Raw Materials & API
Testing of raw materials, APIs and excipients
In compliance with ICH standards
QC testing, stability studies, and pharmacopeia analysis
We offer precise analysis services to ensure pharmaceutical ingredients' quality, safety, and compliance.
Our testing is conducted strictly with pharmacopeial standards and customized methodologies to meet specific client needs. Our adherence to GMP guidelines ensures reliable support for our clients' quality control and regulatory submission processes.
API Testing
Purity and Potency Testing: Ensuring that APIs meet specified potency and purity levels.
Impurity Profiling: Identifying and quantifying impurities to meet regulatory standards.
Physical Properties Analysis: Testing characteristics like solubility.
QNTM Labs provides a robust portfolio of pharmaceutical material testing services, ensuring that all products meet rigorous health and safety standards and achieve the highest levels of market readiness.
Raw Material Testing
We provide comprehensive testing services for APIs, raw materials and excipients that ensure the quality and compliance of raw materials used in pharmaceutical.
Our analyses are conducted according to official standards, including pharmacopoeias, as well as customized procedures developed in-house or provided by clients.
We rigorously verify all methods in compliance with GMP regulations to support our clients' quality control processes and product stability programs.
Analytical Services for Raw Materials
Identification Tests: Verifying the identity of raw materials through advanced techniques like HPLC, GC, TLC, FT-IR and spectrophotometry.
Assay: Quantifying active ingredients and excipients to meet labelled or required concentrations.
Microbiological Assays and Tests: Assessing raw materials for microbial contamination to ensure they are safe and comply with microbial limits.
Impurity Detection: Identifying and quantifying impurities and degradation products to ensure they are within acceptable limits.
Heavy Metals Analysis: Testing for toxic metals such as lead, mercury, and arsenic to ensure compliance with safety regulations.
Residual Solvents: Determining the presence of solvent residues left from manufacturing processes to ensure they are below regulatory thresholds.
Compliance and Quality Control
Stability Testing: Evaluating how raw materials hold up under various storage conditions to ensure they maintain quality and efficacy over time.
Pharmacopoeial Compliance: Ensuring all raw materials meet the stringent requirements of pharmacopeias.
Quality Control Testing: Conduct thorough QC tests on each batch of raw materials to confirm consistency and compliance with specifications.