{"id":989746,"date":"2022-12-02T14:06:29","date_gmt":"2022-12-02T17:06:29","guid":{"rendered":"https:\/\/biogroup.com.ar\/drug-analysis\/"},"modified":"2026-05-19T07:10:06","modified_gmt":"2026-05-19T10:10:06","slug":"drug-analysis","status":"publish","type":"page","link":"https:\/\/biogroup.com.ar\/en\/drug-analysis\/","title":{"rendered":"Drug Analysis"},"content":{"rendered":"\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t
\n
<\/div>\n
\n
\n \ud83d\udc8a USP \u00b7 BP \u00b7 FNA \u00b7 HPLC \u00b7 GC-MS \u00b7 Phytochemicals \u00b7 Vet Residues \u00b7 Pesticides \u00b7 ANMAT\n <\/div>\n

\n Drug & Pharmaceutical Analysis<\/span>\n <\/h1>\n

\n Pharmaceutical quality control, trace residue analysis and phytochemical\n active ingredient characterisation \u2014 to USP, BP, FNA and ANMAT standards.\n <\/p>\n

\n Biogroup provides analytical services across the full pharmaceutical and\n nutraceutical quality chain \u2014 from sterility and\n microbiological control to physicochemical purity<\/strong>, residual solvents,\n ICH Q3D elemental impurities, veterinary drug residues and pesticide residues.\n Our proprietary extraction-purification-concentration techniques enable\n unprecedented analysis of phytochemical active\n principles<\/strong> \u2014 polyphenols, flavonoids, alkaloids, isoflavones and\n anthocyanins directly from plant matrices.\n <\/p>\n

\n Detection limits achieved in our analytical developments satisfy the most\n rigorous international requirements for sensitivity, specificity and selectivity \u2014\n covering USP, European Pharmacopoeia (EP), British Pharmacopoeia (BP) and\n Argentine Farmacopea Nacional Argentina (FNA) monograph requirements.\n <\/p>\n

\n
USP \u00b7 EP \u00b7 BP \u00b7 FNA<\/div>\n
Four pharmacopoeias<\/div><\/div>\n
HPLC \u00b7 GC-MS \u00b7 CE<\/div>\n
Advanced instrumentation<\/div><\/div>\n
Phytochemicals<\/div>\n
Proprietary techniques<\/div><\/div>\n
+35 years<\/div>\n
Pharmaceutical expertise<\/div><\/div>\n <\/div>\n <\/div>\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t
\n
\n
\ud83d\udccb<\/div>\n
\n Pharmacopoeial compliance<\/div>\n
Analysis and reporting\n aligned with USP (United States Pharmacopoeia), EP (European Pharmacopoeia),\n BP (British Pharmacopoeia) and FNA (Farmacopea Nacional Argentina) monograph\n specifications \u2014 accepted by ANMAT for product registration and quality audits.<\/div>\n <\/div>\n
\n
\ud83c\udf3f<\/div>\n
\n Phytochemical expertise<\/div>\n
Biogroup has developed\n proprietary extraction, purification and concentration techniques for plant-matrix\n analytes not covered by standard pharmacopoeial methods \u2014 enabling analysis of\n polyphenols, flavonoids, anthocyanins, alkaloids and isoflavones from complex\n botanical matrices.<\/div>\n <\/div>\n
\n
\ud83d\udd2c<\/div>\n
\n Trace residue capability<\/div>\n
Ultra-trace analysis of\n veterinary drug residues, pesticide residues, mycotoxins, pyrrolizidine alkaloids,\n nitrosamines and inorganic contaminants \u2014 at ppb and sub-ppb levels in complex\n pharmaceutical and nutraceutical matrices.<\/div>\n <\/div>\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t
\n
<\/div>\n Pharmaceutical quality control \u2014 finished product and raw material testing<\/span>\n
