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)1.5
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%
110.458698987356872418759487258872880.26
210.408815888343882500.15
单位质量响应值RSD%判断
8352.928485.581.12数据可信
供试品溶液-2025070921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%
5min193682-9368299.950100.511.7199.95100.511.71
294509-94509100.832100.83
392613-9261398.80998.81
493791-93791100.066100.07
593387-9338799.63599.64
697234-97234103.740103.74
10min195304-95304101.681102.101.28101.85102.271.28
297058-97058103.552103.72
394717-94717101.054101.22
495851-95851102.264102.43
594147-94147100.446100.61
697116-97116103.614103.79
15min194994-94994101.350101.761.60101.69102.101.60
295987-95987102.409102.75
393869-93869100.150100.48
495885-95885102.300102.64
593732-93732100.003100.34
697787-97787104.330104.68
20min193706-9370699.976101.481.62100.48101.981.62
295875-95875102.290102.80
394258-94258100.565101.06
496363-96363102.810103.32
593384-9338499.632100.13
697098-97098103.595104.11
30min194582-94582100.910101.791.62101.58102.471.62
295899-95899102.315103.00
394374-94374100.688101.36
497390-97390103.906104.59
593405-9340599.654100.32
696779-96779103.254103.95
45min195030-95030101.388101.361.48102.23102.211.48
295369-95369101.750102.60
394390-94390100.705101.54
494341-94341100.653101.51
593393-9339399.642100.47
697504-97504104.028104.89
极限193624-9362499.888101.221.48100.90102.231.47
295021-95021101.379102.40
394213-94213100.517101.52
495327-95327101.705102.73
593681-9368199.949100.95
697340-97340103.853104.89
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)1.5
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%
110.458764088032874748826387915878650.36
210.408757386905872390.55
单位质量响应值RSD%判断
8408.138388.370.17数据可信
供试品溶液-G01TD1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%
5min171981-7198176.98480.736.6776.9880.736.67
273034-7303478.11178.11
384044-8404489.88689.89
470323-7032375.21175.21
578347-7834783.79383.79
675193-7519380.42080.42
10min187336-8733693.40793.733.0593.5493.863.05
284329-8432990.19190.32
392149-9214998.55498.70
485996-8599691.97492.10
588771-8877194.94195.08
687253-8725393.31893.45
15min191355-9135597.70597.371.8797.9997.661.88
288102-8810294.22694.51
392886-9288699.34399.66
490248-9024896.52196.80
591320-9132097.66897.97
692322-9232298.73999.03
20min191573-9157397.93897.991.4898.3998.451.48
289305-8930595.51395.95
392251-9225198.66399.14
491884-9188498.27198.71
591324-9132497.67298.13
693418-9341899.911100.37
30min192424-9242498.84898.851.8099.4699.471.79
290183-9018396.45297.05
391896-9189698.28498.93
494629-94629101.207101.81
591393-9139397.74698.37
694038-94038100.575101.20
45min192184-9218498.59298.461.6499.3799.241.64
289408-8940895.62396.38
391640-9164098.01098.82
493316-9331699.802100.57
592177-9217798.58499.37
693661-93661100.171100.96
极限192073-9207398.47398.351.4499.4199.301.43
289882-8988296.13097.05
392157-9215798.56399.53
492459-9245998.88699.82
591310-9131097.65798.61
693873-93873100.398101.35
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)1.5
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%
110.458725887172875098778287519874480.28
210.408742686992872090.36
单位质量响应值RSD%判断
8368.238385.480.15数据可信
供试品溶液-G01TD1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%
5min180452-8045286.26486.266.7386.2686.266.73
283385-8338589.40989.41
371408-7140876.56776.57
477808-7780883.42983.43
582522-8252288.48388.48
687132-8713293.42793.43
10min191047-9104797.62497.653.5797.7797.793.57
292131-9213198.78798.94
385289-8528991.45091.58
490086-9008696.59496.73
593307-93307100.048100.20
694543-94543101.373101.53
15min194039-94039100.83299.481.96101.1499.791.97
292518-9251899.20299.52
389866-8986696.35896.64
491583-9158398.19998.50
594077-94077100.873101.19
694590-94590101.423101.75
20min193979-93979100.76899.771.41101.24100.241.41
291796-9179698.42798.91
391874-9187498.51198.95
491921-9192198.56199.03
594260-94260101.069101.55
694444-94444101.267101.76
30min193789-93789100.564100.130.81101.21100.770.82
293116-9311699.843100.49
393096-9309699.821100.43
492170-9217098.82899.46
593814-93814100.591101.24
694317-94317101.131101.79
45min193568-93568100.327100.511.12101.14101.311.12
292551-9255199.237100.05
393620-93620100.383101.15
492737-9273799.436100.23
594944-94944101.803102.62
694999-94999101.862102.69
极限193465-93465100.217100.111.45101.19101.091.45
291858-9185898.49499.47
393122-9312299.849100.79
491960-9196098.60399.56
594950-94950101.809102.80
694861-94861101.714102.71
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)1.5
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%
110.451741791745241744241740171742431742770.12
