比拉斯汀口崩片项目信息
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%
111.273836553837963835543837633830463835630.08
211.253830763830143830450.02
单位质量响应值RSD%判断
34033.9834048.440.04数据可信
加速6月-供试品溶液-2024121821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%
5min1237644-23764462.57861.632.0662.5861.632.05
2236644-23664462.31562.31
3224995-22499559.24759.25
4232573-23257361.24361.24
5235270-23527061.95361.95
6237180-23718062.45662.46
10min1313287-31328782.49781.161.7582.6081.271.75
2312255-31225582.22582.33
3298523-29852378.60978.71
4306081-30608180.60080.70
5310279-31027981.70581.81
6308925-30892581.34981.45
15min1350399-35039992.27090.981.4492.5191.211.44
2349567-34956792.05192.29
3336964-33696488.73288.96
4344844-34484490.80791.04
5347599-34759991.53391.77
6343551-34355190.46790.71
20min1369016-36901697.17295.971.6097.5796.361.60
2368787-36878797.11297.51
3354568-35456893.36893.75
4363105-36310595.61696.00
5369327-36932797.25497.65
6361991-36199195.32295.71
30min1381349-381349100.42099.661.33100.98100.211.33
2382719-382719100.781101.34
3369728-36972897.36097.89
4378118-37811899.569100.12
5382691-382691100.773101.33
6376188-37618899.06199.61
极限1385854-385854101.606100.811.44102.33101.531.44
2387496-387496102.038102.76
3373049-37304998.23498.93
4383269-383269100.925101.64
5386994-386994101.906102.63
6380342-380342100.155100.87
比拉斯汀口崩片项目信息
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%
111.273829873831423827583831803833093830750.06
211.253827583830263828920.05
单位质量响应值RSD%判断
33990.6834034.840.10数据可信
中间条件6月-供试品溶液-2024121821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%
5min1232268-23226861.21462.291.4161.2162.291.41
2237917-23791762.70362.70
3241259-24125963.58363.58
4236445-23644562.31562.31
5237188-23718862.51062.51
6233042-23304261.41861.42
10min1306387-30638780.74881.781.1980.8581.881.19
2313025-31302582.49782.60
3314940-31494083.00283.11
4311874-31187482.19482.30
5309864-30986481.66481.77
6305704-30570480.56880.67
15min1342440-34244090.24991.371.0390.4991.621.03
2350165-35016592.28592.53
3350606-35060692.40292.65
4348064-34806491.73291.97
5346219-34621991.24591.49
6342747-34274790.33090.57
20min1360116-36011694.90896.271.0295.2996.661.02
2369008-36900897.25197.65
3368803-36880397.19797.60
4367311-36731196.80497.20
5364533-36453396.07296.46
6361999-36199995.40495.79
30min1374018-37401898.57299.961.0599.12100.511.05
2384258-384258101.271101.83
3382132-382132100.710101.27
4381511-381511100.547101.10
5377589-37758999.513100.07
6376174-37617499.14099.69
极限1378430-37843099.735101.221.08100.44101.941.09
2388815-388815102.472103.20
3385127-385127101.500102.23
4388264-388264102.326103.05
5383242-383242101.003101.72
6380589-380589100.304101.01
比拉斯汀口崩片项目信息
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%
111.273842033840883838023836913842903840150.07
211.253835793834763835280.02
单位质量响应值RSD%判断
34074.0934091.380.04数据可信
加速6月-供试品溶液-2024121921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%
5min1233087-23308761.30460.381.4661.3060.381.47
2228320-22832060.05060.05
3224460-22446059.03559.03
4232414-23241461.12761.13
5227558-22755859.84959.85
6231563-23156360.90360.90
10min1308882-30888281.23880.021.3781.3480.121.37
2303595-30359579.84879.95
3298214-29821478.43278.53
4305018-30501880.22280.32
5301244-30124479.22979.33
6308561-30856181.15481.26
15min1346778-34677891.20589.811.3591.4490.041.35
2341176-34117689.73289.96
3333953-33395387.83288.06
4341911-34191189.92590.16
5339472-33947289.28489.52
6345495-34549590.86891.10
20min1365026-36502696.00495.011.2096.3995.391.20
2361113-36111394.97595.36
3354275-35427593.17793.55
