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%
111.014865404867664869624869024870284868400.04
211.024884884885824885350.02
单位质量响应值RSD%判断
44217.9844331.670.19数据可信
供试品溶液-E43216批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1173608-17360835.29040.929.4135.2940.929.41
2206105-20610541.89641.90
3186913-18691337.99537.99
4204837-20483741.63841.64
5207970-20797042.27542.28
6228465-22846546.44146.44
10min1342507-34250769.62374.556.7769.8274.786.78
2370323-37032375.27875.51
3350129-35012971.17371.38
4365119-36511974.22074.45
5359429-35942973.06373.30
6413091-41309183.97284.23
15min1450733-45073391.62394.294.1892.2194.934.20
2467823-46782395.09795.75
3450813-45081391.64092.25
4457909-45790993.08293.73
5454527-45452792.39493.04
6501239-501239101.890102.61
20min1495546-495546100.733101.430.98101.82102.591.01
2502606-502606102.168103.35
3491021-49102199.813100.93
4503672-503672102.384103.55
5499142-499142101.464102.62
6501737-501737101.991103.28
30min1487805-48780599.159102.261.88100.81103.991.87
2498627-498627101.359103.11
3503045-503045102.257103.93
4515258-515258104.740106.47
5509446-509446103.558105.28
6504181-504181102.488104.35
45min1497863-497863101.204101.821.07103.41104.111.10
2499621-499621101.561103.87
3502499-502499102.146104.38
4502366-502366102.119104.43
5493487-493487100.314102.61
6509426-509426103.554105.98
60min1500986-500986101.838100.931.13104.60103.791.10
2496882-496882101.004103.88
3499110-499110101.457104.26
4498023-498023101.236104.11
5485457-48545798.682101.53
6498572-498572101.348104.35
极限1491761-49176199.96399.400.45103.29102.820.39
2486100-48610098.813102.25
3488786-48878699.359102.73
4490443-49044399.695103.14
5490057-49005799.617103.02
6486791-48679198.953102.52
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%
111.014900694900864888694876354876714888660.25
211.024899364900374899860.02
单位质量响应值RSD%判断
44402.0044463.340.10数据可信
供试品溶液-F73104批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min192555-9255518.74720.296.9018.7520.296.90
297585-9758519.76619.77
3111065-11106522.49722.50
498365-9836519.92419.92
595694-9569419.38319.38
6105789-10578921.42821.43
10min1149303-14930330.24231.605.3130.3531.715.30
2156630-15663031.72631.84
3161252-16125232.66232.79
4152865-15286530.96331.07
5146783-14678329.73129.84
6169209-16920934.27434.39
15min1198751-19875140.25841.525.1440.5341.815.14
2215997-21599743.75144.04
3210561-21056142.65042.96
4199400-19940040.38940.67
5189906-18990638.46638.74
6215196-21519643.58943.90
20min1255626-25562651.77853.066.0552.2753.586.02
2280985-28098556.91557.44
3281790-28179057.07857.62
4245960-24596049.82050.33
5248000-24800050.23350.72
6259258-25925852.51453.07
30min1372084-37208475.36778.423.5676.1579.233.57
2400537-40053781.13081.98
3399255-39925580.87181.73
4380896-38089677.15277.94
5371907-37190775.33176.10
6398202-39820280.65781.50
45min1477931-47793196.80797.852.2398.0199.102.23
2488206-48820698.888100.18
3479624-47962497.15098.46
4491839-49183999.624100.84
5465859-46585994.36195.55
6494962-494962100.256101.55
60min1487844-48784498.81598.711.33100.55100.501.35
2491096-49109699.473101.32
3485556-48555698.351100.20
4482984-48298497.83099.60
5479055-47905597.03498.74
6497493-497493100.769102.62
极限1487437-48743798.73298.711.72101.02101.061.70
2495762-495762100.418102.82
3473488-47348895.90798.30
4485893-48589398.419100.73
5485156-48515698.270100.52
6496315-496315100.530102.94
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%
111.014897634898734905794896974894364898700.09
211.024911834914354913090.04
单位质量响应值RSD%判断
44493.1944583.390.15数据可信
供试品溶液-F66942批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min189983-8998318.18319.454.9418.1819.454.94
293890-9389018.97318.97
398962-9896219.99820.00
4103691-10369120.95320.95
597014-9701419.60419.60
694066-9406619.00819.01
10min1165441-16544133.43134.696.1233.5334.806.11
2180571-18057136.48936.59
3183040-18304036.98837.10
4177582-17758235.88536.00
5167500-16750033.84733.96
6155810-15581031.48531.59
15min1229801-22980146.43747.065.4646.7247.365.44
2255501-25550151.63051.94
3239499-23949948.39648.71
4226598-22659845.78946.11
5224772-22477245.42045.72
6221153-22115344.68944.97
20min1274746-27474655.51958.025.1556.0658.585.14
2305956-30595661.82662.42
3305270-30527061.68762.27
4284087-28408757.40657.98
5273816-27381655.33155.88
6278944-27894456.36756.90
30min1359482-35948272.64278.325.2073.4979.215.18
2395647-39564779.95080.89
3411787-41178783.21184.14
4402728-40272881.38182.27
5368688-36868874.50275.36
6387286-38728678.26079.10
45min1460275-46027593.00997.042.8794.2798.362.88
2495968-495968100.222101.60
3487272-48727298.46599.86
4490336-49033699.084100.43
5468049-46804994.58095.85
6479555-47955596.90598.18
60min1480134-48013497.02299.652.2698.80101.512.26
2501887-501887101.418103.36
3487973-48797398.606100.54
4507939-507939102.641104.53
5483069-48306997.61599.41
6497920-497920100.616102.43
极限1474897-47489795.96498.782.0498.28101.202.04
2496030-496030100.235102.74
3484150-48415097.834100.32
4497955-497955100.624103.09
5481688-48168897.33699.67
6498359-498359100.705103.08
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