替米沙坦片项目信息
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对照品来源原料药对照品使用方法直接使用
对照品含量(%)100.00对照品水分(%)0对照品稀释倍数1250
标示量(mg)80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%
111.014856134859184855174855994856174856530.04
211.024870844872604871720.03
单位质量响应值RSD%判断
44110.1744207.990.16数据可信
供试品溶液-E43216批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min148582-485829.90112.2229.759.9012.2229.72
243356-433568.8368.84
386271-8627117.58317.58
450910-5091010.37610.38
578676-7867616.03516.03
652086-5208610.61610.62
10min1106014-10601421.60723.7620.6221.6623.8320.64
298768-9876820.13020.18
3135230-13523027.56127.66
4109900-10990022.39922.46
5155875-15587531.76931.86
693734-9373419.10419.16
15min1161529-16152932.92136.0721.1133.1036.2721.11
2159954-15995432.60032.76
3202067-20206741.18341.43
4155710-15571031.73531.92
5241098-24109849.13849.40
6141567-14156728.85329.02
20min1199443-19944340.64848.3117.6641.0148.7217.68
2235465-23546547.99048.33
3257565-25756552.49452.97
4203334-20333441.44141.80
5310234-31023463.22863.77
6216286-21628644.08144.41
30min1293276-29327659.77266.079.7760.3666.749.84
2328695-32869566.99167.60
3326686-32668666.58167.35
4298819-29881960.90261.49
5381719-38171977.79878.69
6315784-31578464.36064.93
45min1392323-39232379.95981.906.5580.8782.946.64
2396961-39696180.90481.88
3393678-39367880.23581.38
4376083-37608376.64977.58
5452947-45294792.31593.64
6399212-39921281.36382.29
60min1473601-47360196.52492.343.8897.8893.833.93
2441370-44137089.95591.39
3445394-44539490.77592.36
4439781-43978189.63190.98
5477453-47745397.30999.14
6440822-44082289.84391.22
90min1505518-505518103.02997.763.20104.9399.763.16
2464516-46451694.67296.60
3467363-46736395.25397.34
4479011-47901197.62799.48
5488602-48860299.581101.96
6472989-47298996.39998.28
120min1500290-500290101.96497.592.77104.43100.132.72
2479988-47998897.826100.28
3467987-46798795.38098.00
4479566-47956697.740100.13
5482882-48288298.416101.34
6462163-46216394.19396.61
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1490205-49020599.90896.742.60102.9499.832.57
2477712-47771297.362100.36
3472847-47284796.37099.52
4477707-47770797.361100.30
5476971-47697197.211100.69
6452552-45255292.23495.17
替米沙坦片项目信息
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对照品来源原料药对照品使用方法直接使用
对照品含量(%)100.00对照品水分(%)0对照品稀释倍数1250
标示量(mg)80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%
111.014871444874414870554869504866924870560.06
211.024866694864434865560.04
单位质量响应值RSD%判断
44237.6044152.090.14数据可信
供试品溶液-F73104批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min157718-5771811.75415.9318.2211.7515.9318.22
276911-7691115.66215.66
3101426-10142620.65520.65
477436-7743615.76915.77
572759-7275914.81714.82
683223-8322316.94816.95
10min1112108-11210822.83025.727.5522.9025.817.57
2132496-13249626.98227.07
3138183-13818328.14028.25
4119344-11934424.30424.39
5124666-12466625.38725.47
6131052-13105226.68826.78
15min1156235-15623531.81634.776.5832.0135.006.60
2181673-18167336.99737.23
3184872-18487237.64837.92
4163271-16327133.24933.47
5164773-16477333.55533.78
6173694-17369435.37235.61
20min1199966-19996640.72242.316.5041.0942.736.49
2227535-22753546.33646.78
3210646-21064642.89743.38
4192836-19283639.27039.68
5197092-19709240.13740.55
6218446-21844644.48544.92
30min1278922-27892256.80157.173.3357.4057.833.30
2294304-29430459.93360.63
3268861-26886154.75255.47
4282979-28297957.62758.25
5272577-27257755.50956.14
6286748-28674858.39459.08
45min1351181-35118171.51671.102.2572.4372.082.25
2359832-35983273.27874.31
3342502-34250269.74870.77
4341479-34147969.54070.49
5343403-34340369.93270.87
6356497-35649772.59873.61
60min1408661-40866183.22181.102.1584.5382.472.12
2409611-40961183.41584.85
3392898-39289880.01181.42
4390780-39078079.58080.91
5393019-39301980.03681.37
6394468-39446880.33181.74
90min1443285-44328590.27287.893.1092.0489.713.07
2450600-45060091.76293.67
3433016-43301688.18190.04
4415868-41586884.68986.46
5425824-42582486.71688.49
6420900-42090085.71487.57
120min1454621-45462192.58189.811.7494.8592.121.71
2444012-44401290.42092.83
3439973-43997389.59891.94
4434718-43471888.52890.77
5433775-43377588.33690.59
6438885-43888589.37691.71
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1473549-47354996.43593.082.1299.2295.892.05
2460530-46053093.78496.70
3447068-44706891.04393.89
4459350-45935093.54496.28
5451994-45199492.04694.79
6449898-44989891.61994.45
替米沙坦片项目信息
