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%
111.068854808846138852398864848801358843900.28
211.119033269022559027900.09
单位质量响应值RSD%判断
79962.9381259.231.14数据可信
供试品溶液-25012001批-依折麦布-pH4.5SDS
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1142189-14218915.83618.2124.6315.8418.2124.62
2234713-23471326.14126.14
3189279-18927921.08121.08
4135378-13537815.07815.08
5138718-13871815.45015.45
6140840-14084015.68615.69
10min1553407-55340761.63666.108.6561.8166.308.69
2683170-68317076.08876.38
3606693-60669367.57167.80
4552979-55297961.58861.76
5555270-55527061.84362.02
6609154-60915467.84568.02
15min1799280-79928089.02094.513.3489.8895.453.37
2868920-86892096.77697.91
3854878-85487895.21296.20
4833183-83318392.79693.65
5858776-85877695.64696.51
6876429-87642997.61398.54
20min1863397-86339796.16196.980.5498.0198.970.57
2869708-86970896.86499.08
3875393-87539397.49799.54
4871751-87175197.09298.97
5875863-87586397.54999.47
6868396-86839696.71898.73
30min1820374-82037491.36996.503.3794.2999.573.33
2862379-86237996.04899.34
3891650-89165099.308102.43
4846993-84699394.33497.30
5881492-88149298.176101.18
6895935-89593599.785102.87
45min1840185-84018593.57696.301.9097.51100.431.91
2860508-86050895.839100.19
3889067-88906799.020103.25
4858003-85800395.56099.57
5874233-87423397.368101.46
6865698-86569896.417100.61
60min1831004-83100492.55396.152.4497.53101.352.43
2859194-85919495.693101.11
3883720-88372098.425103.75
4856128-85612895.351100.42
5860221-86022195.807100.99
6889353-88935399.052104.32
极限1818865-81886591.20196.433.2897.20102.713.21
2858136-85813695.575102.06
3882926-88292698.336104.76
4856533-85653395.397101.53
5877590-87759097.742103.98
6901064-901064100.356106.72
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%
19.832256082268882271792277672247702264420.55
29.782295612271832283720.74
单位质量响应值RSD%判断
23035.8123350.920.97数据可信
供试品溶液-25012001批-贝派度酸-pH4.5SDS
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min115891-158916.8337.6024.286.837.6024.31
225504-2550410.96610.97
319251-192518.2778.28
414420-144206.2006.20
513915-139155.9835.98
617073-170737.3417.34
10min178667-7866733.82435.598.3033.9035.688.33
294086-9408640.45440.58
380708-8070834.70234.79
476060-7606032.70432.77
579084-7908434.00434.07
688046-8804637.85737.94
15min1127892-12789254.99057.323.6155.4457.803.65
2138371-13837159.49560.07
3130660-13066056.18056.66
4129369-12936955.62556.06
5134077-13407757.64958.09
6139443-13944359.95660.46
20min1156781-15678167.41166.951.3668.4768.071.40
2158384-15838468.10069.33
3152276-15227665.47466.58
4155211-15521166.73667.79
5154849-15484966.58067.67
6156807-15680767.42268.59
30min1174776-17477675.14977.722.8176.9679.592.76
2177078-17707876.13878.13
3182751-18275178.57880.41
4178590-17859076.78878.58
5182442-18244278.44580.27
6188970-18897081.25283.17
45min1203263-20326387.39788.350.9890.0491.080.96
2202806-20280687.20190.04
3206077-20607788.60791.31
4206470-20647088.77691.42
5206421-20642188.75591.45
6207902-20790289.39292.21
60min1215769-21576992.77494.712.2796.3998.412.21
2215175-21517592.51996.32
3223065-22306595.91199.60
4221447-22144795.21698.85
5217903-21790393.69297.37
6228202-22820298.120101.93
极限1221096-22109695.06599.262.6299.71104.022.56
2227566-22756697.847102.68
3231891-23189199.706104.46
4232712-232712100.059104.75
