Saturday, November 17, 2018

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Personal Care Products & Cosmetics: Raw Materials Sourcing & Formulations

Personal care products can be either:  (a) Over-the-counter (OTC) preparations such as eye drops, fluoride-containing toothpastes, or mouth washes which are regulated as drugs by FDA or (b) non-drug preparations such as non-medicated skin creams and shampoos.

Currently, the FDA recognizes three cosmetics categories: drugs, cosmetics and soaps.   When a company launches a cosmetic product claiming to affect the human body structure or function, it must go through clinical trials to prove its effectiveness and safety.For final FDA approval, these products must meet the standards for both 'cosmetics' (color additives) and 'drugs'.

Some cosmetic makers have begun using the term "cosmeceutical" to refer to products that have drug-like benefits, but the new term is not recognized by the FDA.  Instead the FDA classifies a product as either a drug or a cosmetic or a combination of both.

Mass Spec Lab is Equipped to Help Both Large & Small Manufacturers in All Areas of Personal Care Products & Cosmetics in the Following Ways:

Qualify raw material sources and set up quality inspection methods:  A wide array of raw materials is used in the formulation of personal care products.  These raw materials can come from synthetic, biosynthetic, or extract sources.  The range and chemical identities of by-products, contaminants, and degradants that accompany these raw materials varies depending on the source.  Screening of raw material options and fingerprinting of the final choices are therefore of paramount importance.  Mass Spec Lab has the breadth of experience, expertise, and instrumentation to handle this universe of chemical possibilities.
 
Authenticate natural extract raw material sources:  Often suppliers of natural extracts will claim that their products are “organic”, “pesticide-free”, or “natural”.  It is incumbent on the end-user of these raw materials to verify that these claims are in-fact true.  It is also important that ongoing surveillance of suppliers be instituted to detect undesirable “drift” in the quality of these materials.  Mass Spec Lab can help set up these programs and supply ongoing analytical services for surveillance.  For example, pesticide tracking can be accomplished using our highly sensitive GC or LC mass spectrometry techniques.  Part-per-billion (ppb) level detection can be readily achieved.

Screen formulation options for contaminants and degradants:  We have found “surprises” in the analysis of personal care formulations.  Often these unexpected chemical compounds are contaminants, by-products, or degradants of the raw materials used in the formulations.  With high sensitivity and specificity, MSMS chemical analysis of candidate formulations can guide a producer to raw materials that meet their quality standards.

Screen packaging components for migratable species: Another source of “surprise” chemical contaminants can be the materials that are used in the packaging components of a product.  Mass Spec Lab scientists can help in the screening process to locate packaging options with low migratable chemical fractions that will not contribute contaminants to a final preparation or product.

Set up final product quality assurance programs and procedures: Mass Spec Lab can create a quality assurance program for your product which includes documented methods development and validation.  Going forward, the quality assurance program can be conducted by Mass Spec Lab or transferred to the client.

We can help you with raw material sourcing and authentication. Request more information or call us at 949-872-2724.

 

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