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%
111.159663719667339670109674739661769667530.06
211.179622179654819638490.24
单位质量响应值RSD%判断
86704.3086289.080.34数据可信
供试品溶液-2024092721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%
5min160475-604756.2775.6217.846.285.6217.88
249870-498705.1765.18
353577-535775.5615.56
459245-592456.1496.15
537425-374253.8843.88
664245-642456.6686.67
10min180628-806288.3687.956.108.448.026.16
275801-758017.8677.92
379342-793428.2358.30
478224-782248.1198.19
567667-676677.0237.07
678044-780448.1008.17
15min181109-811098.4188.202.928.588.353.00
279447-794478.2468.39
381097-810978.4178.57
479199-791998.2208.38
574925-749257.7777.90
678085-780858.1048.27
20min1100432-10043210.4249.1412.3010.689.3912.07
284362-843628.7568.99
3102773-10277310.66710.91
481095-810958.4178.67
576503-765037.9408.15
683463-834638.6638.92
30min1103276-10327610.7199.9811.4411.0910.3311.23
2104875-10487510.88511.22
3107876-10787611.19711.56
485907-859078.9169.26
580930-809308.4008.70
694224-942249.78010.13
45min1124094-12409412.88014.5636.3313.3715.0135.28
2238225-23822524.72625.18
3113964-11396411.82812.32
4145707-14570715.12315.57
593412-934129.69510.08
6126050-12605013.08313.54
60min1122642-12264212.72914.4336.0313.3615.0434.85
2236889-23688924.58725.32
399806-9980610.35910.98
4107250-10725011.13211.74
5140147-14014714.54615.04
6127195-12719513.20213.81
极限1117163-11716312.16014.6319.9612.9415.4119.51
2186446-18644619.35120.35
3151083-15108315.68116.42
4154234-15423416.00816.74
5122760-12276012.74113.40
6114235-11423511.85712.61
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%
110.162562292576062573582568402563582568780.24
210.192565492567942566720.07
单位质量响应值RSD%判断
25283.2725188.620.27数据可信
供试品溶液-2024092721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%
5min188761-8876135.07431.2227.5835.0731.2227.58
264529-6452925.49925.50
375572-7557229.86229.86
487183-8718334.45134.45
547450-4745018.75018.75
6110548-11054843.68343.68
10min1180022-18002271.13665.3615.8071.5365.7015.86
2156044-15604461.66161.94
3163687-16368764.68165.01
4182653-18265372.17672.56
5118973-11897347.01247.22
6191033-19103375.48775.97
15min1210283-21028383.09480.238.9784.2781.309.08
2208044-20804482.20983.18
3205296-20529681.12382.17
4213744-21374484.46185.65
5166540-16654065.80966.54
6214308-21430884.68486.01
20min1220607-22060787.17386.626.1589.2888.586.30
2225151-22515188.96990.85
3222530-22253087.93389.89
4224894-22489488.86790.99
5192404-19240476.02977.49
6229616-22961690.73393.00
30min1235815-23581593.18392.163.2196.2595.093.45
2236549-23654993.47396.34
3234945-23494592.83995.77
4235975-23597593.24696.36
5218095-21809586.18188.49
6237990-23799094.04297.32
45min1234965-23496592.84793.871.4496.9597.821.65
2241613-24161395.47499.38
3237457-23745793.83297.79
4238217-23821794.13298.28
5232486-23248691.86795.13
6240517-24051795.04199.36
60min1226027-22602789.31590.651.4494.4595.641.48
2232637-23263791.92796.90
3225426-22542689.07894.08
4229380-22938090.64095.83
5229426-22942690.65894.94
6233508-23350892.27197.65
极限1195805-19580577.37377.451.6383.5083.451.19
2198224-19822478.32984.32
3196255-19625577.55183.54
4196143-19614377.50683.71
5199385-19938578.78784.08
6190151-19015175.13981.54
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%