<\/div>\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t
\n
\n Complete pharmaceutical quality control to pharmacopoeial specifications<\/div>\n
\n Quality control of raw materials (active pharmaceutical ingredients, excipients)\n and finished products (tablets, capsules, injectables, liquids, creams, aerosols)\n \u2014 applying USP, EP, BP and FNA monograph test procedures. Method validation\n available on request.<\/div>\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t
\n\n
\n
\n
\ud83e\udda0 Microbiological controls<\/div>\n <\/div>\n
\n
\n \u2022 Sterility test<\/strong> \u2014 USP <71> \/ EP 2.6.1 (membrane filtration and direct inoculation)
\n \u2022 Microbial limit tests<\/strong> \u2014 USP <61>\/<62> \/ EP 2.6.12\/2.6.13
\n \u2022 TAMC \/ TYMC<\/strong> \u2014 total aerobic and yeast\/mould counts
\n \u2022 Specified microorganisms<\/strong> \u2014 Salmonella, E. coli, Pseudomonas aeruginosa, S. aureus, Candida albicans, C. perfringens<\/em>
\n \u2022 Bacterial endotoxins<\/strong> (LAL) \u2014 USP <85> \/ EP 2.6.14
\n \u2022 Hygienic monitoring<\/strong> \u2014 environmental and surface monitoring\n <\/div>\n <\/div>\n <\/div>\n\n
\n
\n
\u2697\ufe0f Physicochemical analysis<\/div>\n <\/div>\n
\n
\n \u2022 Assay (potency)<\/strong> \u2014 HPLC, GC, UV\/Vis, titrimetry
\n \u2022 Related substances \/ impurities<\/strong> \u2014 HPLC-UV\/DAD\/MS
\n \u2022 Dissolution \/ disintegration<\/strong> \u2014 USP <711>\/<701>
\n \u2022 Uniformity of dosage units<\/strong> \u2014 USP <905>
\n \u2022 Water content<\/strong> \u2014 Karl Fischer titrimetry
\n \u2022 Specific rotation<\/strong> \u00b7 Refractive index<\/strong>
\n \u2022 Particle size distribution<\/strong> \u2014 laser diffraction
\n \u2022 pH \u00b7 viscosity \u00b7 density<\/strong>\n <\/div>\n <\/div>\n <\/div>\n\n
\n
\n
\ud83e\uddea Impurities & contaminants<\/div>\n <\/div>\n
\n
\n \u2022 Residual solvents<\/strong> \u2014 ICH Q3C \/ USP <467> by GC-HS
\n \u2022 Elemental impurities<\/strong> \u2014 ICH Q3D \/ USP <232>\/<233> by ICP-MS
\n \u2022 Heavy metals<\/strong> \u2014 USP <231> \/ ICP-OES
\n \u2022 Organic volatile impurities<\/strong> \u2014 USP <467>
\n \u2022 Nitrosamines<\/strong> (NDMA, NDEA, NMBA, NIPEA) \u2014 HPLC-MS\/MS
\n \u2022 Genotoxic impurities<\/strong> \u2014 ICH M7 \/ CPMP\/SWP\/5199\/02\n <\/div>\n <\/div>\n <\/div>\n\n
\n
\n
\ud83d\udcca Analytical techniques<\/div>\n <\/div>\n
\n
\n \u2022 HPLC-UV\/DAD<\/strong> \u2014 reversed phase, normal phase, ion-pair
\n \u2022 HPLC-FLD<\/strong> \u2014 fluorescence for trace organics
\n \u2022 HPLC-MS\/MS<\/strong> \u2014 SRM at sub-ppb levels
\n \u2022 GC-FID\/ECD\/MS<\/strong> \u2014 volatile and semi-volatile compounds
\n \u2022 Capillary Electrophoresis<\/strong> (CE) \u2014 chiral separation, ions
\n \u2022 ICP-MS<\/strong> \u2014 elemental impurities <5 ppb
\n \u2022 AAS \/ AAS-HG<\/strong> \u2014 specific elements
\n \u2022 UV\/Vis spectrophotometry<\/strong>\n <\/div>\n <\/div>\n <\/div>\n\n
\n
\n
\u2705 Method validation<\/div>\n <\/div>\n
\n
\n \u2022 Validation at request \u2014 ICH Q2(R1) full validation
\n \u2022 Specificity \u00b7 Linearity \u00b7 Range<\/strong>
\n \u2022 Accuracy (% recovery) \u00b7 Precision (repeatability\/intermediate)<\/strong>
