Elemental Impurities

Elemental Impurities
Product Description

Brightlabs has in-house validated methods for the analysis of elemental impurities in accordance to ICH-Q3D. Brightlabs has a unique approach for ICHQ3D, which guarantees quick turnaround times at reduced cost

Brightlabs

  • NL
  • 2021
    On CPHI since
  • 2
    Certificates
  • 25 - 49
    Employees
Company types
Contract Service
Specifications

Brightlabs

  • NL
  • 2021
    On CPHI since
  • 2
    Certificates
  • 25 - 49
    Employees
Company types
Contract Service

More Products from Brightlabs (3)

  • Herbal Drugs Analysis

    Product Herbal Drugs Analysis

    Since 2018 Brightlabs possesses an opium exemption from the BMC (Bureau for Medicinal Cannabis), for the analysis of cannabis and related products. The combination of this opium exemption, combined with our GMP accreditation, makes Brightlabs an important partner for the analysis of cannabis and related ma...
  • Method Development

    Product Method Development

    We are specialist in the method development of analytical methods for analysis of API, Final Drug Products or low level impurities. Usually followed by full validation in accordance to ICH guidelines.
  • Nitrosamine Analysis

    Product Nitrosamine Analysis

    In response to nitrosamines present in pharmaceutical products, the European Medical Agency (EMA) and the US Food and Drug Administration (US FDA) have published requirements and limits related to nitrosamine contaminants. Therefore Brightlabs has developed and validated multiple methods to determine low l...

Brightlabs resources (4)

Frequently Viewed Together

  • Product Biotherapeutics

    To accelerate the development and marketing of your Biotherapeutics, Quality Assistance offers a complete analytical package to meet the EMA and FDA requirements, all on one site.

    Whether it is to extend your analytical capacities or to outsource parts or all of your analytical needs, ...
  • Product Analytical services - OEL: 50 ng/m3

    • Control of pharma samples solid state : Identification and quantification of solid state, method development and validation, routine QC. • Analytical techniques available : XRPD, DSC, TGA, DVS, Laser PSD, FTIR, IDR. • All analyses are applicable to toxic samples down to : 50 n...
  • Product Early Stage Development - Integrated Programs

    Accelerating molecules through to proof-of-concept - Simplify early development and accelerate to Proof-of Concept.Proof-of-concept (POC) is a key milestone in the development of a new drug candidate. We understand the transition to POC needs to be fast and cost-effective.With fully integrated capabil...
  • Product ANALYTICAL DEVELOPMENT

    TECNALIA, experts in Pharmaceutical Development, Scale-up & Pilot Batches Manufacturing, Clinical Trials and Contract

    Manufacturing ANALYTICAL DEVELOPMENT
    • Monitoring of the first industrial manufacturing batches.
    • Characterization of raw materials according to Pharmacopoeia. q...
  • Product HPLC Columns by VDS OPTILAB

    HPLC columns from VDS optilab have been impressed customers from all areas of analytics, ranging from universities and government agencies to small and medium-sized companies and large companies in the chemical and pharmaceutical industries. Benefit from the advantages of the VDSpher phases product fa...
  • Product Analytical method development

    MJR PharmJet uses its long gained experience on nano and microparticle formulations to meet your method development needs. We are specialized on the method development of particulate formulations for solid, semi solid and liquid formulations.
  • Product Bioequivalence tests for topical drugs

    We are a GLP lab specialist in vitro permeation testing, including the bioequivalence tests under the EMA draft guideline. We support pharmaceutical companies through bioequivalence studies. Visit our booth and find out more about our R&D dedicated to this topic.
  • Product Assay Development and Compound Screening

    Compound screening against a drug target is a vital step in early stage drug discovery. Biortus has an extensive collection of testing equipment that allows development of many kinds of biochemical assays, biophysical assays, and cell-based assays. Key assays include SPR, Kinase, ADP-Glo, TR-FRET, FP, Cali...
  • Product Wasdell Laboratory Services

    By the end of 2017 we will have a MHRA, GMP licenced laboratory. We will be offering a wide range of services for routine Quality Control analysis including QC release testing, method validation and stability analysis (analytical and microbiological). We work to the highest standards of GMP and GLP with r...
  • Product Analytical Services

    Pharmaffiliates is providing all the Analytical Services (i.e. Method Development, Method Validation & Transfer, Stability Studies, Contract Analysis, etc)
  • Product Walk in Cooling Cabinet.

