沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数125
标示量(mg)50供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.201170153117066711687121169726116870011695920.08
227.991162983116322011631020.02
单位质量响应值RSD%判断
41474.8941554.200.14数据可信
供试品溶液-2024032421批-缬沙坦钠-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%
5min1464129-46412978.07876.588.4578.0876.588.45
2514835-51483586.60886.61
3444029-44402974.69774.70
4438107-43810773.70173.70
5399504-39950467.20767.21
6470670-47067079.17879.18
10min1876328-876328147.420137.105.80147.55137.235.80
2829669-829669139.571139.72
3821346-821346138.171138.30
4732077-732077123.154123.28
5803662-803662135.196135.31
6826691-826691139.070139.20
15min11112303-1112303187.117175.085.74187.49175.445.74
21079865-1079865181.660182.04
31070452-1070452180.077180.43
4944788-944788158.937159.27
51025811-1025811172.567172.90
61011220-1011220170.113170.48
20min11224949-1224949206.067200.285.29206.75200.925.29
21260591-1260591212.063212.74
31220312-1220312205.287205.94
41091495-1091495183.617184.21
51207504-1207504203.132203.76
61138393-1138393191.506192.15
30min11257521-1257521211.547213.522.76212.58214.502.75
21306578-1306578219.799220.83
31294067-1294067217.694218.69
41284196-1284196216.034216.93
51264973-1264973212.800213.76
61208309-1208309203.268204.23
45min11270009-1270009213.647215.812.04215.03217.142.03
21309466-1309466220.285221.68
31297984-1297984218.353219.71
41298736-1298736218.480219.74
51283237-1283237215.873217.19
61237607-1237607208.197209.50
60min11278271-1278271215.037216.921.55216.78218.621.55
21308367-1308367220.100221.87
31301440-1301440218.935220.66
41303624-1303624219.302220.93
51289636-1289636216.949218.63
61255301-1255301211.173212.83
极限11307078-1307078219.883220.240.48221.98222.300.46
21308212-1308212220.074222.21
31308809-1308809220.174222.26
41321315-1321315222.278224.27
51303938-1303938219.355221.39
61305849-1305849219.677221.68
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数125
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.202026926202618820224832024533202318820246640.10
227.992011574201147620115250.01
单位质量响应值RSD%判断
71796.6071865.840.07数据可信
供试品溶液-2024032421批-沙库巴曲-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%
5min1797190-79719073.22671.848.6173.2371.848.61
2886254-88625481.40781.41
3761796-76179669.97569.97
4752480-75248069.11969.12
5684750-68475062.89862.90
6810190-81019074.42074.42
10min11511665-1511665138.854128.885.98138.98129.005.98
21429254-1429254131.284131.42
31413604-1413604129.847129.96
41255507-1255507115.325115.44
51384598-1384598127.182127.29
61423682-1423682130.772130.90
15min11919651-1919651176.330164.885.92176.68165.225.91
21866855-1866855171.480171.83
31846503-1846503169.611169.94
41622251-1622251149.012149.32
51769260-1769260162.515162.83
61745637-1745637160.346160.69
20min12116496-2116496194.411188.695.39195.06189.305.39
22175749-2175749199.853200.49
32105639-2105639193.414194.03
41878659-1878659172.564173.12
52084553-2084553191.477192.06
61964027-1964027180.406181.01
30min12167729-2167729199.117201.082.82200.09202.012.82
22257328-2257328207.347208.32
32232719-2232719205.086206.02
42212091-2212091203.192204.04
52183034-2183034200.523201.43
62081972-2081972191.240192.15
45min12189868-2189868201.150203.302.11202.45204.562.10
22261698-2261698207.748209.07
32239843-2239843205.741207.02
42240475-2240475205.799206.98
52214733-2214733203.434204.68
62132767-2132767195.905197.13
60min12204425-2204425202.487204.301.62204.13205.901.61
22259226-2259226207.521209.19
32247080-2247080206.406208.03
42246967-2246967206.395207.92
52224369-2224369204.319205.90
62162876-2162876198.671200.23
极限12260387-2260387207.628207.930.54209.60209.870.53
22264084-2264084207.967209.98
