Reference substances are those substances that are used as a reference to carry out a quantitative or qualitative determination or to carry out a calibration. Being authentic materials of known purity. They are also indispensable in the pharmaceutical industry.
When reference substances are standardized, with a known purity and issued in batches, they are known as reference standards. These reference standards must be maintained in the optimal environmental conditions to guarantee that the analyzes carried out with them are 100% reliable.
These reference standards should be periodically reviewed for current use and reliability for routine testing. As well as keeping a traceability of its use that enables each analysis carried out. For this, it is essential to have tools that carry traceability and promptly notify when these standards expire or when the inventory available is about to run out.
There are different types of reference standards such as: certified, pharmacopoeial, non-pharmacopoeial, primary and secondary.
Certified Standard
It is a Reference Material generated through a valid metrological procedure that is accompanied by a certificate that establishes the values ??of one or more of the specified properties. Process that is associated with uncertainty and the metrological traceability establishment.
Pharmacopoeic Standard
It is the substance of recognized uniformity that is referenced in a monograph specified in a pharmacopoeia.
Primary Standard
It is a compound of high purity and accurately characterized based on thorough analytical testing. This standard can be:
· Obtained from a recognized official source of supply.
· Prepared by independent synthesis.
· Obtained from a batch of high purity produced material.
Secondary Standard
It is a compound whose purity has been established from a primary standard by chemical analysis. They are used as reference standards for routine laboratory analysis.
Administering Reference Substances
Reference substances are therefore of great importance in the pharmaceutical industry for qualitative and quantitative analysis of manufactured products and their traceability.
For all of the above, it is important to consider systematizing this important process of administration and control of the reference standards that allows us to guarantee efficient management that complies with the regulatory requirements of computerized systems.
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