比拉斯汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
111.153815053814943815063814403814263814740.02
211.153815133816613815870.03
单位质量响应值RSD%判断
34212.9134223.050.03数据可信
中间条件6月-供试品溶液-2024122121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%
5min1207253-20725354.29455.813.3654.2955.813.36
2218056-21805657.12457.12
3224112-22411258.71058.71
4214680-21468056.23956.24
5207977-20797754.48354.48
6206271-20627154.03654.04
10min1280398-28039873.45575.472.2573.5575.562.24
2291774-29177476.43576.53
3298498-29849878.19778.29
4289040-28904075.71975.81
5284559-28455974.54574.64
6284327-28432774.48474.57
15min1312857-31285781.95884.621.9882.1784.841.98
2326856-32685685.62685.85
3329925-32992586.43086.66
4326641-32664185.56985.79
5318144-31814483.34383.56
6323769-32376984.81785.03
20min1327122-32712285.69588.942.1486.0489.302.14
2343421-34342189.96590.33
3343615-34361590.01690.39
4345795-34579590.58790.95
5334272-33427287.56887.92
6342821-34282189.80890.16
30min1339355-33935588.90092.672.4589.3993.182.45
2356130-35613093.29493.81
3355979-35597993.25593.78
4363083-36308395.11695.63
5348103-34810391.19291.69
6359936-35993694.29294.80
45min1345263-34526390.44894.662.6491.0995.322.63
2362885-36288595.06495.73
3364177-36417795.40396.08
4371464-37146497.31297.98
5355739-35573993.19293.84
6368411-36841196.51297.17
60min1349256-34925691.49495.692.6192.2896.512.61
2366435-36643595.99496.82
3368588-36858896.55897.39
4375753-37575398.43599.27
5359790-35979094.25395.06
6371887-37188797.42298.25
极限1377617-37761798.923101.271.2899.87102.261.28
2387189-387189101.431102.42
3392568-392568102.840103.84
4388558-388558101.790102.79
5387408-387408101.488102.45
6386202-386202101.172102.16
比拉斯汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
111.153815243810293813693814963816483814130.07
211.153813803813923813860.01
单位质量响应值RSD%判断
34207.4434205.020.01数据可信
中间条件6月-供试品溶液-2024122221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%
5min1220759-22075957.85256.781.7357.8556.781.73
2214424-21442456.19156.19
3221219-22121957.97257.97
4215739-21573956.53656.54
5211548-21154855.43855.44
6216314-21631456.68756.69
10min1291448-29144876.37676.281.0276.4776.371.02
2288621-28862175.63575.73
3295565-29556577.45577.55
4292578-29257876.67276.77
5287183-28718375.25875.35
6291058-29105876.27476.37
15min1321749-32174984.31784.980.9184.5485.200.91
2320467-32046783.98184.20
3327548-32754885.83686.06
4327682-32768285.87286.09
5323958-32395884.89685.11
6324187-32418784.95685.18
20min1337031-33703188.32289.051.0488.6989.421.04
2336212-33621288.10788.47
3344643-34464390.31690.69
4343579-34357990.03790.40
5339535-33953588.97889.34
6337897-33789788.54888.91
30min1349159-34915991.50092.111.0492.0192.621.04
2348074-34807491.21591.72
3355374-35537493.12893.65
4356571-35657193.44293.96
5351085-35108592.00492.51
6348583-34858391.34991.86
45min1355959-35595993.28293.711.0693.9594.381.05
2354084-35408492.79093.45
3362093-36209394.88995.56
4362557-36255795.01195.68
5356463-35646393.41494.07
6354491-35449192.89793.56
60min1360840-36084094.56194.731.0895.3895.561.08
2357378-35737893.65494.47
3366578-36657896.06596.90
4365789-36578995.85896.69
5360338-36033894.42995.25
6358012-35801293.82094.64
极限1385086-385086100.915100.551.11101.89101.531.10
2384117-384117100.661101.63
3387629-387629101.581102.57
4387337-387337101.505102.49
5381698-381698100.027101.00
6376257-37625798.60199.58
