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%
111.163154793148083147943139973153803148920.19
211.133174903163653169280.26
单位质量响应值RSD%判断
28216.1328475.110.65数据可信
供试品溶液-6010901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%
5min1292817-29281792.97491.202.0692.9791.202.06
2292391-29239192.83992.84
3292016-29201692.72092.72
4284827-28482790.43790.44
5281127-28112789.26289.26
6280136-28013688.94888.95
10min1309636-30963698.31498.860.6798.4799.010.67
2314642-31464299.904100.06
3310507-31050798.59198.75
4311940-31194099.04699.20
5308959-30895998.09998.25
6312351-31235199.17699.32
15min1311211-31121198.81499.440.6199.1399.760.61
2314142-31414299.745100.07
3313247-31324799.46199.78
4315048-315048100.033100.35
5310546-31054698.60398.92
6314901-31490199.986100.30
20min1312115-31211599.10299.430.5799.5999.920.57
2315451-315451100.161100.65
3312536-31253699.23599.72
4313614-31361499.577100.06
5310609-31060998.62399.10
6314608-31460899.893100.37
30min1310390-31039098.55499.260.5999.2099.910.58
2313848-31384899.652100.31
3312474-31247499.21599.87
4314362-31436299.815100.46
5310492-31049298.58699.23
6314172-31417299.755100.40
45min1311319-31131998.84999.670.6299.66100.480.62
2315403-315403100.145100.97
3313523-31352399.549100.36
4315747-315747100.255101.07
5311942-31194299.04799.85
6315445-315445100.159100.97
60min1310641-31064198.63399.380.5499.61100.360.54
2314631-31463199.900100.89
3313341-31334199.491100.47
4314131-31413199.742100.72
5311152-31115298.79699.77
6313988-31398899.696100.68
极限1309511-30951198.27599.150.7299.42100.290.72
2314564-31456499.879101.03
3311915-31191599.038100.19
4314011-31401199.704100.85
5309710-30971098.33899.47
6313843-31384399.650100.80
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%
111.004042614031714038354033954044844038290.14
211.024068124051574059840.29
单位质量响应值RSD%判断
36711.7336840.650.25数据可信
供试品溶液-6010901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%
5min1184996-18499645.22839.2514.5645.2339.2514.55
2166554-16655440.71940.72
3182436-18243644.60244.60
4164637-16463740.25040.25
5132142-13214232.30632.31
6132394-13239432.36832.37
10min1305821-30582174.76772.642.8274.8472.702.83
2298144-29814472.89072.96
3302190-30219073.87973.95
4302821-30282174.03474.10
5285535-28553569.80769.86
6288135-28813570.44370.50
15min1344988-34498884.34383.311.6884.5483.491.69
2338675-33867582.79982.99
3345042-34504284.35684.55
4346717-34671784.76584.96
5332338-33233881.25081.42
6336738-33673882.32682.50
20min1363145-36314588.78288.191.2489.1288.521.25
2358922-35892287.74988.08
3364946-36494689.22289.56
4365117-36511789.26489.60
5353769-35376986.48986.79
6358509-35850987.64887.96
30min1380516-38051693.02892.931.1093.5293.401.11
2377514-37751492.29492.77
3384646-38464694.03894.52
4384732-38473294.05994.54
5373982-37398291.43191.88
6379234-37923492.71593.17
45min1393572-39357296.22096.241.0296.8696.861.02
2389303-38930395.17795.80
3397166-39716697.09997.74
4399305-39930597.62298.26
5389747-38974795.28595.89
6392724-39272496.01396.62
60min1397888-39788897.27597.240.9898.0898.030.99
2394310-39431096.40197.19
3401355-40135598.12398.93
4402621-40262198.43399.23
5392585-39258595.97996.74
6397741-39774197.24098.01
极限1399039-39903997.55797.691.0598.5298.641.06
2395736-39573696.74997.70
3402780-40278098.47199.44
4405304-40530499.089100.05
5394214-39421496.37797.30
6400548-40054897.92698.86
