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%
110.151940301193906819385091930671193338519363870.22
210.191950666195129519509800.03
单位质量响应值RSD%判断
190777.04191460.260.26数据可信
供试品溶液-2024092212批-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1639065-63906530.09429.3715.7730.0929.3715.77
2656887-65688730.93430.93
3496784-49678423.39423.39
4772165-77216536.36236.36
5532165-53216525.06025.06
6645098-64509830.37930.38
10min11285916-128591660.55559.005.7960.6259.065.80
21274023-127402359.99560.06
31180259-118025955.58055.63
41360541-136054164.07064.15
51164043-116404354.81654.87
61252133-125213358.96559.03
15min11512202-151220271.21270.752.5471.4170.952.56
21489763-148976370.15570.36
31453396-145339668.44268.62
41567827-156782773.83174.05
51484490-148449069.90770.08
61506787-150678770.95771.16
20min11614162-161416276.01376.482.1576.3776.832.16
21608754-160875475.75876.12
31574183-157418374.13074.46
41679124-167912479.07279.46
51637706-163770677.12277.45
61630035-163003576.76077.12
30min11730442-173044281.48982.582.2282.0283.102.22
21744031-174403182.12982.66
31696980-169698079.91380.41
41807273-180727385.10785.67
51781169-178116983.87884.38
61761280-176128082.94183.47
45min11817688-181768885.59787.022.5586.3187.732.55
21836744-183674486.49587.20
31780031-178003183.82484.49
41906852-190685289.79690.55
51891330-189133089.06589.76
61854665-185466587.33988.05
60min11865529-186552987.85089.753.1388.7590.653.13
21885871-188587188.80889.71
31824242-182424285.90686.76
41992688-199268893.83894.79
51938604-193860491.29192.18
61927967-192796790.79191.70
极限11921598-192159890.49191.872.5191.5992.962.51
21922755-192275590.54591.64
31892406-189240689.11690.16
42002879-200287994.31895.48
52015343-201534394.90596.00
61949740-194974091.81692.92
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%
110.151933092193451819351491933380193395119340180.05
210.191972129197198919720590.01
单位质量响应值RSD%判断
190543.65193528.851.10数据可信
供试品溶液-2024092212批-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1722897-72289733.88134.5810.6733.8834.5810.67
2799604-79960437.47737.48
3707510-70751033.16033.16
4760442-76044235.64135.64
5829108-82910838.85938.86
6606926-60692628.44628.45
10min11311218-131121861.45562.955.0661.5363.025.06
21424723-142472366.77566.86
31248410-124841058.51258.59
41310388-131038861.41761.50
51416017-141601766.36766.45
61347272-134727263.14563.21
15min11521524-152152471.31273.752.8771.5273.962.88
21625252-162525276.17476.41
31526377-152637771.54071.74
41563591-156359173.28473.50
51622378-162237876.03976.27
61581591-158159174.12874.33
20min11625865-162586576.20378.662.2576.5779.042.25
21723163-172316380.76381.16
31654462-165446277.54377.91
41665689-166568978.06978.45
51717778-171777880.51180.91
61683426-168342678.90079.27
30min11748926-174892681.97084.511.9882.5185.061.99
21843659-184365986.41086.99
31789724-178972483.88384.42
41793916-179391684.07984.63
51841663-184166386.31786.90
61800515-180051584.38884.93
45min11873306-187330687.80089.461.4888.5290.201.49
21939625-193962590.90891.68
31883553-188355388.28089.00
41897053-189705388.91389.65
51937470-193747090.80791.58
61921013-192101390.03690.77
60min11900824-190082489.09091.361.8290.0192.301.83
21989839-198983993.26294.24
31930600-193060090.48591.40
41949272-194927291.36092.30
51990423-199042393.28994.26
61934516-193451690.66991.60
极限11958220-195822091.78093.881.5192.8995.031.52
22033893-203389395.32696.51
31989552-198955293.24894.37
41990738-199073893.30494.44
52037774-203777495.50896.69
62008244-200824494.12495.26
