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%
111.033813033812043816283814943815443814350.05
211.093821083828723824900.15
单位质量响应值RSD%判断
34581.6034489.630.19数据可信
供试品溶液-3176A批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1358639-35863993.08894.641.9193.0994.641.91
2369529-36952995.91495.91
3372906-37290696.79196.79
4370133-37013396.07196.07
5357642-35764292.82992.83
6358817-35881793.13493.13
10min1401641-401641104.24999.692.53104.4099.842.52
2384039-38403999.68199.84
3382346-38234699.24199.40
4385661-385661100.102100.26
5374093-37409397.09997.25
6376615-37661597.75497.91
15min1402190-402190104.39299.742.62104.72100.062.62
2383462-38346299.53199.86
3382807-38280799.36199.69
4386600-386600100.345100.67
5372739-37273996.74897.06
6377781-37778198.05698.37
20min1400388-400388103.924100.402.03104.43100.892.03
2382596-38259699.30699.80
3381664-38166499.06499.56
4385522-385522100.066100.56
5379319-37931998.45698.93
6391363-391363101.582102.06
30min1399793-399793103.77099.402.43104.45100.062.42
2382474-38247499.27499.93
3381057-38105798.90799.56
4384526-38452699.807100.47
5372349-37234996.64697.29
6377628-37762898.01798.67
45min1399101-399101103.59099.232.42104.44100.062.42
2380546-38054698.77499.60
3380699-38069998.81499.64
4384495-38449599.799100.63
5372029-37202996.56397.37
6376913-37691397.83198.65
60min1398543-398543103.44598.343.10104.4799.333.09
2364434-36443494.59295.58
3379458-37945898.49299.48
4383621-38362199.572100.57
5370826-37082696.25197.21
6376320-37632097.67798.65
极限1398191-398191103.35499.312.57104.55100.462.56
2379039-37903998.38399.53
3389155-389155101.009102.16
4382549-38254999.294100.45
5370892-37089296.26897.39
6375843-37584397.55398.69
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%
111.033815943807173815213809383813023812140.10
211.093812543818283815410.11
单位质量响应值RSD%判断
34561.5634404.060.33数据可信
供试品溶液-3176A批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1360400-36040093.68893.741.0593.6993.741.05
2359898-35989893.55893.56
3360363-36036393.67993.68
4356072-35607292.56392.56
5367563-36756395.55195.55
6359198-35919893.37693.38
10min1388168-388168100.90799.171.74101.0699.331.74
2381697-38169799.22599.38
3383268-38326899.63399.79
4368811-36881195.87596.03
5382472-38247299.42699.59
6384500-38450099.953100.11
15min1386985-386985100.59999.241.75100.9299.561.75
2382521-38252199.43999.76
3384826-384826100.038100.36
4368809-36880995.87496.19
5381405-38140599.14999.47
6385888-385888100.314100.64
20min1386597-386597100.49999.071.77100.9999.561.76
2381038-38103899.05399.54
3383669-38366999.737100.23
4368117-36811795.69596.17
5381572-38157299.19299.68
6385550-385550100.226100.72
30min1386917-386917100.58298.891.85101.2499.541.85
2381123-38112399.07699.73
3382581-38258199.455100.11
4366796-36679695.35195.98
5380983-38098399.03999.69
6384158-38415899.865100.52
45min1385534-385534100.22298.701.82101.0599.521.81
2380453-38045398.90199.72
3381723-38172399.232100.05
4366111-36611195.17395.97
5381053-38105399.05799.88
6383115-38311599.593100.42
60min1383995-38399599.82298.341.83100.8299.321.83
2378979-37897998.51899.50
3381010-38101099.046100.03
4364711-36471194.80995.76
5379105-37910598.55199.54
6382037-38203799.313100.30
极限1382933-38293399.54698.181.71100.7199.321.71
2378300-37830098.34299.49
3380629-38062998.947100.10
4364957-36495794.87395.98
5378435-37843598.37799.53
6380715-38071598.970100.12
