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%
19.651869402186853318665251868358186559718676830.09
29.821909732191018019099560.02
单位质量响应值RSD%判断
193542.28194496.540.35数据可信
供试品溶液-20200722批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min126102-261021.2111.0619.401.211.0619.53
225257-252571.1721.17
326554-265541.2321.23
421434-214340.9940.99
514750-147500.6840.68
622769-227691.0561.06
10min134738-347381.6111.529.321.611.529.37
235861-358611.6631.67
335858-358581.6631.67
430235-302351.4031.40
529633-296331.3751.38
630025-300251.3931.40
15min139279-392791.8221.735.821.831.745.83
239594-395941.8371.84
338586-385861.7901.80
436439-364391.6901.70
534005-340051.5771.58
636270-362701.6821.69
20min138717-387171.7961.813.461.811.823.40
240772-407721.8911.90
340326-403261.8711.88
438825-388251.8011.81
537975-379751.7621.77
637253-372531.7281.74
30min138679-386791.7941.832.631.811.842.48
241174-411741.9101.92
340092-400921.8601.87
438871-388711.8031.82
538684-386841.7941.81
638772-387721.7991.81
45min139479-394791.8311.844.241.851.864.28
241758-417581.9371.96
340447-404471.8761.89
440303-403031.8701.89
539508-395081.8331.85
636717-367171.7031.72
60min140511-405111.8791.843.811.901.863.68
242274-422741.9611.98
339664-396641.8401.86
437876-378761.7571.78
539203-392031.8191.84
638915-389151.8051.83
90min138786-387861.7991.833.131.831.863.11
241007-410071.9021.93
340815-408151.8931.92
439349-393491.8251.85
538240-382401.7741.80
638269-382691.7751.80
120min139451-394511.8301.833.071.861.863.03
241177-411771.9101.94
340146-401461.8621.89
438117-381171.7681.80
539329-393291.8241.85
638006-380061.7631.79
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限141355-413551.9181.873.711.951.903.74
241702-417021.9341.97
341573-415731.9281.96
439490-394901.8321.86
538202-382021.7721.80
639102-391021.8141.85
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%
19.651899696190049119016831898303189597718992300.12
29.821931560193026019309100.05
单位质量响应值RSD%判断
196811.40196630.350.07数据可信
供试品溶液-20200722批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min125882-258821.1841.0916.341.181.0916.48
224383-243831.1161.12
323654-236541.0821.08
426831-268311.2281.23
516245-162450.7430.74
625969-259691.1881.19
10min133616-336161.5381.486.771.541.486.79
233377-333771.5271.53
331605-316051.4461.45
433866-338661.5491.55
528202-282021.2901.29
633466-334661.5311.53
15min137040-370401.6951.673.221.701.683.18
237087-370871.6971.70
337127-371271.6991.70
436421-364211.6661.67
534200-342001.5651.57
637256-372561.7041.71
20min138303-383031.7521.731.681.761.741.61
238521-385211.7621.77
337550-375501.7181.73
437675-376751.7241.73
536934-369341.6901.70
638542-385421.7631.77
30min139499-394991.8071.771.641.821.781.58
239225-392251.7951.81
338555-385551.7641.78
438515-385151.7621.78
538718-387181.7711.78
637689-376891.7241.74
45min138729-387291.7721.781.801.791.801.72
240081-400811.8341.85
339177-391771.7921.81
438704-387041.7711.79
538030-380301.7401.76
638542-385421.7631.78
60min139162-391621.7921.771.751.811.781.66
238306-383061.7531.77
338305-383051.7521.77
439612-396121.8121.83
538534-385341.7631.78
637729-377291.7261.75
90min139863-398631.8241.772.921.851.792.97
238845-388451.7771.80
339861-398611.8241.85
438119-381191.7441.77
536908-369081.6891.71
638388-383881.7561.78
120min140386-403861.8481.801.891.881.821.99
239106-391061.7891.82
339372-393721.8011.83
438153-381531.7461.77
539010-390101.7851.81
639653-396531.8141.84
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限141050-410501.8781.803.151.911.833.22
240066-400661.8331.87
338402-384021.7571.79
439724-397241.8171.85
537661-376611.7231.75
638722-387221.7721.80
