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%
110.421758621747861760631747071754461753730.36
210.351756041754511755280.07
单位质量响应值RSD%判断
16830.4216959.230.54数据可信
供试品溶液-G01T7A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%
5min1158260-15826084.13985.533.2684.1485.533.26
2167160-16716088.87188.87
3159458-15945884.77684.78
4155689-15568982.77282.77
5167679-16767989.14789.15
6156983-15698383.46083.46
10min1177599-17759994.42094.511.0394.5694.661.03
2179550-17955095.45895.61
3176482-17648293.82793.97
4176446-17644693.80793.95
5180459-18045995.94196.09
6176124-17612493.63693.78
15min1181963-18196396.74196.490.9597.0496.790.95
2181278-18127896.37696.68
3179077-17907795.20695.50
4183469-18346997.54197.84
5183091-18309197.34097.65
6180045-18004595.72196.02
20min1183274-18327497.43896.861.5197.9097.321.50
2180299-18029995.85696.32
3180095-18009595.74796.20
4186656-18665699.23699.69
5183336-18333697.47197.94
6179512-17951295.43895.89
30min1181673-18167396.58696.771.6997.2197.391.68
2180763-18076396.10396.73
3179579-17957995.47396.09
4187627-18762799.752100.37
5183082-18308297.33697.97
6179394-17939495.37595.99
45min1182055-18205596.79096.591.4297.5797.371.42
2180347-18034795.88196.67
3179278-17927895.31396.09
4186200-18620098.99399.78
5182576-18257697.06697.86
6179610-17961095.49096.26
极限1182124-18212496.82696.361.5297.7797.311.51
2179152-17915295.24696.19
3179392-17939295.37496.31
4185834-18583498.79999.75
5182384-18238496.96497.92
6178631-17863194.96995.90
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%
110.421747691746881740171735991733721740890.37
210.351733931744011738970.41
单位质量响应值RSD%判断
16707.2016801.640.40数据可信
供试品溶液-G01T7A批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1173598-17359893.06686.388.3093.0786.388.30
2158680-15868085.06985.07
3176560-17656094.65494.65
4165446-16544688.69688.70
5150229-15022980.53880.54
6142252-14225276.26276.26
10min1184154-18415498.72595.312.9998.8895.463.00
2178081-17808195.47095.61
3182406-18240697.78897.95
4178933-17893395.92696.07
5171200-17120091.78191.91
6171973-17197392.19592.32
15min1185574-18557499.48797.201.5499.8197.501.55
2182222-18222297.69097.99
3182361-18236197.76498.08
4179999-17999996.49896.81
5177303-17730395.05295.34
6180374-18037496.69996.98
20min1186333-18633399.89397.601.27100.3898.071.28
2182516-18251697.84798.31
3181784-18178497.45597.94
4180496-18049696.76497.23
5179755-17975596.36796.81
6181484-18148497.29497.74
30min1186028-18602899.73097.991.21100.3898.621.20
2183802-18380298.53799.16
3181798-18179897.46298.11
4180024-18002496.51197.14
5181142-18114297.11197.72
6183896-18389698.58799.19
45min1184752-18475299.04697.831.0799.8698.621.06
2183911-18391198.59599.39
3181284-18128497.18798.00
4180675-18067596.86097.65
5180340-18034096.68197.45
6183983-18398398.63499.40
极限1184438-18443898.87897.660.8799.8698.620.87
2183141-18314198.18299.14
3181713-18171397.41798.39
4180286-18028696.65297.60
5180696-18069696.87197.80
6182744-18274497.96998.90
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%
110.421760041761271760391769921748991760120.43
210.351760691768141764420.30
单位质量响应值RSD%判断
16891.7517047.540.65数据可信
供试品溶液-G01T78批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1158790-15879084.04982.156.5084.0582.166.50
2136951-13695172.48972.49
3160415-16041584.90984.91
4159588-15958884.47184.47
5164927-16492787.29787.30
6150587-15058779.70779.71
10min1179476-17947694.99894.605.2995.1494.745.29
2163627-16362786.60986.73
3186217-18621798.56698.71
4180817-18081795.70895.85
5189606-189606100.360100.51
6172558-17255891.33791.47
15min1183326-18332697.03697.294.4097.3397.584.40
2171429-17142990.73991.00
3188836-18883699.953100.26
4187370-18737099.17799.48
5193844-193844102.603102.92
6178019-17801994.22794.51
20min1183590-18359097.17697.954.1797.6498.414.18
2175510-17551092.89993.32
3190939-190939101.066101.54
4189027-189027100.054100.52
5194379-194379102.887103.37
6176874-17687493.62194.06
30min1184717-18471797.77297.913.7698.3998.533.76
2176325-17632593.33093.90
3189692-189692100.406101.05
4188688-18868899.874100.51
5193284-193284102.307102.96
6177178-17717893.78294.38
45min1183275-18327597.00997.743.5097.7998.523.50
2176877-17687793.62394.35
3189898-189898100.515101.32
4189083-189083100.083100.88
5191435-191435101.328102.15
6177408-17740893.90494.66
极限1182275-18227596.48097.803.5797.4398.743.58
2176653-17665393.50494.39
3189555-189555100.333101.31
4189342-189342100.220101.19
5192467-192467101.875102.87
6178270-17827094.36095.27
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%
110.421742251744081742891748211748511745190.18
210.351732191743031737610.45
单位质量响应值RSD%判断
16748.4616788.500.17数据可信
供试品溶液-G01T78批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1161319-16131986.41083.366.4386.4183.356.44
2161805-16180586.67186.67
3167482-16748289.71189.71
4155648-15564883.37383.37
5142022-14202276.07476.07
6145415-14541577.89177.89
10min1180595-18059596.73595.222.7896.8895.362.78
2180451-18045196.65896.80
3184596-18459698.87999.03
4174942-17494293.70793.85
5171209-17120991.70891.83
6174846-17484693.65693.79
15min1185859-18585999.55598.491.1399.8698.781.13
2185490-18549099.35799.66
3185344-18534499.27999.59
4183409-18340998.24398.54
5180697-18069796.79097.07
6182388-18238897.69697.98
20min1185575-18557599.40399.460.4599.8799.930.45
2185823-18582399.536100.01
3185561-18556199.39599.88
4186276-18627699.778100.24
5184238-18423898.68799.13
6186664-18666499.986100.44
30min1185405-18540599.31299.900.5799.95100.530.56
2187079-187079100.209100.85
3185293-18529399.25299.90
4186419-18641999.855100.48
5186730-186730100.022100.63
6188077-188077100.743101.36
45min1184655-18465598.91099.640.8499.71100.440.83
2186669-18666999.989100.79
3184338-18433898.74099.55
4185471-18547199.347100.14
5186437-18643799.865100.64
6188563-188563101.003101.79
极限1186627-18662799.966100.180.98100.93101.130.97
2186298-18629899.790100.76
3185788-18578899.517100.49
4186589-18658999.946100.90
5186122-18612299.696100.63
6190676-190676102.135103.09
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