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%
128.201165899116500511651321164628116387811649080.07
227.991173813117322411735180.04
单位质量响应值RSD%判断
41308.7941926.331.05数据可信
供试品溶液-2024032721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%
5min1419843-41984370.45782.278.9470.4682.278.94
2463880-46388077.84777.85
3498860-49886083.71883.72
4537673-53767390.23190.23
5530524-53052489.03189.03
6490613-49061382.33482.33
10min1866543-866543145.421147.392.36145.54147.532.37
2867901-867901145.649145.78
3854168-854168143.345143.48
4913526-913526153.306153.46
5886065-886065148.697148.85
6881499-881499147.931148.07
15min11123274-1123274188.505184.012.41188.87184.392.41
21096260-1096260183.972184.34
31051756-1051756176.503176.88
41114951-1114951187.109187.51
51110705-1110705186.396186.79
61081822-1081822181.549181.93
20min11247944-1247944209.427201.842.43210.10202.532.42
21204299-1204299202.103202.78
31157900-1157900194.316194.99
41212766-1212766203.524204.24
51199434-1199434201.286201.99
61194150-1194150200.400201.09
30min11286179-1286179215.844211.281.38216.87212.301.38
21245020-1245020208.936209.95
31237526-1237526207.679208.68
41262976-1262976211.950213.01
51254973-1254973210.607211.65
61267119-1267119212.645213.67
45min11302625-1302625218.604214.991.13219.99216.371.13
21265801-1265801212.424213.79
31265820-1265820212.427213.77
41286539-1286539215.904217.31
51277018-1277018214.306215.70
61288711-1288711216.269217.64
60min11306923-1306923219.325216.780.88221.07218.510.88
21276442-1276442214.210215.93
31282680-1282680215.256216.95
41297072-1297072217.672219.44
51288604-1288604216.251218.00
61298656-1298656217.938219.67
极限11315827-1315827220.819221.070.43222.93223.170.42
21308718-1308718219.626221.70
31323878-1323878222.170224.23
41322613-1322613221.958224.09
51314864-1314864220.657222.77
61318062-1318062221.194223.29
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%
128.202016151201557120135512013853201437120146990.06
227.992023152202305820231050.01
单位质量响应值RSD%判断
71443.2372279.560.83数据可信
供试品溶液-2024032721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%
5min1715513-71551365.69877.039.1865.7077.039.18
2793019-79301972.81572.81
3856973-85697378.68778.69
4922637-92263784.71684.72
5909362-90936283.49783.50
6836104-83610476.77176.77
10min11490949-1490949136.898138.702.40137.01138.832.41
21492941-1492941137.081137.20
31467103-1467103134.709134.84
41571900-1571900144.331144.47
51523960-1523960139.929140.07
61516858-1516858139.277139.41
15min11930985-1930985177.302173.092.45177.64173.452.44
21885505-1885505173.126173.48
31806181-1806181165.843166.20
41917666-1917666176.079176.46
51909750-1909750175.352175.72
61860367-1860367170.818171.18
20min12151388-2151388197.539190.032.56198.17190.682.55
22072903-2072903190.333190.97
31987717-1987717182.511183.14
42086700-2086700191.600192.28
52063948-2063948189.511190.18
62054890-2054890188.679189.32
30min12219385-2219385203.783199.071.44204.75200.041.44
22143460-2143460196.811197.77
32130709-2130709195.641196.58
42173192-2173192199.541200.54
52161102-2161102198.431199.41
62180696-2180696200.230201.19
45min12245448-2245448206.176202.601.16207.48203.901.15
22179431-2179431200.114201.40
32181011-2181011200.259201.52
42214451-2214451203.330204.66
52198545-2198545201.869203.18
62220450-2220450203.881205.17
60min12253897-2253897206.952204.270.91208.60205.910.91
22198097-2198097201.828203.45
32210454-2210454202.963204.56
42231982-2231982204.940206.61
52217399-2217399203.601205.25
62236420-2236420205.347206.98
极限12273430-2273430208.745208.920.43210.74210.900.42
22261588-2261588207.658209.61
32290211-2290211210.286212.22
