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%
19.943151893146933162873162433167143158250.27
29.863150923150813150860.01
单位质量响应值RSD%判断
31773.1431955.980.41数据可信
供试品溶液-317273批-pH1.2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%
5min1145703-14570339.01434.4010.3139.0134.4010.31
2130196-13019634.86134.86
3135616-13561636.31336.31
4133827-13382735.83435.83
5114595-11459530.68430.68
6111006-11100629.72329.72
10min1303396-30339681.23770.968.5581.3071.028.55
2259137-25913769.38769.44
3277408-27740874.27974.34
4255333-25533368.36868.43
5237725-23772563.65363.70
6257062-25706268.83168.88
15min1367813-36781398.48692.583.7398.6992.763.74
2346529-34652992.78792.96
3350411-35041193.82694.01
4341209-34120991.36291.54
5329812-32981288.31188.47
6338858-33885890.73390.90
20min1381023-381023102.023101.680.94102.39102.010.94
2384664-384664102.998103.33
3374974-374974100.403100.74
4382250-382250102.351102.68
5377804-377804101.161101.47
6377798-377798101.159101.47
30min1380288-380288101.826102.091.15102.36102.591.15
2385318-385318103.173103.67
3374427-374427100.257100.76
4386501-386501103.490103.99
5381833-381833102.240102.71
6379241-379241101.546102.03
极限1379002-379002101.482101.601.06102.19102.271.05
2383717-383717102.744103.42
3372808-37280899.823100.50
4382860-382860102.515103.18
5380878-380878101.984102.63
6377453-377453101.067101.72
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%
19.943158293157103159493157693157413158000.03
29.863169183153433161300.36
单位质量响应值RSD%判断
31770.6232061.870.65数据可信
供试品溶液-320179批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min171985-7198519.24428.2921.0719.2428.2921.08
292751-9275124.79524.80
3111892-11189229.91229.91
4100179-10017926.78126.78
5126062-12606233.70033.70
6132109-13210935.31735.32
10min1194657-19465752.03861.118.9052.0761.168.91
2222564-22256459.49859.54
3230039-23003961.49661.55
4226500-22650060.55060.59
5253868-25386867.86767.92
6243924-24392465.20865.27
15min1295016-29501678.86786.544.6478.9986.694.64
2328416-32841687.79687.94
3322910-32291086.32486.48
4328916-32891687.92988.07
5338863-33886390.58890.76
6328252-32825287.75287.92
20min1362577-36257796.92899.771.4897.18100.071.49
2377030-377030100.792101.08
3374991-374991100.246100.54
4375847-375847100.475100.77
5376657-376657100.692101.01
6372238-37223899.51099.82
30min1381778-381778102.061102.240.97102.47102.700.96
2383231-383231102.449102.90
3385271-385271102.995103.46
4386230-386230103.251103.71
5382363-382363102.217102.71
6375715-375715100.440100.92
极限1380457-380457101.708102.050.85102.29102.680.84
2382787-382787102.331102.96
3384300-384300102.735103.37
4385181-385181102.971103.60
5381547-381547101.999102.66
6376214-376214100.573101.22
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%
19.943153653150443156723151563148583152190.10
29.863158293161233159760.07
单位质量响应值RSD%判断
31712.1732046.250.75数据可信
供试品溶液-715967批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1118551-11855131.72934.505.0631.7334.505.06
2134226-13422635.92535.92
3136994-13699436.66536.67
4128245-12824534.32434.32
5129717-12971734.71834.72
6125708-12570833.64533.64
10min1264362-26436270.75570.565.9670.8170.615.96
2260586-26058669.74469.80
3277931-27793174.38674.45
4235399-23539963.00363.06
5278428-27842874.51974.58
6264999-26499970.92570.98
15min1351829-35182994.16492.302.6094.3492.482.61
2349440-34944093.52593.70
3351518-35151894.08194.27
4328317-32831787.87288.03
5346499-34649992.73892.92
6341576-34157691.42091.59
20min1379696-379696101.623101.601.13101.95101.931.13
2378744-378744101.368101.70
3384961-384961103.032103.37
4377323-377323100.988101.30
5383647-383647102.680103.02
6373298-37329899.910100.24
30min1380481-380481101.833102.031.22102.33102.521.22
2379309-379309101.519102.02
3386265-386265103.381103.89
4381496-381496102.105102.58
5385895-385895103.282103.79
6373791-373791100.042100.54
极限1377882-377882101.137101.751.25101.80102.411.25
2378586-378586101.326102.00
3385431-385431103.158103.84
4381707-381707102.161102.81
5384574-384574102.928103.61
6372752-37275299.764100.42
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%
19.943150883142823146083144243143983145600.11
29.863176183169333172760.16
单位质量响应值RSD%判断
31645.8832178.091.18数据可信
供试品溶液-715967批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1107498-10749828.74332.1310.5828.7432.1310.59
2130124-13012434.79234.79
3129220-12922034.55134.55
4135260-13526036.16636.17
5107165-10716528.65428.65
6111807-11180729.89529.89
10min1258781-25878169.19367.392.6869.2467.442.67
2239654-23965464.07864.14
3255203-25520368.23668.29
4250714-25071467.03667.10
5256066-25606668.46768.51
6251853-25185367.34067.39
15min1358554-35855495.87091.543.4296.0391.703.42
2328194-32819487.75287.92
3346790-34679092.72492.90
4340405-34040591.01791.19
5349802-34980293.53093.69
6330380-33038088.33788.50
20min1383717-383717102.598101.221.35102.92101.541.35
2377634-377634100.971101.28
3385774-385774103.148103.47
4376732-376732100.730101.05
5372893-37289399.704100.02
6374680-374680100.182100.49
30min1383958-383958102.662101.741.33103.16102.231.33
2382001-382001102.139102.62
3388218-388218103.801104.30
4375927-375927100.515101.01
5375846-375846100.493100.98
6377135-377135100.838101.31
极限1383176-383176102.453101.451.47103.12102.111.46
2381554-381554102.020102.67
3387511-387511103.612104.28
4374168-374168100.045100.70
5373553-37355399.880100.53
6376662-376662100.711101.36
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