非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
110.552039144203711420371952033417203227620358290.15
210.722053101205239120527460.03
单位质量响应值RSD%判断
192969.57191487.500.55数据可信
供试品溶液-250601批-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1583801-58380127.30629.5315.0327.3129.5315.03
2545020-54502025.49225.49
3547605-54760525.61325.61
4688235-68823532.19132.19
5789494-78949436.92736.93
6634240-63424029.66529.67
10min11111095-111109551.96952.885.7452.0352.955.75
21046277-104627748.93848.99
31111614-111161451.99452.05
41140171-114017153.32953.40
51244838-124483858.22558.31
61129689-112968952.83952.91
15min11393878-139387865.19665.992.5365.3766.182.55
21375463-137546364.33564.50
31381115-138111564.59964.77
41410430-141043065.97066.16
51467985-146798568.66268.87
61436862-143686267.20767.39
20min11588730-158873074.31073.551.1174.6373.881.12
21552310-155231072.60672.91
31555485-155548572.75573.07
41571555-157155573.50773.84
51595607-159560774.63275.00
61570740-157074073.46873.80
30min11721314-172131480.51181.200.6581.0081.700.66
21732676-173267681.04381.51
31735067-173506781.15581.63
41741442-174144281.45381.95
51754543-175454382.06582.60
61731499-173149980.98881.48
45min11852020-185202086.62587.190.5087.2987.860.49
21873494-187349487.62988.28
31870591-187059187.49388.15
41869038-186903887.42188.10
51865936-186593687.27687.99
61853099-185309986.67587.35
60min11921980-192198089.89790.410.6690.7591.280.65
21942355-194235590.85091.69
31941291-194129190.80091.65
41942472-194247290.85691.73
51937330-193733090.61591.52
61912727-191272789.46490.33
极限11961685-196168591.75492.440.4692.8193.510.45
21985497-198549792.86893.91
31984939-198493992.84293.90
41978923-197892392.56093.64
51971844-197184492.22993.34
61975490-197549092.40093.47
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
110.552046243204529620448882046108204647620458020.04
210.722103190210343021033100.01
单位质量响应值RSD%判断
193914.88196204.290.83数据可信
供试品溶液-250601批-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1738397-73839734.03728.1023.2934.0428.1023.30
2696581-69658132.10932.11
3439803-43980320.27320.27
4449490-44949020.71920.72
5755237-75523734.81334.81
6578494-57849426.66626.67
10min11267137-126713758.40952.949.1958.4853.009.21
21166512-116651253.77153.84
31023528-102352847.18047.22
41045469-104546948.19148.24
51267944-126794458.44658.52
61120300-112030051.64051.70
15min11477596-147759668.11065.733.9268.3265.913.95
21438819-143881966.32366.51
31356318-135631862.52062.67
41363133-136313362.83462.99
51488657-148865768.62068.83
61430927-143092765.95966.13
20min11604707-160470773.96972.971.6674.3373.301.69
21587813-158781373.19173.53
31546305-154630571.27771.57
41555244-155524471.68971.98
51608387-160838774.13974.50
61595734-159573473.55673.88
30min11751457-175145780.73480.800.8881.2581.290.90
21740039-174003980.20780.71
31742604-174260480.32680.77
41739923-173992380.20280.65
51774577-177457781.79982.32
61769223-176922381.55382.04
45min11861617-186161785.81286.691.0386.5187.351.03
21864984-186498485.96786.65
31880245-188024586.67087.30
41870718-187071886.23186.86
51893578-189357887.28587.99
61912312-191231288.14888.81
60min11930585-193058588.99189.840.7489.8890.700.73
21938566-193856689.35990.23
31950756-195075689.92090.74
41944131-194413189.61590.44
51960344-196034490.36291.26
61969483-196948390.78491.64
极限11972600-197260090.92791.860.8792.0292.920.87
22002155-200215592.29093.36
31995840-199584091.99993.02
41970021-197002190.80991.83
52005750-200575092.45593.56
62010284-201028492.66493.73
