💊 USP · BP · FNA · HPLC · GC-MS · Phytochemicals · Vet Residues · Pesticides · ANMAT

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.

USP · EP · BP · FNA
Four pharmacopoeias
HPLC · GC-MS · CE
Advanced instrumentation
Phytochemicals
Proprietary techniques
+35 years
Pharmaceutical expertise
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Pharmacopoeial compliance
Analysis and reporting aligned with USP (United States Pharmacopoeia), EP (European Pharmacopoeia), BP (British Pharmacopoeia) and FNA (Farmacopea Nacional Argentina) monograph specifications — accepted by ANMAT for product registration and quality audits.
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Phytochemical expertise
Biogroup has developed proprietary extraction, purification and concentration techniques for plant-matrix analytes not covered by standard pharmacopoeial methods — enabling analysis of polyphenols, flavonoids, anthocyanins, alkaloids and isoflavones from complex botanical matrices.
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Trace residue capability
Ultra-trace analysis of veterinary drug residues, pesticide residues, mycotoxins, pyrrolizidine alkaloids, nitrosamines and inorganic contaminants — at ppb and sub-ppb levels in complex pharmaceutical and nutraceutical matrices.
Pharmaceutical quality control — finished product and raw material testing
Complete pharmaceutical quality control to pharmacopoeial specifications
Quality control of raw materials (active pharmaceutical ingredients, excipients) and finished products (tablets, capsules, injectables, liquids, creams, aerosols) — applying USP, EP, BP and FNA monograph test procedures. Method validation available on request.
🦠 Microbiological controls
• Sterility test — USP <71> / EP 2.6.1 (membrane filtration and direct inoculation)
• 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
⚗️ Physicochemical analysis
• Assay (potency) — HPLC, GC, UV/Vis, titrimetry
• 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
🧪 Impurities & contaminants
• Residual solvents — ICH Q3C / USP <467> by GC-HS
• 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
📊 Analytical techniques
• HPLC-UV/DAD — reversed phase, normal phase, ion-pair
• 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
✅ Method validation
• Validation at request — ICH Q2(R1) full validation
• Specificity · Linearity · Range
• Accuracy (% recovery) · Precision (repeatability/intermediate)
• Detection limit · Quantification limit
• Robustness (Youden-Steiner)
• System suitability testing per pharmacopoeial requirements
💊 Dosage form scope
• Tablets (immediate release, extended release, coated)
• 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)
Cosmetics, cleaning and personal hygiene products
Quality control of cosmetics, cleaning products and personal hygiene items
ANMAT Res. 155/98 · EU Regulation 1223/2009 · COLIPA · microbiological challenge testing
Active matter
Anionic, cationic and non-ionic surfactant content by direct titration and two-phase titration (ASTM D4251, ISO 2271)
Preservatives
Parabens, phenoxyethanol, benzalkonium chloride, kathon, DMDM hydantoin — HPLC-UV
Antioxidants
BHA, BHT, tocopherols, vitamin C — HPLC in creams, emulsions and aerosols
Fluoride
F⁻ in oral hygiene products — ion-selective electrode or ion chromatography per ANMAT specifications
Microbiology
Challenge test (preservation efficacy) · USP <51> / EP 5.1.3 · TAMC/TYMC · specified pathogens
Heavy metals
Pb, Cd, Hg, As, Ni, Cr in cosmetics — ICP-MS per EU Reg. 1223/2009 restricted substance list
Aerosol analysis
Propellant content · dose uniformity · particle size distribution · HVLC testing
pH · viscosity
Physical parameters per product specification — applicable to all liquid, gel and cream matrices
Dyes and pigments
Identification and quantification of colourants — HPLC with DAD / MS confirmation
Trace residue analysis — veterinary drugs, pesticides, mycotoxins and contaminants
Ultra-trace contaminant analysis in pharmaceutical, nutraceutical and animal-origin matrices
Applied to raw materials (herbs, botanical extracts, animal-origin APIs), finished products and regulatory submission dossiers. Detection limits at ppb and sub-ppb levels using HPLC-MS/MS, GC-MS and ICP-MS.
🐄 Veterinary Drug Residues
HPLC-MS/MS · EU Reg. 37/2010 · SENASA · ANMAT
Multi-class veterinary drug residue screening in animal-derived pharmaceutical ingredients, honey, propolis, royal jelly, bee pollen and animal-origin APIs.
SulphonamidesTetracyclinesQuinolonesMacrolidesAminoglycosidesPhenicolsβ-LactamsNitrofuransBenzimidazolesEndectocidesAnticoccidialsAntimicrobial dyes
🌿 Pesticide Residues in Phytotherapeutics
GC-MS · HPLC-MS/MS · EP 2.8.13 · EU MRLs
Pesticide residue screening in herbal raw materials, botanical extracts and phytotherapeutic preparations per EP 2.8.13 and EU maximum residue limits. Critical for herbal medicines, dietary supplements and any plant-derived API.
OrganochlorinesOrganophosphatesGlyphosate (HPLC-MS/MS)CarbamatesPyrethroidsBenzimidazolesTriazinesNeonicotinoids
🍄 Mycotoxins
HPLC-MS/MS · immunoaffinity · EP 2.8.18
Mycotoxin contamination in herbal medicines and botanical ingredients per EP 2.8.18. Critical for plant-derived APIs, especially maize, cereals, peanuts and certain root and leaf botanicals.
