乌帕替尼缓释片项目信息
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D5124-1-24101对照品来源自制对照品使用方法直接使用
对照品含量(%)99.48对照品水分(%)0对照品稀释倍数500
标示量(mg)30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%
115.043471763466913474273470853473293471420.09
215.163486513474623480560.25
单位质量响应值RSD%判断
23081.2522958.840.38数据可信
供试品溶液-1261778批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
30min167573-6757317.52117.362.7217.5217.362.73
266813-6681317.32417.32
367255-6725517.43817.44
466742-6674217.30517.31
563825-6382516.54916.55
669451-6945118.00818.01
60min1109653-10965328.43228.422.3628.4628.442.37
2109385-10938528.36228.39
3110648-11064828.69028.72
4108933-10893328.24528.27
5105508-10550827.35727.38
6113455-11345529.41829.45
120min1171696-17169644.51944.701.7944.6044.771.79
2172041-17204144.60844.68
3175578-17557845.52545.60
4171016-17101644.34344.42
5167835-16783543.51843.59
6176125-17612545.66745.75
240min1265217-26521768.76868.761.0068.9268.911.00
2264368-26436868.54868.70
3268689-26868969.66869.82
4265863-26586368.93569.09
5260664-26066467.58767.73
6266224-26622469.02969.18
360min1322563-32256383.63783.270.5283.9083.540.52
2320848-32084883.19283.46
3323241-32324183.81384.08
4320457-32045783.09183.36
5318522-31852282.58982.85
6321274-32127483.30383.57
480min1353044-35304491.54091.900.4291.9592.310.42
2353268-35326891.59892.00
3357105-35710592.59393.00
4354031-35403191.79692.20
5354867-35486792.01392.41
6354322-35432291.87292.28
600min1372540-37254096.59596.620.2897.1597.180.29
2371581-37158196.34796.90
3374302-37430297.05297.62
4373322-37332296.79897.35
5372407-37240796.56197.11
6371624-37162496.35896.92
720min1379269-37926998.34098.730.3099.0699.440.30
2380704-38070498.71299.43
3380086-38008698.55299.28
4380715-38071598.71599.43
5381165-38116598.83299.54
6382626-38262699.21199.93
960min1382592-38259299.20299.510.37100.08100.390.38
2383257-38325799.374100.26
3384717-38471799.753100.64
4383629-38362999.471100.35
5382345-38234599.138100.01
6386087-386087100.108101.00
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1387693-387693100.524100.290.18101.57101.340.18
2387145-387145100.382101.43
3386538-386538100.225101.28
4386485-386485100.211101.26
5385708-385708100.010101.05
6387137-387137100.380101.44
1440min1384349-38434999.65799.610.22100.87100.830.22
2384399-38439999.670100.88
3383672-38367299.482100.70
4382845-38284599.267100.48
5384696-38469699.747100.95
6385152-38515299.866101.09
极限1381367-38136798.88499.350.43100.27100.730.43
2381352-38135298.880100.26
3384982-38498299.822101.21
4384981-38498199.821101.20
5382806-38280699.257100.63
6383402-38340299.412100.80
乌帕替尼缓释片项目信息
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D5124-1-24101对照品来源自制对照品使用方法直接使用
对照品含量(%)99.48对照品水分(%)0对照品稀释倍数500
标示量(mg)30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%
115.043489183470533462473467743468563471700.30
215.163445733456383451060.22
单位质量响应值RSD%判断
23083.1122764.250.99数据可信
供试品溶液-1261778批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
30min166138-6613817.22216.852.7017.2216.852.69
265320-6532017.00917.01
365373-6537317.02217.02
465881-6588117.15517.15
561467-6146716.00516.01
664015-6401516.66916.67
60min1109654-10965428.55327.922.8028.5827.942.80
2109204-10920428.43628.46
3109059-10905928.39828.43
4107926-10792628.10328.13
5101889-10188926.53126.56
6105560-10556027.48727.51
120min1171610-17161044.68543.872.6744.7643.952.67
2172706-17270644.97145.05
3171452-17145244.64444.72
4168795-16879543.95244.03
5161189-16118941.97242.04
6165143-16514343.00243.08
240min1265138-26513869.03967.711.4969.1967.861.49
2262780-26278068.42568.58
3260702-26070267.88468.03
4259049-25904967.45467.60
5253896-25389666.11266.25
6258684-25868467.35967.50
360min1326374-32637484.98482.691.6985.2582.951.69
2321370-32137083.68183.95
3315627-31562782.18682.45
4316209-31620982.33882.60
5311723-31172381.16981.42
6314124-31412481.79582.05
480min1361484-36148494.12792.051.4594.5392.451.45
2356383-35638392.79893.20
3348595-34859590.77191.17
4349025-34902590.88291.28
5350137-35013791.17291.56
6355432-35543292.55192.94
600min1381199-38119999.26096.641.5699.8297.181.56
2374538-37453897.52698.08
3367448-36744895.68096.23
4369499-36949996.21496.76
5368382-36838295.92396.46
6365669-36566995.21695.76
720min1387365-387365100.86698.721.37101.6099.441.37
2382239-38223999.531100.25
3373117-37311797.15697.87
4379938-37993898.93299.64
5376566-37656698.05498.75
6375591-37559197.80098.51
960min1390473-390473101.67599.671.24102.57100.551.24
2386077-386077100.530101.42
3377276-37727698.23999.11
4381555-38155599.353100.23
5380289-38028999.02399.88
6380952-38095299.196100.07
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1395826-395826103.069100.931.29104.14101.971.29
2391408-391408101.919102.97
3383598-38359899.885100.92
4386576-386576100.660101.70
5383801-38380199.938100.96
6384407-384407100.096101.13
1440min1392278-392278102.14599.811.56103.38101.021.56
2388371-388371101.128102.35
3379849-37984998.909100.11
4383599-38359999.885101.09
5377548-37754898.31099.50
6378190-37819098.47799.68
极限1390468-390468101.67499.291.42103.08100.671.42
2385201-385201100.302101.70
3376417-37641798.01599.38
4379253-37925398.754100.13
5377871-37787198.39499.75
6378724-37872498.61699.98
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