非奈利酮恩格列净片项目信息
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C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3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%
111.043104113105223090103096703101293099480.20
211.203091633105063098340.31
单位质量响应值RSD%判断
28075.0027663.751.05数据可信
供试品溶液-1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%
5min1283078-28307889.86789.670.8489.8789.670.83
2280758-28075889.13089.13
3285747-28574790.71490.71
4284411-28441190.29090.29
5279705-27970588.79688.80
6281013-28101389.21189.21
10min1299028-29902894.93095.181.0295.0895.331.02
2301164-30116495.60895.76
3302467-30246796.02296.17
4303353-30335396.30396.45
5295456-29545693.79693.94
6297468-29746894.43594.58
15min1300622-30062295.43695.671.1595.7495.981.15
2302703-30270396.09796.40
3303073-30307396.21496.53
4305857-30585797.09897.41
5295677-29567793.86694.17
6300232-30023295.31295.62
20min1300925-30092595.53295.681.2696.0096.141.25
2302162-30216295.92596.39
3303822-30382296.45296.92
4306608-30660897.33797.81
5295782-29578293.90094.36
6299021-29902194.92895.39
30min1300529-30052995.40795.931.0296.0396.561.02
2302746-30274696.11196.74
3304730-30473096.74097.37
4306441-30644197.28497.92
5298147-29814794.65095.27
6300460-30046095.38596.01
45min1301116-30111695.59396.341.8096.3897.121.79
2304597-30459796.69897.49
3303691-30369196.41197.20
4313404-31340499.494100.29
5297964-29796494.59295.37
6300007-30000795.24196.02
60min1298744-29874494.84096.312.0595.7897.262.04
2304202-30420296.57397.52
3314445-31444599.824100.78
4305339-30533996.93497.90
5297695-29769594.50795.44
6299859-29985995.19496.13
极限1298130-29813094.64595.751.2295.7596.861.22
2305826-30582697.08898.20
3303703-30370396.41497.53
4304874-30487496.78697.91
5297221-29722194.35795.45
6299834-29983495.18696.29
非奈利酮恩格列净片项目信息
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250201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%
1 11.404242434246014229154239384239554239300.15
2 11.434221224245124233170.40
单位质量响应值RSD%判断
37186.8437035.610.29数据可信
供试品溶液-1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%
5min1120893-12089329.31828.784.2729.3228.784.27
2119482-11948228.97628.98
3110869-11086926.88726.89
4124597-12459730.21730.22
5114514-11451427.77127.77
6121716-12171629.51829.52
10min1194771-19477147.23546.701.9247.2846.751.92
2190336-19033646.15946.21
3187616-18761645.50045.54
4196889-19688947.74947.80
5190249-19024946.13846.18
6195610-19561047.43847.49
15min1240108-24010858.23057.571.3358.3657.701.33
2235183-23518357.03557.16
3233298-23329856.57856.70
4240436-24043658.30958.44
5235349-23534957.07657.20
6240007-24000758.20558.33
20min1270987-27098765.71864.921.0665.9465.141.06
2264380-26438064.11664.34
3265773-26577364.45464.67
4270952-27095265.71065.94
5265799-26579964.46064.68
6268197-26819765.04265.27
30min1308940-30894074.92374.410.8775.2674.740.88
2302418-30241873.34173.67
3305721-30572174.14274.46
4309591-30959175.08175.42
5308245-30824574.75475.08
6305935-30593574.19474.53
45min1342700-34270083.11082.551.3783.5783.001.37
2335474-33547481.35881.81
3338118-33811881.99982.44
4348435-34843584.50184.96
5340159-34015982.49482.94
6337521-33752181.85482.31
60min1356088-35608886.35786.761.4986.9587.361.48
2352445-35244585.47386.06
3367845-36784589.20889.79
4356446-35644686.44487.05
5358492-35849286.94087.53
6355255-35525586.15586.75
极限1365078-36507888.53788.360.4889.2889.100.47
2361372-36137287.63888.37
3365052-36505288.53189.26
4363715-36371588.20688.95
5366465-36646588.87389.61
6364450-36445088.38589.12
非奈利酮恩格列净片项目信息
