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%
1114.45497155502765490665506325514015502180.17
2114.85520755530215525480.13
单位质量响应值RSD%判断
4809.604813.140.06数据可信
供试品溶液-49G03N批-pH4.0(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%
5min1187435-18743534.50047.3115.7134.5047.3115.71
2252876-25287646.54546.55
3245014-24501445.09845.10
4283449-28344952.17352.17
5268042-26804249.33749.34
6305212-30521256.17956.18
10min1241706-24170644.48950.377.3644.5550.457.37
2288097-28809753.02853.11
3272378-27237850.13550.21
4268740-26874049.46549.55
5269842-26984249.66849.75
6301109-30110955.42355.52
15min1258396-25839647.56156.1411.3447.6956.3011.33
2291853-29185353.72053.89
3311532-31153257.34257.50
4281100-28110051.74051.91
5339254-33925462.44462.61
6347915-34791564.03964.22
20min1293864-29386454.09062.1211.0854.3062.3811.06
2385408-38540870.94071.20
3302018-30201855.59155.84
4325816-32581659.97160.23
5374189-37418968.87569.14
6343773-34377363.27663.57
30min1309730-30973057.01062.978.9157.3163.338.89
2318554-31855458.63459.01
3368182-36818267.76968.12
4340061-34006162.59362.95
5327570-32757060.29460.68
6388433-38843371.49771.89
45min1346442-34644263.76866.216.2864.1666.676.26
2337191-33719162.06562.54
3363197-36319766.85267.31
4372789-37278968.61769.08
5341961-34196162.94363.43
6396638-39663873.00773.52
60min1347252-34725263.91768.305.8564.4268.885.85
2354858-35485865.31765.89
3368922-36892267.90568.48
4394589-39458972.63073.20
5360566-36056666.36766.96
6400356-40035673.69174.33
极限1363573-36357366.92171.874.6967.5372.564.70
2391335-39133572.03172.71
3382023-38202370.31771.00
4412994-41299476.01776.71
5384336-38433670.74271.44
6408626-40862675.21375.98
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%
1114.45544225533585526265536995531495534510.13
2114.85575305560385567840.19
单位质量响应值RSD%判断
4837.864850.030.18数据可信
供试品溶液-25052801批-pH4.0(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%
5min1283679-28367951.86454.649.6751.8654.649.67
2295909-29590954.10054.10
3259572-25957247.45747.46
4335565-33556561.35061.35
5329533-32953360.24760.25
6288953-28895352.82852.83
10min1328865-32886560.12559.106.8760.2159.196.87
2332849-33284960.85460.94
3279107-27910751.02851.11
4337028-33702861.61861.72
5337460-33746061.69761.80
6324270-32427059.28559.37
15min1344073-34407362.90663.914.7163.0964.104.72
2366141-36614166.94067.13
3321332-32133258.74858.91
4356240-35624065.13065.34
5363458-36345866.45066.65
6346063-34606363.26963.46
20min1352729-35272964.48866.803.4264.7867.103.42
2376966-37696668.91969.22
3356313-35631365.14365.41
4360220-36022065.85866.17
5384388-38438870.27670.59
6361598-36159866.11066.40
30min1375982-37598268.73969.313.0669.1469.723.08
2381586-38158669.76470.18
3360034-36003465.82466.19
4393118-39311871.87272.30
5388323-38832370.99671.43
6375704-37570468.68969.09
45min1379339-37933969.35371.422.3969.8771.942.40
2389740-38974071.25571.79
3383828-38382870.17470.65
4404994-40499474.04474.59
5397561-39756172.68573.23
6388365-38836571.00371.52
60min1395923-39592372.38573.732.8273.0174.372.82
2398569-39856972.86973.52
3396747-39674772.53673.13
4425939-42593977.87378.54
5402464-40246473.58174.25
6399972-39997273.12573.76
极限1416087-41608776.07276.902.1676.8277.662.16
2416127-41612776.07976.85
3421527-42152777.06677.78
4438593-43859380.18680.98
5415892-41589276.03676.83
6415558-41555875.97576.73
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%
1114.45550285554875553505552005556855553500.05
2114.85581795604195592990.29
单位质量响应值RSD%判断
4854.464871.940.26数据可信
供试品溶液-25052801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%
5min1324093-32409359.01873.169.8759.0273.169.87
2408981-40898174.47774.48
3401542-40154273.12273.12
4424160-42416077.24177.24
5418639-41863976.23576.24
6433141-43314178.87678.88
10min1355859-35585964.80378.148.8864.9078.268.88
2432213-43221378.70778.83
3426939-42693977.74777.87
4461603-46160384.05984.19
5445392-44539281.10781.23
6452544-45254482.41082.54
15min1383352-38335269.81080.377.4070.0280.627.41
2440291-44029180.17880.43
3434152-43415279.06079.31
4480090-48009087.42687.69
5450555-45055582.04782.31
6459504-45950483.67783.95
20min1394928-39492871.91881.916.9972.2482.307.00
2449854-44985481.92082.31
3441530-44153080.40480.79
4489449-48944989.13089.54
5458859-45885983.56083.96
6464234-46423484.53884.95
30min1416647-41664775.87383.866.2976.3284.396.30
2456755-45675583.17683.70
3451115-45111582.14982.67
4506188-50618892.17892.74
5463336-46333684.37584.91
6469140-46914085.43285.98
45min1433088-43308878.86785.506.0079.4486.166.01
2462190-46219084.16684.83
3460752-46075283.90484.56
4519465-51946594.59695.31
5468556-46855685.32586.00
6472885-47288586.11486.81
60min1447939-44793981.57186.685.3482.2787.485.35
2471374-47137485.83986.64
3463985-46398584.49385.29
4523607-52360795.35096.22
5474351-47435186.38187.20
6474596-47459686.42587.26
极限1479198-47919887.26388.894.8188.1089.844.81
2482040-48204087.78188.73
3476158-47615886.71087.64
4535906-53590697.59098.62
5477307-47730786.91987.88
6478303-47830387.10088.08
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