沙库巴曲缬沙坦钠片项目信息
介质体积(ml)1000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1000
标示量(mg)10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%
128.011146565114561511450031146264114703811460970.07
228.021148953114871311488330.02
单位质量响应值RSD%判断
40917.4241000.460.15数据可信
影响因素30天-包装高温-供试品溶液-TYN28批-缬沙坦-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%
5min1266068-26606864.96073.3811.3564.9673.3811.35
2290908-29090871.02471.02
3338425-33842582.62682.63
4257428-25742862.85062.85
5322365-32236578.70578.70
6328044-32804480.09180.09
10min1595948-595948145.499152.823.27145.63152.973.27
2622807-622807152.057152.20
3654607-654607159.820159.99
4615380-615380150.243150.37
5625445-625445152.701152.86
6641514-641514156.624156.78
15min1887923-887923216.784213.884.49217.20214.334.48
2842110-842110205.599206.04
3850049-850049207.537208.02
4868181-868181211.964212.39
5858574-858574209.618210.08
6949364-949364231.785232.26
20min11124354-1124354274.508260.555.82275.36261.435.80
21064566-1064566259.911260.77
3994418-994418242.784243.68
41063270-1063270259.594260.44
51006061-1006061245.627246.51
61150470-1150470280.884281.82
30min11294817-1294817316.126296.554.44317.53297.964.43
21204155-1204155293.991295.37
31167860-1167860285.130286.52
41223386-1223386298.686300.06
51147858-1147858280.246281.62
61249831-1249831305.143306.64
45min11294726-1294726316.104308.182.28318.14310.182.27
21295313-1295313316.247318.21
31237384-1237384302.104304.06
41268828-1268828309.781311.75
51228621-1228621299.964301.90
61248810-1248810304.893307.00
60min11292162-1292162315.478310.782.11318.15313.392.10
21302490-1302490317.999320.60
31250878-1250878305.398307.96
41296896-1296896316.633319.22
51247316-1247316304.529307.06
61247754-1247754304.636307.35
极限11289323-1289323314.785313.161.82318.08316.391.80
21301747-1301747317.818321.05
31278216-1278216312.073315.24
41310045-1310045319.844323.06
51271755-1271755310.495313.64
61244959-1244959303.953307.28
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)1000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1000
标示量(mg)10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%
128.011960294195843619579991960466195899419592380.06
228.021961377196048019609280.04
单位质量响应值RSD%判断
69947.8069983.150.04数据可信
影响因素30天-包装高温-供试品溶液-TYN28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%
5min1449391-44939164.23072.5611.6664.2372.5611.66
2488613-48861369.83669.84
3574136-57413682.06082.06
4432727-43272761.84961.85
5545426-54542677.95677.96
6555520-55552079.39979.40
10min11011946-1011946144.635151.893.25144.76152.033.26
21057125-1057125151.092151.23
31111717-1111717158.895159.06
41045910-1045910149.489149.61
51061020-1061020151.649151.80
61088424-1088424155.566155.72
15min11512702-1512702216.207213.094.62216.62213.544.61
21433123-1433123204.833205.27
31441779-1441779206.070206.55
41479315-1479315211.435211.86
51459810-1459810208.647209.11
61618774-1618774231.368231.84
20min11918140-1918140274.155259.836.00275.01260.715.99
21815338-1815338259.462260.31
31687852-1687852241.241242.13
41811807-1811807258.957259.80
51711334-1711334244.597245.47
61963122-1963122280.584281.52
30min12213659-2213659316.393295.794.66317.79297.184.65
22051509-2051509293.217294.59
31984384-1984384283.623285.00
42082139-2082139297.595298.96
51951690-1951690278.950280.32
62133486-2133486304.934306.43
45min12210188-2210188315.897307.572.45317.93309.562.44
22212641-2212641316.248318.20
32103842-2103842300.697302.64
42163802-2163802309.267311.23
52089599-2089599298.661300.59
62131409-2131409304.637306.74
60min12205144-2205144315.176310.232.20317.84312.832.18
22224966-2224966318.009320.60
32129732-2129732304.398306.94
42210478-2210478315.938318.52
52123268-2123268303.474305.99
62129537-2129537304.370307.08
极限12201655-2201655314.677313.151.85317.97316.371.83
22224699-2224699317.971321.20
32183119-2183119312.028315.18
42238482-2238482319.941323.15
52172133-2172133310.458313.59
62125617-2125617303.809307.13
