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(%)100.0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%
110.151933221193116119268251925666192635019286450.18
210.191974263197640419753340.08
单位质量响应值RSD%判断
190014.29193850.251.42数据可信
供试品溶液-2024092212批-shui(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1413536-41353619.39314.4529.9119.3914.4529.91
2363163-36316317.03117.03
3157324-1573247.3787.38
4355028-35502816.64916.65
5250018-25001811.72511.72
6309677-30967714.52314.52
10min11255008-125500858.85548.2218.2258.9048.2518.23
21144834-114483453.68853.73
3711093-71109333.34833.36
41090443-109044351.13851.17
5952812-95281244.68344.71
61015241-101524147.61147.64
15min11660945-166094577.89272.279.0478.0772.419.07
21620955-162095576.01776.17
31280879-128087960.06860.16
41624844-162484476.19976.35
51504077-150407770.53670.66
61554319-155431972.89273.03
20min11776273-177627383.30082.043.3283.6582.343.36
21767246-176724682.87783.20
31635233-163523376.68676.91
41797331-179733184.28884.61
51749299-174929982.03682.32
61771369-177136983.07183.37
30min11890147-189014788.64188.970.9689.1789.450.98
21888180-188818088.54989.06
31877204-187720488.03488.43
41929253-192925390.47590.98
51892904-189290488.77089.23
61904680-190468089.32289.81
45min11971503-197150392.45693.260.8493.1993.940.81
21976604-197660492.69593.40
31999721-199972193.77994.37
42014361-201436194.46695.17
51977181-197718192.72293.38
61991932-199193293.41494.10
60min12006097-200609794.07895.020.9895.0195.900.95
22010560-201056094.28895.20
32047915-204791596.03996.84
42050968-205096896.18397.10
52012040-201204094.35795.22
62028983-202898395.15296.04
极限12023602-202360294.89996.031.1096.0497.131.07
22032866-203286695.33496.46
32073211-207321197.22698.24
42075906-207590697.35298.48
52031272-203127295.25996.34
62049964-204996496.13697.24
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(%)100.0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%
110.151930753193195319323221929870193048819310770.06
210.191974984197507419750290.01
单位质量响应值RSD%判断
190253.89193820.311.32数据可信
供试品溶液-2024092212批-shui(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1181383-1813838.50115.0449.518.5015.0449.51
2186206-1862068.7278.73
3176165-1761658.2578.26
4495581-49558123.22823.23
5503448-50344823.59723.60
6383060-38306017.95417.95
10min1739090-73909034.64146.4128.1934.6646.4528.20
2756685-75668535.46635.49
3737220-73722034.55334.57
41292745-129274560.59160.64
51311561-131156161.47361.53
61104401-110440151.76351.80
15min11292348-129234860.57269.3013.0560.6769.4413.09
21282182-128218260.09660.19
31338039-133803962.71462.81
41636503-163650376.70376.89
51688290-168829079.13079.32
61634050-163405076.58876.74
20min11640616-164061676.89680.224.9377.1380.524.98
21607492-160749275.34375.57
31668960-166896078.22478.46
41748074-174807481.93282.29
51804066-180406684.55784.92
61800654-180065484.39784.72
30min11848287-184828786.62988.022.2787.0388.492.31
21813339-181333984.99185.39
31902806-190280689.18489.59
41868395-186839587.57288.11
51911271-191127189.58190.13
61924319-192431990.19390.71
45min11952351-195235191.50792.351.8392.1093.011.84
21916300-191630089.81790.41
32008260-200826094.12794.73
41955609-195560991.65992.39
51980493-198049392.82693.58
62008468-200846894.13794.85
60min11995700-199570093.53894.091.7194.3494.961.72
21958337-195833791.78792.57
32050256-205025696.09596.91
41991436-199143693.33994.28
52006178-200617894.03094.99
62042424-204242495.72896.65
极限12023707-202370794.85195.171.7495.8696.251.73
21980672-198067292.83493.83
32076970-207697097.34898.38
42017270-201727094.54995.69
52018971-201897194.62995.80
62065051-206505196.78997.92