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%
111.163171913169043171483168913176283171520.10
211.133181963170523176240.26
单位质量响应值RSD%判断
28418.6428537.650.30数据可信
供试品溶液-6010902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%
5min1293254-29325492.67889.282.9192.6889.282.92
2283648-28364889.64289.64
3280578-28057888.67288.67
4268335-26833584.80384.80
5282726-28272689.35189.35
6286548-28654890.55990.56
10min1315110-31511099.58599.191.6099.7499.341.60
2320733-320733101.362101.51
3312019-31201998.60898.76
4317117-317117100.220100.36
5311949-31194998.58698.74
6306179-30617996.76396.91
15min1316168-31616899.92099.791.67100.24100.101.66
2323004-323004102.080102.40
3313891-31389199.20099.51
4319180-319180100.871101.18
5314808-31480899.49099.80
6307452-30745297.16597.48
20min1315867-31586799.82499.871.45100.31100.341.44
2321756-321756101.686102.17
3314356-31435699.34799.82
4319873-319873101.090101.57
5315392-31539299.674100.15
6308751-30875197.57698.05
30min1316261-31626199.94999.871.41100.60100.521.40
2321100-321100101.478102.14
3315080-31508099.576100.22
4319238-319238100.890101.53
5316215-31621599.934100.58
6308211-30821197.40598.04
45min1316615-316615100.061100.061.40100.88100.871.39
2322940-322940102.060102.89
3315631-31563199.750100.56
4318922-318922100.790101.60
5316014-31601499.871100.68
6309513-30951397.81698.62
60min1316093-31609399.89699.881.36100.88100.851.36
2321935-321935101.742102.74
3314902-31490299.519100.49
4318805-318805100.753101.73
5315268-31526899.635100.61
6309164-30916497.70698.67
极限1315898-31589899.83499.781.64100.99100.931.63
2322123-322123101.802102.97
3314393-31439399.359100.50
4318994-318994100.813101.96
5316143-31614399.912101.06
6306844-30684496.97398.10
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%
111.004062514065254059164074994069554066290.16
211.024082274069234075750.23
单位质量响应值RSD%判断
36966.2736985.030.04数据可信
供试品溶液-6010902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%
5min1155620-15562037.84136.536.9037.8436.536.90
2148210-14821036.03936.04
3152055-15205536.97436.97
4141447-14144734.39434.39
5166459-16645940.47640.48
6137590-13759033.45633.46
10min1261389-26138963.55962.691.6963.6262.751.69
2258403-25840362.83362.89
3259854-25985463.18663.25
4252430-25243061.38161.44
5262279-26227963.77663.84
6252528-25252861.40561.46
15min1297032-29703272.22671.491.4172.4071.661.42
2295062-29506271.74771.91
3295524-29552471.86072.03
4287976-28797670.02470.18
5298508-29850872.58572.76
6290000-29000070.51670.67
20min1313291-31329176.18075.801.0076.4776.091.01
2311239-31123975.68175.97
3313030-31303076.11676.40
4307067-30706774.66674.94
5316039-31603976.84877.14
6309775-30977575.32575.60
30min1331531-33153180.61580.241.2281.0380.651.22
2328540-32854079.88880.30
3333059-33305980.98781.40
4324249-32424978.84479.25
5335112-33511281.48681.91
6327383-32738379.60680.01
45min1343243-34324383.46383.331.0584.0183.871.06
2342808-34280883.35783.90
3345156-34515683.92884.48
4336785-33678581.89382.42
5347134-34713484.40984.97
6340990-34099082.91583.45
60min1347835-34783584.58084.441.1685.2785.121.17
2347205-34720584.42685.11
3349768-34976885.05085.74
4340501-34050182.79683.46
5352400-35240085.69086.39
6345772-34577284.07884.75
极限1349475-34947584.97884.961.1485.8185.781.14
2350089-35008985.12885.95
3352091-35209185.61486.44
4343820-34382083.60384.41
5354737-35473786.25887.10
6346137-34613784.16784.98
