Pharmaceutical Product Quality Control
Before a pharmaceutical, over-the-counter (OTC) drug can enter the market, it must undergo an extensive series of testings to ensure it meets regulatory requirements and standards. BOC Sciences' team has over many years of experience in the pharmaceutical industry, and whether you need wet chemical analysis testing of raw materials or finished products, our in-house experts can provide one-on-one guidance to help navigate the regulatory and pharmacopeial requirements for bringing your new products to market. BOC Sciences offers routine 10-15 business day turnaround-time for pharmaceutical raw material testing, which applies to USP, EP, JP, BP, FCC and ACS.
Our Capabilities & Services
- Bench work for routine and investigational wet chemistry analysis of raw materials
- Method validation of of pharmacopoeia wet chemistry methods
- Provide high-quality customer service to ensure the integrity of the analytical data generated and timely/accurate GMP compliant results
- Maintenance and troubleshooting of laboratory equipment
- Generate certificate analysis or external interpretation reports
Pharmaceutical Elemental Impurities Analysis
The purpose of elemental analysis of pharmaceutical products is to identify impurities that may contaminate the drug. All potential sources of impurities in pharmaceutical products include excipients, water, the active pharmaceutical ingredient itself, as well as container systems and manufacturing processes. BOC Sciences is able to provide ICP technology (ICP-MS and ICP-AES)-based wet chemistry analysis. Our experts are able to analyze USP Class 1 impurities and USP Class 2 impurities including Cd, Pb, As, Hg, Ir, Os, Pd, Pt, Rh, Ru, Cr, Mo, Ni, V and Cu. In addition, we have developed and validated analytical methods for specific elements.
Moisture Content Determination
Moisture content measurement has long been a part of routine, regular testing to ensure the quality of pharmaceutical products. From checking raw materials and process control of tablets and capsules to the production of finished drugs, moisture analysis is an important part of drug quality control. BOC Sciences has extensive experience in moisture analysis of pharmaceuticals, and we offer tested drying methods for many common pharmaceutical raw materials and excipients. Our analytical team offers Karl Fischer (KF) titration and moisture analyzers to provide our customers with accurate, rapid and selective determination of moisture content in pharmaceutical products.
Limit Tests for Impurities Detection
Limit testing is a quantitative or semi-quantitative test designed to identify and control small amounts of impurities that may be present in pharmaceutical raw materials and finished products. At BOC Sciences, our limit testing services are able to determine the presence of various inorganic impurities (sulfates, chlorides, arsenic, etc.) and microorganisms in samples. We have introduced a state-of-the-art controlled and HEPA-filtered microbiology laboratory facility to quickly and efficiently complete microbial limit testing programs for pharmaceuticals, including testing for specific undesirable organisms and microbial counts.
Residual Solvent Testing
Residual solvents in pharmaceuticals are organic volatile compounds used or generated in the manufacturing of drug substances or excipients, in the preparation of drug products, or in packaging and storage. Removal of these toxic volatile organic compounds from pharmaceuticals is an important part of drug manufacturing. Our analysts provide comprehensive residual solvent analysis solutions for pharmaceutical substances (APIs), drug products and excipients, and we can provide wet chemical analysis methods at any stage of development. BOC Sciences has a comprehensive wet chemistry analytical laboratory that can provide robust testing for all types of solvents for different applications to ensure the safety and quality of your pharmaceutical products, including solvents that require avoidance of toxic solvents, solvents that require restriction such as genotoxic animal carcinogens, and solvents with low toxicity potential.
Loss on Drying (LOD) for Volatile Content Monitoring
Determination of the moisture content of a material is important for quality control of the drug as well as health and safety protection. Too much moisture in a drug can lead to adhesion, while too little moisture can lead to low stiffness and friability. Loss on drying is a common method for determining moisture content. BOC Sciences' wet chemical analysis laboratory has introduced state-of-the-art moisture analysis technology that provides a complete range of test parameters. Our LOD testing can be used to determine the amount of volatiles (including water, fats, volatile solvents and alcohols) in tablets, capsules or bulk materials.
Residue on Ignition (ROI) for Inorganic Impurities Determination
As a classical type of gravimetric testing, residue on ignition testing is a common analytical method widely used in batch release testing of small-molecule drugs. By collecting the precipitate or residue and drying or igniting it, the ratio of inorganic to organic components in the sample can be accurately determined. BOC Sciences has many years of experience in providing best-in-class wet chemical analysis services for a wide range of pharmaceutical samples. Our novel wet ashing method can be used to measure the amount of residual material that remains unvolatilized when the sample is ignited in the presence of sulfuric acid, thereby determining the amount of inorganic impurities in the organic material.
Dissolution Testing
From early drug development to later quality control in commercial production, the dissolution of a drug has a non-negligible impact on each step. Drug dissolution testing provides drug manufacturers with valuable insights into how dosage forms affect their efficacy. BOC Sciences is committed to providing highly accurate dissolution testing services to measure the rate at which drugs are released from their dosage forms. We offer a broad range of dissolution testing methods for a variety of drug dosage forms ( including tablets, capsules, powders, suspensions, transdermal dosage forms, etc.) including: USP Dissolution Meter I- Basket Method, USP Dissolution Meter II - Paddle Method, USP Dissolution Apparatus III - Reciprocating Cylinder Method, USP Dissolution Apparatus IV - Flow-through Cell, USP Dissolution Apparatus V - Paddle over Disk and USP Dissolution Apparatus VI - Reciprocating Holder Apparatus.
Pharmaceutical Analysis Technologies & Facilities
- ICP Mass Spectrometry (ICP-MS)
- ICP Atomic Emission Spectroscopy (ICP-AES)
- Karl Fischer (KF) Titration
Why Choose BOC Sciences
- BOC Sciences has a team of experienced chemists and our sample management system ensures traceability of samples
- All test documentation is professionally detailed and a full GMP review is performed upon completion of testing and prior to issuance of the COA
- Our dedicated quality assurance group make sure the final results are accurate and reliable.