沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数125
标示量(mg)200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%
128.011152828115057611533741153802115076411522690.14
228.011163116116045611617860.17
单位质量响应值RSD%判断
41137.7741477.540.59数据可信
包装高温-供试品溶液-TYN28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%
5min1178756-17875615.57911.2035.1915.5811.2135.18
277755-777556.7776.78
3127170-12717011.08311.08
4184799-18479916.10616.11
5117257-11725710.21910.22
685663-856637.4667.47
10min1406672-40667235.44234.676.7835.4834.706.77
2429187-42918737.40537.42
3351038-35103830.59430.62
4389688-38968833.96234.00
5415308-41530836.19536.22
6394917-39491734.41834.43
15min1628748-62874854.79752.988.0054.9153.087.99
2680079-68007959.27159.37
3550532-55053247.98048.07
4634400-63440055.28955.40
5566291-56629149.35449.46
6587017-58701751.16051.25
20min1794737-79473769.26364.936.8969.5065.156.88
2796037-79603769.37769.61
3683707-68370759.58759.79
4779786-77978667.96068.19
5694985-69498560.57060.78
6720707-72070762.81163.02
30min11039721-103972190.61484.537.0591.0084.897.04
2982735-98273585.64886.03
3911680-91168079.45579.79
41056078-105607892.04092.42
5888638-88863877.44777.79
6940484-94048481.96582.31
45min11146200-114620099.89498.093.85100.4898.643.86
21148028-1148028100.053100.63
31132221-113222198.67699.18
41177316-1177316102.606103.20
51058143-105814392.22092.74
61091169-109116995.09895.63
60min11197974-1197974104.406103.063.05105.22103.823.06
21197976-1197976104.406105.20
31186463-1186463103.403104.13
41226350-1226350106.879107.70
51121247-112124797.71998.44
61164906-1164906101.524102.26
极限11250224-1250224108.960109.371.35110.00110.371.38
21262965-1262965110.070111.10
31257135-1257135109.562110.52
41280321-1280321111.583112.64
51228986-1228986107.109108.05
61249967-1249967108.938109.90
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数125
标示量(mg)200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%
128.011151183115150211519131152282115131311516390.04
228.011175700117438011750400.08
单位质量响应值RSD%判断
41115.2841950.731.43数据可信
包装高温-供试品溶液-TYN28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%
5min1127915-12791511.08910.7541.5411.0910.7641.55
268703-687035.9565.96
3123358-12335810.69410.69
4187192-18719216.22716.23
563123-631235.4725.47
6174025-17402515.08615.09
10min1288208-28820824.98430.4415.6625.0130.4715.66
2297216-29721625.76525.78
3341914-34191429.63929.66
4435924-43592437.78937.82
5364522-36452231.59931.61
6379319-37931932.88232.92
15min1461615-46161540.01648.4314.7240.1048.5214.72
2452580-45258039.23339.30
3595364-59536451.61051.70
4644181-64418155.84255.96
5574602-57460249.81049.89
6623450-62345054.04554.15
20min1588347-58834751.00261.4614.8951.1761.6614.90
2595167-59516751.59351.75
3728061-72806163.11363.32
4839237-83923772.75172.99
5691374-69137459.93360.13
6811640-81164070.35870.59
30min1792118-79211868.66678.4710.5568.9578.8110.58
2812248-81224870.41170.68
3953465-95346582.65383.00
41010757-101075787.61988.03
5863052-86305274.81575.14
6999628-99962886.65587.04
45min1964069-96406983.57290.485.4984.0191.005.52
21028916-102891689.19389.62
31100042-110004295.35995.89
41095857-109585794.99695.60
5993080-99308086.08786.58
61080894-108089493.69994.27
60min11054965-105496591.45296.404.1392.0797.124.16
21117347-111734796.85997.49
31154359-1154359100.068100.81
41152012-115201299.864100.68
51055855-105585591.52992.21
61137915-113791598.64299.43
极限11211536-1211536105.024105.622.08105.85106.552.03
21249393-1249393108.306109.15
31250877-1250877108.435109.40
41196579-1196579103.728104.76
51206817-1206817104.615105.50
61195441-1195441103.629104.63
