维格列汀片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101002-200701对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数200
标示量(mg)50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%
19.862592192584052586302609762606822595820.46
29.902584742602992593860.50
单位质量响应值RSD%判断
26326.7726200.610.34数据可信
稳定性考察-中间条件36月-供试品溶液-S210101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%
5min1259269-25926998.32396.741.3898.3296.741.38
2252974-25297495.93695.94
3256773-25677397.37797.38
4250834-25083495.12595.12
5252318-25231895.68795.69
6258361-25836197.97997.98
10min1263172-26317299.80499.781.5199.9599.931.51
2258282-25828297.94998.09
3266668-266668101.129101.28
4258974-25897498.21198.35
5268101-268101101.673101.82
6263481-26348199.921100.07
15min1263306-26330699.85499.891.50100.15100.181.50
2258847-25884798.16398.45
3266955-266955101.238101.54
4259075-25907598.25098.54
5268441-268441101.802102.10
6263711-263711100.008100.30
20min1262696-26269699.62399.911.41100.07100.351.41
2258815-25881598.15198.59
3267018-267018101.262101.71
4260168-26016898.66499.10
5268266-268266101.735102.18
6263751-263751100.023100.47
30min1262504-26250499.55099.791.40100.15100.381.40
2258768-25876898.13398.72
3266701-266701101.142101.74
4259564-25956498.43599.02
5267847-267847101.576102.18
6263427-26342799.900100.50
45min1262176-26217699.42699.751.40100.17100.501.40
2258632-25863298.08298.81
3266575-266575101.094101.85
4259528-25952898.42299.15
5267710-267710101.524102.28
6263609-26360999.969100.72
维格列汀片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101002-200701对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数200
标示量(mg)50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%
19.862610072609292610222606462605482608300.09
29.902596872595812596340.03
单位质量响应值RSD%判断
26453.3526225.660.62数据可信
稳定性考察-中间条件36月-供试品溶液-S210102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%
5min1261811-26181199.00398.831.6199.0098.831.61
2268509-268509101.536101.54
3256371-25637196.94696.95
4257907-25790797.52797.53
5261715-26171598.96798.97
6261829-26182999.01099.01
10min1267898-267898101.305100.261.86101.45100.411.86
2271486-271486102.661102.81
3259922-25992298.28998.43
4260502-26050298.50898.65
5262090-26209099.10899.26
6268976-268976101.712101.86
15min1267708-267708101.233100.251.62101.53100.551.62
2271390-271390102.625102.93
3261667-26166798.94899.24
4260437-26043798.48398.78
5262350-26235099.20799.50
6267172-267172101.030101.33
20min1265808-265808100.514100.171.45100.97100.621.45
2271217-271217102.560103.02
3261343-26134398.82699.27
4261895-26189599.03599.48
5262289-26228999.18499.63
6266788-266788100.885101.34
30min1267048-267048100.98399.991.67101.59100.591.67
2270511-270511102.293102.91
3260679-26067998.57599.16
4259811-25981198.24798.84
5261301-26130198.81099.40
6267212-267212101.045101.65
45min1265194-265194100.28299.811.69101.04100.561.69
2268478-268478101.524102.29
3258729-25872997.83798.57
4258944-25894497.91998.66
5263464-26346499.628100.37
6268877-268877101.675102.43
维格列汀片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101002-200701对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数200
标示量(mg)50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%
19.862586882587982587372585712589522587490.06
29.902585272584952585110.01
单位质量响应值RSD%判断
26242.2926112.220.36数据可信
稳定性考察-中间条件36月-供试品溶液-S210103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%
5min1257870-25787098.11697.461.8398.1297.461.83
2250212-25021295.20295.20
3263274-263274100.172100.17
4255291-25529197.13497.13
5252147-25214795.93895.94
6258120-25812098.21198.21
10min1263014-263014100.07399.862.15100.22100.002.15
2254171-25417196.70896.85
3266916-266916101.558101.71
4258136-25813698.21798.36
5262884-262884100.023100.17
6269555-269555102.562102.71
15min1262841-262841100.00799.772.22100.30100.062.21
2253521-25352196.46196.75
3266974-266974101.580101.88
4258186-25818698.23698.53
5262259-26225999.786100.08
6269533-269533102.553102.85
20min1262129-26212999.73699.692.30100.18100.142.29
2253250-25325096.35896.79
3267079-267079101.620102.07
4257774-25777498.07998.52
5262112-26211299.730100.17
6269751-269751102.636103.09
30min1262260-26226099.78699.732.24100.38100.322.24
2253288-25328896.37296.95
3267154-267154101.648102.26
4258004-25800498.16798.75
5262680-26268099.946100.54
6269222-269222102.435103.04
45min1261280-26128099.41399.592.31100.16100.342.31
2252832-25283296.19996.92
3267134-267134101.641102.40
4257634-25763498.02698.76
5262351-26235199.821100.56
6269259-269259102.449103.21
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