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对照品来源原料药对照品使用方法直接使用
对照品含量(%)100.00对照品水分(%)0对照品稀释倍数1250
标示量(mg)80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%
111.014852794854514857264861804859924857260.08
211.024879044881984880510.05
单位质量响应值RSD%判断
44116.8044287.750.28数据可信
供试品溶液-F66942批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min160358-6035812.29011.7615.3812.2911.7615.36
248263-482639.8279.83
365168-6516813.26913.27
445504-455049.2659.27
567037-6703713.64913.65
660264-6026412.27012.27
10min1117520-11752023.92822.6613.1524.0022.7313.15
294927-9492719.32819.38
3127791-12779126.02026.09
491731-9173118.67718.73
5121141-12114124.66624.74
6114681-11468123.35023.42
15min1160670-16067032.71431.5313.1232.9231.7213.12
2130869-13086926.64626.81
3182085-18208537.07437.29
4132323-13232326.94227.10
5169067-16906734.42434.64
6154004-15400431.35731.55
20min1199508-19950840.62239.1112.5641.0039.4712.56
2160593-16059332.69833.01
3225881-22588145.99246.42
4168984-16898434.40734.71
5205591-20559141.86042.26
6191838-19183839.06039.43
30min1252000-25200051.31052.176.8551.9252.756.87
2234017-23401747.64848.14
3285020-28502058.03358.71
4260525-26052553.04653.54
5261676-26167653.28053.92
6244031-24403149.68750.28
45min1318043-31804364.75766.444.9265.6567.324.94
2303692-30369261.83562.59
3347432-34743270.74171.74
4337684-33768468.75669.55
5333600-33360067.92468.86
6317542-31754264.65565.52
60min1351135-35113571.49574.384.5172.7575.624.50
2349685-34968571.19972.30
3370156-37015675.36876.76
4371706-37170675.68376.86
5392860-39286079.99081.30
6356173-35617372.52073.74
90min1433111-43311188.18687.233.7989.8488.893.83
2405799-40579982.62584.12
3440286-44028689.64791.46
4428469-42846987.24188.83
5449054-44905491.43293.19
6413855-41385584.26585.89
120min1428474-42847487.24290.962.7489.3893.102.73
2452916-45291692.21894.17
3458547-45854793.36595.68
4436345-43634588.84490.92
5457954-45795493.24495.51
6446180-44618090.84792.94
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1463579-46357994.38995.401.1497.0198.051.18
2468057-46805795.30197.77
3478642-47864297.456100.29
4466921-46692195.07097.64
5465166-46516694.71397.49
6469038-46903895.50198.10
替米沙坦片项目信息
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对照品来源原料药对照品使用方法直接使用
对照品含量(%)100.00对照品水分(%)0对照品稀释倍数1250
标示量(mg)80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%
111.014847524857344845934839864839014845930.16
211.024904794900894902840.06
单位质量响应值RSD%判断
44013.9044490.380.77数据可信
供试品溶液-F90166批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min166563-6656313.53812.498.4913.5412.498.48
260085-6008512.22012.22
353299-5329910.84010.84
463693-6369312.95412.95
558306-5830611.85911.86
666585-6658513.54213.54
10min1117975-11797523.99422.815.8924.0722.885.90
2107171-10717121.79721.86
3102768-10276820.90220.96
4111822-11182222.74322.81
5112628-11262822.90722.97
6120547-12054724.51824.59
15min1165135-16513533.58631.436.4933.7931.626.47
2147561-14756130.01230.20
3144944-14494429.48029.66
4144500-14450029.38929.59
5159285-15928532.39632.59
6165741-16574133.70933.92
20min1203853-20385341.46139.484.6141.8639.854.61
2184085-18408537.44037.80
3192531-19253139.15839.50
4183181-18318137.25637.62
5200522-20052240.78341.16
6200515-20051540.78241.18
30min1270173-27017354.94954.122.1755.5754.712.17
2260446-26044652.97153.53
3271501-27150155.21955.78
4257441-25744152.36052.93
5269526-26952654.81855.42
6267414-26741454.38855.01
45min1339377-33937769.02466.522.9069.9667.412.89
2319437-31943764.96965.83
3335180-33518068.17169.04
4322648-32264865.62266.48
5315156-31515664.09865.00
6330589-33058967.23768.16
60min1387076-38707678.72674.033.6880.0475.283.66
2354156-35415672.03073.25
3366995-36699574.64275.88
4357347-35734772.67973.90
5350015-35001571.18872.45
6368225-36822574.89276.19
90min1447399-44739990.99586.622.6892.7588.292.69
2416374-41637484.68586.30
3423985-42398586.23387.89
4421785-42178585.78587.41
5417467-41746784.90786.56
6428260-42826087.10288.82
120min1448926-44892691.30590.741.8493.5692.891.81
2436652-43665288.80990.90
3440056-44005689.50191.64
4459575-45957593.47195.58
5449104-44910491.34193.47
6442571-44257190.01392.21
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1480850-48085097.79894.641.76100.5697.301.77
2458256-45825693.20395.79
3460199-46019993.59896.23
4465375-46537594.65197.27
5461389-46138993.84096.47
6465915-46591594.76197.46
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