    The Walk-In Cooling Cabinets / cold rooms are designed according to ICH guidelines, WHO, MCA and USFDA requirements to maintain uniform conditions. They are superior in airflow distribution, temperature control technology, cabinet construction and are manufactured as per cGMP regulations.
    Biggest Walk...
  • Product Biologic drug substance CDMO services

    From pre-clinical development to commercial supply, Patheon by Thermo Fisher Scientific is an industry leader in the development and manufacture of mammalian cell culture drug substances. Patheon offers biotech and pharmaceutical companies the ability to pursue opportunities around the globe with a fully i...
  • Product Inhaler Device Testing Services

    Through advanced laser imaging techniques, we provide analytical services to support the qualification and validation of spray devices. Testing services on pharmaceutical inhaled drug delivery devices are performed with high-speed imaging to evaluate the dynamic performance of devices by looking at its...
  • Product Analytical Development

    BioDuro-Sundia’s Analytical Testing team offers high quality analytical services including method development and validation, qualification of reference standards, testing and release studies, stability studies, and CMC dossier preparation services. ...
  • Product Analytical Services (GMP and R&D)

    Our analytical portfolio comprises 200+ different techniques – all performed by Coriolis’ experts in-house. Our offering includes:
    • Aggregate analytics • Particle characterization • Particle identification • Surfactant characterization • Higher order structure analysis • Funcional assays • Chemi...
  • Product Analytical Services

    Physico-Chemical testing
    - General identification (TLC, HPLC)
    - Assay (UV/VIS, HPLC-UV, GC-FID, LC-MS/MS) and dosage uniformity
    - Related substances identification and quantification (HPLC-UV, GC-FID, LC-MS/MS)
    - Physical determinations (pH, viscosity, density)
    - Moisture...
  • Product ADAPTEK® TECHNOLOGY

    ADAPTEK® TECHNOLOGY is the general name for our 4 international patents and expertise in nanotechnology and controlled release systems.This is a transversal technology that allows to develop customized biopolymeric nanohydrogels, allowing the load with different API (drugs, vitamins, growth factors, etc.)....
  • Product GasSpect O2

    The Gasporox sensor series GasSpect offers non-destructive Headspace Gas Analysis to be integrated into an inspection machine. The sensors with its highly sensitive laser impresses with performance and precision. The GasSpect series comes in different variations depending on which gas to be inspect...
  • Product CordenPharma Drug Product Support Services

    SUPPORT SERVICES FOR OUR CONTRACTED CUSTOMERS • Analytical Development • Validation Support • Regulatory Support • Clinical Supply Services
  • Product PHARMACEUTICAL ANALYSIS DEPARTMENT

    Spark-Lab Pharmaceutical Analysis Department performs routine analyses with a special emphasis on determination of excipients, such as:

    • Quantitative determination of sorbitol, glycerol, maltitol, mannitol in liquid forms based on our own method; • Quantitative determination of glucos...
  • Product Drug Stability Testing and ICH Storage Outsourcing

    Testing of pharmaceutical stability and ICH storage outsourcing: Our extensive capabilities cover all ICH conditions (or custom conditions), including climate control walk-in chambers, cabinets, refrigerated and freezer storage that are fully monitored and controlled, with backup units at every locatio...
  • Product Nitrosamine Analysis

    In response to nitrosamines present in pharmaceutical products, the European Medical Agency (EMA) and the US Food and Drug Administration (US FDA) have published requirements and limits related to nitrosamine contaminants. Therefore Brightlabs has developed and validated multiple methods to determine low l...
  • Product Analytical Services

    Solvias provides cGMP-compliant contract analytical services to help you ultimately provide safer products to consumers. We provide a comprehensive range of analytical services to the pharmaceutical, biotech, medical devices and cosmetics industry with similar regulatory requirements for raw materia...
  • Product Nitrosamine Impurities Testing

    SGS Life Sciences has considerable expertise in the method development of nitrosamine determination in pharmaceutical products. SGS has established a specific method for NDMA which can be applied to various different matrices. Alternatively, a platform method, based on trace-level detection by LC-MSMS, is ...
  • Product Reference Materials Management Services

    To support you in bringing even safer medicines to the market, we go far beyond supplying you with the right reference standards. From impurity profiling and working standards outsourcing services, all the way to managing inventory and logistics of your reference standards, we’re fully equipped to provide ...
  • Product A CDMO PARTNER FOR LIFE

    FUJIFILM Diosynth Biotechnologies is an industry-leading cGMP Contract Development and Manufacturing Organization (CDMO) supporting the biopharmaceutical industry in the development and production of biologics, vaccines and cell and gene therapies. Our focus is to combine technical leadership in process d...
  • Product Sterile Sodium Hyaluronate (Hyaluronic Acid)

    Sterile sodium hyaluronate
    The raw materials of sterile sodium hyaluronate produced by the sterile production process can be used directly by downstream manufacturers for sterile preparations and sterile medical devices without further sterilization procedures.

        ·&nbs...
  • Product Pharmaceutical Reference Standards

    All Pharmaceutical Reference Standards are supplied with Certified COA along with supporting analytical data like HPLC, Mass, NMR, CMR, UV, IR, TGA, ROI, CHNS.
  • Product Analytical Chemistry & Microbiology Services

    Our expert team provides full analytical, microbiology and stability services to ensure that your raw materials, bulk product and finished products are qualified, analyzed and released to cGMP standards.

