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%
110.321700131723571720461717381714911715290.53
210.391713201712341712770.04
单位质量响应值RSD%判断
16621.0316484.790.59数据可信
供试品溶液-2025120221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%
5min1187612-187612101.80499.891.38101.8099.891.38
2183097-18309799.35499.35
3180078-18007897.71697.72
4183920-18392099.80199.80
5184148-18414899.92599.92
6185672-185672100.752100.75
10min1191283-191283103.796101.611.32103.97101.781.33
2185769-185769100.804100.97
3184192-18419299.949100.11
4187345-187345101.660101.83
5186296-186296101.090101.26
6188594-188594102.337102.51
15min1190695-190695103.477101.481.14103.82101.811.14
2186097-186097100.982101.32
3184295-184295100.005100.33
4187301-187301101.636101.97
5186283-186283101.083101.42
6187379-187379101.678102.02
20min1190945-190945103.613101.441.32104.13101.941.32
2186121-186121100.995101.50
3183664-18366499.662100.16
4187443-187443101.713102.22
5185655-185655100.742101.25
6187779-187779101.895102.40
30min1190537-190537103.392101.261.25104.08101.941.25
2185743-185743100.790101.46
3183627-18362799.642100.30
4186747-186747101.335102.01
5185538-185538100.679101.35
6187512-187512101.750102.43
45min1190246-190246103.234101.241.31104.09102.081.30
2185840-185840100.843101.68
3183094-18309499.353100.18
4186563-186563101.235102.08
5185591-185591100.708101.55
6188113-188113102.076102.92
极限1191279-191279103.794101.611.26104.83102.621.27
2187139-187139101.548102.55
3184282-18428299.997100.99
4187129-187129101.542102.55
5185750-185750100.794101.80
6187932-187932101.978103.00
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%
110.321711711714821715621714681713601714090.09
210.391710911706121708520.20
单位质量响应值RSD%判断
16609.4016443.890.71数据可信
供试品溶液-2025120321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%
5min1184763-184763100.41999.640.93100.4299.640.93
2184956-184956100.524100.52
3184491-184491100.271100.27
4180776-18077698.25298.25
5182002-18200298.91898.92
6183035-18303599.47999.48
10min1189895-189895103.208102.150.92103.38102.320.92
2189395-189395102.936103.10
3188205-188205102.289102.46
4185048-185048100.574100.74
5187310-187310101.803101.97
6187847-187847102.095102.26
15min1190662-190662103.625102.301.00103.96102.631.00
2188874-188874102.653102.99
3188422-188422102.407102.74
4185009-185009100.552100.88
5187509-187509101.911102.25
6188835-188835102.632102.97
20min1191237-191237103.937102.451.10104.45102.961.09
2189141-189141102.798103.31
3188692-188692102.554103.06
4184889-184889100.487100.99
5188198-188198102.286102.79
6188838-188838102.633103.14
30min1190183-190183103.364102.150.98104.05102.820.98
2188559-188559102.482103.16
3188110-188110102.238102.92
4184754-184754100.414101.08
5187225-187225101.757102.43
6188836-188836102.632103.31
45min1190424-190424103.495102.180.94104.35103.030.94
2188416-188416102.404103.26
3188309-188309102.346103.20
4185045-185045100.572101.41
5187412-187412101.858102.70
6188405-188405102.398103.25
极限1189550-189550103.020102.090.84104.05103.100.84
2188941-188941102.689103.71
3188886-188886102.659103.68
4185379-185379100.753101.75
5187175-187175101.730102.74
6187076-187076101.676102.70
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%
110.321719451711621709971712571713431713410.22
210.391703031701601702320.06
单位质量响应值RSD%判断
16602.8116384.220.94数据可信
供试品溶液-2025120421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%
5min1180394-18039498.24399.031.5798.2499.021.57
2179366-17936697.68397.68
3186935-186935101.805101.81
4183339-18333999.84799.85
5180820-18082098.47598.47
6180138-18013898.10398.10
10min1185207-185207100.864100.771.45101.03100.941.45
2182138-18213899.19399.36
3189344-189344103.117103.29
4186809-186809101.736101.90
5183390-18339099.874100.04
6183312-18331299.832100.00
15min1185981-185981101.286100.991.51101.62101.321.51
2181956-18195699.09499.42
3189957-189957103.451103.79
4186774-186774101.717102.05
5183865-183865100.133100.46
6184139-184139100.282100.61
20min1185349-185349100.941100.661.31101.44101.161.31
2182404-18240499.33899.83
3189228-189228103.054103.57
4184983-184983100.742101.25
5183241-18324199.793100.29
6183808-183808100.102100.60
30min1185480-185480101.013100.651.52101.68101.321.52
2181194-18119498.67999.34
3189370-189370103.131103.82
4185913-185913101.249101.92
5183140-18314099.738100.40
6183754-183754100.073100.74
45min1184955-184955100.727100.381.36101.56101.221.36
2181776-18177698.99699.82
3188607-188607102.716103.57
4185045-185045100.776101.62
5182130-18213099.188100.02
6183414-18341499.888100.72
极限1185610-185610101.084100.961.68102.09101.971.68
2183426-18342699.894100.88
3190670-190670103.839104.87
4187014-187014101.848102.86
5182416-18241699.344100.34
6183199-18319999.770100.77
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%
110.321705611710411703751705901704821706100.15
210.391709461709621709540.01
单位质量响应值RSD%判断
16531.9816453.710.34数据可信
供试品溶液-G01T79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%
5min1164341-16434189.50182.037.9389.5082.037.93
2162351-16235188.41788.42
3144747-14474778.83078.83
4143153-14315377.96277.96
5133999-13399972.97672.98
6155102-15510284.46984.47
10min1177665-17766596.75794.233.5796.9194.373.58
2176319-17631996.02496.17
3171853-17185393.59293.72
4170901-17090193.07393.20
5162311-16231188.39588.52
6179153-17915397.56797.71
15min1178222-17822297.06096.932.0197.3797.222.02
2178378-17837897.14597.45
3178905-17890597.43297.72
4177494-17749496.66496.95
5171886-17188693.61093.88
6183016-18301699.67199.97
20min1179115-17911597.54797.551.7898.0298.011.79
2178037-17803796.95997.43
3181246-18124698.70799.16
4178488-17848897.20597.65
5174208-17420894.87495.30
6183654-183654100.019100.49
30min1179053-17905397.51397.801.5998.1598.421.59
2177982-17798296.93097.56
3182383-18238399.32699.94
4178594-17859497.26397.87
5175943-17594395.81996.40
6183539-18353999.956100.59
45min1178846-17884697.40097.491.5398.2098.271.54
2177723-17772396.78897.58
3181080-18108098.61799.40
4178682-17868297.31198.08
5174937-17493795.27196.01
6182821-18282199.565100.37
极限1178309-17830997.10897.231.5898.0798.181.58
2176472-17647296.10797.06
3181113-18111398.63599.58
4177824-17782496.84397.78
5175013-17501395.31396.21
6182479-18247999.379100.35
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