In the clean hallways of a pharmaceutical plant, precision and cleanliness are not just ideals; they are essential requirements. Even a small change in the composition of Culture Media or a trace of contamination could spoil an entire batch of life-saving products. That’s why sterility testing is a key pillar of quality assurance to make sure that all materials, processes and products are free from any form of microbial contamination. Among the media that contribute to this accuracy, the Vitamin B12 Assay Medium is a particular medium, used not only for sterility testing but also for determining the vitamin concentration with accuracy.
Vitamin B12 Assay Medium is a defined microbiological medium used for the quantitative determination of Vitamin B12 by Lactobacillus leichmannii (ATCC 7830) as the indicator organism. This is a Vitamin B12-deficient medium, but it has all the other nutrients and vitamins required for the test bacterium to grow.
Lactobacillus leichmannii displays a linear growth response with the addition of a specified amount of the vitamin B12. The response is turbidometric or acidimetric, which provides good accuracy for quantification of Vitamin B12 in the sample.
The Vitamin B12 Assay Medium is formulated based on USP and AOAC guidelines for assay medium, and it leads to consistent outcomes without contamination risk. It is important in microbiological assay testing, in which minor contamination can alter results. Hence the medium, the glassware, and the culture room must undergo rigorous sterility testing to prevent false readings.
The Vitamin B12 Assay Medium provides a balanced nutrient environment that promotes selective growth of L. leichmannii.
This combination provides the best conditions for the growth of the microbe for accurate vitamin determination and at the same time supports routine sterility testing in which detection of even the smallest microbial presence is crucial.
Each step should be carried out under rigidly sterile conditions to ensure the sterility testing and to avoid contamination which may invalidate the results.
These standards are used as a guide for laboratories and ensure the medium provides a reliable estimation of Vitamin B12 and rigorous sterility testing of pharmaceutical products.
| Microorganism | ATCC | Inoculum (CFU/ml) | Growth | Incubation Temperature | Incubation Period |
| Lactobacillus leichmannii | 7830 | 50-100 | A gradual increase in growth with increasing USP Cyanocobalamin reference standard levels of 0.0, 0.025, 0.050, 0.075, 0.1, 0.125, 0.150 and 0.2 ng per assay tube is recorded as an equivalent increase in absorbance at 620 nm. | 35-37°C | 18-24 Hours |
The controlled growth pattern demonstrates the sensitivity of the medium, which is important for accurate vitamin determination and reliable sterility testing where consistency and reproducibility are essential.
For pharmaceutical and nutraceutical industries seeking stable and reliable microbiological assay media, Vitamin B12 Assay Medium (TM 1866) is the most credible choice. Key benefits of TM Media’s formulation (TM 1866) are:
By utilizing this medium, laboratories can meet the highest standards for sterility testing while being confident that their cultures, assays, and analyses remain free from contamination.
In an industry where accuracy is a must and regulatory adherence is the rule, the Vitamin B12 Assay Medium gives the manufacturers the analytical tool necessary to perform an accurate vitamin assay and dependable sterility testing. With this medium, laboratories can guarantee that every product is what it claims on the label, is free from microbial contamination, and can provide the desired therapeutic benefits to patients around the globe.
A. Since bacterial growth depends only on biologically active Vitamin B12, the medium naturally distinguishes between active and inactive forms during quantification.
A. These microbiological assays are for the biologically active form of Vitamin B12, while the chemical methods can measure active and inactive forms, which can cause an inaccurate nutritional analysis.
A. Use sterilized, borosilicate glassware to prevent leaching or contamination that could compromise the results of the assay.
A. No, this medium is designed for the determination of Vitamin B12. There are various assay media available to test other vitamins, including biotin, folic acid, niacin and more.
A. Clouding before sterilization, irregular color or lumps of coagulated medium are indications of under dissolution or contamination, and the medium must be discarded.
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