富马酸比索洛尔片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100711-202203对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
110.328503385531851388482884888850840.33
210.398620686172861890.03
单位质量响应值RSD%判断
8244.578295.380.44数据可信
供试品溶液-2025120521批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min189719-8971997.44497.902.2497.4497.902.24
292672-92672100.652100.65
391987-9198799.90899.91
488781-8878196.42696.43
587256-8725694.76994.77
690431-9043198.21898.22
10min191581-9158199.46799.622.6299.6399.782.61
295968-95968104.232104.40
392437-92437100.397100.56
490099-9009997.85798.02
589043-8904396.71096.87
691195-9119599.04899.21
15min191877-9187799.78899.492.58100.1299.812.58
295480-95480103.702104.04
392798-92798100.789101.12
489455-8945597.15897.48
589138-8913896.81397.13
690842-9084298.66498.99
20min192051-9205199.97799.802.57100.47100.302.57
295573-95573103.803104.32
393549-93549101.604102.11
490450-9045098.23898.72
589140-8914096.81697.30
690572-9057298.37198.86
30min191367-9136799.23499.712.3199.90100.372.31
295221-95221103.420104.11
393473-93473101.522102.19
490627-9062798.43199.08
589766-8976697.49698.14
690349-9034998.12998.79
45min189610-8961097.32699.502.8298.15100.332.82
295810-95810104.060104.92
393813-93813101.891102.73
490448-9044898.23699.05
589576-8957697.28998.09
690431-9043198.21899.04
极限191907-9190799.82199.802.37100.81100.802.37
295178-95178103.374104.41
393739-93739101.811102.82
490606-9060698.40899.39
589699-8969997.42398.39
690204-9020497.97198.96
富马酸比索洛尔片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100711-202203对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
110.328573686170857158582785934858760.22
210.398624686493863700.21
单位质量响应值RSD%判断
8321.328312.800.08数据可信
供试品溶液-2025120522批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min187603-8760394.60795.192.6594.6195.192.65
287674-8767494.68394.68
389235-8923596.36996.37
491737-9173799.07199.07
584602-8460291.36691.37
688003-8800395.03995.04
10min189789-8978996.96897.902.0797.1398.062.07
290041-9004197.24097.40
392379-9237999.76599.93
493120-93120100.565100.73
587933-8793394.96395.12
690650-9065097.89798.06
15min189668-8966896.83797.882.1697.1698.202.16
289825-8982597.00697.33
392296-9229699.675100.00
493304-93304100.764101.10
587880-8788094.90695.22
690826-9082698.08798.41
20min189876-8987697.06297.702.3097.5498.182.30
289622-8962296.78797.27
391552-9155298.87299.36
493655-93655101.143101.64
587449-8744994.44094.91
690643-9064397.89098.37
30min190151-9015197.35998.092.0998.0098.742.09
290230-9023097.44498.09
392569-9256999.970100.63
493064-93064100.504101.17
587829-8782994.85195.48
691106-9110698.39099.04
45min190316-9031697.53798.182.3398.3498.992.33
289994-8999497.18997.99
392837-92837100.259101.08
493459-93459100.931101.77
587619-8761994.62495.41
691230-9123098.52499.34
极限190155-9015597.36398.042.1998.3399.012.19
289882-8988297.06898.04
392553-9255399.953100.94
493250-93250100.705101.71
587757-8775794.77395.72
691071-9107198.35299.33
富马酸比索洛尔片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100711-202203对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
110.328601885911859668602385930859700.06
210.398559785505855510.08
单位质量响应值RSD%判断
8330.438233.970.83数据可信
供试品溶液-2025120621批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min190608-9060898.26798.261.1898.2798.261.18
289696-8969697.27897.28
389534-8953497.10297.10
492396-92396100.206100.21
591188-9118898.89698.90
690195-9019597.81997.82
10min193311-93311101.199100.691.35101.36100.851.35
291295-9129599.01299.17
391560-9156099.30099.46
494471-94471102.457102.62
593761-93761101.687101.85
692660-92660100.493100.66
15min193890-93890101.827101.121.18102.16101.451.18
292292-92292100.094100.42
391826-9182699.58899.92
494549-94549102.541102.88
594098-94098102.052102.39
692774-92774100.616100.95
20min193948-93948101.890101.141.11102.39101.641.11
292336-92336100.141100.64
391950-9195099.723100.22
494704-94704102.709103.22
593566-93566101.475101.98
693029-93029100.893101.39
30min193325-93325101.214100.861.24101.89101.531.24
291911-9191199.680100.34
391600-9160099.343100.00
494693-94693102.698103.38
593656-93656101.573102.25
692801-92801100.646101.31
45min193335-93335101.225100.720.91102.07101.560.91
292510-92510100.330101.16
391541-9154199.279100.10
493976-93976101.920102.77
593246-93246101.128101.97
692617-92617100.446101.28
极限194044-94044101.994100.861.09103.00101.861.08
292432-92432100.245101.24
391491-9149199.225100.22
493926-93926101.866102.89
593547-93547101.455102.47
692545-92545100.368101.37
富马酸比索洛尔片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100711-202203对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
110.328570385850858508550885683857190.17
210.398558685323854540.22
单位质量响应值RSD%判断
8306.108224.640.70数据可信
供试品溶液-G02PSP批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min150412-5041254.78460.9313.4254.7860.9313.42
260288-6028865.51765.52
368688-6868874.64574.65
456187-5618761.06061.06
552628-5262857.19257.19
648204-4820452.38552.38
10min170764-7076476.90180.348.3876.9980.448.38
277778-7777884.52484.63
384150-8415091.44891.57
473372-7337279.73579.84
570803-7080376.94477.04
666704-6670472.48972.58
15min181248-8124888.29589.785.1788.5190.025.18
286563-8656394.07194.32
389072-8907296.79797.07
480996-8099688.02188.26
579907-7990786.83787.06
677926-7792684.68484.89
20min186690-8669094.20994.443.0294.5894.823.04
290469-9046998.31598.72
389624-8962497.39797.84
485805-8580593.24793.63
584959-8495992.32792.70
683858-8385891.13191.48
30min190505-9050598.35496.772.6998.8897.322.70
291884-9188499.853100.42
390142-9014297.96098.56
489209-8920996.94697.48
587244-8724494.81195.33
685317-8531792.71693.22
45min190882-9088298.76497.811.2899.4598.511.30
291175-9117599.08399.82
390682-9068298.54799.31
489546-8954697.31298.01
589630-8963097.40498.08
688103-8810395.74496.40
极限190031-9003197.83997.801.0898.6998.671.10
291137-9113799.04199.94
390498-9049898.34799.27
490468-9046898.31499.17
589492-8949297.25498.10
688369-8836996.03396.85
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