依折麦布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DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数2000
标示量(mg)10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%
111.159656889666149665769667709682409667780.10
211.179673369678559675960.04
单位质量响应值RSD%判断
86706.5586624.530.07数据可信
供试品溶液-1996049批-依折麦布-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%
5min1427929-42792944.32853.8414.2044.3353.8414.20
2470722-47072248.76148.76
3541100-54110056.05156.05
4545876-54587656.54656.55
5492868-49286851.05551.06
6640264-64026466.32466.32
10min1805641-80564183.45586.312.1183.9586.902.15
2852632-85263288.32288.86
3822821-82282185.23485.86
4836945-83694586.69787.33
5831096-83109686.09186.66
6849827-84982788.03288.77
15min1838148-83814886.82289.682.0188.2491.232.04
2886198-88619891.79993.32
3854858-85485888.55390.12
4865647-86564789.67191.26
5869884-86988490.10991.63
6879448-87944891.10092.82
20min1846269-84626987.66390.412.0090.0592.962.00
2894217-89421792.63095.17
3861598-86159889.25191.80
4872324-87232490.36292.95
5887778-88777891.96394.49
6874612-87461290.59993.33
30min1847110-84711087.75089.972.5491.1193.532.49
2903428-90342893.58497.16
3845121-84512187.54491.09
4867155-86715589.82793.42
5882306-88230691.39694.94
6866205-86620589.72893.46
45min1854390-85439088.50489.591.7192.8494.161.68
2890482-89048292.24396.86
3852255-85225588.28392.80
4860574-86057489.14593.74
5874386-87438690.57695.14
6857419-85741988.81893.55
60min1834189-83418986.41288.901.8591.7394.461.84
2880417-88041791.20196.84
3852809-85280988.34193.84
4865481-86548189.65395.23
5865547-86554789.66095.23
6850891-85089188.14293.86
极限1867413-86741389.85390.801.9296.1397.341.86
2899422-89942293.16999.82
3856809-85680988.75595.24
4881565-88156591.31997.90
5891038-89103892.30198.87
6863027-86302789.39996.10
依折麦布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对照品来源中检院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100
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%
110.162565742567362562402565052570732566260.12
210.192562602572332567460.27
单位质量响应值RSD%判断
25258.4625195.880.18数据可信
供试品溶液-1996049批-贝派度酸-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%
5min129477-2947711.65213.0816.7511.6513.0816.75
228257-2825711.17011.17
335387-3538713.98813.99
432313-3231312.77312.77
529899-2989911.81911.82
643134-4313417.05017.05
10min181213-8121332.10333.025.3332.2333.175.38
282432-8243232.58432.71
384626-8462633.45233.61
483129-8312932.86033.00
578312-7831230.95631.09
691522-9152236.17836.37
15min1113452-11345244.84645.903.6145.3346.413.66
2116177-11617745.92346.41
3117152-11715246.30946.84
4114658-11465845.32345.83
5111600-11160044.11444.59
6123670-12367048.88549.48
20min1134002-13400252.96955.283.1453.9556.303.18
2141967-14196756.11857.11
3140799-14079955.65656.70
4138873-13887354.89555.91
5136737-13673754.05155.02
6146631-14663157.96259.10
30min1161785-16178563.95266.662.7265.5268.302.73
2174613-17461369.02370.64
3167490-16749066.20767.87
4169056-16905666.82668.45
5166352-16635265.75767.32
6172587-17258768.22270.00
45min1186829-18682973.85176.702.2576.1379.082.26
2199504-19950478.86281.25
3194992-19499277.07879.47
4193974-19397476.67679.04
5192058-19205875.91878.21
6196880-19688077.82480.36
60min1195202-19520277.16181.422.8280.2784.662.79
2211321-21132183.53386.80
3208372-20837282.36785.62
4209557-20955782.83686.05
5204266-20426680.74483.88
6207204-20720481.90585.31
极限1221534-22153487.57090.171.9491.5394.301.91
2233492-23349292.29796.49
3227118-22711889.77793.94
4232648-23264891.96396.10
5227575-22757589.95894.00
6226283-22628389.44793.76