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
110.552067472206979220660212064550206594720667560.10
210.722114942211562821152850.03
单位质量响应值RSD%判断
195901.04197321.360.52数据可信
供试品溶液-250602批-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1659558-65955830.16232.4612.1330.1632.4612.14
2584339-58433926.72226.72
3674982-67498230.86730.87
4807576-80757636.93136.93
5737929-73792933.74633.75
6794794-79479436.34636.35
10min11212081-121208155.42956.494.6055.5056.574.61
21143566-114356652.29652.36
31212428-121242855.44555.51
41268549-126854958.01158.09
51283249-128324958.68458.76
61292249-129224959.09559.18
15min11462092-146209266.86267.301.9967.0567.502.00
21427415-142741565.27665.45
31452934-145293466.44366.64
41487800-148780068.03868.25
51502784-150278468.72368.93
61496733-149673368.44668.66
20min11616140-161614073.90774.361.5174.2574.701.53
21586601-158660172.55672.88
31617123-161712373.95274.29
41637540-163754074.88575.25
51643214-164321475.14575.50
61655125-165512575.69076.05
30min11782122-178212281.49781.350.8882.0081.870.89
21755005-175500580.25780.74
31767030-176703080.80781.31
41781152-178115281.45381.98
51795359-179535982.10382.63
61793348-179334882.01182.54
45min11910978-191097887.39086.830.7388.0787.530.74
21887589-188758986.32086.98
31879665-187966585.95886.64
41895653-189565386.68987.40
51915437-191543787.59488.30
61903660-190366087.05587.77
60min11986907-198690790.86290.090.8491.7490.980.84
21968812-196881290.03590.89
31945871-194587188.98689.86
41966191-196619189.91590.82
51990386-199038691.02191.92
61962370-196237089.74090.65
极限12032046-203204692.92692.500.4894.0193.590.47
22023708-202370892.54593.60
32013259-201325992.06793.14
42018459-201845992.30593.41
52035762-203576293.09694.20
62013135-201313592.06293.17
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
110.552047533204688020462652044900204510520461370.06
210.722123879212304621234620.03
单位质量响应值RSD%判断
193946.64198084.141.50数据可信
供试品溶液-250602批-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1775217-77521735.56229.9615.1335.5629.9615.13
2648438-64843829.74629.75
3575897-57589726.41926.42
4521033-52103323.90223.90
5755032-75503234.63634.64
6643563-64356329.52329.52
10min11322623-132262360.67456.825.5360.7556.895.53
21198283-119828354.97055.04
31170114-117011453.67853.74
41166501-116650153.51253.57
51295134-129513459.41359.49
61278774-127877458.66258.73
15min11531867-153186770.27368.052.3170.4968.242.33
21462383-146238367.08567.27
31451346-145134666.57966.76
41448684-144868466.45766.63
51496758-149675868.66268.87
61509104-150910469.22969.42
20min11660057-166005776.15374.661.4676.5275.001.47
21601915-160191573.48673.82
31613492-161349274.01774.34
41606399-160639973.69274.01
51645122-164512275.46875.83
61638463-163846375.16375.51
30min11815590-181559083.28882.121.0183.8382.631.03
21775173-177517381.43481.93
31786566-178656681.95782.45
41771936-177193681.28681.77
51782494-178249481.77082.30
61808964-180896482.98483.50
45min11925952-192595288.35187.890.8589.0888.590.85
21898521-189852187.09387.77
31921116-192111688.12988.80
41916508-191650887.91888.58
51895945-189594586.97587.69
61937906-193790688.89989.60
60min12004664-200466491.96291.370.7992.8892.260.79
21982851-198285190.96191.84
32003616-200361691.91492.78
41980728-198072890.86491.72
51970545-197054590.39791.30
62007999-200799992.11593.01
极限12042744-204274493.70993.250.6594.8394.340.65
22017503-201750392.55193.63
32046077-204607793.86294.93
42034626-203462693.33694.40
52015490-201549092.45993.56
62040294-204029493.59694.70
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