Pharmaceuticals Industry

High Quality reference standard , API Working Standards are used to help ensure the identity, potency, quality and purity of drug products and drug substances. This is accomplished by analyzing the substance against its qualified reference standard, so the accuracy of reference materials is essential to manufacture quality APIs.

Products and Services

Pharmaceuticals Standards
Tribio Scientific's pharmaceutical application standards cover process control, design, and performance, as well as quality acceptance/assurance tests for the pharmaceutical manufacturing industry.
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Pharmaceuticals Impurities
An impurity in pharmaceuticals is classified as any component that is not the entity defined as the drug substance. In addition, for a drug product, any component that is not a formulation ingredient is considered an impurity. .
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• Reference standard

High Quality reference standard, API Working Standards are used to help ensure the identity, potency, quality and purity of drug products and drug substances. This is accomplished by analyzing the substance against its qualified reference standard, so the accuracy of reference materials is essential to manufacture quality APIs.

Working Standards can be compendial, referred to as Primary Reference Standard, or a highly characterized in-house standard or a Secondary Reference Standard. Primary Working Standards can be obtained from the standards-setting Pharmacopeias, such as the USP or EP.

We supply multiple pharmaceuticals reference standard and working standard:

To quantitatively determine the product assay.
To detect impurities in the sample.
For releasing raw materials.
For in-process monitoring.
As a retention time reference marker.
For stability studies.

• Impurity standard

Impurity Standards are highly characterized and are used to determine quantitative data (like purity or impurity etc.), qualitative data (identification data), and calibration (like melting point standard, UV-visible spectrum standard etc.). Consequently, the quality and purity of the Impurity Standards are crucial to achieve scientifically valid results.

• Nitrosamine impurity

Nitrosamines are chemical compounds classified as probable human carcinogens on the basis of animal studies. EU regulators first became aware of nitrosamines in medicines in mid-2018 when nitrosamine impurities, including N-nitroso dimethylamine (NDMA), were detected in blood pressure medicines known as 'sartans'. There is a very low risk that nitrosamine impurities at the levels found in medicines could cause cancer in humans.

• Probiotics Strains

Tribio Scientific is proud to be a Supplier with our alliance partner Silaris LLP of probiotics stains manufactured by UAS labs (The Probiotics Company) in State of the art GMP facility at Madison USA. UAS labs offer scientifically proven probiotics stains backed by tireless research and rigorous Clinical trials. Contact us to learn how our expertise team can work for you.