氢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250
标示量(mg)40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%
114.786785836787936770326771556770556777240.14
214.636797036792156794590.06
单位质量响应值RSD%判断
45854.1346442.860.91数据可信
加速1月-供试品溶液-24041501-bz1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%
5min1247926-24792631.17630.946.7031.1830.946.70
2217342-21734227.33027.33
3247182-24718231.08231.08
4242497-24249730.49330.49
5267303-26730333.61233.61
6253954-25395431.93431.93
10min1479084-47908460.24360.085.4660.2960.145.47
2430508-43050854.13554.18
3478256-47825660.13960.19
4479980-47998060.35660.41
5509909-50990964.11964.18
6489109-48910961.50461.56
15min1628803-62880379.07079.884.0279.2280.044.02
2589486-58948674.12674.26
3642158-64215880.74980.90
4639344-63934480.39580.55
5665671-66567183.70683.87
6646194-64619481.25681.41
20min1708565-70856589.09990.612.9089.3890.902.91
2687026-68702686.39186.65
3743128-74312893.44693.73
4720895-72089590.65090.94
5740457-74045793.11093.41
6723489-72348990.97691.27
30min1723653-72365390.99792.672.2191.4393.112.21
2720799-72079990.63891.04
3764100-76410096.08396.53
4733928-73392892.28992.73
5747366-74736693.97894.44
6732085-73208592.05792.50
45min1722277-72227790.82492.542.2291.4193.132.22
2719726-71972690.50391.06
3762931-76293195.93696.54
4731949-73194992.04092.63
5746832-74683293.91194.53
6731640-73164092.00192.60
极限1720373-72037390.58492.302.2491.3293.042.24
2718152-71815290.30591.01
3761093-76109395.70596.47
4730314-73031491.83492.58
5745319-74531993.72194.49
6728694-72869491.63192.38
氢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250
标示量(mg)40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%
114.786770186778586766626766236773196770960.08
214.636788486787166787820.02
单位质量响应值RSD%判断
45811.6446396.580.90数据可信
加速1月-供试品溶液-24041501-bz2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%
5min1256670-25667032.30629.568.2532.3129.568.25
2231547-23154729.14429.14
3241674-24167430.41930.42
4232419-23241929.25429.25
5200177-20017725.19625.20
6246387-24638731.01231.01
10min1493780-49378062.15157.835.7262.2057.885.72
2445767-44576756.10756.16
3465418-46541858.58158.63
4449886-44988656.62656.67
5420912-42091252.97953.02
6481082-48108260.55260.60
15min1651961-65196182.06177.434.2182.2277.584.21
2598029-59802975.27275.41
3618966-61896677.90878.06
4606189-60618976.29976.44
5580636-58063673.08373.21
6635278-63527879.96180.11
20min1735987-73598792.63789.142.6292.9389.412.63
2697200-69720087.75588.02
3707209-70720989.01489.29
4705210-70521088.76389.03
5682643-68264385.92286.17
6720984-72098490.74891.03
30min1751785-75178594.62592.691.1395.0793.111.14
2735140-73514092.53092.94
3731228-73122892.03892.46
4733126-73312692.27792.69
5728418-72841891.68492.08
6738666-73866692.97493.41
45min1750182-75018294.42392.551.0295.0393.131.03
2734457-73445792.44493.01
3729692-72969291.84492.42
4733181-73318192.28392.86
5731906-73190692.12392.67
6732522-73252292.20192.79
极限1749087-74908794.28592.341.0695.0593.071.08
2732502-73250292.19892.92
3729479-72947991.81792.55
4730261-73026191.91692.64
5728004-72800491.63292.33
6732570-73257092.20792.95
氢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250
标示量(mg)40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%
114.786780196791706779096780426778586782000.09
214.636792396793646793020.02
单位质量响应值RSD%判断
45886.3346432.130.84数据可信
高温30天-供试品溶液-24041501-bz1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%
5min1183760-18376023.10222.956.0023.1022.956.01
2182482-18248222.94122.94
3162217-16221720.39320.39
4187022-18702223.51223.51
5184583-18458323.20523.21
6195221-19522124.54224.54
10min1325477-32547740.91840.305.1340.9640.335.13
2320295-32029540.26640.30
3288874-28887436.31636.35
4328630-32863041.31441.35
5323591-32359140.68140.72
6336334-33633442.28342.32
15min1422268-42226853.08652.904.5153.1953.004.51
2420340-42034052.84452.95
3385598-38559848.47648.57
4434939-43493954.67954.79
5422055-42205553.05953.17
6439508-43950855.25355.36
20min1502538-50253863.17763.224.3263.3763.424.33
2502139-50213963.12763.32
3465613-46561358.53558.71
4521706-52170665.58765.79
5498113-49811362.62162.82
6527223-52722366.28066.48
30min1621577-62157778.14278.223.3578.4478.523.35
2625070-62507078.58178.88
3586353-58635373.71473.99
4646153-64615381.23281.54
5615749-61574977.41077.71
6638285-63828580.24380.56
45min1676064-67606484.99285.631.6985.4286.061.70
2683591-68359185.93886.37
3666977-66697783.85084.25
4694296-69429687.28487.73
5671847-67184784.46284.89
6693936-69393687.23987.69
极限1723412-72341290.94591.661.8991.5292.241.90
2737379-73737992.70193.27
3712705-71270589.59990.13
4747527-74752793.97694.57
5716279-71627990.04890.62
6737521-73752192.71893.31
氢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250
标示量(mg)40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%
114.786792096798216826696791436822866806260.26
214.636792066792246792150.01
单位质量响应值RSD%判断
46050.4746426.180.58数据可信
高温30天-供试品溶液-24041501-bz2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%
5min1139726-13972617.53521.339.0917.5421.339.08
2176230-17623022.11722.12
3169418-16941821.26221.26
4174771-17477121.93421.93
5182938-18293822.95922.96
6176780-17678022.18622.19
10min1248853-24885331.23137.087.8331.2637.117.83
2301801-30180137.87637.91
3301383-30138337.82337.86
4302123-30212337.91637.95
5309425-30942538.83238.87
6308956-30895638.77438.81
15min1334768-33476842.01349.317.3442.0949.417.34
2398862-39886250.05750.16
3406414-40641451.00551.10
4401914-40191450.44050.54
5404147-40414750.72050.82
6411517-41151751.64551.75
20min1405569-40556950.89859.447.1651.0559.627.16
2479730-47973060.20660.39
3491739-49173961.71361.90
4485560-48556060.93761.12
5483177-48317760.63860.83
6496172-49617262.26962.46
30min1517429-51742964.93774.416.3965.1774.686.40
2599829-59982975.27875.56
3617839-61783977.53877.82
4609599-60959976.50476.79
5597171-59717174.94475.23
6615490-61549077.24377.53
45min1636659-63665979.90086.454.0580.2486.854.07
2680985-68098585.46385.87
3711389-71138989.27989.69
4710372-71037289.15189.56
5695937-69593787.33987.75
6697849-69784987.57988.00
极限1745544-74554493.56590.742.0194.0491.281.98
2703352-70335288.27088.82
3725451-72545191.04391.61
4730111-73011191.62892.19
5713140-71314089.49890.06
6720402-72040290.41090.98
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