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C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3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%
111.043098713104963116133100343102533104530.23
211.203104143097603100870.15
单位质量响应值RSD%判断
28120.7427686.341.11数据可信
供试品溶液-2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%
5min1278228-27822888.21987.681.5788.2287.681.57
2283414-28341489.86489.86
3272268-27226886.33086.33
4273206-27320686.62786.63
5273408-27340886.69186.69
6278586-27858688.33388.33
10min1297231-29723194.24593.791.1594.3993.941.15
2301411-30141195.57095.72
3296758-29675894.09594.24
4292949-29294992.88793.03
5292356-29235692.69992.84
6294110-29411093.25593.40
15min1299798-29979895.05994.351.4095.3694.651.40
2304904-30490496.67896.99
3293631-29363193.10393.40
4294875-29487593.49893.80
5295775-29577593.78394.08
6296303-29630393.95094.25
20min1299578-29957894.98994.311.4895.4594.781.48
2305354-30535496.82097.29
3293722-29372293.13293.59
4294425-29442593.35593.81
5295246-29524693.61594.07
6296388-29638893.97794.44
30min1300245-30024595.20094.731.4295.8295.341.42
2305596-30559696.89797.53
3294890-29489093.50294.11
4295162-29516293.58994.20
5295889-29588993.81994.43
6300722-30072295.35295.97
45min1300304-30030495.21994.371.3796.0095.141.37
2304618-30461896.58797.38
3294039-29403993.23394.00
4294866-29486693.49594.26
5295375-29537593.65694.42
6296564-29656494.03394.81
60min1299871-29987195.08294.441.3596.0295.381.35
2305075-30507596.73297.69
3294855-29485593.49194.41
4295289-29528993.62994.55
5295176-29517693.59394.52
6296866-29686694.12995.06
极限1299836-29983695.07194.211.4296.1795.301.42
2304199-30419996.45497.57
3293379-29337993.02394.10
4294363-29436393.33594.41
5294006-29400693.22294.30
6296876-29687694.13295.22
非奈利酮恩格列净片项目信息
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250201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%
1 11.404235654248044254724239404244474244460.18
2 11.434242654229414236030.23
单位质量响应值RSD%判断
37232.1137060.630.33数据可信
供试品溶液-2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%
5min1119686-11968628.99829.703.1029.0029.703.10
2130039-13003931.50731.51
3120633-12063329.22829.23
4122562-12256229.69529.70
5120676-12067629.23829.24
6121891-12189129.53229.53
10min1196180-19618047.53248.852.0747.5848.892.07
2208027-20802750.40250.45
3200614-20061448.60648.65
4204739-20473949.60549.65
5200331-20033148.53748.59
6199723-19972348.39048.44
15min1236957-23695757.41159.872.5457.5460.002.54
2254562-25456261.67761.81
3244837-24483759.32159.45
4252685-25268561.22261.35
5247432-24743259.94960.08
6246034-24603459.61159.74
20min1261589-26158963.37966.932.9863.6067.162.98
2284385-28438568.90369.14
3274685-27468566.55266.78
4283554-28355468.70168.94
5277138-27713867.14767.38
6276196-27619666.91867.15
30min1290385-29038570.35675.963.7670.6976.303.75
2320139-32013977.56577.92
3314704-31470476.24876.59
4322540-32254078.14778.50
5314283-31428376.14676.49
6318974-31897477.28377.62
45min1316702-31670276.73283.033.8677.1883.503.85
2348750-34875084.49784.98
3346452-34645283.94084.41
4354296-35429685.84186.32
5344265-34426583.41183.88
6345790-34579083.78084.25
60min1332953-33295380.67087.413.9281.2488.023.91
2367337-36733789.00189.62
3366108-36610888.70389.31
4372731-37273190.30890.93
5361961-36196187.69888.31
6363531-36353188.07988.69
极限1352388-35238885.37989.722.5786.0990.482.57
2374134-37413490.64791.42
3373873-37387390.58491.34
4379997-37999792.06892.84
5368709-36870989.33390.09
6372777-37277790.31991.07
非奈利酮恩格列净片项目信息
