Drug Substance Assay

Inspections of drug substances are designed to confirm manufacturing plants, as well as the quality control laboratory, follow CGMP regulations.

An extensive set of analytical testing and acceptance criteria are applicable to drug substances including universal and specific test criteria established by ICH Q6 guidelines and methods described in the specific monograph for the raw API. All drug substances should undergo a specific, stability-indicating assay to determine their strength and content.

All drug products must be GMP compliant before release for commercial use. We provide the tools you need to release safe and effective medicines, giving you peace of mind when it comes to audits.

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EXPLORE OUR RESOURCES AND ANALYTICAL SOLUTIONS

Direct Trace-Element Analysis in Cell Culture Media and Raw Materials with the NexION 5000 ICP-MS

Introduction Raw material preparation and formulation is a known source of elemental content and variation...

GC-FID: Determination of Diethylene Glycol and Ethylene Glycol according to USP Propylene Glycol Monograph

Introduction Ethylene glycol and diethylene glycol are considered toxic to human health and both are...

GC-FID: Determination of Ethylene Glycol and Diethylene Glycol in Polyethylene Glycol 400 according to USP Monograph

Introduction Polyethylene glycol (PEG) is a polyether compound derived from petroleum and one of the...

GC-FID: Determination of Cetyl Alcohol and Aliphatic Alcohol Impurities According to USP

Introduction Cetyl alcohol, also known as palmityl alcohol or 1-hexadecanol, is a long-chain aliphatic alcohol...

A Novel Approach to Analysis of In-Service Lubricants for Particle Size/Count and Metal Content

Introduction Particle counting is becoming a more routine tool for lubricant condition monitoring and maintenance...

Analysis of Oil Additives Following ASTM D4951 with the Avio 220 Max ICP-OES

Introduction When blending base oils and additives for use as lubricants, it is important to...

Essential Chemistry for Sustainable Energy

Introduction Decarbonization of electricity is playing a key role in meeting the goal of net-zero...

Comprehensive Testing Solutions for Solar Panel Materials

Introduction Free, clean, renewable – the power of the sun has the potential to serve...

Refinery and Natural Gas Analysis Brochure

Oil refineries and natural gas producers around the world require their lab operations to perform...

Advanced Solutions for Biofuels Analysis

Introduction Maximize your laboratory’s prospects in biofuels development and testing while meeting diverse global regulatory...

Battery Analysis Guide

Introduction This guide offers an overview of analyses required throughout the battery value chain –...

PerkinElmer Hand Sanitizer Analyzer – FT-IR for Super Simple Screening

End distributors and hand sanitizer suppliers utilize this simple and affordable screening system for ethanol,...

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