Advancing Drug Purity: Impurity Standards for Josamycin, Ketamine & Maduramicin from Aquigen Bio - Rude0214851/Blog GitHub Wiki

In the pharmaceutical industry, impurity profiling is a cornerstone of quality assurance. As drug development becomes more complex and regulated, access to precise and reliable impurity standards is vital. At Aquigen Bio, we are proud to support this need through an ever-expanding catalog of impurity reference materials tailored to modern pharmaceutical and bioanalytical research.

Today, we spotlight three critical categories of impurity standards that play a key role in anti-infectives, anesthetics, and veterinary applications: Josamycin Propionate, Ketamine Hydrochloride, and Maduramicin.

Josamycin Propionate Impurity Standards: Enhancing Macrolide Accuracy Josamycin Propionate is a macrolide antibiotic used to treat respiratory tract infections and skin diseases. Ensuring its safety and efficacy requires identifying and quantifying its possible impurities, including EP-listed ones.

Aquigen Bio offers a focused range of Josamycin Propionate impurity standards, essential for analytical method development and validation:

Josamycin Propionate — The primary macrolide compound supplied in highly pure form. Josamycin Propionate EP Impurity A — Supports analytical profiling and helps meet pharmacopoeial specifications. Josamycin Propionate EP Impurity B — Critical in stability studies and impurity threshold evaluations. With these impurity standards, pharmaceutical labs can conduct accurate impurity quantification, helping reduce batch failures and maintain consistent product quality.

Ketamine Hydrochloride & Analog Impurities: Ensuring Safety in Anesthetics Ketamine Hydrochloride is a widely used dissociative anesthetic with emerging roles in treating depression and PTSD. The demand for precise impurity standards around ketamine is increasing, particularly as new analogs and degradation products come under regulatory focus.

Aquigen Bio provides both the parent compound and structurally related impurities including:

Ethyl Ketamine — A key analog impurity used in forensic toxicology and formulation stability testing. Hydroxynorketamine Hydrochloride — An active metabolite of ketamine important for pharmacokinetic profiling. These reference standards assist in developing advanced analytical methods (HPLC, LC-MS) for quality control and bioavailability studies. Accurate profiling of these impurities is critical for both clinical and research-based ketamine formulations.

Explore the full Ketamine Hydrochloride impurity standard category to support your regulatory submission and product development workflows.

Maduramicin Ammonium Salt: Supporting Veterinary Drug Purity Maduramicin is an ionophore antibiotic used extensively in veterinary medicine, particularly for the prevention of coccidiosis in poultry. Regulatory guidelines demand strict control over its purity and associated impurities to ensure animal safety and residue compliance.

Aquigen Bio offers:

Maduramicin Ammonium Salt — A high-purity compound supplied with full COA documentation for use in reference studies and impurity profiling. With the growing demand for impurity testing in veterinary formulations, the availability of standardized reference materials like Maduramicin helps ensure regulatory compliance and global product approval.

For a complete list of related reference materials, view the dedicated Maduramicin impurity category.

Why Choose Aquigen Bio for Impurity Standards? Extensive catalog of >700 impurity and metabolite standards COA and spectral data (NMR, LC-MS) included with every compound Custom synthesis and global shipping support Compliant with ICH Q3A/B and pharmacopoeial guidelines Final Thoughts Whether you’re working on antibiotics, anesthetics, or veterinary APIs, Aquigen Bio delivers high-quality impurity standards to ensure compliance, accuracy, and reproducibility. Our offerings in Josamycin Propionate, Ethyl Ketamine, and Maduramicin Ammonium Salt are trusted by global pharmaceutical labs for analytical excellence.