Pharmaceutical Impurity & Primary Reference Standards

Crescent Chemical Company, Inc. is a full line distributor for LGC Standards including their lines of Pharmaceutical Impurity Standards and Pharmaceutical Reference Standards. 

Pharmaceutical Impurity Reference Standards 

Extensive testing is required prior to obtaining approval to place a pharmaceutical drug on the market. As trace amounts of impurities are inevitably present in manufactured drugs, there are specific threshold values set by officials such as pharmacopoeias and ICH guidelines. These impurities can alter the effectiveness and side effects of drug products making analysis and stringent rules necessary before they are available on the market. Drug products on the market are regulated by authorities such as the FDA.

Crescent Chemical Co., Inc. provides over 3000 Pharmaceutical Impurity Reference Standards, manufactured by LGC standards to detect, identify, quantify, and qualify impurities. The pharmaceutical impurity reference materials are all manufactured in compliance with international regulations. 

The impurities reference standards are of the highest purity and are provided with a comprehensive Certificate of Analysis. The CoA provides NMR data as well as mass spectrometry and infrared data. Results of purity and assay are also included with data from an HPLC chromatogram, water content, and residual solvent content.

Primary Reference Standards 

Our company provides primary standards (LGCQuant). Unlike standards provided by the USP, our standards are extremely characterized, accompanied with a comprehensive certificate of analysis. Our products are equivalent to USP guidelines for primary reference standards. They are manufactured completely by LGC making it cost effective to test for impurities. There are new standards being produced every month, in addition to the 3,000 plus reference standards already available. The new products are all manufactured in accordance to ISO Guide 34 as well as to ISO Guide 17025 for some.

These products are all manufactured in accordance with ISO Guide 34, GMP/GLP, ISO 9001, ISO/IEC 17025, and ISO/IEC 17043.

AttachmentSize
Pharmaceutical Impurities5.38 MB
Primary Standards522.71 KB