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2000
标示量(mg)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%
19.981660671662031662311661151661311661490.05
210.041665911668781667340.13
单位质量响应值RSD%判断
16648.2016606.970.18数据可信
供试品溶液-25012001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%
5min1188756-188756101.964100.851.22101.96100.851.22
2188041-188041101.577101.58
3189360-189360102.290102.29
4184825-18482599.84099.84
5184626-18462699.73399.73
6184523-18452399.67799.68
10min1188300-188300101.717100.391.32101.89100.561.32
2187470-187470101.269101.44
3188366-188366101.753101.92
4183231-18323198.97999.15
5183686-18368699.22599.39
6184022-18402299.40699.57
15min1187512-187512101.292100.231.30101.63100.571.30
2187698-187698101.392101.73
3187931-187931101.518101.86
4182844-18284498.77099.10
5183322-18332299.02899.36
6184009-18400999.39999.73
20min1187453-187453101.260100.041.28101.77100.541.28
2186729-186729100.869101.38
3187747-187747101.419101.93
4182581-18258198.62899.12
5183012-18301298.86199.36
6183661-18366199.21199.71
30min1187321-187321101.18899.801.32101.87100.471.32
2186155-186155100.559101.23
3187283-187283101.168101.85
4182084-18208498.36099.02
5182672-18267298.67799.34
6183022-18302298.86699.53
45min1186696-186696100.85199.751.25101.70100.581.25
2186174-186174100.569101.41
3187255-187255101.153102.00
4182183-18218398.41399.24
5182487-18248798.57799.40
6183115-18311598.91699.74
极限1186935-186935100.98099.711.43101.99100.711.43
2186334-186334100.655101.67
3187566-187566101.321102.34
4181869-18186998.24399.23
5182071-18207198.35299.34
6182719-18271998.70399.69
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2000
标示量(mg)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%
19.981652161654381654121654461651751653370.08
210.041659381660111659740.04
单位质量响应值RSD%判断
16566.8316531.270.16数据可信
供试品溶液-25012002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%
5min1188386-188386102.247102.311.22102.25102.311.22
2188816-188816102.480102.48
3187241-187241101.625101.63
4192141-192141104.285104.28
5185202-185202100.519100.52
6189263-189263102.723102.72
10min1188103-188103102.093102.331.50102.26102.501.50
2188415-188415102.262102.43
3186938-186938101.461101.63
4193175-193175104.846105.02
5184782-184782100.291100.46
6189797-189797103.012103.18
15min1187942-187942102.006102.041.41102.35102.381.41
2187948-187948102.009102.35
3186429-186429101.184101.52
4192424-192424104.438104.79
5184502-184502100.139100.47
6188788-188788102.465102.81
20min1187358-187358101.689101.811.41102.20102.321.41
2187854-187854101.958102.47
3185837-185837100.863101.37
4192124-192124104.275104.80
5184310-184310100.034100.54
6188017-188017102.046102.56
30min1186551-186551101.251101.501.48101.93102.181.48
2186968-186968101.477102.16
3185777-185777100.831101.51
4191928-191928104.169104.87
5183514-18351499.602100.27
6187292-187292101.653102.34
45min1186181-186181101.050101.371.46101.90102.221.46
2186655-186655101.307102.16
3185110-185110100.469101.31
4191542-191542103.960104.83
5183542-18354299.618100.45
6187556-187556101.796102.65
极限1186176-186176101.047101.251.36102.06102.271.36
2186717-186717101.341102.36
3185103-185103100.465101.48
4190955-190955103.641104.68
5183366-18336699.522100.52
6186969-186969101.478102.50
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2000
标示量(mg)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%
19.988344183424834718349683491834650.04
210.048345583626835400.15
单位质量响应值RSD%判断
8363.238320.720.37数据可信
供试品溶液-25012003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%
5min194270-94270101.50397.662.86101.5097.662.86
290005-9000596.91196.91
386876-8687693.54293.54
491243-9124398.24498.24
592536-9253699.63699.64
689297-8929796.14996.15
10min194790-94790102.06399.601.83102.2399.761.83
291714-9171498.75198.91
391596-9159698.62498.78
491871-9187198.92099.08
594406-94406101.650101.82
690621-9062197.57497.73
15min194839-94839102.11699.691.79102.46100.021.79
291720-9172098.75899.08
391847-9184798.89499.21
491860-9186098.90899.24
594461-94461101.709102.04
690769-9076997.73498.06
20min194753-94753102.02399.411.86102.5399.911.86
291423-9142398.43898.93
391607-9160798.63699.12
491566-9156698.59299.09
594166-94166101.391101.90
690446-9044697.38697.87
30min194441-94441101.68899.221.74102.3799.881.74
291279-9127998.28398.94
391310-9131098.31698.97
491481-9148198.50099.16
593869-93869101.072101.75
690512-9051297.45798.11
45min194453-94453101.70099.081.83102.5599.911.83
291210-9121098.20999.03
391184-9118498.18198.99
491257-9125798.25999.08
593783-93783100.979101.82
690232-9023297.15697.97
极限194139-94139101.36298.831.85102.3899.821.85
290905-9090597.88098.86
390985-9098597.96698.94
490815-9081597.78398.77
593726-93726100.918101.93
690148-9014897.06598.04
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2000
标示量(mg)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%
19.988313182993831058322183095831090.10
210.048277282786827790.02
单位质量响应值RSD%判断
8327.568244.920.71数据可信
供试品溶液-25012004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%
5min195672-95672103.708100.252.98103.71100.252.99
290129-9012997.69997.70
393450-93450101.299101.30
490705-9070598.32498.32
589450-8945096.96396.96
695473-95473103.492103.49
10min196102-96102104.174101.002.85104.35101.162.85
290839-9083998.46998.63
394240-94240102.155102.32
490534-9053498.13898.30
591159-9115998.81698.98
696162-96162104.239104.41
15min195888-95888103.942100.842.82104.29101.182.82
290674-9067498.29098.62
394086-94086101.989102.33
490461-9046198.05998.39
591049-9104998.69699.02
696005-96005104.069104.41
20min195614-95614103.645100.672.80104.16101.182.80
290550-9055098.15698.65
393931-93931101.821102.33
490320-9032097.90698.40
590886-9088698.52099.01
695921-95921103.978104.50
30min196032-96032104.098100.702.95104.79101.382.95
290633-9063398.24698.90
393765-93765101.641102.32
490285-9028597.86898.52
590660-9066098.27598.93
696036-96036104.102104.80
45min195243-95243103.243100.192.82104.11101.032.82
290339-9033997.92798.74
393535-93535101.391102.24
489869-8986997.41798.23
590187-9018797.76298.58
695392-95392103.404104.27
极限195083-95083103.069100.062.77104.11101.072.77
289861-8986197.40998.39
393155-93155100.979102.00
489698-8969897.23298.21
590758-9075898.38199.36
695285-95285103.288104.33
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