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101278-202003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250
标示量(mg)40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%
19.531784544178504517846821784911178439917847160.02
29.641810100180880918094540.06
单位质量响应值RSD%判断
187273.45187702.700.17数据可信
供试品溶液-2024112422批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1182920-1829208.7816.0339.698.786.0339.67
2100396-1003964.8194.82
3100282-1002824.8144.81
453445-534452.5662.57
5141877-1418776.8116.81
6174428-1744288.3738.37
10min1377564-37756418.12416.448.6418.1416.468.66
2319640-31964015.34415.35
3344143-34414316.52016.53
4299698-29969814.38614.39
5343933-34393316.51016.52
6370460-37046017.78317.80
15min1479294-47929423.00821.794.8623.0721.844.88
2459196-45919622.04322.09
3424888-42488820.39620.44
4434554-43455420.86020.90
5448792-44879221.54321.60
6476428-47642822.87022.93
20min1543567-54356726.09325.723.4226.2025.823.43
2518448-51844824.88724.98
3542441-54244126.03926.13
4509453-50945324.45524.54
5558710-55871026.82026.92
6542677-54267726.05026.16
30min1620135-62013529.76829.231.2429.9429.381.27
2610473-61047329.30529.45
3605382-60538229.06029.21
4597475-59747528.68128.82
5607259-60725929.15029.31
6612192-61219229.38729.55
45min1683287-68328732.80031.842.4633.0332.062.47
2658171-65817131.59431.81
3637703-63770330.61230.83
4657708-65770831.57231.77
5664420-66442031.89432.12
6678009-67800932.54732.78
60min1715912-71591234.36633.532.4734.6733.822.47
2697959-69795933.50433.79
3666414-66641431.99032.27
4700775-70077533.63933.91
5699468-69946833.57733.87
6710343-71034334.09934.40
极限1743099-74309935.67134.892.6336.0635.262.62
2727383-72738334.91735.28
3689370-68937033.09233.45
4733478-73347835.20935.56
5731737-73173735.12635.50
6735779-73577935.32035.70
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101278-202003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250
标示量(mg)40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%
19.531790462179098517905671789802179049217904620.03
29.641821104182131018212070.01
单位质量响应值RSD%判断
187876.39188921.890.40数据可信
供试品溶液-2024112422批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1170823-1708238.1606.9627.958.166.9527.96
2160431-1604317.6647.66
388316-883164.2194.22
4202626-2026269.6809.68
5132556-1325566.3326.33
6118792-1187925.6755.67
10min1399775-39977519.09817.278.1419.1217.298.17
2365511-36551117.46117.48
3328532-32853215.69415.70
4387547-38754718.51418.54
5359006-35900617.15017.16
6328713-32871315.70315.72
15min1505757-50575724.16122.554.2924.2222.614.30
2467392-46739222.32822.38
3449989-44998921.49721.54
4482271-48227123.03923.10
5472536-47253622.57422.63
6454855-45485521.72921.78
20min1567113-56711327.09225.782.8727.2125.892.89
2529698-52969825.30425.41
3522018-52201824.93725.03
4542937-54293725.93726.05
5540763-54076325.83325.94
6535632-53563225.58825.68
30min1629562-62956230.07529.312.2830.2529.472.30
2601133-60113328.71728.88
3592115-59211528.28628.43
4619293-61929329.58429.76
5618142-61814229.52929.69
6620735-62073529.65329.81
45min1690143-69014332.96932.302.7533.2132.522.75
2645961-64596130.85831.08
3660076-66007631.53331.74
4687468-68746832.84133.08
5683431-68343132.64832.87
6689291-68929132.92833.15
60min1718017-71801734.30134.012.9634.6234.312.96
2699017-69901733.39333.69
3676346-67634632.31032.59
4721606-72160634.47234.78
5735801-73580135.15035.45
6720706-72070634.42934.72
极限1742876-74287635.48835.151.8735.8835.521.88
2720211-72021134.40534.77
3719442-71944234.36934.72
4745936-74593635.63436.02
5734058-73405835.06735.44
6752518-75251835.94936.32
