Impurities in finished products and raw materials can seriously impact the safety and efficacy of products. Scientech Laboratories are specialists in impurity profiling, using advanced methods in mass spectrometry to identify and quantify contaminants. Contaminants may come from natural sources, residuals from manufacturing processes, or a result of degradation of active ingredients and excipients over time.

Scientech has high-sensitivity ICP-MS (Inductively Coupled Plasma-Mass Spectrometry) to analyze for elemental impurities such as heavy metals and residual elemental impurities from catalysts in synthetic processes down to ppb (part per billion) levels. Regulatory standards such as USP <233> and ICH Q3D guide Scientech’s methods to ensure compliance with FDA cGMPs and international standards.

Scientech has an advanced LC-MS (Liquid Chromatography-Mass Spectrometry) and GC-MS (Gas Chromatography-Mass Spectrometry) platform for residual impurity and degradant analyses. This includes LC-MS/MS (Liquid Chromatography-Triple Quadrupole Mass Spectrometry) capabilities with high selectivity and sensitivity to ppt (part per trillion) levels.

Residual impurities may include residual solvents (USP <467> & ICH Q3C) analyzed using GC-MS with headspace and direct injection, pesticides and other contaminants in products of botanical origin (USP <561>), process-related impurities such residual starting materials, intermediates, and byproducts. Depending on the chemical properties of the impurities, GC-MS and/or LC-MS methods may be required. Scientech’s highly experienced team of scientists can advise on the best methods to address your impurity testing needs.

Degradants in products such as impurities that arise over time from the API (Active Pharmaceutical Ingredient) or excipients (USP <1086>), nitrosamines (USP <1469> and ICH M7), or extractables & leachables from container closure (USP <1663 & 1664> and ICH Q3E) can seriously impact the safety of finished products. The FDA has recalled several products over the past year due to the presence of small molecule nitrosamine and NDSRI (Nitrosamine Drug Substance Related Impurities) contaminants.

Scientech Laboratories is an FDA cGMP-compliant, MoCRA-registered and ISO 17025 accredited analytical services business that has been family-owned and operated for 45 years. We support the Pharmaceutical, OTC drug, Cosmetics, and Dietary Supplement industries with product release testing, raw material qualification, impurity profiling, heavy metals, nitrosamines, extractables & leachables, microbiology, stability studies and much more.