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(%)100.0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%
110.151967170196613719663571964850196165019652330.12
210.191968145196819019681680.01
单位质量响应值RSD%判断
193619.01193147.010.18数据可信
供试品溶液-2024092213批-shui(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1510140-51014023.74215.9833.1823.7415.9833.19
2217261-21726110.11110.11
3240487-24048711.19211.19
4375748-37574817.48717.49
5425782-42578219.81619.82
6290903-29090313.53913.54
10min11449807-144980767.47452.3821.1967.5352.4121.20
2841435-84143539.16039.18
3903799-90379942.06342.09
41233513-123351357.40757.45
51294156-129415660.23060.27
61029709-102970947.92247.95
15min11742177-174217781.08172.149.7481.2872.309.76
21356722-135672263.14263.25
31411201-141120165.67765.80
41641113-164111376.37776.54
51647896-164789676.69376.87
61501765-150176569.89270.03
20min11853180-185318086.24781.434.2486.6381.744.29
21639201-163920176.28876.54
31703516-170351679.28179.55
41781446-178144682.90883.24
51784859-178485983.06783.42
61735897-173589780.78881.08
30min11960521-196052191.24288.262.4191.8288.752.45
21821189-182118984.75885.18
31885107-188510787.73388.17
41911954-191195488.98289.50
51909801-190980188.88289.41
61889788-188978887.95088.42
45min12037511-203751194.82592.711.6095.6093.401.65
21940403-194040390.30690.91
31986071-198607192.43193.07
42006586-200658693.38694.10
51996807-199680792.93193.66
61985134-198513492.38893.05
60min12068034-206803496.24694.681.2797.2395.571.32
21989224-198922492.57893.39
32031333-203133394.53895.38
42046732-204673295.25596.18
52034853-203485394.70295.64
62035502-203550294.73295.60
极限12084436-208443697.00995.701.0898.2196.801.14
22019520-201952093.98895.00
32048924-204892495.35796.41
42071958-207195896.42997.57
52059255-205925595.83796.98
62053556-205355695.57296.65
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(%)100.0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%
110.151964454196309019643911963601195978119630630.10
210.191996204199620119962020.01
单位质量响应值RSD%判断
193405.22195898.140.91数据可信
供试品溶液-2024092213批-shui(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1376073-37607317.38916.8725.8917.3916.8825.89
2512674-51267423.70523.71
3248617-24861711.49611.50
4297323-29732313.74813.75
5423535-42353519.58419.58
6331242-33124215.31615.32
10min11207721-120772155.84352.0313.7255.8852.0613.73
21329809-132980961.48861.54
3919502-91950242.51642.54
41080662-108066249.96850.00
51219545-121954556.39056.43
6994125-99412545.96746.00
15min11645198-164519876.07174.143.8276.2374.303.84
21676955-167695577.54077.73
31508886-150888669.76869.89
41624411-162441175.11075.25
51608148-160814874.35874.53
61557473-155747372.01572.15
20min11801854-180185483.31581.941.7483.6582.261.75
21792192-179219282.86883.23
31757781-175778181.27781.55
41803673-180367383.39983.71
51737081-173708180.32080.65
61740440-174044080.47580.77
30min11928123-192812389.15388.001.6489.6788.491.63
21904456-190445688.05988.60
31917369-191736988.65689.11
41936848-193684889.55790.05
51859259-185925985.96986.48
61872440-187244086.57987.05
45min12004742-200474292.69692.181.3293.4192.881.30
21983124-198312491.69692.44
32004736-200473692.69693.35
42027751-202775193.76094.45
51950048-195004890.16790.87
61991539-199153992.08592.75
60min12040181-204018194.33593.831.3295.2694.731.30
22017279-201727993.27694.22
32043710-204371094.49895.36
42064975-206497595.48196.38
51987770-198777091.91192.82
62021129-202112993.45494.33
极限12043244-204324494.47694.231.2695.6195.341.24
22026631-202663193.70894.86
32063198-206319895.39996.47
42067678-206767895.60696.72
51999282-199928292.44393.55
62027222-202722293.73594.82
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