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%
111.033809693809283814133814013812743811970.07
211.093811913815213813560.07
单位质量响应值RSD%判断
34560.0234387.380.36数据可信
供试品溶液-3176A批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1234089-23408960.86961.543.2260.8761.543.22
2242550-24255063.06963.07
3245897-24589763.94063.94
4241104-24110462.69362.69
5228164-22816459.32959.33
6228212-22821259.34159.34
10min1317044-31704482.44082.232.1582.5482.332.15
2316654-31665482.33882.44
3324753-32475384.44484.55
4321879-32187983.69783.80
5306861-30686179.79279.89
6310162-31016280.65080.75
15min1345410-34541089.81689.762.2290.0590.002.22
2341612-34161288.82889.07
3355155-35515592.35092.60
4353451-35345191.90692.15
5336783-33678387.57287.80
6338705-33870588.07288.31
20min1358206-35820693.14392.721.9093.5393.111.90
2353368-35336891.88592.28
3362942-36294294.37494.78
4365236-36523694.97195.37
5347714-34771490.41590.79
6351945-35194591.51591.89
30min1367733-36773395.62095.091.9196.1695.631.91
2361315-36131593.95194.49
3370614-37061496.36996.93
4376066-37606697.78798.34
5357675-35767593.00593.53
6360787-36078793.81494.35
45min1372527-37252796.86796.431.6797.5797.131.67
2365808-36580895.12095.82
3374685-37468597.42898.15
4380499-38049998.94099.66
5364713-36471394.83595.52
6366828-36682895.38596.07
60min1375974-37597497.76397.051.7898.6397.921.78
2369913-36991396.18797.05
3376729-37672997.95998.84
4383320-38332099.673100.56
5365676-36567695.08595.93
6367831-36783195.64696.49
极限1376039-37603997.78097.921.7798.8198.951.77
2377150-37715098.06999.09
3379366-37936698.64599.69
4387233-387233100.691101.74
5367823-36782395.64496.64
6371893-37189396.70297.71
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%
111.033751273747923747253752433757953751360.12
211.093823203831473827340.16
单位质量响应值RSD%判断
34010.5234511.631.04数据可信
供试品溶液-3176A批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1239575-23957562.68561.831.3362.6961.831.32
2233436-23343661.07961.08
3232547-23254760.84660.85
4235314-23531461.57061.57
5240098-24009862.82262.82
6236849-23684961.97261.97
10min1311637-31163781.54082.490.9681.6482.600.96
2313711-31371182.08382.18
3319802-31980283.67783.78
4313637-31363782.06482.17
5317891-31789183.17783.28
6315020-31502082.42682.53
15min1337201-33720188.22989.951.5888.4790.191.58
2342376-34237689.58389.82
3353531-35353192.50292.74
4341216-34121689.28089.52
5343816-34381689.96090.20
6344450-34445090.12690.37
20min1349531-34953191.45593.111.7691.8493.501.76
2354472-35447292.74893.14
3367749-36774996.22296.62
4352744-35274492.29692.68
5354612-35461292.78593.18
6356018-35601893.15393.54
30min1360549-36054994.33895.632.1694.8896.172.16
2363289-36328995.05595.60
3381135-38113599.725100.28
4360391-36039194.29794.84
5362127-36212794.75195.30
6365316-36531695.58696.13
45min1364707-36470795.42696.802.7796.1297.512.76
2367669-36766996.20196.90
3390409-390409102.151102.87
4362848-36284894.94095.64
5365510-36551095.63696.34
6368663-36866396.46197.17
60min1370616-37061696.97297.872.7497.8398.732.73
2372307-37230797.41598.28
3394205-394205103.145104.04
4365228-36522895.56396.42
5372401-37240197.43998.30
6369442-36944296.66597.53
极限1371172-37117297.11898.503.2698.1499.533.24
2373899-37389997.83198.86
3399297-399297104.477105.54
4365025-36502595.51096.53
5379963-37996399.418100.45
6369392-36939296.65297.68
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