OTC
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:
Purity, strength, and identity verification.
USP, EP, JP, and FCC compliant testing.
Real-time and accelerated shelf life and expiration date studies.
Residual solvent, heavy metals, microbial impurities, and unidentified impurities.
Performance of the formulation vs. reference standards.
Enabling product innovation and optimization
Specialized protocols for intricate or cutting-edge products.
Attaining microbial safety throughout shelf-life.
Verifying compliance under changing conditions.
Assessing packaging and CCS performance.
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.
FAQs – OTC Medicine Testing
Because OTC medications are so readily available, they need to be held to high standards of quality and safety to ensure public health. Testing ensures that the product is active, pure, and devoid of any deleterious adulterants.
Yes. All OTC drugs are expected to meet FDA safety, effectiveness, and labeling requirements. Independent testing is used to confirm compliance.
Heavy metals, residual solvent, microbial contamination, and undeclared active ingredients are the most frequent impurities analyzed in OTC products.
Stability studies validate the shelf-life of the drug product to ensure the API retains its efficacy and safety for its labeled expiration date.
Yes. We have expertise in method development, validation, and transfer of specialty or challenging formulations that do not meet traditional testing protocols.