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Analytical testing is a critical part in every step of drug development and manufacturing. The qualitative and quantitative results generated from validated analytical testing provide first-hand information to control and ensure the quality and safety of raw materials, intermediates, and finished products. Like many other CMC (chemical, manufacturing and control) activities, analytical testing is also frequently outsourced. Many factors are attributed to this rapid market growth, including continuous outsourcing from pharmaceutical companies, growing pipelines for biological candidates, and increasing demand for more analytical details on drugs and process development by regulatory agencies. In response to the changing market dynamics, service providers are striving to provide analytical testing with quality, accuracy, and robustness all within tight timelines. As the contract research organizations (CROs) have become more integrated, small analytical labs need to establish their niche to succeed. Global contract analytical Laboratories provide QC laboratory analysis, method development, validation and expert advice for both finished products and raw materials for pharmaceutical and biopharmaceutical companies. Quality Compliance testing is done a wide variety of raw material and finished product forms including High Potent Active Pharmaceutical Ingredients (APIs), Raw Materials and Excipients, Powders - Capsules/Semi-solids, Oils - Oral Solutions and Syrups, Liquids, Vitamins, Minerals, and Nutritional, Natural Health Products (NHPs) – Powders, Herbals – Suspensions, Finished Pharmaceutical Products (Tablets, Capsules/Semi-solids, Oral Solutions and Syrups, Gels, Creams and Ointments, Powders, Suspensions, Transdermals etc. Blend uniformity is a function of both the formulation and mixing action. Once the formulation is optimized from a theoretical process standpoint, blend uniformity must be validated during piloting and scale-up. From a manufacturer’s perspective; poor uniformity generates unacceptable amounts of discarded products, resulting in significant loss of revenue. However, no method currently exists that detects uniformity during the blending process, and as a result the true optimum endpoint is realized rarely. CGMP (21 CFR.211.110) for testing homogeneity and uniformity requires an in-process testing of powder blends to demonstrate adequacy of mixing, but it does not state that the blend has to be directly assessed for uniformity. It was on this premise that the original draft stratified sampling guidance document allowed the use of in-process dosage unit data as a surrogate to demonstrate dosage unit uniformity during routine manufacture. Blend uniformity should be assessed during process design (Stage 1 Validation) and process qualification (Stage 2 Validation). Defaulting directly to the testing of in-process dosage units is discouraged, the exception being when blend sampling presents severe risks to the operators taking the samples (which should be discussed and accepted by regulators). Gas Chromatography Mass Spectrometry (GC-MS) combines two powerful techniques to provide the identification of compounds with low detection limits and the potential for quantitative analysis. GC-MS analyses can work on liquid, gaseous and solid samples, but is primarily restricted to volatile and semi-volatile compounds. In Gas Chromatography (GC), a sample is volatilized and carried by an inert gas through a coated glass capillary column. The “stationary phase” is bonded to the interior of the column. The time it takes a specific compound to pass through the column to a detector is called its “retention time”, which can be used for identification when compared to a reference. In the usual Mass Spectrometry (MS) step of GC-MS, compounds leaving the GC column are fragmented by electron impact. The charged fragments are detected, and the subsequent spectrum obtained can be used to identify the molecule. Fragmentation patterns are reproducible, and can be used to produce quantitative measurements. Gas Chromatography Mass Spectrometry analysis can be performed on liquids, gases or solids. For liquids and gases the sample is commonly directly injected into the GC. For solids, the analysis is carried out by solvent extraction, outgassing (desorption) or pyrolysis. Desorption experiments are performed under helium flow at a controlled temperature between 40-300 ºC, with analytes being collected on a cryogenic trap during desorption. The sample chamber is a 1.25”x4” cylinder. GC-MS is a great technique for analysis of trace level impurities such as residual monomers because of its excellent sensitivity and specificity. Gas Chromatography Mass Spectrometry (GC-MS) combines two powerful techniques to provide the identification of compounds with low detection limits and the potential for quantitative analysis. Mass spectrometry expertise and techniques include Mass Spectrometry (MS), High Resolution Mass Spectrometry (HR/MS), Gas Chromatography Mass Spectrometry (GC/MS), Inductively Coupled Plasma Mass Spectrometry (ICP/MS, GC/ICP/MS), Liquid Chromatography Mass Spectrometry (LC/MS), Tandem Mass Spectrometry (MS/MS), HRMS with EI, CI, DEI and DCI, Field Desorption Mass Spectrometry (DCI/MS), Liquid Secondary Ion Mass Spectrometry (LSI/MS), Secondary Ion Mass Spectrometry (TOF-SIMS), MALDI, MALDI-TOF Spectrometry, Thermal desorption (TD) GC-MS, Headspace GC-MS, Pyrolysis GC-MS, Gel-permeation chromatography (GPC-MS) and Accelerator Mass Spectrometry (AMS).

