贝派度酸片项目信息
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BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180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%
110.233089413118373093483095663095923098570.37
210.343091543090263090900.03
单位质量响应值RSD%判断
30289.0529892.650.94数据可信
供试品溶液-24082101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%
5min1109577-10957736.31534.887.8736.3234.887.87
2106600-10660035.32835.33
3100927-10092733.44833.45
4107347-10734735.57635.58
591435-9143530.30330.30
6115634-11563438.32238.32
10min1253144-25314483.89582.591.3483.9682.651.34
2248605-24860582.39082.45
3249266-24926682.60982.67
4250489-25048983.01583.07
5243224-24322480.60780.66
6250484-25048483.01383.08
15min1285684-28568494.67993.631.2094.8893.821.21
2283068-28306893.81294.01
3281966-28196693.44793.64
4286489-28648994.94695.14
5277317-27731791.90692.09
6280532-28053292.97193.17
20min1294225-29422597.50996.471.1797.8796.821.17
2291691-29169196.67097.02
3290850-29085096.39196.74
4295085-29508597.79498.15
5286184-28618494.84495.18
6288444-28844495.59395.95
30min1298360-29836098.88098.011.1899.4098.531.18
2296746-29674698.34598.86
3295525-29552597.94098.45
4300257-30025799.508100.03
5290954-29095496.42596.92
6292662-29266296.99197.51
45min1300787-30078799.68498.881.16100.3799.561.16
2299316-29931699.19799.87
3297959-29795998.74799.42
4303106-303106100.453101.14
5294158-29415897.48798.14
6294865-29486597.72198.40
60min1300636-30063699.63499.031.19100.4999.871.18
2299878-29987899.383100.23
3298525-29852598.93499.77
4304041-304041100.762101.61
5294816-29481697.70598.52
6295024-29502497.77498.62
极限1302039-302039100.099100.270.99101.12101.280.99
2304425-304425100.890101.90
3301811-301811100.023101.03
4307548-307548101.925102.94
5299851-29985199.374100.36
6299717-29971799.329100.33
贝派度酸片项目信息
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BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180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%
110.233089223087323086583086733089793087930.05
210.343088873089033088950.01
单位质量响应值RSD%判断
30185.0429873.790.74数据可信
供试品溶液-24082102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%
5min1122168-12216840.57035.5513.6840.5735.5513.68
2107395-10739535.66435.66
389767-8976729.81029.81
493533-9353331.06131.06
5103679-10367934.43034.43
6125764-12576441.76441.76
10min1250667-25066783.24283.532.6383.3183.602.64
2257785-25778585.60685.67
3247751-24775182.27482.32
4241688-24168880.26180.31
5251683-25168383.58083.64
6259712-25971286.24686.32
15min1278949-27894992.63494.931.6892.8495.131.68
2293219-29321997.37397.58
3286370-28637095.09995.29
4283536-28353694.15894.34
5284850-28485094.59494.79
6288260-28826095.72695.94
20min1285766-28576694.89897.621.7995.2697.971.78
2302052-302052100.306100.67
3295058-29505897.98498.33
4293487-29348797.46297.80
5292385-29238597.09697.45
6294988-29498897.96198.33
30min1289688-28968896.20199.041.7696.7299.561.75
2305860-305860101.571102.10
3299122-29912299.33399.84
4299105-29910599.32899.83
5296461-29646198.45098.97
6299114-29911499.33199.87
45min1292153-29215397.01999.741.7097.70100.421.69
2307744-307744102.197102.90
3300743-30074399.872100.55
4301363-301363100.078100.75
5298315-29831599.06599.75
6301703-301703100.191100.89
60min1292729-29272997.21099.801.6498.05100.661.64
2307714-307714102.187103.06
3300782-30078299.885100.73
4302115-302115100.327101.16
5298332-29833299.07199.92
6301572-301572100.147101.02
极限1292520-29252097.141100.091.8798.14101.111.86
2309126-309126102.656103.70
3303196-303196100.686101.69
4302714-302714100.526101.53
5297977-29797798.95399.96
6302935-302935100.600101.64
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