恩格列净非奈利酮片项目信息
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101566-202301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%
110.983044123044053046803048363046373045940.07
210.933048683049063048870.01
单位质量响应值RSD%判断
27740.8027894.510.40数据可信
供试品溶液-6032401批-恩格列净-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%
5min1261158-26115884.49574.0622.6584.4974.0622.65
2272069-27206988.02588.02
3246873-24687379.87379.87
4172938-17293855.95255.95
5153751-15375149.74449.74
6266626-26662686.26486.26
10min1314792-314792101.84798.951.72101.9999.081.73
2303423-30342398.16998.32
3308081-30808199.67699.81
4306339-30633999.11299.21
5299870-29987097.01997.10
6302547-30254797.88598.03
15min1316059-316059102.257100.102.15102.57100.392.13
2304311-30431198.45698.77
3310301-310301100.394100.69
4315100-315100101.947102.21
5311754-311754100.864101.11
6298857-29885796.69297.00
20min1316070-316070102.261100.192.13102.74100.652.11
2304314-30431498.45798.93
3310646-310646100.506100.97
4315452-315452102.061102.49
5312256-312256101.027101.44
6299363-29936396.85597.32
30min1317068-317068102.584100.402.34103.23101.022.32
2303928-30392898.33298.97
3311295-311295100.716101.35
4316723-316723102.472103.07
5313640-313640101.474102.06
6299204-29920496.80497.43
45min1316425-316425102.376100.242.35103.20101.032.33
2303956-30395698.34199.14
3310809-310809100.559101.36
4316323-316323102.343103.11
5313168-313168101.322102.07
6298322-29832296.51997.31
60min1316178-316178102.296100.092.35103.29101.052.33
2302807-30280797.97098.94
3310664-310664100.512101.48
4315288-315288102.008102.95
5313004-313004101.269102.19
6298219-29821996.48597.44
极限1315585-315585102.10499.982.28103.27101.112.27
2303179-30317998.09099.22
3310223-310223100.369101.51
4314982-314982101.909103.02
5312302-312302101.042102.13
6297921-29792196.38997.50
恩格列净非奈利酮片项目信息
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D250501对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
111.284081484076714083184086544084174082420.10
211.354070694072814071750.04
单位质量响应值RSD%判断
36191.6735874.450.63数据可信
供试品溶液-6032401批-非奈利酮-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%
5min182123-8212320.49222.4119.2620.4922.4119.28
2103351-10335125.78925.79
3116886-11688629.16629.17
473597-7359718.36418.36
573788-7378818.41218.41
689085-8908522.22922.23
10min1295230-29523073.66773.814.7673.7073.844.77
2312086-31208677.87377.92
3313244-31324478.16278.21
4279937-27993769.85169.88
5284157-28415770.90470.94
6290071-29007172.38072.42
15min1352382-35238287.92887.981.9488.0988.141.95
2362368-36236890.42090.59
3358122-35812289.36189.54
4351885-35188587.80487.95
5346281-34628186.40686.55
6344448-34444885.94986.11
20min1370607-37060792.47692.581.6292.7892.891.63
2379974-37997494.81395.14
3374040-37404093.33393.66
4372383-37238392.91993.21
5366069-36606991.34491.64
6363061-36306190.59390.89
30min1384344-38434495.90495.731.6096.3696.181.60
2392151-39215197.85298.33
3385158-38515896.10796.59
4386454-38645496.43096.88
5379158-37915894.61095.05
6374504-37450493.44893.90
45min1387156-38715696.60596.541.6297.2297.161.63
2395767-39576798.75499.40
3388180-38818096.86197.50
4390092-39009297.33897.95
5382464-38246495.43596.04
6377659-37765994.23694.84
60min1387532-38753296.69996.611.7697.4897.391.76
2397533-39753399.195100.00
3388369-38836996.90897.71
