氨溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.713395123399113394333396413392153395420.08
214.823387923388263388090.01
单位质量响应值RSD%判断
23082.3922861.610.68数据可信
供试品溶液-H328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%
5min1142839-14283936.08237.545.4736.0837.545.47
2155347-15534739.24239.24
3152308-15230838.47438.47
4145900-14590036.85536.86
5136966-13696634.59934.60
6158344-15834439.99940.00
10min1352512-35251289.04789.012.9189.1189.082.92
2356964-35696490.17290.24
3354383-35438389.52089.58
4352549-35254989.05689.12
5333489-33348984.24284.30
6364362-36436292.04192.11
15min1408054-408054103.077101.820.76103.29102.030.76
2400537-400537101.179101.39
3403193-403193101.850102.06
4400264-400264101.110101.32
5401367-401367101.388101.59
6405000-405000102.306102.53
20min1407494-407494102.936102.020.68103.32102.410.68
2401941-401941101.533101.92
3402772-402772101.743102.13
4400789-400789101.242101.62
5403328-403328101.884102.25
6406975-406975102.805103.20
30min1406959-406959102.801101.790.60103.35102.340.60
2401094-401094101.319101.87
3401390-401390101.394101.95
4400986-400986101.292101.84
5402666-402666101.716102.25
6404699-404699102.230102.79
45min1405855-405855102.522101.680.60103.25102.400.60
2400602-400602101.195101.92
3402084-402084101.569102.29
4400137-400137101.078101.79
5401343-401343101.382102.09
6405085-405085102.327103.06
极限1405877-405877102.528101.530.64103.42102.420.64
2400069-400069101.060101.95
3400967-400967101.287102.18
4399458-399458100.906101.79
5400877-400877101.264102.14
6404283-404283102.125103.03
氨溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.713386793392623393993390483389723390720.09
214.823387433387633387530.01
单位质量响应值RSD%判断
23050.4422857.830.60数据可信
供试品溶液-H328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%
5min1143592-14359236.30036.897.8136.3036.907.81
2146205-14620536.96136.96
3149188-14918837.71537.72
4128228-12822832.41632.42
5163754-16375441.39741.40
6144685-14468536.57736.58
10min1342591-34259186.60887.151.5286.6787.211.53
2352074-35207489.00589.07
3340864-34086486.17186.23
4339109-33910985.72885.78
5350218-35021888.53688.61
6343479-34347986.83286.89
15min1397080-397080100.383100.990.60100.59101.200.59
2400883-400883101.344101.55
3403309-403309101.958102.16
4397959-397959100.605100.80
5397794-397794100.563100.78
6399957-399957101.110101.32
20min1399751-399751101.058101.280.53101.43101.650.53
2402427-402427101.735102.11
3403440-403440101.991102.37
4398622-398622100.773101.14
5398221-398221100.671101.06
6401202-401202101.425101.80
30min1397718-397718100.544101.270.86101.08101.820.86
2401305-401305101.451102.00
3406103-406103102.664103.21
4397427-397427100.471101.00
5398278-398278100.686101.24
6402747-402747101.815102.36
45min1398371-398371100.709100.920.74101.42101.630.74
2401009-401009101.376102.09
3403745-403745102.068102.79
4395342-39534299.943100.64
5397426-397426100.470101.19
6399259-399259100.934101.65
极限1396461-396461100.226100.700.80101.10101.580.80
2398886-398886100.839101.73
3402191-402191101.675102.56
4394149-39414999.642100.51
5396562-396562100.252101.14
6401641-401641101.536102.42
氨溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.713387853389943385783390353394613389710.10
214.823379193376073377630.07
单位质量响应值RSD%判断
23043.5822791.030.78数据可信
供试品溶液-H328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%
5min1160339-16033940.60039.364.3240.6039.364.32
2144823-14482336.67136.67
3164574-16457441.67241.67
4153798-15379838.94438.94
5154016-15401638.99939.00
6155123-15512339.27939.28
10min1343766-34376687.04688.622.9187.1188.682.91
2333313-33331384.39984.46
3362551-36255191.80291.87
4352292-35229289.20589.27
5352449-35244989.24489.31
6355438-35543890.00190.07
15min1398569-398569100.923101.880.92101.14102.090.92
2406519-406519102.936103.14
3404320-404320102.379102.60
4401926-401926101.773101.99
5405278-405278102.621102.84
6397432-397432100.635100.85
20min1400082-400082101.306102.131.07101.69102.511.07
2408453-408453103.425103.80
3405258-405258102.616103.01
4403483-403483102.167102.55
5405998-405998102.804103.19
6396657-396657100.438100.82
30min1398874-398874101.000101.901.05101.55102.461.04
2409168-409168103.606104.15
3404062-404062102.313102.88
4402230-402230101.850102.40
5403128-403128102.077102.63
6397225-397225100.582101.13
45min1398117-398117100.808101.650.93101.53102.380.92
2407178-407178103.102103.82
3401696-401696101.714102.45
4400429-400429101.393102.12
5404014-404014102.301103.03
6397296-397296100.600101.32
极限1397182-397182100.571101.420.92101.46102.310.92
2405686-405686102.725103.61
3402057-402057101.806102.71
4400523-400523101.417102.31
5402208-402208101.844102.74
6395546-395546100.157101.04
氨溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.713377563385893382423380323379933381220.10
214.823370873371873371370.03
单位质量响应值RSD%判断
22985.8622748.790.74数据可信
供试品溶液-H328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%
5min1141448-14144835.89537.3421.5535.8937.3421.55
2111634-11163428.32928.33
3183124-18312446.47046.47
4176661-17666144.83044.83
5160171-16017140.64640.65
6109784-10978427.85927.86
10min1347912-34791288.28886.0610.5888.3586.1310.58
2273360-27336069.36969.42
3366452-36645292.99393.07
4370653-37065394.05994.13
5350201-35020188.86988.94
6326293-32629382.80282.85
15min1400269-400269101.574101.622.31101.78101.832.33
2383420-38342097.29897.46
3408583-408583103.684103.92
4408547-408547103.675103.91
5399424-399424101.360101.58
6402524-402524102.146102.33
20min1402471-402471102.133102.551.14102.51102.931.15
2399953-399953101.494101.82
3409538-409538103.926104.33
4410065-410065104.060104.46
5399868-399868101.472101.86
6402844-402844102.228102.58
30min1400985-400985101.756102.311.08102.30102.861.10
2399141-399141101.288101.78
3407833-407833103.494104.07
4408854-408854103.753104.33
5398824-398824101.207101.76
6403393-403393102.367102.89
45min1400110-400110101.534102.181.18102.25102.891.20
2398516-398516101.129101.79
3407421-407421103.389104.14
4409038-409038103.799104.55
5397643-397643100.908101.63
6403140-403140102.303103.00
极限1400170-400170101.549102.050.98102.43102.930.99
2399461-399461101.369102.20
3406652-406652103.194104.12
4406080-406080103.049103.97
5396876-396876100.713101.60
6403518-403518102.399103.26
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