他达拉非达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ832-220225对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.86对照品水分(%)0对照品稀释倍数5000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
134.212883102887982879622862392862532875120.42
234.162818942825362822150.17
单位质量响应值RSD%判断
8404.338261.561.22数据可信
长期6月-供试品溶液-2023062021批-达泊西汀-shui(内含0.3%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1186434-18643459.88560.4922.5459.8860.4822.54
2185965-18596559.73459.73
3202683-20268365.10465.10
4226890-22689072.88072.88
5108639-10863934.89634.90
6219221-21922170.41670.42
10min1258314-25831482.97477.5610.1083.3177.9010.14
2235680-23568075.70376.04
3239597-23959776.96177.32
4253230-25323081.34181.75
5197131-19713163.32163.51
6264785-26478585.05285.44
15min1284652-28465291.43483.517.9892.2384.288.02
2262158-26215884.20884.96
3245681-24568178.91679.71
4266408-26640885.57486.43
5226960-22696072.90273.45
6274111-27411188.04888.91
20min1279335-27933589.72685.925.9391.0387.165.98
2281827-28182790.52691.75
3253944-25394481.57082.80
4275129-27512988.37589.71
5242154-24215477.78378.73
6272594-27259487.56188.91
30min1268684-26868486.30588.714.2288.1090.424.28
2287790-28779092.44294.16
3274228-27422888.08589.77
4282234-28223490.65792.48
5257690-25769082.77384.16
6286371-28637191.98693.83
45min1287929-28792992.48693.243.6894.7795.443.71
2306671-30667198.506100.74
3293302-29330294.21296.38
4284012-28401291.22893.55
5275165-27516588.38690.23
6294572-29457294.62096.97
60min1294291-29429194.53095.713.4997.3298.423.48
2318295-318295102.240105.02
3296897-29689795.36798.06
4295919-29591995.05397.89
5288378-28837892.63194.96
6293919-29391994.41097.29
极限1300643-30064396.57097.182.5299.89100.422.45
2315157-315157101.232104.58
3295661-29566194.97098.19
4294200-29420094.50197.86
5304256-30425697.731100.58
6305253-30525398.051101.45
他达拉非达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.487901378901785177860978724787530.26
210.077691676951769340.04
单位质量响应值RSD%判断
7514.607639.921.17数据可信
长期6月-供试品溶液-2023062021批-他达拉非-shui(内含0.3%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min144896-4489653.29252.6821.1353.2952.6821.13
241719-4171949.52149.52
348793-4879357.91857.92
453472-5347263.47263.47
527179-2717932.26232.26
650207-5020759.59659.60
10min166512-6651278.95173.8410.9879.2574.1311.01
258742-5874269.72870.00
364213-6421376.22276.54
467689-6768980.34880.70
549868-4986859.19459.37
666202-6620278.58378.91
15min175006-7500689.03381.637.1989.7782.347.23
266635-6663579.09779.76
367735-6773580.40281.15
472751-7275186.35687.16
560959-6095972.35972.87
669550-6955082.55783.32
20min177766-7776692.30985.256.3693.5486.406.40
272153-7215385.64786.75
370726-7072683.95385.14
475655-7565589.80491.08
564851-6485176.97977.89
669758-6975882.80484.03
30min174588-7458888.53789.102.0490.2890.732.06
273161-7316186.84388.42
377112-7711291.53393.19
476660-7666090.99792.77
574768-7476888.75190.09
674073-7407387.92689.61
45min179180-7918093.98892.574.5696.2294.704.57
278670-7867093.38295.44
383279-8327998.853101.02
477445-7744591.92894.21
572342-7234285.87187.70
677017-7701791.42093.60
60min181454-8145496.68795.054.6499.4497.694.61
281383-8138396.60399.18
385476-85476101.461104.18
480453-8045395.49998.29
575650-7565089.79892.11
676046-7604690.26892.95
极限183733-8373399.39297.142.86102.69100.312.87
281806-8180697.105100.22
385506-85506101.497104.78
480055-8005595.02698.35
579986-7998694.94597.75
679916-7991694.86198.05