4389350-38935097.15397.92
5383049-38304995.58196.34
6377192-37719294.11994.88
极限1386336-38633696.40196.481.4897.3497.421.48
2396658-39665898.97699.95
3386603-38660396.46797.43
4387919-38791996.79697.73
5381416-38141695.17396.09
6380940-38094095.05495.98
恩格列净非奈利酮片项目信息
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101566-202301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%
110.983047733047673046013047273047843047300.03
210.933044423045393044900.03
单位质量响应值RSD%判断
27753.1927858.190.27数据可信
供试品溶液-BJ84960批-恩格列净-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%
5min1241855-24185578.28385.798.9178.2885.798.92
2243868-24386878.93478.93
3245015-24501579.30579.31
4283485-28348591.75791.76
5288762-28876293.46593.47
6287366-28736693.01393.01
10min1288832-28883293.48894.540.8793.6294.680.87
2294040-29404095.17495.31
3292453-29245394.66094.79
4289284-28928493.63493.79
5295135-29513595.52895.68
6292698-29269894.73994.89
15min1289079-28907993.56894.420.8893.8594.720.88
2294647-29464795.37095.66
3291948-29194894.49794.79
4288902-28890293.51193.82
5294693-29469395.38595.70
6290968-29096894.17994.49
20min1288862-28886293.49895.451.3593.9495.911.36
2294422-29442295.29795.75
3292311-29231194.61495.06
4295629-29562995.68896.15
5298985-29898596.77497.25
6299133-29913396.82297.29
30min1-0.0000.00-0.600.622.39
2-0.0000.61
3-0.0000.61
4-0.0000.62
5-0.0000.64
6-0.0000.63
45min1-0.0000.00-0.600.622.39
2-0.0000.61
3-0.0000.61
4-0.0000.62
5-0.0000.64
6-0.0000.63
60min1-0.0000.00-0.600.622.39
2-0.0000.61
3-0.0000.61
4-0.0000.62
5-0.0000.64
6-0.0000.63
极限1-0.0000.00-0.600.622.39
2-0.0000.61
3-0.0000.61
4-0.0000.62
5-0.0000.64
6-0.0000.63
恩格列净非奈利酮片项目信息
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D250501对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
111.284074564078334076054077284076424076530.04
211.354069354072044070700.05
单位质量响应值RSD%判断
36139.4535865.200.54数据可信
供试品溶液-BJ84960批-非奈利酮-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%
5min198582-9858224.62045.5254.4424.6245.5254.43
284685-8468521.14921.15
393414-9341423.32923.33
4282895-28289570.64970.65
5254836-25483663.64263.64
6279256-27925669.74169.74
10min1330910-33091082.64184.482.8882.6884.562.93
2325154-32515481.20381.24
3333361-33336183.25383.29
4345532-34553286.29286.41
5345900-34590086.38486.49
6348877-34887787.12887.24
15min1355312-35531288.73589.160.3788.9189.380.41
2356598-35659889.05689.23
3356294-35629488.98089.16
4358601-35860189.55689.82
5358566-35856689.54789.80
6356710-35671089.08489.35
20min1364808-36480891.10692.252.3691.4392.612.39
2359656-35965689.82090.14
3360579-36057990.05090.38
4375450-37545093.76494.17
5379162-37916294.69195.09
6376592-37659294.04994.46
30min1-0.0000.00-0.480.529.51
2-0.0000.47
3-0.0000.48
4-0.0000.57
5-0.0000.56
6-0.0000.57
45min1-0.0000.00-0.480.529.51
2-0.0000.47
3-0.0000.48
4-0.0000.57
5-0.0000.56
6-0.0000.57
60min1-0.0000.00-0.480.529.51
2-0.0000.47
3-0.0000.48
4-0.0000.57
5-0.0000.56
6-0.0000.57
极限1-0.0000.00-0.480.529.51
2-0.0000.47
3-0.0000.48
4-0.0000.57
5-0.0000.56
6-0.0000.57
恩格列净非奈利酮片项目信息
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101566-202301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%
110.983040893041023042613044963044503042800.07
210.933046413045963046180.02
单位质量响应值RSD%判断
27712.2027869.900.41数据可信
