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Microbial limits test

Microbial limits test
Product Description

Pace analytical life sciences llc offers wide range of services which includes microbial limits test service. It is performed by life sciences meet the requirements of usp <61><62>, which are harmonized with ep chapters 2.6.12 and 2.6.13 and jp requirements. Has experience with a wide range of raw materials and product dosage forms. Our experienced microbiologists work closely with each client to ensure the recovery methods are appropriate for the material/dosage form and are consistent with established specifications. Contact us for more information.

Pace Life Sciences, LLC

  • US
  • 2017
    On CPHI since
  • 4
    Certificates
  • 250 - 499
    Employees
Company types
Contract Service
Specifications
  • Selling Points
    Quality Service
  • Supplied from
    United States

Pace Life Sciences, LLC

  • US
  • 2017
    On CPHI since
  • 4
    Certificates
  • 250 - 499
    Employees
Company types
Contract Service

More Products from Pace Life Sciences, LLC (16)

  • Elemental metals / elemental impurities

    Product Elemental metals / elemental impurities

    Pace analytical life sciences llc offers wide range of services which includes elemental metals / elemental impurities service. It offers full-service gmp analytical laboratory capabilities for assessing levels of elemental metals / elemental impurities in raw materials, in-process formulations and finishe...
  • Endotoxin testing

    Product Endotoxin testing

    Pace analytical life sciences llc offers wide range of services which includes endotoxin testing service. It provides endotoxin testing for the pharmaceutical, biopharmaceutical and medical device industries. This test is also known as the limulus amebocyte lysate, or lal, test. It follow usp bacterial en...
  • Environmental monitoring services

    Product Environmental monitoring services

    Pace analytical life sciences llc offers wide range of services which includes environmental monitoring services service. It covers a range of areas requiring microbiological testing to detect changing trends of microbial counts and micro-flora growth within the manufacturing environments. In aseptic manuf...
  • Extractable and leachable testing

    Product Extractable and leachable testing

    Pace analytical life sciences llc offers wide range of services which includes extractable and leachable testing service. It has developed a comprehensive approach towards extractable and leachable testing. Its study identify extractables, compounds that can be extracted from a component under extreme cond...
  • Facility validation support

    Product Facility validation support

    Pace analytical life sciences llc offers wide range of services which includes facility validation support service. It provides with a comprehensive range of analytical services to support the validation of pharmaceutical facilities. Its analytical testing services provide support for the validation of pur...
  • Method development and validation

    Product Method development and validation

    Pace analytical life sciences llc offers wide range of services which includes method development and validation service. It provides senior level, highly experienced scientists dedicated to performing method development and validation services. Areas of expertise include: stability-indicating assays / imp...
  • Particulate analysis service

    Product Particulate analysis service

    Pace analytical life sciences llc offers wide range of services which includes particulate analysis service. It provides particulate analysis testing for the pharmaceutical, biopharmaceutical and medical device industries. Its particulate analysis, or particulate-particle testing, follows usp testing meth...
  • Sterility test service

    Product Sterility test service

    Pace analytical life sciences llc offers wide range of services which includes sterility test service. It has demonstrated experience with a wide range of dosage forms, including terminally sterilized parenterals, compounded products, medical devices and combination products. Performs traditional membrane ...
  • Extractables and Leachables

    Product Extractables and Leachables

    Pace® Life Sciences has developed a comprehensive approach towards extractable and leachable testing. We design studies to identify extractables, compounds that can be extracted from a component under exaggerated conditions, and leachables, compounds that could migrate into a drug product or patient during...
  • Pharmaceutical / Biopharmaceutical Testing Services

    Product Pharmaceutical / Biopharmaceutical Testing Services

    Pace analytical life sciences llc offers wide range of services which includes product release testing for pharmaceuticals service. It provides pharmaceutical product release testing for both qa pharmaceutical release testing and clinical release testing. It offer quality assurance/quality control product ...
  • Raw Materials Testing Services, Compendial

    Product Raw Materials Testing Services, Compendial

    Pace analytical life sciences llc offers wide range of services which includes raw materials testing service. It provides raw material testing services to the pharmaceutical, biopharmaceutical and medical device industries. It offer excipient testing to support usp/nf, ep, bp, jp, fcc and acs monograph tes...
  • Stability Storage and Testing Services

    Product Stability Storage and Testing Services

    Pace analytical life sciences llc offers wide range of services which includes stability testing and storage service. It provides secure long- and short-term (accelerated) storage and stability testing to support cgmp stability programs. It offer a broad range of conditions—temperature only, temperature an...

Frequently Viewed Together

  • 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 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 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 Biopharmaceutical Characterisation and Testing Services

    Characterization and testing of biopharmaceuticals: Using our expert's insight into a biologic's structure, physicochemical properties, potency, and impurity profile, we help you meet your development milestones.