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数125
标示量(mg)200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%
128.011164317116467811636631164484116385911642000.04
228.011183010118130311821560.11
单位质量响应值RSD%判断
41563.7342204.781.09数据可信
包装高湿-供试品溶液-TYN28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%
5min1171059-17105914.70412.5924.9614.7012.5924.97
2192486-19248616.54516.55
3100675-1006758.6548.65
4169850-16985014.60014.60
5131699-13169911.32011.32
6113302-1133029.7399.74
10min1461732-46173239.68934.2817.6039.7234.3017.60
2499979-49997942.97643.01
3375670-37567032.29132.31
4353634-35363430.39730.43
5310610-31061026.69926.72
6391086-39108633.61633.64
15min1680996-68099658.53650.9012.8958.6651.0112.89
2641426-64142655.13555.27
3532296-53229645.75445.85
4625953-62595353.80553.90
5473782-47378240.72440.81
6598667-59866751.45951.56
20min1855481-85548173.53464.2112.0373.7864.4212.03
2760313-76031365.35465.61
3687011-68701159.05359.25
4830614-83061471.39671.62
5614141-61414152.78952.96
6734306-73430663.11863.33
30min11050855-105085590.32782.289.7790.7482.649.77
2914268-91426878.58778.99
3903392-90339277.65277.98
41046475-104647589.95190.33
5817888-81788870.30370.59
61010202-101020286.83387.18
45min11129391-112939197.07892.237.6297.6992.787.62
21008778-100877886.71187.29
31036168-103616889.06589.56
41140871-114087198.06598.64
5961865-96186582.67883.13
61161188-116118899.811100.36
60min11175861-1175861101.07396.936.80101.9097.686.80
21064607-106460791.51092.28
31095209-109520994.14094.83
41191952-1191952102.456103.25
51025045-102504588.10988.74
61213298-1213298104.290105.06
极限11253360-1253360107.734106.521.77108.79107.491.81
21229437-1229437105.678106.65
31225141-1225141105.308106.21
41233554-1233554106.032107.06
51217486-1217486104.650105.48
61276568-1276568109.729110.73
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数125
标示量(mg)200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%
128.011169253117034011697861170940116689511694430.14
228.011167541116859811680700.07
单位质量响应值RSD%判断
41750.9141701.890.09数据可信
包装高湿-供试品溶液-TYN28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%
5min1155476-15547613.41413.0417.2613.4113.0417.28
2166536-16653614.36814.37
3104944-1049449.0549.05
4152844-15284413.18713.19
5144842-14484212.49612.50
6182264-18226415.72515.73
10min1376499-37649932.48334.2915.2432.5134.3215.25
2462417-46241739.89639.93
3301094-30109425.97726.00
4430801-43080137.16837.20
5367570-36757031.71331.74
6446361-44636138.51038.55
15min1536985-53698546.32950.7912.0946.4350.9012.10
2662757-66275757.18057.30
3490013-49001342.27742.35
4631240-63124054.46154.57
5555372-55537247.91548.01
6655862-65586256.58556.71
20min1746782-74678264.43064.3410.2364.6364.5610.23
2863056-86305674.46174.71
3640899-64089955.29455.47
4767172-76717266.18966.42
5687948-68794859.35459.56
6768395-76839566.29466.54
30min11005794-100579486.77683.455.7387.1283.815.72
21041048-104104889.81890.23
3912887-91288778.76179.06
4964979-96497983.25583.63
5983385-98338584.84385.18
6895409-89540977.25377.65
45min11125053-112505397.06593.744.8497.6194.284.81
21125400-112540097.09597.71
31084921-108492193.60394.07
41099886-109988694.89495.46
51099126-109912694.82995.35
6984334-98433484.92585.49
60min11173464-1173464101.24298.314.51102.0099.074.49
21178783-1178783101.701102.53
31141424-114142498.47899.16
41157010-115701099.823100.60
51147302-114730298.98599.72
61039062-103906289.64690.40
极限11224966-1224966105.686105.672.59106.67106.642.56
21229996-1229996106.120107.17
31260391-1260391108.742109.64
41254419-1254419108.227109.22
51201702-1201702103.678104.63
61176908-1176908101.539102.49
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数125