111.159646449645079632239644219631219639830.08
211.179623469613269618360.08
单位质量响应值RSD%判断
86455.8786108.860.29数据可信
供试品溶液-2024092721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%
5min143625-436254.5396.0316.334.546.0316.30
269519-695197.2337.23
350142-501425.2175.22
461257-612576.3746.37
563817-638176.6406.64
659242-592426.1646.16
10min172154-721547.5088.003.997.568.064.08
280530-805308.3798.46
374918-749187.7957.85
477033-770338.0158.09
576825-768257.9948.07
679612-796128.2838.35
15min178210-782108.1388.393.518.278.543.58
284370-843708.7798.95
378589-785898.1778.32
477692-776928.0848.24
582869-828698.6228.78
682122-821228.5458.71
20min180213-802138.3469.5916.898.579.8416.57
2104653-10465310.88911.16
378815-788158.2018.44
483626-836268.7018.95
588251-882519.1829.44
6117604-11760412.23612.49
30min181697-816978.50011.5518.118.8211.9017.78
2116621-11662112.13412.53
392017-920179.5749.90
4115190-11519011.98512.33
5127954-12795413.31313.67
6132555-13255513.79214.18
45min176288-762887.93814.4228.718.3514.9128.07
2137473-13747314.30414.83
3119224-11922412.40512.84
4168305-16830517.51217.99
5139163-13916314.48014.99
6191270-19127019.90120.45
60min164512-645126.71218.5241.937.2119.1640.84
2163460-16346017.00817.69
3193164-19316420.09820.67
4281894-28189429.33130.00
5139461-13946114.51115.18
6225248-22524823.43724.20
极限1144038-14403814.98726.0427.5315.5626.9027.22
2254679-25467926.49927.37
3251144-25114426.13126.93
4348947-34894736.30737.31
5214857-21485722.35623.19
6288164-28816429.98331.01
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%
110.162568642571522570072567112567492568970.08
210.192564842562322563580.07
单位质量响应值RSD%判断
25285.1425157.800.36数据可信
供试品溶液-2024092721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%
5min158149-5814922.99136.6025.2122.9936.6025.21
2120733-12073347.73547.74
372352-7235228.60728.61
498280-9828038.85838.86
5109555-10955543.31643.32
696285-9628538.06938.07
10min1145514-14551457.53370.6010.7957.7971.0110.86
2191222-19122275.60576.14
3164358-16435864.98465.30
4189895-18989575.08175.51
5190000-19000075.12275.60
6190430-19043075.29275.72
15min1196820-19682077.81983.663.6278.7184.853.76
2214194-21419484.68886.06
3210196-21019683.10784.15
4215511-21551185.20986.47
5215196-21519685.08486.40
6217669-21766986.06287.32
20min1216655-21665585.66187.921.3987.4290.041.54
2221386-22138687.53289.84
3223280-22328088.28090.24
4224759-22475988.86591.08
5223019-22301988.17790.44
6225050-22505088.98091.20
30min1229371-22937190.68992.641.3793.4095.731.42
2234329-23432992.64995.93
3238676-23867694.36897.31
4233901-23390192.48095.68
5232871-23287192.07395.31
6236647-23664793.56596.77
45min1236870-23687093.65494.081.5097.3798.211.40
2235356-23535693.05597.37
3243646-24364696.333100.33
4234688-23468892.79197.02
5236162-23616293.37497.64
6240943-24094395.26499.51
60min1210467-21046783.21490.544.3587.9795.724.29
2232637-23263791.98097.33
3239199-23919994.57499.64
4226982-22698289.74495.00
5230313-23031391.06196.36
6234418-23441892.68497.99
极限1218218-21821886.27987.411.2991.9693.591.31
2217022-21702285.80692.18
3222927-22292788.14194.25
4224333-22433388.69794.95
5222102-22210287.81594.13
6221878-22187887.72694.06
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