Drug & Pharmaceutical Analysis
Pharmaceutical quality control, trace residue analysis and phytochemical active ingredient characterisation — to USP, BP, FNA and ANMAT standards.
Biogroup provides analytical services across the full pharmaceutical and nutraceutical quality chain — from sterility and microbiological control to physicochemical purity, residual solvents, ICH Q3D elemental impurities, veterinary drug residues and pesticide residues. Our proprietary extraction-purification-concentration techniques enable unprecedented analysis of phytochemical active principles — polyphenols, flavonoids, alkaloids, isoflavones and anthocyanins directly from plant matrices.
Detection limits achieved in our analytical developments satisfy the most rigorous international requirements for sensitivity, specificity and selectivity — covering USP, European Pharmacopoeia (EP), British Pharmacopoeia (BP) and Argentine Farmacopea Nacional Argentina (FNA) monograph requirements.
• Microbial limit tests — USP <61>/<62> / EP 2.6.12/2.6.13
• TAMC / TYMC — total aerobic and yeast/mould counts
• Specified microorganisms — Salmonella, E. coli, Pseudomonas aeruginosa, S. aureus, Candida albicans, C. perfringens
• Bacterial endotoxins (LAL) — USP <85> / EP 2.6.14
• Hygienic monitoring — environmental and surface monitoring
• Related substances / impurities — HPLC-UV/DAD/MS
• Dissolution / disintegration — USP <711>/<701>
• Uniformity of dosage units — USP <905>
• Water content — Karl Fischer titrimetry
• Specific rotation · Refractive index
• Particle size distribution — laser diffraction
• pH · viscosity · density
• Elemental impurities — ICH Q3D / USP <232>/<233> by ICP-MS
• Heavy metals — USP <231> / ICP-OES
• Organic volatile impurities — USP <467>
• Nitrosamines (NDMA, NDEA, NMBA, NIPEA) — HPLC-MS/MS
• Genotoxic impurities — ICH M7 / CPMP/SWP/5199/02
• HPLC-FLD — fluorescence for trace organics
• HPLC-MS/MS — SRM at sub-ppb levels
• GC-FID/ECD/MS — volatile and semi-volatile compounds
• Capillary Electrophoresis (CE) — chiral separation, ions
• ICP-MS — elemental impurities <5 ppb
• AAS / AAS-HG — specific elements
• UV/Vis spectrophotometry
• Specificity · Linearity · Range
• Accuracy (% recovery) · Precision (repeatability/intermediate)
• Detection limit · Quantification limit
• Robustness (Youden-Steiner)
• System suitability testing per pharmacopoeial requirements
• Hard and soft capsules
• Injectable solutions and lyophilisates
• Oral liquids — solutions, suspensions, syrups, drops
• Creams, gels, ointments — semi-solid forms
• Aerosols and MDIs — dose uniformity, particle size
• Raw materials (APIs and excipients)
• FNA — Farmacopea Nacional Argentina (all active editions)
• Disposición ANMAT 4622/96 — GMP for pharmaceuticals
• SENASA — veterinary drug residue MRLs
• Law 16.463 — Pharmaceutical law
• CONAL — nutraceuticals and dietary supplements
• EP — European Pharmacopoeia (Council of Europe)
• BP — British Pharmacopoeia
• JP — Japanese Pharmacopoeia
• ICH Q2(R1) — Method validation
• ICH Q3A/B/C/D — Impurities guidelines
• ICH M7 — Mutagenic impurities
• EU Reg. 1223/2009 — Cosmetics regulation
• EFSA 2016 — Pyrrolizidine alkaloids opinion
• EU Reg. 2015/1940 — Nitrite/nitrosamines
• WHO — Guidelines on quality of herbal medicines
• EMA — Herbal medicine guidelines (HMPC)