普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数500
标示量(mg)25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%
113.521680616927168871667716877168350.59
213.561684516827168360.08
单位质量响应值RSD%判断
1245.191241.590.21数据可信
供试品溶液-2024081211批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min115132-1513287.09886.943.4487.1086.943.43
214547-1454783.73183.73
315899-1589991.51391.51
414722-1472284.73884.74
515517-1551789.31489.31
614814-1481485.26885.27
5min117844-17844102.70899.122.57102.7199.122.58
217022-1702297.97797.98
317285-1728599.49099.49
417011-1701197.91397.91
517564-17564101.096101.10
616600-1660095.54895.55
10min117248-1724899.27799.132.2999.2899.132.29
217260-1726099.34699.35
317197-1719798.98498.98
417231-1723199.18099.18
517821-17821102.575102.58
616579-1657995.42795.43
15min117355-1735599.89398.931.8599.8998.931.86
217338-1733899.79599.80
317252-1725299.30099.30
417213-1721399.07699.08
517413-17413100.227100.23
616556-1655695.29495.29
30min117257-1725799.32999.371.6799.3399.381.67
217281-1728199.46799.47
317404-17404100.175100.18
417328-1732899.73899.74
517587-17587101.229101.23
616731-1673196.30296.30
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数500
标示量(mg)25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%
113.521689816874168731675416829168460.34
213.561674616775167600.13
单位质量响应值RSD%判断
1246.011235.990.58数据可信
供试品溶液-2024081211批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min115544-1554489.64383.234.3989.6483.234.38
214575-1457584.05584.06
314071-1407181.14881.15
414502-1450283.63483.63
513684-1368478.91778.92
614215-1421581.97981.98
5min116797-1679796.86999.061.8196.8799.051.81
217408-17408100.393100.39
317642-17642101.743101.74
416921-1692197.58597.58
517120-1712098.73298.73
617169-1716999.01599.01
10min117185-1718599.10799.742.2499.1199.742.24
217657-17657101.829101.83
317767-17767102.464102.46
417190-1719099.13699.14
516688-1668896.24196.24
617284-1728499.67899.68
15min117397-17397100.330100.482.83100.33100.482.83
217618-17618101.604101.60
318154-18154104.695104.70
417296-1729699.74799.75
516636-1663695.94195.94
617438-17438100.566100.57
30min117180-1718099.078100.612.2199.08100.612.21
217817-17817102.752102.75
317823-17823102.786102.79
417206-1720699.22899.23
516934-1693497.66097.66
617716-17716102.169102.17
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数500
标示量(mg)25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%
113.521693716717166351683516850167950.71
213.561692716903169150.11
单位质量响应值RSD%判断
1242.231247.420.30数据可信
供试品溶液-2024081511批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min116834-1683496.78394.063.2996.7894.063.29
215379-1537988.41888.42
316163-1616392.92592.93
416426-1642694.43794.44
516753-1675396.31796.32
616603-1660395.45595.45
5min118875-18875108.517106.383.35108.52106.383.35
217338-1733899.68199.68
318453-18453106.091106.09
418884-18884108.569108.57
518441-18441106.022106.02
619024-19024109.374109.37
10min118834-18834108.282107.353.08108.28107.353.08
217524-17524100.750100.75
318756-18756107.833107.83
419085-19085109.725109.72
518863-18863108.448108.45
618971-18971109.069109.07
15min118810-18810108.144107.293.79108.14107.293.79
217279-1727999.34199.34
318925-18925108.805108.80
419277-19277110.829110.83
518687-18687107.436107.44
618989-18989109.173109.17
30min118977-18977109.104106.983.65109.10106.983.65
217271-1727199.29599.30
318740-18740107.741107.74
419150-19150110.098110.10
518643-18643107.183107.18
618865-18865108.460108.46
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数500
标示量(mg)25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%
113.521691616647168921668116745167760.73
213.561683416917168760.35
单位质量响应值RSD%判断
1240.831244.540.22数据可信
供试品溶液-2024081511批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min115229-1522987.70694.606.3487.7194.606.34
216841-1684196.99096.99
316714-1671496.25896.26
417777-17777102.380102.38
515122-1512287.09087.09
616875-1687597.18697.19
5min116871-1687197.163105.406.4697.16105.406.47
219108-19108110.046110.05
318973-18973109.268109.27
419154-19154110.311110.31
516689-1668996.11496.11
619016-19016109.516109.52
10min117150-1715098.769106.335.8598.77106.335.85
219233-19233110.766110.77
318996-18996109.401109.40
419204-19204110.599110.60
517002-1700297.91797.92
619194-19194110.541110.54
15min118378-18378105.842107.454.55105.84107.454.55
219458-19458112.062112.06
318711-18711107.760107.76
419096-19096109.977109.98
517108-1710898.52898.53
619193-19193110.535110.54
30min117083-1708398.384106.936.6398.38106.936.63
219406-19406111.762111.76
318925-18925108.992108.99
419438-19438111.946111.95
516934-1693497.52597.53
619617-19617112.977112.98
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