Harmonized Culture Media – The Need Of Pharmaceutical Industry

 What is Pharmacopeia?

A pharmacopoeia is a collection of quality standards and specifications for pharmaceutical products. It includes methods for confirming everything from the identity and purity of a medication to the strength or concentration of an active pharmaceutical ingredient. This includes raw materials, excipients, and intermediate products, as well as finished pharmaceutical products.

Harmonisation

The Pharmacopeial Discussion Group is responsible for harmonising excipient monographs and general chapters. This will reduce the burden on the manufacturers to perform analytical procedures in various ways and use various acceptance criteria. The Pharmacopeial Discussion Group strives to maintain an optimal level of science consistent with public health protection at all times.

Harmonization of a pharmacopoeial monograph or general chapter is defined by the Pharmacopeial Discussion Group as follows:

A pharmacopoeial general chapter or other pharmacopoeial document is harmonized when a substance or preparation tested by the harmonized procedure yields the same results and the same accept/reject decision.

Harmonization occurs when the text becomes official in all three pharmacopoeias.

Regardless of which PDG pharmacopoeia is referenced, an analyst will obtain the same results when using a fully harmonised pharmacopoeial monograph or general chapter. This approach lays the groundwork for interchangeability (the same accept/reject decision), and each pharmacopoeia will appropriately flag its fully harmonised monographs and general chapters.

This process began a little more than 30 years ago with the formation of the Pharmacopoeial Discussion Group, with the ultimate goal of obtaining standardised methods to meet the quality requirements of the drugs, regardless of the region in which they are marketed.

TM Media Manufacturer of Harmonized Culture Media

TM Media provides a comprehensive line of Harmonized Media for the pharmaceutical industry's harmonised microbial limit test and sterility test methods. Harmonized microbial limit test media developed by TM Media are USP/EP/BP/JP/IP compliant.

Few of TM Media Harmonized Culture Media are –

  • Baird Parker Agar Base (as per EP/IP/BP) - for the isolation and enumeration of coagulase positive Staphylococci from food, pharmaceuticals, and other materials.

  • Buffered NaCl-Peptone Solution (as per USP/EP/JP/BP) - dilution fluid for samples in case of microbiological contamination.

  • Cetrimide Agar (as per USP/EP/JP/BP) - for selective isolation of Pseudomonas aeruginosa.

  • Columbia Agar (as per USP/EP/JP/BP) - for the detection of Clostridium sporogenes from pharmaceutical products.

TM Media offers a wide range of vegetarian and non-vegetarian culture media. With Culture Media, the TM Media portfolio also includes Biological Media Bases, Media Supplements, Antibiotic Sensitivity Discs, Lab Consumables, and more microbiology products.

For more, visit https://www.tmmedia.in/

Comments

Post a Comment

Popular posts from this blog

Bacillus coagulans Isolation Using Glucose Yeast Extract BC Agar Medium

Image
  Bacillus coagulans is a lactic acid-producing bacterial species. It is a type of probiotic. Probiotics are live microorganisms that are intended to provide health benefits when consumed in the body. Probiotic organisms include Lactobacillus, Bifidobacterium, Enterococcus, Bacillus, and Streptococcus. Bacillus coagulans is a probiotic that produces lactic acid, but it is not the same as Lactobacillus. Unlike Lactobacillus and many other probiotics, it can produce spores during its reproductive life cycle. This ability allows Bacillus coagulans to go dormant during harsh conditions that would otherwise kill off other probiotics. As a result, this bacterial strain is particularly robust. It can withstand harsh environments, such as high levels of acid in the stomach. This may make Bacillus coagulans particularly effective at treating stomach upset and other ailments. Spore forming Bacillus coagulans strains are used as probiotics for antibiotic-treated patients in some countri...
Read more

Triple Sugar Saline Iron Agar

  In 1940, Sulkin, Willett, and Hajna described a triple-sugar ferrous sulphate medium for the identification of enteric bacteria. Triple Sugar Iron (TSI) Agar is used for the presumptive identification of Enterobacteriaceae based on the fermentation of carbohydrates and the production of gas and H 2 S. Triple Sugar Iron Agar contains three carbohydrates: glucose (dextrose), lactose, and sucrose. Triple Sugar Iron Agar is a differential medium that contains lactose, sucrose, a small amount of glucose (dextrose), ferrous sulphate, and the pH indicator phenol red. If an organism can ferment any of the three sugars present in the medium, the medium will turn yellow. If an organism can only ferment dextrose, the organism consumes a small amount of dextrose in the medium within the first ten hours of incubation. After that time, the reaction that produced acid reverses in the aerobic areas of the slant, and the medium in those areas turns red, indicating alkaline conditions.  T...
Read more

Tryptone Soya Agar: An USP-Compliant Media

Image
  Tryptone Soya Agar, also known as Soyabean Casein Digest Agar, is a popular medium for the growth of a wide range of organisms, including pathogenic bacteria such as Neisseria, Listeria, and Brucella. The medium with blood addition provides perfectly defined haemolysis zones, while the sodium chloride content prevents erythrocyte lysis. It has been widely used in the pharmaceutical industry to create antigens, toxins, and other substances. Because of its simple and inhibitor-free composition, it is suitable for detecting antimicrobial agents in food and other products. Various pharmacopoeias recommend Tryptone Soya Agar as a sterility testing medium. Tryptone Soya Agar is USP-compliant and used in microbial limit testing and antimicrobial preservative testing.  It is also used in the pharmaceutical industry to perform various tests such as environmental monitoring, maintenance of stock cultures, etc. Principle Gunn et al. used this medium to grow fastidious organisms and...
Read more