非布司他多替诺雷片项目信息
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241101对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.907130771367713947120171223712980.12
210.997126371449713560.19
单位质量响应值RSD%判断
6541.106492.810.53数据可信
供试品溶液-6041601批-多替诺雷-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%
5min145527-4552762.67958.509.8362.6858.509.83
246021-4602163.35963.36
338396-3839652.86252.86
444446-4444661.19161.19
544477-4447761.23461.23
636099-3609949.69949.70
10min161764-6176485.03484.401.4885.1484.501.48
260868-6086883.80083.91
360921-6092183.87383.96
462251-6225185.70485.81
562124-6212485.52985.63
659910-5991082.48182.56
15min165688-6568890.43690.861.0590.6891.091.04
264946-6494689.41489.66
366071-6607190.96391.19
467057-6705792.32192.57
566016-6601690.88891.13
666176-6617691.10891.33
20min167135-6713592.42892.951.0092.8393.340.99
266612-6661291.70892.10
367239-6723992.57192.95
468242-6824293.95294.35
567509-6750992.94393.34
668345-6834594.09494.47
30min167815-6781593.36494.421.3193.9294.971.30
267971-6797193.57994.13
367940-6794093.53694.07
469653-6965395.89596.45
568348-6834894.09894.65
669772-6977296.05996.59
45min168413-6841394.18895.191.5394.8995.901.53
268584-6858494.42395.13
367958-6795893.56194.25
470354-7035496.86097.58
569046-6904695.05995.77
670507-7050797.07197.76
60min168811-6881194.73695.821.7395.6096.681.72
269334-6933495.45696.32
368143-6814393.81694.66
471057-7105797.82898.70
569194-6919495.26396.13
671053-7105397.82298.67
极限170685-7068597.31697.231.2498.3498.251.24
270425-7042596.95897.98
369239-6923995.32596.33
471829-7182998.89199.93
570356-7035696.86397.89
671207-7120798.03499.05
非布司他多替诺雷片项目信息
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101278-202405对照品来源中检所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250
标示量(mg)40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%
110.865310235316505318375315305314715315020.06
211.105383345388615385980.07
单位质量响应值RSD%判断
48941.2548522.340.61数据可信
供试品溶液-6041601批-非布司他-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%
5min1403985-40398574.53669.549.7474.5469.549.74
2406507-40650775.00275.00
3344918-34491863.63863.64
4395300-39530072.93472.93
5392966-39296672.50372.50
6317701-31770158.61758.62
10min1495677-49567791.45491.091.2791.5891.211.28
2489993-48999390.40590.53
3493287-49328791.01391.12
4501863-50186392.59592.72
5497640-49764091.81691.94
6483899-48389989.28189.38
15min1514657-51465794.95695.171.0095.2395.440.99
2508677-50867793.85294.13
3516686-51668695.33095.59
4524140-52414096.70596.98
5513378-51337894.72094.99
6517327-51732795.44895.69
20min1522112-52211296.33196.500.9496.7796.920.93
2518721-51872195.70696.14
3519954-51995495.93396.35
4530589-53058997.89598.33
5519255-51925595.80496.24
6527390-52739097.30597.71
30min1525635-52563596.98197.501.1697.5898.091.16
2525128-52512896.88897.48
3524374-52437496.74997.33
4538890-53889099.427100.03
5523646-52364696.61497.21
6532938-53293898.32998.90
45min1530674-53067497.91198.211.3798.6798.961.36
2530368-53036897.85598.61
3524212-52421296.71997.46
4544359-544359100.436101.20
5527387-52738797.30598.06
6536891-53689199.05899.79
60min1531212-53121298.01098.511.5498.9399.421.53
2534535-53453598.62399.54
3523707-52370796.62697.52
4547405-547405100.998101.93
5528898-52889897.58398.50
6537792-53779299.224100.12
极限1540334-54033499.69398.941.47100.78100.021.47
2538344-53834499.326100.41
3525541-52554196.96498.02
4547930-547930101.095102.20
5530269-53026997.83698.91
6535125-53512598.73299.79
非布司他多替诺雷片项目信息