42280376-2280376209.383211.39
52270655-2270655208.490210.48
62275718-2275718208.955210.93
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%
128.201163056116356811640261163433116292611634020.04
227.991170195116716611686800.19
单位质量响应值RSD%判断
41255.3941753.480.85数据可信
供试品溶液-2024032821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%
5min1534304-53430489.90883.2112.5789.9183.2112.57
2451282-45128275.93875.94
3419685-41968570.62170.62
4582728-58272898.05798.06
5524183-52418388.20588.21
6454714-45471476.51676.52
10min1893582-893582150.365149.074.80150.51149.204.80
2840933-840933141.505141.63
3849145-849145142.887143.00
4939538-939538158.098158.26
5931347-931347156.720156.87
6860709-860709144.833144.96
15min11043888-1043888175.657183.134.02176.06183.524.02
21048440-1048440176.423176.79
31075539-1075539180.983181.34
41149969-1149969193.508193.93
51132383-1132383190.548190.96
61079599-1079599181.666182.04
20min11155490-1155490194.437200.191.97195.13200.891.97
21175178-1175178197.749198.41
31184852-1184852199.377200.03
41216679-1216679204.733205.48
51192151-1192151200.606201.33
61213908-1213908204.267204.94
30min11291395-1291395217.306211.091.68218.32212.121.67
21255188-1255188211.213212.20
31239275-1239275208.535209.52
41251356-1251356210.568211.66
51230347-1230347207.033208.09
61259244-1259244211.895212.91
45min11323475-1323475222.704217.821.60224.08219.191.59
21298751-1298751218.543219.88
31277725-1277725215.005216.34
41305603-1305603219.696221.14
51265151-1265151212.889214.29
61295852-1295852218.056219.42
60min11320861-1320861222.264220.010.89224.01221.760.89
21313270-1313270220.986222.69
31298445-1298445218.492220.19
41314937-1314937221.267223.07
51289434-1289434216.976218.74
61307997-1307997220.099221.83
极限11315565-1315565221.373221.270.44223.49223.380.43
21324170-1324170222.821224.89
31307850-1307850220.074222.13
41316798-1316798221.580223.76
51310394-1310394220.503222.62
61314939-1314939221.267223.36
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%
128.202011500201241220132462012115201159820121740.04
227.992022047202021120211290.07
单位质量响应值RSD%判断
71353.6972208.970.85数据可信
供试品溶液-2024032821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%
5min1917501-91750184.33977.9412.7884.3477.9412.78
2772359-77235970.99771.00
3717047-71704765.91265.91
41001345-100134592.04692.05
5899668-89966882.69982.70
6779120-77912071.61871.62
10min11539515-1539515141.515140.174.84141.66140.304.84
21447627-1447627133.069133.19
31461344-1461344134.330134.44
41618417-1618417148.768148.92
51603010-1603010147.352147.49
61479520-1479520136.001136.12
15min11793188-1793188164.834172.134.14165.21172.504.15
21802635-1802635165.702166.04
31849550-1849550170.015170.35
41981741-1981741182.166182.57
51951040-1951040179.344179.73
61857448-1857448170.741171.09
20min11986057-1986057182.563188.292.04183.21188.942.04
22022172-2022172185.882186.50
32041761-2041761187.683188.30
42094737-2094737192.553193.26
52054116-2054116188.819189.50
62091555-2091555192.260192.89
30min12225783-2225783204.599198.501.73205.55199.471.71
22160293-2160293198.579199.50
32135625-2135625196.311197.24
42148339-2148339197.480198.51
52117668-2117668194.660195.66
62169056-2169056199.384200.34
45min12288410-2288410210.355205.111.67211.65206.411.66
22238312-2238312205.750207.01
32203192-2203192202.522203.78
42245108-2245108206.375207.73
52180063-2180063200.396201.72
62233197-2233197205.280206.56
60min12282615-2282615209.823207.221.01211.47208.861.01
22262262-2262262207.952209.55
32240543-2240543205.955207.55
42267179-2267179208.404210.10
52217493-2217493203.837205.49
62255847-2255847207.362208.99
极限12273079-2273079208.946208.810.47210.94210.790.47
