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)10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%
110.783435993429133429833417123414673425350.27
210.803404533420703412620.34
单位质量响应值RSD%判断
31775.0531598.330.40数据可信
长期24月-供试品溶液-2023092121批-pH4.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1176022-17602247.39659.1636.6247.4059.1636.62
2246943-24694366.49366.49
3241830-24183065.11665.12
4318983-31898385.89085.89
584011-8401122.62122.62
6250476-25047667.44467.44
10min1300207-30020780.83588.6514.4780.9188.7514.49
2352614-35261494.94695.06
3371833-371833100.121100.23
4363262-36326297.81397.96
5246557-24655766.38966.43
6340988-34098891.81691.93
15min1336692-33669290.65994.276.5490.8794.516.58
2361373-36137397.30597.57
3374553-374553100.853101.13
4361386-36138697.30897.61
5310677-31067783.65483.80
6355855-35585595.81996.08
20min1347801-34780193.65096.044.0594.0196.454.10
2362096-36209697.49997.93
3374871-374871100.939101.38
4361289-36128997.28297.75
5332982-33298289.66089.95
6361122-36112297.23797.66
30min1360134-36013496.97197.732.5697.4998.302.60
2363750-36375097.94598.54
3378911-378911102.027102.64
4362399-36239997.58198.21
5350060-35006094.25894.70
6362526-36252697.61598.20
极限1365510-36551098.41898.651.8499.1099.381.86
2364797-36479798.22698.98
3379538-379538102.196102.98
4362555-36255597.62398.42
5360563-36056397.08697.68
6365279-36527998.35699.11
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)10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%
110.783426103412693409543419913420253417700.20
210.803403313406803405060.08
单位质量响应值RSD%判断
31704.0831528.330.40数据可信
长期24月-供试品溶液-2023092221批-pH4.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1317270-31727085.62068.4232.6685.6268.4232.66
2108449-10844929.26629.27
3318655-31865585.99385.99
4209439-20943956.52056.52
5307810-30781083.06783.07
6259576-25957670.05070.05
10min1344572-34457292.98793.285.3493.1393.395.36
2327717-32771788.43988.49
3365206-36520698.55698.70
4325331-32533187.79587.89
5369436-36943699.69799.84
6341625-34162592.19292.31
15min1349336-34933694.27396.552.6394.5796.822.63
2360688-36068897.33797.53
3368423-36842399.42499.73
4348451-34845194.03494.27
5368607-36860799.47499.78
6351235-35123594.78695.06
20min1352618-35261895.15997.852.3295.6198.282.30
2370864-370864100.083100.44
3368442-36844299.42999.90
4358618-35861896.77897.18
5370668-370668100.030100.50
6354338-35433895.62396.05
30min1357235-35723596.40598.741.9697.0299.331.94
2375318-375318101.285101.81
3369798-36979899.795100.43
4365035-36503598.51099.07
5369797-36979799.795100.43
6358096-35809696.63797.22
极限1362829-36282997.914100.001.4998.69100.761.47
2375827-375827101.422102.12
3372345-372345100.482101.29
4374761-374761101.134101.86
5373063-373063100.676101.48
6364444-36444498.35099.10
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)10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%
110.783407533411983408983411083408493409610.06
210.803418613406773412690.25
单位质量响应值RSD%判断
31629.0431598.980.07数据可信
长期24月-供试品溶液-2023092321批-pH4.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1310674-31067483.84557.7446.0083.8457.7446.00
2152088-15208841.04641.05
3168934-16893445.59245.59
4278830-27883075.25175.25
5303838-30383882.00082.00
669327-6932718.71018.71
10min1370329-37032999.94588.7524.92100.0888.8424.94
2372493-372493100.529100.60
3310454-31045483.78583.86
4374750-374750101.138101.26
5375363-375363101.303101.44
6169678-16967845.79345.82
15min1373883-373883100.90495.4911.59101.2195.7311.63
2375959-375959101.464101.70
3337389-33738991.05591.27
4382716-382716103.288103.58
5375948-375948101.461101.77
6276936-27693674.74074.85
20min1373515-373515100.80497.966.53101.2898.366.59
2376660-376660101.653102.06
3352219-35221995.05795.42
4378225-378225102.076102.54
5378160-378160102.058102.53
6319120-31912086.12486.36
30min1378166-378166102.06099.672.99102.70100.243.07
2374617-374617101.102101.68
3359811-35981197.10697.63
4375206-375206101.261101.90
5376651-376651101.651102.30
6351355-35135594.82495.20
极限1374887-374887101.175100.691.30101.99101.421.36
2375797-375797101.420102.16
3364781-36478198.44799.13
4375084-375084101.228102.03
5377942-377942101.999102.81
6369961-36996199.845100.38
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