Impurity definition

Impurity means any component other than the pure active substance and/or variant which is present in the technical material (including components originating from the manufacturing process or from degradation during storage).

Impurity means a chemical sub- stance unintentionally present with another chemical substance or mix- ture.

Impurity means any component present in the drug substance or drug product that is not the desired product, a product-related substance, or excipients including buffer components. It may be either process- or product-related.

Examples of Impurity in a sentence

• Impurity profiles are normally not necessary for APIs from herbal or animal tissue origin.

• Maximum Impurity 5 PPM (2 PPM Oxygen, 2 PPM Nitrogen)LIQUID ARGON shall be taken by the Purchaser in their own Cryogenic Road tankers having valid license from Chief Controller of Explosives.

• Impurity limitations imposed by reference to AWWA Specifications apply unless specifically superseded under PURITY REQUIREMENTS of the specifications.

• Impurity refers to residues from primary production which may be found in the finished product at concentrations below 100 ppm (0.01% by weight, 100 mg/kg), but not substances that have been added to a raw material or the product actively and for a particular purpose, irrespective of quantity.

• Impurity profiles have been established for the existing API Batches selected for retrospective validation should be representative of all batches produced during the review period, including any batches that failed to meet specifications, and should be sufficient in number to demonstrate process consistency.

More Definitions of Impurity

Impurity means a chemical sub- stance which is unintentionally present with another chemical sub- stance.

Impurity in relation to any product means any substance, matter or thing classified as an impurity with respect to that product for the purposes of this Act;

Impurity means any component present in the final product, intermediate or API that is not the desired entity.

Impurity means a hazardous chemical which is unintentionally present with another

Impurity means a chemical substance which is unintentionally present with another chemical substance.

Impurity means a non-hydrocarbon substance contained in or removed from Gas, including carbon dioxide, hydrogen sulfide, helium, mercury, water vapor, and, when removed from Gas, trace amounts of hydrocarbons.

Impurity means any substances that is contained naturally and can not be removed industrially in the process of refining the industrial materials, or any substances that was produced in the process of synthetic reaction