贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.052985812984962985412984912983822984980.03
210.122983532980882982200.07
单位质量响应值RSD%判断
29701.2929468.380.56数据可信
供试品溶液-2025102721批-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min131225-3122521.05022.5211.1221.0522.5211.12
230744-3074420.72620.73
335125-3512523.67923.68
430352-3035220.46120.46
532919-3291922.19222.19
640086-4008627.02427.02
10min174796-7479650.42351.722.9750.6651.973.00
273430-7343049.50249.73
378483-7848352.90853.17
476395-7639551.50151.73
577876-7787652.49952.75
679342-7934253.48853.79
15min191298-9129861.54863.192.5962.3464.022.62
290463-9046360.98561.76
395840-9584064.61065.46
494831-9483163.92964.73
593604-9360463.10263.93
696399-9639964.98665.88
20min1100729-10072967.90569.702.0269.3871.222.04
2101595-10159568.48969.95
3103131-10313169.52571.09
4104733-10473370.60572.11
5103649-10364969.87471.40
6106472-10647271.77773.39
30min1112343-11234375.73577.561.8877.9779.861.87
2113921-11392176.79979.02
3114682-11468277.31279.65
4118676-11867680.00482.30
5114553-11455377.22579.53
6116162-11616278.30980.72
45min1118294-11829479.74783.472.9982.8286.642.94
2123172-12317283.03586.11
3121246-12124681.73784.94
4128513-12851386.63689.82
5125369-12536984.51687.68
6126330-12633085.16488.45
60min1126836-12683685.50587.782.1489.4791.872.09
2131437-13143788.60792.60
3127935-12793586.24690.35
4134682-13468290.79494.94
5129630-12963087.38991.49
6130713-13071388.11992.35
90min1127009-12700985.62288.403.1990.5393.463.12
2125883-12588384.86389.84
3130870-13087088.22593.29
4136952-13695292.32597.48
5132128-13212889.07394.15
6133892-13389290.26295.47
120min1122098-12209882.31189.105.2888.1795.155.04
2136056-13605691.72197.64
3124588-12458883.99090.04
4138251-13825193.20099.38
5134978-13497890.99497.06
6137081-13708192.41298.62
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1133988-13398890.32791.942.8597.1098.982.74
2139482-13948294.030100.97
3129997-12999787.63694.62
4140613-14061394.793102.01
5136638-13663892.11399.19
6137591-13759192.75699.99
贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.052985322984942986372985522983672985160.04
210.122994102975872984980.44
单位质量响应值RSD%判断
29703.0829495.850.50数据可信
供试品溶液-2025102821批-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min132850-3285022.13420.0317.0722.1320.0317.05
234524-3452423.26223.26
328715-2871519.34819.35
421839-2183914.71514.72
526196-2619617.65117.65
634210-3421023.05123.05
10min171143-7114347.93647.269.3848.1847.489.41
277578-7757852.27252.53
369548-6954846.86247.08
459353-5935339.99240.16
567185-6718545.27045.47
676009-7600951.21551.47
15min188757-8875759.80558.994.6460.5859.744.71
292156-9215662.09562.93
389225-8922560.12060.86
481236-8123654.73755.35
584125-8412556.68457.38
689827-8982760.52661.35
20min1100154-10015467.48466.122.9968.9367.523.10
2101126-10112668.13969.67
398512-9851266.37867.78
493556-9355663.03864.25
595635-9563564.43965.77
699753-9975367.21468.71
30min1112761-11276175.97975.152.2678.1777.282.30
2110843-11084374.68676.97
3112960-11296076.11378.25
4106702-10670271.89673.81
5113177-11317776.25978.30
6112739-11273975.96478.21
45min1120891-12089181.45781.652.4384.4984.622.47
2120968-12096881.50984.62
3120532-12053281.21584.20
4116699-11669978.63281.35
5122097-12209782.26985.16
6125836-12583684.78987.88
60min1125024-12502484.24283.983.5288.1887.863.36
2124612-12461283.96487.99
3131606-13160688.67792.57
4122203-12220382.34185.93
5125996-12599684.89788.70
6118343-11834379.74083.77
90min1130264-13026487.77288.202.5292.6593.012.47
2129429-12942987.21092.16
3137085-13708592.36897.24
4127359-12735985.81590.32
5131280-13128088.45793.21
6129969-12996987.57492.49
120min1132241-13224189.10588.812.2694.9694.602.19
2129131-12913187.00992.93
3134430-13443090.57996.48
4128157-12815786.35391.81
5135800-13580091.50397.24
6131070-13107088.31694.21
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1134460-13446090.60090.721.1997.4497.500.97
2132055-13205588.97995.87
3135147-13514791.06397.97
4136936-13693692.26898.68
5135152-13515291.06697.82
6134072-13407290.33897.21
贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.052983562981732983512982172982802982750.03
210.122968762983392976080.35
单位质量响应值RSD%判断
29679.1029407.910.65数据可信
供试品溶液-2025102921批-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min134032-3403222.97524.4012.8022.9724.4012.81
241684-4168428.14028.14
341923-4192328.30228.30
434404-3440423.22623.23
530472-3047220.57120.57
634343-3434323.18423.18
10min173246-7324649.44752.384.9749.7052.645.00
281717-8171755.16655.48
380146-8014654.10554.42
478233-7823352.81453.07
572426-7242648.89449.12
679734-7973453.82754.08
15min190648-9064861.19562.433.6162.0063.283.64
298397-9839766.42667.35
392055-9205562.14563.06
491738-9173861.93162.78
588538-8853859.77160.54
693504-9350463.12363.98
20min197660-9766065.92968.883.7567.4170.433.77
2105770-10577071.40473.07
3104623-10462370.63072.24
4102487-10248769.18870.72
596967-9696765.46166.90
6104724-10472470.69872.25
30min1108902-10890273.51875.952.9075.7478.262.94
2116401-11640178.58181.04
3112713-11271376.09178.48
4112125-11212575.69478.00
5108927-10892773.53575.70
6115973-11597378.29280.63
45min1118413-11841379.93982.663.0882.9785.813.11
2126038-12603885.08788.42
3126633-12663385.48888.72
4119808-11980880.88184.02
5118987-11898780.32783.31
6124742-12474284.21287.42
60min1124530-12453084.06986.271.9487.9990.352.02
2130114-13011487.83892.11
3129180-12918087.20891.39
4126834-12683485.62489.67
5125643-12564384.82088.69
6130469-13046988.07892.23
90min1128160-12816086.51987.781.9491.3892.812.00
2131777-13177788.96194.21
3132678-13267889.56994.72
4127208-12720885.87690.87
5127905-12790586.34791.16
6132429-13242989.40194.53
120min1127319-12731985.95189.262.7791.7795.272.74
2134023-13402390.47796.72
3136089-13608991.87298.02
4128296-12829686.61192.56
5132338-13233889.34095.11
6135243-13524391.30197.42
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1129066-12906687.13189.782.1293.9096.782.02
2130670-13067088.21495.46
3134841-13484191.02998.20
4132078-13207889.16496.07
5135229-13522991.29198.06
6136049-13604991.84598.98
贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.052983152990902991512988212982962987350.14
210.122974212986732980470.30
单位质量响应值RSD%判断
29724.8829451.280.66数据可信
供试品溶液-2024090421批-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min126228-2622817.67917.5424.4917.6817.5424.49
223479-2347915.82615.83
320852-2085214.05614.06
425485-2548517.17917.18
521779-2177914.68114.68
638328-3832825.83625.84
10min170167-7016747.29748.402.7347.4948.592.72
272498-7249848.86949.04
371045-7104547.88948.05
469481-6948146.83547.03
574813-7481350.42950.59
672789-7278949.06549.35
15min186135-8613558.06158.891.8858.7859.621.88
287509-8750958.98759.71
386964-8696458.62059.31
485489-8548957.62658.34
590182-9018260.78961.51
687898-8789859.24960.08
20min194560-9456063.74065.552.0865.1166.942.05
295704-9570464.51165.89
396606-9660665.11966.46
4100131-10013167.49568.85
598356-9835666.29967.70
698141-9814166.15467.64
30min1106233-10623371.60872.481.3973.6874.601.37
2105400-10540071.04773.14
3108679-10867973.25775.32
4107657-10765772.56874.67
5109361-10936173.71775.85
6107850-10785072.69874.92
45min1114031-11403176.86578.131.2779.7481.051.25
2114844-11484477.41380.29
3117033-11703378.88881.77
4115787-11578778.04980.96
5118087-11808779.59982.55
6115621-11562177.93780.97
60min1118784-11878480.06981.061.3383.7984.851.30
2118051-11805179.57583.32
3121507-12150781.90485.66
4122042-12204282.26586.04
5119968-11996880.86784.71
6121168-12116881.67685.57
90min1123384-12338483.16983.971.2187.7888.661.17
2123834-12383483.47388.10
3123534-12353483.27187.93
4127425-12742585.89390.58
5124595-12459583.98688.72
6124701-12470184.05788.86
120min1123369-12336983.15984.551.5388.7090.171.50
2122979-12297982.89688.45
3125240-12524084.42090.01
4127261-12726185.78391.43
5127348-12734885.84191.51
6126362-12636285.17790.92
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1128285-12828586.47387.651.8592.9494.211.73
2127995-12799586.27892.75
3134619-13461990.74397.27
4129784-12978487.48394.08
5130141-13014187.72494.35
6129324-12932487.17393.86
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