\n \u2022 Detection limit \u00b7 Quantification limit<\/strong>
\n \u2022 Robustness<\/strong> (Youden-Steiner)
\n \u2022 System suitability testing per pharmacopoeial requirements\n <\/div>\n <\/div>\n <\/div>\n\n
\n
\n
\ud83d\udc8a Dosage form scope<\/div>\n <\/div>\n
\n
\n \u2022 Tablets<\/strong> (immediate release, extended release, coated)
\n \u2022 Hard and soft capsules<\/strong>
\n \u2022 Injectable solutions<\/strong> and lyophilisates
\n \u2022 Oral liquids<\/strong> \u2014 solutions, suspensions, syrups, drops
\n \u2022 Creams, gels, ointments<\/strong> \u2014 semi-solid forms
\n \u2022 Aerosols and MDIs<\/strong> \u2014 dose uniformity, particle size
\n \u2022 Raw materials (APIs and excipients)<\/strong>\n <\/div>\n <\/div>\n <\/div>\n\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t
\n
<\/div>\n Cosmetics, cleaning and personal hygiene products<\/span>\n
<\/div>\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t
\n
\n
\n Quality control of cosmetics, cleaning products and personal hygiene items<\/div>\n
\n ANMAT Res. 155\/98 \u00b7 EU Regulation 1223\/2009 \u00b7 COLIPA \u00b7 microbiological challenge testing<\/div>\n <\/div>\n
\n
\n
Active matter<\/div>
Anionic, cationic and non-ionic surfactant content by direct titration and two-phase titration (ASTM D4251, ISO 2271)<\/div><\/div>
Preservatives<\/div>
Parabens, phenoxyethanol, benzalkonium chloride, kathon, DMDM hydantoin \u2014 HPLC-UV<\/div><\/div>
Antioxidants<\/div>
BHA, BHT, tocopherols, vitamin C \u2014 HPLC in creams, emulsions and aerosols<\/div><\/div>
Fluoride<\/div>
F\u207b in oral hygiene products \u2014 ion-selective electrode or ion chromatography per ANMAT specifications<\/div><\/div>
Microbiology<\/div>
Challenge test (preservation efficacy) \u00b7 USP <51> \/ EP 5.1.3 \u00b7 TAMC\/TYMC \u00b7 specified pathogens<\/div><\/div>
Heavy metals<\/div>
Pb, Cd, Hg, As, Ni, Cr in cosmetics \u2014 ICP-MS per EU Reg. 1223\/2009 restricted substance list<\/div><\/div>
Aerosol analysis<\/div>
Propellant content \u00b7 dose uniformity \u00b7 particle size distribution \u00b7 HVLC testing<\/div><\/div>
pH \u00b7 viscosity<\/div>
Physical parameters per product specification \u2014 applicable to all liquid, gel and cream matrices<\/div><\/div>
Dyes and pigments<\/div>
Identification and quantification of colourants \u2014 HPLC with DAD \/ MS confirmation<\/div><\/div>\n <\/div>\n <\/div>\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t
\n
<\/div>\n Trace residue analysis \u2014 veterinary drugs, pesticides, mycotoxins and contaminants<\/span>\n
<\/div>\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t
\n
\n Ultra-trace contaminant analysis in pharmaceutical, nutraceutical and animal-origin matrices<\/div>\n
\n Applied to raw materials (herbs, botanical extracts, animal-origin APIs), finished products\n and regulatory submission dossiers. Detection limits at ppb and sub-ppb levels using\n HPLC-MS\/MS, GC-MS and ICP-MS.<\/div>\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t
\n\n
\n
\n
\ud83d\udc04 Veterinary Drug Residues<\/div>\n
HPLC-MS\/MS \u00b7 EU Reg. 37\/2010 \u00b7 SENASA \u00b7 ANMAT<\/div>\n <\/div>\n
\n
\n Multi-class veterinary drug residue screening in animal-derived pharmaceutical\n ingredients, honey, propolis, royal jelly, bee pollen and animal-origin APIs.<\/div>\n