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Bachem AG

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Cayman Chemical Company Inc

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ChemCon GmbH

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GVK Biosciences

Grace

KriSan Biotech

Megsan Labs Private Limited

Nanjing Dorra Pharmaceutical Technology Co.,Ltd

Neuland Laboratories Inc

PCI Synthesis

PROCOS S.p.A.

Pfanstiehl, Inc

QUINTA-ANALYTICA s.r.o

Temad Co

ZACH SYSTEM SPA

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Virtual BoothQuinta-Analytica, a leading Central European one-stop-shop CRO located in Czech Republic. Providing end-to-end solution to its partners

ICP/MS - Agilent 7800

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Quinta is an established provider of multiple R&D and regulatory services for pharmaceutical, biotechnology and generic drug industries. Quinta holds GMP, GLP and GCP certificates.

Virtual BoothSpecializes in development of innovative, efficient manufacturing processes & reliable production of peptide-based APIs

Mass Spectrometry & GC / MS

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Bachem offers spectroscopic methods such as Electrospray Mass Spectrometry (ESI-MS Iontrap & TOF), Matrix Assisted Laser Desorption/Ionization Mass Spectrometry (MALDI-TOF-MS), Infrared Spectroscopy (IR), UV/VIS Spectroscopy, NMR Spectroscopy etc

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Mass spectrometry and GC / MS

Virtual BoothWe think of World Class Quality.

Mass Spectrometry

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Temad utilizes Analytical Chemistry experts & various analytical equipment including HPLC, GC, FTIR, XRD, NMR, Mass Spectrometry for Method development, separation of active ingredients & impurities to conduct precise analyses according to BP, EP, USP.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Mass spectrometry and GC / MS

Virtual BoothEurope's most reliable and versatile source for Prostaglandin APIs// FDA Inspected 2017

Mass Spectrometry: GC-MS, High Resolution Acc...

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Our scientists perform routine quality control testing on thousands of our catalog products each year, giving them unparalleled expertise in developing and validating methods to analyze, quantify, and purify small molecules.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Mass spectrometry and GC / MS

Virtual BoothCommitted to providing Highly Customized Solutions for all your Development Programs.

GC-HRMS, GC-MS

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Zach has over 30 years of experience in multi-step syntheses involving complex reactions.We have dedicated R&D and analytical development teams on each site, and state-of-the art analytical equipment.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Mass spectrometry and GC / MS

Virtual BoothQuinta-Analytica, a leading Central European one-stop-shop CRO located in Czech Republic. Providing end-to-end solution to its partners

GC / FID, GC / MS (quadrupole)

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GC/FID, GC/MS (quadrupole) with liquid injection, static and dynamic headspace injection, PTV injection, on column injection; El, Cl ionization - Agilent, /CTC CombiPal.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Mass spectrometry and GC / MS

Virtual BoothQuinta-Analytica, a leading Central European one-stop-shop CRO located in Czech Republic. Providing end-to-end solution to its partners

(U)HPLC/MSn , Flow Injection MS

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(U)HPLC/MSn , flow injection MS; Ionization methods: ESI(HESI), APCI, APPImass analyzers: linear ion trap, QQQ, Orbitrap - Thermo

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Mass spectrometry and GC / MS

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Analytical Development (GC-MS)

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Procos S.p.A. is specialized in the development, scale-up and production of Active Pharmaceutical Ingredients (APIs), advanced intermediates and related services for the pharmaceutical industry. Our core business sectors include custom synthesis and Generic API manufacturing.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Mass spectrometry and GC / MS