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)1000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1000
标示量(mg)10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%
128.011147935114735811485361148364114730311478990.05
228.021150401115040311504020.01
单位质量响应值RSD%判断
40981.7641056.460.13数据可信
影响因素30天-包装高温-供试品溶液-TYN28批-缬沙坦-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%
5min1249897-24989760.92265.0610.3260.9265.0610.32
2277020-27702067.53467.53
3272462-27246266.42366.42
4306235-30623574.65774.66
5224480-22448054.72654.73
6271046-27104666.07866.08
10min1562619-562619137.160149.354.74137.28149.484.74
2613054-613054149.456149.59
3628327-628327153.179153.31
4646694-646694157.657157.81
5600259-600259146.337146.45
6624665-624665152.286152.42
15min1849146-849146207.012214.112.44207.41214.542.44
2885726-885726215.930216.36
3910004-910004221.849222.29
4882486-882486215.140215.61
5882261-882261215.086215.49
6859991-859991209.656210.09
20min11025846-1025846250.090261.273.59250.90262.133.58
21040198-1040198253.589254.45
31075285-1075285262.143263.03
41123094-1123094273.798274.69
51109127-1109127270.393271.23
61056785-1056785257.633258.49
30min11270704-1270704309.784305.243.56311.09306.613.55
21276046-1276046311.086312.46
31212925-1212925295.698297.10
41302720-1302720317.589319.03
51266418-1266418308.739310.11
61183488-1183488288.521289.89
45min11279037-1279037311.815311.192.44313.75313.192.44
21289168-1289168314.285316.28
31246162-1246162303.801305.80
41304089-1304089317.923320.00
51308461-1308461318.988320.98
61232038-1232038300.357302.31
60min11275803-1275803311.027312.111.78313.58314.721.78
21287959-1287959313.990316.61
31262897-1262897307.880310.49
41301443-1301443317.278319.99
51306156-1306156318.426321.06
61247174-1247174304.047306.60
极限11274653-1274653310.746314.411.06313.92317.651.06
21287590-1287590313.900317.15
31297253-1297253316.256319.48
41297545-1297545316.327319.68
51307429-1307429318.737322.00
61273610-1273610310.492313.65
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)1000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1000
标示量(mg)10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%
128.011966148196567019662051965113196344219653160.06
228.021966718196651719666180.01
单位质量响应值RSD%判断
70164.8070186.220.03数据可信
影响因素30天-包装高温-供试品溶液-TYN28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%
5min1420096-42009659.86464.1010.5759.8664.1010.57
2468069-46806966.70066.70
3460027-46002765.55465.55
4517688-51768873.77073.77
5376838-37683853.69953.70
6456398-45639865.03765.04
10min1953296-953296135.845148.344.90135.96148.474.91
21040725-1040725148.303148.44
31069346-1069346152.382152.51
41101122-1101122156.910157.06
51019559-1019559145.287145.39
61061892-1061892151.319151.45
15min11446178-1446178206.080213.232.45206.47213.652.45
21508985-1508985215.030215.46
31550381-1550381220.929221.36
41502980-1502980214.174214.64
51504181-1504181214.346214.74
61465247-1465247208.797209.23
20min11747633-1747633249.037260.073.49249.84260.923.48
21772437-1772437252.572253.43
31832141-1832141261.080261.96
41902839-1902839271.154272.04
51894056-1894056269.903270.73
61801350-1801350256.692257.54
30min12166948-2166948308.790304.183.68310.09305.563.66
22176265-2176265310.117311.48
32064979-2064979294.259295.66
42224603-2224603317.006318.44
52160233-2160233307.833309.20
62014700-2014700287.094288.46
45min12183681-2183681311.174310.302.61313.09312.282.60
22201484-2201484313.711315.70
32121044-2121044302.248304.24
42228259-2228259317.527319.59
52234102-2234102318.359320.34
62096566-2096566298.760300.70
60min12180074-2180074310.660311.271.93313.20313.871.93
22198431-2198431313.276315.89
32149279-2149279306.272308.86
42224452-2224452316.984319.69
52230277-2230277317.814320.43
62123473-2123473302.595305.13
极限12177920-2177920310.353314.011.06313.52317.241.06
22199652-2199652313.450316.69
32216521-2216521315.854319.06
42217383-2217383315.977319.31
52233784-2233784318.314321.57
62176412-2176412310.138313.28
