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%
115.792093132093822093522095012094322093960.04
215.682100542099992100260.02
单位质量响应值RSD%判断
13261.3013394.520.71数据可信
供试品溶液-2024042521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%
5min138089-3808919.14920.3230.3119.1520.3230.31
232264-3226416.22116.22
327363-2736313.75713.76
445991-4599123.12223.12
536831-3683118.51718.52
661952-6195231.14731.15
10min1133205-13320566.96971.5210.0867.0871.6310.05
2170705-17070585.82385.91
3140934-14093470.85570.93
4139385-13938570.07670.20
5132451-13245166.59066.69
6136833-13683368.79368.97
15min1192855-19285596.95998.722.4597.4499.242.46
2200879-200879100.993101.56
3189939-18993995.49395.96
4195324-19532498.20098.72
5202740-202740101.928102.40
6196464-19646498.77399.33
20min1198748-19874899.921100.451.09100.94101.511.11
2201092-201092101.100102.23
3196132-19613298.60699.61
4200758-200758100.932102.00
5202349-202349101.732102.77
6199742-199742100.421101.53
30min1199907-199907100.504100.631.38102.08102.241.37
2201817-201817101.464103.15
3196644-19664498.864100.41
4199008-199008100.052101.68
5204597-204597102.862104.47
6198945-198945100.021101.68
45min1200301-200301100.702100.111.03102.83102.281.01
2200016-200016100.559102.81
3197063-19706399.074101.17
4199456-199456100.277102.46
5201598-201598101.354103.53
6196292-19629298.687100.90
极限1199006-199006100.05199.331.08102.74102.061.08
2199411-199411100.255103.07
3194686-19468697.879100.53
4196187-19618798.634101.37
5199838-199838100.469103.21
6196249-19624998.665101.43
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%
115.792092542088522091812091182093052091420.09
215.682083852085102084480.05
单位质量响应值RSD%判断
13245.2213293.880.26数据可信
供试品溶液-2024042521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%
5min155779-5577928.16626.7114.8228.1726.7114.82
254086-5408627.31127.31
353846-5384627.19027.19
454272-5427227.40527.40
561434-6143431.02131.02
638005-3800519.19119.19
10min1162830-16283082.22274.2613.1982.3874.4113.17
2131404-13140466.35366.50
3130744-13074466.02066.17
4175738-17573888.74088.89
5151273-15127376.38676.56
6130376-13037665.83465.94
15min1203366-203366102.69199.791.84103.30100.351.87
2198421-198421100.194100.71
3195489-19548998.71399.23
4195759-19575998.84999.49
5199563-199563100.770101.37
6193129-19312997.52197.99
20min1199747-199747100.86399.792.27102.05100.912.24
2203558-203558102.788103.86
3199722-199722100.851101.92
4192245-19224597.07598.27
5198045-198045100.004101.16
6192422-19242297.16498.18
30min1200367-200367101.17699.371.90102.92101.041.89
2198041-198041100.002101.65
3201122-201122101.558103.18
4193163-19316397.53999.27
5196006-19600698.974100.69
6192007-19200796.95598.51
45min1199750-199750100.86599.412.14103.17101.642.12
2200175-200175101.079103.28
3199693-199693100.836103.03
4191851-19185196.87699.15
5198648-198648100.308102.57
6191138-19113896.51698.61
极限1196781-19678199.36698.421.75102.23101.191.72
2197618-19761899.788102.55
3198816-198816100.393103.14
4189999-18999995.94198.75
5193956-19395697.939100.76
6192279-19227997.09299.72
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%
115.792094212098332097152098442097962097220.09
215.682112712115002113860.08
单位质量响应值RSD%判断
13281.9513481.251.06数据可信
供试品溶液-2024042621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%
5min128271-2827114.15719.5717.2014.1619.5717.19
238879-3887919.46919.47
347069-4706923.57023.57
434863-3486317.45817.46
543360-4336021.71321.71
642074-4207421.06921.07
10min1127863-12786364.02867.878.6264.1167.988.62
2136157-13615768.18168.29
3156613-15661378.42478.56
4139168-13916869.68969.79
5128730-12873064.46264.58
6124676-12467662.43262.55
15min1199771-199771100.03697.432.62100.4797.922.61
2190321-19032195.30495.79
3197839-19783999.06899.64
4198737-19873799.518100.00
5193584-19358496.93897.42
6187136-18713693.70994.17
20min1199830-199830100.06599.241.94101.06100.271.94
2192631-19263196.46097.48
3200285-200285100.293101.41
4201651-201651100.977102.01
5200668-200668100.485101.50
6194038-19403897.16598.15
30min1204227-204227102.267100.101.34103.81101.681.30
2196584-19658498.44099.99
3198255-19825599.277100.95
4199745-199745100.023101.62
5199135-19913599.717101.29
6201500-201500100.902102.43
45min1204153-204153102.23099.591.75104.34101.721.72
2194322-19432297.30799.41
3198653-19865399.476101.70
4199052-19905299.676101.83
5200947-200947100.625102.75
6196148-19614898.222100.31
极限1204834-204834102.57199.882.11105.25102.572.06
2192561-19256196.42599.07
3198570-19857099.434102.21
4201300-201300100.802103.51
5197829-19782999.063101.75