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GC-MS Techniques of Product Analysis

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We also offer a number of basic low cost analytical data only service without any data interpretation assistance for techniques such as GC-MS using in-house instruments.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Mass spectrometry and GC / MS

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Mass Spectrometry Analysis

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CLEARSYNTH team has extensive experience in developing, optimizing and validating methods. Our reliable analytical methods and techniques ensure that the quality of the products that we have produced is of the highest standards.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Mass spectrometry and GC / MS

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Mass Spectroscopy

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Through a cooperative agreement with local universities such as Clark University in Worcester, MA, PCI also provides advanced non-GMP testing techniques including: Mass Spectroscopy.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Mass spectrometry and GC / MS

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TRACE DSQ GC/MS

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Equipped with the advanced instruments HPLC, GC-HS, Particle size analyzer, UV, IR, Digital polarimeter, Multinuclear NMR (400MHz), we are expert in various techniques, for instance, Chiral chemistry (Classical racemate resolution, Resolution by entrainment), Second-order asymmetric transformation..

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Mass spectrometry and GC / MS

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GC-MS (Perkin Elmer)

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Neuland has a separate, specially equipped R&D Centre located at Bonthapally. Custom Synthesis is another area where Neuland has been concentrating and is taking up several projects. We work in close association with clients, under strict confidentiality, to bring products early to markets.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Mass spectrometry and GC / MS

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Agilent 6890 GC-MS

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KriSan Biotech has dedicated analytical team that provides full analytical services for process development, GLP studies and CGMP manufacturing.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Mass spectrometry and GC / MS

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GC-MS-FID / FPD

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Megsan Labs is an USFDA inspected leading analytical testing laboratory, we focused and committed to deliver testing services to our costumers with excellence in quality, compliance and promptness

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Mass spectrometry and GC / MS

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GC-HS-MS/MS

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Megsan Labs is an USFDA inspected leading analytical testing laboratory, we focused and committed to deliver testing services to our costumers with excellence in quality, compliance and promptness

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Mass spectrometry and GC / MS

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GC / GC-MS / GC-HS

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Grace Albany Fine Chemicals' site is designed to meet customers' highest quality, regulatory, and confidentiality expectations for the manufacture of fine chemicals and intermediates.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Mass spectrometry and GC / MS

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Shimadzu GCMS QP-2010

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Analytical Services Laboratory is equipped with modern analytical testing instrumentation

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Mass spectrometry and GC / MS

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Chemcon's analytic machines are regularly calibrated and qulified. Our analytical suite is state-of-the-art and is being extended continuously.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Mass spectrometry and GC / MS

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ICP-MS Elemental Analysis

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In accordance with the updated ICH Q3D Guideline for Elemental Impurities, Dalton now offers ICP-MS testing services.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Mass spectrometry and GC / MS

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Head Space – GCMS & HS-GCMS

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GVK BIO offers a broad range of analytical services for complex research needs. We perform method development, validate and transfer Good Manufacturing Practice (cGMP) compliant methods for a broad spectrum of pharma compounds.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Mass spectrometry and GC / MS

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Residual Solvents - GC-MS Head Space

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Testing should be performed for residual solvents when production or purification processes are known to result in the presence of such solvents. Drug products should contain no higher levels of residual solvents than can be supported by safety data.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Mass spectrometry and GC / MS

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Cebiphar undertakes analytical testing with various techniques, among which GC-MS (Head-Space).

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Mass spectrometry and GC / MS

