盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSZJ-4057-240226对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.432149552147462147802145762137892145690.22
216.452171892164822168360.24
单位质量响应值RSD%判断
13059.5913181.520.66数据可信
长期12月-供试品溶液-2024042521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%
5min121677-2167711.07013.5544.0511.0713.5544.05
241769-4176921.33121.33
339059-3905919.94719.95
426818-2681813.69613.70
514659-146597.4867.49
615185-151857.7557.75
10min196290-9629049.17554.1519.4749.2454.2319.50
2126252-12625264.47764.60
3112444-11244457.42557.54
4131780-13178067.30067.38
587278-8727844.57344.61
682135-8213541.94641.99
15min1179958-17995891.90495.153.8092.2495.533.83
2190699-19069997.39097.87
3197726-197726100.978101.41
4183576-18357693.75294.20
5179121-17912191.47791.77
6186782-18678295.38995.67
20min1188713-18871396.37598.592.7497.2299.502.72
2191111-19111197.60098.62
3201535-201535102.924103.91
4187238-18723895.62296.59
5193369-19336998.75399.55
6196387-196387100.295101.10
30min1192914-19291498.52199.212.1799.90100.662.16
2195234-19523499.706101.27
3199560-199560101.915103.48
4187766-18776695.89297.39
5192375-19237598.24699.59
6197748-197748100.990102.35
45min1194459-19445999.31099.431.98101.24101.431.98
2194923-19492399.547101.66
3200306-200306102.296104.42
4189410-18941096.73198.77
5191822-19182297.96399.86
6197216-197216100.718102.64
极限1193191-19319198.66298.591.73101.14101.151.66
2192390-19239098.253100.92
3193500-19350098.820101.52
4188234-18823496.13198.70
5192395-19239598.256100.69
6198616-198616101.433103.92
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSZJ-4057-240226对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.432151962152492150342153272150032151620.07
216.452173792183122178460.31
单位质量响应值RSD%判断
13095.6813242.920.80数据可信
长期12月-供试品溶液-2024042621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%
5min152725-5272526.82714.6256.5326.8314.6256.54
244099-4409922.43822.44
320304-2030410.33110.33
424840-2484012.63912.64
59927-99275.0515.05
620521-2052110.44110.44
10min1125188-12518863.69759.3416.1163.8559.4216.11
2115937-11593758.99059.11
3110784-11078456.36856.43
4109380-10938055.65455.72
591022-9102246.31346.34
6147400-14740074.99975.06
15min1193546-19354698.47995.593.3998.9896.003.44
2187019-18701995.15895.61
3193210-19321098.30898.68
4187003-18700395.15095.53
5176247-17624789.67789.96
6190185-19018596.76997.24
20min1194764-19476499.09897.322.63100.1598.262.70
2194676-19467699.054100.03
3191708-19170897.54498.46
4190092-19009296.72197.63
5181789-18178992.49793.28
6194596-19459699.013100.03
30min1194834-19483499.13497.052.08100.7398.542.12
2186447-18644794.86796.40
3193053-19305398.22899.69
4190887-19088797.12698.57
5185415-18541594.34295.64
6193813-19381398.615100.18
45min1196047-19604799.75198.252.47101.90100.272.49
2193022-19302298.212100.27
3193214-19321498.310100.31
4185796-18579694.53596.52
5190673-19067397.01798.84
6199825-199825101.674103.78
极限1191216-19121697.29396.652.07100.0099.222.06
2191587-19158797.482100.09
3182661-18266192.94095.49
4189196-18919696.26598.78
5190808-19080897.08699.45
6194238-19423898.831101.51
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSZJ-4057-240226对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.432169402177952183182181352182002178780.26
216.452181122197672189400.54
单位质量响应值RSD%判断
13260.9913309.420.26数据可信
长期12月-供试品溶液-2024042721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%
5min123107-2310711.65415.3623.5311.6515.3623.54
232225-3222516.25316.25
336963-3696318.64318.64
424527-2452712.37012.37
540359-4035920.35520.36
625553-2555312.88812.89
10min1170127-17012785.80574.0422.1085.8774.1222.08
2115126-11512658.06558.16
3182023-18202391.80591.91
4118663-11866359.84959.92
5176375-17637588.95689.07
6118450-11845059.74159.81
15min1183983-18398392.79495.543.1993.3496.043.17
2188855-18885595.25195.66
3196429-19642999.07199.68
4184475-18447593.04293.44
5185504-18550493.56194.17
6197365-19736599.54399.95
20min1183591-18359192.59697.443.4593.6598.473.39
2197317-19731799.519100.46
3196346-19634699.029100.19
4190815-19081596.23997.16
5189006-18900695.32796.45
6202114-202114101.938102.89
30min1181913-18191391.75096.733.9293.3298.303.83
2195487-19548798.596100.09
3191352-19135296.51098.22
4189291-18929195.47196.92
5188509-18850995.07696.73
6204152-204152102.966104.49
45min1184386-18438692.99796.953.1995.0899.063.11
2193637-19363797.66399.71
3192614-19261497.14799.40
4193150-19315097.41799.40
5187358-18735894.49696.68
6202209-202209101.986104.08
极限1181633-18163391.60896.543.5394.2199.193.44
2194548-19454898.122100.71
3188882-18888295.26498.05
4191830-19183096.75199.28
5189587-18958795.62098.33
