Over-the-counter (OTC) drugs are commonly used by customers for common health conditions like headaches, colds, allergies, stomach issues, and pain relief. In contrast to prescription medication, OTC drugs are commercially available to the public without a physician’s prescription. Since these products are used on such a mass scale, it is critical that they are safe, of good quality, and compliant with regulations.
At Chromak Research, we provide comprehensive OTC medicines testing services to manufacturers, formulators, and scientists. With over 30 years of experience, we support companies in guaranteeing that their OTC products meet FDA, USP, and international quality standards. Our testing programs cover everything from raw material verification to finished product analysis and stability studies.
Importance of OTC Medicines Testing
OTC medications are generally controlled by the active pharmaceutical ingredient (API) instead of the final product. Some of the most popular products are acetaminophen, aspirin, antacids, antihistamines, decongestants, laxatives, and the list goes on and on.
Since the drugs are so readily available, dangers include:
Misuse or abuse of some active ingredients when used in excess of the suggested dosages.
Contamination or impurities during raw materials or during manufacture.
Stability problems that will decrease potency over time.
Inaccurate labeling that may mislead consumers or lead to recalls.
Stand-alone testing ensures OTC drugs are safe, effective, and FDA- and internationally approved.
OTC Services at Chromak Research
Our ISO 17025:2017 certified labs are GLP and cGMP compliant and equipped with state-of-the-art equipment like HPLC, LC-MS/MS, GC-MS, ICP-MS, UV/IR spectroscopy, dissolution apparatus, and stability chambers.
We carry out a broad range of OTC drug testing, including:
Why work with Chromak Research?
30+ years pharmaceutical and over-the-counter product testing experience.
Cross-trained, accredited laboratory with stringent cGMP, GLP, and ISO 17025:2017 adherence.
State-of-the-art technology for accurate OTC API and formulation testing.
Cross-training to fulfill client requirements and comply with regulations.
Transparency of the report to help you ensure product safety and regulatory trust.
Our objective at Chromak Research is to assist manufacturers in putting safe, quality OTC pharmaceuticals onto the shelf while guarding consumer health and brand reputation.
