利伐沙班口崩片项目信息
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
115.199751659756459746719763559755269754720.07
215.239758129762959760540.04
单位质量响应值RSD%判断
64218.0464087.590.15数据可信
供试品溶液-2024122521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%
5min1274288-27428825.55124.893.4025.5524.893.41
2268188-26818824.98224.98
3267571-26757124.92524.92
4278846-27884625.97525.98
5261019-26101924.31524.31
6253534-25353423.61723.62
10min1320139-32013929.82229.771.0629.8629.801.05
2323150-32315030.10230.14
3318181-31818129.63929.68
4323540-32354030.13930.18
5316876-31687629.51829.56
6315299-31529929.37129.41
15min1334889-33488931.19631.230.5531.2931.320.56
2337630-33763031.45131.54
3336932-33693231.38631.48
4335190-33519031.22431.32
5333892-33389231.10331.19
6332712-33271230.99331.08
20min1341954-34195431.85431.960.5832.0032.110.57
2346532-34653232.28032.42
3344116-34411632.05532.20
4343292-34329231.97932.12
5341650-34165031.82631.97
6341337-34133731.79631.94
30min1349550-34955032.56232.580.5232.7632.770.52
2351572-35157232.75032.95
3352191-35219132.80833.00
4348532-34853232.46732.67
5347599-34759932.38032.57
6348800-34880032.49232.68
45min1353260-35326032.90733.020.8733.1633.280.86
2356048-35604833.16733.42
3357992-35799233.34833.60
4355579-35557933.12333.38
5349077-34907732.51732.77
6355131-35513133.08133.33
60min1357384-35738433.29133.190.6933.6033.500.69
2356472-35647233.20633.51
3360035-36003533.53833.85
4354505-35450533.02333.33
5352897-35289732.87333.18
6356738-35673833.23133.53
极限1354014-35401432.97733.260.9933.3433.620.97
2356721-35672133.23033.59
3358675-35867533.41233.77
4352131-35213132.80233.17
5359139-35913933.45533.81
6361697-36169733.69334.05
利伐沙班口崩片项目信息
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
115.199733719741829739719751489730069739360.09
215.239706529703689705100.03
单位质量响应值RSD%判断
64116.9263723.570.44数据可信
供试品溶液-t3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%
5min1253490-25349023.69925.286.4723.7025.286.47
2300857-30085728.12828.13
3261556-26155624.45324.45
4266650-26665024.93024.93
5259515-25951524.26324.26
6280489-28048926.22426.22
10min1322228-32222830.12630.392.8630.1730.442.87
2341754-34175431.95132.00
3321876-32187630.09330.13
4322939-32293930.19230.23
5314007-31400729.35729.40
6327762-32776230.64330.69
15min1340115-34011531.79831.991.9431.8932.081.95
2355224-35522433.21133.31
3339338-33933831.72631.82
4340686-34068631.85231.94
5336317-33631731.44331.53
6341308-34130831.91032.00
20min1347859-34785932.52232.671.2532.6632.821.27
2357672-35767233.44033.60
3350856-35085632.80232.95
4347675-34767532.50532.65
5345845-34584532.33432.48
6346800-34680032.42332.57
30min1354325-35432533.12733.191.2433.3233.391.25
2363792-36379234.01234.22
3353363-35336333.03733.24
4353550-35355033.05433.25
5351697-35169732.88133.08
6353289-35328933.03033.23
45min1356952-35695233.37233.601.1933.6233.861.20
2367699-36769934.37734.64
3359524-35952433.61333.87
4356183-35618333.30033.55
5356951-35695133.37233.62
6359074-35907433.57133.83
60min1360528-36052833.70733.840.9834.0134.150.99
2368217-36821734.42534.75
3363447-36344733.98034.29
4357955-35795533.46633.78
5360921-36092133.74334.05
6360416-36041633.69634.01
极限1358834-35883433.54833.801.0233.9134.171.03
2367496-36749634.35834.74
3364316-36431634.06134.43
4358150-35815033.48433.85
5361287-36128733.77834.14
6359244-35924433.58733.96
利伐沙班口崩片项目信息