32260811-2260811207.667209.63
42287405-2287405210.110211.98
52253812-2253812207.024208.94
62255517-2255517207.181209.07
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数125
标示量(mg)50供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.201166131116556711632411165051116505411650090.10
227.991169122116918411691530.01
单位质量响应值RSD%判断
41312.3841770.380.78数据可信
供试品溶液-2024032521批-缬沙坦钠-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%
5min1332667-33266755.92869.7511.2055.9369.7511.20
2416882-41688270.08770.09
3473816-47381679.65979.66
4405857-40585768.23368.23
5427630-42763071.89471.89
6432290-43229072.67772.68
10min1700186-700186117.716130.806.58117.81130.916.58
2827202-827202139.070139.19
3821117-821117138.047138.18
4749021-749021125.926126.04
5815243-815243137.060137.18
6755113-755113126.951127.07
15min1978723-978723164.544172.976.93164.83173.306.92
21162382-1162382195.421195.77
31034952-1034952173.998174.36
4960029-960029161.401161.72
51021245-1021245171.693172.04
61015636-1015636170.750171.08
20min11104455-1104455185.682194.885.83186.25195.505.82
21264025-1264025212.510213.18
31140800-1140800191.793192.45
41088823-1088823183.054183.65
51141181-1141181191.857192.49
61215513-1215513204.354204.97
30min11211157-1211157203.621210.593.90204.49211.543.91
21316290-1316290221.296222.32
31239370-1239370208.365209.34
41189262-1189262199.940200.84
51264556-1264556212.599213.55
61295160-1295160217.744218.70
45min11261824-1261824212.140215.761.92213.35217.051.94
21319582-1319582221.850223.25
31269141-1269141213.370214.69
41257616-1257616211.432212.66
51289637-1289637216.816218.12
61302205-1302205218.928220.25
60min11290126-1290126216.898217.951.12218.46219.611.14
21321906-1321906222.241224.01
31286603-1286603216.305217.98
41282562-1282562215.626217.21
51293226-1293226217.419219.09
61303829-1303829219.201220.89
极限11318159-1318159221.611221.560.40223.54223.580.39
21321766-1321766222.217224.35
31318855-1318855221.728223.76
41324654-1324654222.703224.65
51311978-1311978220.572222.60
61311706-1311706220.526222.58
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数125
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.202019932201924320153472017263201606220175690.10
227.992023971202358320237770.02
单位质量响应值RSD%判断
71545.0072303.570.75数据可信
供试品溶液-2024032521批-沙库巴曲-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%
5min1566406-56640651.96165.2011.4751.9665.2011.47
2713915-71391565.49465.49
3814148-81414874.68974.69
4695704-69570463.82363.82
5734370-73437067.37067.37
6740041-74004167.89067.89
10min11203972-1203972110.451122.816.66110.54122.926.66
21422220-1422220130.473130.58
31415581-1415581129.864129.99
41286467-1286467118.019118.13
51404589-1404589128.855128.97
61299052-1299052119.173119.29
15min11686021-1686021154.673162.647.10154.94162.957.10
22009256-2009256184.327184.65
31780427-1780427163.334163.67
41650282-1650282151.395151.70
51760785-1760785161.532161.86
61750146-1750146160.556160.87
20min11902366-1902366174.521183.275.93175.05183.865.92
22182232-2182232200.195200.83
31966003-1966003180.359180.97
41873852-1873852171.905172.46
51966739-1966739180.426181.02
62095546-2095546192.243192.82
30min12086026-2086026191.369198.083.99192.19198.963.99
22272015-2272015208.432209.40
32134872-2134872195.850196.76
42047881-2047881187.870188.71
52181116-2181116200.093200.99
62232907-2232907204.844205.74
45min12176755-2176755199.693203.041.98200.83204.261.99
22278068-2278068208.987210.30
32188029-2188029200.727201.97
42166595-2166595198.761199.92
52223633-2223633203.993205.22
62246253-2246253206.068207.31
60min12224708-2224708204.092205.191.20205.56206.751.22
22283253-2283253209.463211.13
32219383-2219383203.603205.18
42210370-2210370202.776204.26
