Merck for the pharmaceutical industry

In this page, you will find Analytical Application Notes for Pharma industry to help you find the right tool in a wide range of techniques.

These Merck application notes contain all the relevant technical information you need to perform and succeed in your method. 
All these application notes can be easily downloaded as a pdf file.

R&D

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The Fused-Core® technology behind our Ascentis® Express columns delivers maximum speed and efficiency on both UHPLC and HPLC systems. Fused-Core® particles provide a much shorter diffusion path compared to totally porous particles, minimizing peak broadening. This result in very high efficiencies, which are typically 40% higher in comparison to fully porous particles of the same size. Ascentis® Express column are available with 2, 2.7 and 5μm particles and with a very broad range of column chemistries.

Ascentis® Express columns

BIOshell™ UHPLC and HPLC columns deliver maximum speed and efficiency for the separation of biomolecules on both UHPLC and HPLC systems. The Fused-CoreR superficially porous silica particles (SPP) with pore sizes from 90 A up to 1000 A allows superior separation of glycans as well as very large proteins. In particular, a pore size of 1000 A shows very clear advantages over common 300 A pores for the separation of very large proteins in biotherapeutic drug development such as monoclonal antibodies (mAbs) or proteins with molecular weights greater than 100 kDa.

BIOshell™ columns

Analytical methods for pharmaceutical samples have to follow strong regulations. PurospherR STAR RP-18 endcapped columns are perfectly suitable for this demand and are the best choice for L1 columns listed in the USP (United States Pharmacopeia).

Purospher® STAR columns

Merck knows that only the most accurate analytical products will do. That’s why we offer the Supelco portfolio of analytical GC columns, providing you the accuracy, precision and consistency you need.

Supelco® GC columns

The new Chromolith® WP300 columns are designed specifically for bio applications. Wide pore (WP) 300A monolithic silica columns are made of a single continuous bed- rod of high purity porous silica that is then bonded with C18, C8 and C4. Protein benefits of preparative columns:

  • High biorecovery and special selectivities for biomolecules
  • High speed separation possible
  • Substantially longer column lifetime
  • High resistance to column blockage
  • Cost savings from higher sample throughput and column durability

See Chromolith® WP300 products

Quality control

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Merck´s Secondary Pharmaceutical Standards are certified under double accreditation to ISO/IEC 17025 and ISO Guide 34 and are multi-traceable to reference standards from various Pharmacopeial organizations such as USP, PhEUR, and BP.

Pharmaceutical Secondary Standards

For your highly sensitive UHPLC-MS analyses, how can you reduce noise and additional signals to a minimum? Merck’s new high-end UHPLC-MS solvents raise the standard for low baseline noise and clean mass spectra. The new range of advanced UHPLC-MS LiChrosolv® solvents have been developed to exceed all expectations, providing rapid and reliable results in both ESI/APCI positive and negative ionization modes.

LiChrosolv® UHPLC-MS solvents

To help you obtain the highest quality analysis, Merck offers a wide range of high purity mobile phase additives for LC-MS applications. The LC-MS portfolio includes the most commonly used acids, bases and volatile salts of high purity tested for LC-MS applications.

LiChropur® additives and reagents

As the only manufacturer of analytical standards and Certified Reference Materials (CRMs) with a global presence, Merck provides the scientific community with a comprehensive portfolio and trusted brands. High quality Reference Materials are available only from organizations with a robust quality system. Double Accreditation to ISO/IEC 17025 and ISO Guide 342 represents the pinnacle of quality system achievement and allows the credible production and testing of CRMs.

Certipur® ICP standards

TraceCERT® ICHQ3D element standards

With certified pH values at both 20 °C and 25 °C, Certipur® pH buffer solutions from Supelco® analytical products meet your calibration needs. Compliance, always ensured.

Certipur® buffer solutions

EMSURE® acids, salts and solvents offer you:

  • Accuracy and reliability – every time
  • Convenience and safety
  • Regulatory compliance (ISO 6353, ACS, Reag. Ph. Eur.)

They are tested for up to 70 parameters in Merck’s stringent quality control lab in Darmstadt, Germany.
Discover, for example, product specifications of acetic acid, Reag. Ph. Eur. analytical reagent

1.00063.1000.

 

The specifications include over 50 parameters, far more than the amount of parameters
required for Ph. Eur.



See EMSURE® products

Environment
 

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See Spectroquant® spectrophotometers

Production
 

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Merck Prepsolv® solvents are tailored to facilitate scale-up from analytical to preparative separations and are manufactured taking into account the special requirements of preparative chromatography. They are characterized by an extremely low evaporation residue (< 1 mg/l) and low water content. The solvent quality ensures optimal product yield and column protection. The extensive range of withdrawal systems ensures the solvents can always be safely and easily used without any risk of contamination.

Prepsolv® solvents

General

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Merck Application Notes for Pharmaceuticals companies

Chromatography

Impact of mobile phase additives on LC-MS sensitivity Demonstrated using spice cannabinoids

Comparison of Supel™ BioSPME 96-Pin Device to Rapid Equilibrium Dialysis Technique for Determination of Plasma Protein Binding

HPLC Analysis of Dehydroascorbic Acid and Ascorbic Acid (Vitamin_C) on SeQuant ZIC HILIC

HPLC Analysis of Pain Relievers on Ascentis Express

HPLC Tips and Tricks-Mobile Phase Preparation

HPTLC Application for Passiflora incarnata

Identification, Assay and Organic Impuritiy Profiling Methods for Aripiprazole following the USP Monograph

LC MS Analysis of Sorbitol and Mannitol on SeQuant ZIC HILIC

Peptide Mapping Analysis Workflow for Adalimumab

Sample Preparation of Serum Prior to Determination of Free Testosterone

TLC Identification Test for Dextromethorphan following European Pharmacopeia Monograph on Silica

UHPLC-MS Analysis of Released N-Glycans from Human IgG on a Supel™ Carbon LC Column

UHPLC-MS Bottom-Up Analysis of Trastuzumab on a BIOshell™A160 Peptide C18 Column

Workflow for the Analysis of Polysorbate 80 in Erbitux® Formulation

CHROM HPLC Analysis of Letrozole and its impurities

Determination of Ephedrine HCl and Pseudoephedrine HCl

Determination of Ruthin in Anti-Aging Skin Cream Formulation Using Chromolit

Fast Analysis of Monoclonal Antibodies Using Silica Monoliths Designed for Bioanalysis

Environment

SQ ultrasensitive determination of silicate in process and boiler water clean.pdf

Karl Fisher

Water in Antibiotics

Water in Lyophilisates

Water in Acetyl salicylic acid

Microbiology

EN 17141 Impact on ISO 14698 Validation MAS-100 Air Samplers

Media Fill Testing Cold Filterability Study.

Active air sampling with Tryptic soy agar

Air outlet particle filter for viable air sampler MAS-100 NT

Measure autoclave sterilization effectiveness