5232799-232799100.097104.82
6239089-239089102.801107.70
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%
111.069478929436719488419461779480269469210.22
211.119472189419569445870.40
单位质量响应值RSD%判断
85616.7385021.330.50数据可信
供试品溶液-25012001批-依折麦布-pH6.6
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min146709-467094.9154.4212.714.914.4212.69
247892-478925.0395.04
335607-356073.7473.75
436113-361133.8003.80
540904-409044.3044.30
645033-450334.7394.74
10min169891-698917.3547.371.557.417.421.54
271929-719297.5697.62
369156-691567.2777.32
470242-702427.3917.43
570208-702087.3887.44
668865-688657.2467.30
15min171994-719947.5757.621.077.717.751.09
273972-739727.7847.92
372089-720897.5857.71
472161-721617.5937.72
571958-719587.5727.70
672498-724987.6297.76
20min169870-698707.3527.452.007.577.672.00
273229-732297.7057.93
369507-695077.3147.52
471825-718257.5587.77
570391-703917.4077.62
670160-701607.3837.60
30min167599-675997.1137.281.847.427.581.79
270738-707387.4437.76
370022-700227.3687.66
470006-700067.3667.66
568953-689537.2567.55
667885-678857.1437.44
45min164499-644996.7877.122.727.177.502.54
267419-674197.0947.49
367639-676397.1177.49
470195-701957.3867.76
568310-683107.1887.56
667731-677317.1277.51
60min166687-666877.0177.132.297.477.592.15
267530-675307.1067.58
367153-671537.0667.52
470521-705217.4217.88
568582-685827.2167.67
666307-663076.9777.44
极限167019-670197.0527.091.937.597.631.83
266982-669827.0487.60
365670-656706.9107.44
469636-696367.3277.87
567230-672307.0747.61
667613-676137.1157.65
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%
19.832412282404302414222409462415802411210.19
29.782407172398172402670.27
单位质量响应值RSD%判断
24529.0924567.180.11数据可信
供试品溶液-25012001批-贝派度酸-pH6.6
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min176923-7692331.24824.4138.1631.2524.4138.16
284778-8477834.43934.44
345937-4593718.66118.66
440186-4018616.32416.32
532783-3278313.31713.32
679905-7990532.45932.46
10min1185809-18580975.48072.506.7775.8372.776.84
2191385-19138577.74578.13
3168387-16838768.40368.61
4159347-15934764.73064.91
5182343-18234374.07274.22
6183515-18351574.54874.91
15min1225981-22598191.79988.354.8392.9889.424.90
2226414-22641491.97493.22
3211369-21136985.86386.83
4199210-19921080.92481.82
5222223-22222390.27291.24
6219710-21971089.25190.44
20min1240271-24027197.60393.804.2299.8195.864.29
2239950-23995097.47399.74
3224276-22427691.10693.03
4215768-21576887.65089.45
5236077-23607795.90097.87
6229078-22907893.05795.24
30min1250045-250045101.57497.663.32104.86100.763.38
2244625-24462599.372102.72
3239700-23970097.372100.31
4227106-22710692.25695.03
5244304-24430499.242102.28
6236735-23673596.16799.38
45min1246636-246636100.18997.862.78104.61102.042.86
2242144-24214498.364102.82
3240910-24091097.863101.88
4228114-22811492.66596.46
5245892-24589299.887104.03
6241672-24167298.173102.46
60min1255408-255408103.75298.603.49109.28103.883.52
2244017-24401799.125104.67
3243169-24316998.781103.88
4229845-22984593.36898.20
5245758-24575899.832105.08
6238224-23822496.772102.15
极限1248695-248695101.02698.091.90107.71104.462.03
2242081-24208198.339104.99
3239146-23914697.146103.35
4235336-23533695.599101.46
5243897-24389799.076105.44
6239710-23971097.376103.82
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