非布司他片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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%
110.031954939195659619562611954825195047019546180.13
210.121975477197637319759250.04
单位质量响应值RSD%判断
194877.17195249.510.14数据可信
供试品溶液-20250401-1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%
5min1304737-30473714.06032.7834.5614.0632.7834.56
2568573-56857326.23326.23
3986056-98605645.49645.50
4890059-89005941.06641.07
5711673-71167332.83632.84
6801330-80133036.97236.97
10min11240171-124017157.22079.1414.5757.2479.2014.58
21645877-164587775.93975.98
31923508-192350888.74988.82
41820245-182024583.98484.05
51844311-184431185.09485.15
61817976-181797683.87983.94
15min11813885-181388583.69191.684.4783.8191.874.50
21980030-198003091.35691.53
32058834-205883494.99295.22
42016502-201650293.03993.25
52035323-203532393.90894.10
62017912-201791293.10493.31
20min12014235-201423592.93595.571.6893.1995.911.72
22054963-205496394.81495.14
32115416-211541697.60397.99
42070424-207042495.52795.89
52093481-209348196.59196.94
62079325-207932595.93896.29
30min12120455-212045597.83598.010.8598.2598.510.87
22105965-210596597.16797.65
32156959-215695999.520100.06
42113009-211300997.49298.01
52130609-213060998.30498.82
62118447-211844797.74398.26
45min12147132-214713299.06698.661.3299.6499.321.32
22134641-213464198.49099.13
32179637-2179637100.566101.28
42103363-210336397.04797.73
52154027-215402799.384100.06
62111758-211175897.43498.11
60min12151987-215198799.29098.651.63100.0399.481.61
22142759-214275998.86599.67
32184345-2184345100.783101.66
42090188-209018896.43997.29
52154516-215451699.407100.25
62104772-210477297.11297.95
极限12158204-215820499.57799.390.91100.48100.380.92
22139591-213959198.71899.69
32188497-2188497100.975102.02
42142925-214292598.87299.88
52159943-215994399.657100.67
62135507-213550798.53099.53
非布司他片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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%
110.031968005196852119676411961968196040619653080.20
210.121995378199651319959460.05
单位质量响应值RSD%判断
195942.97197227.870.47数据可信
供试品溶液-20250401-1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%
5min1282613-28261312.93920.4031.5912.9420.4031.60
2560248-56024825.64925.65
3593821-59382127.18627.19
4284471-28447113.02413.02
5545237-54523724.96224.96
6406957-40695718.63118.63
10min11075501-107550149.23956.1311.8449.2656.1611.85
21315959-131595960.24760.29
31386761-138676163.48963.53
41049009-104900948.02648.05
51349537-134953761.78561.83
61179472-117947253.99954.03
15min11494784-149478468.43470.983.0368.5471.113.05
21557919-155791971.32571.47
31614295-161429573.90674.06
41511853-151185369.21669.32
51593187-159318772.93973.08
61530096-153009670.05170.17
20min11684099-168409977.10278.731.5077.3278.981.52
21717700-171770078.64078.90
31759656-175965680.56180.84
41720498-172049878.76878.99
51732451-173245179.31579.58
61703486-170348677.98978.23
30min11827566-182756683.67084.511.2084.0284.881.20
21821784-182178483.40583.80
31878503-187850386.00286.41
41863927-186392785.33585.68
51848676-184867684.63685.03
61834907-183490784.00684.37
45min11947103-194710389.14289.541.1589.6390.061.15
21942346-194234688.92589.46
31993595-199359591.27191.82
41972395-197239590.30090.79
51943466-194346688.97689.52
61936226-193622688.64589.15
60min12004950-200495091.79192.121.1692.4392.781.17
21993028-199302891.24591.93
32051450-205145093.92094.62
41999989-199998991.56492.20
52028637-202863792.87593.56
61994279-199427991.30291.96
极限12041261-204126193.45393.801.5994.2494.621.60
22034105-203410593.12693.96
32113815-211381596.77597.64
42039928-203992893.39294.19
52040261-204026193.40794.25
62023842-202384292.65693.46
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