52230964-2230964204.666206.24
62251510-2251510206.551208.14
极限12279347-2279347209.104209.150.39210.92211.050.38
22284445-2284445209.572211.58
32281592-2281592209.310211.22
42293290-2293290210.383212.21
52269595-2269595208.210210.12
62270804-2270804208.321210.25
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数125
标示量(mg)50供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.201168478117035711700371169402116905611694660.07
227.991163827116281011633180.07
单位质量响应值RSD%判断
41470.4341561.910.16数据可信
供试品溶液-2024032621批-缬沙坦钠-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%
5min1396708-39670866.73468.597.9866.7368.597.98
2393246-39324666.15166.15
3399488-39948867.20167.20
4397743-39774366.90866.91
5473389-47338979.63379.63
6385882-38588264.91364.91
10min1710064-710064119.446121.604.69119.56121.724.69
2682470-682470114.804114.91
3735858-735858123.785123.90
4761373-761373128.077128.19
5757602-757602127.443127.58
6689872-689872116.049116.16
15min1905048-905048152.246157.934.99152.56158.254.99
2911142-911142153.271153.57
3984498-984498165.611165.93
41002807-1002807168.691169.02
5944105-944105158.816159.16
6885383-885383148.938149.24
20min11022833-1022833172.059180.735.43172.62181.315.42
21062531-1062531178.737179.29
31146573-1146573192.875193.47
41142311-1142311192.158192.76
51062581-1062581178.746179.36
61009552-1009552169.825170.38
30min11174334-1174334197.545199.973.75198.40200.853.75
21183592-1183592199.102199.96
31263172-1263172212.489213.40
41199854-1199854201.838202.76
51185951-1185951199.499200.41
61125548-1125548189.338190.17
45min11247725-1247725209.890211.251.76211.07212.461.76
21266600-1266600213.066214.25
31294300-1294300217.725219.00
41231084-1231084207.091208.35
51250184-1250184210.304211.54
61244813-1244813209.401210.55
60min11288742-1288742216.790216.821.39218.32218.381.38
21299034-1299034218.522220.06
31309287-1309287220.246221.88
41256803-1256803211.418213.03
51293792-1293792217.640219.23
61285679-1285679216.275217.77
极限11340467-1340467225.491225.590.84227.38227.520.82
21348154-1348154226.784228.69
31335853-1335853224.715226.72
41321574-1321574222.313224.27
51351826-1351826227.402229.36
61348411-1348411226.828228.69
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数125
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.202023140202397420208782021946201979320219460.09
227.992015586201374520146660.07
单位质量响应值RSD%判断
71700.2171978.060.28数据可信
供试品溶液-2024032621批-沙库巴曲-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%
5min1678914-67891462.35564.138.1762.3664.138.16
2673337-67333761.84361.84
3683721-68372162.79762.80
4681100-68110062.55662.56
5813159-81315974.68574.68
6659024-65902460.52860.53
10min11218123-1218123111.879113.984.84111.98114.084.84
21170137-1170137107.471107.57
31262623-1262623115.966116.07
41310409-1310409120.355120.46
51302024-1302024119.585119.71
61182548-1182548108.611108.71
15min11556855-1556855142.990148.305.11143.28148.595.11
21565527-1565527143.786144.07
31693665-1693665155.555155.85
41728036-1728036158.712159.02
51624215-1624215149.176149.50
61519502-1519502139.559139.84
20min11754405-1754405161.134169.745.56161.66170.295.55
21830450-1830450168.118168.64
31972330-1972330181.149181.71
41969510-1969510180.890181.46
51828401-1828401167.930168.50
61733881-1733881159.249159.76
30min12022299-2022299185.738187.903.75186.54188.733.75
22038322-2038322187.210188.01
32172913-2172913199.572200.43
42065259-2065259189.684190.56
52041098-2041098187.465188.32
61935417-1935417177.759178.54
45min12146271-2146271197.125198.661.85198.23199.801.85
22184165-2184165200.605201.72
32232312-2232312205.027206.22
42119634-2119634194.678195.87
52154353-2154353197.867199.03
62141311-2141311196.669197.75
60min12222250-2222250204.103204.001.35205.54205.471.34
