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%
19.863254113246603247413249783248463249270.10
29.923249733254303252020.10
单位质量响应值RSD%判断
32954.0632782.460.37数据可信
加速6月-供试品溶液-2023091921批-pH2.0盐酸溶液
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1127173-12717366.02474.166.4666.0274.166.46
2150352-15035278.05878.06
3146648-14664876.13576.13
4137466-13746671.36871.37
5151769-15176978.79378.79
6143643-14364374.57574.57
10min1186484-18648496.81696.274.0296.9396.394.02
2196130-196130101.824101.95
3176878-17687891.82991.96
4178130-17813092.47992.60
5191175-19117599.25299.38
6183781-18378195.41395.54
15min1188646-18864697.93997.603.2698.2197.883.27
2197558-197558102.566102.87
3180424-18042493.67093.95
4183671-18367195.35695.63
5191849-19184999.60299.90
6185757-18575796.43996.72
20min1189851-18985198.56498.012.8199.0098.462.81
2197429-197429102.499102.97
3182496-18249694.74695.18
4185743-18574396.43296.86
5191358-19135899.34799.81
6185847-18584796.48696.93
30min1190101-19010198.69498.532.4099.2999.142.40
2197714-197714102.647103.29
3184455-18445595.76396.36
4188483-18848397.85498.45
5191072-19107299.19899.83
6186890-18689097.02797.63
极限1189781-18978198.52898.802.0799.2999.582.08
2197052-197052102.303103.12
3185946-18594696.53797.29
4191361-19136199.348100.10
5190742-19074299.02799.82
6186958-18695897.06297.83
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%
19.863249533247523246863247243244703247170.06
29.923230373234083232220.09
单位质量响应值RSD%判断
32932.7632582.860.76数据可信
加速6月-供试品溶液-2023092021批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1175265-17526591.30184.938.6191.3084.928.61
2169837-16983788.47388.47
3140813-14081373.35473.35
4150158-15015878.22278.22
5170531-17053188.83588.83
6171574-17157489.37889.38
10min1185220-18522096.48699.263.0796.6499.403.06
2196734-196734102.484102.63
3196617-196617102.423102.55
4190884-19088499.43799.57
5182381-18238195.00895.16
6191437-19143799.72599.87
15min1186043-18604396.915100.003.2997.23100.303.27
2198192-198192103.244103.56
3199904-199904104.136104.43
4192373-192373100.213100.51
5184183-18418395.94696.25
6191049-19104999.52399.84
20min1186471-18647197.138100.133.1897.61100.603.17
2197878-197878103.080103.57
3200581-200581104.488104.95
4192582-192582100.322100.78
5185247-18524796.50096.97
6190492-19049299.23399.71
30min1187394-18739497.619100.423.0698.26101.063.05
2198208-198208103.252103.91
3200861-200861104.634105.27
4193261-193261100.675101.31
5186008-18600896.89797.52
6190894-19089499.442100.09
极限1189237-18923798.579100.642.6699.38101.452.65
2197493-197493102.880103.71
3201008-201008104.711105.53
4192952-192952100.514101.31
5187697-18769797.77798.57
6190811-19081199.399100.21
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%
19.863238013238063240633237783242643239420.07
29.923231493233513232500.05
单位质量响应值RSD%判断
32854.1632585.690.59数据可信
加速6月-供试品溶液-2023092022批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1160949-16094983.93983.468.7183.9483.468.71
2169364-16936488.32888.33
3178827-17882793.26393.26
4139211-13921172.60272.60
5150354-15035478.41478.41
6161504-16150484.22984.23
10min1186695-18669597.366100.202.5297.51100.342.52
2195192-195192101.798101.94
3196642-196642102.554102.71
4196592-196592102.528102.65
5186034-18603497.02297.15
6191587-19158799.918100.06
15min1190662-19066299.435101.041.9999.74101.341.99
2195248-195248101.827102.14
3197072-197072102.778103.10
4198610-198610103.580103.87
5188745-18874598.43598.73
6192086-192086100.178100.48
20min1190453-19045399.326101.312.1399.79101.782.13
2195028-195028101.712102.20
3196902-196902102.689103.19
4200507-200507104.570105.03
5189473-18947398.81599.27
6193153-193153100.734101.21
30min1192194-192194100.234101.561.94100.87102.211.94
2194897-194897101.644102.30
3196541-196541102.501103.17
4201154-201154104.907105.55
5190525-19052599.36499.98
6193158-193158100.737101.38
极限1191002-19100299.612101.402.19100.41102.212.19
2194863-194863101.626102.45
3196506-196506102.483103.32
4201673-201673105.178105.99
5190283-19028399.238100.02
6192265-192265100.271101.08
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%
19.863234613235213236093232943237123235190.05
29.923247283246913247100.01
单位质量响应值RSD%判断
32811.2632732.860.17数据可信
加速6月-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%
5min194504-9450449.20746.358.7949.2146.358.79
296191-9619150.08650.09
393855-9385548.86948.87
483207-8320743.32543.32
576156-7615639.65439.65
690197-9019746.96546.96
10min1168438-16843887.70485.124.5487.7985.204.54
2171059-17105989.06889.15
3169373-16937388.19188.27
4158972-15897282.77582.85
5152020-15202079.15579.22
6160957-16095783.80883.89
15min1194199-194199101.11799.581.74101.3599.801.75
2191720-19172099.826100.06
3194637-194637101.345101.57
4191013-19101399.45899.67
5185400-18540096.53696.73
6190495-19049599.18899.41
20min1195062-195062101.566100.211.46101.96100.601.46
2193245-193245100.620101.02
3194818-194818101.439101.84
4192673-192673100.323100.70
5187443-18744397.59997.96
6191544-19154499.735100.12
30min1194039-194039101.034100.001.39101.60100.551.40
2192718-192718100.346100.91
3194884-194884101.474102.04
4192608-192608100.289100.83
5187579-18757997.67098.19
6190458-19045899.16999.72
极限1193655-193655100.83499.811.43101.57100.531.44
2192503-192503100.234100.97
3194566-194566101.308102.04
4191890-19189099.915100.63
5186840-18684097.28597.97
6190639-19063999.26399.98
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