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
115.199757629760139759539745959725169749680.16
215.239922529924619923560.02
单位质量响应值RSD%判断
64184.8665157.981.07数据可信
供试品溶液-2024122621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%
5min1285084-28508426.34526.362.9426.3426.362.94
2288534-28853426.66426.66
3293840-29384027.15427.15
4293576-29357627.13027.13
5274764-27476425.39125.39
6275921-27592125.49825.50
10min1328632-32863230.36930.430.7730.4130.470.77
2330810-33081030.57030.61
3332016-33201630.68230.73
4331341-33134130.61930.66
5326090-32609030.13430.18
6326683-32668330.18930.23
15min1342251-34225131.62831.580.6631.7231.670.67
2340352-34035231.45231.55
3345748-34574831.95132.05
4342148-34214831.61831.71
5339621-33962131.38531.48
6340226-34022631.44131.53
20min1347222-34722232.08732.110.5032.2332.260.50
2346429-34642932.01432.16
3350453-35045332.38632.54
4347106-34710632.07632.23
5345462-34546231.92432.07
6348062-34806232.16532.31
30min1350954-35095432.43232.500.5532.6332.700.56
2349760-34976032.32232.52
3355088-35508832.81433.02
4351955-35195532.52432.73
5352052-35205232.53332.73
6350073-35007332.35132.55
45min1351875-35187532.51732.860.8032.7733.110.79
2356085-35608532.90633.16
3360374-36037433.30233.56
4354659-35465932.77433.03
5355965-35596532.89533.15
6354340-35434032.74533.00
60min1353760-35376032.69132.970.6833.0033.280.68
2356587-35658732.95233.26
3360189-36018933.28533.60
4357608-35760833.04733.36
5358139-35813933.09633.40
6354332-35433232.74433.05
极限1354350-35435032.74632.960.8433.1133.330.83
2355922-35592232.89133.26
3361809-36180933.43533.80
4355817-35581732.88133.25
5358455-35845533.12533.49
6353885-35388532.70333.06
利伐沙班口崩片项目信息
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
115.199732239737669745169737019737029737820.05
215.239892919900399896650.06
单位质量响应值RSD%判断
64106.7864981.290.96数据可信
供试品溶液-t3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%
5min1272495-27249525.23125.471.8325.2325.471.83
2279727-27972725.90125.90
3271518-27151825.14025.14
4283065-28306526.21026.21
5272263-27226325.20925.21
6271406-27140625.13025.13
10min1327067-32706730.28430.330.9430.3330.380.94
2331806-33180630.72330.77
3324916-32491630.08530.13
4330927-33092730.64130.68
5324514-32451430.04730.09
6326437-32643730.22630.27
15min1342055-34205531.67231.790.9531.7631.880.96
2348246-34824632.24532.34
3342623-34262331.72431.82
4346416-34641632.07532.17
5340421-34042131.52031.61
6340350-34035031.51431.61
20min1347632-34763232.18832.390.8132.3332.540.82
2354215-35421532.79832.95
3350606-35060632.46332.61
4351555-35155532.55132.70
5348393-34839332.25832.40
6346603-34660332.09332.24
30min1353925-35392532.77132.970.5732.9733.170.57
2357987-35798733.14733.35
3358055-35805533.15333.35
4357428-35742833.09533.30
5355056-35505632.87533.07
6353839-35383932.76332.96
45min1359515-35951533.28833.310.7133.5433.570.72
2361854-36185433.50533.76
3361533-36153333.47533.73
4361244-36124433.44833.71
5359453-35945333.28333.54
6354999-35499932.87033.12
60min1359478-35947833.28533.330.3933.5933.640.38
2361240-36124033.44833.76
3361620-36162033.48333.79
4359880-35988033.32233.64
5359500-35950033.28733.60
6357806-35780633.13033.44
极限1359352-35935233.27333.450.6833.6433.810.67
2363673-36367333.67334.04
3364807-36480733.77834.14
4360676-36067633.39633.76
5360146-36014633.34733.71
6358862-35886233.22833.59
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