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USP 901 Detection of Asbestos in Pharmaceutical Talc

Asbestos is a naturally occurring mineral that has been used in many industries for decades due to its strength and heat resistance. Unfortunately, it has also been linked to serious health risks, including mesothelioma, lung cancer, and asbestosis. As a result, the use of asbestos has been heavily regulated in many countries. One area of concern is the potential presence of asbestos in talc, which is used in a variety of products such as cosmetics and pharmaceuticals. This article will discuss the methods used to detect asbestos in talc and the implications for public health.

X-ray diffraction graph

The US Pharmacopeia (USP) proposed simulated reference standards to abet the implementation of projected asbestos assessment approaches in pharmaceutical talc. To obstruct possible tainting of talc through asbestos, it is absolutely indispensable for every talc manufacturer to prudently select their mining sites and to apply dependable core sampling mechanisms. There have been numerous occurrences when powdered talcum employed in pharmaceuticals were detected to be beyond the perilous line that can result in a wide range of lethal illnesses. 

A quick look at USP 901;

  • The USP 901 is a general chapter set by the United States Pharmacopeia (USP) for detecting asbestos in pharmaceutical talc. This chapter outlines the requirements for testing and sampling of talc products to ensure that they are free from asbestos contamination. 
  • The USP 901 requires that all talc used in pharmaceuticals must be tested using polarized light microscopy (PLM), transmission electron microscopy (TEM), or X-ray diffraction (XRD). These tests are designed to detect any trace amounts of asbestos present in the talc, which could potentially lead to serious health risks if ingested. 
  • By adhering to the USP 901, manufacturers can ensure that their products are safe for use and do not contain any harmful levels of asbestos. 

What is talc?

Talc is a hydrated magnesium silicate mineral that has a multitude of industrial applications. It is most commonly sourced from mines, which can also hold asbestos and similar substances. In the medical industry it acts as an anti-cake to aid in tablet compression. In cosmetics and other personal care items, talc is used for its absorbed features and its aptitude to provide a soft, cool feeling. 

Talcum has been accepted by the FDA to be utilized in some foodstuffs and is mostly thought safe; however, untamed talc can contain asbestos which may lead to lung cancer if inhaled. By virtue of being able to be pulverized finely, talc can help keep skin dry and ward off chafes.

How talc in asbestos leads to disease?

  • The medical implications of using talc products containing asbestos include the malignant and nonmalignant diseases associated with any asbestos exposure as well as those related to talc.Hazards linked to asbestos in talc items hold all risks of asbestos-associated illnesses. 
  • Observing polarizing light microscopy, transmission electron microscope (TEM), electron diffraction, and X‐ray analysis, a number of over-the-counter Indian talc products were inspected for the presence of asbestos. As the global effort to eliminate asbestos-related afflictions continues, public health worries surrounding the emergence of asbestos in consumer talc products remain intact.
  •  Talc is composed of the parts magnesium, silicon, and oxygen and is categorized as a humid silicate mineral. The asbestos‐forming minerals serpentine and amphibole form under connected geologic settings as talc and are also damp silicate minerals containing magnesium, silicon, and oxygen.

What WHO says ? 

  • The World Health Organization (WHO) reports that 125 million people are occupationally exposed to asbestos worldwide and that approximately half of all occupational cancer deaths are believed to be caused by asbestos.
  • WHO further attests to the fact that global exposure to asbestos in the living space leads to several thousand casualties every year. Unfortunately, there is no information on how many people are subject to asbestos particles contained in care products; as a result, data necessary to measure the present and future effect of asbestos-induced ailments is absent. 
  • Lack of satisfactory records should be taken into consideration, especially when reflecting on the commonly underexposed illness mesothelioma. Investigations conducted on these talc products have sought to determine the presence of asbestos and if any asbestos detected was aerosolized and gageable.
  •  It is highly challenging to eliminate asbestos from talc ore by cleansing it. Thus, mindful selection of talc mines and locales inside those mines is needed to stay away from contamination with asbestos and analogous naturally occurring mineral particles. 
  • It is crucial that suitable control methods are available for identifying asbestos in talc so its appropriateness as an element for use in consumer items can be assured. It is usual consensus among US federal offices, most fully developed countries, and the WHO that there is no well-known safe level of exposure to asbestos. 
  • Inhaling it from any source poses a risk of damaging lung tissue leading either to asbestosis or pleural plaques, or even lung cancers and mesothelioma. 
  • Asbestos conventions and traditional approaches for evaluation hold a wide range of “counting regulations specifying how to calculate asbestos in work-related or natural situations utilizing various microscopic systems. Regulations were personalized to simplify reckoning, to advance statistical investigation, and to provide a limit for moderating peril when asbestos is known to exist. 

Pharmacopoeial methods for estimation of traces of asbestos in talcum powder have been prescribed based on popular techniques like –

  • Infrared Spectroscopy
  • Optical Microscopy
  • X-ray diffraction analysis

Our service

Auriga Research is a trusted provider of X-ray diffraction (XRD) based testing for the detection of asbestos in talc. XRD is an ideal method for detecting trace amounts of asbestos in talc, as it is non-destructive and highly sensitive. Auriga Research utilizes state-of-the-art XRD technology to provide accurate and reliable results that meet the requirements set by the USP 901. Additionally, their testing services are quick and cost-effective, making them an ideal choice for manufacturers who need to ensure that their products are free from asbestos contamination. With Auriga Research, you can be sure that your products are safe for use and do not contain any harmful levels of asbestos. 

Our laboratory in Baddi, Himachal Pradesh is fully equipped to carry out USP 901 asbestos testing pharmaceutical talc. We use X-ray diffraction analysis that  has been included in both USP and BP 2018 editions for determination of asbestos in talcum powders.

It can be used for determining overall purity of a talc product with respect to accessory minerals and can be important in determining general suitability for pharmaceutical use. This test method is used to identify and determine a relative level (presence or absence) of total amphibole and total serpentine in a talc powder matrix. It is intended to be used in combination with the PLM microscopy technique. 

Polarised Light Microscopy  is utilized to distinguish asbestos grains within a talc powder framework. It is planned to be used in conjunction with XRD as an additional microscopy procedure. It can detect asbestos at a smaller amount than XRD and it can separate diverse kinds of asbestos. Comprehensive testing operation and agreement criteria for PLM are explained in this part. This system offers convenient examination of samples for asbestos in talcum powder.

X-ray diffraction (XRD) is a powerful tool for detecting asbestos in talc. XRD utilizes X-rays to analyze the crystalline structure of a material, which can be used to identify the presence of asbestos. This method is advantageous because it is non-destructive and can detect very small amounts of asbestos that may not be visible to the naked eye. Additionally, XRD is highly sensitive and can detect even trace amounts of asbestos in talc, making it an ideal method for ensuring safety and quality control. Furthermore, XRD is relatively quick and cost-effective compared to other methods such as polarized light microscopy or transmission electron microscopy. Overall, XRD provides an effective way to detect asbestos in talc and ensure that products are safe for use. 

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