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%
110.131699291696931689391692571679851691610.45
210.111675471676991676230.07
单位质量响应值RSD%判断
16699.0116579.920.51数据可信
供试品溶液-2025120221批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1183885-18388599.26399.971.5099.2699.961.50
2188416-188416101.708101.71
3182833-18283398.69598.69
4181688-18168898.07798.08
5187712-187712101.328101.33
6186592-186592100.724100.72
10min1184965-18496599.846100.581.47100.01100.741.46
2189610-189610102.353102.52
3183843-18384399.24099.40
4183037-18303798.80598.97
5188503-188503101.755101.92
6187964-187964101.464101.63
15min1184464-18446499.575100.401.4999.91100.741.49
2188996-188996102.022102.36
3183587-18358799.10299.43
4182630-18263098.58598.91
5188484-188484101.745102.08
6187805-187805101.379101.72
20min1183782-18378299.207100.331.9099.70100.831.90
2191274-191274103.251103.76
3182892-18289298.72799.22
4182136-18213698.31898.81
5187783-187783101.367101.87
6187322-187322101.118101.62
30min1183426-18342699.01599.821.4599.68100.491.45
2188014-188014101.491102.17
3182457-18245798.49299.15
4181844-18184498.16198.82
5187413-187413101.167101.84
6186366-186366100.602101.28
45min1182317-18231798.41699.211.4799.24100.041.47
2186807-186807100.840101.69
3181321-18132197.87998.70
4180624-18062497.50298.32
5186284-186284100.558101.40
6185339-185339100.047100.89
极限1180934-18093497.67098.651.4698.6699.651.46
2186149-186149100.485101.50
3180713-18071397.55098.54
4179621-17962196.96197.94
5184954-18495499.840100.85
6184136-18413699.398100.41
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%
110.131677511675851674561671991671111674200.16
210.111666691666331666510.02
单位质量响应值RSD%判断
16527.1516483.780.19数据可信
供试品溶液-2025120221批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1183919-183919100.08699.790.80100.0999.790.80
2185453-185453100.921100.92
3183898-183898100.074100.07
4183288-18328899.74299.74
5182590-18259099.36399.36
6181123-18112398.56498.56
10min1185203-185203100.785100.710.61100.95100.880.61
2186446-186446101.461101.63
3186059-186059101.250101.42
4184670-184670100.495100.66
5184759-184759100.543100.71
6183288-18328899.74299.91
15min1184830-184830100.582100.510.73100.92100.840.73
2186374-186374101.422101.76
3185927-185927101.179101.51
4184169-184169100.222100.56
5184163-184163100.219100.55
6182689-18268999.41799.75
20min1183989-183989100.124100.100.70100.63100.600.70
2185569-185569100.984101.49
3185354-185354100.867101.37
4183205-18320599.697100.20
5183081-18308199.630100.13
6182447-18244799.28599.78
30min1183335-18333599.76899.760.77100.44100.420.77
2185243-185243100.806101.48
3184564-184564100.437101.11
4182755-18275599.452100.12
5182600-18260099.368100.03
6181385-18138598.70799.37
45min1182331-18233199.22299.270.73100.06100.110.73
2183723-18372399.979100.82
3183445-18344599.828100.67
4183227-18322799.709100.54
5181551-18155198.79799.63
6180288-18028898.11098.94
极限1181452-18145298.74398.640.6299.7499.640.62
2182599-18259999.368100.38
3182392-18239299.255100.26
4180537-18053798.24599.24
5180880-18088098.43299.43
6179690-17969097.78498.77
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)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%
110.131663701663861666131666461667271665480.10
210.111649851649981649920.01
单位质量响应值RSD%判断
16441.0716319.680.53数据可信
供试品溶液-2025120321批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1185209-185209101.559100.131.43101.56100.131.43
2181593-18159399.57699.58
3180362-18036298.90198.90
4186422-186422102.224102.22
5181949-18194999.77199.77
6180126-18012698.77198.77
10min1186113-186113102.054101.221.65102.22101.381.65
2183378-183378100.555100.72
3182370-182370100.002100.17
4190042-190042104.209104.38
5183698-183698100.730100.90
6181920-18192099.75599.92
15min1185697-185697101.826100.951.54102.17101.281.54
2183068-183068100.385100.72
3182237-18223799.929100.26
4189095-189095103.690104.03
5182904-182904100.295100.63
6181571-18157199.56499.89
20min1184997-184997101.442100.621.46101.95101.121.46
2182590-182590100.123100.62
3181490-18149099.519100.02
4188225-188225103.213103.73
5182437-182437100.039100.54
6181236-18123699.38099.88