Aflatoxins B1/B2/G1/G2Ochratoxin ADeoxynivalenol (DON)ZearalenoneFumonisins B1+B2
⚠️ Pyrrolizidine Alkaloids & Other Contaminants
HPLC-MS/MS · EFSA 2016 guidance · hepatotoxic alkaloids
Pyrrolizidine alkaloids (PAs) — hepatotoxic, genotoxic and potentially carcinogenic secondary metabolites occurring as botanical contaminants in herbal medicines and dietary supplements. EFSA 2016 opinion established provisional reference values. Also including nitrosamines, PAHs, phenols, phthalates and benzidines.
SenecionineSeneciophyllineLycopsamineEchimidine+ N-oxides of all aboveNDMA · NDEA · NMBA (nitrosamines)PAHsMelamine + cyanuric acid
Phytochemical active ingredient analysis — Biogroup's proprietary speciality
Unprecedented analytical techniques for plant-matrix phytochemical actives
Biogroup has developed proprietary extraction, purification and concentration protocols that enable chromatographic quantification of phytochemical compounds directly from plant matrices — bypassing the interference problems that make these analyses impossible with standard pharmacopoeial methods. Essential for quality control of herbal medicines, nutraceuticals, botanical extracts and functional foods under development.
🌱 Phytosterols
Soy phytosterols: campesterol, stigmasterol and β-sitosterol — GC after saponification and silylation. Expressed individually and as total phytosterols.
🌸 Soy Isoflavones
Daidzein, genistein and glycitein — HPLC-UV/FLD after enzymatic hydrolysis. Reported as aglycone equivalents. Relevant for functional foods, soy supplements and botanical APIs.
🍵 Catechins
Epicatechin and epigallocatechin (EGC, EGCG) in green tea, cocoa and botanical extracts — HPLC-FLD. The primary quality marker for green tea standardised extracts.
🫐 Anthocyanins
Individual anthocyanin identification and quantification on request: cyanidin, peonidin, delphinidin, petunidin, malvidin, pelargonidin, rosinidin and their glycosides — HPLC-DAD/MS.
🌼 Flavonoids
Quercetin, myricetin, kaempferol, hesperidin, morin and other flavonols and flavanones — HPLC-UV after acid hydrolysis. Applied to standardised botanical extracts.
☕ Alkaloids
Caffeine, theobromine, theophylline in coffee, tea, yerba mate, guarana, cocoa — HPLC-UV. Boldine in boldo. Capsaicin and dihydrocapsaicin in chilli.
🫘 Polyphenols
Total polyphenols by Folin-Ciocalteu method. Individual polyphenol chromatographic profile: chlorogenic, caffeic, gallic, syringic, sinapic, rosmarinic, ferulic, salicylic, cinnamic, vanillinic acids and isomers.
🌿 Antioxidant Capacity
DPPH radical scavenging method (IC₅₀). ABTS method (Trolox equivalents). FRAP (ferric reducing antioxidant power). Applied to extracts, juices, botanical preparations and nutraceuticals.
🌺 Aromatic/Flavour Principles
Thymol · carvacrol · eugenol · capsaicin · diallyl sulphide · piperine · cinnamaldehyde · lycopene — GC-MS / HPLC. Authentication of essential oils, spice extracts and herbal preparations.
🍬 Steviosides
Stevioside, dulcoside A, rebaudioside A and C — HPLC-UV. Hydrolysis residue markers (steviol and isosteviol) to detect adulteration or unauthorised processing.
🟤 Anthraquinones
Aloin (barbaloin) in aloe vera products — HPLC. Regulated in food products (EU Reg.) and relevant for laxative standardised preparations.
🎨 Natural Colours
Bixin and norbixin (annatto) · curcuminoids (turmeric) · carmine · chlorophylls — HPLC-DAD. Quantification for functional colour claims and stability studies.
Regulatory frameworks — pharmacopoeias and authorities
🇦🇷 Argentine regulations
• ANMAT — Administración Nacional de Medicamentos, Alimentos y Tecnología Médica
• 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
🌐 International pharmacopoeias
• USP — United States Pharmacopoeia (current edition)
• 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 & International
• EU Reg. 37/2010 — Vet drug MRLs
• 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)
Reference method organisations
Internationally validated methods applied at Biogroup
USP
United States Pharmacopoeia
Chapters <51> <61> <62> <71> <85> <231> <232> <233> <467> <701> <711> <905> and relevant monographs
EP / BP
European & British Pharmacopoeias
EP 2.6.1/12/13/14 · 2.8.13/18 · all relevant monographs and technical requirements for pharmaceutical testing
FNA
Farmacopea Nacional Argentina
Applicable monographs for all products requiring ANMAT registration in the Argentine market
AOAC
Association of Official Analytical Chemists
Official methods for residue analysis and phytochemical active ingredients
ISO / ASTM
International standards
ISO and ASTM methods for cosmetic and cleaning product analysis
ICH
International Council for Harmonisation
Q2(R1) method validation · Q3A/B/C/D impurities · Q3D elemental impurities · M7 mutagenic impurities
Related services
USP · BP · EP · FNA · HPLC · GC-MS · Phytochemicals · Vet Residues · ANMAT
Need pharmaceutical or nutraceutical analysis?
From routine sterility and potency testing to unprecedented phytochemical active ingredient characterisation — Biogroup delivers the analytical evidence for ANMAT registration, export certification and product development.
Request pharmaceutical analysis →
📞 +54 341 425-6431 📞 +54 341 447-4486 ✉ biogroup@biogroup.com.ar 📍 3 de febrero 920 · Rosario, Argentina Mon–Fri 08:00–17:00