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%
1111.65492295481355482865480495463645480130.19
2113.35543455523895533670.25
单位质量响应值RSD%判断
4910.514884.090.39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%
5min1376046-37604668.00370.122.2768.0070.122.27
2391055-39105570.71770.72
3385096-38509669.63969.64
4396697-39669771.73771.74
5380164-38016468.74768.75
6397320-39732071.85071.85
10min1428645-42864577.51479.041.9677.6379.161.96
2437861-43786179.18179.30
3437945-43794579.19679.31
4439009-43900979.38979.51
5427689-42768977.34177.46
6451257-45125781.60381.72
15min1443890-44389080.27181.711.6180.5181.961.61
2455704-45570482.40882.66
3450109-45010981.39681.64
4456164-45616482.49182.74
5443680-44368080.23380.48
6461654-46165483.48483.74
20min1452244-45224481.78283.051.3782.1683.441.37
2464220-46422083.94884.33
3460688-46068883.30983.69
4458654-45865482.94183.33
5452122-45212281.76082.14
6467653-46765384.56884.96
30min1464051-46405183.91785.161.4984.4385.681.49
2481634-48163487.09787.62
3471313-47131385.23085.75
4474956-47495685.88986.42
5462783-46278383.68884.20
6470688-47068885.11785.65
45min1479494-47949486.71087.751.3887.3688.421.38
2492684-49268489.09589.77
3487299-48729988.12188.79
4493155-49315589.18089.85
5478727-47872786.57187.22
6480170-48017086.83287.51
60min1494687-49468789.45789.751.6690.2590.561.65
2502657-50265790.89891.72
3496646-49664689.81190.62
4508344-50834491.92792.75
5488009-48800988.24989.05
6487447-48744788.14888.97
极限1511388-51138892.47792.141.0793.4293.101.07
2514196-51419692.98593.96
3509442-50944292.12593.09
4511943-51194392.57893.55
5498916-49891690.22291.17
6511331-51133192.46793.44
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%
1111.65523745534275534905502985479495515080.43
2113.35583325564295573800.25
单位质量响应值RSD%判断
4941.834919.510.33数据可信
供试品溶液-2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%
5min1382374-38237468.67970.402.2368.6870.402.22
2392918-39291870.57370.57
3384504-38450469.06169.06
4396674-39667471.24771.25
5389228-38922869.91069.91
6406122-40612272.94472.94
10min1426873-42687376.67178.351.7676.7978.461.75
2442327-44232779.44779.56
3430739-43073977.36677.48
4441247-44124779.25379.37
5430760-43076077.36977.49
6445272-44527279.97680.10
15min1441114-44111479.22980.521.7479.4780.761.74
2450951-45095180.99681.25
3437709-43770978.61878.86
4453488-45348881.45281.70
5447991-44799180.46480.71
6458468-45846882.34682.60
20min1450115-45011580.84682.181.4581.2282.561.45
2457781-45778182.22382.61
3450544-45054480.92381.30
4464544-46454483.43783.82
5456687-45668782.02682.41
6465563-46556383.62084.01
30min1467785-46778584.02085.081.2584.5385.601.25
2476363-47636385.56086.08
3466346-46634683.76184.27
4480260-48026086.26086.79
5472219-47221984.81685.33
6479318-47931886.09186.62
45min1475136-47513685.34087.891.6785.9988.551.67
2494122-49412288.75089.41
3484229-48422986.97387.62
4495198-49519888.94389.61
5491366-49136688.25588.91
6495895-49589589.06889.74
60min1480403-48040386.28689.051.7087.0889.861.69
2501108-50110890.00590.82
3496093-49609389.10489.90
4498720-49872089.57690.39
5504500-50450090.61491.42
6493801-49380188.69289.52
极限1499844-49984489.77891.301.0090.7192.251.01
2511771-51177191.92092.88
3504994-50499490.70391.65
4513184-51318492.17493.14
5508447-50844791.32392.28
6511510-51151091.87392.84
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%
1111.65511425529835497875448285491935495870.56
2113.35690135674765682440.20
单位质量响应值RSD%判断
4924.615015.391.30数据可信
供试品溶液-2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%
5min1382421-38242168.14970.312.3668.1570.312.36
2396665-39666570.68770.69
3407671-40767172.64972.65
4401034-40103471.46671.47
5386498-38649868.87568.88
6392958-39295870.02770.03
10min1418493-41849374.57777.172.0974.6977.292.09
2440105-44010578.42878.55
3444104-44410479.14179.26
4435354-43535477.58277.70
5429710-42971076.57676.69
6430638-43063876.74176.86
15min1441613-44161378.69780.811.8578.9481.061.85
2459178-45917881.82782.08
3463626-46362682.62082.87
4458847-45884781.76882.02
5448176-44817679.86780.11
6449503-44950380.10380.35
20min1449387-44938780.08282.261.5980.4582.641.59
2467703-46770383.34683.73
3465400-46540082.93683.33
4468601-46860183.50783.89
5461217-46121782.19182.57
6457361-45736181.50381.88
30min1461116-46111682.17384.751.8882.6885.271.88
2486819-48681986.75387.28
3479505-47950585.45085.98
4480784-48078485.67886.20
5471627-47162784.04684.56
6473548-47354884.38884.90
45min1475464-47546484.73087.812.2185.3788.472.21
2501445-50144589.35990.03
3502715-50271589.58690.26
4498499-49849988.83489.50
5494634-49463488.14688.80
6483780-48378086.21186.87
60min1496614-49661488.49990.182.2489.2890.992.24
2511587-51158791.16791.98
3521578-52157892.94793.77
4512519-51251991.33392.15
5503185-50318589.67090.47
6490879-49087987.47788.27
极限1501647-50164789.39591.631.6490.3292.581.64
2517463-51746392.21493.18
3522823-52282393.16994.14
4521360-52136092.90893.88
5515313-51531391.83192.78
6506524-50652490.26591.21
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