30min1184556-184556101.201100.901.76101.88101.571.75
2182566-182566100.109100.78
3181012-18101299.25799.92
4187759-187759102.957103.65
5187694-187694102.921103.59
6180420-18042098.93399.60
45min1183495-183495100.61999.681.54101.47100.521.54
2181162-18116299.340100.17
3180010-18001098.70899.54
4186577-186577102.309103.17
5180294-18029498.86499.70
6179106-17910698.21299.04
极限1182478-182478100.06198.991.47101.0899.991.47
2180075-18007598.74499.74
3178173-17817397.70198.69
4184782-184782101.325102.36
5179593-17959398.47999.48
6178018-17801897.61698.61
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%
110.131659031653921654621654541653661655150.14
210.111654951658601656780.16
单位质量响应值RSD%判断
16339.0916387.540.21数据可信
供试品溶液-2025120321批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1179034-17903498.274101.281.5098.27101.271.50
2186030-186030102.114102.11
3184938-184938101.515101.51
4186553-186553102.401102.40
5185564-185564101.858101.86
6184894-184894101.491101.49
10min1179952-17995298.778101.961.5998.94102.131.59
2187429-187429102.882103.05
3187408-187408102.871103.04
4187803-187803103.087103.26
5186176-186176102.194102.36
6185775-185775101.974102.14
15min1179690-17969098.634101.781.5998.96102.121.59
2187170-187170102.740103.08
3186608-186608102.431102.77
4187710-187710103.036103.38
5186255-186255102.238102.58
6185125-185125101.617101.96
20min1179528-17952898.545101.511.5099.04102.021.50
2186606-186606102.430102.94
3186042-186042102.121102.63
4186911-186911102.598103.11
5185900-185900102.043102.55
6184604-184604101.331101.84
30min1178411-17841197.932101.411.7798.59102.081.76
2187786-187786103.078103.76
3185589-185589101.872102.55
4186279-186279102.251102.94
5185005-185005101.551102.23
6185398-185398101.767102.44
45min1177573-17757397.472100.551.5798.29101.401.57
2185180-185180101.648102.50
3184395-184395101.217102.07
4185047-185047101.575102.43
5182892-182892100.392101.24
6184000-184000101.000101.85
极限1176718-17671897.003100.021.5097.99101.041.50
2183521-183521100.737101.76
3183008-183008100.455101.48
4184086-184086101.047102.07
5182791-182791100.336101.35
6183169-183169100.544101.56
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%
110.131670581666271662451664371659811664700.25
210.111671841666461669150.23
单位质量响应值RSD%判断
16433.3716509.890.33数据可信
供试品溶液-2025120421批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1183398-183398100.00898.940.78100.0198.940.78
2179808-17980898.05098.05
3182495-18249599.51599.52
4181059-18105998.73298.73
5181827-18182799.15199.15
6180058-18005898.18698.19
10min1184222-184222100.45799.880.88100.62100.040.88
2181063-18106398.73498.90
3185456-185456101.130101.30
4182929-18292999.75299.92
5183474-183474100.049100.21
6181793-18179399.13299.30
15min1183764-183764100.20799.511.06100.5499.851.06
2180118-18011898.21998.55
3184816-184816100.781101.12
4182252-18225299.38399.71
5183665-183665100.153100.49
6180351-18035198.34698.68
20min1183831-183831100.24499.410.87100.7499.900.87
2180891-18089198.64199.13
3184384-184384100.545101.05
4181107-18110798.75899.25
5182708-18270899.631100.13
6180868-18086898.62899.12
30min1182126-18212699.31498.780.9399.9899.440.92
2178890-17889097.54998.21
3183556-183556100.094100.76
4180665-18066598.51799.18
5181716-18171699.09099.76
6179920-17992098.11198.77
45min1181076-18107698.74298.320.8599.5899.140.85
2178274-17827497.21498.03
3182382-18238299.454100.29
4179773-17977398.03198.86
5181173-18117398.79499.62
6179113-17911397.67198.49
极限1181006-18100698.70398.110.8999.7099.100.89
2178943-17894397.57898.56
3182308-18230899.413100.42
4179230-17923097.73598.72
5180146-18014698.23499.23
6177869-17786996.99397.98
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%
110.131652361655651654671656311655671654930.10
210.111640751647011643880.27
单位质量响应值RSD%判断
16336.9216259.940.34数据可信
供试品溶液-2025120421批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1184241-184241101.535101.100.98101.54101.110.98
2184446-184446101.648101.65
3183248-183248100.988100.99
4182161-182161100.389100.39
5185841-185841102.417102.42
6180825-18082599.65299.65
10min1184963-184963101.933101.770.94102.10101.930.94