22288661-2288661210.379212.33
32258497-2258497207.606209.54
42276036-2276036209.218211.26
52263103-2263103208.029210.02
62270037-2270037208.667210.64
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%
128.201166415116755511667521167542116900411674540.09
227.991161654116186611617600.02
单位质量响应值RSD%判断
41399.0841506.250.19数据可信
供试品溶液-2024032921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%
5min1569763-56976395.99287.838.2195.9987.838.21
2529788-52978889.25789.26
3451688-45168876.09976.10
4560290-56029094.39694.40
5505917-50591785.23585.24
6510482-51048286.00486.00
10min1964430-964430162.484152.424.06162.64152.574.06
2884572-884572149.029149.18
3854779-854779144.010144.14
4905869-905869152.617152.77
5919698-919698154.947155.09
6898895-898895151.443151.59
15min11170699-1170699197.235187.273.38197.67187.673.38
21083748-1083748182.586182.98
31060632-1060632178.691179.06
41114890-1114890187.833188.24
51116418-1116418188.090188.49
61122809-1122809189.167189.56
20min11289836-1289836217.307205.043.40218.07205.753.40
21183693-1183693199.424200.13
31200487-1200487202.254202.92
41195353-1195353201.389202.11
51189902-1189902200.470201.18
61242875-1242875209.395210.11
30min11338486-1338486225.503214.323.41226.62215.383.41
21301371-1301371219.250220.28
31234251-1234251207.942208.94
41227327-1227327206.776207.84
51248065-1248065210.269211.32
61283243-1283243216.196217.26
45min11337132-1337132225.275219.292.36226.77220.702.36
21328062-1328062223.747225.15
31268227-1268227213.666215.01
41268084-1268084213.642215.05
51288593-1288593217.097218.50
61319449-1319449222.296223.72
60min11332349-1332349224.469220.901.46226.34222.681.46
21326362-1326362223.461225.23
31290843-1290843217.476219.18
41288608-1288608217.100218.86
51304814-1304814219.830221.59
61324112-1324112223.082224.87
极限11329860-1329860224.050223.030.51226.30225.180.52
21320839-1320839222.530224.67
31323270-1323270222.940225.01
41313064-1313064221.220223.34
51331784-1331784224.374226.50
61324139-1324139223.086225.25
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0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.202019674202042420194782019693202131220201160.04
227.992009281200970620094940.02
单位质量响应值RSD%判断
71635.3271793.280.16数据可信
供试品溶液-2024032921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%
5min1979791-97979190.14682.328.4090.1582.328.40
2909485-90948583.67783.68
3772931-77293171.11371.11
4963866-96386688.68088.68
5866383-86638379.71179.71
6875917-87591780.58980.59
10min11660449-1660449152.769143.244.16152.92143.384.16
21520034-1520034139.851139.99
31468118-1468118135.074135.19
41560156-1560156143.542143.69
51585809-1585809145.902146.03
61546964-1546964142.328142.46
15min12018800-2018800185.739176.033.56186.14176.403.56
21862970-1862970171.402171.77
31819364-1819364167.390167.73
41920314-1920314176.678177.07
51924534-1924534177.066177.44
61933405-1933405177.883178.25
20min12219124-2219124204.170192.673.44204.88193.343.43
22037646-2037646187.473188.13
32064922-2064922189.983190.61
42053984-2053984188.977189.66
52046791-2046791188.315188.99
62142062-2142062197.080197.75
30min12311689-2311689212.687201.633.54213.74202.623.53
22242501-2242501206.321207.29
32123780-2123780195.398196.34
42113151-2113151194.420195.42
52148097-2148097197.635198.62
62209724-2209724203.305204.30
45min12310092-2310092212.540206.502.44213.95207.832.44
22289972-2289972210.689212.00
32185648-2185648201.090202.36
42185525-2185525201.079202.40
52219714-2219714204.224205.54
62275720-2275720209.377210.71
60min12301998-2301998211.795208.061.59213.56209.731.59
22288457-2288457210.549212.21
32223453-2223453204.568206.17