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C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3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%
111.043100773078063103983109473070813092620.56
211.203109593131503120540.50
单位质量响应值RSD%判断
28012.8627861.960.39数据可信
供试品溶液-3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%
5min1272552-27255286.31086.273.6486.3186.273.64
2271197-27119785.88185.88
3273159-27315986.50286.50
4284358-28435890.04990.05
5254843-25484380.70280.70
6278392-27839288.16088.16
10min1296158-29615893.78694.311.5493.9394.451.54
2294781-29478193.35093.49
3296161-29616193.78793.93
4306469-30646997.05197.20
5294177-29417793.15893.29
6299138-29913894.72994.88
15min1296374-29637493.85494.740.9794.1595.040.98
2298444-29844494.51094.81
3297849-29784994.32194.62
4304742-30474296.50496.82
5298340-29834094.47794.77
6299229-29922994.75895.06
20min1296687-29668793.95394.811.5894.4195.271.58
2298071-29807194.39194.85
3295338-29533893.52693.98
4308324-30832497.63898.11
5297255-29725594.13394.58
6300635-30063595.20395.67
30min1295864-29586493.69394.681.1594.3195.301.15
2298090-29809094.39795.01
3297599-29759994.24294.86
4305727-30572796.81697.45
5298393-29839394.49395.10
6298218-29821894.43895.06
45min1296841-29684194.00294.801.5794.7795.581.57
2297232-29723294.12694.90
3297019-29701994.05894.83
4308555-30855597.71198.51
5296500-29650093.89494.66
6299981-29998194.99695.78
60min1294395-29439593.22794.551.6094.1595.481.60
2298152-29815294.41795.34
3296339-29633993.84394.77
4307877-30787797.49798.46
5297998-29799894.36895.29
6296631-29663193.93594.87
极限1296620-29662093.93294.681.2595.0195.771.25
2298432-29843294.50695.59
3295990-29599093.73294.82
4306243-30624396.97998.10
5297879-29787994.33195.41
6298780-29878094.61695.71
非奈利酮恩格列净片项目信息
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250201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%
1 11.404235724203124229574241934201904222450.45
2 11.434244834279804262320.59
单位质量响应值RSD%判断
37039.0437290.640.48数据可信
供试品溶液-3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%
5min1112395-11239527.21827.135.1427.2227.135.14
2113820-11382027.56327.56
3117481-11748128.45028.45
4100828-10082824.41724.42
5114258-11425827.67027.67
6113471-11347127.47927.48
10min1201663-20166348.83647.821.8348.8847.871.84
2198201-19820147.99848.04
3196730-19673047.64247.69
4192486-19248646.61446.65
5194637-19463747.13547.18
6201177-20117748.71848.76
15min1250021-25002160.54759.331.4560.6759.461.45
2247376-24737659.90660.03
3242825-24282558.80458.93
4240944-24094458.34958.47
5242187-24218758.65058.77
6246690-24669059.74059.87
20min1282003-28200368.29267.041.3768.5267.261.36
2278852-27885267.52967.75
3274344-27434466.43766.66
4275170-27517066.63766.85
5271687-27168765.79466.02
6279009-27900967.56767.79
30min1317864-31786476.97676.140.8677.3276.480.87
2317462-31746276.87977.22
3312981-31298175.79476.13
4311748-31174875.49575.82
5311953-31195375.54575.88
6314400-31440076.13776.48
45min1352221-35222185.29683.791.2385.7784.251.23
2346907-34690784.00984.48
3343427-34342783.16783.63
4346355-34635583.87684.33
5339583-33958382.23682.69
6347489-34748984.15084.62
60min1366894-36689488.85087.700.9689.4688.310.95
2365217-36521788.44489.05
3358957-35895786.92887.53
4363201-36320187.95588.55
5358761-35876186.88087.48
6359954-35995487.16987.78
极限1377593-37759391.44189.911.1192.2090.661.11
2374935-37493590.79791.55
3367793-36779389.06789.81
4368493-36849389.23789.98
5368004-36800489.11889.86
6370811-37081189.79890.55
非奈利酮恩格列净片项目信息
