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%
111842861842521846031841941829681840610.35
211853751853921853840.01
单位质量响应值RSD%判断
184061.00185384.000.51数据可信
供试品溶液-2025073121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%
5min196612-966124.6883.5631.834.693.5631.85
251680-516802.5082.51
372520-725203.5193.52
445604-456042.2132.21
570209-702093.4073.41
6104019-1040195.0485.05
10min1136044-1360446.6026.813.046.616.813.02
2136613-1366136.6296.63
3141071-1410716.8466.85
4146849-1468497.1267.13
5143321-1433216.9556.96
6137832-1378326.6896.70
15min1154234-1542347.4857.722.707.507.742.69
2159319-1593197.7317.75
3155838-1558387.5627.58
4165928-1659288.0528.07
5161893-1618937.8567.87
6157375-1573757.6377.66
20min1167260-1672608.1178.272.318.158.302.30
2170076-1700768.2538.28
3166386-1663868.0748.10
4176833-1768338.5818.61
5172986-1729868.3958.42
6168584-1685848.1818.21
30min1174831-1748318.4848.722.898.538.762.87
2179452-1794528.7088.75
3176930-1769308.5868.63
4188846-1888469.1649.21
5182136-1821368.8398.88
6176077-1760778.5458.59
45min1180560-1805608.7628.912.268.828.972.23
2184189-1841898.9388.99
3180427-1804278.7568.81
4190675-1906759.2539.31
5185765-1857659.0159.07
6180235-1802358.7468.81
60min1182466-1824668.8558.972.418.939.052.36
2185761-1857619.0159.09
3181887-1818878.8278.90
4193299-1932999.3809.45
5184862-1848628.9719.04
6181346-1813468.8008.88
极限1182653-1826538.8649.032.278.959.122.28
2186523-1865239.0519.14
3181674-1816748.8168.90
4193222-1932229.3779.47
5187783-1877839.1139.20
6184270-1842708.9429.03
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%
111827041842991845211841241851711841640.50
211856711842981849840.53
单位质量响应值RSD%判断
184164.00184984.000.32数据可信
供试品溶液-2025073121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%
5min1100238-1002384.8684.1817.494.874.1817.52
276286-762863.7053.70
388825-888254.3144.31
462396-623963.0303.03
5102477-1024774.9774.98
686805-868054.2164.22
10min1137584-1375846.6826.772.426.696.782.45
2139819-1398196.7906.80
3135794-1357946.5956.60
4136918-1369186.6506.65
5142018-1420186.8976.91
6144649-1446497.0257.03
15min1158032-1580327.6757.711.127.697.731.12
2159635-1596357.7537.77
3158328-1583287.6897.71
4156839-1568397.6177.63
5161927-1619277.8647.88
6158149-1581497.6817.70
20min1169791-1697918.2468.311.348.288.341.34
2171093-1710938.3098.34
3171537-1715378.3318.36
4167283-1672838.1248.15
5173208-1732088.4128.44
6173322-1733228.4188.45
30min1180333-1803338.7588.760.628.808.810.64
2179683-1796838.7278.77
3182455-1824558.8618.91
4179304-1793048.7088.75
5180682-1806828.7758.82
6180012-1800128.7428.79
45min1185346-1853469.0028.990.869.069.060.84
2183608-1836088.9178.98
3186744-1867449.0699.13
4187391-1873919.1019.16
5183789-1837898.9268.99
6184319-1843198.9529.01
60min1185553-1855539.0129.011.159.099.081.16
2184626-1846268.9679.04
3188935-1889359.1769.25
4182861-1828618.8818.95
5186765-1867659.0709.15
6184353-1843538.9539.03
极限1185964-1859649.0329.060.969.129.140.96
2185774-1857749.0229.11
3189913-1899139.2239.31
4185455-1854559.0079.09
5186758-1867589.0709.16
6184962-1849628.9839.07