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101278-202003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250
标示量(mg)40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%
19.533639259364143536455673648111364972536448190.13
29.643646647364465636456520.04
单位质量响应值RSD%判断
382457.40378179.670.80数据可信
供试品溶液-2024112521批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1294410-2944106.9676.3124.686.976.3124.67
2227706-2277065.3895.39
3157452-1574523.7263.73
4291263-2912636.8936.89
5281527-2815276.6626.66
6348027-3480278.2368.24
10min1560747-56074713.27013.169.7413.2913.179.74
2558538-55853813.21813.23
3458773-45877310.85710.87
4562121-56212113.30313.32
5568916-56891613.46313.48
6626368-62636814.82314.84
15min1670971-67097115.87915.894.9115.9215.934.93
2646426-64642615.29815.34
3623621-62362114.75814.79
4691845-69184516.37316.42
5678165-67816516.04916.09
6716697-71669716.96117.01
20min1734174-73417417.37417.323.4917.4517.403.51
2708312-70831216.76216.84
3694220-69422016.42916.49
4747235-74723517.68317.76
5749355-74935517.73417.81
6759033-75903317.96318.05
30min1760923-76092318.00718.262.5618.1318.382.58
2762895-76289518.05418.17
3743656-74365617.59917.70
4794411-79441118.80018.92
5775865-77586518.36118.48
6792247-79224718.74918.88
45min1807109-80710919.10018.942.4119.2619.102.43
2780283-78028318.46518.62
3796647-79664718.85318.99
4825983-82598319.54719.71
5777640-77764018.40318.56
6815324-81532419.29519.47
60min1823907-82390719.49819.671.3119.7019.871.35
2820656-82065619.42119.61
3822387-82238719.46219.64
4832065-83206519.69119.90
5845034-84503419.99820.20
6843522-84352219.96220.18
极限1833717-83371719.73019.811.8819.9720.061.86
2844234-84423419.97920.22
3831674-83167419.68219.91
4865376-86537620.47920.73
5823588-82358819.49019.74
6824403-82440319.51019.77
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101278-202003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250
标示量(mg)40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%
19.533585093358355735826713584505358487535841400.03
29.643702521370496737037440.05
单位质量响应值RSD%判断
376090.24384205.811.51数据可信
供试品溶液-2024112521批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1363619-3636198.6107.6627.218.617.6627.22
2191367-1913674.5314.53
3235379-2353795.5735.57
4376378-3763788.9128.91
5409147-4091479.6889.69
6365410-3654108.6528.65
10min1607582-60758214.38613.659.4314.4113.669.45
2487165-48716511.53511.55
3536045-53604512.69212.70
4624656-62465614.79014.81
5618903-61890314.65414.68
6583638-58363813.81913.84
15min1709542-70954216.80016.305.1216.8516.345.16
2629560-62956014.90714.94
3666213-66621315.77415.81
4719440-71944017.03517.09
5717234-71723416.98217.04
6687686-68768616.28316.33
20min1757935-75793517.94617.553.6318.0317.643.66
2695376-69537616.46516.53
3725472-72547217.17717.25
4763325-76332518.07418.16
5763179-76317918.07018.16
6743034-74303417.59317.68
30min1801719-80171918.98318.743.5219.1118.863.54
2741204-74120417.55017.66
3779524-77952418.45718.57
4810663-81066319.19519.33
5817627-81762719.36019.49
6797600-79760018.88519.01
45min1826939-82693919.58019.272.8419.7519.432.86
2769406-76940618.21818.36
3829829-82982919.64819.80
4810075-81007519.18119.35
5829197-82919719.63319.81
6816916-81691619.34319.51
60min1837455-83745519.82919.423.6120.0419.623.60
2796772-79677218.86619.05
3825236-82523619.54019.74
4849464-84946420.11320.33
5839093-83909319.86820.09
6772503-77250318.29118.50
极限1812309-81230919.23419.592.4319.4919.842.44
2797423-79742318.88119.11
3840355-84035519.89820.14
4853486-85348620.20920.47
5833874-83387419.74420.01
6826713-82671319.57519.83
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