比拉斯汀口崩片项目信息
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D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6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%
111869631872811869851869201871351870570.08
211872231872241872240.01
单位质量响应值RSD%判断
187057.00187224.000.07数据可信
供试品溶液-3208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%
5min194906-949064.5464.356.194.554.356.19
285102-851024.0764.08
387927-879274.2124.21
488929-889294.2604.26
587807-878074.2064.21
6100159-1001594.7984.80
10min1126541-1265416.0615.884.836.075.894.78
2115683-1156835.5415.55
3121057-1210575.7995.81
4120659-1206595.7805.79
5119824-1198245.7405.75
6132502-1325026.3476.35
15min1149127-1491277.1437.083.317.167.103.30
2141339-1413396.7706.79
3147497-1474977.0657.08
4144883-1448836.9406.96
5148633-1486337.1197.14
6155977-1559777.4717.49
20min1163928-1639287.8527.943.057.887.973.07
2160396-1603967.6837.71
3171347-1713478.2078.24
4159918-1599187.6607.69
5169679-1696798.1288.16
6169622-1696228.1258.16
30min1177094-1770948.4838.581.988.538.621.95
2178051-1780518.5298.57
3178801-1788018.5658.61
4174060-1740608.3378.38
5183340-1833408.7828.82
6182840-1828408.7588.80
45min1181584-1815848.6988.902.898.758.962.86
2184308-1843088.8288.88
3193045-1930459.2479.30
4178736-1787368.5618.62
5190058-1900589.1049.16
6187520-1875208.9829.04
60min1182291-1822918.7329.073.968.809.143.94
2185736-1857368.8978.97
3187476-1874768.9809.05
4187806-1878068.9969.07
5203860-2038609.7659.84
6188708-1887089.0399.11
极限1182507-1825078.7428.962.798.839.042.77
2185820-1858208.9018.98
3189084-1890849.0579.14
4179816-1798168.6138.70
5192276-1922769.2109.30
6192490-1924909.2209.31
比拉斯汀口崩片项目信息
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D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6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%
111871281874661871881869341872481871930.11
211873761876811875280.12
单位质量响应值RSD%判断
187193.00187528.000.13数据可信
供试品溶液-3208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%
5min199048-990484.7394.719.234.744.709.22
2110990-1109905.3105.31
3103658-1036584.9594.96
483744-837444.0074.01
597292-972924.6554.65
695334-953344.5614.56
10min1131375-1313756.2856.156.386.296.156.38
2131489-1314896.2916.30
3137349-1373496.5716.58
4113111-1131115.4125.42
5129978-1299786.2196.23
6127374-1273746.0946.10
15min1154231-1542317.3797.304.047.407.314.03
2155518-1555187.4417.46
3159148-1591487.6147.63
4141588-1415886.7746.79
5154744-1547447.4047.42
6149622-1496227.1587.18
20min1168013-1680138.0388.013.668.078.043.67
2172091-1720918.2338.27
3171494-1714948.2058.24
4155712-1557127.4507.48
5170712-1707128.1678.20
6166769-1667697.9798.01
30min1180439-1804398.6338.603.098.688.653.10
2186342-1863428.9158.96
3182346-1823468.7248.77
4171186-1711868.1908.23
5183250-1832508.7678.81
6175575-1755758.4008.44
45min1184912-1849128.8478.893.188.918.953.18
2195408-1954089.3499.41
3186793-1867938.9379.00
4177787-1777878.5068.56
5187955-1879558.9929.05
6182461-1824618.7308.79
60min1185609-1856098.8808.942.808.959.012.80
2195376-1953769.3479.42
3187149-1871498.9549.03
4179568-1795688.5918.66
5188919-1889199.0399.11
6184553-1845538.8308.90
极限1186798-1867988.9379.013.579.039.103.56
2200040-2000409.5719.66
3187885-1878858.9899.08
4179920-1799208.6088.69
5190338-1903389.1069.20
6185044-1850448.8538.94
比拉斯汀口崩片项目信息