    Our services include:

    Analytical
    • Raw material and drug product...
  • Product Analytical Services & EU Batch Certification

    Method Development and validation
    Stability Studies
    European testing & batch certification

  • Product Analytical Services

    With a team of experienced scientists and a robust toolbox of analytical techniques and equipment, Experic can support the life cycle of your oral solid dose and/or inhalation pharmaceutical products. Our laboratory staff provides comprehensive analytical solutions to support the formulation, development, ...
  • Product Guanidine hydrochloride

    Specification:
    Molecular Formula:NH2C(=NH)NH2 · HCl
    Molecular Wt:95.53
    CAS: 50-01-1
    Shelf Life:two yearsUsage: 
    Usage: Guanidine hydrochloride is used in RNA isolation to dissociate nucleoproteins and inhibit RNase.Strong chaotropic agent useful for the denatur...
  • Product Cell Therapy Services

    KBI's Cell Therapy team, located in The Woodlands, TX, has managed a fully functional manufacturing facility supporting cell therapies and developing therapies under IND since 2001. Our team has substantial expertise and knowledge in cellular therapies' manufacturing, process development, and regulato...
  • Product Lipidomics

    Analysis for the identification of lipids by LC-MS/SM.
  • Product Development

    Synerlab provides wide range of services which includes development. Contact us for more information.
  • Product Fourier PAT

    We celebrate the arrival of our synTQ by Optimal NMR adapter – opening the door to a new world of PAT for the Bruker Fourier 80. This brings a wealth of structural information and direct quantification to online chemical and bioprocess monitoring, resulting in further reductions in risk and cost.
  • Product Green Elephant transparent 96-well plate

    Change your plates, not the climate!

    Our sustainable 96-well plates offer the same high performance and reliability but with a 50% lower carbon footprint as standard plates made from fossil-based plastics. With Green Elephant plates, you are making a sustainable choice without compromising o...
  • Product Inhalation Test Services

    We are the world’s leading provider of orally inhaled and nasal drug product design and development services. We enable the seamless translation of pre-clinical development through to clinical manufacture of OINDPs. We do this through our unique processing technologies and formulation development tools....
  • Product Formulation and Analytical Solutions

    GVK BIO offers a range of Formulation R&D solutions that include pre-formulation studies, formulation development, analytical R&D, reformulation and stability studies. We can also support clinical supplies and manufacturing of exhibit batches in collaboration with our partners and offer standalone ...
  • Product Quality Control

    We offer a highly professional quality management throughout the organization. In more than 500 m² of laboratory facilities, we annually test approx. 1,500 product Batches . The area of responsibility for quality control already starts with choosing the appropriate suppliers. Hence, in...
  • Product GMP Analytical Testing

    Singota solutions offers wide range of services which includes GMP analytical testing.
    Studies & Methodologies: • Material Identity • In Process • Product Release • Product Specific Assays • Compendial • Microbial (Endotoxin, Bioburden, Sterility) • CoA Generation • ICH Stability (All ICH...
  • Product Analytical Development

    Recipharm offer analytical support for drug discovery, pharmaceutical development and manufacturing through our global development facilities.
  • Product Acetonitrile HPLC/Preparative Grade

    Largest synthetic acetonitrile and high purity solvents manufacturer. • 35,000 t/a synthetic acetonitrile ; • 25,000 t/a high purity acetonitrile ; • 10,000 t/a HPLC solvents ; • 10,000 t/a solvent blending and packaging capacity.
  • Product Analytical Development and expertise

    Our analytical experienced team support the pharmaceutical development during every phase of the development process. Analytical development transfer and validation, characterization capabilities, stability analysis, ICH Q3D (residuals solvent risk assesment), ICHQ3C (elemental impurities risk assesment...
  • Product Analytical Development & QC

    Based on an analytical continuum our testing experts provide solutions all along the value chain from early discovery to clinical trials including method development, validation, quality control, stability studies of the main physicochemical and microbiological testing for innovative and generic products.
  • Product Process Development:

    •Evaluating multiple synthetic pathways to determine the most efficient, cost-effective, and scalable route. 

    •Assessing raw material availability and sustainability to ensure a reliable and cost-efficient supply chain. 


     •Developing innovative strategies to minimize h...
  • Product Analytical Chemistry

    • GMP Release Testing Services • Product Characterisation • Occupational Hygiene Analysis • Purity Profiling & 5 Batch Studies • Extractables & Leachables • Material Characterisation • Stability Testing Services • Physico-chemical Properties • De-formulation
  • Product Biosafety Testing & Analytical Development Services

    Choosing the right partner for analytical and biosafety testing is critical in the race to approval. Our BioReliance® Contract Testing Services offer exceptional, risk-mitigating solutions with technical and regulatory expertise, to help bring life-changing drugs to market.
  • Product Pulmonary Delivery

    Where particle size and performance really matters, Upperton have the expertise.
    Drug delivery into the lung is one of the fastest growing, yet technically challenging areas of pharmaceutical development. Producing a successful pulmonary drug product requires expertise in formulation development, part...
  • Product Clopidogrel D4 Hydrogen sulfate

    Labeled Clopidogrel, intended for use as an internal standard for the quantification of Clopidogrel by GC- or LC-mass spectrometry.