Pharmacopeial Monographs

Pharmacopeias are authoritative treatises on drugs and preparations presenting information on their description, formulation, analytic composition, physical constants, main chemical properties used in identification, standards for strength, purity, and dosage, chemical tests for determining identity and purity, etc.

The four major pharmacopeia in we follow in our lab are:

• The International Pharmacopeia (IP) – “official” and primarily used in the developing nations
• The British Pharmacopeia (BP) – “official” and primarily used in the 54 member countries of the British Commonwealth
• The United States Pharmacopeia (USP) – “official” and primarily used in North America and in 27 other countries
• The European Pharmacopeia (Ph. Eur.) – “official” and primarily used in the 26 countries which are member states of the Council of Europe

NSL offers testing from the four major pharmacopeias listed above, BP, USP and Ph.Eur. We also offer testing from the Japanese Pharmacopeia for testing specific to the Japanese marketplace.

• Our highly skilled method development scientists have acquired years of experience, working across many types of products, methods and analytical technologies to ensure that the method will be 'fit for purpose'.

• Our expertise spans a variety of molecules and formulations that include small molecules, biologics, nanoparticles, solids, patches, gels, ointments, liquids and inhaled products.

• NSL’s laboratories are equipped with sophisticated analytical technologies including chromatography, mass spectrometry, elemental analysis and spectroscopy.

• Our teams are experienced with sample preparation techniques which may include procedures for trace levels of analysis and approaches suitable to the physical and chemical properties of the matrix and the dosage form.

• Our method development and validation teams are located in the India and Europe, where our facilities utilize a wide range of analytical technology to meet your specific analytical needs.

• With NSL as your outsourcing partner, you can concentrate on your core activities whilst our strategic approach to method development and validation brings time and cost savings.

• Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory standards.

• Using a wide range of chemical analysis techniques, we provide quality control (QC) testing of raw materials, APIs, finished products, packaging materials and medical devices as outlined in marketing authorizations and pharmacopoeias.

• Our experts perform GMP batch release testing to ensure your products are the highest quality of pharmaceuticals / biopharmaceuticals before sale, supply or export and to help make sure they are regulatory compliant.

• Our state-of-the-art analytical facilities support testing to ensure products meet specifications within the marketing authorization (MA) or Clinical Trial Dossier (CTD).

• Our dedicated service is extended beyond our laboratories with our method transfer and analyst exchange services to make sure QC procedures are smoothly integrated into your production environment.

NSL undertakes harmonised testing as per the ICH guidance for:

• Residue on Ignition/Sulphated Ash
• Extractable Volume Of Parenteral Preparations
• Particulate Contamination: Sub-visible Particles
• Disintegration Test
• Uniformity of Dosage Units
• Dissolution Test
• Tablet Friability
• Polyacrylamide Gel Electrophoresis
• Capillary Electrophoresis
• Analytical Sieving
• Bulk Density and Tapped Density Of Powders

• Inspection Services
• Area Monitoring By Plate Exposures and Air Sampler
• Microbiological Testing Of Water During Different Phases Of Water
• System Validation

The US Pharmacopeia (USP) has finalized the revised methods through USP <232> and USP <233> to determine elemental impurities in pharmaceutical products. This new USP Chapter is officially replacing the long standing USP method Heavy Metals Limit test.

This chapter was revised to address comments received and to further align this chapter with ICH Q3D. USP’s Elemental Impurities Expert Panel approved a recommendation to the General Chapters—Chemical Analysis Expert Committee that this chapter be revised to align with the ICH Q3D Step 4 document to the greatest extent possible. Therefore, this revision includes additional elements and their specific limits in this chapter. Additional changes were made to provide clarity on the topic of risk assessment.

Compliance to these new revisions took effect January 1, 2018. Regardless of the approach used, compliance with the limits specified is required for all drug products unless otherwise specified in an individual monograph or specifically excluded.

Residual solvent identification and quantification in pharmaceutical drug substances, excipients and products

Control of residual solvents in the finished drug product is required by various regulatory agencies worldwide, as they provide no therapeutic benefit and may possibly be harmful.

There are many solvents that may be employed in the manufacture of pharmaceutical materials. ICH guideline Q3C (R5) and USP chapter <467> provide permissible daily exposure (PDE) for some of the commonly used solvents. USP <467> and Ph. Eur. 5.4 provide analytical methods for the analysis of the commonly used solvents. If a solvent other than those listed in the ICH Q3C (R5) or USP <467> is utilized in the manufacture of a pharmaceutical article then the onus falls on the drug product manufacturer to determine the acceptable PDE and establish a suitable analytical procedure for the control of that solvent.

We provide expert determination and identification of residual solvents in pharmaceutical articles, helping customers ensure that residual solvents have been reduced to acceptable levels in drug products, drug substances and excipients. Often it is prudent to ensure residual solvents are controlled for all excipients and the drug substance(s) in order to ensure that the finished product will meet the limits specified in ICH Q3C(R5) or USP <467> or the limit established by the drug product manufacturer for unique solvent(s).