    A range of expertise is available, including assessment of structure...
  • 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 Laboratory Services

    Laboratory Services
    Our 30 years of experience and our continual quest for improvement ensure we deliver analytical services of the highest level for active ingredients, excipients, medicinal products and drug-​related products. In addition to developing and validating analytical methods, batch-...
  • 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 Medical Devices based on substances

    We develop and produce medical devices based on substances of class I, IIa and III.
    In particular:
    Oral Spray
    Nasal Spray
    Ear Spray
    Ear Drops
    Oral drops
    Oral solids (tablets and sachets)
    Vaginal Ovules
    Vaginal washes
    Eye drops (single an...
  • Product Tramadol HCl

    Grünenthal GmbH offers a selected range of products which includes Tramadol HCl, as API, bulk and/ or finished dosage form. Please contact us for more information.

  • 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 FPFs

    • Genexol®PM Inj.(Paclitaxel)   • Genexol® Inj.(Paclitaxel) • Nanoxel®M Inj.(Docetaxel) • Docetaxel Inj.(Docetaxel) • Nexatin® Inj.(Oxaliplatin) • Everose® Tab.(Everolimus) • Pemed®S Inj.(Pemetrexed) • Azalid® Inj.(Azacitidine) • Decilid® Inj.(Decitabine) • Lenalid® Inj.(Lenalid...
  • Product 1 GHz NMR

    New Evo 1 GHz NMR fits in 1 story building, uses 70% less helium. Ideally suited to characterise complex molecules such as RNA, oligonucleotides, peptides, antibodies and more!
  • Product Elemental Impurities

    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
  • Product Polyglykol

    Effective and high-purity ingredients including a complete range of  Polyglykols (Macrogols) our universally applicable pharmaceutical polymers, with various molecular weights, supported by CEP certification and DMF type II documentation.
  • Product Development

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

    Our development laboratories are well equipped for conducting a diverse range of experiments. These encompass formulation development, cycle design and process refinement, as well as evaluating finished product. Ease of scale-up is accomplished by completing process development studies within a pilot scale...
  • 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 Kemwell Biopharma

    SERVICES Kemwell provides integrated development and manufacturing services for companies that require one-stop solution for mammalian cell-culture based protein therapeutics The team is experienced to undertake end-to-end activities right from cell line development till cGMP clinical and commercial manufa...
  • Product Azithromycin Range

    Azithromycin Tablets 250mg / 500mg Azithromycin Capsules 500mg Azithromycin Suspension 200mg Per 5ml API is CEP Grade and from our own group company which is USFDA accredited
  • Product Hovid Ethical & OTC products

    Hovid manufacturers & distributes more than 400 products, comprising generic pharmaceuticals, OTC products, health supplements and traditional/consumer products. The therapeutical ranges are below: a.) Cardiovasular management b.) Diabetes management c.)Dermatologicals range d.) Anti-infectives range ...
  • Product QACS Pharmaceutical services

    QACS Lab is GMP/GLP certified and provides contract laboratory testing for Pharmaceuticals. Methodologies stay in accordance with EMA & FDA. QACS is equipped with Microbiological - Chemical - Molecular - Packaging laboratory premises to provide variety of Pharmaceutical testing solutions &...
  • Product CordenPharma Oligonucleotide Platform

    Your Expert Partner for Oligonucleotide APIs

    • Process Development & Small-scale: scale-up to 10 mmol per run(small-scale equipment can also support early-stage supply)

    • Scale-up & Small to Medium-scale: scale-up to 100 mmol per run(supported by OligoPilotTM equipment)

    • ...
  • 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 Bispecific Antibody Production

    Bispecific antibodies represent a key component of the next-generation of antibody therapy. Bispecific antibodies can target more than two different antigens at the same time. For instance, they can simultaneously bind tumor cell receptors while recruiting cytotoxic immune cells.Biointron has expressed tho...
  • Product R&D Research and Development

    The Pharmaceutical Analyses Department of Spark-Lab conducts research and development work in cooperation with pharmaceutical and cosmetics manufacturing plants. The Laboratory provides services through its highly skilled personnel and state-of-the-art equipment at the initial phase of works on a g...
  • 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 Immune Support Range

    Propolis is known from ancient times for its beneficial properties. Its ingredients help strengthen the body’s natural defense system in order to cope with the symptoms of the common cold. Powerful Manuka Honey provides exceptional nutritional benefits to the organism. Additionally, Echinacea is traditiona...
  • Product Formulation Development

    Recipharm offer formulation development services for all dosage forms. We develop everything from simple formulations for early studies to more complex formulations suited for commercialisation.
  • Product Biosimilars Portfolio

    • Pegfilgrastim (Filed with EMA) • Filgrastim (Filed with EMA) • Trastuzumab (Filed with EMA, MHRA, Received recommendation for marketing authorization in India) • Bevacizumab (Filed with MHRA) • Omalizumab (Global PhIII ongoing) • Denosumab (Global PhIII ongoing) • Ranibizumab (Global PhIII ongoing...
  • Product Analytical services

