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%
110.293373593350043363353371593369443365600.29
210.343325633323433324530.05
单位质量响应值RSD%判断
32707.4832152.131.22数据可信
长期12月-供试品溶液-2023092121批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1312997-31299782.35378.7320.5282.3578.7320.53
2335139-33513988.17988.18
3355695-35569593.58793.59
4263796-26379669.40869.41
5336114-33611488.43588.44
6191683-19168350.43450.43
10min1374860-37486098.63095.488.6098.7795.618.61
2365895-36589596.27196.42
3373163-37316398.18398.34
4384907-384907101.273101.39
5377939-37793999.44099.59
6300468-30046879.05679.14
15min1376278-37627899.00397.315.2499.3097.605.26
2369553-36955397.23397.54
3374079-37407998.42498.74
4387157-387157101.865102.15
5379821-37982199.935100.25
6332191-33219187.40387.62
20min1378554-37855499.60298.422.95100.0798.882.97
2370787-37078797.55898.03
3374276-37427698.47698.96
4387148-387148101.863102.32
5379109-37910999.748100.23
6354603-35460393.30093.66
30min1376543-37654399.07299.201.5399.7199.821.54
2373078-37307898.16198.79
3374914-37491498.64499.29
4387534-387534101.964102.59
5378749-37874999.653100.30
6371373-37137397.71298.23
极限1378775-37877599.660100.311.20100.46101.091.16
2378364-37836499.552100.35
3376523-37652399.06799.88
4388372-388372102.185102.98
5380307-380307100.063100.87
6385122-385122101.330102.01
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%
110.293331743328053329103331783330393330210.05
210.343317073315533316300.04
单位质量响应值RSD%判断
32363.5632072.530.64数据可信
长期12月-供试品溶液-2023092221批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1323155-32315585.58077.9313.0485.5877.9313.04
2267281-26728170.78370.78
3358519-35851994.94594.95
4274239-27423972.62672.63
5281245-28124574.48174.48
6261223-26122369.17969.18
10min1350931-35093192.93694.144.5993.0894.274.60
2333468-33346888.31188.43
3377615-377615100.002100.16
4356937-35693794.52694.65
5369802-36980297.93398.06
6344169-34416991.14591.26
15min1356519-35651994.41596.993.2294.7197.283.23
2348964-34896492.41592.68
3379362-379362100.465100.79
4369745-36974597.91898.20
5377025-37702599.846100.13
6365833-36583396.88297.15
20min1360815-36081595.55398.342.2496.0198.792.24
2361628-36162895.76896.19
3379369-379369100.467100.96
4373996-37399699.04499.49
5379412-379412100.478100.93
6372813-37281398.73199.16
30min1365453-36545396.78199.601.8397.40100.221.83
2369789-36978997.93098.51
3378282-378282100.179100.84
4379490-379490100.499101.11
5382825-382825101.382102.00
6380802-380802100.846101.44
极限1375638-37563899.479101.341.63100.25102.111.62
2376593-37659399.732100.47
3379092-379092100.393101.22
4388342-388342102.843103.62
5387282-387282102.562103.35
6388980-388980103.012103.77
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%
110.293331503329193328273327023329353329070.05
210.343311343311613311480.01
单位质量响应值RSD%判断
32352.4832025.920.72数据可信
长期12月-供试品溶液-2023092321批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1304064-30406480.59780.5214.6980.6080.5214.69
2360240-36024095.48795.49
3229261-22926160.76960.77
4333210-33321088.32288.32
5309631-30963182.07282.07
6286215-28621575.86575.87
10min1379255-379255100.52794.5711.39100.6694.7011.40
2379222-379222100.518100.68
3279304-27930474.03474.13
4377211-37721199.985100.13
5382208-382208101.310101.45
6343528-34352891.05791.18
15min1382116-382116101.28598.583.88101.5998.883.90
2380508-380508100.859101.19
3350775-35077592.97893.20
4378436-378436100.310100.62
5383306-383306101.601101.91
6356411-35641194.47294.75
20min1380867-380867100.95499.891.87101.43100.351.89
2380855-380855100.951101.45
3374471-37447199.25999.64
4378024-378024100.201100.68
5383128-383128101.554102.03
6363838-36383896.44196.88
30min1382843-382843101.478100.811.32102.12101.431.32
2381276-381276101.063101.73
3384810-384810102.000102.54
4378866-378866100.424101.07
5383175-383175101.566102.21
6370928-37092898.32098.92
极限1386972-386972102.573101.691.00103.38102.480.98
2384031-384031101.793102.62
3388603-388603103.005103.72
4379352-379352100.553101.37
5383696-383696101.704102.52
6379294-379294100.537101.30
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%
110.293358133352293351583345473344433350380.17
210.343326413327563326980.03
单位质量响应值RSD%判断
32559.5732175.820.84数据可信
长期12月-供试品溶液-715967批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1147627-14762738.91535.439.4938.9235.439.49
2139336-13933636.73036.73
3114024-11402430.05730.06
4143463-14346337.81837.82
5124178-12417832.73432.73
6137700-13770036.29836.30
10min1282064-28206474.35473.675.3674.4273.735.36
2289133-28913376.21776.28
3272655-27265571.87371.92
4294885-29488577.73377.80
5285152-28515275.16875.22
6252955-25295566.68066.74
15min1357112-35711294.13795.003.6194.3395.183.61
2364118-36411895.98396.17
3358650-35865094.54294.71
4377661-37766199.55399.75
5366289-36628996.55696.74
6338422-33842289.21089.38
20min1380300-380300100.249100.421.22100.59100.761.22
2376895-37689599.35299.70
3383572-383572101.112101.44
4388916-388916102.520102.88
5376954-37695499.36799.71
6378982-37898299.902100.22
30min1379579-379579100.059100.531.20100.57101.041.20
2376706-37670699.30299.82
3384152-384152101.265101.76
4388527-388527102.418102.95
5376932-37693299.36199.87
6382220-382220100.755101.24
极限1380177-380177100.217100.341.16100.90101.021.16
2376641-37664199.28599.96
3382177-382177100.744101.41
4387511-387511102.150102.85
5375283-37528398.92799.60
6382188-382188100.747101.40
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