210.401754401742441748420.49
单位质量响应值RSD%判断
16677.2216811.730.57数据可信
供试品溶液-2025070922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%
5min1186020-18602099.786100.530.8299.79100.520.82
2189705-189705101.762101.76
3188515-188515101.124101.12
4187301-187301100.473100.47
5187227-187227100.433100.43
6185631-18563199.57799.58
10min1188016-188016100.856102.061.10101.02102.221.10
2192962-192962103.510103.68
3192400-192400103.208103.38
4190676-190676102.283102.45
5188801-188801101.277101.44
6188674-188674101.209101.38
15min1188005-188005100.850102.110.94101.18102.440.94
2191659-191659102.811103.15
3192761-192761103.402103.74
4190584-190584102.234102.57
5190373-190373102.121102.46
6188693-188693101.220101.55
20min1187497-187497100.578101.810.90101.08102.320.91
2192263-192263103.135103.65
3190959-190959102.435102.95
4190156-190156102.004102.51
5189373-189373101.584102.09
6188565-188565101.151101.65
30min1187597-187597100.632101.680.84101.30102.360.84
2191163-191163102.544103.23
3191473-191473102.711103.39
4190112-190112101.981102.66
5188426-188426101.076101.75
6188580-188580101.159101.83
45min1187963-187963100.828101.350.87101.67102.190.87
2191277-191277102.606103.46
3190354-190354102.111102.97
4189238-189238101.512102.36
5187287-187287100.465101.31
6187450-187450100.553101.39
极限1186994-186994100.308101.260.85101.31102.280.85
2191264-191264102.599103.63
3189909-189909101.872102.90
4188885-188885101.323102.34
5188060-188060100.880101.89
6187535-187535100.598101.61
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)1.5
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%
110.451737941745101739951738561746411741590.23
210.401736171738741737460.11
单位质量响应值RSD%判断
16665.9316706.350.18数据可信
供试品溶液-G01T7A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%
5min1160435-16043586.36188.255.8986.3688.255.89
2174403-17440393.88093.88
3164596-16459688.60188.60
4171617-17161792.38092.38
5147132-14713279.20079.20
6165450-16545089.06089.06
10min1181228-18122897.55497.741.9697.7097.891.97
2184602-18460299.37099.53
3182907-18290798.45798.61
4182855-18285598.42998.58
5174665-17466594.02194.15
6183225-18322598.62998.78
15min1181776-18177697.84998.620.9298.1698.930.93
2184672-18467299.40799.73
3184817-18481799.48599.80
4183464-18346498.75799.08
5180594-18059497.21297.50
6183881-18388198.98299.29
20min1181860-18186097.89498.830.5698.3699.300.56
2184060-18406099.07899.57
3184590-18459099.36399.84
4184195-18419599.15199.63
5182932-18293298.47198.92
6183955-18395599.02199.50
30min1182665-18266598.32798.690.5498.9699.330.54
2183880-18388098.98199.63
3185028-18502899.599100.24
4183347-18334798.69499.34
5182558-18255898.26998.88
6182599-18259998.29298.93
45min1182757-18275798.37798.490.3099.1799.300.30
2183001-18300198.50899.33
3183344-18334498.69399.50
4182910-18291098.45999.27
5182133-18213398.04198.82
6183697-18369798.88399.69
极限1181242-18124297.56198.150.4898.5299.110.49
2183071-18307198.54699.53
3183472-18347298.76199.74
4181987-18198797.96298.94
5181597-18159797.75298.69
6182599-18259998.29299.26
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)1.5
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%
110.451754981750291758671757291757751755800.20
210.401742951734771738860.34
单位质量响应值RSD%判断
16801.9116719.810.35数据可信
供试品溶液-G01T7A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%
5min1162342-16234286.99884.966.5587.0084.966.55
2158491-15849184.93484.93
3168364-16836490.22590.23
4139351-13935174.67774.68
5156645-15664583.94583.95
6166016-16601688.96788.97
10min1179591-17959196.24295.043.9796.3995.193.98
2177319-17731995.02495.17
3182407-18240797.75197.90
4163807-16380787.78387.91
5177908-17790895.34095.48
6183113-18311398.12998.28
15min1183537-18353798.35697.232.4898.6697.532.49
2181867-18186797.46297.76
3184791-18479199.02899.34
4173418-17341892.93493.20
5179429-17942996.15596.45
6185548-18554899.43499.75
20min1183849-18384998.52497.411.8498.9997.881.85
2181091-18109197.04697.51
3183890-18389098.54699.02
4176723-17672394.70595.13
5179410-17941096.14596.60
6185709-18570999.520100.00
30min1183448-18344898.30997.771.5498.9498.401.55
2179935-17993596.42697.05
3185008-18500899.14599.79
4181666-18166697.35497.94
5178799-17879995.81796.44
6185846-18584699.594100.24
45min1183930-18393098.56797.741.4399.3698.521.42
2180301-18030196.62297.41
3183161-18316198.15598.96
4182732-18273297.92598.67
5178484-17848495.64996.43
6185682-18568299.506100.32
极限1182834-18283497.98097.861.7798.9498.811.77
2179209-17920996.03796.98
3186929-186929100.174101.15
4181847-18184797.45198.36
5179182-17918296.02396.96
6185632-18563299.479100.45
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