Before a new pharmaceutical product can enter the market it must undergo many tests and clinical trials. In addition, products already on the market are tested for quality control. The testing of these products is done for safety and quality purposes.
The testing of pharmaceuticals and biopharmaceuticals is a process that examines the different constituents of a product, as well as how they react together, and how they effect a patient. There are many opportunities for testing in the development of these products. Testing can provide feedback for development as well as ensure safety.
Pharmaceuticals Testing and Research Services
Contract Laboratory can help you with all your Pharmaceuticals testing, analysis, scientific research and development, inspection, certification, engineering, failure investigation, and product development needs including:
Drug Discovery
Drug Development
Non-Clinical Study
Preclinical Study
Clinical Trials
Pharmacokinetics (PK)
Pharmacodynamics (PD)
ADME
Sterility
Pyrogens
Endotoxins
Raw Material
Finished Product Quality Control Release
Real-Time Stability
Accelerated Stability
Method Development
Method Validation
Drug Release/Dissolution
Extractable
Leachable
Elemental Impurities
Packaging
Child-Resistant Packaging
Container Closure Integrity Testing (CCIT)
High Throughput Screening
Reverse Pharmacology
Excipients
Active Pharmaceutical Ingredient API
Toxicology
Toxicity
Microbiology
Strength
Quality
Purity
Consistency
Acid Insolubles
Acid Solubles
Alkali Solubles
Alkalinity
Appearance
Boiling Point
Congealing Temperature
Flash Point
Melting Point
Freezing Point
Hardness
Heat of Combustion
Preservatives
Loss on Drying (under Vacuum)
Loss on Ignition
Melting Point
Mineral Analysis
Non-aqueous Titration
Normality
Organic Acids
Organic Extractives
Oxidizing Substances
Peroxide Value
Pour Point
Reactivity
Reactivity to Water
Reducing Substances
Refractive Index
Residue on Evaporation
Residue on Ignition
Saponification Value
Sieve Analysis
Silver Reducing Substances
Silicon
Sulfur
Sodium
Specific Gravity
Specific Rotation
Sugars
Sulfur Compounds
Surfactants
Talc
Titration Curve
Total Halides
Total Reducing Compounds
Unburned Carbon
Uncarbonized Constituents
Unsaponifiable Matter
UV Absorption
Volatile Matter
Volatile Suspended Solids
Weight Variation
Cytotoxicity
Elution
Agar Diffusion
Bioburden
Antimicrobial Effectiveness
Particulates
Total Combined Mold & Yeast (TYMC)
Total Aerobic Microbial Count (TAMC)
Type of Pharmaceuticals Products
Contract Laboratory can assist your company, academic institution, government agency or organization in outsourcing contract laboratories to perform testing, analysis, and product development for many Pharmaceuticals finished products, processes, systems, in-process materials, raw materials and components such as:
Lead Compounds
Small Molecule Drugs
Immunotherapeutic Drugs
Vaccines
Antipyretics
Anti-Depressants
Analgesics
Pain Killers
Anti-Diuretics
Antimalarial drugs
Antibiotics
Antiseptics
Mood Stabilizers
Hormone Replacements
Hormones
Oral Contraceptives
Stimulants
Tranquilizers
Statins
Antacids
Reflux Suppressants
Antiflatulents
Antidopaminergics
Mast Cell Inhibitors
Hormone Replacement Therapies
Bone Regulators
Prostaglandins
Follicle Stimulating Hormones FSH
Luteinising Hormone LH
Bronchodilators
Estrogens
Antitussives
Mucolytics
Androgens
Antiandrogens
Estrogens
Gonadotropin
Human Growth Hormone
Insulin
Antidiabetics Sulfonylureas
Biguanides
Thiazolidinediones
Insulin
Thyroid Hormones
Antithyroid Drugs
Calcitonin
Diphosponate
Vasopressin Analogues
Decongestants
Proton Pump Inhibitors
H2-Receptor Antagonists
Cytoprotectants
Barbiturates
NSAIDs
Fibrinolytics
Proteolytics
Muscle Relaxants
Anti-fungal
Imidazoles
Polyenes
Antiviral Drugs
Sulfa Drugs
Aminoglycosides
Fluoroquinolones
Prostaglandin Analogues
ACE Inhibitors
Antihypertensives
Thiazide Diuretics
Loop Diuretics
Scabicides
Pediculicides
Aldosterone Inhibitors
Anticoagulants
Heparin
Antiplatelet Drugs
Fibrinolytics
Hypolipidaemic Agents
Anti-Hemophilic Factors
Haemostatic Drugs
Beta Blockers
Calcium Channel Blockers
Diuretics
Cardiac Glycosides
Antiarrhythmics
Nitrates
Antianginals
Vasoconstrictors
Vasodilators
Laxatives
Antispasmodics
Antidiarrhoeals
Benzodiazepines
Cyclopyrrolones
Dopamine Antagonists
Antihistamines
Cholinergics
Anticholinergics
Emetics
Cannabinoids
5-HT (serotonin) Antagonists
Steriods
Corticosteroids
Opiods
Psychedelics
Hypnotics
Anaesthetics
Antipsychotics
Antimalarials
Anthelmintics
Amoebicides
Cytotoxic Drugs
Therapeutic Antibodies
Sex Hormones
Aromatase Inhibitors
Somatostatin Inhibitors
Recombinant Interleukins
G-CSF
Erythropoietin
Antitoxins
Antivenoms
Probiotics
Prebiotics
Diagnostic Contrast Media
Immunoglobulins
Immunosuppressants
Interferons
Monoclonal Antibodies
Electrolytes
Mineral Preparations
Parenteral Nutritions
Anti-Obesity Drugs
Cough Medicines
Allergy Medicines
Cold Medicines
Pain Medicines
Sunscreens
Antiperspirants
Eye Drops
Tablets
Pills
Suspensions
Suppositories
IV
Parenterals
Transdermal Patches
Recombiant Proteins
Blood Products
Gene Therapy
Cell Therapy
Topicals
Inhalators
Ointments
Creams
Gels
Natural Products
New Molecular Entity (NME)
Excipients
Prescription Drugs
OTC Drugs
Compounded Drugs
Bulk Drug Substances
Pharmaceuticals Test Methods and Standards
Contract Laboratory can help with testing, analysis, assays, evaluations, examinations, inspections and certifications to different Pharmaceuticals test methods, standards, procedures or specifications.