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)1000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1000
标示量(mg)10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%
128.011158211115862611586591155834115593511574530.13
228.021171555117046211710080.07
单位质量响应值RSD%判断
41322.8541791.860.80数据可信
影响因素30天-包装高温-供试品溶液-TYN28批-缬沙坦-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%
5min1233200-23320056.11762.949.0656.1262.949.06
2257087-25708761.86561.87
3296811-29681171.42471.42
4275830-27583066.37566.38
5267267-26726764.31564.31
6239099-23909957.53757.54
10min1555831-555831133.755146.205.92133.87146.335.91
2601951-601951144.853144.98
3652421-652421156.998157.14
4620393-620393149.291149.42
5579424-579424139.432139.56
6635379-635379152.897153.01
15min1820110-820110197.350205.134.13197.73205.544.12
2836598-836598201.318201.73
3836407-836407201.272201.73
4863240-863240207.729208.16
5839836-839836202.097202.50
6918350-918350220.991221.41
20min1959708-959708230.943249.406.86231.72250.236.85
2977610-977610235.251236.07
31016890-1016890244.703245.56
41056648-1056648254.271255.12
51048718-1048718252.362253.17
61158801-1158801278.853279.72
30min11136819-1136819273.563296.226.45274.80297.546.44
21130831-1130831272.122273.41
31272333-1272333306.173307.52
41250244-1250244300.857302.21
51269276-1269276305.437306.75
61326224-1326224319.141320.56
45min11229550-1229550295.878306.914.52297.66308.834.52
21186324-1186324285.476287.31
31306049-1306049314.286316.25
41328107-1328107319.594321.55
51273581-1273581306.473308.40
61328687-1328687319.734321.79
60min11267227-1267227304.944310.353.01307.32312.883.02
21233814-1233814296.904299.31
31306815-1306815314.471317.06
41334985-1334985321.249323.85
51270924-1270924305.834308.37
61324359-1324359318.692321.39
极限11297337-1297337312.190313.402.12315.17316.552.13
21274928-1274928306.797309.79
31306847-1306847314.478317.70
41341871-1341871322.906326.15
51270450-1270450305.720308.87
61322645-1322645318.280321.62
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)1000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1000
标示量(mg)10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%
128.011983754198382619834121977617197817019813560.17
228.021990993199023519906140.03
单位质量响应值RSD%判断
70737.4571042.610.31数据可信
影响因素30天-包装高温-供试品溶液-TYN28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%
5min1388487-38848754.80261.919.4554.8061.909.45
2431103-43110360.81360.81
3500394-50039470.58870.59
4463831-46383165.43065.43
5448795-44879563.30963.31
6400449-40044956.48956.49
10min1939278-939278132.499145.446.14132.61145.576.14
21021272-1021272144.065144.19
31108925-1108925156.430156.57
41052209-1052209148.429148.56
5982407-982407138.582138.71
61082217-1082217152.662152.78
15min11394129-1394129196.662204.394.19197.04204.804.19
21421597-1421597200.536200.95
31420967-1420967200.448200.90
41466688-1466688206.897207.32
51426887-1426887201.283201.69
61563210-1563210220.513220.93
20min11630776-1630776230.044248.776.99230.81249.606.98
21660596-1660596234.251235.06
31730120-1730120244.058244.91
41798048-1798048253.640254.48
51786366-1786366251.992252.80
61975440-1975440278.664279.52
30min11931505-1931505272.466295.806.66273.69297.126.65
21921156-1921156271.006272.29
32169452-2169452306.032307.38
42129096-2129096300.339301.69
52166230-2166230305.578306.89
62264032-2264032319.374320.79
45min12090887-2090887294.949306.554.68296.72308.464.68
22015571-2015571284.325286.15
32227051-2227051314.157316.11
42262274-2262274319.126321.08
52173454-2173454306.597308.52
62269382-2269382320.129322.18
60min12154384-2154384303.906310.093.10306.27312.623.11
22099875-2099875296.217298.61
32228659-2228659314.384316.97
42274297-2274297320.822323.41
52170106-2170106306.124308.66
62261899-2261899319.073321.77
极限12216008-2216008312.599313.782.13315.57316.932.14
22176385-2176385307.010309.99
32231780-2231780314.824318.04
42292139-2292139323.339326.57
52170320-2170320306.154309.30
62259646-2259646318.755322.09
