Chemical Lab

Method Development and Validation

Method development and validation is a critical component in the product development process. Our expert team will assist you in developing the most appropriate technique for determining qualitative and quantitative estimations throughout establishment of product specification and shelf life. Our method validation allows you to establish clear limitations of application; taking into account variations in operators and laboratories, to assure your process is robust enough not to impact results. Accuon Labs is able to perform method development and validation on finished products, raw materials, drug substances, intermediates, and key starting materials. We can evolve with you according to which phase of product development you are in. Partnering with our team will assure quality, gap analysis, method improvement and optimization leading to a successful validation, allowing you to meet strict regulatory requirements.

Genotoxic Impurity Analysis

Genotoxic Impurity analysis allows for the detection of potentially cancer causing agents within your product. Genotoxic impurities are DNA reactive substances that have the potential to cause DNA damage when present at very low levels. This may lead to mutations, and in turn, cause cancer. Accuon Labs performs Genotoxic Impurity analysis utilizing varied methodologies, such as, HPLC-UV-PDA, LCMS, GC-FID, GC- MS, and ICPMS. Our experts perform all testing according to the strict guidelines set forth by ICH M7, USFDA, and EMA in order to meet your identification and quantification requirements of impurities within your products. Our scientists perform analysis on active pharmaceutical ingredients, tablets, emulsions, creams, suspensions, lotions, and transdermal patches. Our team will assist you in assuring your product is safe and meets stringent regulatory guidelines.

Nitrosamine Impurities

Nitrosamine impurities became a focus of the FDA in July of 2018, when a recall of some angiotensin II blockers (ARB) was announced, due to being a probable human carcinogen. Accuon Labs performs method development for your products to quantify Nitroso impurities with low detection level recommended by the FDA. Our team of scientists utilizes HPLC, GC, LC-MS, GC-MS to determine the amount of Nitroso impurities. The experienced team at Accuon Labs can assist you in performing the necessary method validations to support your product throughout the regulatory submissions process or for quality assessment of the API or drug substance.

Elemental Impurity Analysis

Elemental impurity analysis is performed at Accuon Labs utilizing the preferred methodology of Inductively Coupled Plasma-Mass Spectrometry (ICP-MS) in the detection, identification, and quantification of trace metals. Our experts are able to identify a variety of metals down to parts per trillion. Our scientists have the ability to analyze solids, aqueous, and organic solutions for measurements across the periodic table with our state of the art instrumentation following the guidelines USP<233> and ICH Q3D. Accuon Labs will assure your product impurities will be controlled and within acceptable limits aiding you in meeting regulatory requirements for product submission.

Ultraviolet-Visible Spectroscopy (UV-Vis)

Ultraviolet-Visible Spectroscopy (UV-Vis) analysis is a methodology utilized by Accuon Labs to perform cost effective analysis of a wide array of products. Our team of experts performs UV-Vis on proteins, pigments, dyes, metallic ions, conjugates, and personal care items. UV-Vis allows us to measure the absorbance of light at a single wavelength or across a spectral range. Measurement of the absorbance allows us to quantify the concentration of the material within a solution. Our team can perform the assay on your materials or develop methods in order to fit your need. UV-Vis is an effective and accurate methodology to perform characterizes your product.

Infrared (IR) Spectroscopy

Infrared (IR) spectroscopy involves the interaction of infrared radiation with matter. It covers a range of techniques, mostly based on absorption spectroscopy. As with all spectroscopic techniques, it can be used to identify and study chemical substances. Samples may be solid, liquid, or gas. The main use of this technique is in organic and inorganic chemistry. It is used by chemists to determine functional groups in molecules. IR methodology is utilized by Accuon Labs to perform cost effective analysis of a wide array of products. Our team of experts performs to identify the wide range of organic compounds.

Residual Solvents Analysis

Residual solvents analysis is performed at Accuon Labs utilizing the preferred methodologies like Gas chromatography, Liquid chromatography, and Mass spectroscopy. For pharmacopeia purposes, residual solvents in pharmaceuticals are deﬁned as organic volatile chemicals that are used or produced during manufacturing of drug substances or excipients, or in the preparation of drug products. The residual solvents are not completely removed by practical manufacturing techniques. Appropriate selection of the solvent for the synthesis of a drug substance or an excipient may enhance the yield, or determine characteristics such as crystal form, purity, and solubility. Therefore, the solvent may sometimes be a critical element in the synthetic process. Our scientists have the ability to analyze solids, liquids, and organic solutions for measurements different types of solvents (non-listed, Class-1, 2&3 solvents) with our state of the art instrumentation following the guidelines USP<467> and ICH Q3C. Accuon Labs will assure your product impurities will be controlled and within acceptable limits aiding you in meeting regulatory requirements for product submission.

Cannabinoids Profiling

Accuon Labs is able to conduct profiling of different cannabinoids in Hemp extract products using the technique of High Performance Liquid Chromatography. Our in-house validated method is sensitive to quantify 16 cannabinoids (CBD, CBDVA, CBDV, CBDA, CBGA, CBG, THCV, THCVA, CBN, CBNA, Delta9-THC, Delta8-THC, CBL, CBC, Delta9-THCA and CBCA) at 0.03% level that is ten times lower to the FDA specification 0.3% of THC.

Potentiometric and Karl Fischer Titration

Potentiometric titration is a volumetric method in which the potential between two electrodes is measured (referent and indicator electrode) as a function of the added reagent volume. This methodology is utilized by Accuon Labs to perform cost effective analysis of a wide array of products. Our team of experts performs to assay and content of organic and inorganic compounds.

Karl Fischer titration is a widely used analytical method for quantifying water content in a variety of products. The fundamental principle behind it is based on the Bunsen Reaction between iodine and sulfur dioxide in an aqueous medium.

TOC Analyzer

TOC analyzer will measure total organic molecules present in pharmaceutical waters measured as carbon as per USP<643>. Using this TOC analyzerwe are quantifying organic residue present in cleaning validation samples.

Dissolution Analysis

Drug absorption from a solid dosage form after oral administration depends on the release of the drug substance from the drug product, the dissolution or solubility of the drug under physiological conditions, and the permeability across the gastrointestinal tract. Our scientists have the ability to analyze different types of dosage forms for measurement of drug dissolution with our state of the art instrumentation following the guideline USP<711>. Accuon Labs will assure your product will be controlled and within acceptable limits aiding you in meeting regulatory requirements for product submission.

Stability Studies

The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light. It is also used to establish a re-test period for the drug substance or a shelf life for the drug product and recommended storage conditions. Accuon Labs has the ability to conduct stability studies (Accelerated, Long-term, intermediate and PHOTO stability) following the guidelines ICH Q1. Accuon Labs will assure your product will be controlled and within acceptable limits aiding you in meeting regulatory requirements for product submission.

Packaging Material Qualifications

Packaging systems qualifications will be performed as per client requirements; using USP <671> Moisture vapor transmission for plastic packaging systems, USP <661.2> physicochemical test methods, USP<661> Plastic Packaging Systems and Their Materials of Construction, USP <670> Auxiliary packaging components methods.