替普瑞酮胶囊项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50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%
1114.45610705566505613795614805595635600280.37
2114.85679275667705673480.15
单位质量响应值RSD%判断
4895.354942.060.68数据可信
供试品溶液-JS1M批-pH6.8(内含5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1263146-26314647.38044.8914.0647.3844.8914.06
2255165-25516545.94345.94
3250718-25071845.14245.14
4256961-25696146.26646.27
5182825-18282532.91832.92
6287173-28717351.70651.71
10min1368842-36884266.41164.595.8366.4964.665.83
2343707-34370761.88561.96
3365689-36568965.84365.92
4379145-37914568.26668.34
5323648-32364858.27358.33
6371238-37123866.84266.93
15min1412562-41256274.28273.604.1774.4773.794.18
2400595-40059572.12872.31
3419197-41919775.47775.66
4415304-41530474.77674.97
5378692-37869268.18468.34
6426413-42641376.77676.97
20min1447671-44767180.60479.312.9480.9279.622.96
2431828-43182877.75178.05
3443793-44379379.90680.22
4453329-45332981.62381.94
5418509-41850975.35375.62
6447717-44771780.61280.94
30min1490406-49040688.29887.802.0988.7588.242.11
2480999-48099986.60587.03
3490321-49032188.28388.73
4500203-50020390.06290.51
5471111-47111184.82485.22
6492900-49290088.74789.21
45min1529878-52987895.40595.521.4596.0096.101.47
2526017-52601794.71095.28
3531043-53104395.61596.21
4544531-54453198.04498.65
5521701-52170193.93394.47
6529797-52979795.39196.00
60min1553111-55311199.58899.651.25100.34100.391.26
2549077-54907798.86299.59
3550560-55056099.12999.88
4567032-567032102.095102.86
5548612-54861298.77899.47
6552246-55224699.433100.20
90min1569418-569418102.525103.041.24103.44103.951.23
2570199-570199102.665103.56
3570512-570512102.722103.64
4586164-586164105.540106.47
5571586-571586102.915103.77
6565917-565917101.894102.83
极限1574157-574157103.378103.991.52104.47105.071.51
2573983-573983103.347104.41
3579128-579128104.273105.36
4593289-593289106.823107.93
5577652-577652104.007105.03
6567227-567227102.130103.23
替普瑞酮胶囊项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50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%
1114.45629825625905609345609805592365613440.27
2114.85665545660015662780.07
单位质量响应值RSD%判断
4906.854932.740.38数据可信
供试品溶液-JS1M批-pH6.8(内含5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1144165-14416525.95141.2933.4225.9541.2933.42
2129620-12962023.33323.33
3253120-25312045.56445.56
4296001-29600153.28353.28
5240073-24007343.21543.22
6313301-31330156.39756.40
10min1315262-31526256.75062.918.1056.7962.988.13
2313447-31344756.42356.46
3353759-35375963.68063.76
4370520-37052066.69766.79
5366090-36609065.89965.97
6377726-37772667.99468.09
15min1356328-35632864.14269.835.0264.2870.005.04
2372115-37211566.98467.12
3392984-39298470.74170.92
4403978-40397872.72072.92
5403691-40369172.66872.85
6398378-39837871.71271.92
20min1387319-38731969.72175.285.1769.9775.575.19
2395226-39522671.14471.39
3423157-42315776.17276.47
4438507-43850778.93579.26
5432230-43223077.80578.11
6432806-43280677.90978.24
30min1427467-42746776.94883.764.7577.3184.174.77
2449262-44926280.87181.23
3475344-47534485.56685.99
4480237-48023786.44786.90
5481886-48188686.74487.18
6477508-47750885.95686.41
45min1466710-46671084.01291.194.4484.5091.754.47
2495082-49508289.11989.62
3513397-51339792.41692.99
4516795-51679593.02893.62
5529421-52942195.30095.88
6518188-51818893.27893.88
60min1491510-49151088.47695.664.0989.1196.374.11
2522631-52263194.07894.72
3540545-54054597.30398.03
4540988-54098897.38398.13
5552012-55201299.367100.10
6540853-54085397.35898.11
90min1526974-52697494.860100.233.0095.64101.103.02
2549159-54915998.85399.66
3565113-565113101.725102.61
4561903-561903101.147102.06
5574157-574157103.353104.25
6563461-563461101.428102.35
极限1554540-55454099.822102.721.65100.76103.751.69
2566022-566022101.889102.86
3577876-577876104.023105.08
4572172-572172102.996104.08
5580823-580823104.553105.63
6572335-572335103.025104.11
替普瑞酮胶囊项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50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%
1114.45623105653935639925660595632945642100.28
2114.85785175761695773430.29
单位质量响应值RSD%判断
4931.915029.121.39数据可信
供试品溶液-JS1M批-pH6.8(内含5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1204453-20445336.35848.0427.4436.3648.0427.44
2290272-29027251.61951.62
3367369-36736965.32965.33
4173369-17336930.83030.83
5330860-33086058.83758.84
6254641-25464145.28345.28
10min1405390-40539072.09069.918.9972.1569.999.00
2377085-37708567.05767.14
3424522-42452275.49375.60
4333337-33333759.27759.33
5428575-42857576.21376.31
6389991-38999169.35269.43
15min1454126-45412680.75777.383.9480.9477.583.94
2414319-41431973.67873.88
3454498-45449880.82381.06
4431563-43156376.74576.90
5437942-43794277.87978.10
6418429-41842974.40974.60
20min1490352-49035287.19983.203.9687.5183.523.95
2440745-44074578.37878.70
3484033-48403386.07686.44
4472067-47206783.94884.23
5465761-46576182.82683.18
6454083-45408380.75081.06
30min1519422-51942292.36989.273.6792.8389.733.66
2480926-48092685.52385.97
3517631-51763192.05092.56
4517390-51739092.00792.43
5494901-49490188.00888.50
6481702-48170285.66186.11
45min1549041-54904197.63694.743.3998.2595.363.38
2516357-51635791.82492.42
3547489-54748997.36098.03
4550481-55048197.89298.46
5521300-52130092.70393.34
6511961-51196191.04291.63
60min1560256-56025699.63097.902.68100.4198.672.66
2541199-54119996.24196.99
3562725-562725100.069100.90
4567494-567494100.917101.65
5538963-53896395.84496.64
6532393-53239394.67595.42
90min1563256-563256100.16499.532.05101.11100.462.05
2557103-55710399.07099.98
3570459-570459101.445102.44
4573100-573100101.914102.82
5550651-55065197.92298.88
6543570-54357096.66397.56
极限1564896-564896100.45599.672.03101.57100.772.03
2559412-55941299.480100.55
3572887-572887101.876103.04
4570091-570091101.379102.45
5553010-55301098.34299.46
6542543-54254396.48097.54
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