美国药品cGMP，即CFR 211.170(a)对原料药留样量要求至少2倍全检量“The reserve sample consists of at least twice the quantity necessary for all tests required to determine whether the active ingredient meets its established specifications”；欧盟药品GMP附录19-4.1，对reference sample，要求至少2倍全检量，未区分物料还是成品，"The reference sample should be of sufficient size to permit the carrying out, on, at least, two occasions, of the full analytical controls on the batch in accordance with the Marketing Authorisation File which has been assessed and approved by the relevant Competent Authority / Authorities."