\n Sulphonamides<\/span>Tetracyclines<\/span>Quinolones<\/span>Macrolides<\/span>Aminoglycosides<\/span>Phenicols<\/span>\u03b2-Lactams<\/span>Nitrofurans<\/span>Benzimidazoles<\/span>Endectocides<\/span>Anticoccidials<\/span>Antimicrobial dyes<\/span>\n <\/div>\n <\/div>\n <\/div>\n\n
\n
\n
\ud83c\udf3f Pesticide Residues in Phytotherapeutics<\/div>\n
GC-MS \u00b7 HPLC-MS\/MS \u00b7 EP 2.8.13 \u00b7 EU MRLs<\/div>\n <\/div>\n
\n
\n Pesticide residue screening in herbal raw materials, botanical extracts and\n phytotherapeutic preparations per EP 2.8.13 and EU maximum residue limits.\n Critical for herbal medicines, dietary supplements and any plant-derived API.<\/div>\n
\n Organochlorines<\/span>Organophosphates<\/span>Glyphosate (HPLC-MS\/MS)<\/span>Carbamates<\/span>Pyrethroids<\/span>Benzimidazoles<\/span>Triazines<\/span>Neonicotinoids<\/span>\n <\/div>\n <\/div>\n <\/div>\n\n
\n
\n
\ud83c\udf44 Mycotoxins<\/div>\n
HPLC-MS\/MS \u00b7 immunoaffinity \u00b7 EP 2.8.18<\/div>\n <\/div>\n
\n
\n Mycotoxin contamination in herbal medicines and botanical ingredients per EP\n 2.8.18. Critical for plant-derived APIs, especially maize, cereals, peanuts\n and certain root and leaf botanicals.<\/div>\n
\n Aflatoxins B1\/B2\/G1\/G2<\/span>Ochratoxin A<\/span>Deoxynivalenol (DON)<\/span>Zearalenone<\/span>Fumonisins B1+B2<\/span>\n <\/div>\n <\/div>\n <\/div>\n\n
\n
\n
\u26a0\ufe0f Pyrrolizidine Alkaloids & Other Contaminants<\/div>\n
HPLC-MS\/MS \u00b7 EFSA 2016 guidance \u00b7 hepatotoxic alkaloids<\/div>\n <\/div>\n
\n
\n Pyrrolizidine alkaloids (PAs) \u2014 hepatotoxic, genotoxic and potentially carcinogenic\n secondary metabolites occurring as botanical contaminants in herbal medicines and\n dietary supplements. EFSA 2016 opinion established provisional reference values.\n Also including nitrosamines, PAHs, phenols, phthalates and benzidines.<\/div>\n
\n Senecionine<\/span>Seneciophylline<\/span>Lycopsamine<\/span>Echimidine<\/span>+ N-oxides of all above<\/span>NDMA \u00b7 NDEA \u00b7 NMBA (nitrosamines)<\/span>PAHs<\/span>Melamine + cyanuric acid<\/span>\n <\/div>\n <\/div>\n <\/div>\n\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t
\n
<\/div>\n Phytochemical active ingredient analysis \u2014 Biogroup's proprietary speciality<\/span>\n
<\/div>\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t
\n
\n Unprecedented analytical techniques for plant-matrix phytochemical actives<\/div>\n
\n Biogroup has developed proprietary extraction, purification and concentration protocols\n that enable chromatographic quantification of phytochemical compounds directly from\n plant matrices \u2014 bypassing the interference problems that make these analyses\n impossible with standard pharmacopoeial methods. Essential for quality control of\n herbal medicines, nutraceuticals, botanical extracts and functional foods under development.<\/div>\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t
\n
\ud83c\udf31 Phytosterols<\/div><\/div>
Soy phytosterols: campesterol, stigmasterol and \u03b2-sitosterol \u2014 GC after saponification and silylation. Expressed individually and as total phytosterols.<\/div><\/div>
\ud83c\udf38 Soy Isoflavones<\/div><\/div>