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241101对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.907205471974720787216172230720990.14
210.997297873128730530.15
单位质量响应值RSD%判断
6614.596647.220.35数据可信
供试品溶液-6042201批-多替诺雷-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%
5min139657-3965753.65952.3512.9253.6652.3612.92
244189-4418959.79159.79
341289-4128955.86755.87
431305-3130542.35842.36
533920-3392045.89745.90
641795-4179556.55256.55
10min158825-5882579.59580.302.5079.6880.392.51
260412-6041281.74281.84
359791-5979180.90281.00
457835-5783578.25578.33
557751-5775178.14278.22
661481-6148183.18983.28
15min163840-6384086.38187.741.0686.6087.961.06
264706-6470687.55287.79
364597-6459787.40587.63
464857-6485787.75787.96
565166-6516688.17588.38
665906-6590689.17689.41
20min166103-6610389.44390.441.1389.8190.811.12
265769-6576988.99189.37
366990-6699090.64391.02
467016-6701690.67891.03
567516-6751691.35591.71
667638-6763891.52091.90
30min167497-6749791.32991.871.0691.8492.391.05
266822-6682290.41690.95
367602-6760291.47192.00
468232-6823292.32392.82
568627-6862792.85893.36
668622-6862292.85193.39
45min168093-6809392.13592.861.1792.8093.531.16
267480-6748091.30691.99
368245-6824592.34193.02
469304-6930493.77494.43
569240-6924093.68794.35
669412-6941293.92094.61
60min168472-6847292.64893.231.1993.4794.051.18
267688-6768891.58792.42
368452-6845292.62193.45
469695-6969594.30395.11
569667-6966794.26595.08
669427-6942793.94094.79
极限169060-6906093.44493.791.1794.4294.771.15
267942-6794291.93192.92
369263-6926393.71894.70
469473-6947394.00394.97
570329-7032995.16196.13
669813-6981394.46395.46
非布司他多替诺雷片项目信息
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101278-202405对照品来源中检所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250
标示量(mg)40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%
110.865397585394545399365393835398275396720.05
211.105515955506625511280.12
单位质量响应值RSD%判断
49693.5549651.170.07数据可信
供试品溶液-6042201批-非布司他-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%
5min1342972-34297262.08060.3313.3862.0860.3313.38
2383489-38348969.41469.41
3355455-35545564.34064.34
4266996-26699648.32848.33
5291478-29147852.75952.76
6359529-35952965.07765.08
10min1470504-47050485.16485.672.0485.2785.772.05
2482110-48211087.26587.38
3473922-47392285.78385.89
4463565-46356583.90883.99
5462948-46294883.79683.88
6486601-48660188.07888.19
15min1498209-49820990.17991.330.9990.4291.570.99
2505103-50510391.42791.69
3500430-50043090.58190.83
4505773-50577391.54891.77
5505222-50522291.44891.68
6512603-51260392.78493.04
20min1513183-51318392.88993.470.8693.2893.860.86
2510266-51026692.36192.77
3515147-51514793.24593.65
4518597-51859793.86994.24
5518359-51835993.82694.21
6522721-52272194.61695.03
30min1522551-52255194.58594.490.7395.1495.040.71
2515230-51523093.26093.83
3520502-52050294.21494.77
4523568-52356894.76995.30
5524482-52448294.93495.47
6525766-52576695.16795.73
45min1526635-52663595.32495.230.9696.0395.940.95
2517422-51742293.65794.38
3523155-52315594.69495.41
4529148-52914895.77996.47
5529518-52951895.84696.54
6530679-53067996.05696.78
60min1529325-52932595.81195.340.9496.6896.200.93
2517299-51729993.63494.51
3525700-52570095.15596.03
4527892-52789295.55296.40
5531027-53102796.11996.97
6528946-52894695.74296.63
极限1528560-52856095.67395.340.9496.7096.360.93
2517672-51767293.70294.74
3526989-52698995.38896.42
4525505-52550595.12096.13
5531942-53194296.28597.30
6529554-52955495.85396.90
非布司他多替诺雷片项目信息
