磷酸奥司他韦干糖浆项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101096-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数500
标示量(mg)75供试品稀释倍数5系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.063101213103583099723092123100933099510.15
210.093106793102643104720.10
单位质量响应值RSD%判断
30810.2430770.270.10数据可信
供试品溶液-2024051621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%
5min1331595-33159598.07894.522.9698.0894.522.96
2322946-32294695.51995.52
3321162-32116294.99294.99
4311368-31136892.09592.10
5305593-30559390.38790.39
6324679-32467996.03296.03
10min1343926-343926101.725101.441.80102.27101.971.81
2352458-352458104.248104.78
3343290-343290101.537102.06
4340437-340437100.693101.20
5333415-33341598.61699.12
6344298-344298101.835102.37
15min1339891-339891100.531101.301.80101.64102.391.79
2353051-353051104.424105.53
3338217-338217100.036101.13
4346934-346934102.615103.69
5339244-339244100.340101.39
6337697-33769799.882100.98
20min1343412-343412101.573101.281.84103.24102.931.84
2353416-353416104.532106.22
3339908-339908100.536102.18
4342359-342359101.261102.90
5334163-33416398.837100.44
6341321-341321100.954102.61
极限1340658-340658100.758100.971.87102.99103.191.86
2349236-349236103.295105.57
3344103-344103101.777103.98
4333080-33308098.517100.72
5334991-33499199.082101.24
6346247-346247102.411104.63
磷酸奥司他韦干糖浆项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101096-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数500
标示量(mg)75供试品稀释倍数5系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.063097903088313090483088863100723093250.19
210.093097683087963092820.23
单位质量响应值RSD%判断
30748.0130652.330.23数据可信
供试品溶液-2024051621批-pH0.95
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1316997-31699794.03598.172.8394.0498.172.83
2324823-32482396.35796.36
3336347-33634799.77599.78
4333886-33388699.04599.05
5343774-343774101.978101.98
6329698-32969897.80397.80
10min1334197-33419799.138102.122.3799.66102.662.36
2340772-340772101.088101.62
3338026-338026100.273100.83
4348651-348651103.425103.98
5356476-356476105.746106.31
6347325-347325103.032103.58
15min1325189-32518996.465101.052.7997.54102.162.78
2336757-33675799.897100.99
3338509-338509100.417101.53
4352776-352776104.649105.77
5345604-345604102.521103.68
6345017-345017102.347103.46
20min1335269-33526999.456101.332.36101.06103.002.35
2334650-33465099.272100.92
3335566-33556699.544101.21
4348849-348849103.484105.19
5341495-341495101.302103.03
6353675-353675104.916106.60
极限1326071-32607196.72799.502.1598.89101.742.15
2333592-33359298.958101.16
3328569-32856997.46899.69
4343177-343177101.801104.08
5342596-342596101.629103.92
6338480-338480100.408102.68
磷酸奥司他韦干糖浆项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101096-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数500
标示量(mg)75供试品稀释倍数5系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.063097473097433103163096953099163098830.09
210.093089803100553095180.25
单位质量响应值RSD%判断
30803.4830675.720.30数据可信
供试品溶液-2024051621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%
5min1320038-32003894.81694.434.1794.8294.434.16
2294249-29424987.17587.18
3316730-31673093.83693.84
4333582-33358298.82898.83
5323444-32344495.82595.82
6324385-32438596.10496.10
10min1336592-33659299.72099.662.01100.25100.182.02
2323979-32397995.98396.47
3340764-340764100.956101.48
4335400-33540099.36799.92
5337959-337959100.125100.66
6343572-343572101.788102.32
15min1336067-33606799.565100.030.43100.65101.110.44
2335931-33593199.524100.54
3339327-339327100.530101.61
4338700-338700100.345101.45
5337333-33733399.940101.03
6338461-338461100.274101.37
20min1331531-33153198.22199.251.1599.85100.891.15
2334250-33425099.026100.60
3329815-32981597.71299.35
4339063-339063100.452102.11
5336484-33648499.688101.33
6338957-338957100.421102.08
极限1328961-32896197.45997.841.2099.64100.021.17
2331897-33189798.329100.45
3326139-32613996.62398.81
4325791-32579196.52098.74
5335541-33554199.409101.61
6333088-33308898.682100.90
磷酸奥司他韦干糖浆项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101096-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数500
标示量(mg)75供试品稀释倍数5系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.063105193104803105243107373100803104680.08
210.093107083101973104520.12
单位质量响应值RSD%判断
30861.6330768.290.22数据可信
供试品溶液-2024051621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%
5min1314715-31471593.01194.534.3193.0194.544.32
2323303-32330395.54995.55
3297911-29791188.04488.04
4316300-31630093.47993.48
5338224-33822499.95899.96
6328778-32877897.16797.17
10min1338537-338537100.05199.881.92100.57100.411.91
2347499-347499102.699103.23
3337191-33719199.653100.14
4333089-33308998.44198.96
5342217-342217101.138101.69
6329285-32928597.31797.86
15min1338715-338715100.103100.341.25101.18101.421.26
2336401-33640199.420100.52
3338704-338704100.100101.14
4335270-33527099.085100.15
5347231-347231102.620103.74
6340691-340691100.687101.77
20min1337170-33717099.64799.461.58101.28101.101.57
2331294-33129497.91099.56
3340914-340914100.753102.35
4329746-32974697.45399.07
5343467-343467101.508103.20
6336629-33662999.487101.13
极限1327124-32712496.67899.131.4198.86101.321.40
2339501-339501100.336102.53
3332980-33298098.409100.57
4336181-33618199.355101.51
5339422-339422100.312102.56
6337298-33729899.685101.88
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