In response to the mandatory regulations in the various sectors, we offer our customers a wide variety of grades.
Products for the pharmaceutical, biopharmaceutical, veterinary, nutraceutical and cosmetics industries.
We offer our mineral salts according to different pharmacopoeias:
- PhEur- European Pharmacopeia
- USP- United States Pharmacopeia
- NF- National Formulary (US)
- BP- British Pharmacopeia
- JP- Japanese Pharmacopeia
- Chinese Standard Pharmacopeia
- DAB- Deutsches Arzneibuch (German Pharmacopeia)
Our products involved in food grade comply with standards:
- FCC - US Food Chemicals Codex
- EU 231/2012 - European Regulation for food additives
- EU 3/2011 - European regulation on colours for use in foodstuffs
- CNFSS - Chinese National Food Safety Standard
This grade will involve grades required mainly for Quality Control Labs for laboratory reagents.
- Ultra-pure grades: special grades, above ACS and ISO grades, for reagents with extremely low trace element content required by demanding sectors like electronics or aeronautics.
- Analytical grade: grade addressed to the Quality Control Labs, generally according to ACS, but with the option to add specific parameters.
- Volumetric grade: Special titration solutions with guaranteed Titer.
- Pure grade: a grade used in non-critical applications (in production and in quality control). It does not follow any directive but we guarantee a certain degree of purity.
Chlorate residue in milk products is an emerging food safety concern for the dairy industry with potential health implications for vulnerable groups, such as those with low iodine intake and infants. It is of particular concern in infant formula manufacturers.
The European Food Safety Agency (EFSA) advises on the risk for public health related to the presence of chlorates and perchlorates in food. These impurities are controlled in our special Baby Food Grade.
We can supply some of our products with very low endotoxin content.
Products to be used as APIs or excipients in parenteral and injection solutions sometimes need to have very low endotoxin content. For manufacturing our special products for parenteral solutions we use purified water with endotoxin content lower than 0.25 EU/ml and a limit of total aerobic count (TAMC) lower than 100 cfu/ml (according to CPMP/QWP/158/01 EMEA/CVMP/115/01). Suitable procedures and equipment are used in order to prevent microbiological contamination.
Customers also ask for products low in endotoxins for non-parenteral use.
These low in endotoxins salts can be manufactured under GMP guidelines in our factory in Venta de Baños or in our factory in Esparreguera which is ISO compliant.