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241101对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.907284572680728587297373030728770.19
210.997338273674735280.29
单位质量响应值RSD%判断
6685.966690.450.05数据可信
供试品溶液-6042401批-多替诺雷-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%
5min126791-2679135.94049.4218.8235.9449.4218.82
239674-3967453.22253.22
342095-4209556.47056.47
429676-2967639.81039.81
543714-4371458.64258.64
639079-3907952.42452.42
10min154623-5462373.27680.576.1373.3480.666.14
262764-6276484.19784.29
361609-6160982.64782.74
456272-5627275.48875.55
563455-6345585.12485.22
661653-6165382.70682.79
15min162184-6218483.41987.923.3083.6088.143.32
266773-6677389.57589.80
366326-6632688.97589.21
463580-6358085.29185.48
567722-6772290.84891.09
666661-6666189.42489.65
20min165979-6597988.51090.801.6388.8391.171.65
268373-6837391.72192.10
367723-6772390.84991.23
466855-6685589.68590.02
568993-6899392.55392.94
668216-6821691.51091.88
30min169075-6907592.66392.481.2493.1393.001.25
269631-6963193.40993.94
368190-6819091.47692.01
468009-6800991.23391.72
570184-7018494.15194.70
668562-6856291.97592.50
45min169159-6915992.77693.401.0793.4094.071.09
270019-7001993.92994.62
369030-6903092.60293.29
469029-6902992.60193.24
570925-7092595.14595.85
669596-6959693.36294.04
60min169632-6963293.41093.991.1294.1994.821.13
270305-7030594.31395.16
369399-6939993.09793.94
469658-6965893.44594.24
571536-7153695.96496.82
669874-6987493.73594.57
极限170338-7033894.35794.420.9795.2995.400.98
270290-7029094.29395.29
369771-6977193.59694.59
470055-7005593.97794.92
571718-7171896.20897.23
670152-7015294.10895.10
非布司他多替诺雷片项目信息
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101278-202405对照品来源中检所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250
标示量(mg)40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%
110.865495095485695495705492225490875491910.08
211.105547525550285548900.04
单位质量响应值RSD%判断
50570.0749990.090.82数据可信
供试品溶液-6042401批-非布司他-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%
5min1232559-23255941.58756.3618.1741.5956.3618.17
2341077-34107760.99360.99
3356862-35686263.81663.82
4252759-25275945.19945.20
5365384-36538465.34065.34
6342338-34233861.21861.22
10min1439568-43956878.60585.455.5378.6785.545.54
2497626-49762688.98889.09
3486035-48603586.91587.02
4449536-44953680.38880.46
5499730-49973089.36489.47
6494529-49452988.43488.54
15min1485508-48550886.82190.742.8687.0290.982.88
2517547-51754792.55092.80
3510923-51092391.36591.62
4493178-49317888.19288.40
5518733-51873392.76293.02
6518658-51865892.74993.00
20min1509688-50968891.14592.771.3891.4993.161.41
2524044-52404493.71294.12
3518860-51886092.78593.19
4510358-51035891.26491.62
5525504-52550493.97394.39
6524232-52423293.74594.15
30min1524093-52409393.72194.100.8994.2294.640.92
2528985-52898594.59595.16
3525837-52583794.03294.59
4518149-51814992.65893.17
5531071-53107194.96895.54
6529100-52910094.61695.18
45min1526391-52639194.13194.731.0494.7895.431.06
2531117-53111794.97795.69
3531317-53131795.01295.73
4520483-52048393.07593.74
5533391-53339195.38396.11
6535681-53568195.79396.51
60min1527933-52793394.40794.851.1195.2295.701.13
2530714-53071494.90595.78
3531055-53105594.96695.84
4520743-52074393.12193.94
5533705-53370595.43996.33
6538196-53819696.24397.12
极限1527943-52794394.40994.591.0695.3895.601.08
2528643-52864394.53495.57
3529557-52955794.69895.73
4519251-51925192.85593.83
5532263-53226395.18296.23
6535981-53598195.84696.88
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