An Active Pharmaceutical Ingredient (API) is the substance in a pharmaceutical drug that is biologically active and responsible for the therapeutic effect. API quality is governed by European Pharmacopoeia (Ph. Eur.) monographs, EU GMP requirements (EudraLex Volume 4, Part II), and Directive 2001/83/EC. Ovalab provides accredited API testing for identity, purity, potency, and related substances.
Key Facts About APIs
- EU regulatory framework: Directive 2001/83/EC (as amended) governs medicinal products. APIs must comply with Ph. Eur. monographs or approved specifications filed in the marketing authorization dossier (CTD Module 3).
- GMP for APIs: EudraLex Volume 4, Part II sets GMP requirements specifically for active substances, aligned with ICH Q7 “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.”
- Key quality parameters: Identity (IR, NMR), assay/potency (HPLC), related substances/impurities (HPLC), residual solvents (GC per ICH Q3C), heavy metals, water content (Karl Fischer), and microbiological quality.
- ICH Q6A: Specifications — Test Procedures and Acceptance Criteria for New Drug Substances. Defines which tests and limits should be included in API specifications.
- Certificates of Analysis: Each API batch requires a Certificate of Analysis (CoA) confirming compliance with specifications, issued by a GMP-certified laboratory.
Testing Methods at Ovalab
Ovalab performs comprehensive API quality testing including assay (HPLC), related substances, residual solvents (GC headspace per ICH Q3C), heavy metals, water content (Karl Fischer), and microbiological examination. Testing follows Ph. Eur. monographs under GMP certification (SÚKL 74726/2023) and ISO/IEC 17025:2017 accreditation (ČIA 537/2025).
Frequently Asked Questions
What tests are required for API quality control?
Standard API testing includes identification (IR spectroscopy or other), assay/potency (typically HPLC), related substances/impurities, residual solvents (ICH Q3C), heavy metals, water content (Karl Fischer), and microbiological quality — as specified in the relevant Ph. Eur. monograph.
What is the difference between an API and an excipient?
An API is the therapeutically active substance that produces the intended pharmacological effect. Excipients are inactive ingredients (binders, fillers, coatings) that serve as the vehicle or matrix for the API in the finished dosage form.
What is ICH Q7?
ICH Q7 is the GMP guideline specifically for active pharmaceutical ingredients, adopted as EudraLex Volume 4, Part II. It covers all aspects of API manufacturing from starting materials through packaging, labeling, and quality control.
Does Ovalab test for residual solvents in APIs?
Yes. Ovalab performs residual solvent analysis by GC headspace per ICH Q3C(R8) and Ph. Eur. 5.4, testing for Class 1, Class 2, and Class 3 solvents with established concentration limits.
Can Ovalab issue Certificates of Analysis for APIs?
Yes. As a GMP-certified laboratory (SÚKL 74726/2023), Ovalab issues Certificates of Analysis confirming API compliance with Ph. Eur. monographs or manufacturer specifications, accepted by regulatory authorities across the EU.