Allen Loyd V
International Journal of Pharmaceutical Compounding Inc., 122 N. Bryant Avenue, Edmond, OK 73034, USA.
Int J Pharm Compd. 2012 Nov-Dec;16(6):486-8.
When comparing a CofA for an official ingredient, product, or preparation, it is required that all the specifications are within the allowable tolerances. For APIs for which there is not an official monograph, one can usually select a monograph of an API in a similar class for a guideline for individual specifications.
在比较官方成分、产品或制剂的分析证书时,要求所有规格均在允许的公差范围内。对于没有官方专论的原料药,通常可以选择类似类别的原料药专论作为个别规格的指导。