标示量(mg)200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%
128.011159020115777311565231155597115564911569120.13
228.011182038118263211823350.04
单位质量响应值RSD%判断
41303.5342211.171.54数据可信
包装光照-供试品溶液-TYN28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%
5min1184789-18478915.93311.4425.8315.9311.4425.82
2121983-12198310.51810.52
393967-939678.1028.10
4140284-14028412.09612.10
5154183-15418313.29413.29
6100751-1007518.6878.69
10min1399845-39984534.47634.065.7534.5134.085.75
2430100-43010037.08437.11
3403744-40374434.81234.83
4363520-36352031.34431.37
5393865-39386533.96033.99
6379069-37906932.68432.70
15min1565015-56501548.71750.7811.3648.8350.8811.34
2676938-67693858.36758.47
3660769-66076956.97357.07
4506448-50644843.66743.76
5544188-54418846.92147.03
6580095-58009550.01750.11
20min1726736-72673662.66165.4411.6462.8865.6611.62
2864330-86433074.52574.76
3844815-84481572.84273.06
4622784-62278453.69853.89
5765998-76599866.04666.26
6729488-72948862.89863.10
30min1901132-90113277.69882.3110.2178.0682.6710.20
21021569-102156988.08288.48
31038383-103838389.53289.92
4790652-79065268.17268.48
51032580-103258089.03289.39
6943434-94343481.34581.69
45min11019225-101922587.88092.807.7788.4193.347.76
21099297-109929794.78495.38
31119956-111995696.56597.15
4938711-93871180.93881.40
51172658-1172658101.110101.66
61108019-110801995.53696.06
60min11074735-107473592.66697.667.4193.3998.417.41
21151122-115112299.253100.06
31168287-1168287100.733101.53
4996191-99619185.89486.54
51232501-1232501106.269107.05
61172941-1172941101.134101.87
极限11225242-1225242105.643106.762.53106.58107.722.51
21204006-1204006103.812104.84
31221725-1221725105.340106.36
41223655-1223655105.507106.34
51277816-1277816110.177111.19
61276697-1276697110.080111.04
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数125
标示量(mg)200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%
128.011158579115702311561561156331115421411564610.14
228.011185597118441611850060.08
单位质量响应值RSD%判断
41287.4342306.531.73数据可信
包装光照-供试品溶液-TYN28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%
5min1165716-16571614.27514.2813.7214.2814.2813.73
2129302-12930211.13911.14
3183392-18339215.79815.80
4155133-15513313.36413.36
5194646-19464616.76716.77
6166705-16670514.36114.36
10min1404397-40439734.83636.894.6234.8736.924.62
2459471-45947139.58039.61
3439227-43922737.83737.87
4426575-42657536.74736.78
5428440-42844036.90736.94
6411241-41124135.42635.46
15min1568249-56824948.95152.828.8349.0652.948.81
2710327-71032761.19061.30
3581570-58157050.09850.22
4643112-64311255.40055.51
5591072-59107250.91751.04
6584669-58466950.36550.48
20min1749669-74966964.57964.256.9764.8064.486.96
2840768-84076872.42772.68
3712235-71223561.35461.58
4759552-75955265.43065.66
5707734-70773460.96761.20
6704874-70487460.72060.94
30min1933461-93346180.41281.418.1580.7781.788.13
21078281-107828192.88793.30
3988246-98824685.13185.50
4901170-90117077.63078.01
5867244-86724474.70775.08
6901600-90160077.66778.02
45min11051381-105138190.57091.898.1191.1192.448.09
21174711-1174711101.194101.81
31173535-1173535101.092101.65
41012451-101245187.21687.77
5977398-97739884.19684.73
61010680-101068087.06387.59
60min11104974-110497495.18696.517.6995.9397.277.67
21222087-1222087105.275106.12
31232933-1232933106.209106.99
41064749-106474991.72192.47
51033126-103312688.99789.72
61064325-106432591.68592.41
极限11219491-1219491105.051106.512.81106.00107.482.83
21282473-1282473110.477111.55
31274352-1274352109.777110.79
41223376-1223376105.386106.34
51193325-1193325102.797103.72
61225219-1225219105.545106.47
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