比拉斯汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
111.153814933817613817673818423815473816820.04
211.153817763815893816820.04
单位质量响应值RSD%判断
34231.5734231.570.00数据可信
中间条件6月-供试品溶液-2024122321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%
5min1201502-20150252.76653.221.4152.7753.221.41
2201523-20152352.77252.77
3200699-20069952.55652.56
4202431-20243153.00953.01
5208251-20825154.53354.53
6204928-20492853.66353.66
10min1282202-28220273.89873.921.0673.9974.011.06
2285065-28506574.64874.74
3278283-27828372.87272.96
4279719-27971973.24873.34
5286026-28602674.90074.99
6282416-28241673.95474.04
15min1318446-31844683.38983.171.2883.6083.381.28
2321199-32119984.11084.32
3311226-31122681.49981.71
4317056-31705683.02583.24
5322314-32231484.40284.62
6315318-31531882.57082.78
20min1335330-33533087.81187.611.5588.1687.961.55
2339903-33990389.00889.36
3326375-32637585.46685.81
4335443-33544387.84088.19
5339427-33942788.88489.24
6330864-33086486.64186.99
30min1348996-34899691.38991.201.8991.8991.701.88
2353976-35397692.69393.19
3338724-33872488.69989.19
4351478-35147892.03992.53
5354621-35462192.86293.37
6341932-34193289.54090.03
45min1355743-35574393.15693.191.9193.8093.841.90
2360852-36085294.49495.15
3346424-34642490.71691.35
4362184-36218494.84395.49
5361126-36112694.56695.23
6349008-34900891.39292.04
60min1359137-35913794.04594.351.9194.8595.151.90
2365057-36505795.59596.41
3351700-35170092.09792.88
4368199-36819996.41897.22
5364833-36483395.53696.35
6352921-35292192.41793.21
极限1388071-388071101.622100.621.83102.58101.581.82
2394415-394415103.283104.26
3380766-38076699.709100.65
4382553-382553100.177101.14
5385940-385940101.064102.04
6373791-37379197.88298.83
比拉斯汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
111.153824093825083823123818173823183822730.07
211.153817393814593815990.06
单位质量响应值RSD%判断
34284.5734224.130.13数据可信
中间条件6月-供试品溶液-3176A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%
5min1179703-17970347.02648.113.1347.0348.113.12
2183308-18330847.97047.97
3195161-19516151.07251.07
4181552-18155247.51047.51
5180176-18017647.15047.15
6183241-18324147.95247.95
10min1261486-26148668.42868.611.9168.5168.701.91
2259152-25915267.81767.90
3271492-27149271.04771.13
4258435-25843567.63067.71
5258753-25875367.71367.79
6263861-26386169.05069.13
15min1304358-30435879.64778.551.5279.8478.741.51
2293947-29394776.92377.12
3304285-30428579.62879.83
4298556-29855678.12978.32
5296250-29625077.52677.72
6303574-30357479.44279.64
20min1327862-32786285.79883.711.6186.1284.041.61
2312869-31286981.87582.20
3321662-32166284.17684.51
4319140-31914083.51683.84
5316239-31623982.75683.08
6321484-32148484.12984.46
30min1347532-34753290.94688.621.6691.4189.091.65
2330955-33095586.60787.07
3337931-33793188.43388.91
4338770-33877088.65389.11
5335351-33535187.75888.22
6341368-34136889.33289.80
45min1360545-36054594.35191.651.9994.9792.261.98
2340973-34097389.22989.83
3347608-34760890.96591.59
4353487-35348792.50493.11
5345459-34545990.40391.01
6353338-35333892.46593.08
60min1367272-36727296.11193.352.0196.8994.122.00
2346961-34696190.79691.55
3352871-35287192.34393.12
4360918-36091894.44895.21
5353368-35336892.47393.23
6358908-35890893.92294.69
极限1389449-389449101.91599.742.52102.85100.662.51
2366143-36614395.81696.72
3377168-37716898.70199.63
4392250-392250102.648103.57
5384663-384663100.662101.57
6377186-37718698.70699.63
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