Sentence examples for substance specifications from inspiring English sources

Impurities resulting from the manufacturing process of the drug substance are usually governed by drug substance specifications and, as such, do not need to be dealt with in drug product specifications.

Any specifications necessary for either characteristics of the drug substance or product (such as moisture content) in addition to sections Drug substance specifications and Preparation specifications above can be set with reference to ICH-Q6A: Test procedures and acceptance criteria for new drug substances and new drug products.

The lower drug substance specification limit is applied to our products, (50 ppm, equivalent to 25 μg 4AP in a tablet containing 500-mg paracetamol) and the pharmacopoeial HPLC assay was not suitable at this low level due to matrix interference.

The drug substance specification is only one part of a total control strategy.

The target was to design a sufficiently robust drug substance specification allowing to obtain a satisfactory drug product.

and final drug substance Drug substance specification (release testing) Drug substance container-closure system Assessment of CQAs and Continuum of Criticality Throughout the API Product Life Cycle: Scientific knowledge based on development experience and first principles and QRM techniques are used to reach a decision on the CPPs and CQAs for a given drug substance manufacturing process.

But Greenpeace notes that's it's impossible to evaluate Apple's communications with its supply chain on hazardous substances because Apple won't disclose its Regulated Substances Specification.

2011), the group notes that Apple's Suppliers Code of Code of Conduct states that "suppliers shall comply with the most recent version of Apple's Regulated Substances Specification, 069-015 and with any applicable laws and regulations prohibiting or restricting the use or handling of specific substances".

Presently, CQAs are similar to the drug product and drug substance release and stability specifications as they traditionally reflect the desired patient deliverables.

Another limitation is that subjects may not be aware of what drug(s) they had actually used; however every effort was made in the attempt to be accurate (e.g., use of substances street names, specification of formulation and route of administration).

Published reports from the RI do not always provide analytical specifications of test substance purity, details of the exposure protocol, or consumption of the test diet or treated water by the animals (see "GLP" below).