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%
116.252074522072582068732072152071102071820.11
216.292087962088332088140.02
单位质量响应值RSD%判断
12749.6612818.540.39数据可信
供试品溶液-2024042421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%
5min160050-6005031.47427.589.4231.4727.589.42
246791-4679124.52524.52
352485-5248527.50927.51
450752-5075226.60126.60
548956-4895625.65925.66
656692-5669229.71429.71
10min1155832-15583281.67678.554.2081.8578.704.21
2139313-13931373.01873.15
3153754-15375480.58780.74
4147238-14723877.17277.32
5148154-14815477.65277.79
6154944-15494481.21181.38
15min1193228-193228101.277102.011.13101.91102.601.11
2193638-193638101.492102.03
3194764-194764102.082102.68
4194865-194865102.135102.71
5198708-198708104.149104.72
6192596-192596100.946101.56
20min1196448-196448102.965101.492.02104.16102.652.01
2190284-19028499.734100.84
3194961-194961102.185103.35
4191911-191911100.587101.73
5199214-199214104.414105.57
6189041-18904199.082100.26
30min1195040-195040102.227101.931.10103.99103.651.10
2191288-191288100.260101.92
3193384-193384101.359103.09
4194182-194182101.777103.48
5197673-197673103.607105.34
6195247-195247102.335104.06
45min1191285-191285100.25898.891.30102.59101.181.27
2189738-18973899.448101.66
3189727-18972799.442101.74
4188342-18834298.716100.98
5188830-18883098.972101.28
6184118-18411896.50298.80
极限1190459-19045999.82699.761.64102.71102.591.59
2190378-19037899.783102.55
3184552-18455296.73099.58
4190898-190898100.056102.87
5191869-191869100.565103.42
6193849-193849101.602104.43
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%
116.252089272087002094462089032086952089340.15
216.292089962092662091310.10
单位质量响应值RSD%判断
12857.4812838.000.11数据可信
供试品溶液-29003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%
5min143981-4398122.93726.1316.9522.9426.1316.94
238292-3829219.97019.97
354642-5464228.49828.50
446733-4673324.37324.37
560787-6078731.70231.70
656198-5619829.30929.31
10min1129058-12905867.30870.207.3367.4470.347.34
2125744-12574465.57965.69
3142929-14292974.54274.70
4123896-12389664.61664.75
5148085-14808577.23177.41
6137853-13785371.89572.06
15min1184549-18454996.24897.083.2996.7597.613.31
2183519-18351995.71196.19
3195523-195523101.971102.54
4177643-17764392.64693.14
5190224-19022499.20899.81
6185370-18537096.67697.24
20min1184919-18491996.44196.392.1697.4897.462.13
2190604-19060499.406100.41
3184882-18488296.42297.56
4180977-18097794.38595.39
5187563-18756397.82098.98
6179998-17999893.87594.97
30min1174346-17434690.92797.123.4292.5098.733.39
2189760-18976098.966100.53
3191908-191908100.086101.76
4188248-18824898.17799.71
5188988-18898898.563100.26
6184046-18404695.98697.61
45min1185727-18572796.86396.703.1798.9498.853.11
2189773-18977398.973101.08
3191561-19156199.905102.14
4185257-18525796.61798.70
5185535-18553596.76299.01
6174672-17467291.09793.25
极限1183074-18307495.47995.483.3298.0998.173.28
2177557-17755792.60295.26
3192526-192526100.408103.19
4183114-18311495.50098.12
5186426-18642697.227100.01
6175801-17580191.68694.35
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%
116.252098452098092099772088572090322095040.25
216.292077392069902073640.26
单位质量响应值RSD%判断
12892.5512729.530.90数据可信
供试品溶液-2024042421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%
5min11775-17750.9287.6946.870.937.6946.87
222196-2219611.61011.61
313941-139417.2927.29
416898-168988.8388.84
517267-172679.0319.03
616107-161078.4258.42
10min173474-7347438.43043.2211.3738.4443.2611.37
278960-7896041.30041.36
398556-9855651.54951.59
484803-8480344.35644.41
585964-8596444.96345.01
674024-7402438.71838.76
15min1109921-10992157.49459.174.3057.7159.464.32
2117928-11792861.68261.98
3117530-11753061.47461.80
4114381-11438159.82760.12
5113836-11383659.54259.84
6105181-10518155.01555.28
20min1120014-12001462.77362.265.2663.3162.875.21
2123457-12345764.57465.21
3110476-11047657.78458.45
4126515-12651566.17366.80
5121137-12113763.36063.99
6112611-11261158.90159.47
30min1125263-12526365.51865.374.2666.4166.324.25
2124152-12415264.93765.93
3131133-13113368.58969.58
4126386-12638666.10667.10
5127598-12759866.74067.72
6115304-11530460.30961.20
45min1129052-12905267.50067.002.5668.7568.322.58
2128837-12883767.38868.74
3131343-13134368.69970.07
4129723-12972367.85169.21
5127745-12774566.81768.17
6121863-12186363.74064.97
极限1135097-13509770.66269.492.8272.2971.192.82
2133495-13349569.82471.55
3136513-13651371.40373.15
4134857-13485770.53672.28
5130970-13097068.50370.23
6126248-12624866.03467.62
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%
116.252100042104552107762099832100482102530.17
216.292098232094702096460.12
单位质量响应值RSD%判断
12938.6512869.610.38数据可信
供试品溶液-29003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%
5min120553-2055310.67212.5116.4310.6712.5116.44
228302-2830214.69614.70
328590-2859014.84614.85
419889-1988910.32710.33
521411-2141111.11811.12
625819-2581913.40713.41
10min174387-7438738.62639.356.7938.6939.426.80
281830-8183042.49142.57
378629-7862940.82940.91
468053-6805335.33735.39
572291-7229137.53837.60
679448-7944841.25441.33
15min1112719-11271958.53058.143.2158.8058.423.22
2114823-11482359.62359.94
3117188-11718860.85161.16
4107835-10783555.99456.25
5109718-10971856.97257.24
6109472-10947256.84457.15
20min1124074-12407464.42665.423.2965.0366.033.28
2124619-12461964.70965.36
3127313-12731366.10866.76
4121445-12144563.06163.63
5124926-12492664.86965.46
6133512-13351269.32769.95
30min1126734-12673465.80766.532.0766.7667.502.06
2125303-12530365.06466.07
3129319-12931967.15068.16
4125409-12540965.11966.03
5130829-13082967.93468.88
6131136-13113668.09369.10
45min1129355-12935567.16866.563.1668.4967.903.12
2125009-12500964.91266.28
3126750-12675065.81667.20
4122778-12277863.75365.03
5132884-13288469.00170.33
6132324-13232468.71070.09
极限1131526-13152668.29668.112.5169.9969.822.48
2126306-12630665.58567.32
3131507-13150768.28670.04
4128668-12866866.81268.44
5133593-13359369.36971.08
6135390-13539070.30272.07
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