沙库巴曲缬沙坦片项目信息
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%
128.011177683117711711771101177426117734611773360.03
227.701141511114112911413200.03
单位质量响应值RSD%判断
42032.7041202.891.41数据可信
供试品溶液-2024032421批-缬沙坦-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%
5min169650-6965011.68912.5790.3511.6912.5790.35
212833-128332.1542.15
3128176-12817621.51121.51
4181921-18192130.53130.53
542141-421417.0727.07
614580-145802.4472.45
10min1380025-38002563.77753.8033.6463.8053.8233.66
2191129-19112932.07632.08
3433753-43375372.79472.83
4433446-43344672.74372.79
5248525-24852541.70941.72
6236427-23642739.67839.68
15min1611671-611671102.65389.5315.88102.7889.6415.91
2430164-43016472.19272.25
3625800-625800105.024105.18
4588481-58848198.76198.93
5467491-46749178.45678.54
6477281-47728180.09980.17
20min1754991-754991126.706116.908.14127.00117.168.17
2648250-648250108.792108.97
3767378-767378128.785129.12
4711625-711625119.428119.76
5663448-663448111.343111.55
6633627-633627106.338106.54
30min1916832-916832153.867146.048.13154.37146.498.14
2840957-840957141.133141.49
3982710-982710164.923165.47
4846153-846153142.005142.54
5856649-856649143.766144.16
6777905-777905130.551130.93
45min1997274-997274167.367159.617.23168.13160.317.25
2906705-906705152.167152.76
31067555-1067555179.162179.98
4927140-927140155.597156.37
5925369-925369155.299155.94
6882393-882393148.087148.69
60min11042823-1042823175.011168.016.35176.05168.986.38
2951860-951860159.745160.59
31109365-1109365186.178187.30
4988697-988697165.927166.96
5968042-968042162.461163.36
6945874-945874158.741159.59
极限11194643-1194643200.490198.112.16201.83199.362.21
21178989-1178989197.863198.98
31218872-1218872204.556205.99
41181791-1181791198.333199.64
51163780-1163780195.310196.48
61144674-1144674192.104193.21
沙库巴曲缬沙坦片项目信息
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%
128.012009407200881820093842009710200923720093110.02
227.701959220195868519589520.02
单位质量响应值RSD%判断
71735.4970720.291.01数据可信
供试品溶液-2024032421批-沙库巴曲-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%
5min181220-812207.5248.2597.907.528.2597.90
210027-100270.9290.93
3155196-15519614.37714.38
4229371-22937121.24821.25
545608-456084.2254.23
613088-130881.2121.21
10min1486616-48661645.07937.9235.5845.0937.9335.60
2237296-23729621.98321.98
3560647-56064751.93751.96
4566116-56611652.44452.48
5310972-31097228.80828.81
6294096-29409627.24427.25
15min1808557-80855774.90364.9117.0474.9964.9817.07
2556576-55657651.56051.60
3829803-82980376.87176.98
4782690-78269072.50772.63
5608055-60805556.32956.38
6618114-61811457.26157.31
20min11019386-101938694.43486.459.1094.6586.649.13
2861498-86149879.80779.93
31037956-103795696.15496.39
4960990-96099089.02489.27
5880839-88083981.59981.75
6838567-83856777.68377.83
30min11276334-1276334118.237111.359.03118.61111.689.04
21163157-1163157107.752108.01
31372467-1372467127.142127.54
41172199-1172199108.590108.98
51170023-1170023108.388108.67
61057722-105772297.98598.26
45min11445777-1445777133.934125.888.53134.50126.408.55
21294390-1294390119.909120.35
31549145-1549145143.509144.12
41326711-1326711122.904123.48
51299279-1299279120.362120.83
61238030-1238030114.688115.12
60min11559131-1559131144.434135.677.97145.22136.407.99
21389462-1389462128.717129.35
31653243-1653243153.153154.00
41439002-1439002133.306134.08
51388359-1388359128.614129.28
61358135-1358135125.815126.44
极限11886760-1886760174.785170.763.14175.82171.713.18
21841915-1841915170.631171.48
31923591-1923591178.197179.30
41844731-1844731170.892171.89
51800656-1800656166.809167.69
61762230-1762230163.249164.09
沙库巴曲缬沙坦片项目信息
