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Analysis of Pharmaceutical Raw Materials

Salamon & Seaber has many years of experience and knowledge in the analysis of pharmaceutical raw materials.

Analysis of these materials is carried out according to the requirements of specific monographs related to the product.

Pharmaceutical materials are derived from a variety of sources such as Animal Extracts, Herbal Raw Materials, and Pharmaceutical Additives.

The monographs are cited in international pharmacopoeias such as BP, BPC, Ph. Eur, JP, FCC VII, JECFA, USP / NF, in which the methods of analysis are detailed.

Depending on customer requirements, full or partial monograph testing may be carried out.

Specific monograph requirements related to a product may include chemical and physical testing.

Chemical Testing:

Most commonly requested tests are:

  • Assay (Purity)
  • Soluble substances
  • Identity tests
  • Impurities and Related substances
Physical Testing:

Most commonly requested tests are:

  • Bulk Density
  • Specific Gravity (SG)
  • Refractive Index (RI)
  • Optical Rotation (OR)
  • Viscosity
  • Weight per ml (Absolute Density)
raw materials

Some of the animal extracts analysed include :-

  • Beeswax
  • Royal Jelly
  • Shellac

Some of the types of Herbal Raw Materials analysed include :-

  • Fruit Extracts, such as Fruit Oils (Orange, etc).
  • Root Extracts, such as Garlic powder, Ipecac, Ginseng, etc.
  • Seed Extracts, such as Caraway Oil, Cardamom Oil, etc.
  • Stem Extracts, such as Ginger etc.
  • Natural Essential Oils, such as Bitter Orange Oil, Eucalyptus Oil, etc.

Some of the types of Pharmaceutical Additives analysed include :-

  • Acidulents, such as Ascorbic Acid, Citric Acid.
  • Antiadherents, such as Magnesium Stearate, Talc, Starch.
  • Anti-Caking Agents, such as Silicon Dioxide (Silica), Bentonite, Cellulose.
  • Antimicrobials, such as Sodium Methyl Hydroxybenzoate.
  • Antioxidants, such as Ascorbic Acid.
  • Binders, such as Sucrose, Starches, Xylitol, etc.
  • Decongestants, such as Menthol Crystals, etc
  • Disintegrants, such as Starch, Low-Substituted Hydroxypropyl Cellulose (L-HPC), etc.
  • Fillers & Diluent, such as Light Magnesium Carbonate, Calcium Carbonate.
  • Lubricants, such as Magnesium Stearate, Glycerol, White Soft Paraffin, etc.
  • Sweeteners, such as Aspartame, Glucose and Invert syrups.
Miscellaneous pills & tablets Amaranth (Azorubin S)

Salamon & Seaber Ltd.
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London. E1 4NQ
United Kingdom
is a registered company in England & Wales, number 1475631

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