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%
111.163183333172973176153181023181383178970.14
211.133175923174533175220.04
单位质量响应值RSD%判断
28485.3928528.480.11数据可信
供试品溶液-6010903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%
5min1260031-26003182.09587.154.8782.1087.154.87
2287490-28749090.76490.76
3281344-28134488.82488.82
4285775-28577590.22390.22
5257832-25783281.40181.40
6283803-28380389.60089.60
10min1315355-31535599.56298.610.6899.7098.760.68
2312672-31267298.71598.87
3313416-31341698.94999.10
4310776-31077698.11698.27
5309322-30932297.65797.79
6312468-31246898.65098.80
15min1319105-319105100.74699.290.85101.0599.600.85
2313873-31387399.09499.41
3315933-31593399.744100.06
4313116-31311698.85599.17
5311617-31161798.38198.68
6313364-31336498.93399.25
20min1318295-318295100.49099.670.47100.96100.150.47
2315488-31548899.604100.08
3316129-31612999.806100.29
4315705-31570599.672100.15
5314471-31447199.28399.74
6314140-31414099.17899.66
30min1319017-319017100.71899.490.78101.36100.130.78
2314944-31494499.432100.08
3316818-316818100.023100.67
4313227-31322798.89099.53
5312326-31232698.60599.23
6314495-31449599.29099.93
45min1319009-319009100.71599.400.86101.52100.210.86
2314273-31427399.220100.03
3317171-317171100.135100.95
4313078-31307898.84399.65
5311930-31193098.48099.27
6313659-31365999.02699.84
60min1318687-318687100.61499.330.88101.59100.300.88
2314750-31475099.371100.35
3316751-316751100.002100.98
4311836-31183698.45199.42
5311720-31172098.41499.37
6313919-31391999.108100.08
极限1319112-319112100.74899.220.92101.89100.360.91
2313332-31333298.923100.07
3316063-31606399.785100.93
4312802-31280298.75699.89
5311004-31100498.18899.31
6313354-31335498.930100.07
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%
111.004078944077294071224077744080344077110.09
211.024058404067904063150.17
单位质量响应值RSD%判断
37064.6436870.690.38数据可信
供试品溶液-6010903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%
5min1132456-13245632.21534.0013.8232.2234.0013.83
2146673-14667335.67335.67
3140430-14043034.15534.15
4161607-16160739.30539.31
5105915-10591525.76025.76
6151657-15165736.88536.89
10min1287710-28771069.97570.062.6070.0370.122.62
2293364-29336471.35071.41
3286142-28614269.59469.65
4297308-29730872.31072.38
5275319-27531966.96167.00
6288493-28849370.16670.23
15min1339045-33904582.46180.822.4582.6380.992.45
2336934-33693481.94782.13
3330146-33014680.29680.47
4340987-34098782.93383.12
5326688-32668879.45579.61
6319975-31997577.82278.00
20min1358431-35843187.17686.581.3487.4886.881.34
2358246-35824687.13187.45
3351122-35112285.39885.70
4363023-36302388.29288.62
5353805-35380586.05086.34
6351174-35117485.41185.72
30min1380026-38002692.42891.771.1192.8892.221.12
2379224-37922492.23392.69
3373615-37361590.86891.32
4382891-38289193.12593.60
5376446-37644691.55791.99
6371743-37174390.41390.86
45min1392025-39202595.34694.811.1295.9595.421.12
2390153-39015394.89195.50
3385960-38596093.87194.47
4396205-39620596.36396.99
5390586-39058694.99695.58
6384108-38410893.42194.02
60min1396675-39667596.47796.010.9797.2496.770.97
2396370-39637096.40397.17
3391895-39189595.31496.07
4398973-39897397.03697.82
5396103-39610396.33897.08
6388508-38850894.49195.25
极限1398229-39822996.85596.311.0997.7897.241.08
2395824-39582496.27097.20
3392182-39218295.38496.30
4402110-40211097.79998.75
5397369-39736996.64697.55
6390280-39028094.92295.84