依折麦布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DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数2000
标示量(mg)10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%
111.159686529682209678409676839681729681130.04
211.179687529701019694260.10
单位质量响应值RSD%判断
86826.2886788.360.04数据可信
供试品溶液-1996049批-依折麦布-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%
5min1456957-45695747.25848.7428.7047.2648.7428.70
2324564-32456433.56633.57
3334190-33419034.56134.56
4514331-51433153.19153.19
5689785-68978571.33771.34
6507666-50766652.50252.50
10min1788722-78872281.56986.286.0982.0986.826.22
2802058-80205882.94883.32
3808468-80846883.61183.99
4846258-84625887.51988.11
5928970-92897096.07396.87
6831164-83116485.95886.54
15min1823479-82347985.16390.674.8886.5992.174.97
2872002-87200290.18191.48
3872169-87216990.19991.51
4893914-89391492.44794.01
5949144-94914498.159100.02
6849751-84975187.88089.42
20min1834940-83494086.34891.443.8288.7393.953.87
2894453-89445392.50394.80
3880854-88085491.09793.41
4918786-91878695.02097.61
5919020-91902095.04497.99
6856944-85694488.62491.14
30min1833251-83325186.17491.384.0889.5194.904.14
2876750-87675090.67294.00
3900490-90049093.12896.45
4899621-89962193.03896.68
5934854-93485496.681100.69
6856509-85650988.57992.08
45min1831000-83100085.94190.944.7890.2495.484.79
2873960-87396090.38494.72
3899622-89962293.03897.40
4893560-89356092.41197.09
5942127-94212797.434102.51
6835916-83591686.44990.93
60min1821266-82126684.93490.104.6190.1895.654.64
2858608-85860888.79694.13
3889768-88976892.01997.41
4898521-89852192.92498.63
5925267-92526795.690101.85
6833829-83382986.23491.68
极限1846902-84690287.58692.674.4193.7899.224.43
2886428-88642891.67398.00
3915658-91565894.696101.11
4931225-93122596.306103.05
5940714-94071497.287104.51
6855401-85540188.46494.87
依折麦布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对照品来源中检院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100
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%
110.162580372566902575712572932571362573450.20
210.192571772584632578200.36
单位质量响应值RSD%判断
25329.2325301.280.08数据可信
供试品溶液-1996049批-贝派度酸-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%
5min131635-3163512.46112.1224.9212.4612.1324.90
220303-203037.9988.00
325122-251229.8969.90
432534-3253412.81612.82
542881-4288116.89116.89
632211-3221112.68812.69
10min184192-8419233.16432.338.9033.3032.478.96
271329-7132928.09728.19
377962-7796230.71030.82
481067-8106731.93332.08
593075-9307536.66336.85
684868-8486833.43133.57
15min1115788-11578845.61045.514.0346.1246.014.13
2109928-10992843.30243.70
3114337-11433745.03945.49
4114724-11472445.19145.69
5124089-12408948.88049.48
6114366-11436645.05045.56
20min1139890-13989055.10456.043.1456.1257.043.01
2150825-15082559.41260.29
3139795-13979555.06756.02
4141716-14171655.82456.82
5142780-14278056.24357.38
6138572-13857254.58555.60
30min1169585-16958566.80267.572.0368.4369.202.02
2169565-16956566.79468.34
3176161-17616169.39270.96
4169596-16959666.80668.43
5175818-17581869.25771.02
6168553-16855366.39568.01
45min1195084-19508476.84677.692.7879.2180.062.75
2196025-19602577.21779.50
3203582-20358280.19482.53
4194902-19490276.77479.14
5203844-20384480.29782.83
6189862-18986274.78977.15
60min1206653-20665381.40382.572.0284.6385.811.99
2208433-20843382.10485.25
3215512-21551284.89388.12
4211054-21105483.13786.35
5212300-21230083.62887.05
6203725-20372580.25083.44
极限1228078-22807889.84391.401.7493.9795.561.69
2233155-23315591.84395.90
3235280-23528092.68096.85
4236834-23683493.29297.43
5232322-23232291.51595.87
6226531-22653189.23393.31
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