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)1000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1000
标示量(mg)10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%
128.011168887117018411668141166249116647011677210.15
228.021188540118734711879440.08
单位质量响应值RSD%判断
41689.4342396.291.19数据可信
影响因素30天-包装高温-供试品溶液-TYN28批-缬沙坦-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%
5min1274475-27447565.28967.3214.6665.2967.3214.66
2238163-23816356.65256.65
3309917-30991773.72073.72
4343267-34326781.65381.65
5237867-23786756.58156.58
6294397-29439770.02870.03
10min1622834-622834148.153148.289.56148.28148.419.57
2544505-544505129.521129.63
3661815-661815157.425157.57
4708265-708265168.475168.64
5570783-570783135.772135.88
6631896-631896150.309150.45
15min1882004-882004209.802209.186.31210.23209.616.32
2826670-826670196.639197.01
3884587-884587210.416210.88
4946582-946582225.163225.66
5805811-805811191.678192.06
6930685-930685221.381221.82
20min11114604-1114604265.130258.305.75265.98259.155.75
21040920-1040920247.603248.37
31110964-1110964264.264265.15
41146061-1146061272.613273.56
5980804-980804233.303234.07
61122049-1122049266.901267.78
30min11291804-1291804307.281297.645.71308.66299.005.71
21256927-1256927298.984300.25
31286480-1286480306.014307.43
41293140-1293140307.598309.09
51108321-1108321263.636264.87
61270914-1270914302.311303.73
45min11290683-1290683307.014306.391.83309.01308.351.82
21328915-1328915316.108317.97
31285318-1285318305.738307.76
41291329-1291329307.168309.28
51259134-1259134299.509301.27
61272963-1272963302.799304.82
60min11287042-1287042306.148307.421.50308.75310.001.46
21325527-1325527315.302317.79
31283058-1283058305.200307.84
41289011-1289011306.616309.34
51301144-1301144309.502311.86
61268666-1268666301.777304.40
极限11285637-1285637305.814306.771.55309.03309.951.51
21323385-1323385314.793317.91
31278346-1278346304.079307.32
41282950-1282950305.174308.51
51300733-1300733309.404312.38
61266778-1266778301.328304.56
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)1000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1000
标示量(mg)10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%
128.011985094198494619850001984953198507419850130.01
228.022009852200980420098280.01
单位质量响应值RSD%判断
70868.0171728.340.86数据可信
影响因素30天-包装高温-供试品溶液-TYN28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%
5min1462634-46263464.89066.8415.3364.8966.8415.33
2397355-39735555.73355.73
3523304-52330473.39973.40
4582301-58230181.67481.67
5396573-39657355.62455.62
6497015-49701569.71269.71
10min11058826-1058826148.512148.499.69148.64148.629.69
2923396-923396129.517129.63
31125987-1125987157.932158.08
41203594-1203594168.817168.98
5966707-966707135.591135.70
61073584-1073584150.582150.72
15min11497058-1497058209.979209.916.37210.41210.346.38
21408207-1408207197.517197.89
31506750-1506750211.338211.80
41613032-1613032226.246226.75
51369475-1369475192.084192.47
61584790-1584790222.284222.73
20min11900462-1900462266.561259.725.76267.41260.575.76
21774035-1774035248.828249.59
31893468-1893468265.580266.47
41955052-1955052274.218275.17
51672879-1672879234.640235.41
61914166-1914166268.483269.37
30min12204526-2204526309.209299.345.87310.59300.715.87
22143541-2143541300.656301.92
32195864-2195864307.994309.41
42208036-2208036309.702311.20
51883660-1883660264.204265.44
62169470-2169470304.292305.71
45min12204204-2204204309.164308.301.91311.16310.271.90
22268705-2268705318.211320.08
32194968-2194968307.869309.90
42206089-2206089309.429311.55
52144152-2144152300.741302.51
62170325-2170325304.412306.44
60min12198498-2198498308.364309.691.47310.98312.271.44
22263041-2263041317.417319.92
32191726-2191726307.414310.06
42202797-2202797308.967311.71
52223477-2223477311.867314.23
62168006-2168006304.087306.73
极限12196093-2196093308.027308.991.54311.26312.201.50
22261710-2261710317.230320.37
32184601-2184601306.415309.68
42191037-2191037307.317310.68
52219780-2219780311.349314.34
62164477-2164477303.592306.84