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%
19.653923074392044039175293915906391148439176870.12
29.823935374393583239356030.01
单位质量响应值RSD%判断
405977.93400774.240.92数据可信
供试品溶液-20200712批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min130456-304560.6800.7619.450.680.7619.39
241355-413550.9230.92
334132-341320.7620.76
442758-427580.9540.95
528670-286700.6400.64
627053-270530.6040.60
10min135837-358370.8000.836.930.800.837.12
240978-409780.9140.92
338879-388790.8670.87
437622-376220.8390.84
533631-336310.7500.75
636047-360470.8040.81
15min137472-374720.8360.834.220.840.844.12
237866-378660.8450.85
338948-389480.8690.87
438836-388360.8670.87
535619-356190.7950.80
635252-352520.7870.79
20min136328-363280.8110.833.470.820.843.54
238014-380140.8480.85
337941-379410.8470.85
438590-385900.8610.87
538220-382200.8530.86
635263-352630.7870.79
30min137087-370870.8280.824.630.830.834.51
239277-392770.8760.88
335932-359320.8020.81
437905-379050.8460.85
536525-365250.8150.82
634295-342950.7650.77
45min136933-369330.8240.833.900.830.843.94
239501-395010.8810.89
337225-372250.8310.84
438310-383100.8550.86
537170-371700.8290.84
635130-351300.7840.79
60min138101-381010.8500.814.870.860.824.82
236345-363450.8110.82
334649-346490.7730.78
436874-368740.8230.83
537737-377370.8420.85
633600-336000.7500.76
90min137849-378490.8450.794.840.860.804.81
235663-356630.7960.81
334681-346810.7740.79
435084-350840.7830.80
535357-353570.7890.80
632596-325960.7270.74
120min136077-360770.8050.804.100.820.823.94
238516-385160.8590.87
334578-345780.7720.79
436303-363030.8100.83
536362-363620.8110.83
634409-344090.7680.78
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限136184-361840.8070.824.360.820.834.54
238458-384580.8580.88
337771-377710.8430.86
436675-366750.8180.84
536463-364630.8140.83
633839-338390.7550.77
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%
19.653816296381447938127963812510381282138137800.05
29.823853888385574738548180.04
单位质量响应值RSD%判断
395210.36392547.660.48数据可信
供试品溶液-20200712批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min128078-280780.6420.616.770.640.616.57
227094-270940.6190.62
323088-230880.5280.53
426430-264300.6040.60
527682-276820.6330.63
627130-271300.6200.62
10min133776-337760.7720.812.940.770.812.98
236348-363480.8310.83
335848-358480.8190.82
435043-350430.8010.80
536368-363680.8310.83
636415-364150.8320.83
15min134952-349520.7990.832.560.800.832.64
236895-368950.8430.85
337531-375310.8580.86
435802-358020.8180.82
535685-356850.8150.82
636330-363300.8300.83
20min136140-361400.8260.842.160.830.842.26
237283-372830.8520.86
335746-357460.8170.82
437156-371560.8490.85
535664-356640.8150.82
637324-373240.8530.86
30min135598-355980.8130.823.430.820.833.37
237417-374170.8550.86
335856-358560.8190.83
437462-374620.8560.86
535267-352670.8060.81
634374-343740.7850.79
45min136914-369140.8430.844.430.850.854.44
238980-389800.8910.90
337605-376050.8590.87
437354-373540.8540.86
534666-346660.7920.80
635119-351190.8020.81
60min136875-368750.8430.852.620.850.862.49
237825-378250.8640.88
338031-380310.8690.88
436677-366770.8380.85
538232-382320.8740.88
635703-357030.8160.83
90min136527-365270.8350.813.800.850.823.57
235765-357650.8170.83
337282-372820.8520.86
434410-344100.7860.80
534573-345730.7900.80
633863-338630.7740.79
120min134431-344310.7870.783.930.800.793.76
234528-345280.7890.80
335679-356790.8150.83
432696-326960.7470.76
532045-320450.7320.75
634212-342120.7820.80
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限132851-328510.7510.763.880.770.783.90
233960-339600.7760.79
333615-336150.7680.78
434575-345750.7900.81
530873-308730.7050.72
633322-333220.7610.78
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