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%
111.163177413181823179383178023179703179270.06
211.133185513178413181960.16
单位质量响应值RSD%判断
28488.0828589.040.26数据可信
供试品溶液-6010904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%
5min1278811-27881187.92789.041.7487.9389.041.74
2288454-28845490.96890.97
3278389-27838987.79487.79
4286906-28690690.48090.48
5276959-27695987.34387.34
6284451-28445189.70689.71
10min1310024-31002497.77096.811.0797.9296.961.08
2309356-30935697.56097.71
3302079-30207995.26595.41
4309365-30936597.56397.71
5303927-30392795.84895.99
6307063-30706396.83796.99
15min1311966-31196698.38397.311.0298.6997.621.02
2310365-31036597.87898.19
3304288-30428895.96196.27
4310986-31098698.07498.39
5305322-30532296.28796.59
6308501-30850197.29097.60
20min1311819-31181998.33697.251.0398.8197.721.03
2309653-30965397.65398.13
3303847-30384795.82296.29
4311148-31114898.12598.60
5305532-30553296.35496.82
6308165-30816597.18497.66
30min1309683-30968397.66397.230.9498.3097.860.94
2310445-31044597.90398.54
3304521-30452196.03596.66
4311439-31143998.21798.86
5305078-30507896.21196.84
6308700-30870097.35397.99
45min1310939-31093998.05997.071.0898.8697.871.08
2309392-30939297.57198.37
3303699-30369995.77696.56
4310693-31069397.98198.79
5303662-30366295.76496.55
6308482-30848297.28498.08
60min1310251-31025197.84297.041.0298.8198.001.02
2309607-30960797.63998.60
3302934-30293495.53496.48
4310574-31057497.94498.91
5304937-30493796.16697.11
6307945-30794597.11598.07
极限1310655-31065597.96997.081.1299.1098.201.12
2310830-31083098.02599.15
3302874-30287495.51596.62
4310277-31027797.85098.98
5304386-30438695.99297.10
6307913-30791397.10598.23
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%
111.004081004075864074774073174072654075490.09
211.024080364075454077900.09
单位质量响应值RSD%判断
37049.9137004.540.09数据可信
供试品溶液-6010904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%
5min1178906-17890643.44244.904.5043.4444.904.50
2187137-18713745.44145.44
3198591-19859148.22248.22
4174441-17444142.35842.36
5187199-18719945.45645.46
6183223-18322344.49044.49
10min1333871-33387181.07179.841.7981.1479.921.79
2326582-32658279.30179.38
3331758-33175880.55880.64
4317943-31794377.20377.27
5332323-33232380.69580.77
6330451-33045180.24180.31
15min1372996-37299690.57189.741.0890.7889.951.08
2367033-36703389.12389.33
3371415-37141590.18890.40
4362650-36265088.05988.26
5372333-37233390.41090.62
6371070-37107090.10490.31
20min1390833-39083394.90393.900.9795.2694.260.97
2383146-38314693.03693.39
3387655-38765594.13194.50
4382054-38205492.77193.12
5390735-39073594.87995.24
6385808-38580893.68294.04
30min1402532-40253297.74397.590.6498.2698.110.64
2398439-39843996.75097.26
3402348-40234897.69998.22
4399893-39989397.10397.60
5405851-40585198.54999.07
6402445-40244597.72298.24
45min1410508-41050899.68099.140.47100.3699.820.47
2405084-40508498.36399.04
3407973-40797399.06599.75
4407448-40744898.93799.60
5409531-40953199.443100.13
6409062-40906299.329100.01
60min1411405-41140599.89899.770.31100.74100.610.32
2409341-40934199.397100.23
3410637-41063799.711100.56
4409980-40998099.552100.38
5412979-412979100.280101.13
6410886-41088699.772100.61
极限1412657-412657100.20299.890.43101.21100.890.42
2411787-41178799.991100.99
3409664-40966499.475100.49
4409640-40964099.469100.46
5413918-413918100.508101.52
6410513-41051399.681100.69
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