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%
111838211835771842501840601849521841320.29
211853021853891853460.04
单位质量响应值RSD%判断
184132.00185346.000.47数据可信
供试品溶液-2025080121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%
5min195326-953264.6264.773.554.634.773.53
292955-929554.5104.51
398778-987784.7934.79
499268-992684.8174.82
5101618-1016184.9314.93
6101596-1015964.9304.93
10min1134899-1348996.5466.622.466.556.632.47
2131208-1312086.3676.37
3135112-1351126.5566.56
4138835-1388356.7376.74
5139813-1398136.7846.79
6139234-1392346.7566.76
15min1154723-1547237.5087.603.047.537.623.04
2149435-1494357.2517.27
3155764-1557647.5587.58
4159519-1595197.7407.76
5163572-1635727.9377.96
6156207-1562077.5807.60
20min1168137-1681378.1598.021.928.198.051.92
2159149-1591497.7227.75
3165927-1659278.0518.08
4166523-1665238.0808.11
5166620-1666208.0858.12
6164775-1647757.9958.03
30min1173148-1731488.4028.421.518.458.471.51
2168904-1689048.1968.24
3175486-1754868.5158.56
4173644-1736448.4268.47
5173707-1737078.4298.48
6176476-1764768.5638.61
45min1177253-1772538.6018.631.388.668.691.37
2173948-1739488.4408.50
3181327-1813278.7998.86
4177193-1771938.5988.66
5178889-1788898.6808.74
6178742-1787428.6738.73
60min1180656-1806568.7668.772.178.848.842.13
2175682-1756828.5258.60
3180935-1809358.7808.85
4179754-1797548.7228.80
5187739-1877399.1109.18
6179873-1798738.7288.80
极限1183230-1832308.8918.821.108.988.901.12
2178231-1782318.6488.73
3183231-1832318.8918.98
4182550-1825508.8588.95
5180341-1803418.7518.84
6182471-1824718.8548.94
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%
111857941854261846801838131848651849160.42
211856011863541859780.29
单位质量响应值RSD%判断
184916.00185978.000.41数据可信
供试品溶液-2025080121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%
5min1101947-1019474.9284.984.114.934.984.08
2103278-1032784.9924.99
3110742-1107425.3535.35
4101710-1017104.9164.92
5102794-1027944.9694.97
697823-978234.7294.73
10min1135011-1350116.5266.722.926.536.732.92
2142721-1427216.8996.91
3144018-1440186.9616.97
4138977-1389776.7186.73
5139458-1394586.7416.75
6133791-1337916.4676.48
15min1153837-1538377.4367.653.187.467.673.16
2162550-1625507.8577.88
3164044-1640447.9307.95
4160432-1604327.7557.77
5157920-1579207.6337.65
6151213-1512137.3097.33
20min1164603-1646037.9578.192.457.998.222.42
2174213-1742138.4218.45
3172434-1724348.3358.37
4171749-1717498.3028.33
5169549-1695498.1968.23
6164382-1643827.9467.98
30min1177316-1773168.5718.632.678.628.682.67
2183216-1832168.8568.90
3181638-1816388.7808.83
4181219-1812198.7608.81
5178282-1782828.6188.66
6169992-1699928.2178.26
45min1179195-1791958.6628.812.838.728.872.83
2187105-1871059.0449.11
3184263-1842638.9078.97
4186246-1862469.0039.06
5183469-1834698.8688.93
6173389-1733898.3818.44
60min1180359-1803598.7188.862.998.798.933.00
2188324-1883249.1039.18
3185363-1853638.9609.04
4187394-1873949.0589.13
5184255-1842558.9068.98
6173633-1736338.3938.46
极限1182356-1823568.8158.942.918.909.032.92
2190850-1908509.2259.32
3185353-1853538.9609.05
4189141-1891419.1439.23
5186271-1862719.0049.09
6175825-1758258.4998.58
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%