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)1000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1000
标示量(mg)10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%
128.011186451118493711846221182631117791611833110.28
228.021198867119859011987280.02
单位质量响应值RSD%判断
42246.0242781.160.90数据可信
影响因素30天-包装光照-供试品溶液-TYN28批-缬沙坦-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%
5min1266331-26633162.64964.4614.6762.6564.4614.67
2324549-32454976.34376.34
3205674-20567448.38048.38
4264774-26477462.28262.28
5284347-28434766.88666.89
6298458-29845870.20670.21
10min1592836-592836139.452143.977.53139.58144.107.54
2669906-669906157.581157.73
3545614-545614128.344128.44
4582859-582859137.105137.23
5638832-638832150.271150.41
6642165-642165151.055151.20
15min1868788-868788204.363208.487.68204.77208.907.68
2937694-937694220.572221.04
3884717-884717208.110208.46
4773748-773748182.007182.41
5879916-879916206.981207.42
6972858-972858228.844229.29
20min11063392-1063392250.140252.807.56250.95253.637.54
21067186-1067186251.032251.94
31135293-1135293267.053267.82
4950764-950764223.647224.41
51043805-1043805245.532246.38
61187677-1187677279.375280.28
30min11216503-1216503286.156284.445.81287.47285.785.79
21149631-1149631270.426271.84
31279270-1279270300.920302.22
41118130-1118130263.016264.23
51195334-1195334281.176282.52
61296399-1296399304.950306.41
45min11281048-1281048301.339297.562.88303.22299.472.89
21252679-1252679294.665296.62
31281215-1281215301.378303.28
41196615-1196615281.478283.21
51282733-1282733301.735303.64
61295598-1295598304.761306.83
60min11292218-1292218303.966301.772.21306.45304.282.22
21272722-1272722299.380301.92
31279904-1279904301.070303.58
41237228-1237228291.031293.33
51323268-1323268311.270313.78
61291968-1291968303.907306.59
极限11297100-1297100305.115304.611.55308.21307.711.53
21280517-1280517301.214304.35
31277450-1277450300.492303.60
41293451-1293451304.256307.14
51332826-1332826313.518316.65
61288282-1288282303.040306.33
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)1000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1000
标示量(mg)10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%
128.012016097201491720162972014919200800020140460.18
228.022025281202472520250030.02
单位质量响应值RSD%判断
71904.5372269.910.36数据可信
影响因素30天-包装光照-供试品溶液-TYN28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%
5min1446207-44620761.89963.9615.2561.9063.9615.24
2549153-54915376.17976.18
3341393-34139347.35947.36
4445886-44588661.85461.85
5480493-48049366.65566.65
6503236-50323669.81069.81
10min11004563-1004563139.355144.107.72139.48144.227.73
21139404-1139404158.060158.21
3923202-923202128.068128.16
4988520-988520137.129137.25
51084434-1084434150.435150.57
61092436-1092436151.545151.68
15min11478786-1478786205.140209.267.85205.54209.677.84
21596837-1596837221.516221.98
31506149-1506149208.936209.29
41312765-1312765182.109182.51
51496757-1496757207.633208.07
61659494-1659494230.208230.65
20min11812946-1812946251.495253.947.70252.31254.777.68
21817114-1817114252.073252.98
31936197-1936197268.593269.36
41614614-1614614223.982224.74
51777174-1777174246.533247.38
62025396-2025396280.966281.87
30min12072697-2072697287.528285.686.02288.84287.026.01
21953159-1953159270.946272.36
32183110-2183110302.845304.15
41899005-1899005263.433264.64
52034731-2034731282.261283.60
62213466-2213466307.056308.52
45min12183394-2183394302.884299.083.02304.78301.003.03
22134188-2134188296.058298.02
32188006-2188006303.524305.44
42033907-2033907282.147283.88
52184349-2184349303.017304.92
62212025-2212025306.856308.94
60min12203602-2203602305.687303.502.29308.18306.012.30
22168751-2168751300.853303.40
32183790-2183790302.939305.46
42106066-2106066292.157294.46
52256883-2256883313.079315.59
62207763-2207763306.265308.96
极限12215208-2215208307.297306.911.53310.41310.031.51
22188965-2188965303.657306.81
32182344-2182344302.739305.86
42209961-2209961306.570309.46
52276588-2276588315.812318.95
62201463-2201463305.391308.70