USP <661> - Plastic Packaging Systems and Their Materials of Construction
USP <671> - Containers-Performance Testing
ISO 7886 - Sterile hypodermic syringes for single use
ASTM D7661 - Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms
USP <561> - Articles of Botanical Origin
USP <616> - Bulk Density and Tapped Density of Powders
USP <1092> - The Dissolution Procedure: Development and Validation
ISO 11418-7:2016 - Containers and accessories for pharmaceutical preparations -- Part 7: Screw-neck vials made of glass tubing for liquid dosage forms
ISO 11418-5:2015 - Containers and accessories for pharmaceutical preparations -- Part 5: Dropper assemblies
ISO 11418-4:2005 - Containers and accessories for pharmaceutical preparations -- Part 4: Tablet glass bottles
ISO 11418-3:2016 - Containers and accessories for pharmaceutical preparations -- Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms
ISO 11418-2:2016 - Containers and accessories for pharmaceutical preparations -- Part 2: Screw-neck glass bottles for syrups
ISO 11418-1:2016 - Containers and accessories for pharmaceutical preparations -- Part 1: Drop-dispensing glass bottles
USP <1151> - PHARMACEUTICAL DOSAGE FORMS
USP <1671> - THE APPLICATION OF MOISTURE VAPOR TRANSMISSION RATES FOR SOLID ORAL DOSAGE FORMS IN PLASTIC PACKAGING SYSTEMS
ISO 22019 - Nanotechnologies - Considerations for performing toxicokinetic studies with nanomaterials
USP 1177 - Good Packaging Practices
EN 862 - ackaging. Child-resistant packaging. Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products
ASTM 2329 - Standard Practice for Identification of Seized Drugs
ASTM 2656 - Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute
ASTM F 2605 - Standard Test Method for Determining the Molar Mass of Sodium Alginate by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS)
ASTM 2900 - Standard Guide for Characterization of Hydrogels used in Regenerative Medicine
IEEE 11073-10472 - Health informatics--Personal health device communication--Part 10472: Device specialization--Medication monitor
ADA 117 - Fluoride Varnishes
ADA 151 - Screening Method for Erosion Potential of Oral Rinses on Dental Hard Tissues
ASTM F2638-18 - Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier
ASTM E1589-05 - Standard Test Method for Evaluation of First Aid Antiseptic Drug Products
ASTM F750-20 - Standard Practice for Evaluating Acute Systemic Toxicity of Material Extracts by Systemic Injection in the Mouse
ASTM E1262-88(2018) - Standard Guide for Performance of Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay
ASTM F1929-15 - Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
ASTM F3106-14 - Standard Guide for in vitro Osteoblast Differentiation Assays
ASTM F640 - 20 - Standard Test Methods for Determining Radiopacity for Medical Use
ASTM F2131-02(2012) - Standard Test Method For In Vitro Biological Activity Of Recombinant Human Bone Morphogenetic Protein-2 (RhBMP-2) Using The W-20 Mouse Stromal Cell Line
ASTM F2212-19 - Standard Guide For Characterization Of Type I Collagen As Starting Material For Surgical Implants And Substrates For Tissue Engineered Medical Products (TEMPs)
ASTM E1968-19 - Standard Practice for Microcrystal Testing in Forensic Analysis for Cocaine
ASTM E1969-19 - Standard Practice for Microcrystal Testing in Forensic Analysis for Methamphetamine and Amphetamine
ASTM E2125-19 - Standard Practice for Microcrystal Testing in Forensic Analysis for Phencyclidine and Its Analogues
USP 51 - ANTIMICROBIAL EFFECTIVENESS TESTING
USP 71 - STERILITY TESTS
Pharmaceuticals Certifications, Licenses, and Accreditations:
Depending on your Pharmaceuticals products, you may need third-party Pharmaceuticals laboratories or research facilities with specific certifications, licenses or accreditations.
FDA cGMP
DEA
ISO 17025
ANVISA
TGA
DEA
United States Pharmacopoeia
USP
British Pharmacopoeia BP
European Pharmacopoeia EP
Caption: Pharmaceutical Packaging Testing
Caption: Compounded Drug Testing
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