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Analysis of Highly Potent Substances

Analytical >> Analytical Testing Services >> High Potency APIs (HPAPIs)

When working with highly potent products like cytostatics hormones and antibiotics, we use our Highly Potent Substance Laboratory (HPSL) which consists of a set of analytical laboratories within a hygienic loop, equipped with dedicated equipment and specially trained personnel.

Active Ingredient Testing

Analytical >> Analytical Testing Services >> High Potency APIs (HPAPIs)

Our product testing division offers full analytical services for active ingredient characterization, potency and a wide range of ingredient-specific analyses.

Analysis of Cytotoxic & High Potent APIs

Analytical >> Analytical Testing Services >> High Potency APIs (HPAPIs)

Our facilities also include HEPA filtered air handling systems for the analysis of cytotoxic, teratogenic and uncharacterised products, a darkroom for the analysis of light sensitive products, and have the capabilities to work with Schedule II-IV controlled substances.

Analytical & GMP Release Testing for HPAPIs

Analytical >> Analytical Testing Services >> High Potency APIs (HPAPIs)

Procos has established new state-of-the art facility to develop and manufacture High potent APIs and intermediates (HPAPI), with dedicated facilities from R&D to cGMP production: 2 Operation Units for HPAPI small scale manufacturing: up to 5 Kg batch; High containment: down to 30 ng/m3; etc.

Potent Compound Containment Monitoring Program

Analytical >> Analytical Testing Services >> High Potency APIs (HPAPIs)

We had Arbro has been supporting numerous clients for their containment monitoring programs. We have established and validated analytical procedures for quantifying numerous beta-lactam, cephalosporin and other potent drugs at ultra trace levels in slab and air samples using LCMSMS.

High Potent Molecules (Oncology, Hormones etc.)

Analytical >> Analytical Testing Services >> High Potency APIs (HPAPIs)

Zenvision has expertise to do the plant setups (concept to commissioning) as per international regulatory compliance.

Analytical testing is a critical part in every step of drug development and manufacturing. The qualitative and quantitative results generated from validated analytical testing provide first-hand information to control and ensure the quality and safety of raw materials, intermediates, and finished products. Like many other CMC (chemical, manufacturing and control) activities, analytical testing is also frequently outsourced. Many factors are attributed to this rapid market growth, including continuous outsourcing from pharmaceutical companies, growing pipelines for biological candidates, and increasing demand for more analytical details on drugs and process development by regulatory agencies. In response to the changing market dynamics, service providers are striving to provide analytical testing with quality, accuracy, and robustness all within tight timelines. As the contract research organizations (CROs) have become more integrated, small analytical labs need to establish their niche to succeed. Global contract analytical Laboratories provide QC laboratory analysis, method development, validation and expert advice for both finished products and raw materials for pharmaceutical and biopharmaceutical companies. Quality Compliance testing is done a wide variety of raw material and finished product forms including High Potent Active Pharmaceutical Ingredients (APIs), Raw Materials and Excipients, Powders - Capsules/Semi-solids, Oils - Oral Solutions and Syrups, Liquids, Vitamins, Minerals, and Nutritional, Natural Health Products (NHPs) – Powders, Herbals – Suspensions, Finished Pharmaceutical Products (Tablets, Capsules/Semi-solids, Oral Solutions and Syrups, Gels, Creams and Ointments, Powders, Suspensions, Transdermals etc.