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Drug Substance Assay
Inspections of drug substances are designed to confirm manufacturing plants, as well as the quality control laboratory, follow CGMP regulations. An extensive se …
DRUG SUBSTANCE
EXCIPIENTS
Production comes to a halt when impurities are identified above the threshold level and the drug substance must be re-evaluated, increasing cost of production and time to market.
Ensuring purity and assuring compliance
Production comes to a halt when impurities are identified above the threshold level and the drug substance must be re-evaluated, increasing cost of production and time to market.
Drug substance is the active pharmacological ingredient used in a finished pharmaceutical product and has a direct effect on both the treatment and prevention of disease. To ensure the purity, quality and safety of a drug substance, it is essential to perform analytical tests to identify if any impurities or adulterants exist.
Our advance analytical tools provide the data to mitigate compliance risk and guide your GMP standards compliance for the identification of incoming raw material testing, drug substance assay and excipient quality.
The suitability of drug substance for its intended use is defined by attributes such as identity, strength, and purity – which can be achieved by using instruments, consumables and services you can find from PerkinElmer.
Contact usANALYSIS OF DRUG SUBSTANCE & EXICIPIENTS
Excipients Characterization
The quality of excipients is extremely important since 90% of medicines are made up of them. When it comes to regulatory guidelines, there are several the indus …
Pharmaceutical Raw Material Identification
The analysis of all incoming pharmaceutical raw materials is a key part of GMP compliance to guarantee safety and efficacy of a finished dosage form which is la …
Polymorphic Forms
During the process of manufacturing finished dosage forms (solids), an organic molecule can adopt more than one crystalline form which can have significant effe …
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