Quality Control - phycheck®

Our specialists test our customers’ samples using state-of-the-art equipment and methods based on pharmacopoeial monographs, method compendia in accordance with § 64 LFGB (German Food and Feed Code), AOAC methods and other recognized standards. Our services include testing for identity, purity and potency, microbiological testing and stability studies, in addition to development and validation of new methods. We provide reliable results in accordance with statutory requirements and your own standards.

Identity

The first step of quality control is identity testing. Pharmacognostic evaluations involve a comparison of macroscopic and microscopic features against authentic reference material. PhytoLab has a uniquely well-suited collection of reference drugs for comparative purposes. Testing for characteristic ingredients and determination of the chromatographic fingerprint using thin-layer chromatography (TLC), gas chromatography (GC) or high-performance liquid chromatography (HPLC) also provide important information concerning identity. In addition, we conduct analyses of organoleptic characteristics, such as odor and flavor.

Purity

Purity testing is used to determine whether a sample is free of impurities or contaminants. The highly experienced PhytoLab Team tests plant material for organic and inorganic contaminants and for microbiological purity to ensure that they comply with regulatory specifications. PhytoLab purity testing is based on conventional methods in line with the European Pharmacopoeia and other applicable standards, as well as instrumental methods, including high-performance liquid chromatography (HPLC) and gas chromatography (GC).

Potency

Is the potency of the major plant constituents sufficient for the intended use? Instrumental chromatography is crucial to answering this question. PhytoLab is proficient in such methods, just as in the classic techniques of titration, gravimetry, and photometry, which are still in demand. We assay our customers’ herbal products using methods from pharmacopeias, such as the DAB, Ph. Eur., USP, or method compendia (e.g. in accordance with § 64 LFGB, AOAC). We can also develop and validate customized, product-specific methods for our customers.

Microbiology

Natural products always carry microbes. PhytoLab determines microbial counts, tests for the absence of pathogenic microorganisms, and identifies any such organisms, as necessary, using biochemical and molecular biological methods.

Our team of experts evaluates the results according to generally accepted criteria. For example, we evaluate spices based on the guidelines of the DGHM (German Society of Hygiene and Microbiology), teas and herbal infusions based on the guidelines of the EHIA (European Herbal Infusion Association), and medicinal teas, raw materials, extracts and finished medicinal products based on the relevant provisions of the European Pharmacopoeia.

Stability studies

Marketing authorization procedures for medicinal products require the active substances and the finished products to be tested and documented in accordance with ICH guidelines. PhytoLab is the ideal partner for this step: our range of services includes ICH-compliant long-term studies for all relevant climate zones and for storage in refrigerators or freezers, as well as in-use testing. In addition to stability studies for marketing authorization procedures, we also conduct ongoing stability studies on our customers’ products.

Method development

The development and validation of selective, sufficiently sensitive analytical methods for herbal products pose a major challenge ascomplex samples often contain only small amounts of suitable marker substances. PhytoLab has many years of experience in method development. We use advanced chromatography simulation techniques for rapid and targeted optimization of chromatographic conditions. The result: robust methods for smooth incorporation into routine operations. Methods are validated in accordance with ICH guidelines CPMP/ICH/281/95 and 381/95. Accurate recording and archiving of all raw data ensures comprehensive documentation of all relevant validation data.