他达拉非达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ832-220225对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.86对照品水分(%)0对照品稀释倍数5000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
134.212870242881832888342885722897022884630.34
234.162829882817582823730.31
单位质量响应值RSD%判断
8432.138266.191.41数据可信
长期6月-供试品溶液-2023062021批-达泊西汀-pH1.0(内含0.3%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1206212-20621266.11171.0014.9466.1171.0014.94
2182037-18203758.36058.36
3263751-26375184.55884.56
4207301-20730166.46066.46
5260635-26063583.55983.56
6208854-20885466.95866.96
10min1292057-29205793.63390.125.4094.0090.525.42
2268256-26825686.00286.33
3292567-29256793.79694.27
4264948-26494884.94185.31
5299375-29937595.97996.44
6269390-26939086.36686.74
15min1319020-319020102.27796.394.06103.1697.294.07
2288162-28816292.38493.19
3304746-30474697.70198.69
4288263-28826392.41693.26
5308041-30804198.75799.75
6295770-29577094.82395.67
20min1320558-320558102.77098.093.26104.2399.523.26
2307542-30754298.59799.91
3305073-30507397.80599.34
4291903-29190393.58394.94
5311632-31163299.908101.45
6298975-29897595.85097.23
30min1322060-322060103.25198.702.78105.28100.682.73
2314665-314665100.881102.74
3303751-30375197.38299.46
4300395-30039596.30698.18
5302555-30255596.99899.10
6303743-30374397.37999.29
45min1320590-320590102.78099.312.30105.38101.832.25
2315085-315085101.015103.44
3302634-30263497.02399.64
4308895-30889599.031101.44
5308963-30896399.053101.69
6302356-30235696.93499.39
60min1313466-313466100.49697.501.93103.67100.581.92
2307213-30721398.491101.48
3299664-29966496.07199.23
4296787-29678795.14998.11
5304490-30449097.618100.81
6303111-30311197.176100.17
极限1315673-315673101.20498.262.38104.93101.882.34
2311914-31191499.999103.53
3299621-29962196.05899.75
4297685-29768595.43798.93
5310570-31057099.568103.30
6303523-30352397.308100.84
他达拉非达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.487856178893788947886979114788660.26
210.077746677334774000.13
单位质量响应值RSD%判断
7525.387686.201.50数据可信
长期6月-供试品溶液-2023062021批-他达拉非-pH1.0(内含0.3%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min137282-3728244.09050.5416.8344.0950.5416.82
235694-3569442.21242.21
354077-5407763.95263.95
438860-3886045.95645.96
548618-4861857.49657.50
641871-4187149.51749.52
10min167224-6722479.50079.626.7979.7479.906.81
265048-6504876.92777.16
375179-7517988.90889.26
464390-6439076.14876.40
569628-6962882.34382.66
662481-6248173.89174.17
15min178027-7802792.27690.005.1592.9690.725.18
273636-7363687.08387.74
382922-8292298.06598.91
472955-7295586.27886.96
576195-7619590.10990.89
672862-7286286.16886.85
20min180936-8093695.71694.274.1396.9295.504.15
280956-8095695.74096.89
384508-8450899.940101.33
476464-7646490.42791.58
579894-7989494.48495.76
675540-7554089.33590.50
30min183849-8384999.16196.953.75100.8998.703.72
284795-84795100.280101.96
385158-85158100.709102.66
481136-8113695.95297.61
578741-7874193.12094.92
678199-7819992.47994.14
45min184131-8413199.49498.463.34101.78100.753.32
285472-85472101.080103.31
385981-85981101.682104.19
484331-8433199.731101.92
580435-8043595.12397.44
679208-7920893.67295.85
60min182158-8215897.16196.872.77100.0099.702.79
283593-8359398.858101.65
385308-85308100.886103.96
481221-8122196.05398.80
579618-7961894.15797.01
679564-7956494.09396.79
极限183257-8325798.46197.452.68101.84100.822.70
284438-8443899.857103.20
385064-85064100.598104.23
481308-8130896.15699.44
580934-8093495.71499.08
679398-7939893.89797.11