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D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6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%
111867691871831868591865991868131868450.12
211875801877401876600.07
单位质量响应值RSD%判断
186845.00187660.000.31数据可信
供试品溶液-3128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%
5min188636-886364.2434.576.074.244.576.06
293383-933834.4704.47
3101154-1011544.8424.84
490079-900794.3124.31
597373-973734.6614.66
6102661-1026614.9154.91
10min1136273-1362736.5246.583.436.536.583.43
2136325-1363256.5266.53
3141737-1417376.7856.79
4129365-1293656.1936.20
5138574-1385746.6346.64
6142280-1422806.8116.82
15min1154062-1540627.3757.733.277.397.743.28
2159467-1594677.6347.65
3169018-1690188.0918.11
4163082-1630827.8077.82
5158175-1581757.5727.59
6164518-1645187.8767.90
20min1164911-1649117.8958.082.617.928.112.62
2172728-1727288.2698.30
3171042-1710428.1888.22
4164356-1643567.8687.90
5165148-1651487.9067.94
6174097-1740978.3348.37
30min1173022-1730228.2838.392.438.338.442.43
2176565-1765658.4528.50
3176712-1767128.4598.51
4171952-1719528.2328.28
5171197-1711978.1958.24
6182626-1826268.7438.79
45min1179450-1794508.5918.552.328.658.612.32
2177717-1777178.5088.57
3181011-1810118.6658.73
4175033-1750338.3798.44
5173438-1734388.3038.36
6184803-1848038.8478.91
60min1181459-1814598.6878.652.748.768.722.75
2183359-1833598.7788.85
3180677-1806778.6498.72
4175904-1759048.4218.49
5174769-1747698.3668.44
6188217-1882179.0109.09
极限1179407-1794078.5888.642.058.678.732.04
2180425-1804258.6378.72
3181369-1813698.6828.77
4176310-1763108.4408.53
5178435-1784358.5428.63
6187171-1871718.9609.05
比拉斯汀口崩片项目信息
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D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6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%
111869371870881870811871291871451870760.05
211878561876231877400.09
单位质量响应值RSD%判断
187076.00187740.000.26数据可信
供试品溶液-3128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%
5min192166-921664.4084.646.434.414.646.46
2108649-1086495.1975.20
395214-952144.5544.55
491388-913884.3714.37
597383-973834.6584.66
697465-974654.6624.66
10min1131259-1312596.2786.504.606.296.514.59
2146385-1463857.0027.01
3133863-1338636.4036.41
4130041-1300416.2206.23
5133948-1339486.4076.41
6140503-1405036.7206.73
15min1150731-1507317.2107.595.297.237.605.30
2170294-1702948.1458.17
3154762-1547627.4037.42
4152299-1522997.2857.30
5155449-1554497.4357.45
6168001-1680018.0368.05
20min1160529-1605297.6788.064.937.718.094.91
2181696-1816968.6918.72
3163430-1634307.8177.85
4161914-1619147.7457.77
5169175-1691758.0928.12
6174618-1746188.3528.38
30min1166755-1667557.9768.425.228.028.475.21
2189599-1895999.0699.12
3173668-1736688.3078.35
4168368-1683688.0538.10
5173304-1733048.2898.33
6184926-1849268.8458.89
45min1170316-1703168.1468.586.048.208.646.01
2194400-1944009.2989.36
3171185-1711858.1888.25
4171237-1712378.1918.25
5177756-1777568.5028.56
6191301-1913019.1509.21
60min1176913-1769138.4628.706.068.538.776.06
2196090-1960909.3799.46
3172053-1720538.2308.30
4172288-1722888.2418.31
5178785-1787858.5528.62
6195414-1954149.3479.42
极限1172265-1722658.2408.716.748.328.806.71
2197274-1972749.4369.53
3172716-1727168.2618.35
4172951-1729518.2738.36
5179547-1795478.5888.67
6197772-1977729.4609.55
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