Daidzein, genistein and glycitein \u2014 HPLC-UV\/FLD after enzymatic hydrolysis. Reported as aglycone equivalents. Relevant for functional foods, soy supplements and botanical APIs.<\/div><\/div>
\ud83c\udf75 Catechins<\/div><\/div>
Epicatechin and epigallocatechin (EGC, EGCG) in green tea, cocoa and botanical extracts \u2014 HPLC-FLD. The primary quality marker for green tea standardised extracts.<\/div><\/div>
\ud83e\uded0 Anthocyanins<\/div><\/div>
Individual anthocyanin identification and quantification on request: cyanidin, peonidin, delphinidin, petunidin, malvidin, pelargonidin, rosinidin and their glycosides \u2014 HPLC-DAD\/MS.<\/div><\/div>
\ud83c\udf3c Flavonoids<\/div><\/div>
Quercetin, myricetin, kaempferol, hesperidin, morin and other flavonols and flavanones \u2014 HPLC-UV after acid hydrolysis. Applied to standardised botanical extracts.<\/div><\/div>
\u2615 Alkaloids<\/div><\/div>
Caffeine, theobromine, theophylline in coffee, tea, yerba mate, guarana, cocoa \u2014 HPLC-UV. Boldine in boldo. Capsaicin and dihydrocapsaicin in chilli.<\/div><\/div>
\ud83e\uded8 Polyphenols<\/div><\/div>
Total polyphenols by Folin-Ciocalteu method. Individual polyphenol chromatographic profile: chlorogenic, caffeic, gallic, syringic, sinapic, rosmarinic, ferulic, salicylic, cinnamic, vanillinic acids and isomers.<\/div><\/div>
\ud83c\udf3f Antioxidant Capacity<\/div><\/div>
DPPH radical scavenging method (IC\u2085\u2080). ABTS method (Trolox equivalents). FRAP (ferric reducing antioxidant power). Applied to extracts, juices, botanical preparations and nutraceuticals.<\/div><\/div>
\ud83c\udf3a Aromatic\/Flavour Principles<\/div><\/div>
Thymol \u00b7 carvacrol \u00b7 eugenol \u00b7 capsaicin \u00b7 diallyl sulphide \u00b7 piperine \u00b7 cinnamaldehyde \u00b7 lycopene \u2014 GC-MS \/ HPLC. Authentication of essential oils, spice extracts and herbal preparations.<\/div><\/div>
\ud83c\udf6c Steviosides<\/div><\/div>
Stevioside, dulcoside A, rebaudioside A and C \u2014 HPLC-UV. Hydrolysis residue markers (steviol and isosteviol) to detect adulteration or unauthorised processing.<\/div><\/div>
\ud83d\udfe4 Anthraquinones<\/div><\/div>
Aloin (barbaloin) in aloe vera products \u2014 HPLC. Regulated in food products (EU Reg.) and relevant for laxative standardised preparations.<\/div><\/div>
\ud83c\udfa8 Natural Colours<\/div><\/div>
Bixin and norbixin (annatto) \u00b7 curcuminoids (turmeric) \u00b7 carmine \u00b7 chlorophylls \u2014 HPLC-DAD. Quantification for functional colour claims and stability studies.<\/div><\/div>\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t
\n
<\/div>\n Regulatory frameworks \u2014 pharmacopoeias and authorities<\/span>\n
<\/div>\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t
\n
\n
\n
\ud83c\udde6\ud83c\uddf7 Argentine regulations<\/div>\n <\/div>\n
\n
\n \u2022 ANMAT<\/strong> \u2014 Administraci\u00f3n Nacional de Medicamentos, Alimentos y Tecnolog\u00eda M\u00e9dica
\n \u2022 FNA<\/strong> \u2014 Farmacopea Nacional Argentina (all active editions)
\n \u2022 Disposici\u00f3n ANMAT 4622\/96<\/strong> \u2014 GMP for pharmaceuticals
\n \u2022 SENASA<\/strong> \u2014 veterinary drug residue MRLs
\n \u2022 Law 16.463<\/strong> \u2014 Pharmaceutical law
\n \u2022 CONAL<\/strong> \u2014 nutraceuticals and dietary supplements\n <\/div>\n <\/div>\n <\/div>\n