4361924-36192495.18995.57
5358925-35892594.40094.78
6366122-36612296.29396.68
30min1379784-37978499.88698.961.12100.4499.501.12
2374286-37428698.44098.98
3369980-36998097.30797.84
4377588-37758899.30899.85
5374391-37439198.46799.01
6381492-381492100.335100.88
极限1383332-383332100.819100.151.19101.54100.861.20
2379315-37931599.763100.47
3373813-37381398.31599.01
4382843-382843100.690101.40
5378541-37854199.559100.26
6386793-386793101.729102.45
比拉斯汀口崩片项目信息
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%
111.273828603828023827943829593826843828200.03
211.253820863820273820560.02
单位质量响应值RSD%判断
33968.0633960.530.02数据可信
中间条件6月-供试品溶液-2024121921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%
5min1235260-23526062.09160.901.5662.0960.901.56
2231859-23185961.19361.19
3233701-23370161.67961.68
4227744-22774460.10760.11
5230258-23025860.77160.77
6225777-22577759.58859.59
10min1307345-30734581.11680.421.5481.2280.521.54
2307440-30744081.14181.24
3310578-31057881.96982.07
4301515-30151579.57779.68
5303836-30383680.19080.29
6297635-29763578.55378.65
15min1343745-34374590.72390.781.2090.9691.021.20
2347855-34785591.80792.04
3349581-34958192.26392.50
4340486-34048689.86390.10
5343164-34316490.56990.80
6338999-33899989.47089.70
20min1361741-36174195.47295.971.1595.8696.361.15
2368461-36846197.24697.64
3369040-36904097.39997.79
4361909-36190995.51795.90
5361905-36190595.51595.90
6358693-35869394.66895.05
30min1376127-37612799.26999.901.2499.82100.451.24
2383747-383747101.280101.83
3384694-384694101.530102.09
4377261-37726199.568100.11
5376594-37659499.39299.94
6372776-37277698.38598.92
极限1379838-379838100.248100.971.09100.96101.681.09
2387733-387733102.332103.05
3387845-387845102.362103.09
4380923-380923100.535101.24
5380807-380807100.504101.21
6378260-37826099.832100.53
比拉斯汀口崩片项目信息
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%
111.273827683825743827023832243827873828110.07
211.253827653827013827330.02
单位质量响应值RSD%判断
33967.2634020.710.12数据可信
加速6月-供试品溶液-2024122021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%
5min1230482-23048260.77759.591.8960.7859.591.90
2219502-21950257.88157.88
3222461-22246158.66258.66
4228939-22893960.37060.37
5228743-22874360.31860.32
6225743-22574359.52759.53
10min1306882-30688280.92379.021.4881.0279.111.48
2293931-29393177.50877.60
3296280-29628078.12778.22
4300010-30001079.11179.21
5300310-30031079.19079.29
6300504-30050479.24179.34
15min1348012-34801291.76989.131.7892.0089.361.77
2331057-33105787.29887.52
3333272-33327287.88288.11
4339488-33948889.52189.75
5339845-33984589.61589.85
6336359-33635988.69688.93
20min1368448-36844897.15794.551.7297.5594.931.72
2351592-35159292.71393.08
3352460-35246092.94293.32
4359744-35974494.86295.24
5360469-36046995.05395.44
6358665-35866594.57894.96
30min1387152-387152102.09098.861.86102.6499.401.86
2367642-36764296.94597.47
3368819-36881997.25597.78
4375132-37513298.92099.46
5376448-37644899.26799.81
6374214-37421498.67899.21
极限1392291-392291103.445103.297.73104.17104.007.68
2373234-37323498.42099.11
3373348-37334898.45099.14
4378895-37889599.912100.62
5380732-380732100.397101.10
6451819-451819119.142119.84
比拉斯汀口崩片项目信息
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%
111.273820123821443821683820063817693820200.05
211.253826493829813828150.07
单位质量响应值RSD%判断
33897.0734028.000.28数据可信
中间条件6月-供试品溶液-2024122021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%
5min1233561-23356161.64660.801.8761.6560.801.87
2227546-22754660.05860.06
3225213-22521359.44259.44
4227758-22775860.11460.11
5231460-23146061.09161.09
6236660-23666062.46462.46
