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%
19.863253933253523254593241923244923249780.19
29.923240303243593241940.08
单位质量响应值RSD%判断
32959.2332680.850.60数据可信
长期6月-供试品溶液-2023092022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%
5min1171880-17188044.68338.2723.9944.6838.2723.99
2125958-12595832.74532.75
3174450-17445045.35145.35
490666-9066623.57023.57
5181341-18134147.14347.14
6138938-13893836.11936.12
10min1192348-19234850.00446.547.9750.0846.617.99
2161728-16172842.04442.10
3193413-19341350.28150.36
4164439-16443942.74942.79
5188622-18862249.03649.11
6173697-17369745.15645.22
15min1192192-19219249.96448.014.5750.1248.154.60
2171640-17164044.62144.75
3193358-19335850.26750.43
4178548-17854846.41746.53
5188634-18863449.03949.20
6183681-18368147.75147.89
20min1191906-19190649.88948.613.0550.1348.843.07
2177367-17736746.11046.31
3192990-19299050.17150.41
4184361-18436147.92848.12
5188461-18846148.99449.24
6186888-18688848.58548.80
30min1191238-19123849.71649.151.3750.0449.451.40
2185219-18521948.15148.43
3192604-19260450.07150.40
4188436-18843648.98749.26
5188062-18806248.89049.21
6188776-18877649.07649.37
极限1191075-19107549.67349.770.9950.0850.160.95
2193227-19322750.23350.59
3192153-19215349.95450.36
4191709-19170949.83850.19
5187921-18792148.85349.26
6192616-19261650.07450.45
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%
19.863242063240223236873233733231933236960.14
29.923229493223863226680.13
单位质量响应值RSD%判断
32829.2132527.020.66数据可信
长期6月-供试品溶液-2023092121批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1348390-34839090.96487.786.9790.9687.786.97
2313752-31375281.92081.92
3371941-37194197.11397.11
4340011-34001188.77688.78
5335261-33526187.53687.54
6307935-30793580.40180.40
10min1381413-38141399.58698.322.1799.7498.472.17
2384771-384771100.463100.60
3381000-38100099.47899.64
4371560-37156097.01397.16
5362600-36260094.67494.82
6378085-37808598.71798.85
15min1381466-38146699.60098.562.0799.9298.872.07
2385558-385558100.668100.97
3380328-38032899.30399.63
4373310-37331097.47097.78
5363739-36373994.97195.28
6380554-38055499.36299.66
20min1381619-38161999.64098.571.96100.1299.041.96
2384387-384387100.363100.83
3379866-37986699.18299.68
4374122-37412297.68298.15
5364113-36411395.06995.53
6380976-38097699.47299.94
30min1381523-38152399.61598.821.97100.2699.461.97
2384839-384839100.481101.12
3379100-37910098.98299.64
4379214-37921499.01299.65
5363939-36393995.02495.64
6382337-38233799.827100.46
极限1381076-38107699.49898.771.88100.3199.581.88
2384498-384498100.392101.20
3376873-37687398.40199.22
4376848-37684898.39499.19
5365667-36566795.47596.25
6384859-384859100.486101.28
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%
19.863231753226033226573226913228013227850.08
29.923224823228553226680.09
单位质量响应值RSD%判断
32736.8232527.020.46数据可信
长期6月-供试品溶液-2023092221批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1215414-21541456.32355.3233.2556.3255.3233.25
2181451-18145147.44347.44
3171674-17167444.88744.89
4133469-13346934.89734.90
5337167-33716788.15788.16
6230183-23018360.18560.18
10min1374898-37489898.02390.907.3398.1290.997.35
2310275-31027581.12681.20
3342788-34278889.62789.70
4329186-32918686.07086.13
5373885-37388597.75897.90
6354870-35487092.78692.89
15min1381915-38191599.85796.922.37100.1197.162.38
2355830-35583093.03793.25
3374313-37431397.87098.09
4370586-37058696.89597.10
5374170-37417097.83298.14
6367229-36722996.01796.27
20min1381656-38165699.79098.581.99100.2198.981.97
2366636-36663695.86296.23
3378381-37838198.93399.32
4388224-388224101.507101.87
5373867-37386797.75398.23
6373362-37336297.62198.04
30min1382907-382907100.11799.352.15100.7199.922.13
2371275-37127597.07597.60
3380334-38033499.444100.00
4394034-394034103.026103.56
5373072-37307297.54598.18
6378293-37829398.91099.49
极限1386709-386709101.11199.992.09101.87100.722.06
2376873-37687398.53999.23
3382662-382662100.053100.77
4394366-394366103.113103.82
5371227-37122797.06397.86
6382594-382594100.035100.78
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%
19.863238813238323241643242573240033240270.06
29.923230113235943233020.13
单位质量响应值RSD%判断
32862.7832590.930.59数据可信
长期6月-供试品溶液-2023092321批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1212603-21260355.42760.2215.7755.4360.2215.77
2277690-27769072.39672.40
3192958-19295850.30650.31
4226181-22618158.96758.97
5202638-20263852.82952.83
6273828-27382871.38971.39
10min1391398-391398102.04195.965.30102.1396.065.30
2383072-38307299.87099.99
3346315-34631590.28790.37
4343606-34360689.58189.68
5375661-37566197.93898.03
6368290-36829096.01696.14
15min1395294-395294103.05699.273.19103.3299.533.19
2387700-387700101.076101.36
3384621-384621100.274100.51
4360573-36057394.00494.25
5382647-38264799.759100.01
6373723-37372397.43397.71
20min1394348-394348102.81099.482.76103.2499.912.75
2387927-387927101.136101.59
3386685-386685100.812101.21
4365987-36598795.41695.82
5381928-38192899.57299.99
6372626-37262697.14797.59
30min1393983-393983102.71499.782.26103.32100.382.25
2387652-387652101.064101.69
3387142-387142100.931101.50
4371874-37187496.95097.51
5382165-38216599.633100.22
6373636-37363697.41098.01
极限1391842-391842102.15699.971.81102.93100.721.80
2387988-387988101.152101.94
3388063-388063101.171101.91
4377357-37735798.38099.10
5381095-38109599.354100.10
6374312-37431297.58698.35
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