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240501对照品来源自制对照品使用方法直接使用
对照品含量(%)99.9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%
115.221724621728111726901725871724571726010.09
215.231725191722921724060.10
单位质量响应值RSD%判断
11340.4111320.160.13数据可信
供试品溶液-1231323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%
30min135811-3581118.94517.035.6018.9417.035.60
231421-3142116.62316.62
330943-3094316.37016.37
431953-3195316.90416.90
531442-3144216.63416.63
631595-3159516.71516.71
60min160923-6092332.23028.796.0132.2628.826.00
253088-5308828.08528.11
351756-5175627.38027.41
453694-5369428.40528.43
553390-5339028.24528.27
653667-5366728.39128.42
120min197570-9757051.61746.505.5151.7046.585.51
285701-8570145.33845.41
384129-8412944.50644.58
486801-8680145.92046.00
586523-8652345.77345.85
686656-8665645.84345.92
240min1147587-14758778.07770.575.3878.2570.725.38
2128836-12883668.15768.31
3128464-12846467.96168.11
4133027-13302770.37570.53
5131655-13165569.64969.80
6130766-13076669.17969.33
360min1180199-18019995.33085.985.5495.6386.265.54
2155898-15589882.47482.74
3157168-15716883.14683.41
4162584-16258486.01186.28
5160987-16098785.16685.43
6158363-15836383.77884.04
480min1203834-203834107.83397.045.72108.2997.465.71
2174935-17493592.54592.95
3177852-17785294.08894.49
4183588-18358897.12397.54
5182209-18220996.39396.80
6178169-17816994.25694.66
600min1186467-18646798.64699.481.8099.29100.061.79
2183527-18352797.09097.65
3186762-18676298.80299.36
4193046-193046102.126102.70
5190786-190786100.931101.50
6187699-18769999.29799.86
720min1191492-191492101.304101.691.86102.11102.441.85
2187303-18730399.08899.81
3190724-190724100.898101.62
4197180-197180104.313105.06
5195504-195504103.427104.16
6191144-191144101.120101.85
960min1193595-193595102.417102.761.96103.39103.671.95
2188503-18850399.723100.61
3193325-193325102.274103.16
4199323-199323105.447106.37
5197514-197514104.490105.40
6193191-193191102.203103.10
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1192647-192647101.915102.291.80103.06103.371.80
2188187-18818799.556100.60
3192013-192013101.580102.64
4197839-197839104.662105.76
5196653-196653104.034105.12
6192745-192745101.967103.03
1440min1191969-191969101.556101.721.85102.87102.971.84
2186750-18675098.795100.01
3191160-191160101.128102.36
4197102-197102104.272105.54
5194971-194971103.145104.40
6191703-191703101.416102.65
极限1191420-191420101.266101.511.83102.75102.941.83
2186560-18656098.695100.07
3190647-190647100.857102.25
4196561-196561103.986105.43
5194859-194859103.085104.52
6191266-191266101.185102.59
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240501对照品来源自制对照品使用方法直接使用
对照品含量(%)99.9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%
115.221723191723261723641721641723601723070.05
215.231727371726231726800.05
单位质量响应值RSD%判断
11321.0911338.150.11数据可信
供试品溶液-1231323批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
30min124260-2426012.83512.612.5312.8312.612.52
224089-2408912.74412.74
322977-2297712.15612.16
424224-2422412.81612.82
523165-2316512.25612.26
624321-2432112.86712.87
60min141507-4150721.96021.982.4521.9822.002.44
242418-4241822.44122.46
339629-3962920.96620.99
442150-4215022.30022.32
541389-4138921.89721.92
642136-4213622.29222.31
120min167660-6766035.79635.771.9635.8535.831.96
268435-6843536.20636.26
365042-6504234.41134.47
468164-6816436.06336.12
568695-6869536.34436.40
667721-6772135.82835.89
240min1104272-10427255.16655.161.2455.2855.271.25
2105170-10517055.64155.76
3101916-10191653.91954.03
4104005-10400555.02455.14
5105633-10563355.88656.00
6104525-10452555.30055.42
360min1129395-12939568.45768.560.7568.6768.770.75
2129792-12979268.66768.88
3128367-12836767.91368.12
4128867-12886768.17868.39
5131138-13113869.37969.59
6129986-12998668.77068.98
480min1149846-14984679.27779.290.6079.6079.610.60
2149414-14941479.04879.37
3150064-15006479.39279.71
4148527-14852778.57978.90
5151225-15122580.00680.33
6150113-15011379.41879.74
600min1161687-16168785.54185.650.7086.0086.110.70
2161212-16121285.29085.75
3162814-16281486.13886.59
4160162-16016284.73585.19
5163250-16325086.36886.83
6162262-16226285.84686.30
720min1170101-17010189.99389.900.7390.5990.500.73
2169503-16950389.67790.28
3171067-17106790.50491.10
4167886-16788688.82189.42
5171290-17129090.62291.23
6169737-16973789.80090.40
960min1179939-17993995.19895.280.8795.9596.030.87
2179190-17919094.80295.55
3181509-18150996.02896.77
4177844-17784494.08994.83
5182144-18214496.36497.12
6179947-17994795.20295.95
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1184962-18496297.85598.080.9698.7698.980.96
2184208-18420897.45698.36
3187117-18711798.99599.90
4182880-18288096.75497.65
5187574-18757499.237100.15
6185571-18557198.17799.09
1440min1187727-18772799.31899.330.95100.39100.400.95
2186534-18653498.68799.76
3189704-189704100.364101.43
4185338-18533898.05499.12
5189895-189895100.465101.55
6187323-18732399.104100.18
极限1187218-18721899.04999.061.07100.28100.301.06
2186068-18606898.44099.67
3189424-189424100.216101.45
4184503-18450397.61298.84
5189639-189639100.330101.58
6186625-18662598.73599.97
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