精氨酸培哚普利片项目信息
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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)5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%
19.943236863237183235643239653236983237260.05
29.863190193190963190580.02
单位质量响应值RSD%判断
32568.0132358.820.46数据可信
供试品溶液-686292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%
5min187392-8739245.93744.984.4145.9444.984.41
284111-8411144.21244.21
386295-8629545.36045.36
481954-8195443.07943.08
591763-9176348.23548.23
681879-8187943.03943.04
10min1158595-15859583.36483.551.7583.4483.621.75
2157845-15784582.97083.04
3157308-15730882.68882.76
4155534-15553481.75581.83
5163134-16313485.75085.83
6161243-16124384.75684.83
15min1186316-18631697.93699.831.3298.15100.051.32
2192123-192123100.988101.20
3188608-18860899.14199.35
4188675-18867599.17699.38
5192920-192920101.407101.63
6190923-190923100.357100.57
20min1190526-190526100.149101.520.85100.53101.900.85
2195094-195094102.550102.93
3192358-192358101.112101.49
4194423-194423102.197102.57
5193662-193662101.797102.19
6192691-192691101.287101.67
30min1190378-190378100.071101.390.83100.62101.940.82
2194809-194809102.400102.95
3192350-192350101.107101.65
4194194-194194102.077102.62
5193349-193349101.633102.19
6192247-192247101.053101.60
极限1190274-190274100.016101.210.79100.73101.930.79
2194249-194249102.106102.83
3192045-192045100.947101.66
4194183-194183102.071102.78
5192700-192700101.291102.02
6191843-191843100.841101.56
精氨酸培哚普利片项目信息
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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)5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%
19.943221413229353227333227903229313227060.11
29.863221813222263222040.01
单位质量响应值RSD%判断
32465.3932677.890.47数据可信
供试品溶液-321605批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min188220-8822046.21842.409.0046.2242.409.00
267494-6749435.36035.36
379528-7952841.66441.66
483962-8396243.98743.99
585440-8544044.76244.76
680948-8094842.40842.41
10min1155672-15567281.55679.793.5481.6379.863.54
2142154-14215474.47474.53
3155325-15532581.37481.44
4156617-15661782.05182.12
5153094-15309480.20580.28
6150911-15091179.06279.13
15min1187589-18758998.27798.271.4898.4998.481.49
2182776-18277695.75695.94
3188721-18872198.87099.08
4191083-191083100.108100.32
5188604-18860498.80999.02
6186693-18669397.80898.01
20min1188896-18889698.962101.332.2999.34101.702.29
2189919-18991999.49899.84
3191028-191028100.079100.45
4200756-200756105.175105.55
5195616-195616102.483102.86
6194279-194279101.782102.15
30min1188336-18833698.669101.182.4399.21101.722.43
2189491-18949199.27499.78
3190547-19054799.827100.36
4200937-200937105.270105.82
5195360-195360102.348102.89
6194155-194155101.717102.25
极限1188225-18822598.610100.962.3599.32101.672.34
2188860-18886098.94399.62
3190367-19036799.733100.44
4200164-200164104.865105.59
5194835-194835102.073102.79
6193813-193813101.538102.24
精氨酸培哚普利片项目信息
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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)5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%
19.943223193220573222623219343221273221400.05
29.863217453216573217010.02
单位质量响应值RSD%判断
32408.4532626.880.48数据可信
供试品溶液-716277批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min184336-8433644.25743.253.4844.2643.253.48
282617-8261743.35543.35
386778-8677845.53845.54
481890-8189042.97342.97
579286-7928641.60741.61
679558-7955841.74941.75
10min1159004-15900483.44083.482.3483.5183.552.33
2161862-16186284.94085.01
3159887-15988783.90383.98
4157985-15798582.90582.98
5163156-16315685.61985.69
6152562-15256280.05980.13
15min1189986-18998699.698100.160.6699.91100.370.65
2192395-192395100.963101.18
3188967-18896799.16499.38
4191012-191012100.237100.45
5190906-190906100.181100.39
6191875-191875100.690100.89
20min1190840-190840100.147101.151.59100.53101.531.58
2193884-193884101.744102.13
3188745-18874599.04799.43
4193179-193179101.374101.75
5192131-192131100.824101.20
6197783-197783103.790104.16
30min1191002-191002100.232101.011.56100.78101.551.55
2193553-193553101.570102.12
3188748-18874899.04999.59
4192832-192832101.192101.74
5191169-191169100.319100.87
6197575-197575103.681104.22
极限1191665-191665100.579100.761.48101.29101.471.47
2192345-192345100.936101.66
3188187-18818798.75499.47
4192175-192175100.847101.56
5190783-190783100.117100.83
6196854-196854103.302104.02
精氨酸培哚普利片项目信息
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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)5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%
19.943224243222133222633221533225913223290.06
29.863188153192733190440.11
单位质量响应值RSD%判断
32427.4632357.400.16数据可信
供试品溶液-716277批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min185527-8552745.05541.6011.9545.0541.6011.94
286818-8681845.73545.73
382186-8218643.29543.29
481152-8115242.75042.75
577159-7715940.64740.65
661025-6102532.14732.15
10min1151356-15135679.73380.264.2979.8180.334.29
2162703-16270385.71085.79
3157798-15779883.12683.20
4148614-14861478.28878.36
5146927-14692777.40077.47
6146710-14671077.28577.34
15min1188947-18894799.53599.833.0799.74100.033.07
2198501-198501104.568104.79
3191477-191477100.868101.08
4185744-18574497.84898.05
5181318-18131895.51795.71
6191032-191032100.634100.82
20min1196016-196016103.259103.903.15103.63104.273.15
2202236-202236106.536106.93
3197471-197471104.026104.40
4192454-192454101.383101.75
5189125-18912599.62999.99
6206052-206052108.546108.90
30min1195397-195397102.933103.623.23103.48104.163.22
2201719-201719106.264106.83
3197084-197084103.822104.37
4191981-191981101.134101.67
5188284-18828499.18699.71
6205688-205688108.354108.89
极限1194703-194703102.568103.293.30103.29104.013.29
2201419-201419106.106106.85
3196642-196642103.589104.31
4191077-191077100.658101.36
5187571-18757198.81199.50
6205076-205076108.032108.74
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