氨溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.476564466562806574456566796570816567860.08
214.546571736573146572440.02
单位质量响应值RSD%判断
45389.5045202.480.30数据可信
加速1月-供试品溶液-24040901-1-bz1批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1264309-26430933.86033.688.5533.8633.688.54
2265656-26565634.03334.03
3285183-28518336.53436.53
4273650-27365035.05735.06
5219734-21973428.15028.15
6268871-26887134.44534.44
10min1522235-52223566.90365.306.5966.9665.366.58
2511796-51179665.56565.62
3541825-54182569.41269.47
4522554-52255466.94367.00
5444618-44461856.95957.01
6515446-51544666.03366.09
15min1685411-68541187.80786.514.8787.9786.684.87
2679300-67930087.02487.19
3704999-70499990.31690.49
4690792-69079288.49688.67
5611077-61107778.28478.43
6680332-68033287.15687.32
20min1778982-77898299.79497.902.75100.1198.222.76
2768110-76811098.40198.71
3778815-77881599.773100.10
4770624-77062498.72399.04
5722863-72286392.60592.88
6766025-76602598.13498.45
30min1799750-799750102.455100.831.35102.94101.301.33
2780569-78056999.997100.47
3779911-77991199.913100.41
4780436-78043699.980100.46
5801582-801582102.689103.12
6780178-78017899.947100.42
45min1799470-799470102.419100.701.42103.07101.341.40
2779478-77947899.858100.50
3777352-77735299.585100.25
4778465-77846599.728100.38
5801264-801264102.648103.25
6780321-78032199.966100.61
极限1798261-798261102.264100.481.46103.09101.301.44
2777461-77746199.599100.41
3778493-77849399.731100.56
4775295-77529599.322100.14
5799897-799897102.473103.24
6776844-77684499.520100.33
氨溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.476568416569056568056561146556346564600.09
214.546574146572776573460.02
单位质量响应值RSD%判断
45366.9745209.490.25数据可信
加速1月-供试品溶液-24040901-1-bz2批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1297737-29773738.14933.1921.4538.1533.1921.45
2292306-29230637.45337.45
3272011-27201134.85334.85
4272371-27237134.89934.90
5271927-27192734.84234.84
6148050-14805018.97018.97
10min1571017-57101773.16465.2019.0373.2365.2619.03
2560826-56082671.85971.92
3550007-55000770.47270.53
4532568-53256868.23868.30
5524475-52447567.20167.26
6314473-31447340.29340.33
15min1744117-74411795.34485.9316.4595.5386.0916.45
2721705-72170592.47292.65
3719187-71918792.14992.32
4702298-70229889.98590.16
5687549-68754988.09688.27
6448935-44893557.52257.62
20min1812345-812345104.08696.0112.90104.4396.3212.92
2778270-77827099.720100.06
3797526-797526102.187102.52
4782980-782980100.323100.65
5770508-77050898.72599.04
6554429-55442971.03971.23
30min1812891-812891104.15699.325.31104.6799.785.36
2779863-77986399.924100.43
3800164-800164102.525103.02
4787603-787603100.916101.40
5774153-77415399.19299.67
6696204-69620489.20589.52
45min1811776-811776104.013100.742.10104.70101.372.14
2779553-77955399.884100.55
3798602-798602102.325103.00
4786467-786467100.770101.43
5773139-77313999.06299.71
6767867-76786798.38798.85
极限1810553-810553103.856100.552.12104.72101.352.17
2777239-77723999.588100.42
3797731-797731102.213103.05
4784528-784528100.522101.35
5771506-77150698.85399.66
6767019-76701998.27898.90
氨溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.476559836560236557376560176557996559120.03
214.546548046548216548120.01
单位质量响应值RSD%判断
45329.0945035.210.46数据可信
高温30天-供试品溶液-24040901-1-bz1批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1115520-11552014.83619.5213.3214.8419.5213.31
2166405-16640521.37221.37
3160724-16072420.64220.64
4165659-16565921.27621.28
5163025-16302520.93820.94
6140804-14080418.08418.08
10min1217375-21737527.91835.1211.8727.9435.1511.88
2290458-29045837.30437.34
3285032-28503236.60736.64
4302553-30255338.85738.89
5293245-29324537.66237.70
6252030-25203032.36932.40
15min1291255-29125537.40646.8911.6137.4846.9811.61
2386378-38637849.62349.72
3381199-38119948.95849.05
4404639-40463951.96852.07
5388520-38852049.89850.00
6338735-33873543.50443.59
20min1351208-35120845.10656.9011.6645.2457.0711.66
2465023-46502359.72459.90
3463532-46353259.53259.71
4492102-49210263.20263.39
5471382-47138260.54060.72
6415063-41506353.30753.46
30min1453602-45360258.25772.6911.1258.4772.9611.12
2593276-59327676.19576.48
3592688-59268876.12076.40
4622241-62224179.91680.21
5602608-60260877.39477.68
6531533-53153368.26668.51
45min1561031-56103172.05487.169.0272.3687.549.03
2698682-69868289.73390.14
3728608-72860893.57693.98
4710903-71090391.30391.73
5706712-70671290.76491.17
6665807-66580785.51185.87
极限1778298-77829899.95899.571.33100.38100.101.32
2765465-76546598.31098.87
3792038-792038101.723102.28
4770282-77028298.92999.51
5779943-779943100.169100.73
6765660-76566098.33598.84
氨溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.476563896562956569676567066569846566680.05
214.546546286549906548090.04
单位质量响应值RSD%判断
45381.3445035.010.55数据可信
高温30天-供试品溶液-24040901-1-bz2批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1180077-18007723.11423.367.9523.1123.367.94
2187282-18728224.03924.04
3191911-19191124.63324.63
4192465-19246524.70424.70
5153912-15391219.75619.76
6186169-18616923.89623.90
10min1317170-31717040.71141.866.1540.7541.906.16
2328315-32831542.14242.18
3336803-33680343.23143.27
4353264-35326445.34445.39
5293396-29339637.66037.69
6327915-32791542.09142.13
15min1431218-43121855.35056.835.8455.4656.945.84
2441129-44112956.62356.73
3458446-45844658.84558.96
4478489-47848961.41861.53
5401887-40188751.58651.68
6445234-44523457.15057.26
20min1526373-52637367.56469.025.3467.7669.225.35
2535985-53598568.79869.00
3553535-55353571.05171.26
4577721-57772174.15574.37
5491601-49160163.10163.28
6541018-54101869.44469.65
30min1665744-66574485.45487.434.5885.7787.754.59
2676170-67617086.79287.11
3709784-70978491.10791.44
4720643-72064392.50192.84
5634063-63406381.38781.67
6680479-68047987.34587.67
45min1776665-77666599.691100.461.80100.15100.921.81
2791498-791498101.595102.06
3802992-802992103.071103.55
4780333-780333100.162100.66
5761288-76128897.71898.14
6782988-782988100.503100.97
极限1802855-802855103.053103.462.18103.67104.092.18
2815148-815148104.631105.26
3836880-836880107.421108.07
4798073-798073102.439103.10
5793955-793955101.911102.50
6789049-789049101.281101.92
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