How can you ensure the preservation of your pharmaceutical products?

Preservatives are used in many medications. These synthetic substances are added to products to prevent bacterial proliferation. Without preservatives, they could be contaminated by micro-organisms that can cause irritation and infection, especially if they come into contact with sensitive or irritated skin.

Among the known preservatives, we find Benzyl Alcohol and monothioglycerol. Monothioglycerol is widely used as a pharmaceutical excipient for various parenteral applications (i.e. microspheres, suspension, solution, lyophilized injection) as an antimicrobial and antioxidant preservative. It is also used in the production of vaccines and biopharmaceuticals.

There is a particular class of preservatives called Antioxidants. Antioxidants prolong the life of the substances in which they are contained because they prevent, as far as possible, their oxidation by inhibiting the formation of free radicals or by interrupting their propagation. They act as anti-free radical agents by preventing the damage done by the free radicals that often attack lipids, fats and proteins.

Among the best known antioxidants, we find butyl hydroxyanisole (BHA) and butyl hydroxytoluene (BHT). BHA and BHT are used in the pharmaceutical industry as antioxidants and preservatives in solid, oral, semi-solid, topical and parenteral formulations.

The issuance of a New Drug Application (NDA) is based on the examination of the benefit/risk balance of the product, and more specifically on :

• The demonstration of its effectiveness
• The profile of the patients for whom it is intended
• The recommended dosage (dose, duration of treatment)
• The foreseeable adverse effects related to its use and their frequency
• The chemical, biological or microbiological quality of the drug

For this last category, the use of preservatives is essential. Each of these substances must meet key attributes:

• Registered by CDMF (CDE # F20200000188)
• Manufacture and packaging under GMP environment
• Low endotoxin suitable for parenteral applications
• TAMC and TYMC control
• Pathogen control
• Control of elemental impurities in accordance with ICH Q3D

Our products are compliant with global pharmacopoeias and we offer end-to-end documentation support for regulatory submissions and subsequent queries, if required.

We invite you to download our brochure to access our catalog illustrating our broad offering of preservatives and antioxidants for all your applications.

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