ISO 12779 is an international standard on lactose that discusses the determination of water content in lactose to enhance lactose quality.
ISO 12779 specifies a method for the determination of the water content of lactose by Karl Fischer (KF) titration.
The test sample is directly titrated with a commercially available two-component Karl Fischer reagent. The water content is calculated from the amount of reagent used.
ISO 12779 on the determination of water content in lactose is useful for:
Water acts as a plasticizer and leads to the molecular mobility of the amorphous domains of lactose. Consequently, the amorphous phase can crystallize as a monohydrate. However, it is precisely the amorphous phase of spray-dried lactose that yields good compression properties for the product.
ISO 12779 provides you with guidance on apparatus, sampling, procedure, KF apparatus drift, water equivalent of the titration component of the KF reagent, calculation and expression of results, precision, test report, etc.
The Karl Fischer method and procedures provided by ISO 12779 assist you in the determination of water content in lactose, reduce crystallisation in lactose and improve the quality of lactose.
With obedience and compliance to ISO 12779, you can enhance lactose effectiveness and efficacy and manufacture a standardized high-quality product.
EN ISO 12779:2013
ISO 12779:2011