\n
\n
\ud83c\udf10 International pharmacopoeias<\/div>\n <\/div>\n
\n
\n \u2022 USP<\/strong> \u2014 United States Pharmacopoeia (current edition)
\n \u2022 EP<\/strong> \u2014 European Pharmacopoeia (Council of Europe)
\n \u2022 BP<\/strong> \u2014 British Pharmacopoeia
\n \u2022 JP<\/strong> \u2014 Japanese Pharmacopoeia
\n \u2022 ICH Q2(R1)<\/strong> \u2014 Method validation
\n \u2022 ICH Q3A\/B\/C\/D<\/strong> \u2014 Impurities guidelines
\n \u2022 ICH M7<\/strong> \u2014 Mutagenic impurities\n <\/div>\n <\/div>\n <\/div>\n
\n
\n
\ud83c\uddea\ud83c\uddfa EU & International<\/div>\n <\/div>\n
\n
\n \u2022 EU Reg. 37\/2010<\/strong> \u2014 Vet drug MRLs
\n \u2022 EU Reg. 1223\/2009<\/strong> \u2014 Cosmetics regulation
\n \u2022 EFSA 2016<\/strong> \u2014 Pyrrolizidine alkaloids opinion
\n \u2022 EU Reg. 2015\/1940<\/strong> \u2014 Nitrite\/nitrosamines
\n \u2022 WHO<\/strong> \u2014 Guidelines on quality of herbal medicines
\n \u2022 EMA<\/strong> \u2014 Herbal medicine guidelines (HMPC)\n <\/div>\n <\/div>\n <\/div>\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t
\n
<\/div>\n Reference method organisations<\/span>\n
<\/div>\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t
\n
\n
\n Internationally validated methods applied at Biogroup<\/div>\n <\/div>\n
\n
USP<\/div>
United States Pharmacopoeia<\/div>
Chapters <51> <61> <62> <71> <85> <231> <232> <233> <467> <701> <711> <905> and relevant monographs<\/div><\/div>
EP \/ BP<\/div>
European & British Pharmacopoeias<\/div>
EP 2.6.1\/12\/13\/14 \u00b7 2.8.13\/18 \u00b7 all relevant monographs and technical requirements for pharmaceutical testing<\/div><\/div>
FNA<\/div>
Farmacopea Nacional Argentina<\/div>
Applicable monographs for all products requiring ANMAT registration in the Argentine market<\/div><\/div>
AOAC<\/div>
Association of Official Analytical Chemists<\/div>
Official methods for residue analysis and phytochemical active ingredients<\/div><\/div>
ISO \/ ASTM<\/div>
International standards<\/div>
ISO and ASTM methods for cosmetic and cleaning product analysis<\/div><\/div>
ICH<\/div>
International Council for Harmonisation<\/div>
Q2(R1) method validation \u00b7 Q3A\/B\/C\/D impurities \u00b7 Q3D elemental impurities \u00b7 M7 mutagenic impurities<\/div><\/div>\n <\/div>\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t
\n
<\/div>\n Related services<\/span>\n
<\/div>\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t
\n
\ud83c\udf7d\ufe0f Chemical Analysis of Food \u2192<\/div>
Pesticides \u00b7 mycotoxins \u00b7 allergens \u00b7 nutritional<\/div><\/a>
\ud83e\udda0 Microbiological Analysis \u2192<\/div>
Pathogens \u00b7 sterility \u00b7 BAX \u00b7 ICMSF \u00b7 ISO<\/div><\/a>
\ud83d\udce6 Migration Analysis \u2192<\/div>
Food contact \u00b7 BPA \u00b7 plasticisers \u00b7 ASSAL<\/div><\/a>
\ud83d\udd2c Materials Analysis \u2192<\/div>
GC-MS \u00b7 ICP-MS \u00b7 HPLC \u00b7 deformulation<\/div><\/a>\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t
\n
<\/div>\n
\n
\n USP \u00b7 BP \u00b7 EP \u00b7 FNA \u00b7 HPLC \u00b7 GC-MS \u00b7 Phytochemicals \u00b7 Vet Residues \u00b7 ANMAT\n <\/div>\n
\n Need pharmaceutical or nutraceutical analysis?<\/div>\n
