XRD is being used to perform GMP analysis

X-ray diffraction or XRD is understood to be the ideal standard that is used for identification of crystals in pharmaceuticals. The different crystal forms have different properties and so GMP analysis is used to determine which crystal forms need to be present in the product. The same information can also be used during process development and so XRD helps to minimises the risks in the production of pharmaceutical formulations.

GMP is defined as a system that ensures that products are manufactured consistently and in accordance with quality standards. As most Active Pharmaceutical Ingredients (APIs) are in crystal forms XRD helps to determine their types and requirement in pharmaceuticals. This is particularly useful when a metastable crystal form is used in a pharmaceutical as it can change form due to storage or temperature. XRD is of great help to determine whether tableting or compressing cause any polymorphism.  GMP analysis with XRD therefore, enables a reading of the stability of the product in all conditions.

XRD labs are fully conversant with analysis that are GMP compliant and therefore can meet the needs of all customers in the pharmaceutical industry. XRD supports process development, stability studies and quality control in batches that are being tested for release. XRD makes it possible to identify different phases in any given material and detect if any changes have taken place in the final dosage. For GMP purposes it is possible to use the data to study physical and chemical properties, solubility, rate of dissolution, density and even chemical reactivity.

XRD is a useful system of analysis to observe if the product is changing into other forms. Pharmaceutical intermediaries, APIs as also the final product can polymorph during production, manufacturing or storage. Besides storage and temperature, even time can cause the final dose to polymorph. Active ingredients can also morph during manufacturing processes like grinding or compacting. This is where XRD is applied so that the right technique can be formulated so that the pharmaceutical drug can be developed according to strict quality control as per GMP compliance requirements.

Laboratories that have X-ray diffraction instruments also have scientists and technicians that are well–versed with detecting any crystallographic changes in the end product. XRD analysis is therefore used to control the quality of raw materials, APIs as well as excipients that are used to make a finished product that will fulfil GMP requirements.  Any unwanted impurities can also be removed right up to final testing of the product. XRD also helps to determine the percentage of APIs to be used in the final dosage along with the percentage of excipients.

XRD analytical services that support GMP requirements are as follows

  • Identification of API and the form it exists in which can be crystalline or amorphous
  • Analysis that will help determine physical and chemical stability
  • XRD can identify solid form of the API as well as excipients in a given drug product
  • Impurities can be detected without any difficulty in the pharmaceutical drug product.

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Author: Kelly Kerry

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