2186126-186126102.574102.74
3185187-185187102.056102.22
4183900-183900101.347101.51
5186187-186187102.607102.78
6181593-181593100.076100.24
15min1184496-184496101.676101.561.07102.01101.901.07
2185750-185750102.367102.71
3184769-184769101.826102.16
4183195-183195100.959101.29
5186478-186478102.768103.11
6181016-18101699.758100.09
20min1184668-184668101.770101.220.98102.28101.730.98
2184783-184783101.834102.34
3184363-184363101.602102.11
4182047-182047100.326100.83
5185336-185336102.139102.65
6180838-18083899.660100.16
30min1184251-184251101.541100.710.88102.22101.380.88
2183863-183863101.327102.01
3182731-182731100.703101.38
4182090-182090100.350101.02
5183591-183591101.177101.86
6179893-17989399.13999.80
45min1182051-182051100.328100.220.93101.18101.060.93
2182514-182514100.583101.43
3182597-182597100.629101.47
4181257-18125799.891100.73
5183852-183852101.321102.17
6178876-17887698.57899.41
极限1180911-18091199.700100.221.33100.71101.231.33
2184608-184608101.737102.75
3182597-182597100.629101.64
4180428-18042899.434100.44
5184233-184233101.531102.55
6178331-17833198.27899.27
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%
110.131653111645501644001651751654531649780.29
210.111659251646591652920.55
单位质量响应值RSD%判断
16286.0816349.360.28数据可信
供试品溶液-G01T79批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1150851-15085183.03582.0911.8883.0482.0911.87
2141054-14105477.64377.64
3155575-15557585.63685.64
4119607-11960765.83765.84
5155136-15513685.39485.39
6172576-17257694.99494.99
10min1169313-16931393.19895.264.9493.3495.404.95
2172691-17269195.05795.19
3179641-17964198.88399.03
4158100-15810087.02687.14
5177629-17762997.77597.92
6180948-18094899.60299.76
15min1172801-17280195.11898.001.8795.4198.291.88
2179433-17943398.76899.06
3180993-18099399.62799.93
4175078-17507896.37196.63
5179139-17913998.60698.91
6180742-18074299.48999.81
20min1173953-17395395.75298.211.4596.2098.661.46
2178635-17863598.32998.78
3180053-18005399.11099.58
4177478-17747897.69298.11
5178866-17886698.45698.93
6181480-18148099.895100.39
30min1172559-17255994.98597.491.4295.6098.121.42
2177522-17752297.71698.33
3179526-17952698.81999.46
4176459-17645997.13197.71
5177540-17754097.72698.36
6179093-17909398.58199.24
45min1171283-17128394.28296.911.4495.0597.691.44
2176920-17692097.38598.16
3178529-17852998.27199.07
4176017-17601796.88897.63
5175980-17598096.86897.66
6177608-17760897.76498.58
极限1171885-17188594.61496.691.1595.5497.631.15
2176008-17600896.88397.82
3177745-17774597.83998.81
4175395-17539596.54697.45
5176655-17665597.23998.20
6176207-17620796.99397.98
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%
110.131662121656401649881653831654281655300.28
210.111626841631491629160.21
单位质量响应值RSD%判断
16340.5716114.340.99数据可信
供试品溶液-G01T79批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1154695-15469585.62981.892.5185.6381.892.51
2143964-14396479.68979.69
3148297-14829782.08782.09
4148427-14842782.15982.16
5146374-14637481.02381.02
6145860-14586080.73880.74
10min1177699-17769998.36295.772.3698.5195.912.36
2168198-16819893.10393.24
3173176-17317695.85996.00
4171896-17189695.15095.29
5177839-17783998.44098.57
6169335-16933593.73393.87
15min1177336-17733698.16197.401.5698.4797.701.56
2173905-17390596.26296.55
3173986-17398696.30796.60
4173481-17348196.02796.32
5180516-18051699.922100.22
6176535-17653597.71898.01
20min1177353-17735398.17197.541.6098.6498.001.59
2175085-17508596.91597.36
3174148-17414896.39796.85
4172626-17262695.55496.01
5180363-18036399.837100.30
6177750-17775098.39198.84
30min1177511-17751198.25897.391.4298.8998.021.42
2174684-17468496.69397.30
3173473-17347396.02396.64
4173278-17327895.91596.53
5179309-17930999.25399.89
6177439-17743998.21898.84
45min1176246-17624697.55897.011.5098.3697.801.50
2173511-17351196.04496.82
3176269-17626997.57198.35
4171270-17127094.80495.58
5178914-17891499.03599.83
6175331-17533197.05297.83
极限1175511-17551197.15196.241.6698.1197.191.65
2172829-17282995.66796.60
3171605-17160594.98995.93
4170160-17016094.18995.12
5177983-17798398.51999.48
6175128-17512896.93997.88
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