• Method development and qualification
• Method feasibility and optimization
• Transfer, verification and validation of analytical methods or monographs
• Assay and related substances in drug substance and drug products
• Dissolution studies
• Residual solvents
• Genotoxic impurities
• Excipients and additives
• Support any chromatographic analysis requirements (GC, HPLC, UPLC, IC, chiral)
• In-depth expertise in mass spectrometry (GC/MS, LC/MS, ICP-MS)

Screening can be performed to support risk assessment for general nitrosamines impurities. Our general analytical method can be used to test the main nitrosamines listed by Health Canada, and the FDA, and several others, upon the client's request. Method validation and confirmatory testing on drug substances and drug products of interest can also be performed according to USP <1469>, Health Canada, FDA and EMA guidelines. Development and validation of custom methods for complex nitrosamines (nitroso adducts of drug substances or excipients) are also available.

• Extractable and Leachables assessment as per USP <1663/1664>
• Complete studies on biomedical devices, packaging components and manufacturing components
• NIST database with more than 243,000 molecules for interpretation of GC/MS results
• Statistical analysis of the LC/MS results using a state-of-the-art mass profile software
• Complete database with more than 1,000 potential leachables for interpretation of LC/MS results
• Confirmation of tentative structures identified using the databases with real standards
• Materials of construction characterization as per USP <661.1/661.2>

• Multiple approaches to analyze elements listed in USP <232> (or more, upon client request) for many dosage forms
• Method development and validation of elemental impurities methods as per USP <233> and ICH Q3D requirements
• Quantitative and limit test approaches to support any client's needs
• In-house screening methods available for risk assessment evaluation

The stability-indicating and mass balance of analytical methods are demonstrated using study protocols performed under GMP conditions. Results are reported and explained in detailed reports. If needed, our development team can determine the stress conditions (e.g. acid, alkaline, oxidative, thermal and photolytic) suitable for each particular drug substances and drug products in solution and/or on solid form.

Compatibility studies are performed during pre-formulation to demonstrate the drug compatibility with excipients and/or administration sets/devices to therefore evaluate the stability of the formulation. In-use stability studies are also performed to demonstrate stability of drug products (e.g. solid, liquid, parenteral, etc.) during their utilization period especially for multidoses products after opening and reconstitution (i.e intravenous drug products in infusion bags).

For all your non-sterile products, we can validate the microbial enumeration (USP <61>, EP 2.6.12), microbial characterization, detection of specified microorganisms (USP <62>, EP 2.6.13), and Antimicrobial Effectiveness Testing (preservative formulation testing as per USP <51>, EP 5.1.3). For sterile products and devices, we can also validate the Sterility Tests (USP <71>, EP 2.6.1) to confirm that products are free from the presence of viable microorganisms, along with the Bacterial Endotoxins Tests (USP <85>, EP 2.6.14) to detect or quantify endotoxins from Gram-negative bacteria. We can also validate methods using other pharmacopeias or official methods. Neopharm can also develop and validate microbial assays, mainly for your antibiotics, vitamins, drug substances, or drug products.

The use dilution technique is used to determine disinfectant efficacy with quantitative or qualitative methods. Recovery, neutralization, and challenge efficacity on surfaces are also available for more representative results. Both sampling method efficacy and subsequent testing conditions are validated by our microbiology R&D team.

• Determination of detergents and chemical markers residues on various surfaces
• Sampling method development and swab/rinse sampling evaluation
• API-detergent cleanability evaluation study
• Validation of sampling conditions and analytical method

Through our sister company Averica Discovery in the Boston area, our scientists have developed an in-depth expertise in profiling, isolation, purification and characterization of impurities, as well as a specialization in chiral chromatography. They're able to isolate and purify highly pure, or isomerically pure test samples of drugs, even for a variety of substances that are difficult to purify, including natural products, impurities and degradants, and external contaminants. The Averica team has developed a reputation for excellence, speed, and an ability to solve the toughest problems. For more information, visit avericadiscovery.com.