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)1000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1000
标示量(mg)10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%
128.011166783116734911672811167685116656211671320.04
228.021192827118522811890280.46
单位质量响应值RSD%判断
41668.4042434.981.29数据可信
影响因素30天-包装光照-供试品溶液-TYN28批-缬沙坦-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%
5min1216160-21616051.40869.9016.9251.4169.9016.92
2254958-25495860.63560.63
3329458-32945878.35278.35
4301980-30198071.81871.82
5350414-35041483.33683.34
6310424-31042473.82673.83
10min1524240-524240124.676149.1710.46124.78149.3110.46
2598268-598268142.281142.40
3711809-711809169.284169.44
4609586-609586144.973145.12
5644562-644562153.291153.46
6674970-674970160.523160.67
15min1857870-857870204.021213.418.26204.37213.858.26
2838736-838736199.470199.88
31014061-1014061241.166241.66
4852871-852871202.832203.27
5853198-853198202.910203.38
6967438-967438230.078230.55
20min11046898-1046898248.976255.627.78249.74256.497.78
2958464-958464227.944228.75
31163190-1163190276.633277.61
41117734-1117734265.822266.66
51007698-1007698239.653240.53
61155113-1155113274.712275.64
30min11303540-1303540310.011292.796.26311.27294.176.24
21108735-1108735263.682264.94
31255204-1255204298.516300.05
41311002-1311002311.786313.16
51181695-1181695281.033282.39
61226609-1226609291.715293.19
45min11307859-1307859311.038303.053.53312.92305.023.53
21188917-1188917282.751284.54
31270711-1270711302.203304.33
41312380-1312380312.113314.11
51288720-1288720306.486308.41
61277150-1277150303.735305.80
60min11307138-1307138310.867306.861.74313.37309.421.74
21253719-1253719298.162300.52
31272424-1272424302.611305.34
41309699-1309699311.476314.09
51302023-1302023309.650312.18
61296705-1296705308.385311.05
极限11306003-1306003310.597310.161.29313.72313.341.27
21297774-1297774308.640311.59
31274895-1274895303.199306.54
41306923-1306923310.815314.06
51323231-1323231314.694317.85
61316077-1316077312.992316.28
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)1000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1000
标示量(mg)10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%
128.011999677199849019985911999711199777819988490.05
228.022037169203556120363650.06
单位质量响应值RSD%判断
71361.9872675.411.29数据可信
影响因素30天-包装光照-供试品溶液-TYN28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%
5min1360713-36071350.09068.8517.4450.0968.8517.44
2427628-42762859.38259.38
3556163-55616377.23177.23
4510896-51089670.94570.95
5594386-59438682.53982.54
6525091-52509172.91672.92
10min1887595-887595123.255147.8410.58123.36147.9810.58
21015336-1015336140.994141.11
31209256-1209256167.923168.08
41033718-1033718143.547143.69
51095272-1095272152.094152.26
61146730-1146730159.240159.39
15min11461601-1461601202.964211.918.28203.31212.348.28
21424031-1424031197.747198.15
31724835-1724835239.518240.01
41450753-1450753201.458201.89
51449997-1449997201.353201.82
61644907-1644907228.419228.88
20min11783504-1783504247.665254.147.99248.42255.007.99
21625064-1625064225.664226.46
31984485-1984485275.574276.54
41906487-1906487264.743265.58
51712816-1712816237.849238.72
61968632-1968632273.373274.29
30min12224829-2224829308.950291.096.53310.20292.456.51
21877865-1877865260.769262.02
32141334-2141334297.355298.88
42236799-2236799310.612311.97
52010293-2010293279.158280.51
62086020-2086020289.674291.14
45min12233243-2233243310.118301.463.74311.98303.403.73
22017252-2017252280.124281.89
32167021-2167021300.922303.04
42239722-2239722311.018313.00
52194425-2194425304.727306.63
62173607-2173607301.837303.88
60min12230924-2230924309.796305.451.82312.28308.001.83
22132929-2132929296.188298.52
32171148-2171148301.495304.21
42236819-2236819310.614313.22
52217174-2217174307.887310.40
62208689-2208689306.708309.36
极限12231607-2231607309.891309.421.32313.00312.581.30
22215924-2215924307.713310.63
32177839-2177839302.424305.74
42232431-2232431310.005313.23
52261021-2261021313.975317.11
62250361-2250361312.495315.76
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