\n From routine sterility and potency testing to unprecedented phytochemical\n active ingredient characterisation \u2014 Biogroup delivers the analytical\n evidence for ANMAT registration, export certification and product development.\n <\/div>\n \n Request pharmaceutical analysis \u2192<\/a>\n
\n \ud83d\udcde +54 341 425-6431<\/span>\n \ud83d\udcde +54 341 447-4486<\/span>\n \u2709 biogroup@biogroup.com.ar<\/span>\n \ud83d\udccd 3 de febrero 920 \u00b7 Rosario, Argentina<\/span>\n Mon\u2013Fri 08:00\u201317:00<\/span>\n <\/div>\n <\/div>\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

💊 USP \u00b7 BP \u00b7 FNA \u00b7 HPLC \u00b7 GC-MS \u00b7 Phytochemicals \u00b7 Vet Residues \u00b7 Pesticides \u00b7 ANMAT Drug & Pharmaceutical Analysis Pharmaceutical quality control, trace residue analysis and phytochemical active ingredient characterisation \u2014 to USP, BP, FNA and ANMAT standards. Biogroup provides analytical services across the full pharmaceutical and nutraceutical quality chain \u2014…<\/p>\n","protected":false},"author":3,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"inline_featured_image":false,"_joinchat":[],"footnotes":""},"class_list":["post-989746","page","type-page","status-publish","hentry"],"yoast_head":"\nDrug Analysis - BioGroup<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/biogroup.com.ar\/en\/drug-analysis\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Drug Analysis - BioGroup\" \/>\n<meta property=\"og:description\" content=\"💊 USP \u00b7 BP \u00b7 FNA \u00b7 HPLC \u00b7 GC-MS \u00b7 Phytochemicals \u00b7 Vet Residues \u00b7 Pesticides \u00b7 ANMAT Drug & Pharmaceutical Analysis Pharmaceutical quality control, trace residue analysis and phytochemical active ingredient characterisation \u2014 to USP, BP, FNA and ANMAT standards. Biogroup provides analytical services across the full pharmaceutical and nutraceutical quality chain \u2014...\" \/>\n<meta property=\"og:url\" content=\"https:\/\/biogroup.com.ar\/en\/drug-analysis\/\" \/>\n<meta property=\"og:site_name\" content=\"BioGroup\" \/>\n<meta property=\"article:modified_time\" content=\"2026-05-19T10:10:06+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"16 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/biogroup.com.ar\\\/en\\\/drug-analysis\\\/\",\"url\":\"https:\\\/\\\/biogroup.com.ar\\\/en\\\/drug-analysis\\\/\",\"name\":\"Drug Analysis - BioGroup\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/biogroup.com.ar\\\/#website\"},\"datePublished\":\"2022-12-02T17:06:29+00:00\",\"dateModified\":\"2026-05-19T10:10:06+00:00\",\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/biogroup.com.ar\\\/en\\\/drug-analysis\\\/\"]}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/biogroup.com.ar\\\/#website\",\"url\":\"https:\\\/\\\/biogroup.com.ar\\\/\",\"name\":\"BioGroup\",\"description\":\"Centro de Investigaci\u00f3n Cient\u00edfica y Tecnol\u00f3gica\",\"publisher\":{\"@id\":\"https:\\\/\\\/biogroup.com.ar\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/biogroup.com.ar\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/biogroup.com.ar\\\/#organization\",\"name\":\"BioGroup\",\"url\":\"https:\\\/\\\/biogroup.com.ar\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/biogroup.com.ar\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/biogroup.com.ar\\\/wp-content\\\/uploads\\\/2024\\\/10\\\/cropped-logo-1.jpg\",\"contentUrl\":\"https:\\\/\\\/biogroup.com.ar\\\/wp-content\\\/uploads\\\/2024\\\/10\\\/cropped-logo-1.jpg\",\"width\":573,\"height\":145,\"caption\":\"BioGroup\"},\"image\":{\"@id\":\"https:\\\/\\\/biogroup.com.ar\\\/#\\\/schema\\\/logo\\\/image\\\/\"}}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Drug