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C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3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%
111.043109673101883108733115873086333104500.37
211.203085143110343097740.58
单位质量响应值RSD%判断
28120.4727658.391.18数据可信
供试品溶液批-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%
5min1241189-24118976.51476.031.9076.5176.021.90
2238967-23896775.81075.81
3243518-24351877.25377.25
4239642-23964276.02476.02
5231188-23118873.34273.34
6243412-24341277.22077.22
10min1291158-29115892.36792.210.5092.4992.340.50
2290566-29056692.17992.31
3290473-29047392.14992.28
4291423-29142392.45192.58
5288033-28803391.37591.50
6292307-29230792.73192.86
15min1299511-29951195.01694.310.5395.3094.600.53
2296549-29654994.07794.36
3297402-29740294.34794.63
4295806-29580693.84194.12
5295762-29576293.82794.10
6298755-29875594.77795.06
20min1300730-30073095.40394.710.7295.8495.150.72
2297715-29771594.44794.88
3297722-29772294.44994.89
4298518-29851894.70195.14
5295449-29544993.72894.16
6301153-30115395.53795.98
30min1302221-30222195.87694.830.6696.4895.420.66
2298719-29871994.76595.36
3298030-29803094.54795.14
4299305-29930594.95195.55
5296186-29618693.96294.55
6298989-29898994.85195.45
45min1300959-30095995.47694.870.6896.2395.620.67
2296516-29651694.06694.82
3301396-30139695.61496.37
4298350-29835094.64895.40
5297216-29721694.28895.03
6299856-29985695.12695.88
60min1301031-30103195.49995.220.8396.4296.130.83
2297762-29776294.46295.37
3303172-30317296.17897.09
4299228-29922894.92795.84
5297211-29721194.28795.19
6302491-30249195.96296.88
极限1308684-30868497.92798.711.4999.0099.781.48
2307806-30780697.64898.71
3315606-315606100.122101.20
4315601-315601100.121101.19
5304896-30489696.72597.78
6314326-31432699.716100.79
非奈利酮恩格列净片项目信息
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250201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%
1 11.404252534241484245954257994215214242630.40
2 11.434213834246614230220.55
单位质量响应值RSD%判断
37216.0537009.800.40数据可信
供试品溶液批-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%
5min192828-9282822.51120.479.9322.5120.479.93
270986-7098617.21417.21
383187-8318720.17320.17
493196-9319622.60022.60
580165-8016519.44019.44
686079-8607920.87520.87
10min1218603-21860353.01251.552.6453.0551.582.64
2203241-20324149.28749.32
3210362-21036251.01451.05
4212221-21222151.46551.50
5217899-21789952.84252.87
6213148-21314851.68951.72
15min1273287-27328766.27364.492.1566.4064.602.15
2264273-26427364.08864.20
3263796-26379663.97264.09
4258654-25865462.72562.85
5272296-27229666.03366.15
6263185-26318563.82463.94
20min1303588-30358873.62272.111.8273.8672.341.82
2298181-29818172.31072.53
3292987-29298771.05171.28
4290502-29050270.44870.68
5303389-30338973.57373.80
6295402-29540271.63671.86
30min1336302-33630281.55580.212.0981.9180.562.09
2335012-33501281.24281.58
3326603-32660379.20379.55
4321843-32184378.04978.39
5339060-33906082.22482.58
6325815-32581579.01279.36
45min1354540-35454085.97885.732.4286.4786.212.41
2355327-35532786.16986.64
3361314-36131487.62088.10
4339850-33985082.41582.89
5362387-36238787.88188.37
6347727-34772784.32684.80
60min1365695-36569588.68389.263.0289.3289.883.00
2366920-36692088.98089.60
3382717-38271792.81193.43
4349038-34903884.64385.26
5372310-37231090.28790.92
6371656-37165690.12890.75
极限1386257-38625793.66993.911.5694.4694.681.55
2386827-38682793.80794.57
3393112-39311295.33296.11
4376173-37617391.22491.98
5390944-39094494.80695.59
6390184-39018494.62295.39
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