他达拉非达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ832-220225对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.86对照品水分(%)0对照品稀释倍数5000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
134.212892572901722892852889662885802892520.21
234.162842822842822842820.00
单位质量响应值RSD%判断
8455.198322.071.13数据可信
长期6月-供试品溶液-2023062021批-达泊西汀-pH4.5(内含0.3%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1200636-20063664.01859.1024.1564.0259.1024.15
2176554-17655456.33456.33
3268665-26866585.72585.72
4158342-15834250.52350.52
5154858-15485849.41249.41
6152372-15237248.61848.62
10min1251183-25118380.14777.8613.6680.5078.1913.71
2233696-23369674.56774.88
3307272-30727298.04398.52
4215980-21598068.91469.19
5221107-22110770.55070.82
6234887-23488774.94775.22
15min1273771-27377187.35486.228.0688.1586.988.13
2271851-27185186.74187.47
3306154-30615497.68798.71
4248039-24803979.14379.81
5246782-24678278.74279.41
6274692-27469287.64888.33
20min1291580-29158093.03690.736.0494.3291.976.13
2286816-28681691.51692.73
3308643-30864398.481100.04
4261420-26142083.41384.52
5267899-26789985.48086.58
6289802-28980292.46993.64
30min1302860-30286096.63695.223.7698.4496.963.84
2304579-30457997.18498.90
3307868-30786898.233100.34
4277327-27732788.48990.06
5294652-29465294.01795.60
6303163-30316396.73298.42
45min1320359-320359102.21997.842.77104.56100.112.79
2302897-30289796.64798.90
3305716-30571697.547100.20
4295503-29550394.28896.35
5303741-30374196.91799.02
6311563-31156399.412101.64
60min1299355-29935595.51792.972.0398.4395.791.95
2292236-29223693.24696.04
3285144-28514490.98394.18
4294031-29403193.81896.40
5283771-28377190.54593.18
6293765-29376593.73496.51
极限1303106-30310696.71492.852.76100.1596.182.66
2282611-28261190.17593.49
3284318-28431890.71994.42
4293323-29332393.59396.70
5286020-28602091.26294.40
6296540-29654094.61997.92
他达拉非达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.487914579338791347905878695790740.30
210.077736177621774910.24
单位质量响应值RSD%判断
7545.237695.231.40数据可信
长期6月-供试品溶液-2023062021批-他达拉非-pH4.5(内含0.3%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min143996-4399651.93150.5223.1351.9350.5223.13
240911-4091148.28948.29
361994-6199473.17573.17
437221-3722143.93443.93
537260-3726043.98043.98
635415-3541541.80241.80
10min163725-6372575.21874.9014.6875.5175.1814.70
260464-6046471.36971.64
381599-8159996.31696.72
455471-5547165.47565.72
558378-5837868.90769.15
661084-6108472.10172.33
15min170327-7032783.01184.249.1383.7284.949.18
271177-7117784.01484.68
382968-8296897.93298.87
464148-6414875.71776.33
566699-6669978.72879.36
672877-7287786.02186.65
20min175702-7570289.35589.317.3090.5290.477.36
275687-7568789.33790.47
384232-8423299.424100.91
467436-6743679.59880.63
573118-7311886.30587.37
677790-7779091.82092.93
30min178597-7859792.77294.255.1094.4495.915.14
281610-8161096.32997.96
383467-8346798.521100.56
472223-7222385.24986.72
580978-8097895.58397.13
682210-8221097.03798.66
45min183490-8349098.54897.393.40100.7399.583.41
282160-8216096.97899.14
382849-8284997.791100.38
477207-7720791.13293.08
584180-8418099.362101.44
685173-85173100.534102.69
60min177546-7754691.53292.181.8194.2694.911.81
278702-7870292.89695.60
377420-7742091.38394.51
476063-7606389.78192.23
578646-7864692.83095.46
680195-8019594.65897.38
极限178940-7894093.17792.232.7596.4195.462.66
275789-7578989.45892.68
376866-7686690.72994.37
476378-7637890.15393.10
579506-7950693.84596.99
681328-8132895.99699.24
