085.60
63635109-363510985.43986.34
极限14089347-408934796.11595.831.0497.1896.911.04
24095948-409594896.27197.28
33998054-399805493.97095.04
44121877-412187796.88098.00
54090144-409014496.13497.22
64069061-406906195.63996.73
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500
标示量(mg)20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%
110.063816022381673138153783813952381427838152720.04
210.173919122392012339196220.02
单位质量响应值RSD%判断
379251.69385410.231.14数据可信
供试品溶液-2024112521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%
5min11761319-176131941.46438.3015.6641.4638.3015.65
21965988-196598846.28246.28
31385951-138595132.62732.63
41540074-154007436.25536.26
51793231-179323142.21542.22
61314182-131418230.93830.94
10min13413064-341306480.34878.301.7980.4478.381.80
23333170-333317078.46778.57
33281806-328180677.25877.33
43247362-324736276.44776.53
53367089-336708979.26679.36
63313005-331300577.99378.06
15min13866098-386609891.01389.321.0991.2889.581.09
23754061-375406188.37688.65
33778068-377806888.94189.18
43762794-376279488.58188.83
53815467-381546789.82190.09
63788267-378826789.18189.42
20min14016595-401659594.55693.380.9095.0393.840.90
23911919-391191992.09292.57
33951564-395156493.02593.47
43955839-395583993.12693.57
53984540-398454093.80194.27
63979259-397925993.67794.12
30min14127017-412701797.15695.761.0297.8496.421.02
24032519-403251994.93195.61
34048074-404807495.29795.95
44018982-401898294.61295.27
54084839-408483996.16396.84
64094186-409418696.38397.03
45min14150377-415037797.70597.020.9098.6097.900.89
24067626-406762695.75796.65
34094657-409465796.39497.25
44118706-411870696.96097.82
54127656-412765697.17198.06
64168945-416894598.14399.01
60min14158213-415821397.89096.920.6999.0198.020.69
24077283-407728395.98597.09
34108891-410889196.72997.80
44099087-409908796.49897.58
54125935-412593597.13098.24
64133563-413356397.31098.39
极限14158003-415800397.88596.780.7199.2298.090.71
24085939-408593996.18897.50
34081497-408149796.08497.37
44098724-409872496.48997.78
54114986-411498696.87298.20
64127528-412752897.16898.46
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500
标示量(mg)20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%
110.063889790389034138904793881225388332738870320.12
210.174005243400304040041420.04
单位质量响应值RSD%判断
386384.89393720.941.33数据可信
供试品溶液-2024112521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%
5min12106912-210691248.61950.388.6148.6250.388.61
21912711-191271144.13744.14
32437937-243793756.25756.26
42074762-207476247.87747.88
52263830-226383052.24052.24
62303478-230347853.15553.15
10min13586774-358677482.76882.261.9282.8882.381.92
23455204-345520479.73279.83
33625146-362514683.65383.78
43573209-357320982.45582.56
53516186-351618681.13981.26
63632963-363296383.83483.95
15min13933291-393329190.76490.261.5191.0690.561.52
23817508-381750888.09288.37
33965434-396543491.50691.82
43934168-393416890.78491.07
53861555-386155589.10989.40
63957312-395731291.31891.62
20min14066096-406609693.82993.611.2094.3294.101.20
23971062-397106291.63692.11
34108372-410837294.80495.32
44083993-408399394.24294.73
54034131-403413193.09193.59
64075930-407593094.05594.56
30min14143261-414326195.60995.351.1796.3196.051.17
24067224-406722493.85594.53
34164519-416451996.10096.82
44173755-417375596.31397.01
54075924-407592494.05594.76
64167231-416723196.16296.88
45min14151429-415142995.79895.981.0796.7196.891.08
24102573-410257394.67095.55
34195462-419546296.81497.75
44208524-420852497.11598.03
54112682-411268294.90495.81
64184274-418427496.55697.49
60min14172241-417224196.27896.071.0597.4197.201.05
24105922-410592294.74895.84
34192546-419254696.74697.90
44208763-420876397.12198.25
54112771-411277194.90696.03
64186481-418648196.60797.75
极限14151599-415159995.80295.690.9697.1497.040.96
24116681-411668194.99696.30
34157697-415769795.94297.31
44191677-419167796.72698.07
54085414-408541494.27495.61
64178222-417822296.41697.78
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