Analysis - BioGroup","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/biogroup.com.ar\/en\/drug-analysis\/","og_locale":"en_US","og_type":"article","og_title":"Drug Analysis - BioGroup","og_description":"💊 USP \u00b7 BP \u00b7 FNA \u00b7 HPLC \u00b7 GC-MS \u00b7 Phytochemicals \u00b7 Vet Residues \u00b7 Pesticides \u00b7 ANMAT Drug & Pharmaceutical Analysis Pharmaceutical quality control, trace residue analysis and phytochemical active ingredient characterisation \u2014 to USP, BP, FNA and ANMAT standards. Biogroup provides analytical services across the full pharmaceutical and nutraceutical quality chain \u2014...","og_url":"https:\/\/biogroup.com.ar\/en\/drug-analysis\/","og_site_name":"BioGroup","article_modified_time":"2026-05-19T10:10:06+00:00","twitter_card":"summary_large_image","twitter_misc":{"Est. reading time":"16 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/biogroup.com.ar\/en\/drug-analysis\/","url":"https:\/\/biogroup.com.ar\/en\/drug-analysis\/","name":"Drug Analysis - BioGroup","isPartOf":{"@id":"https:\/\/biogroup.com.ar\/#website"},"datePublished":"2022-12-02T17:06:29+00:00","dateModified":"2026-05-19T10:10:06+00:00","inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/biogroup.com.ar\/en\/drug-analysis\/"]}]},{"@type":"WebSite","@id":"https:\/\/biogroup.com.ar\/#website","url":"https:\/\/biogroup.com.ar\/","name":"BioGroup","description":"Centro de Investigaci\u00f3n Cient\u00edfica y Tecnol\u00f3gica","publisher":{"@id":"https:\/\/biogroup.com.ar\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/biogroup.com.ar\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/biogroup.com.ar\/#organization","name":"BioGroup","url":"https:\/\/biogroup.com.ar\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/biogroup.com.ar\/#\/schema\/logo\/image\/","url":"https:\/\/biogroup.com.ar\/wp-content\/uploads\/2024\/10\/cropped-logo-1.jpg","contentUrl":"https:\/\/biogroup.com.ar\/wp-content\/uploads\/2024\/10\/cropped-logo-1.jpg","width":573,"height":145,"caption":"BioGroup"},"image":{"@id":"https:\/\/biogroup.com.ar\/#\/schema\/logo\/image\/"}}]}},"_links":{"self":[{"href":"https:\/\/biogroup.com.ar\/en\/wp-json\/wp\/v2\/pages\/989746","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/biogroup.com.ar\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/biogroup.com.ar\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/biogroup.com.ar\/en\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/biogroup.com.ar\/en\/wp-json\/wp\/v2\/comments?post=989746"}],"version-history":[{"count":5,"href":"https:\/\/biogroup.com.ar\/en\/wp-json\/wp\/v2\/pages\/989746\/revisions"}],"predecessor-version":[{"id":993235,"href":"https:\/\/biogroup.com.ar\/en\/wp-json\/wp\/v2\/pages\/989746\/revisions\/993235"}],"wp:attachment":[{"href":"https:\/\/biogroup.com.ar\/en\/wp-json\/wp\/v2\/media?parent=989746"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}