地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号2.0对照品来源EP对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数100
标示量(mg)90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%
110.251687841169202416886921688362169068616895210.11
210.311742012172773917348760.59
单位质量响应值RSD%判断
164831.32168271.191.47数据可信
供试品溶液-1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%
5min1216815-21681513.00612.811.9713.0112.811.98
2213257-21325712.79312.79
3210612-21061212.63412.63
4207239-20723912.43212.43
5214930-21493012.89312.89
6218760-21876013.12313.12
15min1287484-28748417.24617.082.2017.3917.222.17
2283971-28397117.03517.18
3276819-27681916.60616.75
4286693-28669317.19817.34
5294066-29406617.64017.78
6278910-27891016.73116.88
30min1312186-31218618.72718.841.0019.0619.170.97
2309979-30997918.59518.93
3318852-31885219.12719.45
4313990-31399018.83619.16
5316208-31620818.96919.31
6313230-31323018.79019.12
45min1328785-32878519.72319.700.8020.2720.240.77
2329605-32960519.77220.31
3329761-32976119.78220.32
4331635-33163519.89420.43
5326284-32628419.57320.12
6324441-32444119.46320.00
60min1331476-33147619.88519.620.9920.6520.380.96
2322332-32233219.33620.09
3328778-32877819.72320.48
4326442-32644219.58320.34
5325132-32513219.50420.27
6328696-32869619.71820.47
90min1341324-34132420.47520.141.3921.4621.121.33
2327949-32794919.67320.65
3337497-33749720.24621.22
4338618-33861820.31321.29
5333581-33358120.01121.00
6335252-33525220.11121.09
120min1342267-34226720.53220.493.0321.7421.692.87
2325496-32549619.52620.72
3351245-35124521.07022.27
4354001-35400121.23622.44
5336659-33665920.19521.40
6339842-33984220.38621.59
极限1349938-34993820.99220.800.9822.4322.230.90
2350479-35047921.02522.43
3349077-34907720.94022.38
4343847-34384720.62722.07
5344105-34410520.64222.07
6343306-34330620.59422.02
地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号2.0对照品来源EP对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数100
标示量(mg)90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%
110.251709857171378817172821720968171847917160750.26
210.311689471169746216934660.34
单位质量响应值RSD%判断
167421.95164254.701.36数据可信
供试品溶液-1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%
5min1207885-20788512.52412.532.9212.5212.522.91
2203980-20398012.28912.29
3215016-21501612.95412.95
4212743-21274312.81712.82
5209549-20954912.62412.62
6198358-19835811.95011.95
15min1276559-27655916.66116.592.1916.8016.732.19
2278486-27848616.77716.91
3278958-27895816.80616.95
4278116-27811616.75516.90
5276712-27671216.67016.81
6263186-26318615.85615.99
30min1303068-30306818.25818.321.4218.5818.641.44
2307250-30725018.51018.83
3307110-30711018.50218.83
4308273-30827318.57218.90
5301733-30173318.17818.50
6297044-29704417.89518.20
45min1318034-31803419.16019.220.4619.6919.750.44
2317996-31799619.15819.69
3320712-32071219.32119.86
4317231-31723119.11219.65
5320553-32055319.31219.84
6319404-31940419.24219.75
60min1318001-31800119.15819.151.7619.9019.891.69
2317739-31773919.14219.88
3312998-31299818.85719.61
4316458-31645819.06519.81
5328495-32849519.79020.53
6313798-31379818.90519.63
90min1325301-32530119.59819.882.2320.5520.832.18
2333971-33397120.12021.07
3338209-33820920.37521.34
4331948-33194819.99820.96
5332796-33279620.04921.01
6317617-31761719.13520.07
120min1334577-33457720.15720.230.9821.3321.410.95
2338963-33896320.42121.60
3331006-33100619.94121.13
4337199-33719920.31521.50
5339533-33953320.45521.64
6333919-33391920.11721.26
极限1318834-31883419.20819.952.2620.6021.352.09
2332818-33281820.05121.46
3335294-33529420.20021.61
4332195-33219520.01321.42
5327269-32726919.71621.13
6340692-34069220.52521.89
地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号2.0对照品来源EP对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数100
标示量(mg)90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%
110.251687690169692617007231711477170563317004900.53
210.311715820173201717239180.67
单位质量响应值RSD%判断
165901.46167208.340.56数据可信
供试品溶液-1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%
5min1219436-21943613.16212.981.7113.1612.981.72
2212392-21239212.74012.74
3217076-21707613.02013.02
4221024-22102413.25713.26
5216437-21643712.98212.98
6211787-21178712.70312.70
15min1267355-26735516.03616.151.4916.1816.291.50
2271477-27147716.28416.43
3263414-26341415.80015.94
4273763-27376316.42116.57
5266720-26672015.99816.14
6272499-27249916.34516.49
30min1298011-29801117.87517.851.7718.2018.181.73
2290757-29075717.44017.76
3303662-30366218.21418.53
4293258-29325817.59017.92
5296771-29677117.80118.12
6303514-30351418.20518.53
45min1303075-30307518.17918.401.2918.7018.921.26
2300985-30098518.05318.57
3309802-30980218.58219.10
4307216-30721618.42718.95
5308699-30869918.51619.04
6310917-31091718.64919.17
60min1309761-30976118.58018.831.6419.3019.561.58
2313136-31313618.78219.50
3313665-31366518.81419.54
4322726-32272619.35720.09
5316036-31603618.95619.68
6308328-30832818.49419.23
90min1334372-33437220.05619.632.2320.9920.562.12
2333621-33362120.01120.94
3317540-31754019.04619.98
4328041-32804119.67620.62
5330584-33058419.82920.76
6319026-31902619.13620.07
120min1329630-32963019.77219.951.1820.9321.101.13
2333277-33327719.99021.14
3336695-33669520.19521.35
4336326-33632620.17321.34
5332863-33286319.96621.12
6326534-32653419.58620.74
极限1330269-33026919.81019.791.4421.1821.171.38
2329603-32960319.77021.14
3327661-32766119.65321.03
4338081-33808120.27821.67
5330766-33076619.84021.22
6323563-32356319.40820.78
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