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%
111.159834098466984109865498404984550.13
211.199771797958978380.18
单位质量响应值RSD%判断
8830.048743.340.70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%
5min112083-1208312.45111.584.9412.4511.584.95
211190-1119011.53111.53
311460-1146011.80911.81
411208-1120811.54911.55
510366-1036610.68210.68
611126-1112611.46511.46
10min133009-3300934.01433.044.1034.1533.164.09
232935-3293533.93834.07
332624-3262433.61733.75
431234-3123432.18532.31
532819-3281933.81833.94
629741-2974130.64730.77
15min146812-4681248.23747.282.3348.7547.782.32
246675-4667548.09648.60
345983-4598347.38347.89
445039-4503946.41046.90
544174-4417445.51946.01
646645-4664548.06548.53
20min154099-5409955.74655.451.2256.8056.471.22
254600-5460056.26257.30
353786-5378655.42456.45
454297-5429755.95056.95
552961-5296154.57355.57
653129-5312954.74755.75
30min163012-6301264.93164.941.3066.6066.581.30
263403-6340365.33367.00
363741-6374165.68267.33
463826-6382665.76967.39
561724-6172463.60365.21
662421-6242164.32265.93
45min170546-7054672.69471.681.5875.0974.041.57
270019-7001972.15174.54
370521-7052172.66875.04
468777-6877770.87173.23
567758-6775869.82172.13
669779-6977971.90474.23
60min174777-7477777.05476.681.0080.2579.840.98
275294-7529477.58680.78
373918-7391876.16979.35
474644-7464476.91780.06
574672-7467276.94680.03
673201-7320175.43078.55
90min180614-8061483.06882.011.1587.1386.021.14
280698-8069883.15587.21
379279-7927981.69385.72
478695-7869581.09185.09
579643-7964382.06886.01
678601-7860180.99484.96
120min182740-8274085.25985.101.1590.2490.021.09
281346-8134683.82388.80
383686-8368686.23491.17
483638-8363886.18591.08
581998-8199884.49589.35
682095-8209584.59589.46
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184247-8424786.81287.840.9092.7493.710.83
285223-8522387.81893.73
386365-8636588.99594.89
484915-8491587.50093.36
584859-8485987.44393.24
685867-8586788.48194.28
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%
111.159778598104978679799697955979410.13
211.199924298989991160.19
单位质量响应值RSD%判断
8783.958857.550.60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%
5min115564-1556415.97615.646.5015.9815.646.49
216702-1670217.14417.14
314172-1417214.54714.55
414061-1406114.43314.43
515562-1556215.97415.97
615387-1538715.79415.79
10min142883-4288344.01841.816.8044.2041.986.78
239721-3972140.77240.96
336282-3628237.24237.40
440857-4085741.93842.10
540348-4034841.41641.59
644289-4428945.46145.64
15min155077-5507756.53457.413.3057.2058.043.25
257698-5769859.22559.87
354793-5479356.24356.82
456854-5685458.35858.98
557885-5788559.41760.05
653247-5324754.65655.34
20min163261-6326164.93565.422.0966.2366.702.10
263627-6362765.31166.61
361503-6150363.13064.33
463920-6392065.61166.89
564826-6482666.54167.84
665286-6528667.01468.30
30min171577-7157773.47173.401.4075.4975.411.35
272560-7256074.48076.51
372126-7212674.03575.94
470288-7028872.14874.15
570289-7028972.14974.19
672234-7223474.14576.18
45min174938-7493876.92180.672.7779.7583.482.67
279075-7907581.16784.02
379833-7983381.94584.67
477964-7796480.02782.83
578300-7830080.37283.21
681418-8141883.57286.43
60min180234-8023482.35783.511.8686.0487.221.77
280937-8093783.07986.84
383777-8377785.99489.63
479455-7945581.55785.25
581933-8193384.10187.83
681781-8178183.94587.73
90min185180-8518087.43487.561.9492.0492.201.84
286258-8625888.54193.22
385495-8549587.75792.35
486058-8605888.33592.94
582118-8211884.29188.96
686685-8668588.97993.70
120min186855-8685589.15389.272.0094.7394.881.92
287064-8706489.36895.03
387735-8773590.05795.62
484367-8436786.59992.18
586157-8615788.43794.04
689616-8961691.98797.69
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186970-8697089.27190.991.5995.8497.601.54
289560-8956091.93098.59
389051-8905191.40797.97
486857-8685789.15595.70
589196-8919691.55698.14
690250-9025092.63899.37
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%
111.159931199450991349889499100991780.22
211.199963299822997270.14
单位质量响应值RSD%判断
8894.898912.150.14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%
5min116857-1685717.14218.147.9217.1418.147.92
216763-1676317.04617.05
320512-2051220.85920.86
417130-1713017.42017.42
517585-1758517.88217.88
618196-1819618.50418.50
10min142022-4202242.73243.035.9942.9243.245.99
239757-3975740.42940.62
346336-4633647.11947.35
443821-4382144.56244.76
539674-3967440.34540.54
642297-4229743.01243.22
15min157687-5768758.66258.632.3159.3359.312.34
255611-5561156.55157.19
359148-5914860.14860.90
459039-5903960.03760.73
556984-5698457.94758.59
657488-5748858.46059.14
20min163845-6384564.92465.482.3166.2466.812.30
263645-6364564.72165.99
365526-6552666.63468.06
466432-6643267.55568.91
564651-6465165.74467.03
662248-6224863.30064.63
30min173242-7324274.48072.182.5776.5274.242.53
268515-6851569.67371.66
372326-7232673.54875.71
469882-6988271.06373.17
572039-7203973.25775.28
669853-6985371.03473.07
45min176337-7633777.62778.912.4080.4981.772.38
275188-7518876.45979.22
379226-7922680.56583.55
478461-7846179.78782.68
579883-7988381.23384.07
676480-7648077.77380.60
60min180932-8093282.30081.311.5686.0385.051.57
278707-7870780.03783.65
381520-8152082.89886.77
479330-7933080.67184.45
580674-8067482.03885.78
678593-7859379.92183.61
90min180954-8095482.32283.483.4386.9788.123.30
278531-7853179.85884.36
383381-8338184.79089.59
480128-8012881.48286.16
586455-8645587.91692.57
683113-8311384.51889.10
120min182582-8258283.97886.272.2289.5491.842.11
285488-8548886.93392.32
385189-8518986.62992.37
484073-8407385.49491.08
588014-8801489.50295.13
683686-8368685.10090.62
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186140-8614087.59687.852.1094.0994.371.87
289902-8990291.42297.77
385605-8560587.05293.75
484689-8468986.12092.65
586252-8625287.71094.33
685728-8572887.17793.64
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