磷酸西格列汀片项目信息
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101546-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.813299063298593297963293333294183296620.09
212.853296613290573293590.13
单位质量响应值RSD%判断
25734.7425631.050.29数据可信
稳定性考察-长期36月-供试品溶液-2022030701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%
5min1277506-27750675.64778.736.7675.6578.736.76
2306468-30646883.54183.54
3266056-26605672.52572.53
4270791-27079173.81673.82
5309651-30965184.40984.41
6302453-30245382.44782.45
10min1316559-31655986.29287.222.9886.4287.352.99
2324194-32419488.37388.51
3308263-30826384.03184.15
4310741-31074184.70684.83
5328896-32889689.65589.80
6331039-33103990.23990.38
15min1333082-33308290.79690.571.4291.0790.841.42
2329103-32910389.71290.00
3327255-32725589.20889.47
4329161-32916189.72789.99
5335036-33503691.32991.62
6339800-33980092.62792.92
20min1341612-34161293.12192.181.2093.5492.601.20
2333118-33311890.80691.24
3335353-33535391.41591.82
4335952-33595291.57991.99
5339229-33922992.47292.91
6343667-34366793.68294.12
30min1349328-34932895.22594.301.3395.8094.881.32
2338742-33874292.33992.93
3348569-34856995.01895.58
4342787-34278793.44294.01
5345320-34532094.13294.73
6350859-35085995.64296.24
45min1355896-35589697.01595.851.2497.7596.581.23
2344662-34466293.95394.69
3353640-35364096.40097.12
4348891-34889195.10695.83
5351007-35100795.68296.44
6355548-35554896.92097.68
极限1362440-36244098.79997.211.2899.7098.111.27
2349363-34936395.23496.13
3355322-35532296.85997.74
4357118-35711897.34898.23
5355343-35534396.86497.78
6360189-36018998.18599.10
磷酸西格列汀片项目信息
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101546-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.813298243296793294573299903296573297210.07
212.853313183316783314980.08
单位质量响应值RSD%判断
25739.3425797.510.16数据可信
稳定性考察-长期36月-供试品溶液-2022030801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%
5min1266937-26693772.52480.428.3472.5280.428.35
2304335-30433582.68482.68
3315809-31580985.80285.80
4263116-26311671.48671.49
5306148-30614883.17783.18
6319577-31957786.82586.83
10min1306811-30681183.35787.414.5083.4887.544.51
2327316-32731688.92889.07
3336664-33666491.46891.61
4301248-30124881.84681.96
5324715-32471588.22188.36
6333637-33363790.64590.79
15min1323642-32364287.93090.843.7688.1991.123.76
2334021-33402190.75091.04
3355925-35592596.70197.00
4320485-32048587.07287.33
5333816-33381690.69490.98
6338141-33814191.86992.16
20min1333837-33383790.70092.031.5391.1192.461.55
2338872-33887292.06892.50
3346168-34616894.05094.51
4332262-33226290.27290.67
5338848-33884892.06192.50
6342344-34234493.01193.46
30min1340697-34069792.56394.071.2693.1294.651.26
2343905-34390593.43594.03
3352548-35254895.78396.40
4349641-34964194.99395.54
5343673-34367393.37293.96
6346911-34691194.25294.86
45min1348037-34803794.55895.341.2395.2796.081.24
2350532-35053295.23695.98
3358634-35863497.43798.21
4348994-34899494.81895.53
5346728-34672894.20294.95
6352503-35250395.77196.53
极限1355239-35523996.51496.860.9797.3897.760.98
2356654-35665496.89997.80
3362242-36224298.41799.35
4356601-35660196.88497.75
5351511-35151195.50296.40
6356774-35677496.93197.85
磷酸西格列汀片项目信息
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101546-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.813297713302273303513303793303483302150.08
212.853293533294073293800.02
单位质量响应值RSD%判断
25777.9125632.680.40数据可信
稳定性考察-长期36月-供试品溶液-2022030901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%
5min1249464-24946467.94371.028.1067.9471.028.10
2254018-25401869.18469.18
3231729-23172963.11363.11
4288452-28845278.56278.56
5281741-28174176.73476.73
6259156-25915670.58370.58
10min1320240-32024087.22085.634.0587.3385.754.06
2310714-31071484.62584.74
3295010-29501080.34880.45
4331714-33171490.34590.48
5320924-32092487.40687.53
6307888-30788883.85683.97
15min1321256-32125687.49789.191.9387.7689.451.93
2332680-33268090.60890.86
3320066-32006687.17287.41
4334197-33419791.02191.30
5332209-33220990.48090.75
6324383-32438388.34888.61
20min1330302-33030289.96091.661.9890.3692.071.99
2340779-34077992.81493.22
3330655-33065590.05690.44
4346347-34634794.33094.76
5339634-33963492.50292.93
6331647-33164790.32790.73
30min1339701-33970192.52093.580.9293.0794.140.93
2347796-34779694.72595.29
3341654-34165493.05293.59
4345839-34583994.19294.78
5345230-34523094.02694.60
6341324-34132492.96293.52
45min1344461-34446193.81795.601.8794.5396.321.87
2363294-36329498.94699.67
3348750-34875094.98595.67
4351755-35175595.80396.55
5350713-35071395.51996.25
6347134-34713494.54595.25
极限1354282-35428296.49197.100.8497.3697.980.84
2362322-36232298.68199.57
3355221-35522196.74797.60
4355356-35535696.78497.69
5356960-35696097.22198.12
6355017-35501796.69297.56
磷酸西格列汀片项目信息
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101546-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.813299723299463298733307513305343302150.13
212.853318803315613317200.07
单位质量响应值RSD%判断
25777.9125814.790.11数据可信
稳定性考察-长期36月-供试品溶液-U011530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%
5min1234773-23477363.71656.139.0663.7256.129.06
2199675-19967554.19154.19
3187144-18714450.79050.79
4225038-22503861.07461.07
5194520-19452052.79252.79
6199665-19966554.18854.19
10min1285641-28564177.52170.207.0477.6370.307.04
2262476-26247671.23471.32
3235614-23561463.94464.03
4271317-27131773.63473.74
5245833-24583366.71866.81
6251131-25113168.15668.25
15min1304358-30435882.60176.755.7482.8476.965.75
2278118-27811875.48075.69
3260943-26094370.81871.01
4298994-29899481.14581.37
5273624-27362474.26074.46
6280748-28074876.19376.40
20min1317735-31773586.23181.134.4786.6081.464.48
2296706-29670680.52480.86
3278314-27831475.53375.84
4307963-30796383.57983.94
5293733-29373379.71780.04
6299100-29910081.17481.50
30min1332731-33273190.30186.833.4390.8287.313.44
2322989-32298987.65788.13
3300318-30031881.50581.94
4325636-32563688.37688.87
5316936-31693686.01586.47
6321124-32112487.15187.62
45min1340585-34058592.43391.082.3893.1091.692.39
2342187-34218792.86893.48
3320724-32072487.04387.61
4340656-34065692.45293.10
5334774-33477490.85691.45
6334591-33459190.80691.42
极限1348601-34860194.60896.011.1095.4396.781.08
2359349-35934997.52598.30
3354520-35452096.21596.93
4355476-35547696.47497.27
5354556-35455696.22496.98
6350144-35014495.02795.79
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