10min1308151-30815181.33380.521.2081.4480.621.20
2302714-30271479.89880.00
3300021-30002179.18779.29
4305038-30503880.51180.61
5304422-30442280.34980.45
6310126-31012681.85481.96
15min1343170-34317090.57690.301.1090.8190.541.10
2341197-34119790.05590.29
3335389-33538988.52288.75
4344270-34427090.86691.10
5342443-34244390.38490.62
6346387-34638791.42591.67
20min1363024-36302495.81695.490.9496.2195.880.95
2362740-36274095.74196.12
3354909-35490993.67494.05
4363267-36326795.88096.27
5363029-36302995.81796.20
6363845-36384596.03396.43
30min1378592-37859299.92599.881.11100.47100.421.11
2383385-383385101.190101.73
3370727-37072797.84998.38
4379812-379812100.247100.79
5379586-379586100.187100.73
6378503-37850399.902100.45
极限1382891-382891101.060101.051.00101.78101.771.00
2383310-383310101.170101.88
3375456-37545699.09799.80
4384137-384137101.389102.10
5385658-385658101.790102.50
6385756-385756101.816102.54
比拉斯汀口崩片项目信息
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%
111.273839393822933818343835653835403830340.24
211.253836633836493836560.01
单位质量响应值RSD%判断
33987.0534102.760.25数据可信
加速6月-供试品溶液-3L77C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%
5min1185524-18552448.84847.881.7248.8547.881.72
2182804-18280448.13248.13
3177094-17709446.62946.63
4184604-18460448.60648.61
5181027-18102747.66447.66
6180085-18008547.41647.42
10min1259471-25947168.31967.351.7768.4067.431.77
2255063-25506367.15867.24
3253395-25339566.71966.80
4262969-26296969.24069.32
5252454-25245466.47166.55
6251445-25144566.20566.28
15min1298570-29857078.61477.541.8778.8177.731.87
2294676-29467677.58877.78
3293210-29321077.20277.39
4302439-30243979.63279.83
5291147-29114776.65976.85
6286915-28691575.54575.73
20min1321203-32120384.57384.051.3084.9084.371.30
2318659-31865983.90384.22
3319012-31901283.99684.31
4326132-32613285.87186.20
5315366-31536683.03683.35
6314924-31492482.92083.23
30min1346229-34622991.16290.720.9091.6391.190.90
2345421-34542190.94991.41
3344330-34433090.66291.12
4349088-34908891.91592.39
5341335-34133589.87490.33
6340995-34099589.78490.24
极限1370204-37020497.47596.391.0298.0997.001.03
2368849-36884997.11897.73
3364456-36445695.96196.57
4368673-36867397.07297.70
5363709-36370995.76596.37
6360609-36060994.94895.55
比拉斯汀口崩片项目信息
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%
111.273848153836513846053851773839933844480.17
211.253819313811613815460.15
单位质量响应值RSD%判断
34112.5133915.200.42数据可信
中间条件6月-供试品溶液-3L77C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%
5min1195436-19543651.50650.602.1351.5150.602.13
2185770-18577048.95848.96
3192620-19262050.76350.76
4188306-18830649.62749.63
5193888-19388851.09851.10
6195918-19591851.63351.63
10min1262769-26276969.25169.012.0169.3469.102.01
2260215-26021568.57868.66
3267400-26740070.47170.56
4252425-25242566.52566.61
5262843-26284369.27069.36
6265513-26551369.97470.06
15min1304176-30417680.16380.210.2980.3680.410.29
2303860-30386080.08080.28
3304821-30482180.33380.54
4303066-30306679.87180.06
5305578-30557880.53380.73
6304635-30463580.28480.49
20min1334448-33444888.14186.392.2288.4886.722.21
2328129-32812986.47686.81
3331024-33102487.23987.57
4313617-31361782.65182.98
5329925-32992586.94987.28
6329588-32958886.86087.20
30min1354182-35418293.34292.472.2993.8292.942.28
2354788-35478893.50193.97
3355555-35555593.70494.18
4334657-33465788.19688.66
5352821-35282192.98393.46
6353193-35319393.08193.56
极限1368668-36866897.15996.192.4197.8096.822.40
2369950-36995097.49798.13
3369807-36980797.46098.10
4347457-34745791.56992.18
5368939-36893997.23197.87
6365172-36517296.23896.87
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