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%
110.17 3177263181663177023183713175003178930.12
210.163184143181443182790.06
单位质量响应值RSD%判断
31257.9231326.670.16数据可信
加速3月-供试品溶液-2024051421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%
5min1315618-31561891.85488.944.5991.8588.944.59
2296434-29643486.27186.27
3321217-32121793.48493.48
4300022-30002287.31687.32
5284917-28491782.91982.92
6315386-31538691.78791.79
10min1325988-32598894.87294.301.2395.3894.801.23
2317170-31717092.30692.79
3327854-32785495.41595.93
4321524-32152493.57394.06
5326342-32634294.97595.44
6325299-32529994.67295.18
15min1326985-32698595.16395.500.6996.2096.510.67
2327044-32704495.18096.17
3327706-32770695.37296.42
4331463-33146396.46697.47
5330137-33013796.08097.07
6325433-32543394.71195.75
20min1323722-32372294.21395.211.2995.7896.761.25
2327338-32733895.26596.79
3325841-32584194.83096.41
4324407-32440794.41295.95
5335283-33528397.57899.10
6326200-32620094.93496.50
极限1330520-33052096.19195.011.2898.2897.091.26
2323018-32301894.00896.06
3329692-32969295.95098.06
4330371-33037196.14898.21
5323866-32386694.25596.32
6321340-32134093.52095.61
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%
110.17 3179093181663182473178623169803178330.16
210.163187783184753186260.07
单位质量响应值RSD%判断
31252.0231360.830.25数据可信
长期3月-供试品溶液-2024051421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%
5min1317772-31777292.44091.953.4492.4491.963.44
2300609-30060987.44787.45
3313726-31372691.26391.26
4323058-32305893.97793.98
5309511-30951190.03790.04
6331928-33192896.55896.56
10min1327094-32709495.15295.801.8095.6796.311.79
2320495-32049593.23293.72
3333777-33377797.09697.60
4325488-32548894.68495.21
5335767-33576797.67498.17
6333304-33330496.95897.49
15min1325261-32526194.61894.971.0595.6696.011.04
2329341-32934195.80596.81
3320380-32038093.19894.24
4326353-32635394.93695.98
5329496-32949695.85096.89
6327972-32797295.40796.48
20min1327554-32755495.28595.082.9496.8596.652.91
2314899-31489991.60493.14
3321773-32177393.60495.17
4331935-33193596.56098.14
5322460-32246093.80395.38
6342513-34251399.637101.24
极限1319122-31912292.83294.101.3194.9396.201.30
2325731-32573194.75596.80
3320809-32080993.32395.41
4327101-32710195.15497.27
5319333-31933392.89494.99
6328736-32873695.62997.79
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%
110.17 3173173171593170913172773168813171450.06
210.163183613185133184370.04
单位质量响应值RSD%判断
31184.3731342.220.36数据可信
加速3月-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%
5min1326391-32639195.07892.924.4695.0892.924.46
2315550-31555091.92091.92
3293907-29390785.61685.62
4319850-31985093.17393.17
5336478-33647898.01798.02
6321661-32166193.70093.70
10min1327698-32769895.45997.532.1595.9998.052.16
2336052-33605297.89398.40
3325329-32532994.76995.24
4337512-33751298.31898.84
5344951-344951100.485101.03
6337362-33736298.27498.79
15min1325449-32544994.80497.021.3195.8698.081.31
2336357-33635797.98199.04
3330446-33044696.26097.26
4335065-33506597.60598.67
5334270-33427097.37398.48
6336688-33668898.07899.14
20min1323860-32386094.34196.961.9295.9398.561.92
2331357-33135796.52598.12
3328539-32853995.70497.24
4339344-33934498.852100.46
5340566-34056699.207100.85
6333472-33347297.14198.75
极限1322885-32288594.05795.151.4096.1797.281.40
2321063-32106393.52695.66
3325166-32516694.72196.79
4328943-32894395.82297.98
5333645-33364597.19199.39
6328052-32805295.56297.71
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%
110.17 3186293182423176553177223182133180920.13
210.163191853190663191260.03
单位质量响应值RSD%判断
31277.4831410.040.30数据可信
长期3月-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%
5min1312796-31279690.88488.873.8490.8888.873.85
2308153-30815389.53589.53
3301441-30144187.58587.58
4285261-28526182.88482.88
5307994-30799489.48989.49
6319567-31956792.85192.85
10min1316796-31679692.04694.922.7092.5595.422.70
2331507-33150796.32096.82
3331337-33133796.27196.76
4314174-31417491.28491.74
5332017-33201796.46996.97
6334359-33435997.14997.66
15min1315441-31544191.65294.682.3692.6795.702.36
2324675-32467594.33595.37
3333029-33302996.76397.78
4318625-31862592.57893.55
5328931-32893195.57296.61
6334375-33437597.15498.21
20min1326546-32654694.87994.481.9696.4096.021.96
2321312-32131293.35894.91
3324192-32419294.19595.75
4315392-31539291.63893.12
5331645-33164596.36197.92
6331955-33195596.45198.05
极限1317352-31735292.20894.152.1094.2696.222.09
2315500-31550091.67093.74
3329917-32991795.85997.94
4321566-32156693.43295.42
5331017-33101796.17898.28
6328940-32894095.57597.71
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