玛巴洛沙韦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号115240801对照品来源原料对照品使用方法直接使用
对照品含量(%)100.6对照品水分(%)0对照品稀释倍数2500
标示量(mg)20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%
111.159767397117975109731197795974810.28
211.199780497858978310.04
单位质量响应值RSD%判断
8742.698742.720.01数据可信
供试品溶液-B0083N01批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min111976-1197612.40211.4512.4912.4011.4512.50
28869-88699.1859.18
312214-1221412.64912.65
411831-1183112.25212.25
511672-1167212.08812.09
69797-979710.14610.15
10min132257-3225733.40633.255.1733.5433.375.19
228782-2878229.80729.91
333104-3310434.28334.42
432715-3271533.88034.02
533122-3312234.30134.44
632633-3263333.79533.91
15min144451-4445146.03446.953.5346.5447.453.56
242626-4262644.14444.58
347021-4702148.69549.22
446462-4646248.11648.63
546094-4609447.73548.25
645375-4537546.99147.48
20min153816-5381655.73255.172.2856.7556.192.32
250930-5093052.74353.67
354396-5439656.33357.40
453499-5349955.40456.45
553248-5324855.14456.19
653753-5375355.66756.68
30min161664-6166463.86064.942.0565.5066.572.04
261327-6132763.51165.02
362708-6270864.94166.63
463215-6321565.46667.13
562397-6239764.61966.28
664915-6491567.22668.86
45min167043-6704369.43071.001.5971.7873.361.61
267378-6737869.77771.99
369569-6956972.04674.46
469219-6921971.68474.07
569389-6938971.86074.24
668777-6877771.22673.60
60min173615-7361576.23676.731.5579.3679.881.55
272882-7288275.47778.47
375958-7595878.66381.87
473119-7311975.72378.91
574316-7431676.96280.14
674675-7467577.33480.50
90min179545-7954582.37782.071.6686.3586.061.64
278418-7841881.21085.04
381478-8147884.37988.46
479030-7903081.84485.87
579443-7944382.27286.30
677576-7757680.33884.36
120min180995-8099583.87984.571.6388.7689.481.64
279355-7935582.18186.91
382805-8280585.75390.78
482880-8288085.83190.77
581984-8198484.90389.85
681981-8198184.90089.82
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限184272-8427287.27388.011.1193.0993.851.13
284168-8416887.16592.81
386670-8667089.75695.73
485114-8511488.14594.04
584404-8440487.40993.30
685248-8524888.28394.15
玛巴洛沙韦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号115240801对照品来源原料对照品使用方法直接使用
对照品含量(%)100.6对照品水分(%)0对照品稀释倍数2500
标示量(mg)20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%
111.159786197506977659797097507977220.22
211.199829198219982550.06
单位质量响应值RSD%判断
8764.308780.610.14数据可信
供试品溶液-B0083N01批-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%
5min116105-1610516.62215.766.9716.6215.766.98
216600-1660017.13317.13
313734-1373414.17514.17
414399-1439914.86114.86
515550-1555016.04916.05
615257-1525715.74715.75
10min142399-4239943.76041.636.8743.9441.816.86
239831-3983141.10941.30
335625-3562536.76836.93
441015-4101542.33142.50
539559-3955940.82941.01
643591-4359144.99045.17
15min154789-5478956.54756.793.5257.2257.433.54
255894-5589457.68858.34
351693-5169353.35253.92
454436-5443656.18356.82
555974-5597457.77058.40
657386-5738659.22859.90
20min162405-6240564.40865.052.1765.7166.322.20
262959-6295964.98066.27
361103-6110363.06464.22
463371-6337165.40566.66
563047-6304765.07066.34
665283-6528367.37868.71
30min169746-6974671.98473.361.4674.0075.351.42
272057-7205774.37076.38
371741-7174174.04475.90
469803-6980372.04374.03
571315-7131573.60475.60
671786-7178674.09076.17
45min177866-7786680.36580.612.6783.1883.422.59
278660-7866081.18584.02
379207-7920781.74984.43
477350-7735079.83382.62
574676-7467677.07379.89
680880-8088083.47686.38
60min178320-7832080.83482.961.9684.5486.671.85
280279-8027982.85686.59
382716-8271685.37188.96
480838-8083883.43287.11
579032-7903281.56985.24
681122-8112283.72687.56
90min184393-8439387.10287.051.7091.7191.681.66
285594-8559488.34193.00
384656-8465687.37391.91
481721-8172184.34488.94
584084-8408486.78391.36
685620-8562088.36893.13
120min183798-8379886.48789.042.0092.0694.631.94
286881-8688189.66995.31
386868-8686889.65695.17
486172-8617288.93894.48
585075-8507587.80593.35
688824-8882491.67597.42
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限185888-8588888.64590.561.3895.1897.141.34
288964-8896491.81998.46
388090-8809090.91797.42
486631-8663189.41195.94
588338-8833891.17397.69
688529-8852991.37098.13
玛巴洛沙韦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号115240801对照品来源原料对照品使用方法直接使用
对照品含量(%)100.6对照品水分(%)0对照品稀释倍数2500
标示量(mg)20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%
111.159788297709977799752797608977010.15
211.199797397982979780.01
单位质量响应值RSD%判断
8762.428755.850.06数据可信
供试品溶液-B0083N01批-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%
5min116899-1689917.46818.327.3617.4718.327.35
216811-1681117.37717.38
317374-1737417.95917.96
420300-2030020.98320.98
517730-1773018.32718.33
617240-1724017.82017.82
10min143637-4363745.10643.455.5645.3043.655.55
239878-3987841.22041.41
342045-4204543.46043.66
445585-4558547.12047.35
539329-3932940.65340.86
641736-4173643.14143.34
15min158803-5880360.78358.842.5961.4859.532.62
255557-5555757.42758.08
356145-5614558.03558.72
458755-5875560.73361.49
555780-5578057.65858.31
656499-5649958.40159.08
20min165026-6502667.21566.051.9768.5967.391.98
262587-6258764.69465.98
362359-6235964.45865.79
465212-6521267.40768.84
564695-6469566.87368.17
663526-6352665.66566.99
30min169550-6955071.89172.541.8674.0174.621.84
268283-6828370.58272.59
369417-6941771.75473.80
471220-7122073.61875.80
571654-7165474.06676.11
670961-7096173.35075.41
45min177243-7724379.84379.151.8082.7682.031.80
274554-7455477.06479.86
375662-7566278.20981.05
477965-7796580.59083.59
577946-7794680.57083.43
676050-7605078.61081.48
60min177441-7744180.04881.712.0983.8585.462.04
277981-7798180.60684.25
377257-7725779.85883.57
480556-8055683.26887.16
580417-8041783.12486.88
680618-8061883.33287.08
90min180047-8004782.74283.593.1987.4388.263.08
279473-7947382.14886.69
377216-7721679.81584.41
482066-8206684.82989.65
584757-8475787.61092.29
681667-8166784.41689.09
120min181342-8134284.08087.042.6989.6992.632.57
284619-8461987.46892.92
382630-8263085.41290.90
485155-8515588.02293.78
587862-8786290.82096.47
683615-8361586.43092.04
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限183951-8395186.77788.301.8493.3294.861.79
284537-8453787.38393.81
384624-8462487.47393.91
485648-8564888.53195.27
588364-8836491.33998.00
685420-8542088.29694.86
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