111849811846291855341862431845191851810.39
211842931862791852860.76
单位质量响应值RSD%判断
185181.00185286.000.05数据可信
供试品溶液-2025080122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%
5min196205-962054.6564.865.324.664.875.31
298312-983124.7584.76
398736-987364.7784.78
499931-999314.8364.84
598692-986924.7764.78
6111110-1111105.3775.38
10min1139486-1394866.7506.892.226.766.902.24
2139042-1390426.7296.74
3144175-1441756.9776.99
4141477-1414776.8466.85
5142143-1421436.8796.89
6147490-1474907.1377.15
15min1157104-1571047.6037.731.587.627.751.60
2155899-1558997.5447.56
3161385-1613857.8107.83
4161627-1616277.8227.84
5161276-1612767.8057.82
6160904-1609047.7877.81
20min1165631-1656318.0158.071.848.058.101.84
2162646-1626467.8717.90
3166590-1665908.0628.09
4169545-1695458.2058.24
5170914-1709148.2718.30
6164867-1648677.9788.01
30min1168197-1681978.1408.341.958.188.391.94
2169925-1699258.2238.27
3174170-1741708.4298.47
4176524-1765248.5438.59
5175198-1751988.4788.52
6170279-1702798.2408.29
45min1171528-1715288.3018.563.128.368.623.11
2172726-1727268.3598.42
3177177-1771778.5748.63
4178859-1788598.6568.72
5186603-1866039.0309.09
6174073-1740738.4248.48
60min1171517-1715178.3008.552.468.378.622.46
2174757-1747578.4578.53
3178289-1782898.6288.70
4182709-1827098.8428.92
5179938-1799388.7088.78
6172905-1729058.3678.44
极限1173263-1732638.3858.611.828.478.701.80
2176665-1766658.5498.64
3178767-1787678.6518.74
4180898-1808988.7548.84
5181895-1818958.8028.89
6175987-1759878.5178.61
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%
111849021849151840901853711854431849440.30
211858101860861859480.11
单位质量响应值RSD%判断
184944.00185948.000.39数据可信
供试品溶液-2025080122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%
5min1102353-1023534.9484.773.224.954.783.23
299623-996234.8164.82
395301-953014.6074.61
498353-983534.7544.75
594947-949474.5904.59
6101941-1019414.9284.93
10min1141004-1410046.8166.801.536.826.801.54
2142580-1425806.8926.90
3138430-1384306.6916.70
4143563-1435636.9406.95
5138516-1385166.6966.70
6139617-1396176.7496.76
15min1159007-1590077.6867.672.177.717.692.18
2164174-1641747.9367.96
3154463-1544637.4667.49
4160507-1605077.7597.78
5157800-1578007.6287.65
6156074-1560747.5447.56
20min1166530-1665308.0508.092.858.088.122.87
2172655-1726558.3468.38
3163276-1632767.8927.92
4173669-1736698.3958.43
5165108-1651087.9818.01
6162592-1625927.8597.89
30min1171225-1712258.2778.382.578.328.432.56
2179861-1798618.6948.74
3172019-1720198.3158.36
4177692-1776928.5898.64
5171759-1717598.3028.35
6167992-1679928.1208.17
45min1175027-1750278.4608.502.988.528.562.97
2182027-1820278.7998.86
3172369-1723698.3328.39
4182213-1822138.8088.87
5174604-1746048.4408.50
6169229-1692298.1808.24
60min1175042-1750428.4618.592.828.538.662.82
2182777-1827778.8358.91
3175228-1752288.4708.54
4184844-1848448.9359.01
5175858-1758588.5018.57
6172098-1720988.3198.39
极限1178237-1782378.6168.652.598.708.742.60
2184921-1849218.9399.03
3174822-1748228.4518.54
4184275-1842758.9079.00
5176976-1769768.5558.64
6174284-1742848.4258.51
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