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%
110.151931377193193019306511930429193097819310730.04
210.191954471195569219550820.05
单位质量响应值RSD%判断
190253.50191862.810.60数据可信
供试品溶液-2024092213批-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1719504-71950433.89433.2413.6833.8933.2413.68
2510592-51059224.05224.05
3748355-74835535.25335.25
4751539-75153935.40335.40
5758699-75869935.74035.74
6744865-74486535.08835.09
10min11341425-134142563.19061.565.8363.2761.645.84
21155533-115553354.43454.49
31353091-135309163.74063.82
41323078-132307862.32662.40
51310992-131099261.75761.84
61356798-135679863.91563.99
15min11565727-156572773.75771.913.1573.9772.123.16
21435910-143591067.64167.82
31543385-154338572.70472.92
41525569-152556971.86572.08
51523807-152380771.78272.00
61564876-156487673.71673.94
20min11679970-167997079.13877.712.0379.5278.082.04
21587568-158756874.78575.11
31667412-166741278.54778.93
41648261-164826177.64478.02
51644210-164421077.45477.83
61670566-167056678.69579.08
30min11809401-180940185.23583.911.3685.7984.451.38
21741962-174196282.05882.55
31791207-179120784.37884.93
41771349-177134983.44383.99
51774362-177436283.58584.13
61799453-179945384.76785.33
45min11909984-190998489.97389.210.8790.7289.940.88
21877038-187703888.42189.09
31892364-189236489.14389.89
41912646-191264690.09990.83
51873067-187306788.23488.97
61898009-189800989.40990.16
60min11963414-196341492.49091.360.9493.4492.290.96
21908136-190813689.88690.76
31946233-194623391.68192.62
41936675-193667591.23192.17
51936761-193676191.23592.16
61945271-194527191.63692.58
极限12009550-200955094.66493.640.9295.8194.770.93
21961141-196114192.38393.45
31983607-198360793.44294.59
41975716-197571693.07094.21
51992008-199200893.83794.97
62004533-200453394.42795.58
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%
110.151966568196781319700081966491196093719663630.18
210.191978425197926719788460.04
单位质量响应值RSD%判断
193730.34194194.900.17数据可信
供试品溶液-2024092213批-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1631408-63140829.29828.2925.0129.3028.2925.02
2812407-81240737.69637.70
3672212-67221231.19131.19
4423739-42373919.66219.66
5434554-43455420.16420.16
6684053-68405331.74131.74
10min11232770-123277057.20157.0710.8357.2757.1310.85
21387798-138779864.39564.48
31240629-124062957.56657.64
41044918-104491848.48548.53
51115652-111565251.76751.81
61357645-135764562.99663.07
15min11477511-147751168.55869.225.5568.7569.415.58
21593027-159302773.91874.14
31489433-148943369.11169.31
41366845-136684563.42363.57
51451538-145153867.35267.51
61572591-157259172.96973.18
20min11616348-161634875.00075.173.2975.3475.513.33
21681013-168101378.00078.39
31615866-161586674.97775.33
41533841-153384171.17171.46
51601078-160107874.29174.60
61671548-167154877.56177.93
30min11759219-175921981.62981.591.8082.1482.101.84
21793219-179321983.20783.77
31756132-175613281.48682.00
41705790-170579079.15079.60
51748281-174828181.12281.60
61788189-178818982.97383.52
45min11859586-185958686.28686.831.2586.9887.521.25
21880950-188095087.27888.03
31859851-185985186.29887.00
41837959-183795985.28385.91
51902968-190296888.29988.95
61886077-188607787.51588.24
60min11917259-191725988.96289.240.8189.8590.130.85
21933575-193357589.71990.66
31913486-191348688.78789.68
41902489-190248988.27789.09
51926695-192669589.40090.25
61946148-194614890.30391.23
极限11960113-196011390.95191.560.6292.0392.640.63
21976488-197648891.71192.85
31977533-197753391.75992.85
41957255-195725590.81891.83
51988646-198864692.27593.32
61979566-197956691.85392.98
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