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%
128.011137540113762111377821137485113678711374430.04
227.701139496113940911394520.01
单位质量响应值RSD%判断
40608.4641135.450.92数据可信
供试品溶液-2024032521批-缬沙坦-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%
5min154314-543149.28114.2261.389.2814.2261.38
268557-6855711.71511.71
312043-120432.0582.06
480986-8098613.83913.84
5135241-13524123.11023.11
6148139-14813925.31425.31
10min1362353-36235361.91856.1727.1661.9356.2027.17
2367190-36719062.74462.76
3176014-17601430.07730.08
4270662-27066246.25046.27
5419413-41941371.66871.71
6376759-37675964.37964.42
15min1599420-599420102.42792.5513.26102.5592.6713.27
2560226-56022695.73095.85
3419258-41925871.64171.70
4507021-50702186.63886.74
5618347-618347105.661105.82
6545404-54540493.19793.35
20min1744821-744821127.273118.399.56127.56118.669.58
2704829-704829120.439120.72
3601771-601771102.829103.00
4662510-662510113.208113.45
5785628-785628134.246134.58
6657417-657417112.337112.64
30min1842585-842585143.978147.316.48144.48147.786.49
2878492-878492150.114150.60
3789079-789079134.835135.18
4910383-910383155.563156.00
5934738-934738159.725160.28
6817327-817327139.662140.15
45min1939758-939758160.583163.354.90161.32164.064.90
2963596-963596164.656165.39
3904499-904499154.558155.13
41015422-1015422173.512174.20
51003293-1003293171.440172.26
6909151-909151155.353156.08
60min11006164-1006164171.930173.683.67172.94174.663.69
21025748-1025748175.277176.29
3979477-979477167.370168.20
41060451-1060451181.207182.19
51054695-1054695180.223181.33
6971793-971793166.057167.04
极限11184829-1184829202.460204.751.95203.76206.021.96
21228180-1228180209.868211.17
31166962-1166962199.407200.51
41221186-1221186208.672209.96
51187166-1187166202.859204.27
61200990-1200990205.221206.48
沙库巴曲缬沙坦片项目信息
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%
128.011952780195230519521921951394195131619519970.04
227.701954988195470019548440.02
单位质量响应值RSD%判断
69689.2970571.990.90数据可信
供试品溶液-2024032521批-沙库巴曲-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%
5min163384-633845.9649.3966.135.969.3866.15
279794-797947.5087.51
39299-92990.8750.87
493721-937218.8188.82
5167930-16793015.80015.80
6184451-18445117.35417.35
10min1468435-46843544.07339.2628.9044.0839.2728.90
2470434-47043444.26144.27
3214386-21438620.17120.17
4331302-33130231.17131.19
5538415-53841550.65750.68
6480418-48041845.20145.23
15min1803156-80315675.56666.7214.3375.6566.8014.35
2735229-73522969.17569.26
3538832-53883250.69750.73
4656510-65651061.76861.84
5810664-81066476.27276.38
6710409-71040966.84066.94
20min11017223-101722395.70787.1510.5495.9287.3410.56
2939519-93951988.39688.60
3794595-79459574.76074.88
4879136-87913682.71482.88
51055399-105539999.29899.54
6871780-87178082.02282.24
30min11172561-1172561110.322111.266.95110.69111.606.96
21201895-1201895113.082113.43
31069153-1069153100.592100.84
41250084-1250084117.616117.92
51287832-1287832121.167121.57
61113680-1113680104.782105.13
45min11332824-1332824125.400127.165.41125.95127.685.41
21362190-1362190128.163128.70
31263637-1263637118.891119.30
41445359-1445359135.988136.49
51422066-1422066133.797134.40
61283150-1283150120.727121.25
60min11451211-1451211136.539138.374.06137.30139.104.07
21488841-1488841140.079140.83
31400917-1400917131.807132.42
41545896-1545896145.447146.18
51525753-1525753143.552144.38
61411194-1411194132.774133.50
极限11829192-1829192172.102174.792.63173.09175.762.64
21912356-1912356179.926180.91
31790455-1790455168.457169.29
41910425-1910425179.744180.72
51832704-1832704172.432173.50
61871489-1871489176.081177.03
沙库巴曲缬沙坦片项目信息
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%