他达拉非达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ832-220225对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.86对照品水分(%)0对照品稀释倍数5000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
134.212871882874972871452866722870082871020.11
234.162799102821672810380.57
单位质量响应值RSD%判断
8392.348227.111.41数据可信
长期6月-供试品溶液-2023062021批-达泊西汀-pH6.8(内含0.3%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1137490-13749044.28852.5715.6844.2952.5715.68
2165504-16550453.31253.31
3159161-15916151.26951.27
4199232-19923264.17664.18
5183967-18396759.25959.26
6133855-13385543.11743.12
10min1206348-20634866.46873.359.6066.7173.649.61
2252419-25241981.30981.60
3219410-21941070.67670.96
4248119-24811979.92480.28
5238909-23890976.95777.29
6201098-20109864.77765.02
15min1237409-23740976.47481.158.8877.0981.858.90
2269027-26902786.65887.41
3234370-23437075.49576.17
4283776-28377691.40992.21
5259790-25979083.68384.44
6227198-22719873.18573.78
20min1252822-25282281.43984.986.7582.4886.136.80
2276632-27663289.10890.34
3248579-24857980.07281.17
4290027-29002793.42394.73
5269666-26966686.86488.09
6245214-24521478.98879.99
30min1261809-26180984.33390.136.9785.8391.757.00
2289634-28963493.29695.02
3261693-26169384.29685.84
4310847-310847100.129101.96
5286717-28671792.35794.06
6268112-26811286.36487.81
45min1283966-28396691.47193.924.5993.4396.044.67
2297888-29788895.95598.20
3278069-27806989.57191.58
4311235-311235100.254102.64
5299431-29943196.45298.67
6278754-27875489.79291.72
60min1294927-29492795.00195.033.6097.4797.683.69
2297648-29764895.87898.65
3284968-28496891.79394.30
4312478-312478100.655103.60
5297116-29711695.70698.46
6283026-28302691.16893.59
极限1299866-29986696.59296.024.0499.5999.194.09
2307353-30735399.004102.31
3295457-29545795.17298.19
4309873-30987399.816103.32
5299820-29982096.57799.86
6276088-27608888.93391.86
他达拉非达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.487932679401793107940679329793540.06
210.077655277374769630.76
单位质量响应值RSD%判断
7571.957642.800.66数据可信
长期6月-供试品溶液-2023062021批-他达拉非-pH6.8(内含0.3%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min134280-3428040.52846.0414.7240.5346.0414.73
236138-3613842.72542.72
337610-3761044.46544.46
446560-4656055.04655.05
545613-4561353.92653.93
633438-3343839.53239.53
10min155907-5590766.09772.577.3366.3272.827.35
263813-6381375.44475.68
360707-6070771.77172.02
464795-6479576.60576.91
566687-6668778.84179.14
656386-5638666.66366.88
15min164730-6473076.52881.556.1477.1282.216.17
269804-6980482.52683.18
366549-6654978.67879.32
474632-7463288.23488.97
573144-7314486.47587.21
665034-6503476.88777.48
20min169002-6900281.57885.454.1582.6086.574.20
272014-7201485.13986.25
370679-7067983.56184.64
476227-7622790.12091.34
575637-7563789.42390.64
670127-7012782.90883.93
30min171020-7102083.96490.354.7885.4391.934.80
274925-7492588.58190.17
374764-7476488.39189.94
481146-8114695.93697.66
579527-7952794.02295.74
677124-7712491.18192.66
45min176938-7693890.96193.752.9592.9095.842.97
276310-7631090.21892.30
378766-7876693.12295.16
481107-8110795.89098.14
582013-8201396.96199.20
680652-8065295.35297.34
60min179443-7944393.92294.962.4996.3697.572.47
276726-7672690.71093.29
380879-8087995.62098.18
481074-8107495.85198.64
581496-8149696.34999.13
682326-8232697.33199.84
极限181637-8163796.51695.912.0799.4899.052.00
279010-7901093.41096.50
383590-8359098.825101.91
479973-7997394.54997.87
582243-8224397.233100.54
680317-8031794.95698.01
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