How can you ensure the preservation of your pharmaceutical products?

How can you ensure the preservation of your pharmaceutical products?

In the pharmaceutical field, it is extremely important that drugs are stable in order to increase patient safety by extending their shelf life. To achieve this, preservatives and antioxidants are added to the various excipients. Antioxidants and preservatives are key ingredients in pharmaceutical formulations that are used to protect the active ingredients from oxidation and degradation.

Why add a preservative?

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.

Which ones are the most used?

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.

The following is a non-exhaustive list of preservatives used in the pharmaceutical industry:

CASR No. Product Name Pharmacopoeia / DMF
8001-54-5 Benzalkonium chloride 50% Solution USP-NF, Ph.Eur, IP, BP
121-54-0 Benzethonium chloride USP, Ph.Eur
65-85-0 Benzoic acid USP, Ph.Eur, IP
100-51-6 Benzyl alcohol USP-NF, Ph.Eur, BP, IP
62-54-4 Calcium acetate USP
10035-04-8 Calcium chloride USP, Ph.Eur, IP
60-27-5 Creatinine USP-NF
Ethyl Paraben NF, BP, PhEur
50-00-0 Formaldéhyde USP, Ph.Eur, BP
56-81-5 Glycerin USP, Ph.Eur, BP, IP, JP
67-63-0 Isopropyl alcohol (IPA) USP, Ph.Eur, BP, IP, JP, CDMF
79-33-4 L-(+)-Lactic acid USP-NF, BP, IP, JP, Ph.Eur
108-95-2 Liquefied Phenol USP
108-39-4 meta-Cresol USP, Ph.Eur, BP, CDMF
Méthyl Paraben SL98I/USP40-NF35/PhEur9.0/BP2017
96-27-5 Monothioglycerol USP-NF, IP, CDMF
108-95-2 Phenol USP, Ph.Eur, IP
Propyl Paraben Propyl Paraben SL98I/USP40-NF35/PhEur9.0/BP2017
57-55-6 Propylene glycol USP, Ph.Eur, BP, IP, CDMF
122-99-6 Phenoxyethanol BP, USP-NF, Ph.Eur, IP
60-12-8 Phenyl ethyl alcohol USP, IP
8003-05-2 Phenylmercuric nitrate USP-NF, Ph.Eur, IP
69-72-7 Salicylic acid USP, Ph.Eur, IP
127-09-3 Sodium acetate anhydrous USP
6131-90-4 Sodium acetate trihydrate USP, Ph.Eur, BP, IP
532-32-1 Sodium benzoate USP-NF, Ph.Eur, BP, IP
144-55-8 Sodium bicarbonate USP, Ph.Eur, BP, IP
7631-90-5 Sodium bisulfite JP
Sodium Ethyl Paraben BP/PhEur/SL98I
7681-57-4 Sodium metabisulphite USP-NF, Ph.Eur, IP, CDMF
Sodium Methyl Paraben SL98I/USP40-NF35/PhEur9.0/BP2017
Sodium Propyl Paraben BP, PhEur and SL98I Specifications
7757-83-7 Sodium sulfite anhydrous USP-NF, Ph.Eur, BP
110-44-1 Sorbic acid USP-NF, Ph.Eur, BP, IP
54-64-8 Thimerosal USP, Ph.Eur, BP, IP
1314-13-2 Zinc oxide USP, Ph.Eur, IP

What is an antioxidant?

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 following is a non-exhaustive list of antioxidants used in the pharmaceutical industry:

CASR No. Product Name Pharmacopoeia / DMF
25013-16-5 Butylated hydroxyanisole USP-NF, Ph.Eur, CDMF
128-37-0 Butylated hydroxytoluene USP-NF, Ph.Eur, IP, CDMF
5949-29-1 Citric acid monohydrate USP, Ph.Eur, BP, IP
50-00-0 Formaldehyde USP, Ph.Eur, BP
110-17-8 Fumaric acid USP-NF, IP, CDMF
6915-15-7 DL-Malic acid USP-NF, Ph.Eur, IP
96-27-5 Monothioglycerol USP-NF, IP, CDMF
7631-90-5 Sodium bisulfite JP
7681-57-4 Sodium metabisulphite USP-NF, Ph.Eur, IP, CDMF

How to choose a reliable preservative?

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

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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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