替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2500
标示量(mg)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.113864933861603857113859393854973859600.11
211.033881803879983880890.04
单位质量响应值RSD%判断
34739.8735184.860.90数据可信
供试品溶液-24042201批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1140743-14074336.23137.225.4736.2337.225.47
2155095-15509539.92639.93
3152262-15226239.19739.20
4145272-14527237.39737.40
5134504-13450434.62534.63
6139518-13951835.91635.92
10min1247911-24791163.82063.624.8064.0263.824.80
2269388-26938869.34969.57
3244676-24467662.98763.20
4243082-24308262.57762.78
5234090-23409060.26260.45
6243570-24357062.70262.90
15min1306853-30685378.99379.974.0579.5580.544.05
2322839-32283983.10883.72
3319540-31954082.25982.83
4304160-30416078.30078.86
5290295-29029574.73175.26
6320292-32029282.45383.00
20min1355547-35554791.52891.854.1292.5292.864.12
2372578-37257895.91396.98
3355356-35535691.47992.50
4358725-35872592.34793.34
5330450-33045085.06886.01
6368183-36818394.78195.79
30min1349496-34949689.97190.583.2091.4792.103.12
2331852-33185285.42987.03
3356192-35619291.69593.23
4365508-36550894.09395.60
5351681-35168190.53391.95
6356483-35648391.76993.30
45min1355067-35506791.40589.961.7293.4191.981.67
2342233-34223388.10190.18
3357412-35741292.00994.05
4343852-34385288.51890.54
5349340-34934089.93191.85
6348793-34879389.79091.83
60min1360822-36082292.88690.612.6095.4093.132.56
2359391-35939192.51895.08
3360124-36012492.70795.26
4346013-34601389.07491.59
5340201-34020187.57890.00
6345432-34543288.92591.47
极限1353194-35319490.92390.031.3393.9593.051.28
2342494-34249488.16891.25
3347629-34762989.49092.56
4355568-35556891.53494.55
5348151-34815189.62592.53
6351342-35134290.44693.48
替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2500
标示量(mg)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.113864323865283866563865663873493867060.10
211.033821633816683819160.10
单位质量响应值RSD%判断
34807.0234625.200.38数据可信
供试品溶液-24042201批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1150657-15065739.05739.636.9139.0639.636.91
2151419-15141939.25539.25
3170318-17031844.15444.15
4153528-15352839.80239.80
5154139-15413939.96039.96
6137248-13724835.58135.58
10min1239427-23942762.07163.367.1262.2963.587.10
2259689-25968967.32467.54
3258573-25857367.03467.28
4215064-21506455.75555.98
5256328-25632866.45266.67
6237406-23740661.54761.74
15min1300074-30007477.79380.874.1378.3681.444.13
2333289-33328986.40487.00
3320868-32086883.18483.80
4300821-30082177.98778.52
5308849-30884980.06880.66
6307672-30767279.76380.30
20min1347986-34798690.21489.061.7591.2190.081.75
2346863-34686389.92391.00
3340056-34005688.15989.24
4333281-33328186.40287.37
5349226-34922690.53691.57
6343708-34370889.10590.09
30min1363227-36322794.16694.101.7995.6695.621.74
2367265-36726595.21296.78
3353689-35368991.69393.26
4372217-37221796.49697.94
5363021-36302194.11295.65
6358435-35843592.92394.40
45min1367135-36713595.17993.910.9597.2095.950.92
2361959-36195993.83795.94
3363063-36306394.12396.20
4364258-36425894.43396.41
5357528-35752892.68894.75
6359574-35957493.21995.21
60min1368315-36831595.48593.442.7398.0396.002.67
2360034-36003493.33895.96
3365281-36528194.69897.30
4363904-36390494.34196.85
5363854-36385494.32896.90
6341153-34115388.44390.95
极限1363824-36382494.32092.352.7397.4095.432.61
2351630-35163091.15994.30
3338988-33898887.88291.01
4363615-36361594.26697.30
5362500-36250093.97797.08
6356685-35668592.47095.47