供试品溶液-G79580批-恩格列净-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%
5min1236167-23616776.48278.067.7576.4878.067.75
2224850-22485072.81772.82
3225819-22581973.13173.13
4275689-27568989.28189.28
5245292-24529279.43779.44
6238352-23835277.19077.19
10min1299716-29971697.06298.001.8897.1998.131.88
2292801-29280194.82394.94
3305531-30553198.94699.07
4308859-308859100.023100.17
5303295-30329598.22198.35
6305449-30544998.91999.05
15min1302909-30290998.09699.411.3598.3999.701.35
2301121-30112197.51797.80
3310810-310810100.655100.94
4311081-311081100.743101.06
5307253-30725399.50399.80
6308539-30853999.920100.21
20min1302955-30295598.11199.551.2998.56100.011.30
2302161-30216197.85498.30
3311072-311072100.740101.19
4311184-311184100.776101.26
5307765-30776599.669100.13
6309259-309259100.153100.61
30min1303554-30355498.30599.611.2298.92100.241.22
2302591-30259197.99398.60
3311087-311087100.745101.37
4311342-311342100.827101.48
5308156-30815699.796100.42
6308805-308805100.006100.63
45min1304086-30408698.47899.541.1499.26100.331.15
2302320-30232097.90698.67
3310718-310718100.625101.42
4310900-310900100.684101.50
5308104-30810499.779100.57
6308111-30811199.781100.57
60min1302280-30228097.89399.341.2698.84100.301.26
2301890-30189097.76698.70
3310514-310514100.559101.52
4310494-310494100.553101.54
5307328-30732899.528100.49
6308040-30804099.758100.72
极限1302694-30269498.02799.211.2799.13100.331.27
2300675-30067597.37398.47
3310306-310306100.492101.62
4309784-309784100.323101.48
5307024-30702499.429100.56
6307523-30752399.591100.72
恩格列净非奈利酮片项目信息
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D250501对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
111.284062714064164064804069774068994066090.08
211.354071614067324069460.08
单位质量响应值RSD%判断
36046.9035854.270.38数据可信
供试品溶液-G79580批-非奈利酮-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%
5min184519-8451921.13818.9314.6521.1418.9314.63
281862-8186220.47320.47
357001-5700114.25614.26
469498-6949817.38117.38
586184-8618421.55421.55
675117-7511718.78618.79
10min1206172-20617251.56351.093.1951.6051.123.20
2205949-20594951.50751.54
3199166-19916649.81049.83
4194326-19432648.60048.63
5212647-21264753.18253.22
6207509-20750951.89751.93
15min1262736-26273665.70965.852.6765.8365.962.67
2262269-26226965.59265.71
3257814-25781464.47864.58
4255092-25509263.79763.91
5274817-27481768.73068.85
6267054-26705466.78966.91
20min1296254-29625474.09274.351.9074.3274.581.91
2296356-29635674.11774.35
3293581-29358173.42373.64
4289746-28974672.46472.68
5304013-30401376.03276.27
6303711-30371175.95776.19
30min1333990-33399083.52983.991.4283.8884.341.43
2334380-33438083.62783.98
3333017-33301783.28683.62
4330507-33050782.65883.00
5343231-34323185.84086.21
6339959-33995985.02285.38
45min1362740-36274090.71991.221.1191.2191.711.12
2363118-36311890.81491.31
3362467-36246790.65191.13
4360567-36056790.17690.65
5370396-37039692.63493.14
6369226-36922692.34292.84
60min1373800-37380093.48694.351.0794.1394.991.07
2376842-37684294.24694.89
3375634-37563493.94494.57
4372988-37298893.28293.91
5381563-38156395.42796.09
6382616-38261695.69096.34
极限1383426-38342695.89396.330.9496.6997.130.95
2384188-38418896.08496.88
3385987-38598796.53397.32
4379546-37954694.92395.70
5389288-38928897.35998.18
6388580-38858097.18297.99
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