About Purity Grade Standards
Purity Grade Standards Labs (PGS Labs) provides high-grade, high-quality, and highly characterized products with complete documentation. We work with clients across the globe aiming to provide tools to improve the quality of Active Pharmaceutical Ingredients (APIs) offered to the population. In today’s marketplace, quality and timeliness of delivery are essential for success. PGS prides itself in rapidly and efficiently responding to all clients’ requests, ensuring your Research. Production and Quality Control processes progress seamlessly.
Pharmaceutical impurities are also becoming essential in the registration of APIs, where an exact identification and quantification of susceptible impurities is required for an assured quality and safety. According to the United States National Institute of Health (NIH), “understanding the metabolic and pharmacokinetic fate of a drug in humans is a key factor in its development and registration, as well as in the elaboration of new therapeutic agents. To carry out these studies, stable isotope labeling techniques have been effectively used by drug metabolism scientists and toxicologists in order to gain better understanding of drugs’ disposition, bioavailability and toxicity in in vivo studies” . PGS offers a wide range of Isotopic labeled compounds and metabolites.
We strive to work together with our customers through the entire lifecycle of the production, P&D and QC efforts in order to provide the highest quality of products and services. We supply products to several customers worldwide, including major biotechnology corporations pharmaceutical, contract research organizations, manufacturers of active ingredients, and research institutions.
PGS aims at offering the highest quality of products to our customers, developed by custom synthesis and following customer’s technical specifications, as outlined below:
- Organic process research and development
- Process scale up and custom manufacturing
- From grams to multi-kilograms
- Combinatorial building blocks, intermediates and compound libraries
- Reference compound preparations
- Facilitator for western customers to access India and China
- Bridging the gaps created by cultures and geographic distances
- Supplier evaluation and technical support
- Quality system implementation
All items listed in the PGS Labs catalog are supplied based on the terms and conditions described below. These terms and conditions shall have effect not withstanding any inconsistent provision contained in any document received from a purchaser.
All chemical substances or biological preparations listed in this catalog are distributed exclusively for use as reference standards in tests and assays carried out in accordance to internal validated methods and for no other purpose. These chemical substances are not intended for human use.
PGS Labs makes no representation, contractual statement or expression of opinion concerning the quality or safety of any item supplied, the presence of any defects in it, or fitness for a particular purpose other than those tests and assays conducted in accordance with specific analytical methods and by professionals having technical skills at their own discretion and risk. Purchasers of these items, who are responsible for persons in a workplace, shall independently determine the risks associated with the item according to the conditions of use and to take appropriate safety measures, including provision of appropriate information to persons working with the substance. Any liability of the PGS Labs for injury, loss or damage arising from the supply or use of any such items is in any event hereby excluded to the fullest extent permitted by law. In particular, no liability is accepted for loss of profits or indirect or consequential loss.
The listed Reference Standards, Impurities, Metabolites and Isotopic Enriched compounds comply with our minimum specifications for Quality Control release. The minimum standard for Chemical Purity is 98%, unless noted otherwise.
A Certificate of Analysis is provided with each product shipped, with the exception of NMR Solvents, reagents grades compounds and polymers. All of our products are non-radioactive and have a shelf life comparable to that of the corresponding unlabeled compounds.
Please inquire about any labeled compounds that are not found in the catalog. Such products may have already been prepared but not included in the catalog. PGS Labs would be pleased to provide a quote for custom synthesis. Our extensive expertise in the preparation of stable isotope labeled compounds enables us to offer custom synthesis of products to meet your specific requirements. Please contact our Technical Staff to ask how we can meet your research requirements.