Capabilities

QUALITY STANDARDS

Research Organics is an ISO 9001:2000 certified and registered manufacturer of biochemicals, compliant to strict industry and international standards for Quality Assurance. The company's Quality System monitors batch processes to ensure conformance to controlled specifications, procedures and lot traceability. Quality Systems inspects all batch lots, utilizes statistical process controls and adheres to cGMP guidelines in equipment qualification, product testing, methods validation, change control, impurity profiles, stability studies and out-of-specification procedures.

QUALITY CONTROL TESTING

Quality Control tests raw materials and authorizes release into batch processes. Each in-process and final batch lot is tested to conform to internal and customer specifications. Analytical results are documented in a lot-specific Certificate of Analysis, provided with each product. QC also conducts Trace Metal Analysis on all biological buffers and applicable reagent biochemicals. QC test capabilities include aqueous, non-aqueous, redox, complexometric and argentometric titrations, Karl Fisher titrations (volumetric), melting points,

UV-Vis analysis, infrared identification, conductivity, elemental analysis (CHN/O), Gas Chromatography (GC) and High Performance Liquid Chromatography (HPLC). QC conducts full compedial testing to USP, ACS and FCC standards.

MOLECULAR BIOLOGY GRADE TESTING

Research Organics offers a complete line of Molecular Biology Grade products, tested for absence of DNase, RNase and bacterial contaminants. Special testing services offered for bulk accounts:

• Endotoxin Testing
• USP Objectionable Organism Identification
• Protease Testing
• Cytotoxicity Testing
• Yeast and Mold Testing

BULK PRODUCTION OF BUFFERS AND BIOCHEMICALS

Research Organics specializes in large-scale production of high purity buffers, reagent biochemicals and specialty chemicals.

At our manufacturing plant, Research Organics produces a complete line of biological buffers, which include HEPES, MES, ADA , Bis-Tris, MOPS, PIPES, Tris, BES, Bicine, ACES and Tricine, and salt derivatives, such as Tris HCl, and HEPES Na, MES Na and MOPS Na. The company also bulk manufactures unique second-generation Good's buffers, including MOPSO, POPSO, TAPSO and their sodium salts.

Biochemical reagents and specialty chemicals produced in bulk include amino acid compounds, enzymatic substrates and Trinder reagents.

Buffers and biochemical reagents exhibit high clarity, superior solubility and minimal trace metal content. All processes use non-animal derived raw materials.

Increased batch processing capabilities enable production of up to 1600 kg lot sizes. Production adheres to a strict ISO 9001:2000 compliant documentation program to assure lot consistency, identification and traceability. Batch records are required to follow the product through manufacturing, cleaning, testing, packaging and labeling.

LABORATORY PRODUCTION

Laboratory production chemists synthesize synthetic and rare amino acids, metabolic intermediates, chromogenic substrates, high purity fluorescent label compounds and histochemical stains. Lab synthesis quantities range from milligrams to kilograms.

Research Organics offers custom synthesis and scale-up capabilities. Chemists coordinate with customers' technical personnel to identify critical specifications and develop compounds suitable for these needs.