替普瑞酮颗粒项目信息
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DQTL-3106-251103对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.60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%
1115.25842725812715887185849065904595859250.63
2119.85770525760125765320.13
单位质量响应值RSD%判断
5086.154812.453.92数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-1批-pH6.8(内含2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1362968-36296865.79074.996.2865.7974.996.28
2428833-42883377.72877.73
3416085-41608575.41775.42
4415237-41523775.26475.26
5434904-43490478.82878.83
6424298-42429876.90676.91
10min1469675-46967585.13184.170.6585.2484.300.64
2461906-46190683.72383.85
3463161-46316183.95084.08
4462497-46249783.83083.96
5462894-46289483.90284.03
6466123-46612384.48784.62
15min1492230-49223089.21990.341.8289.4790.611.82
2492296-49229689.23189.50
3492960-49296089.35189.62
4494556-49455689.64189.91
5504093-50409391.36991.64
6514421-51442193.24193.51
20min1526765-52676595.47991.503.8695.8891.923.84
2519926-51992694.23994.66
3519926-51992694.23994.65
4492831-49283189.32889.74
5486263-48626388.13888.56
6483213-48321387.58588.01
30min1518126-51812693.91396.881.8094.4797.451.79
2528383-52838395.77296.35
3542475-54247598.32698.90
4542756-54275698.37798.94
5536554-53655497.25397.82
6538636-53863697.63098.20
45min1528368-52836895.76995.840.6696.4996.570.65
2522793-52279394.75995.49
3528893-52889395.86496.60
4530455-53045596.14896.87
5533395-53339596.68097.41
6528640-52864095.81996.55
60min1537284-53728497.38597.490.7998.2698.380.79
2531633-53163396.36197.25
3537279-53727997.38498.28
4539321-53932197.75598.64
5544719-54471998.73399.63
6536997-53699797.33398.23
极限1539424-53942497.77398.270.7398.8199.320.73
2536323-53632397.21198.26
3541153-54115398.08799.14
4544089-54408998.61999.67
5547153-54715399.174100.23
6544713-54471398.73299.79
替普瑞酮颗粒项目信息
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DQTL-3106-251103对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.60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%
1115.25784105802515783105788065760625783680.27
2119.86129756093156111450.43
单位质量响应值RSD%判断
5020.565101.381.13数据可信
供试品溶液-1批-pH6.8(内含2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1385806-38580668.33864.394.0768.3464.394.07
2348060-34806061.65261.65
3364730-36473064.60564.61
4346143-34614361.31361.31
5370485-37048565.62565.62
6365870-36587064.80764.81
10min1444757-44475778.78175.413.1078.8975.513.10
2410291-41029172.67672.78
3430717-43071776.29476.40
4411128-41112872.82472.93
5426348-42634875.52075.63
6430983-43098376.34176.45
15min1477246-47724684.53580.843.3184.7881.073.30
2435281-43528177.10277.33
3460551-46055181.57881.81
4442633-44263378.40478.63
5460730-46073081.61081.85
6461756-46175681.79282.03
20min1493419-49341987.40084.082.6987.7984.452.69
2458886-45888681.28381.64
3477725-47772584.62084.99
4461545-46154581.75482.11
5477846-47784684.64285.01
6478781-47878184.80785.18
30min1506469-50646989.71286.852.5290.2487.362.52
2474435-47443584.03784.53
3493910-49391087.48788.00
4476795-47679584.45584.95
5494079-49407987.51788.03
6496183-49618387.89088.40
45min1514803-51480391.18888.292.6791.8788.942.68
2484521-48452185.82486.45
3504061-50406189.28589.94
4480272-48027285.07185.70
5505677-50567789.57190.23
6501215-50121588.78189.44
60min1517905-51790591.73789.122.4892.5789.922.48
2485438-48543885.98686.76
3507000-50700089.80690.61
4490829-49082986.94187.71
5511236-51123690.55691.36
6506457-50645789.71090.52
极限1516627-51662791.51189.142.1892.5090.092.19
2489227-48922786.65887.57
3508372-50837290.04991.00
4490941-49094186.96187.88
5509788-50978890.30091.26
6504549-50454989.37290.33
替普瑞酮颗粒项目信息
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DQTL-3106-251103对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.60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%
1115.25716385770715770855756535752185753330.39
2119.85830105827555828820.04
单位质量响应值RSD%判断
4994.214865.461.85数据可信
供试品溶液-1批-pH6.8(内含2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1383699-38369969.78168.931.7169.7868.931.71
2376280-37628068.43168.43
3381700-38170069.41769.42
4367435-36743566.82366.82
5379798-37979869.07169.07
6385164-38516470.04770.05
10min1453128-45312882.40781.381.5282.5281.501.52
2448074-44807481.48881.60
3445227-44522780.97081.09
4435447-43544779.19279.30
5454326-45432682.62582.74
6448748-44874881.61181.73
15min1479804-47980487.25887.611.2487.5187.861.24
2487312-48731288.62488.87
3480898-48089887.45787.71
4471506-47150685.74985.99
5487550-48755088.66788.92
6483412-48341287.91588.17
20min1503906-50390691.64290.871.3892.0491.271.38
2503687-50368791.60292.00
3499665-49966590.87091.27
4486252-48625288.43188.82
5504327-50432791.71892.12
6500090-50009090.94891.35
30min1520769-52076994.70894.090.9595.2694.640.96
2521622-52162294.86495.41
3517110-51711094.04394.59
4508851-50885192.54193.07
5520878-52087894.72895.28
6514931-51493193.64794.20
45min1523722-52372295.24595.351.2895.9696.061.27
2531388-53138896.64097.35
3518895-51889594.36895.07
4516984-51698494.02094.71
5533296-53329696.98797.70
6521485-52148594.83995.55
60min1533122-53312296.95595.920.8797.8296.780.87
2528344-52834496.08696.96
3527426-52742695.91996.78
4519142-51914294.41395.26
5527772-52777295.98296.86
6528778-52877896.16597.03
极限1529786-52978696.34896.531.2597.3897.551.25
2536436-53643697.55898.59
3529897-52989796.36897.39
4518591-51859194.31295.31
5534124-53412497.13798.17
6535830-53583097.44798.47
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