    Analytical services 

    In addition to the basic product quality control, the following connected services are offered, which are required throughout the product development or before the market launch of the respective products:

     

    GMP for excipients, risk assessment...
  • Product Analytical Services

    Pharmaffiliates is providing all the Analytical Services (i.e. Method Development, Method Validation & Transfer, Stability Studies, Contract Analysis, etc)
  • Product Functional film coating

    Easy, fast and reliable enteric protection? Why not! - High performance protection against acidic conditions. - Suitable for granules, pellets, tablets and capsules. - For pharmaceutical and nutraceutical applications.
  • Product Grindeks FDF portfolio

    Please see Grindeks up-to-date Final Dosage Form (FDF) product portfolio, including pipeline products, in the link attached. Dossiers are harmonized according to ICH and EMA requirements. https://grindeks.com/en/products/final-dosage-forms/
  • Product Analytical Chemistry Services

    Delivering a product from discovery to the market is a long and often difficult process filled with a great number of scientific, safety and regulatory challenges. From early discovery to final product release, SGS offers a broad portfolio of high quality, analytical chemistry services using advanced metho...
  • Product Silicone tubes & Hoses

    Platinum cured silicone tubes, peroxide cured silicone tubs, reinforced hoses, TPE tubes, FEp tubes and many more
  • Product Cephalosporins Finished Products

    <Injection> Cefazolin Sodium 1g Cefmetazole Sodium 1g, 2g Cefotaxime Sodium 1g Ceftazidime Hydrate 0.5g, 1g, 2g Ceftizoxime Sodium 1g, 2g Cefoperazone Sodium 1g, 2g Cefotiam HCl 1g Ceftriaxone Sodium 1g Cefepime HCl 1g *Flomoxef Sodium 0.5g, 1g *Cefamandole Nafate 1g, 2g *Ceftaroline Fosamil 400mg...
  • Product Biotest Human Serum Albumin

    • Human Serum Albumin for the biotechnology and pharmaceutical industry • We offer a human serum albumin (HSA) product that complies with the regulatory requirements of multiple health authorities.   • It is manufactured in a GMP compliant, state-of-the-art manufacturing plant and supplied und...
  • Product Analytical package

    XEDEV provides a broad range of analytical tools including : • Solid state analysis: mDSC, XRPD, PLM, TGA, FTIR, RAMAN • Powder characterisation : SEM, PSD (both wet and dry), flowability • Tablet characterisation : friability, disintegration, hardness, dissolution • Residual solvent determination :...
  • Product Shedir Products

    With more than 150 products, Shedir is fully capable of satisfying the needs of every potential customer.

    Our products range from Food Supplements to Medical Devices Class I, Cosmeceuticals and Pharmaceutical Drugs, all of them produced in plants complying to the highest standards of the...
  • Product UV Light Blocking Tyvek Equipment Covers

    UV Light Blocking Tyvek Equipment Covers are designed to keep cleaned pharmaceutical equipment and supplies clean and protected from external sources of contamination while also providing in-process protection to light sensitive biotech products.
  • Product Biocompatibility & Toxicology Testing

    Nelson Labs offers a full trifecta of services to meet the requirements of ISO 10993 for Extractables & Leachables, Biocompatibility and Toxicological Assessments of medical devices. Biocompatibility testing is very common in the medical device industry. However, with 24 possible categories, each with...
  • Product Pharmaceutical and Biological Products Contract Development and Manufact...

    Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO). Our six state-of-the-art cGMP manufacturing facilities across Asia and North America deliver to more than 100 markets around the world. Our sites have the highest industry standards for quality, dev...
  • Product RELIEF® Range

    Iasis Pharma S.A. provides a wide range of products which includes Relief® solution for injection (Active ingredient: Thiocolchhicoside). It belongs to musculoskeletal system category. Active ingredient: thiocolchicoside. Contact us for more information.
  • Product Analytical Testing and Formulation Development

    Quality Chemical Laboratories is known for its capabilities in the development and validation of analytical methods for raw materials, drug substances, and drug products. With a strong focus on quality and precision, QCL employs cutting-edge technologies and a highly skilled team of scientists to offer com...
  • Product Complex drug formulation

    We like to get involved right from the start of a development project and work closely together with our clients and partners on transforming the idea into a product with a solid and commercially viable target product profile (TPP). We set the bar high but always work step by step with a clear focus on...
  • Product products

    Tablets 1ZefinibGefitinib250mg1 x 10 2CapetazCapecetabine500mg1 x 10 3AnastrozAnastrozole1mg1 x 10 4ZutamTamoxifen20mg1 x 10 5ZuvitrexMethotrexate 2.5mg1 x 10 6ZuvitrexMethotrexate7.5mg1 x 10 7ErlononErlotinib100mg1 x 10 8ErlononErlotinib150mg1 x 10 9ZuvitrozLetrozole...