42218612-2218612204.123205.78
52249867-2249867206.999208.65
62286010-2286010210.324212.01
极限12298413-2298413211.465210.560.54213.58212.580.55
22283473-2283473210.091212.11
32288638-2288638210.566212.51
42268671-2268671208.729210.72
52304076-2304076211.986213.99
62288215-2288215210.527212.56
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%
128.201180147117859811769761174241117751211774950.19
227.991182726117866611806960.25
单位质量响应值RSD%判断
41755.1442182.780.73数据可信
供试品溶液-2024032921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%
5min135487-354875.9055.3012.875.915.3012.84
226069-260694.3384.34
337105-371056.1756.17
429737-297374.9484.95
529854-298544.9684.97
632988-329885.4895.49
10min151564-515648.5817.4644.888.597.4644.81
243218-432187.1927.20
381869-8186913.62413.63
429433-294334.8984.91
530220-302205.0295.04
632529-325295.4135.42
15min1124040-12404020.64114.9235.5220.6714.9535.50
285291-8529114.19314.21
3124586-12458620.73220.77
444894-448947.4717.49
564711-6471110.76810.79
694575-9457515.73815.76
20min1135654-13565422.57421.1820.1122.6321.2320.10
2121935-12193520.29120.33
3161101-16110126.80826.88
4144015-14401523.96523.99
5113250-11325018.84618.88
687827-8782714.61514.66
30min1148481-14848124.70831.3612.5024.8031.4412.46
2183011-18301130.45430.53
3206854-20685434.42234.53
4185157-18515730.81230.88
5190802-19080231.75131.82
6216587-21658736.04236.11
45min1231960-23196038.60041.1217.6538.7441.2517.59
2217704-21770436.22836.36
3240913-24091340.09040.26
4207553-20755334.53834.66
5255172-25517242.46342.58
6329232-32923254.78754.92
60min1280486-28048646.67548.5015.0446.8848.7014.99
2236503-23650339.35639.54
3258507-25850743.01843.25
4298170-29817049.61849.80
5314330-31433052.30752.50
6360819-36081960.04360.26
极限1464282-46428277.26076.494.1077.5476.774.11
2426243-42624370.93071.18
3472750-47275078.66978.98
4470287-47028778.25978.52
5449206-44920674.75175.03
6475048-47504879.05279.37
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%
128.202033521203147920275742027349202981920299480.13
227.992043792203878020412860.18
单位质量响应值RSD%判断
71983.9772929.120.93数据可信
供试品溶液-2024032921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%
5min162030-620305.6495.0912.255.655.0912.22
245408-454084.1354.14
363810-638105.8115.81
452488-524884.7804.78
553386-533864.8624.86
658445-584455.3225.32
10min194035-940358.5637.4746.488.577.4846.43
280315-803157.3147.32
3152312-15231213.87013.88
452595-525954.7904.80
554565-545654.9694.98
658344-583445.3135.32
15min1235358-23535821.43315.0737.2721.4615.0937.26
2161657-16165714.72114.74
3233775-23377521.28921.32
481988-819887.4667.48
5115811-11581110.54610.56
6164117-16411714.94514.96
20min1257137-25713723.41622.0719.7623.4822.1119.75
2231901-23190121.11821.16
3301027-30102727.41327.48
4278690-27869025.37925.41
5219182-21918219.96019.99
6165985-16598515.11615.16
30min1278258-27825825.34032.6212.9725.4432.7012.92
2346668-34666831.57031.65
3387779-38777935.31435.43
4353708-35370832.21132.28
5367384-36738433.45633.52
6415454-41545437.83437.90
45min1436509-43650939.75142.5018.6639.8942.6418.60
2408468-40846837.19837.33
3443825-44382540.41740.59
4391489-39148935.65135.78
5489317-48931744.56044.68
6630801-63080157.44557.58
60min1523365-52336547.66149.7916.3047.8750.0016.24
2439030-43903039.98140.17
3469347-46934742.74242.98
4564646-56464651.42051.60
5603285-60328554.93955.14
6681093-68109362.02562.25
极限1854708-85470877.83577.284.2778.1277.574.28
2778975-77897570.93871.20
3864924-86492478.76579.08
4873168-87316879.51679.79
5843622-84362276.82577.11
6876389-87638979.80980.14
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