Analytical testing is a critical part in every step of drug development and manufacturing. The qualitative and quantitative results generated from validated analytical testing provide first-hand information to control and ensure the quality and safety of raw materials, intermediates, and finished products. Like many other CMC (chemical, manufacturing and control) activities, analytical testing is also frequently outsourced. Many factors are attributed to this rapid market growth, including continuous outsourcing from pharmaceutical companies, growing pipelines for biological candidates, and increasing demand for more analytical details on drugs and process development by regulatory agencies. In response to the changing market dynamics, service providers are striving to provide analytical testing with quality, accuracy, and robustness all within tight timelines. As the contract research organizations (CROs) have become more integrated, small analytical labs need to establish their niche to succeed. Global contract analytical Laboratories provide QC laboratory analysis, method development, validation and expert advice for both finished products and raw materials for pharmaceutical and biopharmaceutical companies. Quality Compliance testing is done a wide variety of raw material and finished product forms including High Potent Active Pharmaceutical Ingredients (APIs), Raw Materials and Excipients, Powders - Capsules/Semi-solids, Oils - Oral Solutions and Syrups, Liquids, Vitamins, Minerals, and Nutritional, Natural Health Products (NHPs) – Powders, Herbals – Suspensions, Finished Pharmaceutical Products (Tablets, Capsules/Semi-solids, Oral Solutions and Syrups, Gels, Creams and Ointments, Powders, Suspensions, Transdermals etc. Blend uniformity is a function of both the formulation and mixing action. Once the formulation is optimized from a theoretical process standpoint, blend uniformity must be validated during piloting and scale-up. From a manufacturer’s perspective; poor uniformity generates unacceptable amounts of discarded products, resulting in significant loss of revenue. However, no method currently exists that detects uniformity during the blending process, and as a result the true optimum endpoint is realized rarely. CGMP (21 CFR.211.110) for testing homogeneity and uniformity requires an in-process testing of powder blends to demonstrate adequacy of mixing, but it does not state that the blend has to be directly assessed for uniformity. It was on this premise that the original draft stratified sampling guidance document allowed the use of in-process dosage unit data as a surrogate to demonstrate dosage unit uniformity during routine manufacture. Blend uniformity should be assessed during process design (Stage 1 Validation) and process qualification (Stage 2 Validation). Defaulting directly to the testing of in-process dosage units is discouraged, the exception being when blend sampling presents severe risks to the operators taking the samples (which should be discussed and accepted by regulators). Gas Chromatography Mass Spectrometry (GC-MS) combines two powerful techniques to provide the identification of compounds with low detection limits and the potential for quantitative analysis. GC-MS analyses can work on liquid, gaseous and solid samples, but is primarily restricted to volatile and semi-volatile compounds. In Gas Chromatography (GC), a sample is volatilized and carried by an inert gas through a coated glass capillary column. The “stationary phase” is bonded to the interior of the column. The time it takes a specific compound to pass through the column to a detector is called its “retention time”, which can be used for identification when compared to a reference. In the usual Mass Spectrometry (MS) step of GC-MS, compounds leaving the GC column are fragmented by electron impact. The charged fragments are detected, and the subsequent spectrum obtained can be used to identify the molecule. Fragmentation patterns are reproducible, and can be used to produce quantitative measurements. Gas Chromatography Mass Spectrometry analysis can be performed on liquids, gases or solids. For liquids and gases the sample is commonly directly injected into the GC. For solids, the analysis is carried out by solvent extraction, outgassing (desorption) or pyrolysis. Desorption experiments are performed under helium flow at a controlled temperature between 40-300 ºC, with analytes being collected on a cryogenic trap during desorption. The sample chamber is a 1.25”x4” cylinder. GC-MS is a great technique for analysis of trace level impurities such as residual monomers because of its excellent sensitivity and specificity. Gas Chromatography Mass Spectrometry (GC-MS) combines two powerful techniques to provide the identification of compounds with low detection limits and the potential for quantitative analysis. Mass spectrometry expertise and techniques include Mass Spectrometry (MS), High Resolution Mass Spectrometry (HR/MS), Gas Chromatography Mass Spectrometry (GC/MS), Inductively Coupled Plasma Mass Spectrometry (ICP/MS, GC/ICP/MS), Liquid Chromatography Mass Spectrometry (LC/MS), Tandem Mass Spectrometry (MS/MS), HRMS with EI, CI, DEI and DCI, Field Desorption Mass Spectrometry (DCI/MS), Liquid Secondary Ion Mass Spectrometry (LSI/MS), Secondary Ion Mass Spectrometry (TOF-SIMS), MALDI, MALDI-TOF Spectrometry, Thermal desorption (TD) GC-MS, Headspace GC-MS, Pyrolysis GC-MS, Gel-permeation chromatography (GPC-MS) and Accelerator Mass Spectrometry (AMS).

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