128.011145519114613511462331145959114618711460070.03
227.701145561114498811452740.04
单位质量响应值RSD%判断
40914.2141345.630.75数据可信
供试品溶液-2024032621批-缬沙坦-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%
5min1110090-11009018.69415.4145.7118.6915.4145.70
2105041-10504117.83617.84
3147941-14794125.12125.12
492875-9287515.77015.77
529853-298535.0695.07
658568-585689.9459.95
10min1419513-41951371.23460.5025.4371.2760.5225.44
2456161-45616177.45777.49
3433752-43375273.65273.69
4309482-30948252.55152.58
5266277-26627745.21545.22
6252577-25257742.88842.90
15min1575823-57582397.77691.7312.7897.9391.8612.80
2643423-643423109.255109.41
3570065-57006596.79996.96
4460653-46065378.22078.33
5476729-47672980.95081.03
6514749-51474987.40687.49
20min1702186-702186119.233116.238.99119.55116.518.99
2775155-775155131.623131.96
3661344-661344112.298112.62
4585901-58590199.48899.73
5687544-687544116.747116.97
6694954-694954118.005118.24
30min1857615-857615145.625145.4010.07146.14145.8810.05
2972652-972652165.159165.72
3789502-789502134.060134.57
4730520-730520124.044124.45
5909375-909375154.414154.83
6878173-878173149.116149.55
45min1961086-961086163.195161.956.90163.95162.676.91
21049620-1049620178.228179.06
3894729-894729151.927152.66
4868681-868681147.504148.12
5994830-994830168.925169.60
6953737-953737161.947162.63
60min11007363-1007363171.053172.674.40172.08173.664.42
21091653-1091653185.366186.50
31009155-1009155171.357172.35
4960636-960636163.119163.98
51039264-1039264176.470177.42
6993195-993195168.647169.60
极限11213985-1213985206.138202.141.62207.45203.411.64
21196528-1196528203.174204.62
31206783-1206783204.915206.19
41161492-1161492197.225198.36
51181569-1181569200.634201.88
61182176-1182176200.737201.97
沙库巴曲缬沙坦片项目信息
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%
128.011965359196628619661641965452196591419658350.03
227.701965333196400419646680.05
单位质量响应值RSD%判断
70183.3370926.640.75数据可信
供试品溶液-2024032621批-沙库巴曲-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%
5min1148697-14869713.90611.7741.3813.9111.7741.38
2142500-14250013.32613.33
3201093-20109318.80618.81
4125150-12515011.70411.70
551724-517244.8374.84
685882-858828.0328.03
10min1558033-55803352.18744.1326.6552.2144.1526.65
2614374-61437457.45657.48
3577014-57701453.96253.99
4405993-40599337.96837.99
5344777-34477732.24332.25
6331294-33129430.98231.00
15min1782500-78250073.17967.8414.2673.2967.9314.27
2877363-87736382.05082.17
3771188-77118872.12172.24
4609478-60947856.99857.08
5625145-62514558.46358.52
6686632-68663264.21364.28
20min1969293-96929390.64787.4310.0890.8887.6310.09
21076705-1076705100.692100.95
3912583-91258385.34485.59
4786326-78632673.53773.71
5916549-91654985.71585.87
6947680-94768088.62688.80
30min11216267-1216267113.744112.6010.72114.13112.9510.71
21387807-1387807129.786130.21
31122238-1122238104.951105.33
41006469-100646994.12494.42
51253592-1253592117.235117.54
61237952-1237952115.772116.09
45min11411553-1411553132.007129.768.07132.58130.308.08
21561080-1561080145.991146.63
31312436-1312436122.738123.30
41228886-1228886114.924115.38
51421812-1421812132.967133.46
61389119-1389119129.909130.42
60min11515279-1515279141.708141.685.94142.50142.445.96
21668686-1668686156.054156.94
31515245-1515245141.704142.47
41389298-1389298129.926130.57
51518209-1518209141.982142.70
61483443-1483443138.730139.46
极限11929055-1929055180.404175.642.76181.43176.632.79
21916917-1916917179.268180.41
31918036-1918036179.373180.37
41800599-1800599168.390169.26
51838935-1838935171.976172.93
61865052-1865052174.418175.38
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