替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2500
标示量(mg)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.113848043846943877083858123857303857500.32
211.033876413879683878040.06
单位质量响应值RSD%判断
34720.9735159.020.89数据可信
供试品溶液-2024050921批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1144197-14419737.14438.014.9237.1438.014.92
2142044-14204436.59036.59
3140870-14087036.28736.29
4144725-14472537.28037.28
5157125-15712540.47540.47
6156323-15632340.26840.27
10min1235830-23583060.74961.164.2460.9561.374.23
2236602-23660260.94761.15
3242532-24253262.47562.68
4224731-22473157.88958.10
5230838-23083859.46359.69
6253938-25393865.41365.64
15min1298559-29855976.90779.313.9577.4579.863.94
2301385-30138577.63578.18
3298384-29838476.86277.41
4302070-30207077.81278.34
5323916-32391683.43983.99
6323016-32301683.20783.79
20min1348344-34834489.73289.162.2090.7090.152.19
2341692-34169288.01888.99
3332908-33290885.75586.73
4350753-35075390.35291.31
5353794-35379491.13592.15
6349176-34917689.94691.00
30min1357453-35745392.07893.481.0193.5594.971.01
2363302-36330293.58595.05
3363308-36330893.58695.04
4365459-36545994.14095.60
5360197-36019792.78594.31
6367687-36768794.71496.26
45min1363814-36381493.71792.490.9095.7094.500.86
2360946-36094692.97894.96
3355226-35522691.50493.48
4359948-35994892.72194.71
5358320-35832092.30194.34
6356032-35603291.71293.79
60min1362232-36223293.30992.890.7195.8195.410.70
2361826-36182693.20495.70
3355601-35560191.60194.08
4362213-36221393.30495.81
5361333-36133393.07795.63
6360343-36034392.82295.41
极限1362890-36289093.47892.191.4096.5095.221.37
2357506-35750692.09295.11
3356275-35627591.77594.76
4353506-35350691.06194.08
5352295-35229590.74993.82
6364757-36475793.95997.06
替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2500
标示量(mg)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.113849583849293849103847963845023848190.05
211.033796493802473799480.12
单位质量响应值RSD%判断
34637.1734446.780.39数据可信
供试品溶液-2024050921批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1140311-14031136.55937.844.5036.5637.844.49
2139818-13981836.43036.43
3140557-14055736.62336.62
4145032-14503237.78937.79
5156140-15614040.68340.68
6149506-14950638.95438.95
10min1224810-22481058.57560.873.1758.7861.083.17
2226176-22617658.93159.13
3231074-23107460.20760.41
4237181-23718161.79962.01
5242803-24280363.26363.49
6239679-23967962.44962.67
15min1280878-28087873.18474.735.6173.7175.285.60
2284788-28478874.20374.73
3267028-26702869.57570.11
4277762-27776272.37272.93
5312485-31248581.41982.00
6297888-29788877.61678.18
20min1325671-32567184.85586.704.4485.7987.664.43
2340568-34056888.73789.68
3315053-31505382.08883.01
4323262-32326284.22785.18
5356568-35656892.90593.94
6335379-33537987.38588.38
30min1369511-36951196.27894.222.4697.6895.672.39
2364447-36444794.95896.39
3355155-35515592.53793.92
4365042-36504295.11396.54
5346821-34682190.36691.91
6368737-36873796.07697.56
45min1361997-36199794.32094.022.8196.2695.992.80
2362104-36210494.34896.31
3341324-34132488.93490.83
4362905-36290594.55796.51
5366046-36604695.37597.42
6370788-37078896.61098.62
60min1363121-36312194.61393.282.2797.0895.772.25
2358582-35858293.43095.92
3342700-34270089.29291.68
4366224-36622495.42197.90
5358508-35850893.41195.99
6358868-35886893.50596.06
极限1359882-35988293.76993.511.5296.7696.521.50
2364053-36405394.85697.86
3349810-34981091.14594.03
4364060-36406094.85797.86
5355788-35578892.70295.80
6359755-35975593.73696.81
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