22233365-2233365205.124206.57
32257537-2257537207.344208.88
42167631-2167631199.087200.60
52230618-2230618204.872206.37
62215026-2215026203.440204.84
极限12318000-2318000212.897213.030.85214.67214.840.83
22329835-2329835213.984215.77
32310892-2310892212.244214.12
42285336-2285336209.897211.74
52338351-2338351214.766216.60
62334345-2334345214.398216.14
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数125
标示量(mg)50供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.201172415116981711723851171652117269211717920.10
227.991186669118849811875840.11
单位质量响应值RSD%判断
41552.9142428.871.48数据可信
供试品溶液-2024032621批-缬沙坦钠-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min14614-46140.7670.5078.820.770.5078.87
2-0.0000.00
33690-36900.6140.61
4-0.0000.00
55001-50010.8320.83
64673-46730.7770.78
10min18010-80101.3323.65104.881.333.65104.84
263170-6317010.50710.51
33271-32710.5440.55
45783-57830.9620.96
518074-180743.0063.01
633406-334065.5575.56
15min136446-364466.06211.8933.876.0711.9033.87
2109772-10977218.25918.28
375409-7540912.54312.55
480640-8064013.41313.41
564566-6456610.74010.75
662036-6203610.31910.33
20min174264-7426412.35316.8024.2312.3716.8324.24
2140839-14083923.42623.47
396530-9653016.05616.08
4117967-11796719.62219.65
593652-9365215.57815.60
682802-8280213.77313.80
30min1130173-13017321.65229.6030.7121.6929.6630.70
2266999-26699944.41144.50
3159652-15965226.55626.61
4219902-21990236.57736.63
5161762-16176226.90726.96
6129369-12936921.51921.57
45min1196328-19632832.65639.5023.0032.7339.6023.00
2291478-29147848.48348.64
3265147-26514744.10344.20
4294876-29487649.04849.17
5215181-21518135.79235.89
6161684-16168426.89426.98
60min1216978-21697836.09144.2617.4936.2244.4317.50
2303440-30344050.47350.71
3298545-29854549.65849.83
4318710-31871053.01353.21
5245509-24550940.83740.99
6213452-21345235.50435.64
极限1433752-43375272.14873.435.6072.3373.675.61
2443722-44372273.80674.13
3473377-47337778.73978.99
4462987-46298777.01177.30
5404283-40428367.24667.47
6430619-43061971.62771.82
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数125
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.202025448202262920256082026399202596220252090.08
227.992043501204510320443020.06
单位质量响应值RSD%判断
71815.9273036.871.20数据可信
供试品溶液-2024032621批-沙库巴曲-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.13244.950.000.13244.95
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
68421-84210.7670.77
10min115226-152261.3873.99105.331.393.99105.29
2126117-12611711.49011.49
36009-60090.5470.55
411641-116411.0611.06
536875-368753.3603.36
666852-668526.0916.09
15min171288-712886.49512.9333.006.5012.9333.01
2213297-21329719.43319.45
3150364-15036413.69913.70
4160946-16094614.66314.67
5132137-13213712.03912.04
6123293-12329311.23311.24
20min1145519-14551913.25818.0523.2213.2718.0823.24
2270763-27076324.66824.72
3189362-18936217.25217.28
4231781-23178121.11721.14
5187985-18798517.12717.15
6163195-16319514.86814.90
30min1253670-25367023.11131.6229.9523.1531.6829.94
2514122-51412246.84046.93
3310465-31046528.28528.34
4428717-42871739.05939.12
5322152-32215229.35029.40
6253509-25350923.09623.15
45min1376398-37639834.29241.5822.6234.3741.6922.61
2553551-55355150.43250.60
3513789-51378946.81046.91
4563808-56380851.36751.49
5420133-42013338.27738.38
6310619-31061928.29928.39
60min1409147-40914737.27646.1017.1237.4146.2817.13
2570225-57022551.95152.21
3570908-57090852.01452.19
4601882-60188254.83555.05
5476102-47610243.37643.54
6407623-40762337.13737.28
极限1805086-80508673.34975.185.3573.5475.445.37
2816711-81671174.40874.75
3889637-88963781.05281.32
4865445-86544578.84879.15
5769996-76999670.15270.39
6804344-80434473.28173.48
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