6201677-201677100.990103.62
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%
115.792099532103142100982099422098582100330.09
215.682089572086452088010.11
单位质量响应值RSD%判断
13301.6513316.390.08数据可信
供试品溶液-2024042621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%
5min129622-2962214.91316.6661.1214.9116.6661.12
28297-82974.1774.18
350922-5092225.63725.64
425185-2518512.68012.68
521432-2143210.79010.79
663138-6313831.78731.79
10min1131298-13129866.10365.4216.5466.1965.5216.59
288387-8838744.49944.52
3148759-14875974.89475.04
4138700-13870069.82969.90
5130397-13039765.64965.71
6142141-14214171.56271.74
15min1194897-19489798.12297.342.3098.5797.802.34
2186497-18649793.89394.16
3193735-19373597.53798.10
4199979-199979100.681101.14
5193769-19376997.55497.98
6191176-19117696.24996.82
20min1202945-202945102.17499.362.00103.17100.361.96
2198771-198771100.072100.86
3197641-19764199.504100.60
4198897-198897100.136101.15
5191768-19176896.54797.51
6194134-19413497.73898.85
30min1196231-19623198.79498.141.07100.3699.691.05
2193593-19359397.46698.81
3192117-19211796.72298.38
4197611-19761199.488101.06
5196247-19624798.802100.30
6193774-19377497.55799.21
45min1193810-19381097.57598.431.9099.69100.521.89
2191601-19160196.46398.35
3193087-19308797.21199.40
4201319-201319101.355103.48
5198705-198705100.039102.09
6194535-19453597.940100.13
极限1193695-19369597.51798.271.91100.17100.921.83
2195878-19587898.616101.04
3193471-19347197.404100.13
4200277-200277100.831103.52
5198094-19809499.732102.34
6189784-18978495.54898.29
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%
115.792075292082752085772086822088882083900.26
215.682100392103652102020.11
单位质量响应值RSD%判断
13197.5913405.741.11数据可信
供试品溶液-2024042721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%
5min144026-4402622.17914.0371.3722.1814.0371.37
211252-112525.6685.67
315284-152847.7007.70
438405-3840519.34719.35
553225-5322526.81326.81
64931-49312.4842.48
10min1133078-13307867.04071.3017.8067.1671.3817.79
297282-9728249.00749.04
3165113-16511383.17883.22
4137585-13758569.31069.42
5161336-16133681.27581.42
6154856-15485678.01178.02
15min1193942-19394297.70196.512.5398.2096.982.59
2185690-18569093.54493.85
3186786-18678694.09694.60
4196181-19618198.82999.32
5197023-19702399.25399.85
6189853-18985395.64196.09
20min1197507-19750799.49798.592.01100.5499.612.04
2192854-19285497.15397.98
3190939-19093996.18897.22
4201853-201853101.686102.73
5197172-19717299.328100.48
6193959-19395997.71098.69
30min1197278-19727899.38298.731.31100.97100.281.30
2196103-19610398.790100.15
3192620-19262097.03598.60
4200120-200120100.813102.42
5194649-19464998.05799.76
6195097-19509798.28399.80
45min1196292-19629298.88598.791.70101.03100.901.62
2198433-19843399.964101.88
3192704-19270497.07799.18
4200863-200863101.188103.35
5192193-19219396.82099.07
6196131-19613198.804100.87
极限1196325-19632598.90298.731.05101.59101.380.99
2198338-19833899.916102.38
3192711-19271197.08199.72
4197716-19771699.602102.33
5194659-19465998.062100.85
6196175-19617598.826101.44
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%
115.792110702115192112332112522117992113750.14
215.682085942087912086920.07
单位质量响应值RSD%判断
13386.6413309.440.41数据可信
供试品溶液-2024042721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%
5min113790-137906.92212.6627.056.9212.6627.05
233705-3370516.92016.92
327378-2737813.74313.74
427905-2790514.00814.01
527167-2716713.63813.64
621426-2142610.75610.76
10min1134733-13473367.63476.405.9867.6776.475.99
2151924-15192476.26476.36
3158660-15866079.64579.72
4158645-15864579.63879.72
5157193-15719378.90978.98
6151992-15199276.29876.36
15min1177709-17770989.20894.323.0889.6294.823.10
2184212-18421292.47292.99
3191936-19193696.35096.87
4191268-19126896.01496.53
5190248-19024895.50296.02
6191991-19199196.37796.86
20min1189535-18953595.14495.953.1496.0596.973.11
2184363-18436392.54893.58
3187764-18776494.25595.31
4192003-19200396.38397.44
5191118-19111895.93996.98
6202060-202060101.432102.45
30min1194098-19409897.43596.931.4498.8798.481.40
2193740-19374097.25598.80
3190545-19054595.65197.23
4190489-19048995.62397.21
5191921-19192196.34297.92
6197803-19780399.295100.88
45min1188534-18853494.64295.741.6896.6297.831.68
2188607-18860794.67896.76
3187783-18778394.26596.37
4195254-19525498.015100.14
5189981-18998195.36897.48
6194227-19422797.50099.63
极限1192736-19273696.75196.893.1899.2699.513.10
2190430-19043095.59498.21
3195771-19577198.275100.91
4189159-18915994.95697.62
5186304-18630493.52296.17
6203645-203645102.227104.90
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