6202016-202016101.889104.55
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSZJ-4057-240226对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.432149122142022141432141622136562142150.21
216.452151302147802149550.12
单位质量响应值RSD%判断
13038.0413067.170.16数据可信
长期12月-供试品溶液-2024042221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%
5min130780-3078015.8018.9474.5015.808.9474.48
21924-19240.9880.99
37692-76923.9493.95
47805-78054.0074.01
529885-2988515.34115.34
626351-2635113.52713.53
10min191667-9166747.05742.4419.7747.1442.4819.79
268859-6885935.34935.35
359389-5938930.48730.51
4102552-10255252.64552.67
593576-9357648.03748.12
679947-7994741.04141.12
15min1141176-14117672.47285.0610.4672.8285.3410.39
2180230-18023092.52092.72
3160333-16033382.30682.50
4186972-18697295.98196.30
5153035-15303578.56078.91
6172409-17240988.50688.81
20min1194343-19434399.76596.522.53100.5297.272.55
2188434-18843496.73297.45
3179728-17972892.26392.91
4189279-18927997.16698.01
5187144-18714496.07096.86
6189140-18914097.09497.89
30min1193555-19355599.36199.291.42100.67100.591.42
2193918-19391899.547100.80
3193205-19320599.181100.34
4198126-198126101.707103.10
5189923-18992397.49698.82
6191792-19179298.45699.79
45min1191523-19152398.31898.081.46100.1899.921.44
2193314-19331499.237101.04
3189535-18953597.29799.01
4190965-19096598.03199.98
5194391-19439199.790101.65
6186579-18657995.78097.66
极限1193170-19317099.16398.321.08101.57100.711.01
2189791-18979197.42999.79
3194210-19421099.697101.95
4189184-18918497.11799.61
5192611-19261198.876101.29
6190200-19020097.638100.05
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSZJ-4057-240226对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.432151512154692149322145752150452150340.16
216.452165392169162167280.13
单位质量响应值RSD%判断
13087.8913174.950.47数据可信
长期12月-供试品溶液-2024042321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%
5min113841-138417.0636.2053.417.066.2053.43
25946-59463.0343.03
323724-2372412.10612.11
46893-68933.5173.52
59500-95004.8484.85
613040-130406.6546.65
10min193396-9339647.65744.819.5147.7044.859.54
276148-7614838.85638.87
397997-9799750.00550.07
484572-8457243.15543.17
581641-8164141.65941.69
693188-9318847.55147.59
15min1172066-17206687.80089.833.0288.1090.123.01
2181189-18118992.45592.69
3175882-17588289.74790.09
4167885-16788585.66785.93
5177855-17785590.75491.01
6181427-18142792.57792.88
20min1192264-19226498.10797.832.6498.9098.622.62
2195316-19531699.664100.41
3194795-19479599.398100.24
4196042-196042100.034100.77
5182795-18279593.27594.04
6189139-18913996.51297.33
30min1190951-19095197.43798.650.8398.7799.980.83
2192444-19244498.19899.50
3194135-19413599.061100.46
4195126-19512699.567100.86
5192621-19262198.28999.57
6194744-19474499.372100.72
45min1190038-19003896.97198.021.1598.8599.901.14
2194296-19429699.143100.99
3192767-19276798.363100.31
4193414-19341498.693100.54
5188726-18872696.30198.13
6193313-19331398.642100.55
极限1188928-18892896.40497.331.5698.8299.751.52
2191574-19157497.755100.15
3189642-18964296.76999.26
4195519-19551999.768102.16
5186917-18691795.37897.74
6191863-19186397.902100.35
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSZJ-4057-240226对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.432134802145612135482133372132592136370.25
216.452164812169782167300.17
单位质量响应值RSD%判断
13002.8613175.080.94数据可信
长期12月-供试品溶液-2024042421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%
5min131784-3178416.2726.6874.2116.276.6874.22
211193-111935.7305.73
312557-125576.4286.43
47919-79194.0544.05
53988-39882.0422.04
610803-108035.5315.53
10min197220-9722049.77141.8416.6649.8641.8816.69
298142-9814250.24350.27
382529-8252942.25042.29
477245-7724539.54539.57
567330-6733034.46934.48
667958-6795834.79134.82
15min1175870-17587090.03588.434.0290.4088.704.04
2176354-17635490.28390.59
3176739-17673990.48090.75
4178326-17832691.29391.53
5168860-16886086.44686.65
6160277-16027782.05282.28
20min1190552-19055297.55295.663.4298.4296.423.44
2190238-19023897.39198.20
3187334-18733495.90496.68
4192047-19204798.31799.07
5186399-18639995.42596.11
6174569-17456989.36990.05
30min1188909-18890996.71097.212.3098.1298.502.31
2192524-19252498.56199.91
3191691-19169198.13599.44
4192145-19214598.36799.66
5192583-19258398.59199.80
6181452-18145292.89394.07
45min1189289-18928996.90596.502.6598.8598.332.67
2194439-19443999.541101.44
3189735-18973597.13398.98
4189121-18912196.81998.66
5189150-18915096.83498.59
6179231-17923191.75693.45
极限1185225-18522594.82496.771.5497.3199.141.49
2188277-18827796.38798.84
3194184-19418499.411101.80
4188831-18883196.67099.05
5189304-18930496.91399.21
6188373-18837396.43698.64
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