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Analytical services

Vitex Analytical Services

Vitex Analytical Services (VAS) boasts a brand new, state-of-the-art chemical and microbiological laboratory. The high-quality laboratory division, driven by an exceptional team of scientists offers a broad range of knowledge and expertise for your regulatory submissions and quality compliance. Underscored by the breadth of experience of manufacturing thousands of products, you’ll feel assured of the quality and integrity of your product and the scientific data of which it is founded.

We work at every stage of the product lifecycle allowing speed and efficiency of being in-house. The fully equipped GMP laboratories provide comprehensive analysis of:

Raw materials and active ingredients

  • Vitamins, Minerals, Herbals, excipients
  • Active Pharmaceutical Ingredients

Intermediates

Finished products and release for sale (complementary medicines, pharmaceutical products, household products, veterinary products and personal care/cosmetics)

  • Tablets
  • Capsules
  • Powders & granules
  • Syrups, creams, ointments & gels
  • Oral and topical liquid

Water

Environment

Stability evacuation

Ad hoc and special projects as required

Method development

We cover a diverse range of international compendial and standard methods for chemical analysis including but not limited to the British, European, Japanese, United States Pharmacopeia, International Conference on Harmonisation (ICH), International Organization for Standardization (ISO) and Food Chemicals Codex (FCC). We can also accommodate customer supplied methods.

Our strong method development capabilities have yielded the successful development and validation of many new methods across various analytical techniques. Specialising in method development for UPLC, HPLC, GC and ICP analysis. We can support the entire process from protocol preparation, analytical testing to the final report.

Laboratory testing

Quality and integrity of data is paramount at Vitex and is governed by our Quality Assurance procedures. Protocols are strictly adhered to and established investigation procedures require the evaluation of results using sound scientific reasoning including but not limited to the following areas:

Physical testing

  • Hardness
  • Disintegration
  • Dimensions
  • Viscosity
  • Melting Point
  • Friability
  • Uniformity of Weight
  • Specific Gravity
  • Loss on drying
  • Loss on Ignition

Chemical techniques and equipment

  • High/Ultra Performance Liquid Chromatography (HPLC/UPLC)
  • Gas Chromatography (GC)
  • High Performance Thin Layer Chromatography (HPTLC)
  • Inductively Coupled Plasma (ICP)
  • Dissolution Testing
  • Fourier Transform Infra-Red
  • Karl Fischer Titrator
  • Auto-titrator
  • Total Organic Carbon Analyser
  • Ultraviolet- Visible (UV/VIS) spectrophotometer
  • Refractive Index

Microbiological quality testing

  • Microbial Limit Testing
  • Total Viable Count (TVC)
  • Total Yeast, Mould & Fungi Count
  • Microbial Identification
  • Staphylococcus aureus
  • Pseudomonas
  • Escherichia coli and Coliforms
  • Salmonella
  • Candida albicans
  • Bile Tolerant Gram Negative Bacteria
  • Clostridia

Stability

The general principles around stability testing is to provide evidence on how the quality of a material or product varies with time under the influence of a variety of environmental factors, such as temperature, humidity, and light. It also provides supportive data to establish the shelf life and recommended storage conditions for the product or retest period for a material. Stability information is vital for initial product registration and/or Product Quality Review (PQR).

Protocol development

The study approach varies depending on the product and at Vitex we offer a comprehensive stability trial design providing scope and rationale while taking into consideration the composition of a product (for example, the closure system, the technical difficulties that may be associated with stability testing of a complex multi-ingredient complementary medicine), as well as selecting the appropriate climatic zones for the end market:

  • Zone I: Temperate climate
  • Zone II: Subtropical and Mediterranean climate
  • Zone III: Hot and dry climate
  • Zone IVa: Hot and humid climate
  • Zone IVb: Hot and very humid climate

Stability storage conditions available

The stability chambers at Vitex are secure and fully validated to meet GMP regulations and can be utilised for both long term and short-term shelf life studies. All are monitored in real time with audible and visual alarms for temperature and humidity (above and below set conditions) with emergency back-up utilities on site, guaranteeing that the conditions are maintained at all times.

  • 25ºC/60%RH:
    Long term conditions for cold stored products or retained/control samples
  • 30ºC/65%RH:
    Long term conditions for climatic zones I and II
  • 30ºC/75%RH:
    Intermediate and long term conditions for climatic zones I, II,III and IVa
  • 40ºC/75%RH:
    Long term conditions for climatic zone IVb and Accelerated conditions for climatic zones I, II, III and IV

Analysis

Vitex Analytical Services provide a full suite of analytical tests to generate data which allows a definitive conclusion regarding the stability of a product. The strong method development capabilities have yielded the successful development and validation of stability indicating methods across various analytical techniques.

Reporting and trend analysis

Reporting of stability data is performed in a timely manner and any out of specification results are acted on immediately. Reports are issued providing a summary of the study detailing any trends along with recommendations for product reformulation.