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1000
标示量(mg)15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%
114.701724621724031723021724181720581723290.10
214.781715471721491718480.25
单位质量响应值RSD%判断
11723.0611627.060.59数据可信
供试品溶液-2025081121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%
30min130162-3016215.42014.742.9315.4214.742.92
228889-2888914.77014.77
328144-2814414.38914.39
429278-2927814.96814.97
528693-2869314.66914.67
627789-2778914.20714.21
60min152441-5244126.81126.431.4726.8426.461.47
251395-5139526.27626.30
351428-5142826.29326.32
452254-5225426.71526.74
552235-5223526.70526.73
650452-5045225.79425.82
120min183739-8373942.81242.620.9842.8842.690.98
284240-8424043.06843.14
383177-8317742.52442.59
483889-8388942.88842.96
583273-8327342.57442.64
681917-8191741.88041.95
240min1125286-12528664.05364.040.8264.1964.180.82
2126468-12646864.65764.80
3125575-12557564.20064.34
4125539-12553964.18264.32
5125347-12534764.08464.22
6123374-12337463.07563.21
360min1150090-15009076.73476.700.6676.9876.940.66
2151329-15132977.36777.62
3150268-15026876.82577.07
4149912-14991276.64376.89
5150232-15023276.80677.05
6148277-14827775.80776.05
480min1165867-16586784.80084.790.9285.1885.160.92
2167838-16783885.80886.18
3165251-16525184.48584.86
4166258-16625885.00085.38
5166554-16655485.15185.53
6163281-16328183.47883.85
600min1175334-17533489.64089.340.8690.1689.860.86
2176612-17661290.29390.81
3174749-17474989.34189.86
4173257-17325788.57889.10
5175797-17579789.87790.39
6172737-17273788.31288.82
720min1182062-18206293.08092.450.8193.7593.110.80
2182767-18276793.44094.11
3180479-18047992.27092.93
4178960-17896091.49492.16
5181101-18110192.58893.25
6179585-17958591.81392.47
960min1185926-18592695.05595.590.9795.8896.410.97
2189529-18952996.89797.72
3186760-18676095.48196.30
4184313-18431394.23095.05
5188241-18824196.23997.06
6187096-18709695.65396.46
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1189963-18996397.11997.480.9698.1098.450.95
2193019-19301998.68199.67
3190279-19027997.28198.26
4187959-18795996.09497.07
5192352-19235298.34099.32
6190390-19039097.33798.30
1440min1191334-19133497.82098.581.1398.9699.721.12
2195032-19503299.711100.86
3194880-19488099.633100.77
4189540-18954096.90398.04
5193840-19384099.101100.25
6192343-19234398.33699.46
极限1190911-19091197.60498.110.9498.9199.410.94
2194626-19462699.503100.82
3191617-19161797.96599.27
4189380-18938096.82198.12
5193074-19307498.709100.02
6191759-19175998.03799.33
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1000
标示量(mg)15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%
114.701724631719631725251725041722881723490.14
214.781723431732021727720.36
单位质量响应值RSD%判断
11724.4211689.580.22数据可信
供试品溶液-2025081121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%
30min129024-2902414.79814.693.1614.8014.693.15
229702-2970215.14415.14
329813-2981315.20015.20
428141-2814114.34814.35
527459-2745914.00014.00
628761-2876114.66414.66
60min151394-5139426.20326.222.0626.2326.242.06
252555-5255526.79526.82
352502-5250226.76826.79
451275-5127526.14326.17
549679-4967925.32925.35
651137-5113726.07226.10
120min181334-8133441.46842.161.0741.5442.221.06
282380-8238042.00142.07
383332-8333242.48742.56
482850-8285042.24142.31
583863-8386342.75842.82
682336-8233641.97942.05
240min1122419-12241962.41563.280.9962.5563.410.99
2125244-12524463.85664.00
3124726-12472663.59263.73
4125493-12549363.98364.12
5123439-12343962.93563.07
6123312-12331262.87163.01
360min1148457-14845775.69176.020.5975.9376.270.59
2149353-14935376.14876.39
3149184-14918476.06176.31
4150616-15061676.79277.04
5148948-14894875.94176.18
6148101-14810175.50975.75
480min1164012-16401283.62183.910.5883.9984.280.58
2164818-16481884.03284.41
3164252-16425283.74484.12
4166182-16618284.72885.10
5164783-16478384.01584.38
6163375-16337583.29783.67
600min1173924-17392488.67588.570.8189.1889.080.81
2174359-17435988.89789.41
3172771-17277188.08788.60
4175762-17576289.61290.13
5173791-17379188.60789.12
6171658-17165887.52088.03
720min1179368-17936891.45191.630.8692.1192.290.86
2181117-18111792.34293.00
3179077-17907791.30291.96
4181892-18189292.73893.40
5179316-17931691.42492.08
6177592-17759290.54591.20
960min1184937-18493794.29094.820.8495.1095.630.84
2186807-18680795.24496.06
3185385-18538594.51995.33
4188588-18858896.15296.97
5185948-18594894.80695.61
6184203-18420393.91694.72
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1187589-18758995.64297.102.3296.6198.072.30
2190530-19053097.14298.12
3188258-18825895.98396.95
4199160-199160101.542102.52
5189214-18921496.47197.44
6187915-18791595.80896.77
1440min1189692-18969296.71497.201.2297.8498.341.22
2192269-19226998.02899.16
3189540-18954096.63797.77
4194599-19459999.216100.36
5188357-18835796.03497.16
6189470-18947096.60197.72
极限1189122-18912296.42496.951.4097.7198.251.39
2192110-19211097.94799.25
3189876-18987696.80898.10
4193879-19387998.849100.16
5186153-18615394.91096.20
6189809-18980996.77498.06
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